WHAT I WANTED TO SAY ARE THINGS THAT ARE NOT INCLUDED ON THE AGENDA. THE MOST IMPORTANT ONE IS I WANT TO GIVE CREDIT AND MENTION TO DAILYMED TEAM. THESE ARE THE DAILY TECH PEOPLE THAT MADE THIS POSSIBLE. AND THEY ARE NOT TALKING HERE TODAY. WE COULDN'T FIT THEM IN. BUT, THEY REALLY DESERVE TO BE RECOGNIZED AND KNOWN FOR THE WORK THEY DO BECAUSE REALLY, FROM THE BEGINNING, THEY MADE THIS HAPPEN. SO, I WANT TO ACKNOWLEDGE THEM AND POINT OUT THEIR CONTRIBUTION. THE NEXT THING I WANT TO SAY IS ABOUT THE VALUES THAT I'M NOT THINKING ABOUT VISION STATEMENTS OR POSTERS WITH EAGLES ON IT. I MEAN LIKE WHAT WE CARE GO ENOUGH TO PAY ATTENTION TO AND DO AND MY BACKGROUND IS RETAIL. IT REALLY PENETRATED ME AND I WANT TO TALK ABOUT THAT A A LITTLE BIT THAT IS RESPONSIVE CUSTOMER SERVICE. WE REALLY WANT THESE PRODUCTS TO WORK FOR OUR USERS. REALLY. IT'S NOT PRETEND GOVERNMENT THING. WE REALLY WANT THIS TO WORK. FOR THE EPRESCRIBERS AND PEOPLE THAT USE DATA AND CARE ABOUT DATA, WE WANT THIS STUFF TO WORK. AND ONE WAY THAT THAT IS DEMONSTRATED IS IN THE PRESCRIBE NAMES PROJECT THAT TAMMY WILL TALK ABOUT TODAY. THE LARGEST PROJECT WE HAVE EVER DONE IN RxNORM SINCE THE BIRTH OF OUR RxNORM AND SHE'LL DESCRIBE IT CAME FROM THE USER'S NEEDS. THEY NEEDED SOMETHING APPROXIMATE AND WE TRIED TO MAKE IT FOR THEM. ANOTHER WAY THIS SHOWS UP, WHICH IS VERY RECENTLY, THE PEOPLE IN THIS PHOTOGRAPH AND HER TEAM, REALLY HAD TO HUSTEL AND MOVE TO GET THE INDEX FILES FROM THE FDA UP IN TIME FOR THIS JAMBOREE. THE FDA IS TALK ABOUT INDEXING FILES THEY HAVE, LATER ON TODAY, AND THOSE FILES, WE WANTED TO GET THEM UP BY TODAY AND TOOK A LITTLE SWEAT AND ACTION. BUT WE HUSTLED. I ALSO USED TO WORK AT UPS FOR YEARS LOADING TRUCKS, BEFORE I WORKED AT THE STORE AND IT'S INTERESTING HOW MUCH THEY CARE ABOUT GETTING THAT LITTLE PACKAGE DELIVERED. I MEAN, YOU REALLY WILL BE SURPRISED WHETHER IT'S A LITTLE ENVELOPE OR A BIG BOX OF SCREWS, THEY ARE REALLY SERIOUS ABOUT GETTING THAT THING IN THE TRUCK AND GETTING IT OUT THE DOOR. THEY DON'T MESS AROUND. THAT'S HOW WE APPROACH THIS. WE REALLY WANT TO GET THIS STUFF OUT THE DOOR AND IN YOUR HANDS. BUT THE OTHER VALUE THEY WANT TO SAY IS DATA INTEGRITY AND DATA QUALITY. DATA HAS TO BE RIGHT. AND DOWN TO THE DETAILS. AND FOR DAILYMED, THIS MEANS VERY CLEARLY DISTINGUISHING KEEPING CLEAR THE DIFFERENCE BETWEEN WHAT CONTENT HAS COME FROM NLM AND WHAT COMES FROM THE FDA. SO, THE RxNORM IDENTIFIERS, AND THE PUBMED LINKS ON DAILYMED, THAT COMES FROM NLM. NO DOUBT ABOUT THAT. THE HOW AGO APPLIED SECTION ON THE LABEL, THAT COMES FROM FDA FROM THE LABORERS WHO GAVE IT TO THE FDA WHO GAVE IT TO US. IT'S VERY, VERY IMPORTANT WE KEEP THAT DISTINCTION CLEAR. WE ARE NOT EDITING THE FDA LABELS HORRIDITING CONTENT TO IT. IF THE CONTENT IS NOT TO YOUR LIKING, IT'S BECAUSE OF THE LABELERS AND THE FDA NOT BECAUSE OF NLM AND IF THE OTHER CONTENT ISN'T TO YOUR LIKING, IT'S BECAUSE OF US. THERE IS ONE PIECE OF CONTENT ON THE LABELS AND THAT'S THE PHOTOS, THAT MOST OF THE PHOTOS COME FROM THE NLM. WE RECENTLY LEARNED THERE ARE SOME INCONSISTENCIES BETWEEN THE PHOTOS OF THE PILLS AND THE DESCRIPTIONS OF THE PILLS ON THE LABEL. AND THIS IS -- WE TAKE THIS VERY, VERY SERIOUSLY. AND WE ARE GETTING TO THE BOTTOM OF THIS. UNTIL WE GET TO THE BOTTOM OF THIS, WE ADDED A NEW DISCLAIMER. WHEN YOU CLICK THROUGH TO GET TO THE PILL, YOU FIRST HAVE TO READ THIS MESSAGE THAT SAYS, NOT ALL THE PHOTOS MATCH THE DESCRIPTIONS. NOW THAT YOU KNOW THIS, YOU CAN PROCEED. WE ARE WORKING WITH CONTRACTOR THAT DOES THESE PHOTOS IN AN ATTEMPT TO GET TO THE BOTTOM OF THIS AND FIND THE PHOTO THAT IS DO MATCH THE LABELS AND WE DON'T HAVE TO HAVE SUCH ALLOWED DISCLAIMER. AND THE PHOTOS THAT DON'T MATCH THE LABELS WE'LL DEAL WITH THAT. AND IF YOU'RE A LABELER AND YOU HAVE CONCERNS ABOUT THE PHOT SPOKE HOW THEY ARE BEING DISPLAYED, PLEASE CONTACT ME. I'M TRYING TO GET A MEETING WITH THE LAKE IRES AND THE CONTRACTORS THAT ARE DOING THIS SO WE CAN GET THIS RIGHT. BECAUSE I DON'T LIKE THAT WE ARE PERHAPS GIVING THE IMPRESSION WE ARE PUTTING UPDATE THAT THAT DIDN'T COME FROM THE LAKERS. THE FDA/SPL DAILYMED IS MEANT TO BE THE LABEL DATA AND NOT ADDED THINGS WE WANT TO HELP WITH. SO THAT IS THE NEWS FROM DAILYMED AND RxNORM. NOW I'D LIKE TO HAVE A BIZ BIZ COME UP. HE IS OUR FIRST SPEAKER. TOM BIZZARO. >> GOOD MORNING, EVERYONE. THERE IS A LOT OF FAMILIAR FACES OUT THERE AND A FEW NEW FACES. I'LL SPEND A MINUTE TO INTRODUCE MYSELF. MY NAME IS TOM BIZZARO. I'M A PHARMACIST CELEBRATING MY 41st ANNIVERSARY AS A PHARMACIST. OVER THOSE 41 YEARS, I HAVE SEEN PHARMACY CHANGE DRASTICALLY IN THE WAY THAT IT HAS USED ELECTRONIC INFORMATION TO HELP BOTH WITH THE EFFICIENCIES AND THE FINANCIAL NEEDS IN PHARMACY, AS WELL AS THE CLINICAL NEEDS OF THE PHARMACIST TO SERVE THE PATIENT. I THINK FOR ALL OF US IN THIS ROOM, I THINK THE ONE THING THAT IS IN COMMON WITH ALL OF US IS THAT, ULTIMATELY, WHAT WE DO IS GOING TO AFFECT THE CARE OF A PATIENT. SO WE HAVE TO ALWAYS KEEP THAT IN MIND. I HAVE BEEN WITH FIRST DATA BANK FOR ALMOST 20 YEARS NOW. VERY ACTIVE WITH NCPDP. I WAS ON THEIR BOARD AND PAST CHAIR OF THAT ORGANIZATION. AND I ALSO WILL MENTION AND TALK ABOUT THIS A LITTLE BIT LATER, THAT WORK WITH TERRY AND THE HL7SPL WORK GROUP TO COMMON GOALS WE WOULD HAVE AT NCPDP AND HL7. SO WHO IS FIRST DATABANK? JUST TO GIVE YOU INFORMATION AND BACKGROUND. WE HAVE BEEN IN THE BUSINESS OF PROVIDING ELECTRONIC HEALTH INFORMATION FOR 35 YEARS. IF YOU THINK BACK ABOUT HOW LONG COMPUTERS HAVE BEEN AROUND AND THE USE OF THOSE COMPUTERS, IT'S ABOUT THAT LONG. AT LEAST IN HEALTH CARE. AND PHARMACY HAS BEEN COMPUTERIZED FOR MANY YEARS, UNLIKE THE REST OF HEALTH CARE WHICH IS TRYING TO CATCH-UP. SO I THINK WHAT WE HAVE LEARNED IN PHARMACY IS THAT WE HAVE A MEANS TO IMPROVE THE CARE TO THE PATIENT USING ELECTRONIC MEANS. AND WE HAVE DONE THAT. SO WE ARE A SUBSIDIARY OF THE HURST CORPORATION. WE HAVE A PARENT COMPANY THAT PROVIDES WITH US FINANCIAL RESOURCES AND LOOKS AT HEALTH CARE AS AN AREA OF GROWTH FOR THAT CORPORATION. WE PROVIDE DRUG DATABASES NOT END USER SOLUTIONS. SO THEY ARE USED TO PROVIDE DRUG INTERACTION CHECKING. DOSE CHECKING, ALLERGY CHECKING AND A LOT OF OTHER CLINICAL INFORMATION FOR THE PHARMACIST. WE ALSO PROVIDE THE DETAILED INFORMATION ABOUT OUR PRODUCT, ITS NAME, PACKAGING, NDC NUMBERS AND LOTS OF OTHER CODES THAT ARE IMPORTANT TO OUR CUSTOMERS IN THE USE OF THE CONTENT. SO WE TAKE DATA THAT IS GENERALLY PUBLICLY AVAILABLE AND WE PUT IT INTO A USEABLE FORMALT. AND RxNORM IS PART OF THAT NOW. WE HAVE THOUSANDS OF DRUG IMPLEMENTATIONS OUT THERE. IF YOU LOOK AT FDB AND WHAT IS OUR TRADITIONAL MARKET, IT WOULD HAVE BEEN HOSPITAL AND RETAIL PHARMACY. AND THAT HAS CHANGED DRASTICALLY IN THE LAST 10 YEARS. OUR DATA IS NOW USED BY HEALTH CARE PROFESSIONALS, PHYSICIANS, NURSES, USE IN LONG TERM AND HOME HEALTH CARE. SO IT'S BROADER IN ITS USE. SOME OF THE DIFFERENT AREAS WHERE WE HAVE SEEN THE MOST GROWTH IN THE USE OF ELECTRONIC DATA HAS BEEN IN ELECTRONIC PRESCRIBING, PHYSICIAN ORDER WANT RESYSTEMS, ELECTRONIC MEDICATION ADMINISTRATION RECORDS AND MEDICATION RECONCILIATION. WE WILL CONTINUE TO SEE THIS GROWTH OF USE OF ELECTRONIC DATA. AND OUR END USERS ARE ANYONE IN HEALTH CARE THAT HAS THE NEED FOR ACCESS TO INFORMATION ABOUT DRUG PRODUCTS. MY FIRST JOB AT FDB WAS DOING DATA ACQUISITION AND DATA MAINTENANCE. AND I WAS HIRED TO DO THAT ROLE AND I HAVE MOVED FROM THAT ROLE AND THEN MOVED INTO PRODUCT MANAGEMENT AND MOVED INTO SALES. MY CURRENT ROLE NOW IS AS VICE PRESIDENT OF HEALTH POLICY AND INDUSTRY RELATIONS. AND IN THAT ROLE, I FEEL THAT MY BIGGEST RESPONSIBILITY IS TO MAKE SURE THAT WE ARE AWARE OF WHAT IS HAPPENING IN THE WORLD THAT IS GOING TO AFFECT OUR CUSTOMERS AND ULTIMATELY, THE PATIENT. WE ARE TALKING ABOUT DATA ACQUISITION IN A WAY IT USED TO HAPPEN. IT WAS REALLY A DEPENDENCY ON GETTING PAPER INFORMATION FROM MANUFACTURERS AND OTHER SOURCES. SO THE FDA APPROVED PRESCRIBING INFORMATION IS STILL A KEY ASSET FOR FDB AND OUR COM PATRIOT IN PROVIDING INFORMATION. BUT HOPEFULLY, WE CAN MOVE AWAY FROM THAT PAPER AND MORE TO THE ELECTRONIC SOURCES OF THIS INFORMATION. WE USE DRUG FACTS, LABELING, OTC MONOGRAPHS, SECONDARY AND TERTIARY REFERENCES, PRIMARY MEDICAL LITERATURE, AND OUR CLINICAL PHARMACISTS USE REVIEW OVER 300 JOURNALS, TREATMENT GUIDELINES, THE BEERS LIST, AND A LOT OF THIS OF COURSE IS NO LONGER PAPER. THANKFULLY IT'S ELECTRONIC SOURCES OF INFORMATION. SO ANY TIME WE HAVE ACCESS TO ELECTRONIC INFORMATION, IT IMPROVES THE EFFICIENCY. AND THAT IS IMPORTANT BECAUSE THE TIMELINESS OF THE DATA IS SO CRITICAL BOTH TO THE CARE OF THE PATIENT AND TO THE EFFICIENCIES OF RUNNING A BUSINESS THAT IT IS DEPENDENT ON ELECTRONIC HEALTH INFORMATION. SO WHY DO WE USE THE SPL ANNOUNCEMENTS WE WANT TO USE THEM AS A SINGLE POINT OF TRUTH. AND WE ARE ALMOST THERE. WE STILL HAVE SOME ISSUES ABOUT THE TIMELINESS OF THE INFORMATION AND I'LL TALK ABOUT THAT AS IT PERTAINS TO SOMEONE WHO IS RE-ISSUING INFORMATION BASED ON THAT LABELING. BUT WE REALLY DO SEE THE SPL COMING FROM THE NLM AND THE FDA OF COURSE AS A SINGLE POINT OF TRUTH AND THAT IS A HUGE ADVANTAGE. WHY DO WE DO IT? WE DO IT FOR THE BENEFIT OF THE CLINICIANS AND ULTIMATELY THE PATIENT. SO AGAIN, EVERYTHING WE DO AND YOU ALWAYS NEED TO KEEP THIS IN THE BACK OF YOUR MIND, WILL AFFECT THE OUTCOMES FOR A PATIENT. WE WANT TO IMPROVE INTERNAL EFFICIENCIES WHEREVER POSSIBLE AND USING ELECTRONIC DOCUMENTS ALLOWS US TO DO THAT. WE ALSO USE THE SPL TO DO COMPARISONS. JOHN MENTIONED WHEN HE GAVE HIS OPENING REMARKS, THE DISCREPANCIES HE SEES BETWEEN THE IMAGE AND THE ACTUAL DESCRIPTION OF A PRODUCT WITHIN PRODUCT LABELING. THAT'S SOMETHING THAT WE ALSO HAVE TO DEAL WITH. AND WE ARE LOOKING FOR WHATEVER SOURCES WE CAN HAVE TO MAKE SURE THAT THE DATA WE HAVE IS AS ACCURATE AS POSSIBLE. WE HAVE A CONTINUOUS IMPROVEMENT POLICY AND A QUALITY MANAGEMENT GROUP OF ABOUT 20 PEOPLE WHOSE SOLE ROLE IS TO ENSURE THAT THE DATA WE OUTPUT IS APPROPRIATE, ACCURATE AND TIMELY. AND THE MAIN REASON I THINK THAT WE LIKE THE SBV SO WE DON'T HAVE TO READ PRINT THAT SIZE. AND IF YOU EVER BEEN IN A PHARMACY AND HAD TO LOOK UP SOMETHING USING A PACKAGE INSERT, YOU KNOW EXACTLY WHAT I'M TALKING ABOUT. AND IF YOU'RE AN OLDER PHARMACIST OR CLINICIAN, YOU KNOW HOW MUCH HARDER IT IS TO READ THAT PRINT THAN IT USED TO BE. BUT IT IS A HUGE ADVANTAGE. WHEN I STARTED IN DATA ACQUISITION, WE HAD LITERALLY THOUSANDS OF FOLDERS THAT HAD PACKAGE INSERTS, THE PAPER PACKAGE INSERTS IN THEM AS PART OF THE DOCUMENTATION FOR THE PRODUCT, IF YOU CAN IMAGINE THAT. NOW WE HAVEN'T STOPPED COLLECTING THE PACKAGE INSERTS BUT WE ARE MUCH LESS DEPENDENT THAN WE USED TO BE ON THOSE THINGS. SO WHAT DO WE USE NOW? WE USE THE DAILYMED AND EVERYONE IN DATA ACQUISITION AND MAINTENANCE AS WELL AS OUR CLINICIANS HAS ACCESS TO THE STRUCTURE PRODUCT LABELING THROUGH A BROWSER. THAT IS AVAILABLE TO ANYONE WHO WANTS TO USE IT. AND THE LAST TIME I LOOKED AND THIS MAY NOT BE ACCURATE ANY LONGER, THERE WERE OVER 77,000 SPLs OUT THERE ON DALE DAILYMED AND THAT SAY HUGE ACCOMPLISHMENT FOR THE LIBRARY AND THE ASSOCIATION AND THEIR WORK WITH THE FDA. AND I THINK THEY CAN BE VERY PROUD OF THAT ABILITY TO ACCESS THAT TYPE OF INFORMATION. WE ALSO USE COMPUTERS TO HELP US IDENTIFY THINGS LIKE PHYSICAL DESCRIPTION AND WE USE CHARACTERISTIC EXTRACTION AND EDITING. SO OUR TECHNICAL FOLKS ARE VERY ACTIVE IN LOOKING AT THIS LABELING AND HOW THEY CAN USE ELECTRONIC MEANS TO MAKE SENSE OF THOSE DATE AS AND FINE TRIGGERS. WE USE THE XML STRUCTURE EXTENSIVELY. THE TEXT AND THE ELECTRICAL FORMAT IS OF GREAT VALUE BECAUSE NOW WE KNOW WHERE IN AN XML DOCUMENT TO LOOK FOR CERTAIN TYPES OF INFORMATION. AND SINCE WE KNOW WHERE TO LOOK, WE CAN USE THOSE TEXT DESCRIPTIONS AS TRIGGERS FOR CHANGES WITHIN THE DOCUMENTS AND WE DO A NUMBER OF OTHER THINGS BUT THAT IS ONE WAY THAT WE USE THE XML FORMAT. WE ARE VERY HAPPY WITH THAT FORMAT. WE WOULD VERY MUCH LIKE TO SEE MORE CODEIFICATION OF INFORMATION WITHIN THAT XML DOCUMENT. THE SPL NOW IS OUR PRIMARY SOURCE FOR INACTIVE IN GREED ENT INFORMATION. SO INACTIVE INGREDIENTS IS VERY DIFFICULT TO FIND. IT'S ALSO VERY DIFFICULT TO KNOW WHEN THAT CHANGES. WE ARE NOW USING THE SPL AS OUR PRIMARY SOURCE FOR INACTIVE INGREDIENTS. AND THOSE TYPES OF -- OR THAT TYPE OF INFORMATION IS IMPORTANT FOR PATIENT ALLERGIES AND SO IT'S VERY IMPORTANT FOR US TO HAVE A SOURCE OF THAT INFORMATION. AND WE ARE USING SPL FOR THAT. WE ALSO USE THE NSDE FILE. AND THIS IS VERY IMPORTANT FOR ANY CUSTOMER OR USE THEY'RE HAS NEEDS FOR INFORMATION ABOUT MEDICAID DRUG REBATES, OR MEDICARE PART D FORMULARIES. WE ARE THE CURRENT ISSUES WITH THE SBL. IT IS STILL THE TIMELINESS. THIS IS SOMETHING THAT WILL BE DIFFICULT TO DEAL WITH TO HAVE A MORE COMPLETE DEPENDENCY ON JUST SPL AS A SINGLE POINT OF ACCESS FOR THE LABELING INFORMATION. AND THE REASON I SAY THAT IS THAT SOMETHING THAT IS MADE AVAILABLE AT THE POINT OF TIME A PRODUCT IS RELEASED, IS TOO LATE. SO DOWNSTREAM FROM FDB, OUR USERS HAVE NEED OF THAT INFORMATION THE MOMENT THE PRODUCT IS AVAILABLE IN THE MARKETPLACE. AND IF YOU THINK ABOUT HOW THAT INFORMATION IS COMPILED AND OUTPUT, WE NEED TIME TO PUT IT TOGETHER TO BUILD THAT DATABASE. NOW ONCE THAT DATABASE OUTPUT, THE END USER NEEDS TIME TO TAKE THAT INFORMATION AND INSERT IT AND IMPLEMENTED INTO THEIR APPLICATION, THEN IT GOES OUT TO AN END USER. SO OUR DATA IS AVAILABLE ON A WEEKLY, MONTHLY, QUARTERLY, BIANNUALLY AND ANNUAL SCHEDULE. MOST OF OUR CUSTOMERS ARE USING IT ON A WEEKLY OR MONTHLY SCHEDULE. WE ALSO HAVE DALA INFORMATION THAT IS AVAILABLE TO OUR CUSTOMERS. SO WE HAVE A DAILY OUTPUT ALSO. THE DAILY INFORMATION IS NOT AS COMPLETE AS THE WEEKLY CLINICAL INFORMATION BUT IT DOES GIVE BASE INFORMATION ABOUT OUR PRODUCT. SO THE TIMELY THINKS OF THE DATA IS CRITICAL. IT'S CRITICAL BOTH FOR FINANCIAL REASONS AND FOR CLINICAL REASONS. CERTAINLY IF THERE IS INFORMATION THAT IS CHANGED THAT CAN AFFECT THE HEALTH OF A PATIENT, CLINICAL INFORMATION, YOU WANT TO GET THAT OUT TO THE END USER AS AS SOON AS POSSIBLE. AND I THINK THAT THE ISSUE WE HAVE TO DEAL WITH IN GATHERING THE INFORMATION IS, WHERE CAN WE HAVE THE MOST LIKELY SOURCE FOR THE INFORMATION AT THE TIME WE NEED TO BUILD THE PRODUCT? AND AGAIN, WE ARE DEPENDENT ON SPL BUT WE CANNOT USE SPL AS A SOLE SOURCE OF INFORMATION. I ALSO THINK THAT MOST OF MY COLLEAGUES WOULD AGREE THAT CHANGE CONTROL OF THE DATA IS MORE DIFFICULT THAN THE INITIAL DATA ENTRY FOR THAT PARTICULAR INFORMATION. SO, KEEPING UP WITH THE CHANGES IS VERY DIFFICULT. MANUFACTURERS IN CERTAIN CASES, I THINK DON'T UNDERSTAND THE CRITICAL NATURE OF THE LABELING CHANGE THAT IS THEY MAKE. AND I KNOW THAT THE HL7/SPL WORK GROUP WITH WE TALK ABOUT THE CRITICAL NEED FOR MANUFACTURERS TO UPDATE THAT LABELING AS SOON AS SOMETHING CHANGES. THAT THEY HAVE KEEP IN MIND IT IS USED DOWNSTREAM AND CAN AFFECT THE CARE OF A PATIENT. SO WE ARE HOPING TO SEE THAT MANUFACTURERS BECOME MORE COGNIZANT OF THAT FACT AND ARE MORE LIKELY TO UPDATE INFORMATION AS SOON AS THERE IS A CHANGE. NOT JUST TO MEET REGULATORY REQUIREMENTS. SO FOR THE MANUFACTURERS IN THE ROOM, I ASK THAT YOU KEEP THAT IN MIND AND THAT YOU WORK TO KEEP YOUR DATA AS TIMELY AS POSSIBLE. WE USE TEXT FOR COMPARISONS AND TRIGGERS. WE WOULD MUCH RATHER USE CODES. I THINK THIS IS ONE AREA WHERE RxNORM CAN BE OF GREAT VALUE. AND NOT JUST THE RxNORM THAT IDENTIFIED IN THE DISPENSABLE PRODUCT BUT THINGS LIKE INGREDIENTS. SO WE ARE VERY ADAMANT ABOUT OUR DESIRE TO SEE CODES USED WITHIN LABELING. WE WANT TO USE CODES FOR THINGS LIKE INDICATIONS AND CONTRAINDICATIONS ALSO. WE THINK THAT LOIN CODES ALSO HAVE A PLACE IN LABELING. SO IF YOU LOOK TO THE FUTURE, AND WE HAD AN OPPORTUNITY TO HAVE RxNORM CODES, WE HAVE SNOW MED CODES AND LOIN CODES, ATTACHED TO THE APPROPRIATE PARTS OF THE SPL LABELING, YOU CAN SEE THAT WE HAVE AN ABILITY ELECTRONICALLY AND THROUGH THE POWER OF A COMPUTER TO TRIGGER EVENTS MORE QUICKLY THAN WE DO WITH USING THE TEXAS A REFERENCE. WE STILL FIND DIFFERENT VERSIONS OF LABELING AT VARIOUS SITES. SO I MENTIONED THAT WE USE THE DAILYMED AND THE SPL FILES FOR ACCESS TO THE LABELING BUT WE ALSO GO OUT AND LOOK FOR LABELING AT MANUFACTURER SITES. AND I THINK YOU WOULD BE SURPRISED TO SEE HOW OFTEN THE LABELING THAT IS AVAILABLE ON A MANUFACTURER'S WEBSITE DOESN'T MATCH THE LABELING THAT IS AVAILABLE WITHIN THE SPL DOCUMENTS. SO WE WOULD LIKE TO SEE A SINGLE SOURCE OF THAT INFORMATION. THE TIMELY TRIGGERS IS ONE OF THE MOST IMPORTANT THINGS THAT CAN BE ADVANCED WITH THE USE OF THE SPL. I MENTIONED IT NUMEROUS TIMES BECAUSE I THINK IT BEARS REPEATING THAT THOSE TIMELY TRIGGERS HELP US BUILD A PRODUCT AND GET IT OUT TO THE PATIENT INTO THE END USER IN A TIMELY MANNER. CONSISTENT CODEIFICATION CAN HELP US IN CLINICAL DECISION SUPPORT. SO THE BREATH OF CLINICAL DECISION SUPPORT NOW AND THE USERS OF OUR CDS IS VERY BROAD. IT'S GONE FROM THE PHARMACIST TO THE PHYSICIAN TO THE NURSE TO SOMEONE PROVIDING HOME HEALTH CARE THE PATIENT END USERS ARE DOING SOME OF THEIR OWN CLINICAL DECISION SUPPORT. AND WE WANT TO MAKE SURE THAT INFORMATION IS ALWAYS AS UP-TO-DATE AS POSSIBLE. WE ARE LOOKING AT WAYS TO IMPROVE THAT ACCESS. WE KNOW THAT IN THE FUTURE, WE WILL HAVE BIOSIMILAR LABELING AND THAT LABELING IS GOING TO BE AS CRITICAL AT THE SMALL MOLECULE LABELING, MAYBE MORE SO. SO THAT IS AN ACCESS POINT WITHIN THE STRUCTURE PRODUCT LABELING AND ALSO THE INFORMATION ON PHARMACOGENOMICS CAN BE PART OF THE STRUCTURE PRODUCT LABELING IN THE FUTURE AND AGAIN THAT INFORMATION ESTIMATE POINT IN TIME TO BE CODIFIED. I MENTIONED EARLIER THE CODIFICATION OF MEDICAL CONDITIONS, INDICATIONS, DISEASE, CONTRAINDICATIONS. WE WANT TO SUPPORT INTEROPERABILITY IN EXCHANGE OF DATA AND SO AS I TALK ABOUT THE USE OF RxNORM, SNOW MED CT AND THE LINK IN PRODUCT LABELING, YOU ALSO CAN SEE THE VALUE THAT THOSE NATIONAL VOCABULARIES WILL HAVE SO THE FUTURE IS ON THE HORIZON. IT'S NOT OFF IN THE DISTANCE ANY LONGER. WE MADE GREAT STRIDES IN THE LAST 10 YEARS AND I EXPECT TO SEE US MAKE GREAT STRIDES IN THE NEXT 10 YEARS. I KNOW THAT STEWART NELSON WAS ON THE AGENDA AND I DON'T KNOW IF STEWART IS HERE YET BUT -- I THINK WE HAVE BEEN TALKING TO STEWART FOR PROBABLY 10 OR 12 YEARS ABOUT THE USE OF RxNORM AND ITS DEVELOPMENT. SO I THINK THAT YOU SHOULD BE VERY PROUD OF YOURSELF FOR ALL OF YOU THAT ARE EITHER ACCESSING THE INFORMATION, MAKING THE INFORMATION AVAILABLE TO THE LIBRARY OR THE FDA AND TO THOSE THAT HAVE AN OPPORTUNITY TO USE IT IN THE FUTURE. SO IT'S NO LONGER IN ITS INFANCY, IN MY OPINION. WE ARE AND WITH RxNORM IN PARTICULAR, WE ARE IN ITS TEEN YEARS NOW. SO WE NEED TO SEE IT CONTINUE TO MATURE AND BECOME MORE USEABLE. SO, RxNORM IS SIMPLY A COMMON VOCABULARY FOR DRUGS. RIGHT NOW WE ARE ALL TALKING DIFFERENT LANGUAGES WHEN WE TALK ABOUT THINGS LIKE DRUGS. FDB AND MY COLLEAGUES, ALL HAVE PROPRIETARY IDENTIFIERS THAT ARE COMMONLY USED IN THE INDUSTRY. WE ARE ALL TALKING DIFFERENT LANGUAGES. THOSE CODES ONLY MEAN SOMETHING TO SOMEONE WHO IS USING THAT PARTICULAR SET OF PROPRIETARY IDENTIFIERS. IT DOESN'T MEAN ANYTHING TO ANYONE ELSE. NOW IF WE HAD A COMMON SET OF CODES LIKE RxNORM, A NONPROPRIETARY SET OF CODES, A CODE PUBLICLY AVAILABLE AT NO COST, THEN WE SEE THAT WE HAVE AN OPPORTUNITY TO HAVE A SINGLE LANGUAGE FOR DRUG PRODUCTS. AND I THINK THAT RxNORM AND ITS CHANGES, JOHN KILBOURNE AND HIS TEAM GOING BACK TO STEWART AND HIS WILLINGNESS TO WORK WITH FOLKS IN THE INDUSTRY TO IDENTIFY PRACTICAL USES OF THE RxNORM CODES AND TO IMPROVE THOSE RxNORM CODES, IS A REALLY GOOD EXAMPLE OF HOW THAT PUBLIC-PRIVATE CORPORATION CAN BENEFIT THE PATIENT. IT ALSO BENEFITS THE INDUSTRY. BECAUSE HEALTH CARE IS AN INDUSTRY. YOU CAN'T PROVIDE THE BEST HEALTH CARE IF YOU CAN'T KEEP THE LIGHTS ON. SO YOU HAVE TO HAVE WAYS TO BECOME MORE EFFICIENT. YOU HAVE TO HAVE WAYS TO IMPROVE THE PROCESSES THAT YOU'RE USING TO PROVIDE THAT CARE TO THE PATIENT. I THINK RxNORM WAS GOING TO PROVIDE A VALUE NOT JUST CLINICALLY BUT ALSO IN THESE FINANCIAL AREAS. THE FIRST TIME IT CAME TO THE NATIONAL LIBRARY OF MEDICINE, AND I WISH I COULD REMEMBER WHO MADE THIS COMMENT TO ME BUT IT WAS A NUMBER OF YEARS AGO. AND WE WERE TALKING IN AN INTRODUCTORY PHASE FOR THE MEETING AND THE GENTLEMAN STOOD UP AND SAID, WHAT IS THE FIRST THING THAT SOMEONE ASKS YOU WHEN YOU WALK INTO A LIBRARY? AND IF YOU THINK ABOUT THAT, IT IS OFTEN, HOW CAN I HELP YOU? AND THAT IS HOW I VIEW THE NATIONAL LIBRARY OF MEDICINE. I THINK THAT WHAT HAPPENS HERE IS EXACTLY THAT. THEY ARE LOOKING AT HOW CAN I HELP YOU? HOW CAN I HELP YOU, THE USER OF THAT INFORMATION, THAT I'M STORING? NO VALUE IN HAVING HUGE GIGABYTES OF DATA AND STORAGE THAT CAN'T BE USED. THERE IS NO VALUE TO IT. YOU HAVE TO BE ABLE TO USE IT. WHETHER YOU'RE USING IT FOR RESEARCH OR FOR PHARMACY DISPENSING OR e-PRESCRIBING. THERE HAS TO BE A VALUE TO THAT DATA. THE COLLECTION IS NOT THE VALUE. THE COLLECTION IS THE PROCESS THAT YOU NEED TO HAVE TO MAKE IT VALUABLE FOR USE. WITHIN RxNORM, WE HAVE CROSS-REFERENCE TO ALL THE PROPRIETARY IDENTIFIERS I TALKED ABOUT. SO IT'S A ROSETTASTONE FOR PHARMACICENTRIC HEALTH INFORMATION. AND I THINK THAT THAT IS WHERE IT HAS BECOME OF HUGE VALUE BECAUSE IT DOESN'T MAKE ANY DIFFERENCE WHO YOU'RE TALKING TO, YOU'RE ALL TALKING THE SAME LANGUAGE. MY GOAL AT SOME POINT IN TIME IS TO SEE THE COMPENIAD TO CODE DIRECTLY TO RxNORM CODES INSTEAD OF PROPRIETARY IDENTIFIERS. SO IF WE EVER REACH THAT POINT, WE WILL NOT ONLY HAVE A COMMON LANGUAGE, WE WON'T HAVE TO WORRY ABOUT ANY TYPE OF ERRORS THAT COULD HAPPEN IN CROSS-REFERENCING TO THOSE TYPES OF CODES. THAT'S WHAT THE GOAL IS. AND I THINK THE BIGGEST ISSUE WE HAVE WITH THAT RIGHT NOW IS THE TIMELINESS ISSUE AND WHERE OUR NEEDS ARE AND HOW WE CAN IMPROVE THAT. AND I UNDERSTAND THE REASONS FOR THE DELAY IN ACCESS TO THAT INFORMATION FROM THE FDA'S POINT OF VIEW BECAUSE OF THE CONFIDENTIAL NATURE OF THE INFORMATION THEY GATHER BEFORE A PRODUCT IS RELEASED. WE NEED TO FIND A WAY TO TAKE CARE OF THAT. MY TECHNICAL PEOPLE, AS I ASKED THEM ABOUT USING THE FILES THEY DOWNLOAD FROM NLM FOR THE SPL, AND I ASKED THEM ABOUT THAT. THEY SAY THEY ARE ALMOST PERFECT. AND I SAID ALMOST PERFECT? I SAID YOU GUYS NEVER SAY ANYTHING IS ALMOST PERFECT. THEY SAY FOR THE RECENT SET OF DOWNLOADS THEY HAVE, THEY ARE NOT EXPERIENCING ANY PROBLEMS WHATSOEVER. AND SO, AS I TALKED ABOUT THAT PUBLIC-PRIVATE COOPERATION WE HAD, I THINK IN THE EARLY DAYS OF DOWNLOADING THE FILES, WE DID HAVE ISSUES. THOSE ISSUES WERE DISCUSSED AMONG THE FOLKS IN NLM AND THE COMPENDIUM. WE SOLVED MOST OF THOSE YOURS. ALMOST PERFECT FROM ONE OF MY TECHNICAL GUYS S HIGH PRAISE. SO JOHN, TAKE THAT AS HIGH PRAISE. THIS IS JUST A QUICK SCREENSHOT OF SOMETHING I GOT OFF OF THE NLM WEBSITE AND TALKS ABOUT THE DIFFERENT DATABASES THAT ARE OUT THERE. AND THE FOLKS THAT PROVIDE THESE DATABASES, THE ONES THAT ARE IN THE COMMERCIAL MARC UP PLACE ARE FIERCE COMPETITORS. WE ARE FIERCE COMPETITORS. WE ARE ALSO GENERALLY GOOD FRIENDS. AND I THINK WHAT IS HAPPENED HERE IS THAT SOMETHING LIKE RxNORM ASS WE SEE WITH COMMUNICATION STANDARDS, THERE IS A REALIZATION THAT WE NEED TO MAKE SURE THAT THE PATIENT ISN'T HARMED BY OUR COMPETITIVE NATURE. SO I THINK WHAT WE HAVE DONE HERE WITH RxNORM AS A SOURCE OF ACCESS TO INFORMATION FROM THESE DIFFERENT COM PENDIA, HAS REALLY IMPROVED OUR ABILITY TO COMMUNICATE ACROSS DIFFERENT SYSTEMS. AGAIN, I JUST WANTED TO SHARE THAT. THIS SLIDE IS THE ONE SLIDE THAT YOU ALWAYS HAVE TO HAVE ONE SLIDE IN YOUR PRESENTATION THAT IS EITHER NONSENSE KEL OR IMPOSSIBLE TO READ. SO THIS IS MY SLIDE. AND THE REASON I'M SHOWING YOU THIS SLIDE IS THAT AS AN END USER PHARMACIST, OR PHYSICIAN, OR NURSE, I DON'T CARE ABOUT ANY OF THIS. I DON'T CARE ABOUT THIS STRUCTURE. I DON'T CARE HOW IT IS OUTPUT OR INPUT OR PUT INTO A SYSTEM I CAN USE. WHAT I CARE ABOUT IS THAT THE APPLICATION I'M USING CAN MAKE SENSE OF THIS SO THAT I CAN SERVE MY PATIENTS. AND THAT IS WHAT WE HAVE HERE. SO WE ARE USING A STANDARD STRUCTURE HERE THAT IS VERY EASY TO BE READ BY FOLKS AT THE COM PENDIA, NL. SOME CONSISTENT IN THE WAY THEY OUTPUT THE DATA. I MENTIONED ALMOST PERFECT IN THE UPDATES. SO THAT IS I DIDN'T WANTED TO SHOW THIS. SO THE END USER DOESN'T CARE ABOUT THIS BUT THOSE FOLKS WHO HAVE TO MAKE USE OF IT CERTAINLY DO. SO HOW ARE WE GOING TO SEE THE USE OF RxNORM IN THE FUTURE? ONE OF THE THINGS THAT WE HAVE BEEN TALKING ABOUT FOR QUITE A WHILE NOW IS THE USE OF RxNORM AND FORMULARIES. RxNORM, BECAUSE IT DESCRIBES A DISPENSABLE PRODUCT IS VERY USEFUL IN THE CONSTRUCTION OF FORMULARIES. FORMULARIES ARE OFTEN USED IN THE NDC NUMBER. AND THE NDC NUMBER IDENTIFIES A PRODUCT AND ITS CONTENTS BUT ALSO THE PACKAGING AND THE MANUFACTURER AND A LOT OF OTHER INFORMATION THAT GETS DOWN TO THE DETAILS WHAT HAVE SITS ON THE SHELF. THAT NDC-BASED FILE. AND I THINK THAT THE SIZE OF THOSE FORM LAYER CEASE PROHIBITIVE IN THEIR USE. ESPECIALLY AS WE HAVE THEM USED OUTSIDE OF PHARMACY WHERE WE HAVE PHYSICIANS WHO WANT TO ACCESS FORMULARIES AT THE POINT IN TIME WHEN THEY WRITE AN ELECTRONIC PRESCRIPTION. THEY WANT TO HAVE ACCESS TO THAT INFORMATION. AND I THINK THE USE OF RxNORM TO DEVELOP THOSE FORMULARIES WILL DRASTICALLY CUT DOWN ON THE SIZE OF THOSE FORMULARY FILES. SO FOR EXAMPLE, NOW FOR LIE SIN APRIL FOR EXAMPLE, 10 MILLIGRAM TABLET COMES FROM MULTIPLE MANUFACTURERS AND MULTIPLE SIZES. AND IT MAY HAVE 50 OR 60NDC NUMBERS T HAS ONE RxNORM CODE TO IDENTIFY THE 10 MILLIGRAM TABLETS. YOU CAN SEE WHERE THE VALUE OF THAT WOULD BE. AND UNLESS YOU'RE IN A PHARMACY, OR ADMINISTERING A PARTICULAR DRUG, YOU DON'T CARE WHAT THE NDC NUMBER IS. NDC NUMBERS IS SOMETHING THAT A PHARMACIST IS VERY FARM WITH AND USES BUT THE REST OF THE HEALTH CARE DOESN'T CARE. AND MY FAVORITE OR MOST IMPORTANT USE OF RX WILL BE IN e-PRESCRIBING AND IS IN E-PRESCRIBING. SO, RIGHT NOW, IN E-PRESCRIBING, WE SEND NDC NUMBERS TO IDENTIFY A PRODUCT T IS ALSO REPRESENTED TEXT RESULTY AND THERE ISES PROBLEMS WITH THAT. IF WE HAD RxNORM CODES AS A NONPROPRIETARY IDENTIFIER THAT IS SENT FROM A PHYSICIAN AND THE TEXTURAL REPRESENTATION TO THAT TO THAT PHYSICIAN AND BEHIND-THE-SCENES WE HAVE THE CODE, AND THAT CODE IS SENT ALONG WITH THE ELECTRONIC PRESCRIPTION TO A PHARMACY, THAT PHARMACY TAKES THAT CODE IN. DOESN'T HAVE TO TRIBE THE ELECTRONIC PRESCRIPTION INTO A SYSTEM. HE CAN USE THE RxNORM CODE AS A IDENTIFIER FOR THAT PRODUCT AND BE BE ASSURED WHAT HE IS GOING TO DISPENSE MATCHES WHAT THE PHYSICIAN'S INTENT WAS AND WHAT HE PRESCRIBED. SO WE ARE NOT THERE YET. BUT THAT IS WHERE I THINK WE ARE GOING TO HEAD. THE DEVELOPMENT OF THE PRESCRIBABLE NAMES BY NATIONAL LIBRARY OF MEDICINE IS ALREADY PROVIDING GREAT VALUE. AND IN e-PRESCRIBING NOW, WE SEE NAMES THAT DON'T MEAN THE SAME THING TO THE PHYSICIAN AND TO THE PHARMACIST. THEY ARE CONFUSING SOMETIMES. THE NAMES ARE COMING FROM ARE GENERALLY EASY TO UNDERSTAND AND TO VIEW AND YOU KNOW WHAT YOU MEAN WHEN YOU SEE IT, BUT THE PROBLEM IS THOSE NAMES CAN BE ADJUSTED BY THE END USER IN SOME CASES. SOMETIMES THOSE NAMES BECOME NONSENSE KEL OR AT LEAST CAUSE CONFUSION AT THE POINT IN TIME WHEN A PHARMACIST OR PHARMACY TECHNICIAN IS REVIEWING THAT ELECTRONIC PRESCRIPTION. SO HAVING A COMMON PRESCRIBABLE NAME IS OF VALUE A REPRESENTATIVE NDC GIVING INFORMATION ABOUT THE PRODUCT AT THE PACKAGE LEVEL IS NOT OF VALUE WHEN THEY ARE DOING DISPENSING OR TO THE PHYSICIAN WHEN HE IS DOING PRESCRIBING. HE DOESN'T CARE IN MOST CASES WHO THE MANUFACTURER IS. THE PHARMACY DOES BECAUSE THEY HAVE TO FINISH THEY HAVE INVENTORY. BUT THEY CAN USE THEIR RxNORM CODE TO GO TO INVENTORY AT A NDC LEVEL. SO I HOPE TO SEE THAT RxNORM CODE TO REPLACE THE NDC. EVENTUALLY WE WILL HAVE THE ABILITY TO SEND AN ELECTRONIC PRESCRIPTION FROM A PHYSICIAN TO A PHARMACY WHERE WE CAN TRUST THAT THAT KODAK RATTILY REPRESENTS THE DISPENSABLE PRODUCT AND CUT DOWN ON THE MANUAL INTERVENTION THAT TAKES PLACE NOW. I UNDERSTAND THAT THIS IS SOMETHING THAT MAY NEVER HAPPEN WHERE PHARMACISTS MAY ALWAYS FEEL THAT THEY HAVE TO VIEW THAT TEXTURAL DESCRIPTION OF A DRUG PRODUCT, BUT WE WILL IMPROVE OUR EFFICIENCIES AND ACCURACY. SO I'M HOPING THAT THAT IS WHERE WE GET TO. AT THIS POINT IN TIME, RIGHT NOW, WHEN AN RxNORM CODE IS SENT, IT IS USED IN QUALITY MANAGEMENT SYSTEMS IN THE PHARMACY AS A DOUBLE CHECK ON THE ACCURACY OF THE PRESCRIPTION BEING DISSPENDS. SO RIGHT NOW, IT HAS VALUE. THE PROBLEM IS THAT IT'S NOT SENT ENOUGH. IT'S NOT COMMONLY SENT. WE ARE STILL USING REPRESENTATIVE NDCs WHICH ARE PROBLEMATIC. I WANT TO TALK ABOUT THE NCPDP FOUNDATION, THE NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS. STANDARD OF DEVELOPMENT ORGANIZATION. AND A FOUNDATION HAS BEEN AROUND FOR ABOUT TWO YEARS NOW. I HAPPEN TO SIT ON THE FOUNDATION BOARD. AND WE ARE EXAMINING THE POSSIBILITY OF EXPANDED USE OF THE NCPDP SCRIPT STANDARD AND PART OF THIS RESEARCH WOULD LOOK AT THE USE OF RxNORM CODES WITHIN A TRANSMISSION OF ELECTRONIC PRESCRIPTION. THERE ARE OTHER PARTS OF THE SCRIPT STANDARD WE WANT TO EXAMINE ALSO. BUT FOR THIS GROUP IT'S FOR THE USE OF RxNORM CODES N THIS PILOT WE WANT TO REPLACE THEREMENTIVE NDC WITH RxNORM CODES AND SEE IF IT DOES IMPROVE THE ACCURACY AND HOW OFTEN WE HAVE HITS BETWEEN THIS SYSTEM SENDING THE RxNORM CODE AND THE SYSTEM RECEIVING THE RxNORM CODE. SO, TO GET AWAY FROM THAT FOREIGN LANGUAGE THAT PHARMACISTS SPEAK OF THE NDC CODE TO A COMMON LANGUAGE THAT WE ALL CAN SPEAK, WHICH WOULD BE RxNORM CODES. AND OF COURSE ULTIMATELY WE WANT TO DAUGHTER-IN-LAW THE AFFECTS OF THE CHANGES AND EFFICIENCY -- WE WANT TO DETERMINE EFFECTS OF THE CHANGES AND EFFICIENCY AND PATIENT SAFETY. AND I WANT TO THANK YOU ALL WORKING TO PROVIDE THE INFORMATION IN THE SPL. THE GREAT INCREASE IN THE NUMBER OF SPLs AVAILABLE IS EVIDENT IN THE WAY THAT IT HAS BECOME A REQUIREMENT FOR LABELING. NUMEROUS DISCREPANCY FOUND EARLY ON IN THE LABELINGS HAVE BEEN CORRECTED. I HOPE AND THINK THAT MANUFACTURERS ARE BECOMING MORE AWARE OF THE DOWNSTREAM USE. I MENTIONED HL7 WORKING GROUP AND TERRY AND THE CHAIR IS HERE. WORK GROUP 2 FROM NCPDP AND THE SPL TRAFFIC GROUP WORKING TOGETHER WITH FOLKS IN THE INDUSTRY. FDA OUTREACH TO MANUFACTURERS AND DISTRIBUTORS TO HELP THEM UNDERSTAND THE CRITICALITY OF THE TIMELINESS OF THE UPDATES ON THEIR INFORMATION. SO IN CONCLUSION, I JUST WANT TO SAY THAT SPL RIGHT NOW IS OUR PRIMARY SOURCE OF DRUG PRODUCT INFORMATION. DEPENDENCY EXIST ON THAT INFORMATION AND UPDATE PROCESS RIGHT NOW. SO, THE NLM AND ONE OF THE THINGS THAT YOU OFTEN WORRY ABOUT AS YOU HAVE A DEPENDENCY ON ANNEX TERNAL DATA SOURCE, NO MATTER WHO IT IS, IS THAT YOU DON'T CONTROL WHETHER OR NOT THAT DATA SOURCE WILL BE AVAILABLE FAR INTO FUTURE. AND SO, THE NLM AND FDA HAVE TO BE AWARE THAT THERE ARE NOW DEPENDENCY ON THIS DATA THEY ARE OUTPUTTING AND SO IT HAS TO BE STABLE T HAS TO BE AVAILABLE LONG TERM. RxNORM WILL BE THE COMMON LANGUAGE OF DRUGS. I HAVE NO DOUBT IN MY MIND. AND WHEN I TALK ABOUT RxNORM, I'M TALKING ABOUT THE NUMBER OF DIFFERENT IDENTIFIERS AVAILABLE WITHIN RxNORM JUST JUST A DRUG PRODUCT BUT ALSO THINGS LIKE INGREDIENTS. THE VALUE THAT IS NOW TAKEN FROM NLM AND THE SPL FILES CAN BE GREATLY INCREASED WITH INCLUSION OF ADDITIONAL CONTENT AND CODIFICATION OF THAT CONTENT. AND IT IS REALLY EXCITING. AS I GET TOWARDS THE END OF MY CAREER AND I LOOK BACK ON WHAT I HAVE SEEN OF CHANGES THAT HAPPENED, THERE HAVE BEEN MORE CHANGES IN THE LAST 5 YEARS TO HEALTH CARE AND PHARMACY THAN I SAW IN THE FIRST 35 YEARS. SO CHANGES ALWAYS HAPPEN. THERE IS NO QUESTION OF THAT. BUT CHANGE HAS NEVER HAPPENED AS RAPIDLY AS IT IS HAPPENING NOW IN HEALTH CARE IN PARTICULAR. I THINK WE ARE GOING TO CONTINUE TO SEE THAT. SO, I WOULD BE VERY HAPPY TO ENTERTAIN ANY QUESTIONS YOU MAY HAVE. IT'S JUST BEEN A PLEASURE FOR ME PERSONALLY TO WORK WITH THE FOLKS AT NL MONTH. THIS TYPE OF WORK AND WITH -- NLM ON THIS TYPE OF WORK AND I WOULD BE REMISS NOT TO MENTION THE WORK THAT THE FDA ALSO IN ASSOCIATION WITH THE NATIONAL LIBRARY OF MEDICINE. SO I'M VERY PLEASED TO HAVE BEEN PART OF A SMALL PART OF THAT WORKING TOGETHER AND THAT PUBLIC-PRIVATE COOPERATION. SO IF HAVE YOU ANY QUESTIONS -- SHELLI? >> THANK YOU TOM, THAT WAS REALLY GREAT. I WAS WONDERING IF YOU COULD TALK O ESPECIALLY IN THE PHARMACY, THE USE OF WHERE WE ARE GOING TO SEE RxNORM FOR NOT ONLY THE CLINICAL EXCHANGE OF INFORMATION, ALLERGY INFORMATION, AND ALSO JUST OVERALL USE IN PHARMACY AS WE MOVE TOWARDS CLINICAL QUALITY MEASURES, ANYTHING THAT PQA IS DOING. >> SO AND THAT IS A GOOD QUESTION. AGAIN, I THINK WHEN PEOPLE HEAR RxNORM, THEY THINK MAINLY ABOUT A DISPENSABLE PRODUCT. I MENTIONED IT A NUMBER OF TIMES. I THINK WE NEED TO THINK OF THE RxNORM FILES AND THOSE BEING AVAILABLE FOR THINGS LIKE INGREDIENTS, ESPECIALLY IN THINGS LIKE ALLERGIES. WHEN LISTING AN ALLERGY FOR A PATIENT, YOU WANT IT TO BE AS SPECIFIC AS POSSIBLE. SO IF YOU HAVE A COMBINATION DRUG PRODUCT, YOU WOULD LIKE TO KNOW THAT WHAT INGREDIENT WITHIN THAT COMBINATION PRODUCT THAT PATIENT IS ALLERGIC TO. WE WANT TO HAVE THIS TYPE OF INFORMATION. THE USE OF RxNORM AS A PRODUCT NAME IN THINGS LIKE MEDICATION RECONCILIATION WHERE WE ARE LOOKING AT MAKING SURE THAT A PATIENT, AS THEY HAVE TRANSITIONS OF CARE FROM ONE CARE -- FROM A HOSPITAL TO LONG-TERM CARE FACILITY TO THE HOME, THAT WE HAVE A MEANS OF LOOKING AT THOSE DRUG PROFILES, THE DRUG LIST FOR THAT PATIENT, USING A COMMON LANGUAGE. SO I THINK RxNORM HAS GREAT VALUE THERE ALSO. SO, THE CLINICAL USE OF RxNORM IS SUBSTANTIAL. SHELLI ASKED ABOUT QUALITY MEASURES. AGAIN, I THINK THAT UNLESS YOU HAVE A NEED FOR MANUFACTURE-LEVEL INFORMATION ABOUT A PRODUCT, QUALITY MEASURES SHOULD BE BASED ON CODES LIKE RxNORM ABUSE THAT IS WHAT IS GENERALLY AVAILABLE TO YOU. SO WHEN A PATIENT COMES IN AND TELLS A PHYSICIAN OR A PHARMACIST WHAT DRUGS THEY ARE TAKING, I'LL BET THEY NEVER SAY I'M TAKING LIE SIN APRIL MADE BY TEVA. THEY SAY I'M TAKING LIE SEN APRIL. AND HOPEFULLY THEY KNOW THE STRENGTH. HOPEFULLY WE CAN GET MORE AND MORE INFORMATION FROM THE PATIENT AND CODIFY THAT TO GET INTO OUR ELECTRONIC SYSTEMS, OUR ABILITY TO DO QUALITY MEASURES AND CLINICAL DISTANCE SUPPORT IS IMPROVED. >> TOM, CAN I COMMENT? >> THE ONE AREA THAT RxNORM DOES NOT ADDRESS THAT MIGHT BE OF CONCERN WITH ALLERGIES AND ADVERSE REACTIONS IS THE SO-CALLED INACTIVE INGREDIENT. BECAUSE THERE ARE CERTAIN TIMES WHERE YOU MIGHT WANT TO GIVE SOMEBODY SOMETHING, ALCOHOL-FREE OR NOT CONTAINING A CERTAIN DYE OR SOMETHING LIKE THAT, THAT THEY WOULD HAVE AN ADVERSE REACTION TO. AND THAT IS SOMETHING THAT IN THE EARLY DAYS WE DELIBERATELY AVOIDED JUST BECAUSE OF THE COMPLEXITY OF DOING THAT. >> AND I THINK THAT AS I MENTIONED, IS THERE ADDITIONAL INFORMATION THAT CAN BE PROVIDED WITHIN AN SPL OR FROM THE SPL FILES THAT WOULD PROVIDE US ADDITIONAL VALUE? THAT IS CERTAINLY SOMETHING THAT WE WOULD LIKE TO SEE MADE AVAILABLE. AND I DON'T WANT PEOPLE TO THINK THAT RxNORM HAS TO BE 100% OF EVERYTHING. WE KNOW THAT THERE ARE EDITORIAL POLICIES AROUND WHAT IS AND WHAT IS NOT IN RxNORM AND WE UNDERSTAND THOSE. AND WE DON'T WANT THE PERFECT TO GET IN THE WAY OF THE GOOD. AND I REALLY THINK THAT AS RxNORM EXISTS RIGHT NOW, AND SOME OF THE RESEARCH I HAVE SEEN AS TO WHAT TYPE OF COVERAGE YOU GET WITH AN RxNORM CODE BEING AVAILABLE FOR AN ELECTRONICALLY PRESCRIBED SUBSTANCE, WE THINK RIGHT NOW IT IS IN ACCESS OF 95% OF THOSE CODES THAT ARE AVAILABLE. SO DO I THINK THAT RxNORM WILL EVER BE 100% OF EVERYTHING YOU NEED IN A DISPENSABLE? I DON'T. I MEAN, IN PHARMACY, WE HAVE A NEED TO BE ABLE TO DISPENSE THINGS LIKE ADULT DIAPERS. BECAUSE THOSE CAN COME THROUGH ON A PHARMACY CLAIM FOR MEDICAID FOR A PATIENT THAT NEEDS THEM. DO I EXPECT THAT RxNORM WILL EVER HAVE ADULT DIAPERS IN IT? I DON'T. BUT THAT'S OKAY. I, WORK AROUND THAT. I KNOW THERE IS PROBABLES WITH CERTAIN MULTIINGREDIENT PRODUCTS. AND WE DEAL WITH THOSE AND SO I KNOW HOW DIFFICULT THAT IS FOR OUR COLLEAGUES AT NLM TO DEAL WITH. THAT IS OKAY. AGAIN, DON'T LET THE PERFECT GET IN THE WAY OF THE GOOD. AND IT'S BETTER THAN GOOD. MIKE? >> YES, THIS IS MIKE FROM KROGER. YOU TALKED A LITTLE BIT ABOUT SORT OF LIKE YOU THOUGHT IN THE FUTURE AS WE SORT OF A SEAMLESS TRANSMISSION OF PRESCRIPTION FROM THE PRESCRIBER TO THE PHARMACY. AND I ALMOST WANT TO SAY, WE ARE THERE NOW. WHAT WE SEE AT KROGER IS ABOUT HALF OF -- A LITTLE MORE THAN HALF BETWEEN 50-60% PRESCRIPTIONS COME IN ELECTRONICALLY. OF THOSE, ABOUT HALF OF THOSE HAVE RxNORM VALUES, WHICH WE ARE ABLE TO USE. WHICH BRINGS ME A LITTLE BIT TO THE POINT THEY WANTED TO ASK ABOUT. I WANTED TO ASK ABOUT THE GRANULARITY OF RxNORM BECAUSE WE ACCEPTED A BULK TRANSFER AND WE UPDATE IT PERIODICALLY BUT NOT ROUTINELY YET. SO WHAT I'D LIKE TO KNOW IS, ARE THE PROBLEMS SUCH AS COLSTEER MEAN POWDER PACKETS, LIGHT POWDER, LIGHT PACKETS, HAVE THOSE ALL BEEN ALL RESOLVED? AND THERE ARE OTHER ISSUES LIKE THE NITRO FER AN TOINES, DOCKSYCYCLINE, VERSUS MONOHYDRATE. I THINK THE INSULIN WAS RESOLVED WHICH WAS THE FLEX PEN VERSUS CARTRIDGE. THOSE KINDS OF THINGS. IS THERE A TARGET DATE ON THAT OR ARE THEY ALREADY RESOLVED? >> SO I'M GOING HAVE TO LET NLM RESPOND TO THAT. WHAT SPIKE TALKING ABOUT IS NLM LOOKS AT A PRODUCT AND AN ENTITY AND ITS CLINICAL USE AND IF THERE IS NOT A SPECIFIC DIFFERENCE IN THE CLINICAL USE OF A PRODUCT BASED ON THE SALT, FOR EXAMPLE, IT MAY NOT HAVE A UNIQUE CODE. AM I GETTING THAT RIGHT? SOMEONE CORRECT ME IF I'M NOT. >> YES. AND THANK YOU MIKE FOR BRINGING THIS UP. WE HAVE LIKE THE DOCKS ICYCLINES, WE HAVE ADDRESSESSED THAT, I THINK, AND WE ARE -- WE LEARN ABOUT THESE INCH BY INCH AND PIECE BY PIECE AND AS WE LEARN ABOUT THEM, WE FEEL THAT WE GET THEM RIGHT. BUT IF THERE IS ONES WE HAVEN'T GOT TONE YET, WE WANT TO HEAR ABOUT THAT. THERE ISN'T REALLY A SIMPLE WAY TO DO THIS. THERE IS THE ORANGE BOOK THAT DESCRIBES THINGS THAT ARE SIMILAR AND THINGS THAT ARE DIFFERENT BUT BECAUSE OF THE WAY WE HAVE CHOSEN A PATH OF SIMPLICITY IN RxNORM, AND THAT LIMITS US IN SOME WAYS. SO, LIKE THE DOXYCYCLINES WE WERE ABLE TO DO BUT I CAN'T PROMISE WE CAN DO ALL THE ORANGE BOOK DISTINCTIONS THAT ARE IN THERE THAT SAYS THESE ARE DIFFERENT CLINICALLY AND THESE ALL HAVE SAME INGREDIENTS. BUT WE WANT TO WORK WITH YOU AND OTHERS TO FIND THE ONES WE CAN FIX. >> SO CAN YOU TALK TO THE PROCESS BY WHICH YOU WOULD PREFER TO HAVE FEEDBACK SO THAT IF I HAVE THOSE KIND OF CONCERNS I CAN RAISE THEM WITH YOU? >> BASICALLY RIGHT NOW, WE DO IT BY E-MAIL, EXCELL AND PHONE CONFERENCE. AND THAT HAS ACTUALLY WORKED AND IT'S A LIGHT WEIGHT PROCESS BUT TAMMY POWELL SITTING OVER THERE, SHE WILL BE PRESENTING -- I THINK YOU KNOW HER. SHE IS THE HEAD OF THE EDITING AND THAT IS HOW WE DO IT. >> AND I THINK WHAT MIKE HAS JUST DESCRIBED IS PART WHAT HAVE WE WERE TALKING ABOUT. THAT PUBLIC-PRIVATE COOPERATION WE HAVE. WE HAVE BEEN RAISING THESE ISSUES THROUGH OTHER ORGANIZATIONS WE ARE JOINT MEMBERS OF OR INDIVIDUALLY. AND TAMMY HAS BEEN VERY ACTIVE IN UNDERSTANDING WHAT THE NEEDS ARE AND JOHN HAS BEEN VERY SUPPORTIVE ALSO. >> [ OFF MIC ] OTHER ISSUE IS THAT SEVERAL YEARS AGO, USP ADOPTED A POLICY WHERE THE ACTUAL MONOGRAPH FOR THE DISPENSABLE PRODUCT IN USP CHANGED THE NAMES TO THE ACTIVE -- SO PRIOR TO THAT PERIOD, LIKE SA FOX TIN SODIUM, FOR EXAMPLE, WOULD INCLUDE SODIUM IN THE OFFICIAL NAME OF THE PRODUCT. AS A RESULT OF THAT POLICY, THE SALTS FOR MOST DRUGS, HAVE BEEN DROPPED FROM THE OFFICIAL PRODUCT NAME AND THAT IS REALLY REFLECTED IN WHAT YOU SEE IN RxNORM AS WELL. THERE IS GREAT CONSISTENCY BETWEEN THAT PHILOSOPHY THAT THE FOCUS BE ON THE ACTIVE MIGHTY AS OPPOSED TO THE SALT FORM. AND THE THINKING WHEN USP DID THAT IS THAT THAT INFORMATION, WHEN NEEDED, IS IN THE LABEL ITSELF. FURTHER DOWN IN THE DESCRIPTION OF THE PRODUCT IT CLEARLY IDENTIFY THAT IS IT IS THERE. SO GOING BACK TO THE PREVIOUS COMMENT YOU MADE WHERE PERHAPS RxNORM CAN'T BE EXPECTED TO FULFILL ALL NEEDS, THAT THERE IS STILL THE NEED TO MIND SOME OF THAT DATA THROUGH SPL, COMES INTO PLAY. BUT USP ALSO HAS AS PART OF THAT POLICY, AN OPPORTUNITY TO BRING TO THEIR ATTENTION SITUATIONS WHERE THE IMPORTANCE OF THOSE DISTINCTIONS AND THE OFFICIAL NAME OF THE DRUG CAN BE AN EXCEPTION SO THAT IS ANOTHER GROUP THAT MIGHT BE IMPORTANT TO BRING TO THEIR ATTENTION WHERE THEY HAVE CHANGED THE NAME AND MAY HAVE NOT FULLY CONSIDERED CLINICALLY IMPORTANT DISTINCTIONS BETWEEN PRODUCTS BASED ON SALT FORMS. >> TAMMY, DO YOU WANT TO COMMENT? THEN I'M GOING TO STEP DOWN. >> YES, MIKE HAD ASKED ABOUT IMPLEMENTATION OF SOME OF THESE ADDITIONAL THINGS AND SO, RIGHT NOW OUR PRIMARY FOCUS IS PRESCRIBABLE NAMES AND I TOLD JOHN, I GUESS IN THE SPRING, THAT WE COULD TALK ABOUT SOME OF THESE OTHER THINGS IN THE FALL. AND I THINK YESTERDAY WAS THE FIRST DAY OF FALL. SO UPROBABLY JUST TO START THINKING ABOUT WHAT IS NEXT AFTER THE PRESCRIBABLE NAME IMPLEMENTATION AND SO WE HAVE RECEIVED FEEDBACK FROM MIKE ABOUT SOME SUGAR-FREE THINGS. I KNOW WE HAD SOME COMMENTS MADE ABOUT HOW WE ARE DEALING WITH SOME OF THE ALLERGENS AND INGREDIENTS AND WE SPENT SOME TIME TALKING ABOUT THAT BUT WE REALLY HAVEN'T PLANNED OUR NEXT BIG THING. AND I THINK AS A ED IS, THE NEXT MONTH OR TWO, WE WILL TRY TO FIGURE OUT WHAT IS NEXT AFTER WE ARE DONE WITH PRESCRIBABLE NAMES. BUT, I KIND OF SAID IN THE SPRING THAT I REALLY WANTED TO FOCUS ON GETTING THOSE MOVING ALONG AT A BETTER RATE. BUT AS JOHN SAID, WE ARE ALWAYS HAPPY TO TALK TO PEOPLE SO WHEN WE SIT DOWN AND TRY TO FIGURE OUT WHAT IS NEXT, WE MAKE THOSE DECISIONS BASED ON USER FEEDBACK. >> THANK YOU, TAMMY. I DID WANT TO MENTION AND I MEANT TO DO THIS EARLIER. LONI SMITH FROM THE FDA AND HOW HELPFUL HE HAS BEEN TOO. I NEEDED TO GATE OUT THERE BECAUSE HE HAS BEEN GREAT TO DEAL WITH ALSO. THANK YOU VERY MUCH FOR YOUR KIND ATTENTION. I'LL BE HERE FOR THE REST OF THE DAY IF YOU HAVE ANY ADDITIONALLY WITHS. AN ADDITIONAL QUESTIONS. THANK YOU. [ APPLAUSE ] >> IT'S BLINDING UP HERE. IT'S REALLY NICE COME BACK AND SEE HOW MY CHILDREN HAVE GROWN. SO I'M VERY HAPPY TO COME BACK. CURRENTLY, I'M DOING A VISITING PROFESSORSHIP AT THE UNIVERSITY OF NEW MEXICO. THE PHOTOGRAPH THERE IS ONE TAKEN BY MY WIFE OF ONE OF THE NEWER NATIONAL HISTORICAL MONUMENTS THAT IS KNOWN AS TENT ROCKS. AND IT IS A GREAT HIKE. YOU GO THROUGH A CANYON THAT IS ABOUT THIS WIDE, CHOO AND CLIMB 630 FEET TO GET TO A TOP WHERE YOU HAVE A 360 DEGREE VIEW. THE INTERESTING PART ABOUT THAT IS THAT IN NEW MEXICO ON A CLEAR DAY, THE VISIBILITY IS 50-70 MILES IN EVERY DIRECTION. SO IT IS PRETTY AMAZING. I AM WORKING WITH A GROUP THAT IS CALLED THEIL LOOMABLE DRUGABLE GENOME. THE WHOLE IDEA IS TO FIND -- THERE ARE ABOUT 70% OF THE PROTEINS THAT MIGHT BE ABREAST BY PHARMACEUTICALS, THERE IS VERY LITTLE-KNOWN ABOUT. THEY ARE CALLED DARK TARGETS. THERE IS VERY LITTLE-KNOWN ABOUT AND THE WHOLE IDEA OF THIS DRUGABLE GENOME PROJECT IS TO USE COMPUTATIONAL MEANS TO TRACK WHAT IS KNOWN AND WHAT IS COMING ABOUT. IT'S ALSO INTERESTING TO NOTE IN A RELATED MATTER THAT ONLY ABOUT A QUARTER OF THE DISEASES THAT WE KNOW ABOUT IN OUR CURRENT AREAS ARE ADDRESSABLE WITH MEDICATIONS SO THERE IS STILL A LOT OF ROOM ABOUT NEW MEDICATIONS TO TAKE PLACE. SO EVENTUALLY WHAT WE WANT TO DO IS TO BE ABLE TO LINK THESE TARGETS TO WHAT THEIR CLINICAL AFFECTS ARE AND THEN GO AHEAD AND PREDICT FROM THAT WHERE SOME KIND OF MEDICATION MIGHT BE OF USE. NOW, IN DAILYMED, WE ARE TALKING ABOUT ALREADY DRUGS APPROVED AND AS PART OF THAT, ONE OF THE THINGS WE WANT TO KNOW, HERE IS AN EXAMPLE OF ONE. IF YOU LOOK AT THE PATHWAY OF WHAT IS GOING ON, AND PATIENTS WHO HAVE THIS GENE, PCSK9, PEOPLE WITH A LOW LDL, CHOLESTEROL, AND LOW RISK FOR HEART DISEASE, HAVE VERY LOW LEVELS OF THE EXPRESSION OF THIS GENE. AND IT'S A PROTEASE, WHICH RECYCLES THE LDL RECEPTOR. SO IF YOU INHIBIT IT, YOU INCREASE THE NUMBER OF LDL RECEPTORS AND CLEAR THEM OUT OF THE BLOODSTREAM. AND ACTUALLY WHAT HAPPENED IS THAT BECAUSE THEY DID NOT KNOW A PHARMACOLOGIC PRODUCT TO ADDRESS THIS, IT WAS FAST TORE BUILD MONOCLONAL ANTIBODIES TO THEM. OF COURSE THE DIFFICULTY WITH A MONOCLONAL ANTIBODIES IS YOU HAVE TO INJECT THEM. BUT IT'S A REAL APPROACH FROM A PHENOTYPE TO THE GENOTYPE, AND THEREBY GOING AHEAD AND DEVELOPING A NEW DRUG. SO THIS IS NOW BEING SOLD, APPROVED, AS A PRODUCT TO USE TO LOWER CHOLESTEROL IN PEOPLE WHO CANNOT TAKE AN HMG COA REDUCTASE INHIBITOR. SO WHAT DO WE WANT TO KNOW ABOUT DRUGS THAT ARE CURRENTLY ON THE MARKET? THERE IS ACTUALLY QUITE A BIT. WE ARE BUILDING A DATABASE CALLED, DRUG CENTRAL. AND CENTRAL TO THAT IS THE FACT THAT THESE ARE DRUGS THAT ARE APPROVED BUT EVERYTHING FROM THE PHARMACEUTICAL PRODUCT INGREDIENT -- DOES THIS THING POINT? TO THE TARGET. AND WE KNOW ABOUT TARGETS, THE CLASSES, WHETHER THEY ARE G PROTEIN DEPENDENT RECEPTOR OR WHATEVER WE WANT TO KNOW AND LOTS OF INFORMATION ABOUT THE PHARMACOLOGIC CLASS AND SOY WE ARE BUILDING THIS DATABASE OF INFORMATION ABOUT THEM. ABOUT THESE DRUGS THAT ARE APPROVED. AND OUT OF THE DAILYMED DRUG LABELS, THERE ARE THERE IS TEXT THAT HAS INFORMATION THAT CAN BE EXTRACTED AND IDENTIFIERS THAT CAN BE EXTRACTED. PHARMACOLOGIC ACTIONS BASED ON THE EXTENDED PHARMACOLOGIC -- EXPRESS PHARMACOLOGIC CLASS, AND THE MECHANISM OF ACTION AND THE PHYSIOLOGIC AFFECT THAT IS KNOWN FOR DRUGS. ALL OF THIS INFORMATION CAN BE IMPORTED INTO THE DRUG CENTER RECALL DATABASE. IF YOU LOOK AT THIS, THEN WE CAN LOOK AT THE CLASSIFICATIONS FROM -- I GUESS TOM, THIS IS MY SLIDE THAT NOBODY CAN READ. BUT AS YOU LOOK ALONG HERE, I THINK DAILYMED IS -- I CAN'T EACH SEE IT [ OFF MIC ] THESE ARE WHERE WE GET THE INFORMATION ABOUT THE PHARMACOLOGIC CLASSES ON THE MEDICATIONS. IF YOU LOOK FOR THE DRUGS AND WHAT TARGETS THEY HIT -- [ OFF MIC ] SO YOU CAN SEE THE VARIATION THERE. THE G PROTEINS SEEM TO BE VERY IMPORTANT INTRACELLULAR SIGNALS. AND YOU CAN ALSO LOOK AT THIS IN A DIFFERENT WAY AND SAY, OKAY, WHAT ARE THE DRUGS THAT WE USE FOR DIABETES; AND WHAT TARGETS ARE THEY HITTING? SO WE HAVE AN AMIA LIN RECEPTOR. PPRA GAMMA RECEPTOR AND OF COURSE THE INSULIN RECEPTOR. A NUMBER OF THEM. AND THE VARIOUS EXAMPLES OF HOW THEY AFFECT THE METABOLIC PATHWAYS IN DIABETICS. I'M LOOKING AT A, RIGHT NOW, A HORMONE THAT IS SECRETED BY FAT CELLS, AT POE NECTIN, WHICH MAY IN FACT HAVE A SIGNIFICANT AFFECT ON TYPE II DIABETES AND METABOLIC SYNDROME. THERE IS NO PRODUCT YET, BUT THEY ARE DOING TESTING IN ANIMALS AT THIS POINTED. WE CAN TAKE THIS AND THE CMS PART D DATE, AND LOOK TO SEE HOW MUCH IS SPENT PER DRUG TARGET. AND THE BIG WINNER IS HMGCOA REDUCTASE. AND THE SECOND ONE IS THE INSULIN RECEPTOR. BUT THEY CAN BE BROKEN DOWN PER DRUG TARGET IN TERMS OF COST, OR IN TERMS OF THE CLAIMS OR NUMBER OF PRESCRIPTIONS THAT WERE WRITTEN AND ONCE AGAIN, HMG-COA REDUCTASE IS THE BIG WINNER HERE. ANOTHER AREA THAT I'M INTERESTED IN LOOKING AT IS THE SIDE EFFECTS OF PLACEBOS. IF YOU GO THROUGH AND YOU, IN THE STRUCTURED PRODUCT LABEL, THERE WILL BE A TABLE OF CLINICAL TRIAL AND IT WILL HAVE THE RCT AND PLACEBO AFFECTS AND THE MEDICATION AFFECTS. AND IT IS INTERESTING TO LOOK AT THAT AND TO SEE IF WE CAN CHARACTERIZE A TYPE OF INVESTIGATOR BY THE SIDE EFFECTS OBSERVED. FOR EXAMPLE, IF SOMEBODY IS TAKING A NEUROLEP TICK, WHAT KIND OF SIDE EFFECTS IS THAT INDIVIDUAL GOING TO NOTE AT A MORE PRECISE METHODOLOGY THAN SAY THEY MIGHT IN A GENERAL PROBLEM LIKE A RASH OR SOMETHING. SO THAT WOULD BE ANOTHER AREA THAT WE WOULD BE LOOKING AT. I DO WORK WITH A NICE GROUP WHO HAS DONE MOST OF THE WORK ON DRUG CENTRAL, OLEG URSU, ALONG WITH JEREMY YANG, CHRIS TOUGH LAMBERT IS THE A COMPUTER SCIENTIST AND THE LEADER OF THE GROUP IS TUDOR AND NOW I'LL STOP AND ASK IF THERE IS ANY QUESTIONS. >> THIS IS PRETTY COOL WORK YOU'RE DOING. I WAS CURES WAT RELATIONSHIP OF WHAT YOU'RE BUILDING HAS WITH DRUG BANK, WHAT SEEMS ALREADY TO HAVE A TON OF THAT INFORMATION LOADED INTO IT. >> YES, AND WHAT OLEG TELLS ME, HE GOES TO DRUG BANK AND LOOKS TAT VERSUS WHAT THE INFORMATION IS THAT HE HAS. DRUG BANK IS NOT BEING UPDATED VERY WELL. AND IN SOME PLACES IT'S JUST PLAIN WRONG. SO, I THINK THAT HE'S LOOKING MORE AND MORE AT DRUGS BANK AS -- DRUG BANK AS NOT THAT RELIABLE IT'S INTERESTING BECAUSE BACK IN THE DAY WHEN IS WE STARTED BUILDING DAILYMED, DRUG BANK WAS ONE OF THOSE EXTERNAL REFERENCE THAT IS I LATCHED ON TO RIGHT AWAY. AND SO I WAS KIND OF LIKE, YES? OLEG, THIS IS TRUE? CAN YOU SHOW ME SOME EXAMPLES? AND HE DID. SO THAT IS ONE OF THE THINGS THAT WE HAVE LEARNED HERE. >> CAN I FOLLOW UP WITH THAT? SO, DRUG BANK, WHICH IS BEING USED BY SO MANY PEOPLE IN THE BIOMEDICAL INFORMATICS COMMUNITY IS BEING UPDATED INFREQUENTLY AND YOU'RE BUILDING SOMETHING NEW. CAN YOU COMMENT ABOUT MAINTAIN ABILITY OF THE REALLY GREAT RESOURCES WE ARE PUTTING? THE WHAT IS YOUR IDEA FOR HOW THESE THINGS CAN BE MAINTAINABLE OVER THE LONG RUN? >> WELL, I THINK THAT MAINTAINING THE RESOURCES IS A REAL CHALLENGE BECAUSE MOST OF THEM ARE FUNDED OUT OF GRANTS, AND YOU DON'T OFTEN GET GRANTS FROM MAINTENANCE. WHEN I WORKED HERE, THAT WAS ONE OF THE BIG THINGS THAT I COULD SAY IS HERE WE CAN BUILD DAILYMED AND WE COULD BUILD RxNORM AND WE KNOW THAT THEY ARE GOING TO BE MAINTAINED BECAUSE THEY HAVE A STEADY SOURCE OF FUNDING. AND I THINK THIS IS ONE OF THE BIG CHALLENGES THERE IS OUTSIDE OF A GOVERNMENT INSTITUTION. WITHOUT A STEADY STREAM OR SOME SORT OF -- WITHOUT A STEADY STREAM OF INCOME, WHETHER IT BE GOVERNMENTAL SUPPORT OR COMMERCIAL SUPPORT OR WHATEVER, IT IS GOING TO BE VERY, VERY HARD. THE PKG DATABASE, THE PHARMACOGENETICS DATABASE AT STANFORD, I THINK YOU ARE PROBABLY AWARE OF IT, HAS -- OR IS LICENSING THROUGH A SUBSIDIARY SO THAT IS ONE WAY THAT THEY CAN HAVE A STREAM OF REVENUE TO HELP SUPPORT THEIR EFFORTS. [ APPLAUSE ] >> THANK YOU. >> JUST ONE QUESTION. AND NOW MAYBE, I DON'T KNOW YOU MIGHT GET INVOLVED IN THIS PART OF IT, BUT CAN YOU SAY ANYTHING ABOUT THE TOOLING YOU'RE USING TO PUT TOGETHER THESE GRAPHS OF INFORMATION? >> NO. >> OKAY. THAT'S FINE. >> [ OFF MIC ] [ LAUGHS ] >> GOOD MORNING. HOW ARE Y'ALL? THIS IS A JAMBOREE! LOOK THE YOU ALL! [ APPLAUSE ] CHEERS! I LOVE COMING TO JAMBOREES. SO THANK YOU SO MUCH FOR SPENDING THE NEXT 20 MINUTES WITH ME. I'M JON WHITE. I AM THE DEPUTY NATIONAL COORDINATOR AT THE OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH IT. EXTREME PRIVILEGE TO BE HERE WITH TOM AND STEWART, STEWART IS SO NICE TO SEE YOU AGAIN, AND THANK YOU SO MUCH TO JOHN FOR INVITING MOOY AND HAVING ME COME. THIS MAY FEEL LIKE SLIGHTLY DOWN IN THE WEEDS TALK FOR SOMEBODY WHO IS THE DEPUTY NATIONAL COORDINATOR BUT IT'S NOT AND I'LL TELL YOU WHY IN JUST A SECOND. SO, I'M REALLY PLEASED TO BE ABLE TO BE HERE AND TALK WITH YOU ABOUT RxNORM AND HOW THAT FACTORS INTO WHAT WE DO AT THE OFFICE OF NATIONAL COORDINATOR FOR HEALTH IT. SO, BE HONEST WHEN I ASK YOU THIS QUESTION. DOES ANYBODY NOT KNOW WHO THE OFFICE OF NATIONAL COORDINATOR FOR HEALTH IT IS? RAISE YOUR HAND. TOTALLY COOL. I'M NOT OFFENDED. SO THE BIG PICTURE IS THAT WE NEED TO USE GOOD INFORMATION TOOLS AND GOOD INFORMATION SYSTEMS AND GOOD INFORMATION PRACTICES TO DELIVER BETTER HEALTH CARE AND GET BETTER HEALTH OUTCOMES. THAT WAS SOMETHING THAT WAS POSITIVE YEARS AGO AND AS TIME HAS GONE BY HAS BEEN BORNE OUT. 11 YEARS AGO, AT THIS POINT, PRESIDENT GEORGE W. BUSH ESTABLISHED AN OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH IT WITH OF COURSE, A NATIONAL COORDINATOR, TO FOCUS ON DRIVING FOR THE USE OF HEALTH IT IN THE DELIVERY OF HEALTH CARE TO GET TO THOSE BETTER HEALTH OUTCOMES THAT WE ALL WANT AND DESIRE. THE OFFICE DID A LOT OF WORK FROM 2004-2009 AND TOOK A BIG STEP FORWARD BECAUSE IN 2004 IT WAS ESTABLISHED BY EXECUTIVE ORDER. IN 2009, IT WAS PUT INTO STATUTE IN THE HIGH-TECH ACT, WHICH IS PART OF THE AMERICAN RECOVERY AND REINVESTMENT ACT. AND GIVEN CERTAIN AUTHORITIES AND GIVEN CERTAIN ROLES WITHIN THE FEDERAL GOVERNMENT, SO IT IS IN THAT CAPACITY HERE THAT I'M TO TALK TO YOU TODAY. SINCE 2009, THERE WAS ALSO PUT INTO PLACE AN INCENTIVE PROGRAM MEANT TO INNOCENT, ELIGIBLE PROVIDERS AND ELIGIBLE HOSPITALS, MEANING FOLKS WHO PARTICIPATE WITH MEDICARE AND MEDICAID, TO PROVIDE INCENTIVE PAYMENTS AND THEN EVENTUALLY DISINCENT I WAS, WHICH WAS PART OF THE LAW. TO ADOPT AND MEANINGFULLY USE HEALTH IT. AND IN PARTICULAR, ELECTRONIC HEALTH RECORDS, OF WHICH E-PRESCRIBING IS A IMPORTANT PART. AND THAT'S IN THE LAW THAT SAYS YOU HAVE TO BE ABLE TO E-PRESCRIBE WHEN YOU USE THESE THINGS. ANOTHER PART OF WHAT WE DO IS TO HELP TO PROMOTE AND DEVELOP, ESTABLISH, AND SOMETIMES EVEN REQUIRE THE USE OF STANDARDS IN WHAT WE DO AND THE PRODUCTS THAT WE REGULATE DO AND THAT'S WHERE RxNORM COMES INTO PLAY AND WE'LL TALK ABOUT THAT IN IA A SECOND. I'M GOING TO BREAK OFF FROM THE TECHNICAL PIECE OF THIS FOR JUST A SECOND. SO, ALMOST EXACTLY A YEAR AGO STEWART, I DID THE TENT ROCKS HIKE. AND I AM JUST HERE TO TESTIFY -- WHERE ARE YOU, SIR? I'M HERE TO TESTIFY THAT THAT -- IT WAS JUST I GOT IN THE CAR DROVE OUT OF TOWN AND WAS IN ALBUQUERQUE FOR A MEETING. BEST SHORT NIKE MY LIFE. SO, TESTIFY, BROTHER, TENT VOCES A GREAT PLACE TO GO. SO IF YOU'RE EVER OUT IN ALBUQUERQUE. DRIVE AN HOUR NORTH AND GO DO IT. IT WAS FANTASTIC. SO, I JUST GAVE THE SHORT RUNDOWN ON ONC'S HISTORY. BUT HERE IS THE MORE DETAILED VERSION OF IT AS I SAID, 2004 EXECUTIVE ORDER, 2005 INITIAL FUNDING PROVIDED TO INITIATE CERTIFICATION OF HEALTH IT, WHICH IS ULTIMATELY AT THE END OF THE DAY WHERE IT LANDS TO OUR AUTHORITY TO BE ABLE TO REGULATE HEALTH IT. 2009, HIGH-TECH ACT. 2010, OUR FIRST EDITION OF OUR CERTIFICATION RULE WAS RELEASED WHICH IS THE FIRST REGULATION GOVERNING THE CERTIFICATION OF HEALTH IT AND THEN TWO SUBSEQUENT VERSIONS OF THAT. AND THE KEY OPPORTUNITIES THAT WE HAVE THROUGH THIS RULE AND THROUGH A LOT OF OUR OTHER ACTIVITIES WHICH SOME OF WHICH YOU'LL HEAR ABOUT IS TO SUPPORT PATIENT SAFETY THROUGH THE USE OF STRUCTURED DRUG DESCRIPTIONS. SUPPORT INTEROPERABILITY THROUGH CONSISTENT STANDARDS-BASED APPROACHES AND THEN ACCELERATE INDUSTRY ADOPTION OF ESTABLISHED TERMINOLOGIY AND CODING SYSTEMS THROUGH ONC CERTIFICATION. WHAT YOU DON'T KNOW, IN MY HISTORY HERE, IS THAT -- I HAVE TO USE MY BLASTER. WHAT YOU DON'T KNOW IS RIGHT AROUND HERE, I WAS NOT AN ONC. I DIDN'T GET THERE UNTIL LATE REALLY UNTIL LIKE THE BOTTOM OF THE CIRCLE. BUT AROUND HERE, I JOINED THE FEDERAL GOVERNMENT AND I STARTED AT THE AGENCY FOR HEALTH CARE RESEARCH AND QUALITY AND THIS IS WHERE JOHN KNOWS ME FROM. AND AROUND HERE, THERE WAS SOME ADDITIONAL INCENTIVES PROVIDED TO PROVIDE TOURS ELECTRONICALLY PRESCRIBE AND PART OF THAT PACKAGE WAS REQUIREMENT THAT THE CENTERS FOR MEDICARE AND MEDICAID SERVICES, WHY. MORE. S, PILOT TEST STANDARDS RELATED TO -- CMS -- ELECTRONIC PRESCRIBING AND IT HAD TO BE DONE BY GRANTS. AND CMS SAYS WE DON'T DO GRANTS. SO THEY CAME TO US AT AHRQ AND SAID CAN YOU WORK WITH US? AND WE DID. SO IN COLLABORATION WITH NLM AND CMS AND SOME WHO ARE IN THE ROOM WITH US TODAY, WE DID PILOT TESTING OF A NUMBER OF STANDARDS THROUGH ELECTRONIC PRESCRIBING AND A NUMBER WERE ADOPTED. RxNORM WAS IN THAT MIX. GOOD, I HOPE YOU FELT LIKE IT WAS GOOD FEEDBACK THAT CAME OUT OF THE PILOTS THAT LED TO THE REALLY ROBUST STATE OF WHERE IT IS TODAY AND I AM A -- TO WHERE MY FLAG ON MY SLOWSLEEVE, I'M A HUGE RX FAN BECAUSE OF THE GREAT COLLABORATION WITH JOHN AND STEWART AND COLLEAGUES OVER THE YEARS. SO, PATIENT SAFETY AND RxNORM. SO, STEPPING LACK FROM THE STANDARDS HERE FOR A SECOND AND LIVING IN THE WORLD WHERE A LOT OF YOU LIVE BASED ON SOME OF THE COMMENTS THAT I HEARD, SO REALLY WE HAVE GONE FROM 0-60 FAST IN ELECTRONIC PRESCRIBING. IN 2014 THE LARGEST E-PRESCRIBING NETWORK ROUTED 2.2 BILLION e-PRESCRIPTIONS. SO IS THAT A LOT OF PRESCRIPTIONS. IT'S NOT ALL OF THEM BUT WE ARE GETTING THERE AND GETTING THERE FAST. SO, IN ORDER TO MAKE THAT WORK OPTIMALLY, AND TO ACHIEVE ALL THE BENEFITS WE HOPE TO GET OUT OF GOOD STRUCTURED COMMUNICATION OF DATA THROUGH THIS TRANSACTIONAL PROCESS, DRUG DESCRIPTIONS EACH AND EVERY TIME A PROVIDER e-PRESCRIBES OF THE SO TO ACHIEVE THAT, ONCEY LEADS GUIDANCE ON THE IMPORTANCE OF USING STRUCTURED DRUG DESCRIPTIONS INSTEAD OF ENTERING FREE-TEXT DRUG DESCRIPTIONS TO IMPROVE e-PRESCRIBING PRACTICES AND TO IDENTIFY ADVANCED e-PRESCRIBING FEE TODAY. WE HAVE A GREAT RESOURCE. IF YOU GO TO HEALTH IT.GOV AND SEARCH FOR PRESCRIPTION FOR E-PRESCRIBERS YOU WILL FIND THIS GUIDE WHICH INCLUDES SUPPORT FOR THINGS LIKE, DOES YOUR SYSTEM ALLOW YOU TO TO ENTER FREE-TEXT? IF IT DOES, YOU SHOULD BE USING STRUCTURED DRUG DESCRIPTIONS. SO FOR FOLKS WHO ARE OUT THERE WRESTLING THROUGH THIS WHAT IS THIS e-PRESCRIBING? WE HAVE A SIGNIFICANT PROVIDER OUTREACH PROGRAM, AN EXTENSION PROGRAM, AT ONC THAT WE SUPPORTED UNDER FUNDING THROUGH THE AMERICAN RECOVERY AND REINVESTMENT ACT, CALLED THE REGIONAL EXTENSION CENTERS AND THIS IS ONE OF THE RESOURCES THEY USE WHEN GOING OUT TO DOCTOR'S OFFICES IN IDAHO. YOU WOULD BE AMAZED WHAT HAPPENS WHEN MY PHONE RINGS AND I PICK IT UP AND THIS IS DR. SO-AND-SO IN BOISE. HELLO. AND WE TALK ABOUT STUFF LIKE THIS. AND THIS IS ONE OF THE RESOURCES WE HAVE. AND THE BOTTOM LINE HERE IS THAT RxNORM SUPPORTS SAFETY AND E-PRESCRIBING BECAUSE IT LETS YOU BE PRECISE. SO THAT IS STUFF THAT WE DEFINITELY SUPPORTED IN THE CAPACITY WE ARE LOVING TO HAVE IT OUT THERE. BUT, WE ARE NOT RESTING ON OUR LAURELS. MONDAY, LITERALLY, WE ISSUED A 2016 DRAFT INTEROPERABILITY STANDARDS ADVISORY. WHAT IS THAT? SO WE HAVE A REGULATION THAT I TALKED ABOUT, WHICH IS HOW WE CERTIFY HEALTH TEMPT T AND IT'S A RULE. AND IT'S A RULE THAT APPLIES TO HEALTH IT PRODUCTS THAT ARE TO BE USED EITHER IN FEDERAL CONTRACTS WHERE THEY ARE PROVIDING CARE OR FOR PROVIDERS WHO ARE PARTICIPATING IN THE INCENTIVE PROGRAM. THE INTEROPERABILITY STANDARDS ADVISORY IS NON-REGULATORY GUIDANCE WHICH DOES NOT MEAN IT'S NOT IMPORTANT. SO WE CAME TO THE SALES THAT THE YEAR THAT IN THE PAST, BEFORE WE HAD THIS CERTIFICATION AUTHORITY, WE HAD BEEN ISSUING A POINT OF THE BEST STARTS AND WE STOPPED DOING THAT AND REALIZED IT WAS NEEDED. SO WE DID IT IN 2015 AND EVERY YEAR WE ARE PLANNING ON UPDATING IT. THIS SILENT 2016 VERSION RELEASED ON MONDAY FOR PUBLIC COMMENT. REPRESENTS THE BEST AVAILABLE INTEROPERABILITY STANDARDS AND IMPLEMENTATION SPECIFICATION AND IDENTIFIES RxNORM AS THE REFERENCE STANDARD FOR REPRESENTERRING PATIENT MEDICATIONS AND MEDICATIONS AS A PATIENT ALLERGEN. AND WE ARE ACCEPTING PUBLIC COMMENT ON THAT NOW THROUGH NOVEMBER 6, 2015. AND LET ME GIVE YOU MORE DETAIL ON THAT. HERE IS WHAT IS IN THERE. SO ONE IS REPRESENTING PATIENT MEDICATIONS. WE ARE LIKE THIS IS IT. RxNORM, HIGH ADOPTION LEVEL. REGULATED THE AND IT'S FREE AND WE ARE ASKING FOR FEEDBACK AND SECONDARILY, THERE NEED FOR REPRESENTING PATIENT ALLERGENS, MEDICATIONS, IN PARTICULAR RxNORM, THERE IS A LIMITATION THAT I'LL CALL OUT TO YOU HERE THAT WE HAVE IDENTIFIED IN THE DRAFT VERSION WHICH IS WHEN A MEDICATION ALLERGY NECESSITATES CAPTURE BY MEDICATION CLASS, NDFRT IS THE BEST AVAILABLE ADDS RECOMMENDED BY THE HEALTH IT STANDARDS COMMITTEE. ONE OF THE THINGS THAT I MENTIONED EARLIER IS WE HAVE ADVISORY COMMITTEES AND ONE IS THE HEALTH IT STANDARDS COMMITTEE. THAT WAS THEIR SPECIFIC RECOMMENDATION SO WE HAVE THAT OUT THERE FOR DRAFT FEEDBACK. ADDITIONAL NOTES, SNOMED CT RECOMMENDED AS THE BEST AVAILABLE FOR REPRESENTING ALLERGIC REACTIONS AND FOOD SUBSTANCES. THERE ARE NO VOCABULARY CODE SETS CONSIDERED BEST AVAILABLE FOR ENVIRONMENTAL ALLERGENS AND WE WILL CONTINUE OUR CONVERSATIONS WITH OUR COLLEAGUES TO TRY TO GET THAT THE BECAUSE AT THE END OF THE DAY, AS EVIDENCE BY THE INACTIVE INGREDIENT DISCUSSION WE JUST HAD HERE, TRYING TO GET OUR HEAD AROUND ALL THE DIFFERENTALLER GENS IN A INSTRUCT -- DIFFERENT ALLERGENS IS IMPORTANT. SO THAT IS THE ISA AGAIN NONREGULATORY GUIDANCE. LET'S TALK ABOUT REGULATIONS. EVERYBODY'S FAVORITE TOPIC. SO CURRENTLY WE HAD ISSUED EARLIER THIS YEAR, A NOTICE OF PROPOSED RULE MAKING. SO THIS IS A PROPOSED RULE FOR 2015 EDITION. I TALKED PREVIOUSLY ABOUT THE 2011 AND 2014. THIS IS 2015. HEALTH IT CERTIFICATION CRITERIA BASED ON ELECTRONIC HEALTH RECORD DEFINITIONS AND ONC HEALTH IT CERTIFICATION PROGRAM MODIFICATIONS. THIS IS THE UPDATE AND IN THAT WE PROPOSED TO UPDATE THE MINIMUM DATA STANDARDS CODE SET TO FEBRUARY 2, 2015 VERSION. AND THAT IS THE PROPOSED BESIDES STANDARD FOR CODING MEDS AND MEDALLER GEES. FOR THOSE WHO ARE LIKE, WHO IS THE CERTIFICATION PROGRAM AND HOW DOES IT WORK? I'M NOT GOING TO BORE YOU WITH THE DETAILS BUT I'M HAPPY TO SHARE THESE SLIDES THROUGH NLM OR WHOMEVER ELSE. I'M SURE IT IS ALSO AVAILABLE IN HEALTH IT.GOV. A QUICK SKIP THROUGH IT. WE USE REGULATION AND DEVELOPERS CREATE PRODUCTS AND WE HAVE DELEGATED CERTIFYING AUTHORITY TOW TEST LABS THAT TEST THOSE PRODUCTS AND THEY CERTIFY THOSE PRODUCTS AND SUBMIT THAT INFORMATION TO O IN. C FOR POSTING ON OUR CHAPEL PRODUCTS LIST AND THEN PROVIDERS USE THOSE PRODUCTS AND ATTEST TO THE INCENTIVE PROGRAM IF THEY ARE PARTICIPATING IN THAT PROGRAM. SO, I DON'T KNOW HOW FAST DID I GO? NOT TOO FAST. THAT WAS ALREADY. 15 MINUTES. SO WE HAVE 5 MINUTES LEFT. SO I'LL SAY AGAIN KIND OF THE KEY POINTS HERE ARE NUMBER 1, THE RxNORM SUPPORTER. NUMBER 2, ONC BROADLY RECOGNIZES THE REAL VALUE THAT RxNORM PROVIDES TO THE NATION AND HAS FOR A WHILE. AND THAT WE ARE INCORPORATING INTO OUR REGULATORY AND OUR NONREGULATORY GUIDANCE TO THE HEALTH IT INDUSTRY. SO THANK YOU VERY MUCH FOR ATTENTION. STEWART THANK YOU AGAIN FOR PUTTING UP TENT ROCKS AND MAKING ME FEEL ALL NOSTALGIC WHILE YOU WERE GIVING YOUR TALK AND I LOOK FORWARD TO YOUR QUESTIONS. THANK YOU. >> HELLO. SHELLI? >> HI, JOHN. SHELLI EXECUTIVE DIRECTOR OF THE PHARMACY HIT COLLABORATIVE AND THANK YOU FOR THAT. AND APPRECIATE ALL THE WORK THAT YOU HAVE BROUGHT OVER FROM YOUR PREVIOUS POSITIONS TO ONC. MY QUESTION IS MORE IN RELATIONSHIP TO IMMUNIZATION. AND WHERE DO YOU SEE RxNORM FITTING INTO IMMUNIZATIONS? I KNOW YOU DIDN'T MENTION THAT WITHIN SOME CERTIFICATION BUT FOR PHARMACY THIS IS A REALLY IMPORTANT PIECE. PHARMACISTS ARE ONE OF THE MAJOR IMMUNIZERS IN THE UNITED STATES. NOT ONLY FOR ADMINISTRATION BUT ALSO FOR PROVIDING FLU VACCINES AS AN EXAMPLE. HOW DO YOU SEE RxNORM IN THAT MODE OR IS THAT GOING TO BE ANOTHER TYPE OF CODING METHOD? >> SO THAT'S A GREAT QUESTION. I THINK THAT IS PROBABLY ONE OF THE THINGS WE ARE SEEKING COMMENT ON. NOT IT'S EXPLICITLY CALLED OUT. THERE IS DIFFERENT PIECES OF THIS. FIRST LET ME SAY THAT IMMUNIZATIONS ARE AN ABSOLUTELY CRITICAL PIECE OF WHAT WE CAN DO WITH HEALTH IT TO ADVANCE THE HEALTH OF THE NATION. SO THAT'S JUST A PLANKET STATEMENT BEGIN WITH. AND THAT INVOLVES NOT JUST BEING ABLE TO TRACK THOSE SPECIFIC MEDICATIONS AS WE TALKED ABOUT WITH RxNORM AND SAID WHAT IS BEING ADMINISTERED? BUT THEN YOU NEED ADDITIONAL INFORMATION LIKE, WHEN WAS IT GIVEN? BY WHOM WAS IT GIVEN? WHERE IT WAS GIVEN? THERE IS SAY LOT OF INTERPLAY ON THE INTEROPERABILITY KIND OF TRACK WITH THE USE OF IMMUNIZATION REGISTRIES AND THAT INVOLVES NOT JUST TRACKING THE MED THAT WAS GIVEN OR THE IMMUNIZATION THAT WAS GIVEN BUT ALSO INVOLVES THE WHO AND WHAT AND WHERE AND STUFF LIKE THAT. THAT IS A REALLY CRITICAL PIECE. WE FIND THAT ACTUALLY THE USE OF HEALTH IT, SOME OF THE RESEARCH THAT I HAD SPONSORED PREVIOUSLY AT MY PREVIOUS JOB THAT WE SUBSEQUENTLY FOUND, IS THAT HEALTH IT REALLY LETS US DO A MUCH BETTER JOB OF NOT OF RIGHT IMMUNIZING OR OVER IMMUNIZING OR UNDER IMMUNIZING BUT RIGHT IMMUNIZING AND MAKING SURE THAT FOLKS WHO HAVEN'T GOTTEN THEM ARE GETTING THEM BUT YOU'RE NOT GETTING EXTRA SHOTS WHEN YOU DON'T NEED THEM. SO, THE BOTTOM SIDELINE IT IS IMPORTANT. I WOULD LOVE TO HEAR FEEDBACK OR ADDITIONAL THOUGHTS THROUGH THE COMMENT PROCESS. I'M SURE WE CAN HAVE A GREAT DISCUSSION HERE BUT THEN WE SUE PLANT THE NEXT SPEAKER ON WHICH YOU ARE THINKING ABOUT THAT. GREAT QUESTION, THANK YOU. >> YES, I WANTED TO ASK A LITTLE BIT ABOUT THE STRUCTURED DRUG DESCRIPTIONS YOU DISCUSSED. RECENTLY ISMP PUT OUT A PAPER ASKING FOR FEEDBACK ON IT AND IT WAS A GUIDANCE. AND IT WAS ABOUT ONE OF THE THINGS THAT WAS INCLUDE SAID A COMMENT YOU SHOULD INCLUDE THE BRAND NAME IN THE GENERIC NAME BOTH IN THE DRUG DESCRIPTION. NOW, FOR A PHARMACY THAT POSED A LOT OF PROBLEMS. SO WE HAD SOME CONVERSATION WITH THEM AND I GUESS IT WAS, WONDERING IF YOUR AGENCY WORKS WITH PEOPLE LIKE ISMP? I THINK FROM A STATE BOARD PERSPECTIVE, THE PROBLEMS ARE MANIFEST WHETHER YOU SEE THEROSE MIDE AND LASIKS IN THE SAME DESCRIPTION, OKAY, WHICH ONE ARE YOU WRITING? THAT'S THE FIRST QUESTION THAT POPS UP T ISN'T SO IMPORTANT WITH THEROSE MIDE BUT IT MIGHT BE WITH ANTICONVULSANTS OR THE HORMONES OR A VARIETY OF OTHER NEUR'S THERAPEUTIC INDEX DRUGS. SO WONDERING IF YOU COULD COMMENT ON IF YOU'RE AWARE OF THOSE THINGS? IF YOU'RE WORKING WITH THESE KIND OF ENTITIES AND OTHER AGENCIES INCLUDING STATE BOARDS, NCPDP, ISMP. WHOMEVER. >> A GREAT QUESTION. I'LL GIVE YOU THE CANDID ANSWER AND THEN THE KIND OF MORE POLITIC ANSWER. THE CANDID ANSWER IS WAS I PERSONALLY AWARE OF THAT PARTICULAR ISSUE? NO. SO THANK YOU FOR LETTING ME KNOW ABOUT IT. THE SLIGHTLY LONGER ANSWER IS FIRST ON, ISMP, SO WE ACTUALLY -- TRISHA IS A PHARMACIST ON OUR STAFF. WE HAVE LITTLER WHO ACTUALLY WORK AT ONC BECAUSE WE CARE ABOUT THESE THINGS AND HAVE GOOD WORKING RELATIONSHIPS WITH A LOT OF FOLKS ACROSS THE SPECTRUM OF WHICH ISMS ONE. WE ARE HAPPY TO DIG DOWN INTO THAT PARTICULAR ISSUE. THERE IS THOSE KIND OF INFORMAL CONVERSATION THAT IS CAN HAPPEN TO A PERSON-TO-PERSON LEVEL AND THEN CONVERSATION THAT IS HAPPEN IN TERMS OF REGULATORY GUIDANCE AND NONREGULATORY GUIDANCE WE PROVIDE. THAT IS THE KIND OF THING I WOULD LOVE TO DIG INTO BECAUSE SPEAKING NOW AS STEPPING OFF MY KIND OF UBER POWERFUL PUBLIC SERVANT STEP AND COMING DOWN TO DR. WHITE AND I'M LIKE, I CAN SEE TIMES I WANT TO KNOW THAT INFORMATION BOTH OF THOSE AND THEN MORE IN THE BROADICALITY GORIZATION INFORMATION BUT THEN TIMES WHEN I WOULD WANT TO KNOW NO, SPECIFICALLY WHAT WAS IT? AND JUST TAKING IT OUT OF THE DISCUSSION, SAY AGO - THINKING OF OTHER MEDICATIONS AND OTHER FUTURE CLASSES OF MEDICATION THAT IS MIGHT BE PENDING OUT THERE. >> I SHOULD POINT OUT THAT THEIR GUIDANCE WAS INTENDED, FROM MY CONVERSATIONS, WAS INTENDED TO CLARIFY LOTS OF PROBLEMS. THE LOOK-A-LIKE, SOUND ALIKES. SO THEY WERE SOUNDING IT'S NOT ALL DRUGS. JUST MAINLY INTERESTED IN THESE. THE TROUBLE IS WHEN YOU'RE A DEVELOPER FOR A SYSTEM, YOU DON'T SAY LET'S JUST PICK OUT A CERTAIN BUNCH OF DRUGS AND COMBINE THEM THIS WAY. YOU SAY, IF THAT'S WHAT THEY WANT, HERE. AND THEY ALL COME THAT WAY. >> YES. OKAY. SO THAT'S GREAT. >> IT'S A SAFETY ISSUE. >> THAT SOUNDS LIKE A GREAT FOLLOW-ON DISCUSSION. >> I THOUGHT THAT THE CONFUSION WAS ADDRESSED BY THE TALL MAN LABELING NAMING? >> THAT'S INCLUDED IN THAT DISCUSSION AS WELL. TALL MAN SUPPORT WAS ONE OF THEIR GUIDANCE -- THAT WAS ALSO A TOPIC. I WILL PROVIDE THAT SHEET. I ALREADY HAVE IT. >> PERFECT. THAT'S WHY I THREW IT UP THERE. NOT BECAUSE IT'S JUST AN EMPTY GESTURE BUT IF THERE IS FOLLOW-UP, I WANT TO MAKE SURE YOU GET TO THE RIGHT PEOPLE. AND BEHIND YOU? >> IT'S TONY. >> HI, TONY! WE HAVE FRIENDS IN THE DARK! >> SPEAKING, I WAS REMINISCING WHEN YOU WERE TALKING ABOUT THOSE PILOTS. SO ONE OF THE NEW SORT OF GAPS IN e-PRESCRIBING THAT THE INDUSTRY IS BEGINNING TO TAKE ON IS COMPOUNDING. HOW DO YOU WRITE PRESCRIPTIONS FOR COMPOUNDS ELECTRONICALLY? JUST WONDERED IF ONC HAS DONE ANY WORK AROUND THAT? I KNOW TO SOME DEGREE, AHRQ SUPPORTS IT BUT ONLY IN THE INGREDIENT LEVEL. WONDERING IF YOU GAVE ANY THOUGHT THAT AND HOW WE MOVE THAT PIECE OF THE MISSING PUZZLE FORWARD? >> SO, FIRST OF ALL, LOVELY TO SEE YOU. SORT OF SEE YOU VAGUE DETAILS OF YOU BUT AT LEAST TO HEAR YOUR VOICE. SO SECOND OF ALL, JUST BROADLY, AGAIN, GOING FROM BROAD TO MORE SPECIFIC, COMPOUNDING IS A BIG DEAL AND WE HAVE ALL HEARD ABOUT IT ON THE US. >> ALL THE DIFFERENT NAIS WHICH COMPOUNDING IS A BIG DEAL. -- DIFFERENT WAYS IN WHICH -- IT'S THE SPOKE PART OF -- PARTS OF IT ARE THE SPOKE WHEN THE PHARMACIST HAS TO GO UNDER THE HOOD AND PUT SOMETHING TOGETHER BUT THEN FOR COMPOUNDING PHARMACIES IT'S A BIGGER SCALE TO IT. CERTAINLY, OUR COLLEAGUES, THE FDA, TYPE OF COLLEAGUES, ARE PAYING CAREFUL ATTENTION TO THIS. WE ARE WORKING WITH THEM. AGAIN, OUR KIND OF TAKE ON THIS IS THE INFORMATION SYSTEMS THAT SUPPORT THAT SO WHICH GETS AT THE QUESTION YOU'RE ASKING ABOUT. GETTING DOWN TO THE MORE SPECIFIC. I KNOW WE HAD DISCUSSIONS ON IT. I CAN'T SAY WE HAVE THIS ONE THING THAT IS IN OUR GUIDANCE THAT THE POINT THAT ADDRESSES THAT, BUT THAT IS A FOLLOW-UP THAT I WOULD SAY LET'S HAVE THAT, IF YOU WANT TO HAVE IT, LET'S HAVE THAT DISCUSSION WITH TRISHIA WHO IS OUR PHARMACIST. BUT IT IS A CRITICAL ISSUE BROADLY FOR THE HEALTH CARE SYSTEM. SO YES, WE CARE ABOUT IT. >> HELLO. >> MY NAME IS LEE PETERS AND WE DEVELOP ENTER OPERABLE APPLICATIONS FOR NMRs. DOES THE ONC INTEND TO STICK WITH THE CCD FORMAT OR EXPLORING THINGS SUCH AS HL7 FIRE OR OTHER ALTERNATIVES? >> GREAT QUESTION. SO, CCD FORMAT HAS BEEN SOMETHING THAT WE HAVE ABSOLUTELY BEEN SUPPORTIVE OF RIGHT IN OUR PREVIOUS REGULATIONS AND THAT IS BEING USED WITH THE SYSTEM. I THINK AS RUBBER MEETS THE ROAD, YOU'RE SEEING SOME OF THE WAYS IN WHICH CCD HELPS AND SOME OF THE WAYS IMPLEMENTATION OF CCD DOESN'T ALWAYS HIT THE MARC. I GET DOCTORS CALLING ME SAYING, I HAVE 700 PAGES ON EACH PATIENT BECAUSE WE ARE PRINTING OUT THE WHOLE CCD. SO WE ARE TAKING A GOOD HARD LOOK AT THAT AND IN PARTICULAR, WE ARE INTERESTED IF CONSTRAINING SOME OF THE PORTIONS OF THE INFORMATION THAT IS CONTAINED IN THE CCD. WE HAVE ACTUALLY AWARDED WORKING RELATIONSHIP WITH HL7 SPECIFICALLY TO DRILL DOWN AND TAKE A LOOK AT THAT. ON THE FIRE ISSUE, SO FIRE IS A REALLY INTERESTING NEW APPROACH TO HOW WE ARE EXCHANGING A LOT OF INFORMATION IN HEALTH CARE. IT CAN BE APPLICABLE TO THIS PARTICULAR INCIDENCE BUT YES, WE ARE REALLY SUPPORTIVE OF THAT AND ACTUALLY WE HAVE KIND OF GOTTEN BEHIND -- THERE IS A FIRE IS AN HL7 INITIATIVE. THERE ARE SPECIFIC PRIVATE SECTOR INITIATIVES THAT ARE IN SUPPORT OF THE DEVELOPMENT OF FIRE WITH LIKE THE AGER NAUGHTS. FOR WHICH, I AM GOING TO CLAIM A TINY BIT OF CREDIT FOR THE NAME BECAUSE THEY CAME TOGETHER AFTER DISCUSSION OF THE JASON REPORT THEY FUNDED. SO JUST ANY HOW. SO AND I THINK WE HAVE POINTED TO IT ACTUALLY IN A COUPLE OF DIFFERENT PLACES IN OUR GUIDANCE, OR POE PROCEEDS GUIDANCE. SO WE ARE VERY SUPPORTIVE OF IT. I WOULD ALSO ADD THAT I LOVE INNOVATION AND I SUPPORT INNOVATION. I HAVE ALSO GOT A RESPONSIBILITY TO THE AMERICAN FLICK MAKE SURE THAT THIS STUFF ACTUALLY WORKS AND JUST BECAUSE WE SAY IT IS INNOVATIVE DOESN'T MEAN IT WORKS. SO THE APPROACH WOULD SAY WE ARE TAKING FOR FIRE IS A TRUST BUT VERIFY APPROACH. THAT IT IS IN DEVELOPMENT AND WE WANT TO SEE IT MOVE FORWARD. WE LOVE INDUSTRY. I WOULD LIKE NOTHING BETTER THAN TO BE ABLE TO LIKE GOOD JOB PRIVATE SECTOR. IT'S WORKING WELL. BUT I WANT TO MAKE SURE IT'S WORKING WELL. SO WE ARE PAYING VERY CLOSE ATTENTION TO T GREAT QUESTION. >> THANK YOU. OTHER QUESTIONS? I LIKE THE MUSIC. >> [ OFF MIC ] [ LAUGHS ] THANK YOU VERY MUCH FOR YOUR TIME AND ATTENTION. I HOPE YOU HAVE A GREAT REST OF THE JAMBOREE. [ APPLAUSE ] >> I'M PROBABLY THE LEAST EDUCATED PERSON STANDING HERE OR WHO WILL STAND UP HERE TODAY. THERE IS ONE ADVANTAGE TO THAT WHICH IS THAT IT MEANS THAT YOU CAN ONLY GO ON THE FACT THAT THE DRUG DATA HAS TO MAKE SENSE. IT HAS TO MAKE INTERNAL SENSE AS YOU PROCESS IT BECAUSE YOU DON'T REALLY UNDERSTAND FUNDAMENTALLY WHAT IT MEANS. YOU'RE NOT A PHARMACIST. YOU'RE NOT A DOCTOR. YOU'RE JUST A DRUG GUY. COMING FROM A POSITION OF IGNORANCE, SOMETIMES YOU CAN ACTUALLY FIND THINGS THAT PERHAPS SOMEBODY WHO DOES KNOW A LOT OF THINGS WILL OVERLOOK OR SKIP BY OR AT LEAST THEY CAN UNDERSTAND WHAT IS GOING ON. BECAUSE YOU CAN'T AND YOU'RE PERPLEXED BY IT. IT MEANS THOSE THINGS WILL JUMP OUT TO YOU MORE. I'M GOING TO TALK ABOUT ENDING UP WITH SOMETHING LIKE WHAT IS ON THE LEFT-HAND SIDE OF THE SCREEN THERE. NOW IF YOU USE GOOGLE OR BING OR SOMETHING AND YOU SEARCH FOR DRUGS, FOR CERTAIN PERCENTAGE OF DRUGS YOU END UP WITH A BOX ROUGHLY LIKE WHAT IS ON THE SIDE OF THE SCREEN T SUMMARIZES THEIR GUESS ABOUT PARTICULAR DRUG PRODUCTS. OFTEN YOU HAVE TO LOOK UP UNDER BRAND T WON'T WORK UNDER GENERIC OR VICE VERSA. AND YOU WILL END UP WITH A SUMMARY WHAT HAVE THEY CURRENTLY HAVE AND VERY MANY CASE IT IS IS OUT-OF-DATE. THEY KEEP IT IN BING'S CASE THEY KEEP IT IN THEIR GRAPH STORE AND IN GOOGLE'S CASE ON THE RIGHT-HAND SIDE COMES FROM THE KNOWLEDGE GRAPH. SO OBVIOUSLY THEY ARE ONLY AS GOOD AS THE DATA THEY HAPPEN TO HAVE IN THEIR GRAPHS. JUST BECAUSE IT'S COMING FROM THE SEARCH ENGINE DOESN'T MEAN IT'S CURRENT. ONE TOPIC THAT COME UP OVER THE TALKS IS CURRENCY. IT'S EASY TO ESTABLISH SOMETHING. IT'S DIFFICULT TO MAINTAIN IT OVER TIME. AND THEY HAVE THE SAME PROBLEMS EVERYBODY ELSE DOES. SO ONE OF THE TASKS WE HAD WAS TO GO BACK TO ORIGINAL SOURCES PERIODICALLY AND TO MAINTAIN CURRENT REPRESENTATIONS OF WHAT THOSE ORIGINAL DATA SOURCES SAY ABOUT DRUGS OUT THERE AND REDUCE IT TO A FORM SO THAT YOU CAN PRODUCE SUMMARIES LIKE YOU SEE THERE ON THE LEFT. AND I THINK I HAVE GOT UP THERE IT IS AUTOMATICALLY GENERATED SO AGAIN COMING FROM A POSITION THE DATA GUY IGNORANCE, THIS IS NOT SOMETHING WHERE WE HAVE A PANEL OF PEOPLE THAT WILL ADJUDICATE ON THINGS. WE HAVE TO RELY ON WHAT IS ACTUALLY IN THOSE SOURCES THEMSELVES. JUST LIFTING FROM TOP-TO-BOTTOM, SOME THINGS COME FROM RX SNOWSTORM BLURBS, SOME BASIC DESCRIPTIONS ABOUT USES AND INDICATIONS FROM SPLs. I'M TALK ABOUT WHICH IN A MINUTED. SOME THINGS COME FROM ORANGE BOOK IF YOU WANT TO KNOW IF SOMETHING IS AVAILABLE GENERICALLY OR NOT. WHEN WAS IT FIRST MADE AVAILABLE? AND THEN YOU GET THE DRUG CLASS FROM FDA. SOMEBODY ELSE MENTIONED THAT BEFORE AND THERE IS OTHER INDICATIONS THAT PARSED FROM SPL, SOMETIMES AND WILL SOMETIMES NOT AND I'LL TALK ABOUT THAT IN A MINUTE. SO TALKING ABOUT THE FLOW HERE GOING FROM LEFT TO RIGHT. I'M NOT GOING TO TALK MUCH ABOUT THE RAW FORMS. ONE OF THE BIG ISSUES FOR MAINTENANCE AND FOR PRODUCING THESE IS THAT THE BASIC RAW DATA IS PRODUCED BY DIFFERENT ORGANIZATIONS AND DIFFERENT SCHEDULES. ORANGE BOOK IS EVERY FIVE WEEKS OR SO AND CAN COME AT A DIFFERENT TIME AND SOMETIMES THE FORMAT CHANGES. PURPLE BOOK IS PDFs AND YOU HAVE TO SCAN THE SITE PERIODICALLY AND WE HAVE BACKGROUND JOBS THAT DO THAT. RxNORM AS STEWART NELSON SAID, IS THE NICEST FORM AND EASIEST ONE TO USE. AND THEN THE SPLs THEMSELVES. AND THE IDEA IS TO TAKE ALL OF THOSE THINGS ON A PERIODIC BASIS AND INTEGRATE THEM INTO ONE FORM. WE ACTUALLY COLLECT ALL OF THESE SOURCES EVERY MONTH ON A GET CALLED SIMPLE KNOWLEDGE SERVICE. SO IF YOU'RE TECHNICAL, YOU CAN LOOK THAT UP AND YOU CAN SEE THE LATEST REDUCTIONS THAT EVENTUALLY PRODUCE THOSE CARDS. WE PUT THEM INTO A FORM CALLED GRAPHS AND I MENTIONED A MINUTE AGO THAT BEHIND GOING SELL A KNOWLEDGE GRAPH, BEHIND BING IS A GRAPH, BEHIND FACEBOOK AN OPEN GRAPH, BEHIND LINKED IN, MOST PEOPLE HERE ARE ON LINKED IN. IT IS A GRAPH. AND A GRAPH IS A VERY GOOD FORM FOR INTEGRATING MULTIPLE SOURCES OF DATA AND SHOWING UP DISCREPANCIES AND REDUNDANCY AND ALSO THE NOVELTYIES AND DIFFERENT DAYSA SOURCES F THERE WE PRODUCE DOCUMENTS ON CARDS OR WHAT I'M CALLING SUMMARIES ON THE LEFT-HAND SIDE. SO LET ME GET INTO THE DETAIL OF THAT. WHY GRAPHS? THE BIG THING ABOUT A GRAPH FORM IF YOU REMEMBER BEFORE, AND THE OTHER SLIDE, SOME OF THOSE DATA SOURCES ARE RELEASED AS PDFs OR RFF, THE RxNORM FORM. THEY ALL HAVE 70s WEAKNESSES. THE BIG STRENGTH GRAPHS IS IT PRIVILEGES LINKS. WHAT IT DOES IS FIGHTS YOU PUTTING IN JUST STRINGS ALL OVER THE PLACE T MAKES YOU LINK THINGS TO EACH OTHER. SO I'M STANDING HERE. I'M THAT THE MEETING A NODE IN THE GRAPH. JOHN IS A NODE IN THE GRAPH. JOHN KNOWS PEOPLE. THOSE PEOPLE LIKE THE REDSKINS. THE REDSKINS HAS A PLAYER'S ROSTER AND IT GOES ON AND ON. SO YOU CAN QUICKLY GATHER LOTS OF INFORMATION EVEN IF IT WAS DEFINED IN DIFFERENT PLACES. AND SUDDENLY WHAT USED TO LOOK VERY DISPARATE ACTUALLY IS SOMETHING THAT SUPPORTS TO MAKE SENSE T ALSO MEANS THAT YOU CAN QUICKLY ANALYZE THE REDUNDANCY AND THE OVERLAPS AND OTHER THINGS. HERE YOU SEE A PARTICULAR NDC CODE AND IT WILL BE LINKED INTO RxNORM, WHICH IS THE RED. THE ORANGE BOOK IS THE ORANGE AND SO THEY ALL BASICALLY INTERLINK TOGETHER. WE DO THESE GATHERINGS AND REDUCTIONS THROUGH THAT PIPELINE ONCE A MONTH ON RxNORM SCHEDULE. SO BECAUSE JOHN TOOK LABOR DAY OFF, THE LAST RELEASE WAS THE TUESDAY AFTER THE FIRST MONDAY OF THE MONTH, WHICH IS RxNORM'S RELEASE. WE TAKE THE SPLs FROM THE LAST WEEK OF THE MONTH AND THE LITTLER ON WHATEVER SCHEDULE THE MOST RECENT JUST BEFORE THE RxNORM RELEASE. SO FOR EXAMPLE, ORANGE BOOK WAS ACTUALLY RELEASED THREE DAYS AFTER THIS RELEASE SO THE CURRENT ONE THAT SITE IS MORE UP-TO-DATE THAN THE VERSION WE ARE USING TO DO THE DRUG SUMMARIES. YOU CAN SEE THE DIFFERENT SOURCES ARE USED FOR DIFFERENT THINGS. SO LABEL PRODUCT FROM SPLS AND BLURBS AS WELL. BRANDS, DOSES, INGREDIENTS, APPLICATIONS AND PATENTS FROM ORANGE BOOK. CLASSES AND ALL THE USAGES AND THINGS BELOW ARE MORE SUPPORTING SCHEMES. SOMEBODY MENTIONED CODIFYING EVERYTHING. WHEN YOU PUT THINGS IN A GRAPH, YOU WANT CODES. YOU WANT NOSED. YOU WANT THINGS LINKING TO EACH OTHER. WE DON'T WANT A BUNCH OF STRINGS. THIS VERY MUCH PRIVILEGES CODIFYING EVERYTHING. SO WE HAVE THIS BIG GRAPH AND THE FIRST THING THAT JUMPS OUT IS THAT LOTS OF THINGS DON'T LINK UP. THIS IS THE PROBLEM WITH MAINTENANCE. HOW DO YOU KNOW WHEN TO KEEP THINGS AROUND ANYMORE? SO IF YOU LOOK AT THE TOP LEFT HAND PIE CHART, YOU SEE THE TOTAL NUMBER OF SPLs THAT WE CAN INDEX FROM THE LAST WEEK OF LAST MONTH. AND YOU'LL SEE GRAY. THESE ARE THE THINGS THAT WE DON'T ACTUALLY TAKE. THERE IS ONE THING WHICH IS CATEGORY EXCLUDED. I WAS HOPING THE PERSON WHO DID HOMEOPATHIC SPLs WAS HERE BECAUSE MY PICTURE OF HIM IS HE IS A WHOLE FOODS HIPPIE-TYPE GUIDE. WE EXCLUDE THOSE. WE EXCLUDE ANIMAL SPLs AND A FEW OTHERS. THERE ARE ALSO A SET OF SPLs THAT ARE NOT INDEXED BY RxNORM. SO WHEN I SAID CURRENT DRUGDOCS IT WAS THAT UNION OF CURRENT SPLs AND I UNDERSTAND THINGS ARE CURRENTLY SOLD THAT ARE NOT IN SPS AND ALSO INDEXIBLE BY RxNORM. AND AGAIN, THE CURRENT IS WITHIN THAT PARTICULAR BOUND I JUST SAID. BUT IF YOU LOOK ON THE TWO BARS ON THE RIGHT, YOU'LL SEE THAT MOST OF THE THINGS NOT INDEXED BY RxNORM ARE OVER-THE-COUNTER PRODUCTS. SO THEY ARE LESS IMPORTANT. AND THERE ARE SOME OOZE I HIGHLIGHTED THERE IN RED, THAT AREN'T INDEXED THAT IS A LIST WE HAVE AND OBVIOUSLY WE WANT TO LOOK THROUGH THOSE AND WE TALK ABOUT VARIOUS THINGS AS WE GO ALONG BECAUSE IT WOULD BE GOOD IF THAT BAR ON THE RIGHT WAS COMPLETELY ORANGE AND THEN YOU WOULD BE COVERING EVERY SINGLE THING WITHIN THE SPLs. THIS GETS US DOWN TO A NUMBER OF SPLs. 52,596 OUT OF 77,000. THOSE ARE THE PRODUCTS WE WILL TRY TO PRODUCE THOSE BOXES FOR. YOU NEVER WANT TO GET A MESSAGE YOU'RE STANDING UP HERE. AT THE BOTTOM YOU'LL SEE SOME NUMBERS ABOUT RxNORM'S INDEXING ABILITY. SO, THE TOTAL NUMBER OF INGREDIENTS OR INGREDIENT COMBINATIONS NEEDED TO INDEX THE PRODUCTS WITHIN THE 52,596SPLs, ARE 2,305. SO THAT IS THE NUMBER OF INGREDIENTS IF YOU WERE TO PRODUCE AN INGREDIENT OR MULTI-INGREDIENT INDEX THAT YOU WOULD NEED. RxNORM ITSELF HAS 10,717 INDIVIDUAL INGREDIENTS AND MULTIINGREDIENTS, 3,977. WE ONLY NEED A FRACTION OF THE INGREDIENTS TO DO THIS JOB. SO RIGHT THERE YOU SEE IF YOU IMAGINE A GRAPH, THESE THINGS STANDING OUT IN SPACE GOING WHAT AM I FOR? NOTHING AS FAR AS WE ARE CONCERNED. IN THE MIDDLE, YOU SEE DOSE FORMS. AND THAT IS REALLY THE THING WE DO THE BOXES ON. SO IN OTHER WORDS, WE WANT ORAL TABLETS. THAT'S BASICALLY THE INDEXED FORM THAT WE WANT FOR THE BOXES AND THERE YOU HAVE JUST UNDER 4000. AGAIN RxNORM HAS 18.5000 ODD DOSE FORMS. WE DON'T ACTUALLY NEED THE MAJORITY OF THEM. AND THEN AT THE RIGHT YOU GET DOWN TO DRUGS WHICH INCLUDE STRENGTH AND NOW YOU'RE GETTING CLOSER TO THE NUMBER. SO IF YOU PUT IN ALL THE STRENGTHS AVAILABLE, HAVE YOU ABOUT 8000. YOU HAVE OVER 20,000 HERE. I'LL SHOW AN EXAMPLE IN A MINUTE AS TO WHY THERE IS AN SCD AND YET IT DOESN'T LINK TO ANYTHING. BUT OBVIOUSLY OVER TIME, AND THIS GETS INTO THE MAINTENANCE STORY IN PART, OVER TIME, THERE ARE PRODUCTS THAT ARE NO LONGER SOLD, STRENGTHS NO LONGER AVAILABLE BUT THEY STILL WILL BE IN RxNORM N SOME CASES THEY ARE STILL IN THE PRESCRIBABLE SET. EVEN THOUGH THEY ARE NOT CURRENTLY PRESCRIBABLE. MAINTENANCE IS HARD. BUT ONE THING THIS SORT OF REDUCTION DOES IT IT GETS YOU DOWN TO RIGHT NOW, THIS POINT IN TIME, WHAT IS IT THAT WE ACTUALLY NEED IF WE WERE TO COVER WHAT THE FDA PUT IN SPLs THAT WE ACTUALLY COVER? SO, DOCUMENTS. IF YOU THINK ABOUT -- AGAIN YOU'RE ON FACEBOOK AND YOU'RE LINKING ALL OVER THE PLACE AND YOU CAN FOLLOW LINKS TO VARIOUS THINGS IF YOU WERE TO CLICK AROUND VARIOUS THINGS OR IF YOU WERE MARC ZUCKERBERG, YOU COULD DO IT BECAUSE YOU HAVE THE RAW UNDER FACE. WHAT A FACEBOOK DOES, WHAT A GOOGLE DOES, IS THEY PRESENT YOU WITH A CERTAIN PERSPECTIVE ON THEIR GRAPH. IF THEY WERE TO LITERALLY PUT YOU IN THE MIDDLE OF THEIR GRAPH, YOU WOULD GET LOST AND THEY WANT TO DIRECT YOU SO THEY CAN FEED YOU CERTAIN ADVERTISEMENTS. AND SO WHAT THEY DO IS OVERLAY DOCUMENTS ON THE GRAPH. A DOCUMENT IS JUST A PERSPECTIVE, HIERARCH ALPER SUSPECT THEY'VE GATHERS UP CERTAIN THINGS. SO WHAT WE WANT TO DO -- HIERARCH ALPER SUSPECTIVE -- THESE ARE THE VARIOUS DOSE FORMS AND VARIOUS BRAND AND HOW MANY SPLs ARE AVAILABLE. THAT IS ONE SET OF THINGS AND THAT IS FROM RxNORM. BUT REALLY WE ARE IN THE BOXES AND THEY ARE BASED ON A CD. AND THEY GATHER UP INTO THESE DOCUMENTS ALL THE STRENGTHS, ALL THE ORANGE AND ALL THE PATENTS AND PRODUCTS AND ALL THE BLURBS WE NEED FROM SPLS AND ALL THE USES. THIS IS GOING INTO THE GRAPH SAYING I WANT THIS PARTICULAR PERSPECTIVE SO THAT I CAN NOW PRODUCE THESE SUMMARIES. AND AGAIN, THERE IS NOTHING ABOUT THIS TECHNIQUE THAT ISN'T THE EXACT SAME TECHNIQUE NOW USED IN ALL OF THE ORGANIZATIONS I JUST MENTIONED. THIS IS ALL THEY ARE DOING AS WELL T JUST HAPPENS TO BE DONE ON HEALTH DATA. ONE OF THE THINGS THAT JUMPS OUT WHEN YOU START DOING THAT, BECAUSE NOW YOU HAVE A DESCRIPTION OF THINGS GATHERED TOGETHER THAT SHOULD BE CONSISTENT AND MAKE SENSE, IS THAT IT JUMPS OUT AND THEY DON'T MAKE SENSE AND WHEN THEY ARE NOT CONSISTENT. SO, IT IS A QA TOOL BEFORE YOU EVER PRODUCE THOSE CARDS AND SUMMARIES AT THE EVENED. IN SOME CASE IT IS FORCES YOU TO MANUALLY PUT IN OVERRIDES BUT THOSE OVERRIDES AT LEAST CAN BE RELEASED EXPLICITLY AND YOU CAN SAY I HAVE TO DO THESE OVERRIDES, NO GUESS WORK. NO PHARMACIST WAS INJURED IN THE PRODUCTION OF THIS DATA. IF YOU LOOK, HERE IS THREE SIMPLE EXAMPLES. SO ON THE TOP LEFT-HAND SIDE, AND IT'S HARD TO READ UP THERE, I KNOW. BUT MERCK WITHDREW A DRUG, NO CURRENT SPLs FOR THAT DRUG. IN THE ORANGE BOOK, THE APPLICATIONS WERE WITHDRAWN. BUT RxNORM SAYS IT'S IN THE PRESCRIBABLE FIT. SO, CAN I PRESCRIBE THAT? SURE. IT'S IN THE PRESCRIBE ANNUAL SET. I CAN PRESCRIBE IT BUT NO YOU CAN'T. IT'S NOT ACTUALLY IN THE U.S. MARKET RIGHT NOW. NOTHING IN THAT SET OF RxNORM TO TELL YOU THAT. SO IN THIS CASE, BOTH THE SPLs AND THE ORANGE BOOK IF YOU LIKE OUTVOTE THAT RxNORM IS RIGHT AND BECAUSE WE INSIST BOTH SP R AND RxNORM THAT WON'T SHOW UP IN OUR INDEX. GOING TO THE RIGHT-HAND SIDE, YOU GET INTO, YOU CAN LOOK AT THE SIGNATURES, THE DIFFERENT DRUG SOURCES PRODUCED. SO RxNORM AND SOMEBODY SAID THIS EARLIER, NO SALTS INVOLVED. ORANGE BOOK, SALTS ARE INVOLVED, SO ORANGE BOOK THERE IS ONE OF EACH. THAT MEANS FOR THIS DRUG YOU HAVE AGREEMENT RxNORM IS NOT GATHERING TOO MANY THINGS. IT'S NOT SAYING CERTAIN ORANGE BOOK THINGS ARE THE SAME AND ORANGE BOOK DISTINGUISHES AND EVERYBODY IS HAPPY. WHAT YOU SEY SHEAR IN THE SPLs AND YOU LOOK AT THE DIFFERENT SIGNATURES, INACTIVE AND MOSEY, YOU SEE THIS SLIGHTLY DIFFERENT NUANCE. THIS IS DOWN TO MORE A POLICY THINGS. SHOULD THE SPL, IF THIS DOESN'T PUT US OFF BECAUSE IT'S NOT A PRIME RESOURCE FOR THE INFORMATION, BUT SHOULD THE SPL AGREE WITH ORANGE BOOK? SHOULD THE SPLs FOR EXAMPLE, FOR THE ACTIVE INGREDIENT BE USED IN WHAT THE ORANGE BOOK SAYS THE ACTIVE INGREDIENT SAYS OR SHOULD THEY USE THE VARIATION FROM WHICH THERE ARE UNICODES AS WELL AS THE ORANGE BOOK SOURCE? IT GETS DOWN WHEN YOU HAVE THINGS CODIFIED IN A GRAPH, MY UNDERSTANDING RIGHT NOW IS THAT KIND OF THING ISN'T ENFORCED AS THE FDA CHECKS SPLs. BUT IF YOU HAVE ALL THESE SOURCES IN A GRAPH, YOU COULD ENFORCE ORANGE BOOK CONSISTENCY OVER THE SPLs IF YOU WANTED TO. DEVELOPING DRUGS IS EXPENSIVE. AND MAT ROSENBURG HELPED ME WITH THIS EARLIER IN THE YEAR. ARE YOU HERE? YES! SO, IF YOU WANT TO DEVELOP A DRUG AND YOU DON'T WANT TO GO THROUGH THE LICENSING PROCESS, YOU JUST WANT TO JUST RELEASE IT ON THE TO THE MARKET, YOU CAN USE 075659. SO JUST MAKE AN SP R AND STUFF THAT IN THERE. THERE ARE 17 DIFFERENT DRUGS AVAILABLE WITH THAT. ONLY ONE SHOULD HAVE IT IT'S WHAT WE CALL THE WANDERINGANDA. SO BASICALLY IT WANDERS AROUND SPLs BECAUSE OBVIOUSLY SOMEONE CUT AND PASTED IT. AND IT SHOWS, I THINK, PERHAPS NOW THESE CHECKS ARE IN, BUT THERE IS NO CHECK AS LONG AS SIN TACTICALLY THAT I IN. D IN THE SPV RIGHT, NO CHECK TO SAY WHETHER SEMANTICALLY MAKES FERENCE WHAT THE ORANGE BOOK SAYS THAT SPV FOR. AND THESE ARE MAINLY PROBLEMS IF YOU WILL, ABOUT RELABELLERS. SO FAIRLY EARLY ON, WE REALIZED AS THEY SAY, BEWARE OF GREEKS WEARING GIFTS, BEWARE OF RELABELLERS WEARING SPLs. THOUGH THEY ARE IN THE INDEX AND IN THE DOCS, WE DON'T USE THEM WHEN WE PRODUCE SUMMARIES. VERY OFTEN THEY ARE NOT UP-TO-DATE. SOMETIMES THEY SAY A PROSOUCT IS JUST SOLD IT'S ACTUALLY NOT. A LOT OF TIME THE LINGERING THINGS THAT ARE PUZZLING ARE RELABELLER ISSUES. AND AGAIN YOU HAVE THIS WHERE IT WANDERS AROUND. IF YOU THINK ABOUT IT FROM A TECHNICAL PERSPECTIVE. IF YOU START COUNTING THE RELABELLER STUFF LIKE THIS, THE COMPLICATION IS IT PULLS IN A LOT OF STUFF. IT PULLS IN ANY APPLICATIONS FROM ANY PRODUCTS THAT ARE REFERENCED. NOW WE ARE GOING TO BE PULLING IN ALL THE PRODUCTS BECAUSE ONCE THATANDA SHOWS UP, IT WILL LINK OUT TO ALL THE PRODUCTS WHO IN TURN WILL NULL THEIR INGREDIENTS AND ATENTS AND THEN EVERY ONE OF THESE PRODUCTS IS FULL OF ALL OF THIS MUSH. ATENTS AND OTHER THINGS THAT DON'T APPLY TO THEM. PATENTS -- AND THESE ARE THE KIND OF CONSISTENCY CHECKS THAT ARE AVAILABLE WHEN YOU LOOK AT SOMETHING LIKE THIS BUT ALSO YOU HAVE TO HAVE OVERLAY FILES TO ACCOUNT FOR THEM BECAUSE THE DATA SOURCES ARE GOOD, CERTAINLY THE CONSISTENCY BETWEEN THEM DOESN'T SEEM TO BE APPLIED RIGHT NOW. ON THIS SCORE, I REMEMBER ONE THING IN THE FEEDBACK LOOP AND JOHN MENTIONED TAMMY. I NEVER MET YOU BEFORE. BUT WHEN I CAME IN TO SEE YOU LAST YEAR AND I HAD A A LIST OF INCONSISTENCIES, YOU SAID WE HAVE TO FEED THAT TO TAMMY. I ALWAYS REMEMBERED THINKING TO MYSELF, WHAT DOES TAMMY STAND FOR? THIS MUST BE SOME FANCY SYSTEM. THIS MUST BE A FANCY SYSTEM THEY HAVE AND I ACTUALLY ASKED WHAT DID TAMMY STAND FOR. AND HE LOOKED AT ME COMPLETELY BLANK BECAUSE OBVIOUSLY IT HAD NEVER OCCURRED DO HIM THAT TAMMY WASN'T A PERSON. AND IT NEVER OCCURRED TO ME TAMMY WASN'T A PERSON. AND IT TOOK ME A WHILE TO CLEAR UP THE FACT THAT TAMMY SITS DOWN THE HALL. OBVIOUSLY THERE IS A MANUAL NATURE AND THERE ARE PEOPLE BEHIND THIS. AND IT'S GREAT TO COME HERE AND SEE THOSE FACES. THE LAST THING SYMANTIC CHECKS THIS GETS INTO THE WEEDS ADMITTEDLY BUT REMEMBER WHEN YOU'RE SHOWING THE DOSE FORM PER CARD, CAPSULE AND TABLET ARE DIFFERENT. THEY ARE DESIGNATED DIFFERENTLY WITH DIFFERENT COUEYS. AND HERE YOU HAVE A CASE WHERE THE SPL, STRUCTURED PART OF IT, SAYS I'M A CAPSULE DELAYED REPOLICE THAT'S CODED DATA. AND QUITE RIGHTLY, WHATEVER ROUTINE JOHN IS RUNNING OR TAMMY IS RUNNING, YOU WILL PICK UP THE DELAYED RELEASE ORAL CAPSULE FOR THAT AND YOU'RE RIGHT. BECAUSE YOU'RE GOING ON THE STRUCTURED DATE A THE ORANGE BOOK, IT SAYS HOLD ON. THAT IS A TABLET DELAYED RELEASE. THAT'S NOT THE RIGHT THING. IN FACT, WHEN WE INTEGRATE NIECE DOCUMENTS, WE START AGAIN PULLING IN APPLICATIONS THAT ARE NOT -- YOU DON'T AND WANT YOU START TO GET THE DOCUMENT GETS TOO BIG. AND SO YOU START SEEING MULTIPLE FDA ORANGE BOOK SIGNATURES. YOU CAN SEE THERE IS MULTIPLE SIGNATURES. THAT IS WHAT SIGNALS THINGS. SO NOW MANUALLY YOU GO IN AND LOOK AT THE IMAGES AND THE OTHER THINGS IN THE LABEL AND IT'S VERY CLEAR T SHOULD HAVE BEEN A TABLET. HERE THE SPL STRUCTURE DATA IS WRONG. WHICH SETS RxNORM WRONG, WHICH MEANS THEN YOU'RE PULLING IN LOTS OF STUFF BUT BY ROLLING THESE THINGS UP TOGETHER AND SAYING, LITTLE GET-TOGETHER IN ONE DOCUMENT, ORANGE BOOK AND SPLs, YOU HAVE DISCREPANCY JUMP OUT AND YOU CAN CORRECT THEM. THEN YOU HAVE TO MANUALLY CORRECT THEM. TELL THE TAMMY SYSTEM AND HAVE THEM FIXED. THAT'S THE ONLY WAY AROUND IT. SO, THE IDEA OF THOSE BLURBS IF YOU REMEMBER IN THE BOX ON THE TOP, THAT IS THE HUMAN READABLE TEXT PART. WHERE ARE YOU GOING TO GET THAT FROM? AND ONE ISSUE IS THAT A LOT MORE SPLs THAN YOU LIKE. IT WILL BE IDEAL IF FOR LIPITOR ORAL TABLET, THERE WAS ONE BLURB YOU COULD JUST GO TO AND THE SPL'S REFERENCED IT OR DID A BIG BATCH JOB AND INTEGRATED IT RATHER THAN SOMEBODY IN INDIA CUTTING AND PASTING IT INTO EACH SPL OVER TIME. AND SO FOR LIPITOR IF YOU LOOK AT THE DOCUMENT FROM THIS MONTH, THERE IS 101SPLs. WHICH ONE ARE WE GOING TO TAKE THE BLURB OUT OF? WHICH ONE ARE WE GOING TO EXTRACT THAT DATA FROM? AND THIS IS WHERE WE HAVE TO COME UP WITH THE NOTION THAT THERE IS SAY MASTER OR DEFINING SPL. AND IN SOME CASES, IT IS VERY CLEAR-CUT WHAT THAT IS AND IN OTHER CASES YOU NEVER TRUST YOUR RELABELLER OR YOU DON'T KNOW. SO YOU CAN COME UP WITH WITH THIS ONE SPL. LIPITOR IS PRETTY CLEAN. SO IF YOU FOLLOW THE LOGIC ON THE SCREEN HERE. YOU HAVE 101 TO DEAL WITH. SO REMEMBER WE STARTED WITH OVER 52,000. WE ONLY WANT ONE FOR EACH OF THE 3,990SCDFs WHICH MEANS WE ONLY WANT 7.6% OF THE SPLs. THAT'S THE REDUCTION. THE ORANGE BOOK LUCKILY HERE HAS ONE REFERENCE LISTED DRUG. AGING MILLIGRAM VERSION ASSOCIATED WITH THIS PARTICULAR APPLICATION OR NDA. SO FROM THAT NOW WE KNOW LET'S LOOK INSIDE THE LIST OF PRODUCTS HANGING OFF THE SCD AGING MILLIGRAM ORAL TABLET AND WE FIND THERE IS ONLY ONE THAT MEETS THE MATCH OF THAT APPLICATION AND THEN GO DOWN TO ITS SP NOTES AND THE MASTER SPL TO RULE THEM ALL. THAT'S THE LORD OF THE RINGS OF LIPITOR. RIGHT THERE. AND THAT'S THE ONE WE THEN TAKE THE BLURB OUT OF. THERE IS SOME OTHER CHECKS YOU DON'T WANT TO TAKE SOMETHING THAT IS MUCH OLDER THAN THE MOST RECENT ONE. THERE IS VARIOUS WARNINGS IF THE ALGORYTHM SEEMS TO BE GOING AWRY. BUT BROADLY SPEAKING, THIS IS THE IDEAL CASE AND THE OTHERS WILL HAVE TO KICK IN IF YOU DON'T HAVE NDAs USED ANYMORE AND IT'S ONLYANDAS AND WHICH ONES DO YOU CHOOSE? SO THIS GETS YOU TO THE CARD. SO AGAIN, BLURB. BRANDS FROM RxNORM, NAMES, THAT CAN GET A BUSY -- LIKE NECKS YUM 24-HOUR WHICH HAS ITS OWN NDA, THE GENERIC FORM -- IS THE OVERTHE COUNTER FORM OF 20 MILLIGRAM. SO THERE WERE MISSING THE BRAND NAME BECAUSE WE DIDN'T TAKE IT FROM THE SPL. WE TOOK IT FROM RxNORM AND RxNORM DOESN'T DISTINGUISH THAT BLAND NAME. SO SOME THINGS YOU MISS OUT WHEN YOU CHOOSE ONE SOURCE OR ANOTHER. NOW DOWN HERE THERE IS MULTIPLE FORMS AND BECAUSE THIS CARD IS ABOUT THE ORAL CAPSULE FORM, THE OTHER FORMS ARE JUST THINGS YOU CLICK OFF TO GET DETAILS ABOUT THEM. IN THE CASE OF THESE OM EP ZOL OTHER THE CASES FOR INJECTABLE ARE THE SAME BUT OBVIOUSLY THERE ARE CASES WHERE IT IS DIFFERENT DEPENDING ON DOSE FORM AND THAT IS WHY YOU WANT TO GET IT TO THIS LEVEL. THE EDGE CONDITIONS BEYOND WHAT I JUST SAID. LET'S GET INTO JUST ONE MORE MESSY ONE THAN A VERY SIGNIFICANT ONE. THIS IS AGAIN BRAND MATTERS. SO ONE REASON OBVIOUSLY THAT DERMATOLOGY IF YOU WERE GETTING INTO MEDICINE, IS A WONDERFUL THING T. DO, I THINK IT'S THE SECOND MOST LUCRATIVE MEDICAL PROFESSION. THANKS TO BOTOX. AND IF YOU HAD A MELANOMA TAKEN OFF YOUR ANKLE YOU HAVE TO SIT ON THOSE SCREENS AND TALK ABOUT THE BOTOX. OBVIOUSLY BOTOX IS USED FOR MULTIPLE REASONS. IT'S NOT JUST USED FOR NICHOLE KIDMAN. SO YOU HAVE MIXTURES OF DIFFERENT STRENGTHS YOU WERE HERE FOR DIFFERENT THINGS AND YOU HAVE TWO DIFFERENT BRANDS AND THE BANDS ARE ALL ASSOCIATED WITH THE SAME APPLICATION. THIS IS UNUSUAL. GENERALLY MOSTLY ONE BRAND ON THE APPLICATION. BUT THERE ARE CASES THAT JUMP OUT WHERE THERE IS MULTIPLE BRANDS AND THAT GIVES YOU, MAYBE THERE ARE FROM PRESENTATION REASONS FROM A CONSUMER PERSPECTIVE, QUITE A DIFFERENCE BETWEEN THESE TWO THINGS EVEN THOUGH CHEMICALLY THEY ARE THE SAME AND EVEN THOUGH THE SAME THING IS LITERALLY USED FOR MULTIPLE PURPOSES. SO WHAT HAPPENS IS WHEN WE PRODUCE THESE BOXES, WE END UP WITH A HUGE DIFFERENT INDICATIONS LIST OF WHAT IT IS USED FOR IN VARIOUS WAYS AND YOU ALSO HAVE TWO DIFFERENT BRAND NAMES WHICH YOU RATHER SPLIT SO THAT IS SOMETHING WE ARE LOOKING AT RIGHT NOW WHERE THERE ARE SOME CASES WHERE BRAND MATTERS AND HOW CAN WE CLEANLY SEPARATE THEM EVEN THOUGH FOR PRESENTATION REASONS, EVEN THOUGH THERE IS ONLY ONE APPLICATION, WHICH COMPLICATES IT, WE CAN'T EACH SPLIT ON THAT. CERTAINLY ONLY ONE RxNORM AND SO, THAT INTRODUCES A COMPLICATION OR A WRINKLE OR NUANCE WE HAVE TO DEAL WITH. THIS IS MUCH MORE SIGNIFICANT AND LET ME -- THIS IS MY LAST SLIDE. RIGHT NOW WE ARE ALIGNING A RFT AND THE VA'S PARSES OF INDICATION MEDICATION GUIDE AND OTHER SECTIONS OF THE SPLs. BUT YOU HAVE NO IDEA WHEN YOU TAKE THE NDFRT WHICH SPL THEY PARSE THIS DATA FROM, WHEN DID THEY PARSE IT IF AND EVERYTHING ELSE WE HAVE IN HERE, WE KNOW WHERE WE GOT IT FROM. SO YES WE KNOW WE GOT IT FROM NDFRT BUT THAT'S TOO GROWTH IN THIS CASE T INTRODUCES TWO OTHER PROBLEMS. ONE IN MANY CASES, IT IS INCORRECT. WHICH IS -- AND I KNOW OLIVIA IS TALKING ABOUT PARSING SPL STUFF IN THE AFTERNOON SO I DIDN'T WANT TO GET INTO TA TODAY TOO MUCH. AND THE SECOND IS THE SCOPING ISSUE. SO LET ME CORRECT. IF YOU CAN READ UP THERE, YOU'LL SEE SALLA GWEN IS FOR DRY MOUTH CAUSED BY RADIO THERAPY WHILE A SIMPLE PARSE WHICH ONLY GOES ON KEYWORDS WILL TELL THAT YOU IT'S FOR HEAD AND NECK NEOPLASMS WHICH IS WHAT NDFRT TELLS YOU. ON THE RIGHT-HAND SIDE YOU WILL SEE HEAVY MONTHLY PERIOD MENSTRUATION AND YOU WILL SEE THE VARIOUS THINGS IT IS ED TO TREAT. AND THERE ARE BASICALLY TAKING KEYWORDS, PROBABLY NOT FROM THESE EXACT PARAGRAPHS BUT I DON'T KNOW WHAT PARAGRAPH, BECAUSE THAT IS NOT IN THE METADATA. AND THEN THEY PRODUCE THESE PARTICULAR LISTS. AND THERE IS ALSO CASES WHERE YOU MIGHT HAVE 6 OR 7 INDICATIONS AND THEY ONLY HAVE TWO, AND THAT ALSO BECOMES AN ISSUE. THE OTHER THING IS THE SCOPING RULE. REMEMBER I SAID IF YOU LOOK AT MEM ZOL WHERE THE LARGELY INDICATIONS ARE THE SAME IRRESPECTIVE OF THE DOSE, WHEN YOU LOOK AT THESE TWO PRODUCTS, THE INDICATIONS ARE QUITE DIFFERENCE. SO IF YOU TAKE THE SOLUTION, YOU HAVE DIFFERENT INDICATIONS THAN IF YOU TAKE THE TABLET. AND WHEN YOU'RE AT THE INGREDIENT LEVEL, WHEN YOU ATTACH THE USES, WHICH IS WHAT NDFRT DOES, IT MEANS THESE THINGS ARE FUZZED UP TOGETHER. REALLY WE NEED THAT AT THE NUANCE AT THE DOORS FORM NOT AT THE LEVEL OF INGREDIENTS. THE SAME THING IS HAPPENING ON THE RIGHT-HAND SIDE. SO, AND DISCREPANCY WITH INJECT I BELIEVE SO VERSUS SOMETHING ELSE IS NOT UNUSUAL. THERE ARE BUNCHES OF EXAMPLES OF THAT. SO WHAT THIS IS LEADING US TO DO, AND WE HAVEN'T DONE IT, THIS IS IN PROGRESS THING THAT SHOULD BE BY THANKSGIVING. WE ARE ULTIMATELY EXCEPT FOR DRUG CLASS, WILL PULL OUT NDFRT AND WE WILL PARSE THESE BLURBS FROM THE MASTER SPLs OURSELVES FOR OUR OWN INDICATIONS AND OTHER THING AND THAT PIPELINE IS XM R AND HTM R AND MICRODATA BUT IT DOES SHOW YOU THAT AGAIN, WHEN YOU START GETTING THE INFORMATION TOGETHER AND YOU PRESENT IT IN A FORM, YOU HAVE AN SQA TOOL TO SHOW YOU MAYBE BOTH MY SCOPING APPROACH AND MY LACK OF METADATA MIGHT BE A PROBLEM IN THESE PARTICULAR THINGS. SO LET ME CONCLUDE. DESPITE ALL OF THOSE MULTIPLE FORMS, DESPITE THE FACT THAT YOU CAN GO DO DIFFERENT WEBSITES AT DIFFERENT TIMES TO GET DIFFERENT DATA, THAT IS A TECHNICALLY DOABLE PROBLEM IT'S JUST BATCH JOBS THAT RUN EVERY NIGHT AND IF THEY END UP WITH EYE PROBLEM THEY MAIL YOU AND ANNOY YOU. AND YOU CAN REPRESENT THEM CONSISTENTLY. THE GRAPH FORM IS THE SAME USED BY LINKED IN AND GOOGLE AND IT'S A VERY EFFECTIVE WAY TO CREATE COHERENT REPRESENTATIONS OF ALL THE DATA IRRESPECTIVE OF THE SOURCE FORM. THE SUM OF THE PARTS IS GREATER THAN THE INDIVIDUAL PARTS THAT ACTUALLY CORRELATING THESE THINGS TOGETHER AND SEEING IF ORANGE BOOK AND RxNORM OR SPL AGREE OR NOT IS A VALUABLE QA TOOL APART FROM MAKING A PRESENTABLE FORM. THEY CAN FILL IN GAPS AND YOU CAN OPEN ISSUES AND TRACK ISSUES AROUND IT. AND THE IDEA AGAIN WHICH HAS BEEN ONGOING THINGS I KNOW WITH THESE TALKS IS LOOKING AT THESE S APPROXIMATE. L BLURBS. ONCE HAVE THE MASTER IDENTIFIED, THERE ARE VARIOUS WAYS NOW WITH STRUCTURED DATA AND RAFAEL RICHARDS AND THE VA IS HERE AND HE IS DOING WORK ON THAT, TO PRODUCE BASICALLY TO TAKE OUT IN A TRACEABLE WAY, WHAT YOU'RE SEEING ABOUT A PARTICULAR DRUG AND THE TRACEABLE IS KEY. ALL OF THESE TOOLS FOR BOTH DEFINING WHAT METADATA IS, TRACKING IT OVER TIME, THE MAINTAIN ABILITY PROBLEM, THOSE THINGS SOLVE PROBLEMS, THERE ARE STANDARDS FOR THOSE THINGS. WE DON'T HAVE TO MAKE IT UP. IT'S NOT SPECIFIC TO HEALTH CARE JUST LIKE GRAPHS AREN'T. THAT CAN PRODUCE AN AUTOMATICALLY GENERATED UP-TO-DATE, WHICH IS KEY, DRUG SOURCE THAT IS COMPLETELY COMPUTER GENERATED. AND THAT IS ULTIMATELY THE GOAL, I THINK. THANK YOU TAMMY BY THE WAY FOR ALL THE WORK YOU DO. THAT'S ME. >> A QUESTION FOR YOU AND THEN AN OBSERVATION TO SHARE. SO THE QUESTION FIRST IS WHEN FDA WENT DOWN THE ROUTE OF ELECTRONIC LABELING, THEY DECIDED TO USE THE NCI AT THE SOURCE CONCEPT CODES FOR DOSE ANNUAL FORMS AND UNFORTUNATELY, THOSE ARE NOT THE -- NOT ALWAYS THE OFFICIAL DOSAGE FORM TERM FOR THE PRODUCT. AND AN EXAMPLE THAT I HAVE BEEN USING FOR MANY YEARS IS, THE OFFICIAL USP TERM FOR WHAT NCI REFERS TO AS A PATCH EXTENDED RELEASE IS A TRANSDERMAL SYSTEM. SO IF YOU'RE EXTRACTING INFORMATION ABOUT THAT DOSE FORM, FOR EXAMPLE, FROM THE TITLE OF THE SPL OR FROM THE SOURCE CONCEPT CODE ITSELF, YOU'RE IDENTIFYING THAT PRODUCT AS A PATCH EXTENDED RELEASE. YET THE ACTUAL PACKAGE ITSELF WILL HAVE THE OFFICIAL NAME ON IT AND NLM IS AWARE OF THAT AND THEY HAVE BEEN DOING A PROJECT TO CORRECT THAT IN THEIR DATA WHERE THEY WILL REPRESENT WHAT REALLY YOU WOULD ENCOUNTER IF YOU PICKED UP A PACKAGE. SO IN YOUR PROCESS, HOW HAVE YOU RECONCILED THAT? THAT DISCREPANCY BETWEEN THE IN. CI AT THE SOURCE CODE AND WHAT THE OFFICIAL DOES DOSE FORM NAME IS FOR THAT PRODUCT? >> BECAUSE OF RxNORM IS THE MASTER, THAT IS THE INDEX. IT IS WHATEVER REDUCTION RxNORM HAS DONE. IT IS THE POINT AT WHICH THE DOCUMENTS ARE GATHERED UP OF THE SO IF THAT HAPPENS TO SWEEP UP MORE DOSE FORMS AND MORE NUANCE THAT THE NCITs HAVE, THAT IS GOING TO APPEAR IN THE DOCUMENT AND THEN THOSE SIGNATURES, I WAS SHOWING YOU, YOU ARE GOING TO SEE MULTIPLE SIGNATURES. ALWAYS ONE RxNORM SIGNATURE. YOU MAY SEE MULTIPLE FROM ORANGE BOOK, BECAUSE SOMETIMES THEY SWEEP UP MULTIPLE APPLICATIONS THAT ARE DISTINGUISHED IN THE ORANGE BOOK TO DO OTHER THINGS. THEN YES DOWN TO THE DOSE FORM AGAIN YOU'LL YOU'LL HAVE MULTIPLE SIGNATURES. I DON'T KNOW HOW TO GO BACK ON WINDOWS. I HAD THE PREVIOUS SLIDE WITH THOSE SIGNATURES YOU WILL SEE MULTIPLE NCITs. SO IN SAME RESOLVE BECAUSE RxNORM IS THE MASTER, THAT IS ULTIMATELY WHAT IS GENERATED AND WHAT WE POP OUT ARE WARNINGS AND ERRORS, AND THEN WE LOOK TO SEE, ARE THOSE RIGHT NOW -- THE ONES CONCERNING US ARE WHEN THERE IS THAT KIND OF INCONSISTENCY OF IT'S THE WRONG APPLICATION SO THAT PULLS IN EXTRA STUFF AND WE ARE NOT AS CONCERNED RIGHT NOW WITH THE SPL SIGNATURES. WE THINK THAT IS JOHN'S JOB AND IF HE DOES IT WRONG IT'S HIS FAULT. >> AND THEN A RELATED INCONSISTENCY. SO, I GUESS ABOUT TWO OR THREE YEARS AGO, WE DISCOVERED THAT WHEN FDA BEGAN DEVIATING FROM STANDARD PROCEDURES FOR NONPROPRIETARY NAMES WAS SELECTED DRUGS. SO INSTEAD OF APPLYING THE USE FOR EXAMPLE, THEY WERE CREATING UNIQUE NAMES ON THEIR OWN. SO TRANZTUZUMB IS A EXAMPLE OF THAT. IT STILL REMAINS EACH THOUGH FDA CHOSE TO RENAME IT. AND WE LOOKED AT THE VARIOUS FEDERAL TERMINOLOGIES AND DISCOVERED THAT THEY WERE STILL APPLYING THE USE OR INN FOR THOSE DRUG NAMES AND OUR INITIAL ASSUMPTION WAS THAT BECAUSE FDA HAD DEVIATED FROM THE STANDARD, AND ANYONE THAT WAS APPLYING THE STANDARD MAY NOT HAVE CAUGHT THAT, THAT THAT IS WHY THESE ERRORS WERE SHOWING UP. THE SECOND THING WE NOTICED AT THE SAME TIME WAS THAT THE UNIQUE INGREDIENT IDENTIFIERS THAT WERE BEING APPLIED TO THESE PRODUCTS THAT FDA HAD GHEE BUN TO UNIQUELY NAME, HAD THE IDENTICAL UNICODE. SO FOR EXAMPLE, TBL FILL GRASS TEMAND FILL GRASS TEMHAVE UNIQUE NAMES BECAUSE OF AGAIN, FDA'S DEVIATION FROM THE INN AND USEAND AND THOSE TWO DRUG PRODUCTS YET THEY HAVE THE IDENTICAL UNIQUE INGREDIENT IDENTIFIER. SO ANY DATA DRIVEN MODEL THAT RELIES ON UNI CODES IS NOT PICKING THOSE UP. THAT FDA INTENDED. WHAT WE DISCOVERED IN OUR CONVERSATIONS WITH JOHN AND TAMMY IS THAT IN FACT, THAT WAS THE CAUSE OF THE DISCREPANCY WITHIN THE FEDERAL TERMINOLOGIES. THEY WERE DRIVING POPULATION OF THOSE TERMINOLOGIES USING UNICODES AND DIDN'T REALIZE THAT FDA WAS APPLYING THE IDENTICAL UNICODE TO MULTIPLE UNIQUE DRUG NAMES. AND THAT WAS SOMETHING THAT YOU WERE AWARE OF? >> THERE IS AN EXAMPLE THERE. >> AND I KNOW JOHN HAS SOME OBSERVATIONS ABOUT THAT THAT I HOPE HE WOULD SHARE WITH THE GROUP HERE BECAUSE I THINK THAT IS A HUGE ISSUE. AND MY UNDERSTANDING OF THE CONVERSATIONS HE HAS HAD IS THAT FDA REALLY ISN'T PLANNING TO CORRECT THAT POLICY OF APPLYING THE SAME UNICODE WHENEVER THEY APPLY UNIQUE NAMES. >> THREE TALKS AT THE END OF THE DAY ADDRESSING THAT. I DON'T HAVE ANYTHING TO SAY AT THIS MEETING ABOUT THAT. I'LL LET THE FDA SPEAK FOR THEMSELVES AND USP AND SO ON. BUT THAT'S JUST OUT OF TIME CONSTRAINTS IF NOTHING ELSE. >> I MEAN, ON THAT SCORE, JUST TO BE VERY CLEAR ABOUT THE NATURE OF THE PROCESS, YOU HAVE TO PRIVILEGE CERTAIN DATA SOURCES WHEN YOU DO SOMETHING LIKE THIS. SO WE ARE PRIVILEGING JOHN. AND WE ARE SAYING THAT AS IT FLOWS DOWN INTO THE SPLs, IF THIS DISCREPANCY THERE, HE IS RIGHT AND THEY ARE WRONG. NOW CERTAIN CASES LIKE I SHOWED YOU EARLIER WHERE THE ORANGE BOOK SAYS SOMETHING ELSE AND YOU START TO SAY MAYBE HE IS WRONG AND IN THAT PARTICULAR CASE, THOSE CREPANCY YOU TRY TO ADDRESS AND WE HAVE TO MAIL THEM IN AND IF THEY ARE CHANGED IN THE NEXT VERSION WE CAN GET RID OF THE OVERRIDE BUT WHEN WE SHIP THIS, WE SHIP THE OVERRIDE FILES SO YOU SEE WHAT WE HAD TO CHANGE TO MAKE SOMETHING CONSISTENT. BUT THE MAIN CONCERN RIGHT NOW IN AUTOMATION IS THAT BOTH OUR ERROR REPORTING IS VERY, VERY CLEAR THAT THE DISCREPANCY REPORTS ARE VERY CLEAR, THAT THEY ARE NOT JUST A BIG LONG MUSH NO ONE CAN READ AND THEN THE QUESTION IS, FOR THESE DIFFERENT SO LITTLE OF CATEGORIES OF DISCREPANCY, HOW ARE YOU GOING TO ADDRESS THEM? CERTAIN OF THEM ARE FUNDAMENTAL. AND YOU'RE RELYING THEY WILL BE ADDRESSED AT THE RxNORM LEVEL AND WE WILL JUST PIGGYBACK ON THAT. WE ARE NOT TRYING TO SAY WE ARE COMPOSING A NEW SCHEME. THIS IS REDUCTION OF EXISTING DATA AND ANY DISCREPANCY YOU WANT TO SIGNAL BACK TO THE ORIGINAL PUBLISHER AND HOPEFULLY THINGS WILL IMPROVE FROM THERE. >> RxNORM IS FOLLOWING THE FDA'S DISTINCTIONS THAT THEY ARE MAKING EVEN THOUGH THE NONUNIPART OF THE FDA. SECTIONS OF THAT IS REFLECTED IN RxNORM AND REBE REFLECTED AND WHERE IT'S NOT REFLECTED IN RxNORM, WE WILL REPAIR RxNORM TO DO THAT. >> IT IS REFLECTED AS YOU CAN SEE HERE. THERE IS A DISTINCTION HERE AND ONLY ONE UNICODE. THERE IS A DISTINCTION IN RxNORM. >> I WAS CURES AS TO HOW YOU'RE COMPUTATIONALLY DECIDING THAT A MEDICATION WAS NOT ON THE MARKET WHEN RxNORM HAD IT IN THE CURRENT PRESCRIBABLE SET? I THINK MAYBE A DIFFERENT DEFINITIONS THERE? >> EXACTLY. THAT'S WHY I WAS TRYING TO SAY WHAT I MEANT BY CURRENT PRESCRIBEABLES. I'M SAYING THERE HAS TO BE A NONREELABLER SPL OF A DRUG WITH NO MARKETING DATE BEFORE THE TIME WE ARE CREATING THIS. THERE IS AN RxNORM INDEX FOR IT, SO IN OTHER WORDS IF THE SPL ISN'T IN RxNORM, WE WON'T SEE IT EITHER, AND WE STILL PUT IT OUT IF THE THE ORANGE BOOK APPLICATION SAYS IT IS DISCONTINUED F THAT PERSPECTIVE, WE SAY HAVE YOU TWO OUT OF 3 VOTING AND THE ORANGE BOOK IS A DISCREPANCY PERHAPS THIS IS NOT. AND I CAN'T THINK OF THE EXAMPLE OFFHAND BUT THERE ARE EXAMPLES WHERE APPLICATIONS ARE DISCONTINUED IN ORANGE BOOK AND LITERALLY LAST MONTH THERE WAS A NEW SPL FROM THE PRIMARY APPLICANT OF A STRENGTH OF THAT PARTICULAR DRUG USING THAT APPLICATION. SO, THIS IS WHERE THINGS DO CONTRADICT AND WE HAVE TO GO WITH WHAT TWO OUT OF 3 AIN'T BAD. >> I CAN ADDRESS WHY YOU MIGHT SEE AN SPL OUT THERE THAT IS FOR A PRODUCT THAT IS NO LONGER MARKETING. I'M TERRY BERNARD FROM GSX. AND ALSO WITH THE SPL WORKING GROUP. SO, IF WE HAVE A REFERENCE LISTED DRUG AND THERE IS A CHANGE AND WE HAVE TAKE 10 OFF THE MARKET BUT THERE ARE GENERICS OUT THERE THAT ARE STILL SELLING, HAPPILY SELLING ALONG. WE HAVE THE RESPONSIBILITY TO KEEP THAT LABEL UP TO DATE. SO YOU MIGHT SEE AN UPDATE TO THAT LABEL. THAT SPL WILL STAY OUT IN DAILYMED. SO IT WILL BE PICKING UP INFORMATION INTO RxNORM ALL THE WAY OUT TO THE LAST BATCH EXPIRE DATE. EVEN THOUGH THE PRODUCT IS NO LONGER POTENTIALLY BEING SOLD, WE ARE NOT SELLING IT, BUT IT IS STILL OUT THERE. WE STILL KNOW YOU NEED PATIENT SAFETY INFORMATION AND WE STILL HAVE A RESPONSIBILITY FOR KEEPING THAT APPLICATION. SO THAT IS HOW COULD GET IT OUT THERE AND THEN -- YOU WOULDN'T SEE IT IN YOUR DRUGSTORE WITH YOUR PHARMACY BUT IT WOULD STILL BE OUT THERE. >> BUT IN THAT CASE, BECAUSE THERE IS STILL GENERICS, ACTIVE SPLs, THERE WILL BE A BOX FOR IT. WE WILL HAVE IT IN THE INDEX BECAUSE THERE IS AN RxNORM AND ACTIVE SPLs. TO THE DOESN'T HAVE TO BE THE ORIGINAL APPLICANT. IT JUST HAS TO BE ACTIVE SPLs OF IS THAT DRUG. >> YOU WERE ASKED IF I WOULD BE ANNOYED ABOUT YOUR MASH UP OF SPLs. I THINK IT'S AN EXTRAORDINARILY WONDERFUL EXAMPLE OF TAKING PUBLIC DATA AND BRINGING IT TOGETHER. SO, THANK YOU FOR THAT. >> THANK YOU. >> I'M FROM VA. JUST A QUICK QUESTION ON FUTURE EXSTENS BUILTO THIS. I'M INTRIGUED WITH THE NOTION THIS MEDIUM YOU'RE PUTTING THIS INTO, A GRAPH DATA BASE IS NOT A PROPRIETARY SPECIAL THING, IT IS SOMETHING THAT GOOGLE AND FACEBOOK AND ALL USING GRAPH DATABASES TO REPRESENT INFORMATION IN A COMMON MEDIUM. THIS SOMETHING THAT COULD BE EXSTENSIBLE TO EXTEND THE REACH OF ARE. X NORM BEYOND THE PHARMACY DRUGS, PER SE TO OTHER VOCABULARIES AS WAS ALLUDED TO EARLIER SUCH AS SNOMED LOINC THAT WOULD EXTEND THE CAPABILITY FOR CLINICAL DECISION SUPPORT BECAUSE NOW WE ARE LOOKING AT INDICATIONS AND OTHER APPLICATIONS? DOES YOUR MEDIUM AND APPROACH EXTEND TO THESE? AND WHAT WOULD BE A VISION TO MAKE THAT HAPPEN? >> SO, DO YOU REMEMBER -- HOW DO YOU GO BACKWARDS? CAN GO BACK AWARDS? THE MANUAL WAY? VERY NICE. AND I HAVE ALL THESE DEVICES IN FRONT OF ME. Y SEE ON THE LEFT HAND SIDE ISSUES THE SIMPLE KNOWLEDGE SERVICE? SO THE IDEA OF TURNING ANY OF THESE VOCABULARIES OR TERMINOLOGIES INTO THE GRAPHS IS EXACTLY THE SAME FOR -- WE HAVE SNOMED, LOINC, EVERYTHING ELSE IN THE SAME GRAPH FORM. SO THERE IS NO DIFFERENCE BETWEEN THE DRUG DATA, CATEGORICALLY AND LAB DATA. OR IF THE TEAMSTERS CAME IN AND HAD A CATEGORIZATION SYSTEM ABOUT TRUCKING, YOU COULD PUT INTO THE SAME THING. I MEAN, FUNDAMENTALLY THERE IS NO DIFFERENCE MEDIUM WISE ON THE LEFT-HAND SIDE BETWEEN MEDICAL INFORMATION OR ANYTHING ELSE. YOU WANT TO KNOW WHERE IT CAME FROM, WHO PRODUCED IT AND KEEP IT UP-TO-DATE AND PRIVILEGE LINKS. [ APPLAUSE ] >> WE ARE EATING INTO OUR LUNCH AND BREAK EARLY HERE. I THINK WE ARE OKAY. JEN IS GOING TO COME DOWN IN A SECOND. >> GOOD MORNING. LET ME JUST GET STARTED HERE. I'M JENNIFER AND THIS IS MY COLLEAGUE, BROOKS ROBINSON AND WE ARE HERE TO TALK ABOUT MEDLINE PLUS CONNECT. WE WORK AT THE NLM AND WORK ON THE TEAM THAT SUPPORTS WEBSITE CALLED MEDLINE PLUS. WE WANT TO THANK JOHN FOR INVITING US. THIS IS OUR FIRST JAMBOREE. AND WE ARE GOING TO TALK ABOUT MEDLINE PLUS CONNECT, OUR PRODUCT FOR EHR SYSTEMS AND OTHER HEALTH IT SYSTEMS. AND WE MAKE GOOD USE OF RxNORM SO WE'LL GET INTO HOW WE DO THAT. SO I HOPE YOU FIND THIS INTERESTING. SO BEFORE I TELL BUT MEDLINE PLUS CONNECT, I HAVE TO GIVE YOU THE BACKGROUND ON MEDLINE PLUS.GOV. LET ME GO BACK AND SHOW YOU. THIS IS THE ENGLISH VERSION OF OUR SITE AND THEN SPANISH VERSION. THE NATIONAL LIBRARY OF MEDICINE'S WEBSITE FOR CONSUMERS. SO FOR PATIENCE AND FAMILIES, FRIENDS, IT CONTAINS INFORMATION ABOUT DISEASES, CONDITIONS, WELLNESS ISSUES, ALSO INFORMATION ABOUT DRUGS AND SUB MINUTES FROM ASHP. WE STARTED THIS WEBSITE OR I WASN'T HERE, BUT IT STARTED IN 1998 ABOUT 16 YEARS IT'S BEEN AROUND. A FEW YEARS AFTER ITS DEBUT, WE DEVELOPED A SPANISH VERSION. SO IT'S QUITE POPULAR FREE PUBLIC RESOURCE ON THE WEB RECEIVING ABOUT 1.9 MILLION VISITORS PER DAY. AND LAST YEAR WE HAD OVER A BILLION PAGE VIEWS. SO WHAT MAKES MEDLINE PLUS SORT OF DIFFERENT FROM OTHER CONSUMER HEALTH RESOURCES OUT THERE IS THAT WE TRY TO -- WE HAVE LIBRARIANS ON STAFF WHO ARE CURATING LINKS TO INFORMATION OTHER FREE INFORMATION AVAILABLE ON THE INTERNET FROM REPUTABLE SOURCES. A LOT OF NIH INSTITUTE INFORMATION, CDC, MAYO CLINIC ET CETERA. AND SO WE ARE SORT OF BRINGING THAT INFORMATION TOGETHER INTO MEDLINE PLUS AS WELL AS HAVING SOME LICENSE CONTENT TO SORT OF COMPLIMENT IT. SO WE BELIEVE WE ARE A RELIABLE SOURCE FOR INFORMATION. WE ARE CONSUMER FRIENDLY. THE INFORMATION IS WRITTEN BETWEEN 6 AND 8 GRADE READING LEVEL. WE DON'T HAVE ANY ADVERTISEMENTS OR POINT TO ANYTHING THAT HAS ADVERTISEMENTS. WE HAVE A COLLECTION OF INFORMATION AND MULTIPLE LANGUAGES MORE THAN 40 OF THEM. AND AS I MENTIONED, WE HAVE THIS MIX OF CONTENT. WE HAVE CONTENT THAT WE HAVE SUNDAY OURSELVES AS WELL AS LICENSE INFORMATION SUCH AS HEALTH NEWS, IMAGES, MEDICAL ENCYCLOPEDIA, DICTIONARIY AND VIDEO, ET CETERA. SO MEDLINE PLUS.GOV IS THE WEBSITE. BUT MEDLINE PLUS CONNECT A TOOL THAT LEVERAGES THE INFORMATION IN MEDLINE PLUS. AS ITS NAME IMPLIES, IT PROVIDES A CONNECTION BETWEEN PATIENT PORTALS, EHRs AND OTHER HEALTH IT SYSTEMS AND THAT PATIENT CENTER THE INFORMATION ON MEDLINE PLUS. SO AN EHR OR PHR PORTAL WITH MEDLINE PLUS IMPLEMENTED ALLOWS PATIENCE AND PROVIDE TOURS EASILY ACCESS TARGETED INFORMATION THAT RELATES OR RELEVANT TO THEM. IT IS INFORMATION THAT IS JUST A CLICK AWAY FROM THEIR POINT OF NEED WHETHER THEY ARE A PATIENT OR PROVIDER. WITH CONNECT SYSTEMS CAN DELIVER USER'S INFORMATION RELATED TO DIAGNOSIS, MEDICATIONS AND LABS. AND WHAT REALLY ENABLES THIS CONNECTION ARE THE MEDICAL CODES THAT ARE ALREADY IN USE IN THESE SYSTEMS WHICH I KNOW A LOT OF YOU ARE FAMILIAR WITH. AND WE'LL GIVE EXAMPLES LATER OF HOW WE ARE DOING THAT CODE MAPPING. THIS IS AN OVERVIEW OF THE PROCESS BY WHICH CONNECT WORKS. IT'S FAIRLY SIMPLE AND EHR HEALTH IT SYSTEM WILL SEND A URL-BASED REQUEST TO OUR SERVERS AND IN THAT LONG STRING, THERE WILL BE A PROBLEM MEDICATION OR LAB TEST CODE. MAYBE A LITTLE BIT OF TEXT AS WELL BUT REALLY THE CODE THAT MAKES IT WORK THE BEST. MEDLINE PLUS THEN CONNECT RETURNS THE TARGETED HEALTH INFORMATION TO THAT SYSTEM AND THEN THEY CAN SERVE IT UP TO THEIR PATIENTS IN THEIR CLINICAL SETTING. WE HAVE SORT OF TWO BIG GROUPS OF PEOPLE WHO IMPLEMENT CONNECT, BOTH IT COMPANIES WHO ARE DEVELOPING NEW EHR PRODUCTS AND THEN WE ALSO HAVE IT AT THE SORT OF ENTERPRISE LEVEL WHERE WE HAVE ORGANIZATIONS THAT CONTACT US THAT WANT TO PUT IT IN THEIR DOCTOR'S OFFICE OR CLINIC. THEY MAY ALSO BE USING ANY OF THE VARIOUS EHR PRODUCTS THAT ARE OUT THERE AND THEY WANT TO FINISH THEY CAN HAVE CONNECT ENABLED LOCALLY AND THAT CAN HAPPEN IN SOME CASES. SO WE TRY TO EXPLAIN TO THEM HOW OR WHO THEY NEED TO SPEAK WITH. AND WE HAVE SEEN RAPID IMPLEMENTATION OF CONNECT FROM BOTH OF THE GROUPS HERE. ONE REASON IS LIKELY THE FACT THAT CONNECT CAN HELP THESE GROUPS MEET ONE OF THE MEANINGFUL USE CORE OBJECTIVES AND THAT IS THE ONE THAT REQUIRES PROVIDE TOURS PROVIDE PATIENT-SPECIFIC EDUCATION RESOURCES AND PROVIDE THEM TO THE PATIENT. CONNECT IS FAIRLY EASY TO IMPLEMENT. IT INTEGRATES INTO A SYSTEM. IT'S NOT A STAND ALONE SYSTEM. IT IS USING THE HL7 INFO BUTTON STANDARD. IT IS EASY TO SET UP IN THAT YOU JUST HAVE TO SORT OF SET IT UP ONCE AND TO SET UP THESE REQUESTS, TO BE SENT OUT, AND THEN WE'LL MANAGE THE CODE MAPPINGS ON OUR END OF THE WE MAKE IT AVAILABLE AS A WEB SERVICE AND A WEB APPLICATION. AND IT'S A FREE SERVICE SO IT'S A FREE ALTERNATIVE TO SYSTEMS THAT ARE LOOKING FOR PATIENT LEVEL INFORMATION AND WE DENT REQUIRE ANY REGISTRATION OR LICENSING. BECAUSE WE DON'T REQUIRE LICENSING OR REGISTRATION, WE DON'T NECESSARILY KNOW THE BREATH OF USERSHIP. SO WE HAVE OR ASKED PEOPLE TO IMPLEMENT CONNECT TO LET US KNOW AND WE HAVE A LIST OF THOSE PEOPLE ON OUR WEBSITE. BUT WE DON'T KNOW OF EVERYBODY. BUT IN TERMS OF USE, WE KNOW THAT HAS GROWN TREMENDOUSLY IN THE 5 YEARS SINCE WE HAVE IMPLEMENTED SO, IN THE FIRST YEAR WE HAD JUST OVER A MILLION REQUESTS. AND THEN IN FY2014, WE HAD 68 MILLION REQUESTS. AND WE ARE NOT DONE WITH FY15 YET BUT WE ARE OVER 173 MILLION JUST IN THE FIRST THREE-QUARTERS. SO, WE SEE THE USAGE AND DON'T NECESSARILY KNOW OF EVERYBODY WHO IS USING US. SO I MENTIONED THAT WE HAVE BETH A WEB APPLICATION AND A WEB SERVICE. THIS IS GOING TO BE AN OVERVIEW OF THE APPLICATION TO A USER. SO ON THE LEFT WE HAVE THIS SORT OF MOCK UP OF A PATIENT PORTAL AND IT IS FOR JANE SMITH AND SHE HAS ULCERATIVE COLITIS. IF SHE CLICKS ON HER CONDITION IN HER POLTAL, IF CONNECT HAS BEEN IMPLEMENTED IT WILL SEND THAT CODE-BASED REQUEST USING DIAGNOSIS CODE TO THE MEDLINE PLUS CONNECT SERVICE. MEDLINE PLUS WILL RESPOND WITH THIS APPLICATION RESPONSE PAGE. THIS INTERIM PAGE AND THIS IS A PAGE THAT IS HOSTOD OUR WEBSITE. SO THAT PAGE IS GOING TO CONTAIN SOME INFORMATION ABOUT THE CONDITION OR A SUMMARY, SOME LINKS TO PATIENT HANDOUTS THAT MIGHT BE USEFUL. DOWN AT THE BOTTOM, YOU SEE THAT THERE IS HARD TO SEE, BUT INFORMATION THERE ALSO FROM GENETICS HOME REFERENCE WHICH IS ANOTHER NLM RESOURCE THAT PROVIDES CONSUMER-LEVEL INFORMATION ABOUT GENETIC CONDITIONS. AND WE HAVE BEEN HAPPY TO PARTNER WITH THEM. SO FROM THIS PAGE, THE PATIENT OR DOCTOR COULD GET THE INFORMATION THEY NEEDED OR CHOOSE TO CLICK THROUGH AND GO TO OUR WEBSITE. SO THESE WILL LINK TO VARIOUS PAGES ON MEDLINE PLUS AND YOU CAN SEE THAT LAST LINK IS TO GENETICS HOME REFERENCE WEBSITE. SO IN THE CASE OF THE WEB SERVICE, THIS MIDDLE PART IS REALLY JUST DATA. WE DON'T PROVIDE A RESPONSE PAGE. WE PROVIDE RAW DATA IN FORM OF XML OR JASON P. AND THEN THE IMPLEMENTERS ARE GUIDE HOW THEY WANT TO DISPLAY. WHAT PIECES THEY WANT TO DISPLAY AND HOW TO DISPLAY IT. SO HERE IS THE CLOSE UP OF ANOTHER VIEW OF THE PORTAL. IN THIS CASE, WE HAVE A DIAGNOSIS OF DIABETES TYPE II AND CLICKING ON THAT WE'LL TAKE TO YOU THAT INTERIM PAGE. A CLOSER LOOK AT THAT PAGE. SO YOU HAVE A SUMMARY. IF YOU WANT TO CONTINUE A TRUNCATED SUMMARY, YOU CLICK THROUGH TO READ MORE ON MEDLINE PLUS. THERE ARE SOME PATIENT HANDOUTS AT THE BOTTOM. AND ONE OF WHICH IS FROM ANOTHER NIH INSTITUTE. I'M GOING TO HAND IT OVER TO REX WHO WILL START BY TALKING ABOUT HOW CONNECT RESPONSE TO DRUG CODES. >> THANK YOU. SO, IN THE INTEREST OF TIME AND NOT TO -- IT'S A SIMILAR EXAMPLE. AGAIN THE PATIENT WOULD SEE SOMETHING IN THE E HAD. R. THEY CLICK ON IT AND TAKES THEM TO RESPONSE PAGE AGAIN WITH THE WEB APPLICATION AND RETURN A PREFORMATTED HTML PAGE BUT THEN ALSO HAVE THE WEB SERVICE. AND THAT CAN BE FORMATTED OR SELECTIVELY USED AS YOU SEE FIT. USER WOULD CLICK ON IT AND TAKES THEM TO THE INFORMATION ON MEDLINE PLUS AND HERE IS A DRUG MONOGRAPHS AND IT WILL LICENSE THIS INFORMATION FROM AHSP AND I'LL TALK MORE ABOUT THAT LATER. THE INFORMATION CONSUMER LEVEL. BROKEN DOWN IN DIFFERENT SECTIONS DO MAKE IT EASY TO USE. WE HAVE THIS PARTIAL LIST OF WHERE ALL THESE QUERIES ARE COMING FROM. BUT SINCE THERE IS NO REGISTRATION OR COST OR WE JUST MAKE SOMETHING THAT MEETS THE STANDARD AND PEOPLE JUST START USING IT OF THE SO THESE ARE THE PEOPLE, ORGANIZATION THAT IS WE KNOW ABOUT AND YOU'LL SEE THERE ARE SOME BIG NAMES ON HERE, LOTS OF LITTLE NAMES, AND AND SOME OF THEM ARE FULL 360EHR SYSTEMS AND THEN VERY SPECIFIC TOOLS. AND ONLY FOR THE HEALTH CARE ORGANIZATIONS. WE HAVE HOSPITAL SYSTEMS, WE HAVE ORGANIZATIONS AND A WIDE RANGE. SO TO HAVE MORE DETAIL ABOUT THE CODE SYSTEMS WE USE. NOT ALL THESE PEOPLE ARE LOOKING FOR DRUG RESPONSES. WE HAVE RESPONSES FOR DIAGNOSIS, MEDICATIONS AND LABS AND THESE ARE THE CODE SYSTEM WE USE FOR THOSE OR ACCEPT FOR THOSE. WHETHER PEOPLE ARE USING RXQs OR NDCs, THEY GET TO THE SAME INFORMATION. AGAIN HERE IS A SAMPLE OF ONE OF OUR PAGES AND THIS IS LICENSED FROM AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACIST. ONE OF THE KEY THINGS FOR US IS THE INFORMATION IS IN ENGLISH AND SPANISH. MOST OF THE CONTENT ON MEDLINE PLUS AVAILABLE IN BOTH LANGUAGES AND MOST PAGES YOU CAN TOGGLE BACK AND FORTH BETWEEN THEM. IT'S GREAT IF YOU'RE A SPANISH SPEAKING PERSON WITH A SPANISH SPEAKING HEALTH CARE PROVIDER AND IF THERE IS A MIX, YOU CAN EASILY BON PERSON CAN FIND THE INFO AND SHARE WITH THE OTHER PERSON IN THE OTHER LANGUAGE. BACK TO THE RxNORM AND NDC SITUATION. MOST OF THE QUERIES ARE NDC CODES. WE ARE GETTING SEVERAL, 2 MILLION AND 2014. AND THIS IS A VERY SIMPLIFIED SCHEMATIC WITH WHAT WE ARE DOING WITH THE QUERIES, BUT FOR THOSE WHO ARE INTERESTED IN THIS SORT OF THING, GOING ACROSS THE TOP OF THE SCHEMATIC IS THE MOST STRAIGHTFORWARD APPROACH. WE MATCH THIS UP WITH INFORMATION FROM ASHP AND SEND A LINK BACK TO THE USER. ALSO THANKS TO THE RxNORM API WHICH WE MAKE HEAVY USE OF, IN THE LOWER LEFT, REPRESENTS WHERE SOMEBODY SENDS NDC OR TEXT, WE CAN USE THAT WITH API AND FEED IT THROUGH THE SAME SYSTEM. JUST ALONG THE BOTTOM OF THE SCHEMATIC AS A BACKUP MEASURE, IF WE ARE HAVING TROUBLE FINDING AN RXQ MATCH WE CAN USE THE BRAND NAME INFORMATION WE FOUND IN THE PREVIOUS STEPS AND JUST SEARCH MEDLINE PLUS THAT WAY. WE ALSO HAVE A ROUGHLY ANALOGOUS SYSTEM FOR DEALING WITH SUPPLEMENTS. ALSO JUST POINT OF INTEREST, THE MOST REQUESTED DRUG CODES WE HAD IN 2014. A LOT OF ANTIBIOTICS. THE FACT THAT SALINE SOLUTION ON THERE MIGHT SEEM UNUSUAL DEPENDING ON WHERE YOU'RE COMING FROM. CONNECT IS DRIVEN BY CODES WHICH IMPLIES SOME SORT OF DOCTOR OR HEALTH 50. THIS IS TILTED TOWARDS WHAT IS HAPPENING IN THE HOSPITAL. THIS LIST WOULDN'T MATCHUP WITH THE THINGS THAT PEOPLE ARE SEARCHING FOR ON OUR SITE. BUT WHEREVER THEY ARE COMING FROM AND HOWEVER THEY ARE USING MEDLINE PLUS, THE GOAL IS TO PROVIDE COMPREHENSIVE AND COMPREHENSIBLE INFORMATION FOR PATIENTS AND OF COURSE WHEN PEOPLE ARE LESS CONFUSED, THEY ARE MORE HAPPY. AND IF YOU THINK THAT THE API WOULD MAKE YOU OR YOUR CLIENTS HAPPY, PLEASE COME TALK TO US OR JUST LOOK UP MEDLINE PLUS CONNECT ON THE NLM WEBSITE. THANK YOU. [ APPLAUSE ] SO THERE ARE TWO MAIN TYPES OF PRESCRIPTION DRUG PLANS. THERE ARE THE STAND ALONE PRESCRIPTION DRUG PLANS OR THEY COULD BE PART OF A MEDICARE ADVANTAGE PLAN THAT MAY OR MAY NOT INCLUDE PART B AND PART A. AS OF SEPTEMBER, THERE ARE 41 MILLION AMERICANS ENROLLED IN THE PART D PROGRAMS. IN 2013, THERE WERE 1.4 BILLION PRESCRIPTIONS. NOW TO TRANSLATE THAT INTO ECONOMIC TERMS, THAT IS OVER 69.2 BILLION DOLLARS OF PRESCRIPTION COSTS. SO WHEN THE PROGRAM FIRST WAS IMPLEMENTED IN 2006, THE SPONSORS WERE INSTRUCTED TO SUBMIT REPRESENTATIVE NDCs AND ASSOCIATED INFORMATION ALSO SUBMIT THEIR RELATION MANAGEMENT SUCH AS PRIOR AUTHORIZATION, STEP THERAPY OR QUANTITY LIMITS. THERE WERE -- ARK ASSUMING THIS INFORMATION CAUSED A LOT OF ERRORS AND MADE THAT VERY DIFFICULT TO REVIEW. IT WAS ALSO VERY LABOR-INTENSIVE. IT WAS CUMBERSOME. BECAUSE THE NDCs ARE VERY SPECIFIC SO ERRORS WERE OFTEN MADE BY PLANS. SO, IN AN EFFORT TO STREAMLINE THE SYSTEM, CMS INTRODUCED THE FORMULARY REFERENCE FILE IN 2007. SO WHAT IS THE REFERENCE FILE? FRS? IT'S A LISTING OF ELIGIBLE PART D DRUGS THAT SPONSORS ALL THE PLANS MUST USE TO SUBMIT THEIR PART D FORMULARIES. EACH ROLE WHICH IS EACH -- AT FIRST IT WAS A ROW REPRESENTED BY UNIQUE WRAPPED NAME, GENERIC NAME, DOSE ANNUAL FORM, ROUTE OR STRENGTH OF A DRUG. -- BRAND NAME. SO HERE ARE THE ELEMENTS OF THE FORMULARY REFERENCE FILE. TODAY WE HAVE THE RX COUEY. THE TTY, AND THEN YOUR RxNORM AND BRAND NAME ANDY IS MANTIC CLINICAL DRUG COMPONENT AND RELATED DOSE FORM AND RELATED NDC. HERE YOU HAVE THE COLUMNS WHICH SHOWS ALL THE DRUGS THAT EXIST. HOW DID IT EVOLVE? IN 2007 WE INTRODUCED A FORMULARY REFERENCE FILE TO BE UTILIZED FOR FORMULARY SUBMISSIONS BY THE PLANS. THE FRF SERVED AS A SUBSET FOR ALL AVAILABLE DRUGS ON U.S. MARKET FOR FORMULARY INCLUSION. HAVING FRF ALLOWS TO STREAMLINE THE SUBMISSION BY THE PLANS AND ALSO ALLOWED US TO STREAMLINE REVIEW PROCESS. IT ALLOWS FOR GREATER SYNCHRONIZATION OF CMS AND PLAN SPONSOR FILES. HOWEVER, IN 2007, THEY WERE STILL USING PROXY NDCs TO REPRESENT THE DISTINCT BRAND NAMES GENERIC NAMES. AND THAT WAS ACTUALLY NOT AS EFFECTIVE AS WE THOUGHT IT WOULD BE. SO THEREFORE IN 2010, WE FURTHER REFINED OUR PROCESSES AND WE, IN TALKING WITH THE NLMs WITH JOHN AND TAMMY, WE BEGAN TO ADOPT THE RxNORM SYSTEM OF CODING AND NOMENCLATURE SYSTEM. THE RXCUIS. SO, THIS DIAGRAM OR GRAPH, SHOWS HOW THE RXCUIs HAVE EVOLVED. Y AXIS IS THE NUMBER OF RXCUIs AND ON THE X AXIS YOU HAVE THE DATE FROM '08. IT SHOWS HOW IT EVOLVED INCREASING AND DECREASING AND IT HAS IN THE LAST COUPLE OF YEARS, YOU CANNY SEE INCREASE IN RXCUIs TOTAL IN THE REFERENCE FILE. AND WHAT ACCOUNTS FOR THESE CHANGES CAN BE A LOT OF THINGS. IT COULD BE CHANGES SUCH AS NEW DRUG LAUNCHES, NEW GENERIC ENTRIES. IT WOULD BE CHANGES BY RxNORM T COULD BE CHANGES EVEN WITH CMS GAP COVERAGE AGREEMENT THAT IT MUST HAVE IN ORDER TO BE ON THE F ARE. F. SO A NUMBER OF REASONS CAN GO INTO WHY THE NUMBER OF RXCUIs GO INTO THE REFERENCE FILE. BUT IT IS INTERESTING OF NOTE THAT IN THE PAST COUPLE OF YEARS, YOU CAN SEE A PRETTY STEEP INCREASE IN THE NUMBER OF RXCUIS. SO WE AT CMS ADOPTED THIS RxNORM CONCEPT UNIQUE IDENTIFIER, SIMILAR DRUG PRODUCTS WITH SAME BRAND NAME, ACTIVE INGREDIENT, STRENGTH, DOSAGE FORM, ROUTE OF ADMINISTRATION. NOW, THE INCLUSION ON THE FRF REFLECTS OUR UNDERSTANDING OF THAT ONE OR MORE DRUG PRODUCTS WITH THE NDCs REPRESENTED BY THE RXCUI CAN CERTIFY THE REQUIREMENT TO BE CONSIDERED A PART D DRUG. HOWEVER, IT DOES NOT REPRESENT A COVERAGE DETERMINATION THAT ANY SPECIFIC DRUG PRODUCT IS A PART D DRUG. THAT IS RESERVED FOR THE PLANS. HOW DO YOU GET ON TO THE FRF? FIRST, YOU MUST BE COVERABLE UNDER PART D. AT LEAST ONE OF THE NDCs MUST BE FROM THE FDA'S NDC FILE AND ALSO MUST HAVE A MARKETING CATEGORY OF ANDA, BLA OR NDA-AUTHORIZED STATUS. IT MUST BE AVAILABLE ON THE U.S. MARKET AND IT MUST BE FLAGGED ACTIVE ON SOME OF OUR OTHER COMMERCIAL NDC DATABASES WE USE AND OF COURSE, IT MUST BE IN RxNORM. SO THERE IS ONE OTHER ONE, WHICH IS LAST POINT IS IT HAS TO BE HAVE AN AGREEMENT, GAP DISCOUNT COVERAGE PROGRAM CMS IN ORDER TO BE QUALIFIED TO BE ON THE FORMULARY REFERENCE FILE. SO NOW I'M GOING TO SHIFT TO TALK ABOUT THE FORMULARY REVIEW PROCESS. SO EACH YEAR, WE RECEIVE -- LIKE IN THE SPRING AND SUMMERTIME. WE RECEIVE PLAN FORMULARIES FOR THE NEXT OPERATIONAL CALENDAR YEAR. THEY ARE SUBMITTED THROUGH OUR HEALTH PLAN MANAGEMENT SYSTEM, SYSTEM,HPMS. SO THESE DRUG LISTS ARE RELATION MANAGEMENT REQUIREMENTS AND TEARING INFORMATION REVIEWED IN THREE STAGES. THE PLANS MUST PROVIDE CLINICAL JUSTIFICATIONS, AND REVISED SUBMISSIONS OR BOTH. THE THE VERY LAST STAGE REALLY IS JUST FOR CMS TO KIND OF RECONCILE AND TO TRY TO RESOLVE ANY DISCREPANCY OR OUTLIERS THAT WE OBSERVED UNDER STAGE I AND STAGE TWO. THEN WE GIVE THEM AN ADDITIONAL APPROVAL. WOPS THEY HAVE SATISFIED ALL THE REQUIREMENTS. SO THEY MUST SUBMIT A COST SHARE INFORMATION. I MENTIONED UTILIZATION MANAGEMENT SO QUANTITY LIMITS. PRIOR AUTHORIZATION, STEP THERAPY REQUIREMENTS, IF APPLICABLE. AND ALSO ANY THERAPEUTIC CLASSES OR DRUGS, HOW THEY CLASSIFY IT. NOW ELABORATE A LITTLE MORE ON EACH ONE. SO FOR THE STAGE I OF THE REVIEW PROCESS, WE LOOK FOR DRUGS THAT ARE IN THE MOST COMMONLY USED DRUG CLASSES BY THE MEDICARE POPULATION. WE LOOK FOR THE DRUG CATEGORIES AND CLASS THAT IS COVER ALL DISEASE STATES. WE LOOK AT ALL DRUGS FROM THE SIX PROTECTIVE CLASSES. WE LOOK FOR DRUGS AS A SUPPORTED AND WIDELY ACCEPTED TREATMENT GUIDELINES. IN STAGE II, WE LOOK MORE CLOSELY AT THE RELATION MANAGEMENT OF EACH PLANS. LOOK AT THE PRIOR AUTHATION AND MAKE SURE THEY ARE NOT WITH HOLDING FROM PATIENTS. AT THE SAME TIME WE WANT TO MAKE SURE THEY ARE BEING USED APPROPRIATELY. SUCH AS A HEP C DUG THAT IS BEING USED FOR SOMEBODY WITH THE DIAGNOSIS OF HEP C. FORMULARY TIERING. WE LOOK AT THE TIERING INFORMATION AND HOW THE BENEFITS THAT COMPLY WITH THE GUIDELINES THAT WE GIVE THEM EACH YEAR ON A CALL LETTER. AND ALSO WE HAVE A REQUIREMENT OF TWO DRUGS PER EACH THERAPEUTIC GROUP OR CATEGORY. OF THE TWO DRUGS, ARE THEY SATISFIED? AND LASTLY, AT THE LAST STAGES, WE TRY TO RESOLVE ANY OUTLIERS OR ANYTHING ANALYZED FURTHER IF IT MEETS THE CMS GUIDELINES OR REQUIREMENTS. SO, HERE IS AN EXAMPLE. I WANT TO ILLUSTRATE USING THE HPMS, HEALTH PLANS MANAGEMENT SYSTEM. SO THE FORMULARY REQUIREMENTS ARE LOADED ON TO THE SYSTEM AND WE LOOK AT THE RXCUIs. FOR EXAMPLAR HERE FOR HYPERTENSION, WE ARE LOOKING FOR AT LEAST 2 ACE INHIBITORS. SO THE RXCUI represented here and we are looking for these Coueys FOR THEIR PRESENCE IN THE HUBER TENSION CATEGORY. >> A LOT OF GREAT PRESENTATIONS AND MORE OF A GENERIC, MORE GENERAL VIEW. SO MANY CONSIDER EDUCATING A PATIENT ABOUT EDUCATING THE INFORMATION WITH ALL THE INFORMATION SUBLISHED ON A PARTICULAR-- >> PROVIDING PATIENT CAREGIVER WITH INFORMATION THEY NEED TO MAKE EMPOWERED ACTIVE DECISION MAKENER THEIR CARE IS VERY IMPORTANT. THE PATIENT HAS TO UNDERSTAND IT. SO THIS IS A SERIES PROBLEM TODAY. PATIENTS ARE PROVIDED FAR TOO MUCH INFORMATION IN A WAY THAT IS NOT EASY TO ABSORB AT A TIME THAT CAN BE VERY STRESSFUL IN THEIR LIVES. ONE STUDY AT A NEW YORK HOSPITAL, 72% OF PATIENTS COULDN'T LIST THEIR MEDICATIONS AFTER DISCHARGE. THIS IS JUST ONE STUDY BUT THERE ARE MANY STUDIES WITH SIMILAR RESULTS. SO MANY PATIENTS FORGET WHAT THEY ARE TOLD BEFORE THEY WALK OUT THE DOOR. THIS IS MAG FIELD FUNCTIONSIFIED BECAUSE A GOOD CHUNK OF THE INFORMATION PROVIDED OR THAT CAN BE FOUND ON A PARTICULAR MEDICATION IS NOT EVEN FOUND RELEVANT FOR THE CONDITION SUCH AS AGE, GENDER OR CONDITION AND IT BE SCARE A PATIENT TO SEE MULTIPLE MEDICATIONS ON ON A MEDICATION AND HAS NOTHING TO DO WITH THEIR MEDICATION. SO INFORMATION OVERLOAD IS NOT ONLY PROBLEM. IT'S ESTIMATED OVER 47% OF THE U.S. ADULT VS LIMITED HEALTH LITERACY SKILLS AND OVER 8.6% OF THE U.S. POPULATION IS DEFINED AS LEP, THAT'S HAVING LIMITED ENGLISH PROFICIENCY. SO IT SHOULD BE NO SURPRISE WHEN YOU HEAR ABOUT NONADHERENCE AS AN EPIDEMIC. IF THE PATIENT DOESN'T UNDERSTAND THEIR THERAPY AND HAPPY, HOW CAN THEY FOLLOW IT? PATIENTS NEED TO UNDERSTAND HOW TO TAKE THEIR MEDICATION, WHEN TO TAKE THEIR MEDICATION AND WHY THEY NEED TO TAKE THEIR MEDICATION. IT'S ESTIMATED THAT OVER 25--25-30% OF PRESCRIPTIONS ARE NOT TAKEN PROPERLY. WHAT MAKES THOSE FIGURES WORSE IS THAT ONLY INCLUDED PRESCRIPTIONS THAT WERINE PICKED UP IN THE FIRST PLACE SO ANOTHER 30 SORE OR PERCENT WERE NOT EVEN PICKED UP IN THE FIRST PLACE AND AS EVERYBODY KNOWS NONADHERENCE LEADS TO BAD OUTCOMES. IT'S ESTIMATED THAT 25% OF NURSING HOME ADMISSIONS COME FROM NONADHERENCE. SO LET ME TAKE YOU INTO AN ACTION PLAN APPLICATION. SO AN ACTION PLAN MY DAILY SCHEDULE ALLOWS THE HEALTHCARE PROVIDE TORE PRINT A PERSONALIZED CLEAR AND CONCISE MEDICATION SCHEDULED FOR THEIR PATIENT. SO LET'S BREAK DOWN THE ANATOMY OF A PATIENT FRIENDLY SCHEDULE. FIRST IT CAPTURES--FIRST IT CAPTURES THE TOTAL PICTURE OF THE PATIENT'S MEDICATION THERAPY. THIS INCLUDES VITAMINS, VITAMINS ARE AN IMPORTANT PART OF MEDICATIONS THERAPY. AND INCLUES THE INFORMATION, PATIENT INFORMATION, AND THE REVISION DATE, TIME AND PROVIDER NAME AND DATE. THIS IS IMPORTANT BECAUSE FOR MANY PATIENTS THEIR MEDICATIONS OR DOSES MAY CHANGE AND THE SCHEDULE MAY BECOME OUTDATED QUICKLY. SOWF EVERYTHING ABOUT THE SCHEDULE IS PERSONALIZED AND EASY TO FOLLOW. --SO EVERYTHING ABOUT THE SCHEDULE IS PERSONALIZED ASK EASY TO FOLLOW. OUR BRAND AND GENERIC NAMES ARE FORMATTED TO BE READ AND EASILY UNDERSTOOD BY PATIENTS. WE SO IMAGES FOR BRAND MEDICATIONS. WE SHOW THE MEDICATION STRENGTH THAT PATIENT FRIENDLY FORM AND ROUTE. WE INCLUDE SPECIFIC TIMES, QUAWBTITIES AND TIME TO TAKE THE MEDICATION SO WE HAVE FRIENDLY TERM, AND RUST BUST TERMINOLOGY AND IT IBT--INTEGRATE CLUEDS TWO FORMS OF EDUCATION ALL AT A LOW READING LEVEL. SO IF YOU LOOK AT THE SCHEDULE, YOU'LL NOTICE, THE AMOUNT OF WHITE SPACE WE USE. OUR SCHEDULES ARE CAREFULLY DESIGNED TO USE THE MOST WHITE SPACE TO MAKE IT THE LEAST CROWDED AS POSSIBLE AND THE MOST CLEAR AND CONCISE FOR THE PATIENTS, WE EVEN SEPARATE THE BRAND NAME, GENERIC NAME, THE STRENGTH PLUS FORM AND THE ROUTE INTO SEPARATE ROWS AND USE NO ABBREVIATIONS TO MAKE IT AS CLEAR AS POSSIBLE. SO THE SCHEDULE'S USED TO EDUCATE PATIENTS ABOUT MEDICATIONS AND FACILITATE TEACH BACK, IMPROVE PATIENT PROVIDER COMMUNICATION AND MAKE THE PATIENT MORE COMFORTABLE AND CONFIDENT IN THEIR ABILITY TO FOLLOW THEIR THERAPY AND ONE LAST THING IN ORDER FOR A PATIENT TO UNDERSTAND AND FOLLOW THE THERAPY IT HAS TO BE IN THE PATIENT'S LANGUAGE. OKAY, SO I WILL SKIP THIS SLIDE AND GO TO THE NEXT ONE. OKAY. SO LET'S TALK ABOUT HOW THIS RELATES TO FUTURE HEALTHCARE. JUST BE CLEAR, THIS IS TWO COMPUTERS TALKING NOT FLIRTING. SO IF YOU LOOK INTO THE FUTURE OF PATIENT EDUCATION IN MUCH BROADER, THE FUTURE OF HEALTHCARE AND THINK WHAT SHOULD IT BE LIKE, EVERYBODY'S FUTURE WILL HAVE ONE THING IN COMMON AND THAT'S DATA ACCESSIBILITY. SO THIS MEANS ACCESS TO ACTIONABLE DATA. IT'S BREAK THAT DOWN FARTHER. ACCESS DATA IS AVAILABLE AND INTEROPERABLE AND ACTIONABLE. DATA IS MACHINE READABLE. SO LET'S LOOK AT TWO SERVICES THAT YOU MAY OR MAY NOT KNOW. THEY ARE PAVING THE PAST YEAR. LET'S START WITH DAILY MED AND HOW WE ARE USING--I MEAN ACTION PLAN AND HOW WE USE IT IN PATIENT EDUCATION TODAY. DAILY MED IS A GREAT SOURCE OF INFORMATION. HOWEVER IN TERMS OF PATIENT EDUCATION AS AN OFFICIAL PRODUCT LABEL WITH ALL THE MEDICAL TERMINOLOGY, IT ITSELF IS NOT A PATIENT EDUCATION TOOL. INSTEAD IT IS IMPORTANT RESOURCE, IMPORTANT PART OF OUR PROCESS, CONTINUING TO DEVELOP OUR PATIENT FRIENDLY TERMINOLOGY. --TO DYNAMIC CONTENT IN PRODUCT LABELS AND THUS FOR THEM TO BE AUTOMATICALLY CONNECTED HOWEVER AS WE KNOW PRODUCT LABELS TODAY ARE NOT COMPLETELY DYNAMIC AND THUS WE CURRENTLY USE DAILY MED AS A RESOURCE AND PLAYS AN IMPORTANT ROLE IN OUR QA PROCESS FOR MEDICATION PROFILES. SO STEPPING INTO THE FUTURE OF HEALTHCARE, MAKING PRODUCT LABELS EASILY ACCELLIBLE FOR THE KEY FIRST STEP MAKING MATERIAL MACHINE READABLE IS AN IMPORTANT SECOND STEP AND I ENCOURAGE ALL EFFORTS TO ACCOMPLISH THIS. SO BEFORE I MOVE ON TO INTEROPERABILITY, I HAVE TWO QUICK NOTES ON PATIENT MEDICATION AND PATIENT EDUCATION. MEDICATION IMAGES ARE A VALUABLE SOURCE FOR RESOURCE PATIENTS. HOWEVER IN PATIENT EDUCATION, THEY MUST USE APPROPRIATELY. FROM WORKING WITH THOUSANDS OF PATIENTS OF PROVIDERS OVER THE YEARS, HERE ARE TWO THINGS THAT WE LEARNED. ONE, IT IS COMMON FOR GENERIC PILLS TO SWITCH AT RETAIL, SO PROVIDING PATIENTS WITH AN IMAGE OF A GENERIC MEDICATION MAY LEAD TO MORE CONFUSION WITH THE PILL LOOKS DIFFERENT AN THEY REFILL IT. AND TWO RETURNING TO THE TOPIC OF HEALTH LITERACY SHOWING THE FRONT AND BACK OF A MEDICATION CAN CONFUSE THE PATIENT HAS TO WHETHER THEY TOOK ONE OR TWO. IS ONE TABLET OR DOSE CONSIDERED ONE OR TWO PILLS? CERTAIN PATIENT POPULATION THIS IS IS NOT AS OBVIOUS AS IT MAY SEEM. ESPECIALLY WHEN YOU INTRODUCE MEDICATIONS THAT COME IN PACKS. >> OKAY, SO ANOTHER KEY PART IS INTEROPERABILITY, SO THE LAST FEW YEAR SYSTEM AN ENORMOUS PUSH TOWARDS ELECTRONIC HEALTH RECORDS, AND 2008-2013 EACH ADOPTION INCREASED FIVE FOLD. THIS WAS A HUGE STEP FOR HEALTHCARE. HOWEVER THE NEXT STEP IS JUST AS IMPORTANT. THE DIFFERENT SYSTEMS HAVE TO BE ABLE TO COMMUNICATE. DIFFERENT SYSTEMS ARE STRUCTURED CURRENT WAYS SO SEABEDDING PATIENT INFORMATION FROM ONE SYSTEM TO ANOTHER IS NOT STRAIGHT FORWARD. TO MAKE THINGS MORE CONFUSING IS EVERYONE IS USING DIFFERENT DATABASES SO THAT MAKES RX NORM ONE INTEROPERABLE PUZZLE. MEANINGFUL USE REQUIRES PROVIDERS AND EMRs TO BE ABLE TO SEND A CCD, CONTINUING OF CARE DOCUMENT FROM ONE PROVIDER TO THE NEXT. CCD IS A STRUCTURED AND FORMATTED DOCUMENT THAT INCLUDES IMPORTANT PATIENT INFORMATION AND AS JOHN TOUCHED ON EARLIER, I DON'T KNOW IF HE'S HERE STILL BUT AS JOHN TOUCHED ON EARLIER, THE MEDICATION SECTION OF CCD, RXNORMS IS A REQUIRED IDENTIFIER. RXQ, I NEVER GOT THE MEMO THAT IT WAS RXQ UNTIL JUST A FEW MONTHS AGO. HERE'S WHERE IT GETS EXCITING. INTEROPERABILITY IS MORE THAN JUST SENDING A PATIENT'S PROCIDER FROM ONE TO THE NEXT. THE KEY TO THE FUTURE OF HEALTHCARE MEANS YOU'LL SEND A PATIENT'S INFORMATION INTO AND THROUGH DIFFERENT APPLICATIONS, DATA SETS, SUCH AS SPLs, AND ALGORITHMS. WITH AN ACTION PLAN WE HAVE APPS THAT ALLOW CARE TEAM MEMBERS TO ENTER THIS MANUELLY INTO OUR APPLICATIONS. HOWEVER TODAY, WITH THE BUILDING THE NEXT ERA OF APPLICATIONS WITH OUR MAP PRO ENGINE. OUR MAP PRO ENGINE AND DESIGNED TO DROP IT INTO A STANDARD OUR APPLICATION CANS USE. SO I TALKED BEFORE, WITH PATIENT EDUCATION, PERSONALIZATION IS KEY. SO TO EXPLAIN HOW MAP PRO ENGINE EMPOWERED A PROVIDER WITH A PERSONALIZE PATIENT EDUCATION TOOL, LET ME EXPLAIN HOW IT WORKS IN APPLICATIONS SUCH AS ACTION PLANS MY DAILY SCHEDULE. STEP ONE, THE MAP PRO ABSORBS THE PATIENT INFORMATION FROM THE SOURCE SUCH AS THE EHR. STEP TWO, OUR ENGINE THEN PARSES THE INFORMATION, STEP THREE, USES MEDICATION IDENTIFIERS SUCH AS RXQEs AND NDCs AND DATA SUCH AS THE PATIENT'S CONDITION TO LINK THE APPROPRIATE MEDICATION PROFILES, TERMINOLOGY AND ALGORITHMS. THUS ALLOWING THE PROVIDER TO PRINT A PERSONALIZED PATIENT FRIENDLY SCHEDULE. AND TO EDUCATE THROUGH PATIENTS ABOUT THEIR MEDICATION AND SEND THE PATIENT HOME WITH A TOOL THE PATIENT UNDERSTANDS AND CAN USE TO FOLLOW THEIR MEDICATION THERAPY. SO THERE ARE A FEW SHORT COMINGS WITH RXNORM WITH INTEROPERABILITY AND HERE ARE A FEW EXAMPLES, MOSTLY GOING TO REPEAT, WHICH IS STUFF THAT'S ALREADY BEEN SAID TODAY, STUFF THAT EVERYBODY'S FAMILIAR WITH, BUT WE HAVE TWO DIFFERENT MEDICATIONS WITH THE SAME RXCUI, WHICH IS BETA PACE VERSUS BETA BASE AF, ANOTHER EXAMPLE IS WHERE YOU HAVE THE SAME MEDICATION DELIVERED DIFFERENTLY AND THIS IS SOMETHING THAT'S GREATLY REDUCE WIDE THE BREAK DOWN OF THE INJECTABLE FORMS BUT IT DOES STILL EXIST FOR EXAMPLE, POLYGLYCOL, ORAL PACKET VERSES SCOOP, NOW, IN TERMS OF MOST LEVELS OF INTEROPERABILITY, THE ORAL PACKET OR SCOOP IS THE SAME MEDICATION, HOWEVER, IN TERMS OF EXPLAINING THE PATIENT. WHEN YOU EXPLAIN TO THE PATIENT HOW TO TAKE THEIR MEDICATION, YOU NEED TO BE ABLE TO TELL THE PATIENT TAKE ONE PACKET OR TAKE ONE SCOOP. SO IT IS DIFFERENT IN TERMS OF HOW AN APPLICATION CAN EXPLAIN THAT MEDICATION TO THE PATIENT. AND THEN EXAMPLE THREE, THE LACK OF VITAMINS. SO VITAMINS ARE A VERY IMPORTANT PART OF MANY PATIENTS THERAPY. SO FOR REASONS LIKE THESE, AT THE END OF THE DAY FOR NOW, IN TERMS OF PATIENT EDUCATION AND INTEROPERABILITY, THE NDCs STILL KING AND HE CAN KEEP HIS CROWN AND SCEPTER. OKAY, SO I WANT TO TOUCH ON A MUCH BIGGER PICTURE HERE THAN PATIENT EDUCATION. TECHNOLOGY HAS A WAY OF PROGRESSING. THINGS THAT APPEAR IMPOSSIBLE TODAY ARE THINGS WE CANNOT IMAGINE LIVING WITHOUT TOMORROW. AND WE'RE ON THE VERGE OF A REVOLUTION IN HEALTHCARE. THE FUTURE OF HEALTHCARE RELYS ON DATA ACCESSIBILITY, MAKING INFORMATION AVAILABLE TO APP DEVELOPERS AND RESEARCHERS WHO WOULDN'T OTHERWISE HAVE THE RESOURCES TO GATHER DATA OR WORK WITH EXISTING SOFTWARE SYSTEMS WILL INCREASE THE NUMBER OF CREATIVE MINDS IN THE AREA A THOUSAND FOLD. AND AS A COLLECTION OF INDIVIDUALS HERE TODAY, THIS GROUP REALLY HAS THE MOST POTENTIAL TO MAKE A LARGE IMPACT ON THIS FUTURE. SO I URGE EVERYONE TO CONTINUE TO WORK TOWARDS IT, DEVELOP STANDARDS, COLLABORATE AND BUILD IT. OKAY, SO A QUICK RECAP AND THEN CAN YOU GO OFF TO LUNCH. OKAY. SO TODAY, I EXPLAINED TO YOU THE IMPORTANCE OF PATIENT EDUCATION. I EXPLAINED WHERE IT IS CURRENTLY COMING SHORT AND WHERE IT'S HEADING IN THE FUTURE. I EXPLAINED HOW IT OFFERED PERSONALIZED PATIENT EDUCATION AND FACILITATE ENGAGEMENT. AND HOW YOUR WORK ON RX NORM AND DAILY MED WILL SCULPT THE FUTURE OF HEALTHCARE. OKAY, AND THAT'S ALL. ANY QUESTIONS? IT'S KIND OF DARK SO I CAN'T REALLY SEE. >> HI, TAKEN--THEY LEE, THAT WAS INTERESTING, QUICK QUESTION FOR YOU. WHEN WE'RE TRYING TO ENGAGE OUR PATIENTS IT'S REALLY IMPORTANT THAT WE UNDERSTAND THE INDICATION OR THE USE OF THE MEDICATION. IS THAT ANYWHERE IN THE MED ACTION PLAN? >> YES IT IS. SO IF WE WERE TO GO ALL THE WAY--SORRY ABOUT THAT I KIND OF RUSHED THROUGH AND EVERYBODY'S PROBABLY HUNGRY. >> IT'S OKAY, I CAN LOOK, I JUST WANT TO KNOW IF IT IS THERE. >> YEAH, SO WE ENCLUED THE PUNCHS ON OF EVERY--INCLUDE THE PURPOSE OF EVERY MEDICATION AND THE WAY IT WAS IN THE INGRATED VERSION AND THE PATIENT MEDICATION AND THE MEDICATION THAT COMES OVER FROM EMR, WE USE THE RXQ TO MAP TO OUR MEDICATION PROFILES. AND THEN WE USE LET'S SAY ALGORITHMS IN THAT CASE, LET'S SAY WHAT IS THE PATIENT'S CONDITION TAKEN--THEY CAME OVER? DOES THAT FILTER WHICH--IF IT'S A MULTIINDICATION MEDICATION DOES THAT FILTER WHAT INDICATION IS FOR THIS PATIENT AND OF COURSE THE PROVIDER TAKES IT. >> THIS IS MIKE FROM KROGER, IT SOUNDS LIKE YOUR COMPANY IS MARKETING THIS TO THE PRESCRIBER END AND BECAUSE OF THAT, YOU'RE LIMITED TO PROVIDING THE PRODUCT IMAGES FOR BRAND PRODUCTS AND I NOTICE YOU SAID BRAND PRODUCTS AND THAT'S WHY YOU DON'T PROVIDE THE IMAGES FOR GENERIC PRODUCT SYSTEM THAT--IT COULD BE CONFUSING IF THEY GET IT FROM THE DOCTOR AND THEY GET A BRAND IMAGE AND THEY GO TO THE PHARMAC SCHEYEAH, THEY GOT THE PILL BUT THE NAME LOOKS TOTALLY DIFFERENT. >> SO, MOSTLY, WE OFFER A GENERATED --GENERIC ICON THAT SAYS GENERIC AND AS THE PROVIDER EDUCATES THE PATIENT THEY EXPLAIN THAT THE MEDICATION MAY LOOK DIFFERENTLY WHEN THEY FILL IT. SO THE REASON WE DON'T PROVIED GENERIC IMAGES, FOR MOST WE DO BUT NOT FOR A COUPLE. REALLY TWO REASONS. ONE IS MAINTAINING. IT COULD BE HUNDREDS OF GENERICS FOR ONE PARTICULAR BRANDT AND TWO FOR THE REASON OF EDUCATING THE PATIENT TO UNDERSTAND WHAT THEIR MEDICATION LOOKS LIKE AND THEN THEY'LL BE COMPLETELY CONFUSED. IF YOU WERE TO GOOGLE WHY DOES MY MEDICATION LOOK DIFFERENT, YOU WILL HAVE A BUNCH OF YYAHOO QUESTIONS. >> I'M FOLLOW WITH THAT, I'M A PHARMACIST SO I KNOW THEY COME IN LOTS OF DIFFERENT SHAPES AND SYSTEMS. >> I WAS MORE CURIOUS AS TO WHY YOU WOULDN'T MARKET IT AT THE PHARMACY END SO THEY WOULD KNOW EXACTLY WHAT THEY'RE GETTING. >> SO THIS IS MOSTLY USED IN THE ACTUAL-MARKED FOR IDENTIFICATION IN THE ACTUAL HEALTHCARE SYSTEMS. IT IS USE INDEED A COUPLE PHARMACY, I KNOW OF AT LEAST--I DO NOT KNOW THIS OFF THE TOP OF MY HEAD, BUT, I GUESS IT JUST COMES DOWN TO THE WAY WE ENTERED THE MARKET IN THE FIRST PLACE. >> OKAY. >> GREAT QUESTION THOUGH. THANK YOU. >> THANKS, THANKS. >> THANK YOU JOHN. [ APPLAUSE ] >> 2:30, 2:30 WE'LL COME BACK AND I'M REALLY LOOKING FORWARD TO THE AFTERNOON AS WELL SO I'LL SEE YOU AT 2:30. THANK YOU THANK YOU VERY MUCH. VERY MUCH. THANK YOU VERY MUCH. >> GOOD AFTERNOON, SO WE'RE GOING TO GIVE YOU A PRESENTATION OF THE CURRENT STATUS OF USING STRUCTURED PRODUCT LABELING TO STANDARDIZE RISK EVALUATION AND MITIGATION STRATEGIES. I WILL OPEN THE PRESENTATION AND THEN EDMILIKAN WILL EXAMPLES OF HOW IT WILL BE POTENTIALLY IMPLEMENTED DOWN STREAM. SO RISK EVALUATION AND MITIGATION STRATEGIES WERE AUTHORIZED BY THE FDA AMENDMENTS ACT OF 2007 AND THEY REPLACED RISK MINIMIZATION ACTION PLANS ARE AT RISK MAPS AS A MECHANISM TO REALLY FOCUS ON DRUGS THAT HAVE IMPORTANT AND DISTINCT RISK CHALLENGES, ASSOCIATED WITH THEM. LABELING AND ROUTINE REPORTING REQUIREMENTS ARE TYPICALLY SUFFICIENT TO MITIGATE THE RISKS AND PRESERVE THE BENEFITS FOR THE VAST MAJORITY OF DRUGS BUT REMs MAY BE REQUIRED WHEN ADDITIONAL MEASURES ARE NEEDED TO INSURE THAT THE BENEFITS OF A DRUG OUTWEIGH ITS RISKS. FDA CAN REQUIRE REMS BEFORE OR AFTER DRUG APPROVAL AND EACH REMS HAS SPECIFIC SAFETY MEASURES THAT TARGET THE SERIOUS RISKS ASSOCIATED WITH THE DRUG OR IN SOME CASES A CLASS OF DRUGS AS IS THE CASE WITH EXTENDED RELEASE OPIOIDS. SO WHAT ARE REMSS? THEY'RE DESIGNED TO MAKE SURE DRUGS WITH SERIOUS RISKS ARE USED SAFELY AND A NUMBER OF PARTIES PLAY A ROLE IN THE DESIGN ASK IMPLEMENTATION. SO THE FIRST THING TO NOTE IS THAT THE DOCUMENT AND THE DESIGN OF REMS ARE REALLY THE RESPONSIBILITY OF THE DRUG SPONSOR SO THE MANUFACTURE OF THE GIVEN PRODUCT, THOSE GET SUBMITTED TO FDA, WHO'S RESPONSIBLE FOR APPROVAL AND REVIEW OF THE DOCUMENTS, THE SPONSOR IS RESPONSIBLE FOR IMPLEMENTATION OF THE REMETABOLISMS PROGRAM, ADOPTION INVOLVES A LOT OF PLAYERS AND AS WE MOVE TO THE ADOPTION POINT, THIS IS WHERE THE DOWN STREAM BURDEN BEGINS TO BE REALLY GREAT WITH REMS AND HOW THEY GET ADOPTED. SO DISTRIBUTORS, DISPENSERS INSTITUTIONS LIKE HOSPITALS, PRESCRIBERS AND PATIENTS ALL ARE EFFECTED IN THE ADOPTION PHASE. THE SPONSOR THEN IS RESPONSIBLE FOR AN ASSESSMENT PHASE AND THE REMS PROGRAM WILL DEFINE THE TIME PERIOD FOR EXAMPLE WHEN CERTAIN ASPECTS ABOUT THE REMS NEED TO BE ASSESS AND THE WHAT THOSE THINGS ARE AND THEN FDA PERIODICALLY WILL REVIEW AND POTENTIALLY MODIFY THE SPECIFIC REMS PROGRAM FOR A DRUG. SO IT'S A COMPLEX PROGRAM FOR LOTS OF DATA POINTS ALONG THE WAY POTENTIALLY AND A LOT OF PEOPLE TOUCHING THE REMS PROGRAM. SO AS OF SEPTEMBER OF THIS YEAR, THERE WERE 83 APPROVED REMS, AND THOSE ADDRESSED 198 DISTINCT DRUG APPLICATIONS. SO THE REMS SUBMISSION PROCESS CURRENTLY REMS ARE A DISTINCT FDA REQUIRED SAFETY PROGRAM BUT THEY'RE NOT PART OF THE OFFICIAL LABELING. SO THERE'S NOTHING IN STRUCTURED PRODUCT LABELING THAT WILL EVEN TELL YOU THAT A REMS APPLIES TO A GIVEN DRUG. THEIR CURRENTLY IS NO ELECTRONIC SUBMISSION REQUIREMENT, DOCUMENTS TYPICALLY ARE SUBMITTED EITHER AS ELECTRONIC WORD FILES OR PDF FILES BUT THEY REALLY DON'T INCLUDE STRUCTURE OR CODIFIED DATA THAT CAN BE EASILY MANIPULATED AND PUT INTO AUTOMATED APPLICATIONS FOR PRESCRIPTION PROCESSING. PRODUCT LABELING ON THE OTHER HAND IS FILED ELECTRONICALLY IN A STRUCTURED AND CODIFIED FORM BUT AGAIN THERE'S NOTHING WITHIN THE STRUCTURED PRODUCT LABELING THAT GIVES YOU A CLUE THAT THERE IS A REMS PROGRAM THAT APPLIES TO THAT DRUG NEGLIGENCE THE DRUG HAPPENS TO HAVE MED GUIDE AND THAT MED GUIDE IS PART OF THE REMS PROGRAM AND FOR MANY DRUGS NOW, THAT HAVE MED GUIDES ONLY THEY'RE NO LONGER PART OF THE REMS PROGRAM. SO THE ABSENCE OF STRUCTURED AND CODIFIED STEMS DATA PLACES A BURDEN ON THE PARTIES THAT ARE PART OF THE ADOPTION PROCESS THAT WE JUST DESCRIBED. SO STAKEHOLDER VS EXPRESSED CONCERN OVER THAT BURDEN BECAUSE REMS FAIL TO INTEGRATE WITH EXISTING SYSTEMS FOR PRESCRIPTION PROCESSING. THEY INHERENTLY OPPOSE A BURDENOT HEALTHCARE SYSTEM. SIGNIFICANT RESOURCES OFTEN ARE REQUIRED TO AUTOMATE THE CONTINUUM NEEDED FOR IMPLEMENTATION AND PRESCRIPTION PROCESSING AND AN FDA'S PUBLIC HEARING FOR EXAMPLE, THERE ARE A COUPLE OF HOSPITALS THAT DESCRIBE THE HUGE AMOUNT OF RESOURCES THAT WERE REQUIRED INTERNALLY TO THOSE INSTITUTIONS TO ACTUALLY MANAGE REMS, AND IN LARGE PART BECAUSE THERE WAS NOT A STRUCTURED CODIFIED DATA FROM WHICH TO DRAW. STAKEHOLDERS ARE AWIVE FACE WIDE INDEPENDENTLY DEVELOPING PROCEDURES THAT CAN BE IMPLEMENTED MORE SEAMLESSLY AND INFINITELY WHERE STRUCTURED CODIFIED HONDURAS DATA WERE AVAILABLE. THE LACK OF STANDARDIZATION OF REMS POSS CHALLENGES SO IT MAKE ITS DIFFICULT FOR STAKEHOLDERS TO ADOPT TO NEW REMS PROGRAMS. SO IF THEY'RE NOT STANDARDIZED THEN EACH NEW REMS IS JUST THAT, A NEW REMS. IF YOU KNOW ONE REM, YOU DON'T REALLY UNDERSTAND ALL THE OTHER ONES. AND THAT CREATES A SERIES OF BURDENS TO DOWN STREAM USE. AND STAKEHOLDERS DON'T ALWAYS UNDERSTAND WHAT THEY NEED TO DO TO IMPLEMENT NEW REMS, SO ABOUT--I GUESS IT'S NOW GOING TO BE FIVE YEARS, THIS NOVEMBER, I SUGGESTED AT NCPDPs ACTIVITIES GROUP, THAT FDA CONSIDER USING STRUCTURED PRODUCT LABELING AS A MEANS TO CODIFY AND STRUCTURE THAT INFORMATION. AND THAT GROUP WITHIN NCPDP HAS WORKED WITH FDA OVER THE YEARS AND HAS MADE A NUMBER OF SUGGESTIONS OF DATA ENHANCEMENT, STRUCTURE ENHANCEMENTS THAT COULD BE APPLIED TO SPL TO FACILITATE SOME SPECIFIC TYPES OF DOWN STREAM USE, THIS WAS JUST ANOTHER ONE OF THOSE TYPES OF INFORMATION THAT WAS SUGGESTED TO FDA AND WAS CONSIDERED AS A GOOD CASE TO POTENTIALLY IMPLEMENT WITH SPL. WE'VE BEEN ADVISING THIS FDAA FOR SIX YEARS ON POTENTIAL ENHANCEMENTS TO SPL, AND 2010 IS WHEN WE SUGGEST THAD SPL BE THE PREFERRED PATH FOR CAPTUR REPRESENTING REMS DATA AND THAT IT BE IN A HIGHLY STRUCTURED AND CODIFIED FORMAT AND STRUCTURE INDEED SUCH A WAY THAT IT WOULD BE SUITABLE FOR AUTOMATED EXTRACTION AND INCORPORATION INTO VARIOUS DOWN STREAM APPLICATIONS. THE REASON NCPDP MADE THOSE RECOMMENDATIONS, PROBABLY THE MOST IMPORTANT ONE IS THAT WE'RE DEALING WITH DOCUMENTS THAT HAD NO HIGHLY STRUCTURAL ELECTRONIC REMS AND THERE WERE NO REQUIREMENTS FOR THE SPONSORS TO EVEN ATTEMPT TO SUBMIT THE DATA IN A STRUCTURE FORMAT THAT WOULD ALLOW ITS EASY ELECTRONIC MANIPULATION IN A MEANINGFUL WAY. THERE WAS NO STANDARDIZED DATA MECHANISM, SO CODING MECHANISM, NO CONNECTION FOR LABELING AND FOR EXAMPLE IN SPL ONE THING THAT COULD HAVE BEEN DONE INITIALLY IS PUT IN AN IDENTIFYING CODE WITHIN EXISTING SPL AND THE LIMITATIONS TO USE IDENTIFIER THAT AT LEAST TOLD YOU ALL OF THE DRUGS THAT HAD A REMS PROGRAM ASSOCIATE WIDE IT. SO AGAIN DOWN STREAM AUTOMATED PRESCRIPTION AUTHORIZATION AND PROCESSING REALLY REQUIRE HIGHLY STRUCTURED CODIFIED REMS DATA TO WORK EFFECTIVELY AND THIS WAS THE BASES OF NCPDPs WORK WITH FDA AND MOVING THIS PROPOSAL FORWARD. WE WORK COOPERATIVELY WITH FDA, SPL TECHNICAL AND PHARMACEUTICAL INDUSTRY GROUPS AND OTHER STAKEHOLDERS SINCE 2010 AND NCPDP CREATE A GROUP OF NATIONAL STAKEHOLDERS IN 2012, WE PRESENTED AN INITIAL SCHEMA AT A DIA SPL WORKSHOP IN 2011 AND IT MADE A NUMBER OF PRESENTATIONS OVER THE YEAR. IN 12012 JAMBOREE AS WELL, SO WE'RE FURTHER DEFINING AND PROTOTYPING SPL-STRUCTURALLY STRUCTURED REMS DATA. NCPDP ADVOCATED SPL AS A MEANS OF REMS STANDARDIZATION AND A NUMBER OF OTHER ORGANIZATIONS THAT CAME TO THE PODIUM AND SEVERAL PHARMACY ASSOCIATIONS SUPPORT THAD RECOMMENDATION AND AS A RESULT OF THAT FDA DESIGNATED NCPDP'S INFORMATION AND TEST SPL AS ONE OF THE FOUR PRIORITY PROJECTS UNDER PDUFA FIVE AND THAT OCCURRED IN SEPTEMBER 2014. SO ADAM IS NOW GOING TO PROVIDE INFORMATION ON WHERE WE STAND A YEAR LATER AFTER FDA MADE THAT DECISION. >> THANKS JERRY, I'M ADAM KROETSCH AND I WILL TALK ABOUT FDA AND I WHERE WE STAND BUT FIRST I WANT TO PUT MORE CONTEXT ON REMS, AND HOW REMS SPL WORKS ONE THING TO KNOW IS THAT THEY EMPLOY ELEMENTS TO INSURE SAFE USE AND THESE ARE INTERVENTIONS IN THE HEALTHCARE SYSTEM TO HELP MAKE SURE DRUGS ARE USED SAFELY AND THEY CAN INCLUDE THINGS LIKE REQUIRING HEALTHCARE PROVIDERS TO GET TRAIN ASKED ENROLL BEFORE THEY USE THE DRUG, AND COUNSELING BEFORE THE DRUG IS USED OR VARIOUS SAFETY CHECKS AND VARIOUS POINTS IN THIS PROCESS, AND OF THESE 83 APPROVED REMS, AND SINCE WE SUBMITTED THESE SLIDES, WE'RE NOW UP TO 84 AND 45 USE ELEMENTS TO ASSURE SAFE USE, SO THERE ARE NEW ONES ADADDED PRETTY CONSISTENT. ANOTHER IMPORTANT PIECE OF BACKGROUND INFORMATION IS THAT WHEN THESE COME IN, THEY COME TO FDA AS TWO PIECES. ONE IS A REM DOCUMENT WHICH IS AN OVERARCHING DESCRIPTION OF WHAT THE REMS ACTUALLY REQUIRE OF THE MANUFACTURES AND ALSO OF THE PEOPLE WHO ARE INVOLVED IN IT AND THEN THIS THESE MATERIALS WHICH ARE STAKEHOLDER FACING MATERIALS LIKE ENROLLMENT FORMS, EDUCATION MATERIALS AND THINGS THAT ARE RELATED TO THE REMS, SO ONE OTHER THING TO AND THIS MAY SOUND SIMILARLY TO THOSE WHO HEARD WHAT GER ALLUDED TO, YOU'VE SEEN ONE REMS, THAT IS TRUE, THEY DO A LOT OF THEIR OPERATIONAL DETAILS DIFFER BUT THE REALITY IS UNDERLYING THEM IS SIMILARITIES AND THE SIMILARITIES ARE THE KINDS OF THINGS THEY REQUIRE AND TOOLS THEY USE. FOR SIN STANCE THEY REQUIRE TRAINING, SOME SORT OF ENROLLMENT FORM AND BECOME CERTIFIED TO PRESCRIBE, I THINK ALMOST ALL ALL EVER THAT REQUIRE THAT, COUNSELING EDUCATING THAT IS COMMON, MAKE SURE THE PATIENTS AGREE TO PARTICIPATE AND THEN THE DISPENSER SIDEOT FARM--FOR PHARMACIES AND HOSPITALS THERE'S ALSO USUALLY OFTEN A REQUIREMENT COMPLETE TRAINING AND ENROLLMENT FORMS AND CHECKING TO MAKE SURE THE SAFE USE CONDITIONS THAT THE PRESCRIBER WAS SUPPOSED TO CHECK FOR WERE MET BEFORE DISPENSING THE DRUG AND THEREY ALSO USUALLY REQUIREMENTS ON THE DISTRIBUTORS SO YOU CAN MAKE SURE THE DRUG IS ONLY BEING DISPENSED AT THE END OF THE DAY FOR PATIENTS FOR WHOM THOSE SAFETIES ARE MET. THEY'RE USUALLY REQUIRED TO MAYBE SURE THE DISPENSERS ARE PARTICIPATING THE PROGRAM BEFORE THEY SHIP THE DRUG TO THEM. ALL OF THESE ARE COMMON TULES AND INTERVENTIONS AND WAYS IN WHICH THEY'RE UNDER THE HOOD WORKING SIMILARLY. THE CHALLENGE IS THERE'S NOT A LOT OF AND THE FORMAT OF THOSE DOCUMENTS VARIES A LOT AND THERE'S A LOT OF TERMINOLOGY, SO YOU'LL SEE A SIMILAR ENROLLMENT OR CERTIFICATION OR REGISTRATION, ALL USED INTERCHANGEABLY BUT THEY CAN MEAN SUBTLEY DIFFERENT THINGS AND DIFFERENT CONCEPT VS THE SAME NAMES AND THERE'S A LOT OF REGULATORY LANGUAGE THAT STEMS FROM THE INFORMATION THAT WAS PASS INDEED 2007 THAT USES REGULATORY TERMS LIKE THE ONE I USE, ELEMENTS TO INSURE SAFE USE, ELEMENT A-F, THESE WERE THE MEANINGFUL AND DON'T PROVIDE A LOT OF USEFUL PRACTICAL INFORMATION ABOUT HOW THEY WORK BUT THEY TEND TO BE THE TERMINOLOGY YOU SEE IN THESE DOCUMENTS AND MATERIALS AND MORE OVER I THINK EVEN WHEN THIS INFORMATION IS CAPTURED, THE INFORMATION THAT IS CAPTURED IS NOT VERY ACCESSIBLE IT'S NOT ALWAYS EASY TO FIND INFORMATION ABOUT WHAT'S EXPECTED OF YOU AS A PATIENT OR PRESCRIBENER PARTICULAR. WHEN A NEW REMS COMES INTO EXISTENCE. SO THAT GETS TO WHAT WE WANT TO CAPTURE IN SPL. NUMBER ONE IS WE WANT TO CAPTURE THE REM DOCUMENTS AND THESE ARE AGAIN OVERARCHING DESCRIPTIONS OF WHAT THE REMS REQUIRE OF THE MANUFACTURE BUT WE ALSO WANT TO CAPTURE SOMETHING WE'RE CALLS THE REMS SUMMARY WHICH IS A MORE STAKEHOLDER FRIENDLY VIEW OF THE REMS, ASK WHAT IT REQUIRES AND ASSOCIATE WIDE THAT SUMMARY IS STRUCTURED METADAT AND WE COME UP WITH A--WE'RE WORKING ON A CODIFICATION SCHEMA AND IMPLEMENTATION STRUKS AND I'LL GO INTO THAT IN MORE DETAIL LATER. SO WHY SPL? OBVIOUSLY WHERE SPL IS ONE OF A FEW DIFFERENT PATHS TO CAPTURE THIS INFORMATION BUT WE FELT LIKE SPL WAS A NATURAL FIT FOR THE INFORMATION WE'RE CAPTURING IN REMS, BOTH BECAUSE SPL IS WELL EQUIPPED TO KACCT TININE PATHWAY THAT YOU ARE KIND OF INFORMATION BECAUSE REMS INCLUDE A COMBINATION OF BOTH DOCUMENTS THAT ARE ALREADY SUBMITTED TO US AND HUMAN READABLE BUT UNSTRUCTURED DOCUMENTS, BUT THEY'RE ALSO--IT'S ALSO CAPABLE OF CAPTURE TAG AND THE MACHINE READABLE INFORMATION AND SUPPORT ELECTRONIC HEALTH RECORDS TO SUPPORT AUTOMATION AND CODIFICATION AND THE OTHER GREAT THING ABOUT CAPTURING REMS THROUGH SPL IS IT UNITES THE REMS INFORMATION WITH THE INFORMATION THAT'S IN THE SPL, SO IT'S GIVING YOU--FOR A REMETABOLISMS PRODUCT RIGHT NOW, SPL ISN'T CAPTURING EVERYTHING YOU NEED TO KNOW TO BE ABLE TO USE THE PRODUCT AND THAT IS A SENSE IS A LARGE PART OF WHAT LABELING PROVIDE SYSTEM AN OVERVIEW OF WHAT YOU NEED TO KNOW TO USE THE PRODUCT SAFELY. THIS IS ADDING THE REMS INFORMATION TO WHAT'S IN THE SPL AND IT'S ATTACHED AT THE SPL LEVEL SO IT'S A LOGICAL PLACE TO PUT THE INFORMATION. AND THEN SPL OF COURSE WE HAVE THIS EXISTING INFRASTRUCTURE AND PROCESS TO DEVELOP AND REFINE THE STANDARD SIZE AND TO GET FEEDBACK AND HOW WELL IT'S GOING, AND PART OF THAT IS THAT WE KNOW HOW TO PROCESS IT AND MANUFACTURES KNOW HOW TO SUBMIT IT AND THAT INFORMATION IS GOING TO CHANGE THAT PROCESS AND WE HOPE WE CAN LEVERAGE A LOT OF WHAT WE'RE DOING AND WHAT WE KNOW HOW TO DO TO MAKE THIS WORK WELL. SPL HAS BENEFITS DOWN STREAM, IT CAN HELP PROVIDERS, TELL HELP CLARIFY WHAT THE REMS CLARIFY IN A USER FRIENDLY FORMAT. IT CAN HELP SUPPORT THE INTEGRATION OF SOME OF THE EXISTS STANDARDS LIKE NCPDP PRESCRIBING AND TELECOMMUNATION STANDARD INTO'S REM AND I'LL TALK MORE ABOUT THAT LATER ASK. ANOTHER THING IS THAT IT SUPPORTS INTEGRATION OF REMS IN EXISTING PROCESSES THROUGH STANDARDIZE PRESCRIPTION PROCESSING AND I'LL SHOW EXAMPLES OF PICTURELY HOW THAT WOULD WORK. AND THEN FINALLY AS I MENTIONED BEFORE, IT'LL PUT ALL THIS INFORMATION IN ONE PLACE. IT WILL MAKE EVERYTHING AVAILABLE ONLINE TO GET A LOT OF DETAILED INFORMATION ON REMS, YOU OFTEN HAVE TO NAVIGATE DIFFERENT WEB SITES OR CAN YOU NOW FIND A LOT OF INFORMATION ON OUR NEW REMS WEB SITE BUT FOR A LONG TIME IT'S BEEN A CHALLENGING PROCESS ABOUT FINDING INFORMATION ON THE PROGRAMS AND WE HOPE SPL CAN HELP WITH THAT. AND THEN THERE'S ANOTHER SET OF BENEFITS THAT SPL CAN PROVIDE TO FDA AND THE MANUFACTURES OF REMS DRUG AND IT CAN HELP MAKE THE DESIGN AND DEVELOPMENT OF THE REMS MORE EFFICIENT. FIRST OF ALL IT CAN HELP DEFINE THE DOCUMENTS WE CAN DESIGN AND CLARIFY THE FORMATS THAT THOSE NEED TO TAKE IN THE SAME WAY THAT WE DO FOR LABELS RIGHT THOU THROUGH SPL, WE CAN CREATE VALIDATION RULES THAT AUTOMATICALLY CHECK TO MAKE SURE THOSE DOCUMENTS ARE IN THE STANDARDIZED FORMAT AND MAKE ITA EASIER TO FIND AND RESTEVE THOSE IN A CENTRALIZED REPOSITOR SCHEWE'RE ALSO HOPING THAT THE AVAILABILITY OF THE SPL INFORMATION WILL HELP SUPPORT FUTURE STANDARDIZATION EFFORTS. THESE WILL BE MUCH SIMPLER WITH THIS CODIFIED DATA TO TRACK HOW THE TOOLS ARE USED AND WHERE WE MIGHT NEED MORE STANDARDIZATION. SO NOW I'M GOING TO GET INTO A LITTLE BIT OF A DATA MODAND HE WILL APPROACH WE'RE USING TO CAPTURE INFORMATION SO THIS GETS INTO THE NUTS AND BOLTS OF REMS SPL. SO THE WAY WE DESCRIBE IT IS THAT THE REMSS ARE THE FOUR Ws OF REMS, THE FIRST W WHICH IS THIRD ON THE LIST HERE IS WHO, WHAT WAS THE PARTY THAT NEEDS TO MEET THE REMS REQUIREMENT. ARE WE TALKING THE PRESCRIBER, THE DISPENSER, HEALTHCARE SETTING, THE HOSPITAL. THE NEXT PIECE IS WHEN DOES THAT PARTY NEED TO DO SOMETHING? AT THE TIME THEY'RE CERTIFIED TO PRESCRIBE OR DISPENSE, DO THEY NEED TO DO IT EACH TIME THEY PRESCRIBE, DO THEY NEED TO DO IT AT A CERTAIN TIME INTERVAL, AFTER THE DRUG IS ADMINISTERED SO WHO NEEDS TO DO SOMETHING, WHEN DO THEY NEED TO DO IT, WHAT DO THEY NEED TO DO, WHAT IS THE CLINICAL OR ADMINISTRATIVE TASK, WHETHER IT'S COUNSELING OF PATIENTS COMPLETING A FORM, CONDUCTING A LAB TEST, AND THEN FINALLY WE HAVE THIS USING WHAT? THIS MATERIAL REFERENCE. THIS IS--SO FOR MANY OF THESE ACTIVITIES COUNSELING THERE MAY BE SUPPORTING COUNSELING TOOL THAT THE REMS PROVIDES THAT'S ASSOCIATE WIDE THAT IN THE REMS SPL AND THIS IS A DIAGRAM OF HOW THOSE FOUR Ws ARE CAPTURED IN THE HL-SEVEN DATA MODEL. I'M NOT GOING INTO THIS IN GREAT DETAIL BUT I WANT TO MAKE SURE IT WAS AVAILABLE TO YOU WHEN YOU GO BACK AND LOOK--IF YOU GET A CHANCE TAKE A LOOK AT THESE SLIDES. AND THEN ONCE WE HAVE THE FOUR Ws HOW DO WE GET TO THESE, TO THE FOUR Ws, THAT'S WHERE WE GET THE TERMINOLOGY AND DATA ELEMENTS YOU'LL NOTICE THERE ARE THREE BLOCKS OF REMS DOCUMENT TEXT ON THE LEFT-HAND SIDE OF THE SCREEN HERE AND ALL THREE OF THOSE ARE SAYING THE SAME THING AND WE CAPTURE THEM USING DATA ELEMENTS THAT ARE ON THE RIGHT SO THAT'S THE CRUX OF HOW SPL CAN TAKE LOTS OF REMETABOLISMS THAT SEEMOT SURFACE TO WORK DIFFERENTLY AND THEY HELP CATEGORIZE AND ORGANIZE THEM TO MAKE THEM MORE USEFUL TO STAKEHOLDERS AND YOU CAN IMAGINE YOURSELF SAY MANAGING AND ELECTRONIC HEALTH RECORD AND DEVELOPING AN ELECTRONIC HEALTH RECORD TO HAVE THE SABLE TO USE THAT PROTOCOL ELEMENT TO KNOW THAT THIS IS SOMETHING THAT HAS TO HAVE TO PRESCRIBE AND I HAVEN'T YET DONE THIS, PERHAPS KIPUT UP SOME SORT OF ALERT THAT WOULD WEB CONNECTED MIND ME THAT THIS IS THE TIME TO ENROLL, SO WE'RE HOPING THESE DATA ELEMENTS MAKE IT EASIER TO DO THAT KIND OF THING. SO NOW I'M GOING TO TALK ABOUT USE CASES WHERE WE SEE THIS DATA MODEL, SPL DATA BEING USEFUL. ONE IS AN INCORPORATING REMETABOLISMS INTO THE E-PRESCRIBING THIS IS RELATED TO ANOTHER EFFORT THATTA WORK GROUP 11 HAS BEEN INVOLVED IN. A FEW PEOPLE FROM NCPDP HERE IN THE AUDIENCE ARE INVOLVED IN THAT EFFORT AND WE ARE GOING TO BE ESSENTIALLY TRYING TO HANDLE TO DO THAT TO MAKE SURE THAT REMS CAN BETTER MEET THE GOAL OF HAVING PRESCRIBERS MEET CERTAIN SAFE USE CONDITIONS BEFORE PRESCRIBING AND REMS IS HAPPENING AND RIGHT NOW THEY DON'T MAKE THE WAY FOR PRESCRIBERS TO DOCUMENT THAT THESE SAFE USE HAVE BEEN MET AND RECEIVE CONFIRMATION THAT THESE SAFETY CONDITION VS BEEN MET. FOR EXAMPLE A PRESCRIBER MAY NEED TO BEFORE PRESCRIBING COMPLETE SOME FORM THAT DOCUMENTS THEY MONITORED THE PATIENTS. RIGHT NOW, THE RESCRIBER WHEN THEY TRY TO PRESCRIBE THERE'S NOTHING STOPPING THEM FROM SHIP TAG TO A PHARMACY NECESSARILY AND REMINDING AND TO REMIND THEM THEY NEED TO DO THIS AND THEN WHAT HAPPEN SYSTEM A LOT OF TIMES THE PATIENT SHOWS UP AT THE PHARMAC SCHETHE PHARMACIST SAYS THERE'S A REMS REQUIREMENT OUT THERE AND IT HASN'T BEEN MET AND THE ISSUE WOULD HAVE BEEN BETTER GETTING RESOLVED IN THE DOCTOR'S OFFICE. SO NCPDP IS WORKING ON THE SCRIPT STANDARD ASK THAT COULD BE USED TO REMIND THE PRESCRIBER OF ANY REMS REQUIREMENTS THAT ARE LET AT THE TIME OF PRESCRIBING AND ALLOW THE PRESCRIBE TORE ELECTRONICALLY TRANSMIT INFORMATION ABOUT WHETHER OR NOT THOSE REQUIREMENT VS BEEN MET TO THE MANUFACTURE AND POTENTIALLY THE SPL TO LET THEM KNOW THAT THE PRESCRIBING SYSTEM KNOW THAT A-REMETABOLISMS EXISTS FOR WHICH THIS KIND OF PROCESS IS NEEDED AND B-THAT THE MANUFACTURE SUPPORT THIS IS VERIFICATION PROCESS AND SO ESSENTIALLY FPL IS ACTING AS THE TRIGGER THAT CAN KICKOFF--KICK OFF THE USE OF THIS ELECTRONIC STANDARD AND WE CAN IMAGINE THAT THAT MODEL COULD BE EXTENDED TO OTHER DATA STANDARDS IN HEALTHCARE. ANOTHER POSSIBLE USE CASE IS PROVIDING ADDITIONAL INFORMATION AND TRIGGERS WHO WANT TO INTEGRATE REMS INTO THERE PROCESSES. AND THIS CHART I DON'T EXPECT YOU TO BELIEVE ABLE TO READ IS FROM KISER'S STANDARD OPERATING PROCEDURES PHARMAC. YOU AND LOOK AT THE ARTICLE THAT DESCRIBES HOW THEY TAKE THE REMS, THEY GO THROUGH THE REMS REQUIREMENTS AND DOCUMENTATION AND THEY CAPTURE WHAT EXACTLY THAT MEANS FOR THEIR OPERATING PROCEDURES, WHO NEEDS TO DO WHAT, WHEN, AT WHAT TIME, WHAT DOES THAT MEAN FOR ELECTRONIC SYSTEM. THE ISSUE WITH THAT RIGHT NOW IS THAT IT'S A VERY LABOR INTENSIVE PROCESS AND WE SUSPECT THAT NOT EVERYBODY IS GOING THROUGH ALL OF THOSE STEPS AND CAREFULLY AS THEY HAVE IN THIS EXAMPLE. SO THE AVAILABILITY OF REMS SPL WILL MAKE IT A LOT EASIER FOR HEALTH SYSTEMS TO DO THIS AND HERE HERE'S ANOTHER EXAMPLE OF THE PROCESS FROM THE CLEVELAND CLINIC, EVERY TIME A REMS COMES IN, THEY COMPLETE A CHECK LIST THAT GOES THROUGH A LOT OF DETAILS AND MEDICATION GUIDES, WHERE--DOES IT REQUIRE SOME SORT OF ENROLLMENT PROCESS, THINGS LIKE THAT. THIS WILL ALL STUFF WE'RE HOPING TO CAPTURE THROUGH REMS SPL TO MAKE LIFE EASIER FOR PHARMACIST WHO IS ARE WORKING TO INTEGRATE REMS IN PROCESSES AND PRESCRIBERS OFFICES AND ELSEWHERE. SO WITH THAT I TELL TURN IT OVER TO ED AND HE WILL TALK ABOUT THE PRACTICAL IMPLEMENTATION OF REMS SPL AND HOW IT WORKS. >> SO IT'S PRETTY AMAZING TO ME HOW FAR WE'VE COME WHEN I GAVE A TALK ABOUT RX NORM, AND NOW WITH THE ADOPTION OF THAT AND NOW SPL AND WHICH WAS JUST A FEW FILES AND HOW HOW FAR LONG WE ARE. TODAY I ONLY HAVE A FEW SLIDES WITH YOU BECAUSE WE'RE AWAITING SAMPLE INFORMATION FROM THE FUTURE FROM FDA ON REMS, BUT IT SEEMS LIKE A LOT OF PLACES TO STORE THE PRODUCT STRUCTURE AND LABELING, THAT THERE'S A PLACE CAN YOU GO AND DOWNLOAD INDEXING FILES AND THERE'S ACTUALLY SPL WAS DEVELOPED TO HOLD GRANULAR DRUG INFORMATION ALONG WITH PRESCRIPTION LABELING AND DRUG LISTING INFORMATION AND THE REMS ARE ADJUSTED SO CAN YOU CODIFY THE REMS INTO THE SPL. AN EXAMPLE OF WAWE DO, JUST AS A DOWN STREAM USER, COUPLE THREE TIMES A WEEK WE GO IN AND WE DOWNLOAD THE FULL SPL DATABASE OR THE FILES, THEN WE HAVE SCRIPTS THAT RUN AND WE PULL THEM INTO OUR DATABASE. AND WHAT HAPPENS IS INITIALLY SPONSOR, THE DRUG LABEL TO THE FDA, SEND ITS TO THE NLM AND IT'S POSTED ON THE DAILY MED WEB SITE WHERE WE DOWNLOADED AND WE DO MANIPULATIONSOT VALIDATION ON OUR 18 AND PROCESSES CURRENTLY THERE ARE SEVEN TYPES, THEY'RE THE FDA PHARMACOLOGICAL CLASS, BILLING UNIT CLAY, NCPDP INITIATIVE AND PRODUCT CONCEPT INDEXING SPL, WE NOW HAVE OVER OWN HUNDRED FILE SPECIALIZATION OF SPECIFIC ENDOTHELIAL THAT'S WORK WE WILL WORK ON AND THERE'S ALSO A NEW SET OF INDEXING FILES I JUST NOTICED CALLED THE BIOLOGIC DRUG INDEXING FILES AND THE PRODUCT CONCEPT FILE, IT CONTAINS ORANGE BOOK INFORMATION LINKED TO THE INGREDIENTS IN NDA NUMBERS. FUTURE OF POSSIBILITIES FOR INDEXING OF THE LABELING FOR THE SPL INCLUDE INDICATIONS, ADVERSE EFFECTS, CONTRA INDICATIONS AND A HOPE OF MY IS THAT FDA MED WATCH, AND AS ADAM AND JERRY SAID THAT LABELING SHOULD CONTAIN THE INFORMATION TO SAFELY AND EFFECTIVELY PRESCRIBE A DRUG AND THAT'S NOT NECESSARILY COMLITELY TRUE BECAUSE YOU HAVE THE INFORMATION, HAVE YOU THE MED WATCH UPDATES AND IT WOULD BE IDEAL TO HAVE IN THOSE ONE SINGLE LOCATION SO YOU DON'T HAVE TO GO TO SO MANY WEB SITES TO PULL THAT INTO A DATABASE WOULD BE A HUGE HELP FOR THE CLINICIANS AND HELPING TO UPDATE INFORMATION TO ULTIMATELY DO SOMETHING THAT NEAR AND DEAR TO MY HEART, ULTIMATELY IT'S TO HELP THE PATIENT. SO THAT PATIENT COULD BE YOUR MOM, YOUR DAD, YOUR BROTHER, SISTER GRANDMOTHER, SPOUSE, SO IT'S--THE WORK THAT WE DO, RXNORM IS BEHIND THE SCENES BUT IT MAKES A GREAT IMPACT IN SOCIETY AND I'M VERY PRINTOUT TO WORK WITH ALL OF Y'ALL IN THE COLLEAGUES ON THIS. THIS SLIDE IS MY NONSENSICAL SLIDE. THIS IS PRESCRIBER, DISPENSER, PATIENT, INITIATION OF THERAPY, BEFORE EACH PRESCRIPTION AND DISENSELLING AND OFFICE VISITS SO IF YOU TAKE A STYLE SHEET, IT WOULD TAKE THAT TEXT LOOKING DOCUMENT AND CONVERT IT TO A PRETTIER VERSION, AND HERE YOU CAN MORE CLEARLY SEE THAT YOU CAN SEE THE WIN WHEN AND THE WHAT AND THE MATERIAL REFERENCE AS WHAT NEEDS TO BE DONE WHETHER IT'S INFORMATION TO BE HANDED OUT OR WHETHER IT NEEDS TO DO A LAB TEST. AND THIS IS AN EXAMPLE OF WHAT WE PULL OUT NOW. WE PULL OUT DIFFERENT INFORMATION FROM THE STRUCTURED PRODUCT LABELING AND IMPORT INTO A DATABASE, HERE WE PULL THE DRUG NAME, ROUTE NAME, DOSAGE FORM, STRENGTH AND THE UNIT. AND IN THE FUTURE, WHEN WE GET SAMPLE FILES A REMS INFORMATION COULD BE TAKEN ASK EXTRACT INFORMATION TO A DATABASE WHERE YOU HAVE A REMS CODE AND THE LINK TO THE CODE ASK FROM THAT YOU WOULD BE ABLE TO HELP PASS THE INFORMATION ALONG TO OTHER PEOPLE AND IT'S IMPORTANT THAT WE CODIFY THIS BECAUSE AS ADAM SAID, REMETABOLISMS INFORMATION CAN SOMETIMES GET UPDATED AND TELL TAKE A TIME FOR US TO GO THROUGH AND UPDATE IT AND I KNOW FOR A FULL FTE OF A PHARMACIST'S TIME TO MAINTAIN THESE DATABASES SO ANYTHING I BELIEVE CAN BE COMPUTERIZED AND PUT INTO AN ELECTRONIC FORMAT THAT IS RELIABLE CONTENT WE SHOULD UTILIZE THAT BECAUSE WE CAN TAKE A HUMAN OUT SOMETIME ITS HELPS REDUCE ERRORS AND WITH THAT MY FINAL SLIDE IS UP AND ADAM WILL GIVE YOU AN UPDATE ON WHERE WE ARE THAT THAT WE'RE GOING. >> SO PROGRESS WE MADE A LOT OF PROGRESS SO FAR, ONE OF THINGS JERRY MENTIONED BEFORE IS THAT WE ESTABLISHED THE INCORPORATION OF SPL AS A PRIORITY PROJECT AND PRODUCE OF FIVE AND THIS COMES BACK TO A COMMITMENT WE MADE BACK IN 2000, 12, I THINK 2013 TO HELP STANDARDIZE REM BY IDENTIFYING CERTAIN PRIORITY PROJECTS THAT WOULD HELP MOVE THE GOLD REMS PROJECT ALONG AND ANOTHER THING WE'VE DONE IS WE VALIDATED THOSE REMS, SPECIFIC DATA ELEMENTS AND THAT BALLOT PASS INDEED FEBRUARY OF 2015 SPECIAL THANKS TO LONIE FOR HELPING WITH THAT AND WE ARE NOW WORKING WITH HLSEVEN EXPERMITS AND THEY'RE AMONG THEM TO HELP DRAFT THE ARTIFACTS ENCLUEDING A STRUCTURED PROTOTYPE AND I THINK IT'S BET TORE DRIB THIS AS A KIND OF TEMPLATED REMS TO SEE HOW THE STANDARD ACTUALLY WORKS. ALSO A TERMINOLOGY NEAR F REMETABOLISM SET AND THAT CONTROLLED TERMINOLOGY IS READY TO GO IN DRAFT FORMAT AND IMPLEMENTATION GUIDE WHICH ALSO WE'RE NEARING COMPLETION OF THE DRAFT OF THAT SO OUR NEXT STEP IS ONCE WE GET THESE DRAFT MATERIALS TOGETHER IS TO PILOT THE STANDARD AND WE HOPE TO PILOT THAT SOON AND SEEKING PARTICIPANTS FOR THE PILOT BECAUSE I THINK IT'S SOME PARTICIPANTS MIGHT BE SITTING IN THIS ROOM. [LAUGHTER] WE'RE GOING TO ALSO KEEP WORKING AS WE BEGIN THE PILOT TO GET FEEDBACK FROM STAKEHOLDERS INCLUDING STANDARD ORGANIZATIONS HL-SEVEN AND PDP IN GETTING US TO THIS POINT WE WILL LEARN MORE AS WE PILOT THAT INDUSTRY EXPERIENCE AND ALSO WHETHER THE SPHRUCTURED INFORMATION ADEQUATELY ADDRESSES THEIR USE CASES AND NEEDS BECAUSE THAT'S A MAJOR GOAL FOR THIS IS TO MAKE IT EASIER TO INDGREAT REMS INTO YOUR PROCESSES. FINALLY WE'RE GOING TO PREPARE THE PILOT TO RECEIVE THE REGULATORY FORMAT SO BASED ON FEEDBACK FROM THE PILOT WE'LL FINALIZE IMP LEMMATION AND MATERIALS AND CONTROL TERMINOLOGY AND WE WILL ALSO WORK TO MAKE SURE THAT THE SPL IS AVAILABLE ON CONVENIENT FORMAT SO WE WILL BE IN TOUCH WITH YOU ABOUT THAT, TOO. SO THAT'S--THOSE ARE OUR MAJOR NEXT STEPS, I THINK WITH THAT WE'RE ON TO QUESTIONS. I WOULD LIKE TO KNOW ARE THE REMS, ARE THEY INGREDIENT BASED OR INGREDIENT-DOSE BASED OR MANUFACTURE BASED? BECAUSE WHILE I CERTAINLY UNDERSTAND THE NEED TO PUT THE REMS DATA INTO THE SPLs, I'M THINKING OF IT MORE IN THE RX NORM WORLD WHERE I COULD CONCEIVE OF IF YOU'RE USING RXNORM FOR E-PRESCRIBING WHY YOU MIGHT WANT TO HAVE A FLAG THAT SAYS THERE'S REMS ON THIS AND HAVE IT BE APPROPRIATE KIND OF AT WHAT LEVEL YOU NEED TO HAVE THAT FLAG AVAILABLE. UNFORTUNATELY THERE ISN'T A SIMPLE ANSWER TO THAT QUESTION, THE MOST STRAIGHT FORWARD IS THAT THE REMS ARE AT THE APPLICATION LEVEL BECAUSE THEY'RE REQUIRED BY FDA WHEN A DRUG APPLICATION COMES IN AND WE'LL COVER THAT APPLICATION AND THE PRODUCTS UNDER IT, BUT IN CERTAIN CASES HAVE SHARED SYSTEM REMS, WHERE THE REMS MAY BE FOR A BRAND AND GENERIC, THEY'LL FORM A SINGLE REMS PROGRAM, BUT THERE ARE ALSO CASES WHERE THEY HAVEN'T WORKED TOGETHER AND THERE HAVE BEEN A SEPARATE REMS PROGRAM FOR THE BRAND AND THE GENERIC. THERE'S NO SIMPLE ANSWER TO YOUR QUESTION, I WOULD SAY IT'S THE REMS SPL WILL BE AT THAT PRODUCT NBC LEVEL SO YOU'LL SEE THE INFORMATION AT THAT LEVEL. BUT THAT MAKE ITS A PROSPECT IF YOU USE RXNORM. >> THERE'S MORE POTENTIALLY BUT THERE WERE IN YEARS PASS SAID WHERE REMS ONLY APPLIED TO A SPECIFIC IMPLICATION AND IT MAY BE APPROVED FOR INDICATIONYOU REMS ONLY APPLIED TO ONE OF THOSE FOUR. SO NOW HAVE YOU THE SAME NDC. AND THE NDC IS NOT GRANULAR ANNOUNCED BECAUSE YOU LINK IT TO THE INDICATION THAT IS DONE THROUGH LOINC. SO THERE IS BEYOND THE SURFACE OF JUST NDCs OR RXNORM CODING THERE ARE THOSE THINGS, DO YOU FINISH THERE ARE ANY OF THOSE LEFT? THAT ARE INDICATION SPECIFIC? >> YES. >> OKAY. >> SHELLY? >> GOOD TO SEE YOU. SHELLY FOR PHARMACY I.T. COLLABORATIVE. PART OF WHAT JERRY WAS TALKING ABOUT BUT DIFFERENT AS WE MOVE TOWARD ADVERSE EVENT REPORTING WITH THIS INFORMATION OR HOW THEY WILL BE FIT BUT INTO IT AND AS YOU LOOK TO STRUCTURE AND CODIFY THE INFORMATION AND CODIFYING THE REACTION THAT OCCURRED SO WE COULD PREBEGIN BEGIN TO FEED IT INTO ADVERSE DRUG EVENT REPORTING. >> THAT'S PROBABLY SOMEONE OUTSIDE OF THE PURVIEW OF THE REMETABOLISMS EFFORT, THERE HAVE BEEN SHOULD DISCUSSION OF CODING THAT SORT OF THING: I'M AFRAID I'M NOT ABLE TO ANSWER THAT. >> THANKS. >> HOW ARE YOU I'M HAD A QUESTION REGARDING THE ITASUs, WILL THERE BE CODING--WELL YOU HAVE IMPLEMENTATION SYSTEM, COMMUNICATION PLAN, ARE YOU CODIFYING THOSE? WELL I SHOULDN'T SAY THE SUBSETS OF OF ATSU, THE SPECIFIC AAND SESSION HEADINGS OF THE DOCUMENT, WHICH ARE ORGANIZED RIGHT NOW, ALONG THOSE LINES SO YOU'LL BE ABLE TO TELL FROM A SECTION, IF THERE'S IMPLEMENTATION SECTION HEADING FOR THE RAMS, IMPLEMENTATION SIZE IT'S NOT NEARLYY AS USEFUL AS KNOWING THE PRESCRIBER ENROLLMENT FOR INSTANCE AND THAT'S THE FOCUS OF THE CODING SCHEME THAT WE PUT TOGETHER. >> O I'M OLIVIER BODENREIDER, I'M WITH NLM AND IN ADDITION TO RESEARCH, WE DO DEVELOPMENT, AND WE DO DEVELOPMENT OF RXNORM AND RXCLASS WHICH I WILL TALK ABOUT. SO I KNOW IF YOU REMEMBER WHAT BSS WAS ADVERTISING, THEY SAID WE DON'T MAKE A LOT OF THE PROD UBIQUITINNATIONS YOU BUY, BUT THE PRODUCTS BUY BETTER BUT THEY CAN SAY, RX NORM BUT WE TRY TO MAKE RX NORM EASIER TO USE, AND THAT WAS REALLY HOW WE GOT STARTED WITH THE APPLICATIONS THAT WE DEVELOPED SO IT WAS OVER 10 YEARS AGO AND WE HAVE FROM THE RX NORM TEAM AND IT WAS STEWART AT THAT TIME. WE LOOKED AT A WAY IN WHICH WE COULD LOOK AT THE DATA IN AN EASIER WAY THAN THE RELATION OF FORMATTING WHICH RX NORM WAS OFFERED. AND THE RX NORM, GRAPH AND YOU SHOW THE GRAFF, SO THAT'S WHAT WE DID BY CREATING RX NAV WHICH I WILL DEMONSTRATE IN A MINUTE. AND WHEN WE STARTED KEEPING THE FILES SO WE CREATED AN API AND WE SAID IT WAS USEFUL FOR US, MIGHT BE USEFUL TO OTHERS AND WE MADE THIS PUBLICLY AVAILABLE AND THEN WE CREATED THE SAME KIND OF RESOURCES AND ATS Is FOR COMPANION RESOURCES SUCH AS OUR DEVELOPED BY [INDISCERNIBLE] AND AND WE ENRICHED THIS AND WE ENRICHED AND AVAILABLE AND THE NEXT THING WE KNOW IS THAT PEOPLE STARTED USING APIs AND THIS YEAR WE'RE GOING TO GET A BILLION WITH A B QUERIES TO THESE APIs. SO THE LAST THING THAT WOO WE CREATED WAS RX CLASS WHICH IS IN THE SAME WAY THAT RX NOX FAMILY ACTIVATOR IS A DRUG CENTERED BROWSER WE CREATE THIS AS A CLASS CENTRIC BROWSER AND SO WE MADE THIS AVAILABLE AND WE DEVELOPED IT IN THE SAME WAY WHICH IS THAT WE PROVIDED BROWSER BUT WE ALSO PROVIDE AN ATI, SO THAT ANY OF YOU CAN ACTUALLY USE THIS ATI AND RECREATE A BETTER BROWSER OR INTEGRATE THE INFORMATION IN YOUR APPLICATION. AND SO, IF I CAN GET I.T. TO LET ME COMPUTER HERE, THAT WOULD BE GREAT, [INDISCERNIBLE]. SO--I WILL SHOULD A LOT OF THEM IN THE ROOM, SO YOU MIGHT HAVE TWO OF THEM IN THE ROOM AND THE OTHER DEVELOPER IS [INDISCERNIBLE] SO IT'S IN THERE THAT WORKS BUT YOU WILL BE ABLE TO SEE IS BECAUSE OF THE TWO OF THEM. SO WHILE I'M GETTING PLUGGED IN OR WAITING FOR THAT, I CAN TALK TO YOU ABOUT A FEW COMING ATTRACTIONS. SO WE'VE BEEN WORKING THIS YEAR A LOT ON THE NDCs BECAUSE AS MUCH AS WE LIKE, THE NDCs EXTREME PREVALENT IN TERMS OF THEIR USE. AND RX NORM DOES A GREAT JOB AT PRUNING THE OBSOLETE AND THAT'S FOR PRESCRIPTION WE WOULD HAVE INCENTIVE TO USE THEM IN A PRESCRIPTION SYSTEM. HOWEVER WHEN IT COMES TO ANALYZING HISTORICICAL DATA SETS SO FOR EXAMPLE, MEDICARE DATA SETS, CLAIMS DATA SET, WITH THE NDCs FROM A FEW YEARS AGO, YOU WANT TO KEEP RESOLVING THESE NDCs INTEREST OUR [INDISCERNIBLE] AND LINK THEM TO CLASSES SO WE HAVE DEVELOPED ATIs TO SUPPORT THIS FUNCTION AND OF COURSE WE NEED TO USE INFORMATION THAT'S NOT IN RXNORM AND ACTUALLY TEST IN PREVIOUS VERSIONS OF RX NORM SO THERE'S A FUNCTION CALLED GET NDC STATUS THAT DOES THIS. AND--OKAY, SO WE--WAS A GOFFA APPLICATION AND WE ARE REWRITING THIS AS WE SPEAK AS A WEB APPLICATION FELT SO THIS IS THE MANY PAGE FOR ALL THAT I'VE BEEN TALKING ABOUT, SO THE APPLICATIONS RX NOX FAMILY ACTIVATOR AND RX CLASS AND THE APIs. ALTHOUGH, NOT SHOW YOU TOO MUCH INFORMATION ABOUT THE APIs BECAUSE THAT CAN BE SEVERELY BORING AND SO I WILL SPARE YOU THAT IF I CAN BUT WHAT I WANT TO YOU KEEP IN MIND IS THAT EVERYTHING THAT YOU SEE ME DEMONSTRATE WITH THESE APPLICATION, EVERYTHING CAN YOU DO TO THIS APPLICATIONS MRIICATION HAPICATIONS CAN YOU GET THE SAME INFORMATION FROM THE API AND YOU CAN EMBED THIS, INTO APPLICATIONS. SO IT CAN BE WEB APPLICATIONS, IT CAN BE [INDISCERNIBLE] AND WE HAVE A LOT OF USERS IN IN DEPARTMENT. SO LET'S FIRST LOOK AT RXNAV AND THE IMAGE THAT SOME OF YOU ARE FAMILIAR WITH RX NAV AND HAVE SEEN IT BEFORE. SO I WILL JUST GIVE YOU A BROAD OVERVIEW. SO RX NAV IS THIS DRUG CENTRIC APPLICATION AND IT TELLS YOU EVERYTHING YOU NEED TO KNOW OR YOU WOULD LIKE TO KNOW ABOUT THE DRUG THAT WE CAN GO FROM THE PUBLICLY AVAILABLE SOURCES THAT I MENTIONED INVITE--MARILYN CLUING RX NORM AND WE ALSO DRAW FROM DRUG BANKS FOR DRUG-DRUG INTERACTION. SO, WE CAN START BY TYPING A DRUG NAME, SO IF I WANT TO SEARCH FOR [INDISCERNIBLE] THAT I CAN ACTUALLY CANNOT SPELL AND I'M SPELLING IT [INDISCERNIBLE] AND IF I CANNOT, I'M GOING TO GET SOME INTERACTION AND I'M GOING TO GET HOPEFULLY WHERE I NEED ON TO GO, SO I LANDED INTO AN INGREDIENT AND WE TALKED THIS MORNING ABOUT THE TRADE NAME, THAT'S THE WAY WE USE TO [INDISCERNIBLE] THE DRUG NAME WHEN IT'S AVAILABLE FROM RXNORM. THE GRAPH GETS POPULATED WHICH MEANS THAT EVERY TERM, EVERY TYPE OF DRUG ELEMENT IN THE GRAPH GETS POPULATED FROM WHERE WE STARTED, FROM [INDISCERNIBLE] AND I CAN EXPLORE THE GRAPH FURTHER. FOR EXAMPLE, I CAN FOCUS ON FLUOXETINE 10-MILLIGRAM CAPSULE AND YOU CAN SEE THE GRAPH DEPARTMENT CHANGE BECAUSE I JUST PICKED ONE ELEMENT HERE, WHAT CHANGED IS WHAT TYPE OF INFORMATION BECAME AVAILABLE AND IT'S REFLECTED BY WHICH OF THE TYPES GET HIGHLIGHTED ON THAT. SO VERY BRIEFLY BESIDES THE GRAPH THAT YOU ALL KNOW, THE RX NORM PRESENTATION, WE CAN WE OFFER SOME INFORMATION THAT'S IN RXNORM IN A TABLE VIEW HERE AND I'M SAYING SOME OF THE INFORMATION BECAUSE THIS--THE APIs IN THESE APPLICATIONS ARE OUTSIDE THE LICENSE AGREEMENT THAT YOU NEED TO SIGN IF YOU WANT TO GET THE DATA SIGNS BUT THE WAY WE GET AWAY WITH BEING OUTSIDE THIS LICENSE AGREEMENT IS WE PROVIDE THIS INFORMATION THAT AWE PUBLICLY AVAILABLE AND THAT IS OWN BY NLM. SO WE DON'T PROVIDE ANY OF THE DRUG NAME, THE PROPERTY DRUG NAME OR THE PROPERTY DRUG CODE, WE RESULT THOSE INTO OUR [INDISCERNIBLE] BUT WE DON'T PROVIDE THE PROPERTY DRUG NAMES OR DRUG BRANDS. WE HAVE A TAB FOR THE NDCs BECAUSE IT'S A PARTICULARLY IMPORTANT PIECE OF INFORMATION HERE. RXTERMS AND THE DATA SET THAT'S DERIVE FRIDAY RX NORM, IT'S CREATE BIDE [INDISCERNIBLE] HERE AND IT PROVIDES DRUG NAMES THAT ARE APPROPRIATE FOR PHYSICIAN FRIENDLY IF YOU WISH AND THAT ARE MORE APPROPRIATE FOR A CDL FOR WHAT YOU WOULD LIKE TO SEE IN THE [INDISCERNIBLE] FOR EXAMPLE IN THE APPLICATION. WE DRAW INFORMATION FROM THE [INDISCERNIBLE] AND IN ADDITION TO THE CODES AND THIS KIND OF INFORMATION, WE ALSO SHOW--WE ALSO SHOW THE DRUG HIERARCHY, I MEAN EACH OF THE MAIN HIERARCHYS IN FRT WE CAN RESULT HERE AND FROM THERE WE GO TO THE DHSs AND THE EPCs, THE PHARMACOLOGIC CLASSES AND AND I AM NOT GOING TO GO THROUGH ALL THE TABS THAT WE CAN SEE THE MECHANISM HERE, AND WE CAN--LET'S SEE THESE THINGS, A LITTLE BIT MORE. CLOSELY. AND WE TALKED THIS MORNING ABOUT IMCANCER CENTERS, THIS SELECTION OF IMAGES THAT'S CREATED AT NLM AND WE MAKE IT AVAILABLE SO WE LINK THE IMAGES TO THE RX KD--SALLY WAAND WE DISPLAY IMAGES FOR A GIVEN [INDISCERNIBLE]. OF COURSE IMAGES ARE LINKED TO GROUPS OF NDCASKS THIS IN THIS CASE, WE ARE AN RX NORM CENTRIC APPLICATION, WE GREW THE IMAGES AND I MENTIONED THE INTERACTIONS ALSO AND WE USED TO TAKE DIRECTIONS WHEN THEY'RE AVAILABLE, AND THESE IN THE INTERACTIONS AND WE NOW GET THEM FROM ANOTHER PUBLICLY AVAILABLE SOURCE WHICH IS DRUG BANK. SO I'M GOING TO LITTLE BIT PASSED THIS AND AGAIN, IT'S FREELYY AVAILABLE SO FEEL FREE TO SEND US FEEDBACK IF YOU WANT. AND I'M GOING TO SWITCH TO RXCLASS VERY BRIEFLY. SO, RXCLASS IS--YOU CAN THINK OF IT AS BEING THE SAME THING AS RXNORM BUT FROM A CLASS PERSPECTIVE AND SO WE INCLUDE CLASSES FROM THE SOURCES, WE INCLUDE APC CLASSES, ATC IS THE THERAPEUTIC CHEMICAL CLASSIFICATION OF DRUGS CREATED BY THE W. H. O. CENTER IN SWEDEN--NO, WAIT. SWEDEN OR SCANDINAVIA SOMEWHERE? I'M ALWAYS CONFUSING THE COUNTRIES. WE TAKE THE CLASSIFICATIONS FROM MESH. THERE'S A BUNCH OF RELATIONS TO MECHANISM TO THE PHYSIOLOGICAL EFFECTS THAT ARE AVAILABLE FROM SEVERAL SOURCES. AND I KNOW THAT CAN GET CONFUSING AT SOME POINT, BUT WE--WHENEVER WE CAN, WE GET THIS INFORMATION FROM THE DAILY MED, YOU MENTIONED SEVERAL TIMES TODAY, BUT WE CAN ALSO DRAW THE SAME INFORMATION FROM THE NDFRT PROPER RELATIONS AND ALSO FROM FPSPL, WHICH IS PRETTY MUCH THE [INDISCERNIBLE]. BECAUSE WE'RE ALSO INGEST THESE [INDISCERNIBLE]. SO VERY BRIEFLY WE CAN DO TWO TYPES OF THINGS AS WITH ANY GOOD BROWSER IF WE WISH, WE CAN NAVIGATE THROUGH THE CLASSES. SO LET'S SAY WE'RE INTERESTED IN THE STATINS IN APC, SO WE CAN GO TO OPEN ATC, WE WILL FIND THEM AND THE CARDIOVASCULAR TRIAL. AND THEY'RE UNDER THE LIPIDS, AND AGENTS, AND LET'S EXPLORE THE LIPID METASTATIC AGENTS AND YOU WON'T BE SURPRISED TO FIND--TO FIND THESE DRUGS IN THE LISTS. SO, WE CAN--WE CAN EXAMINE THE LIST OF COURSE AND WHAT'S INTERESTING HERE, IS THAT WE RANDOM THE DRUGS, BOTH AS WITH THEIR ORIGINAL NAMES AND CODES, SO WE HAVE THE NAMES AND CODES IN APC BUT WE HAVE TRANSLATED THESE INTO THEIR RXNORM COUNTERPART, SO TO TO THE LEFT HERE WE HAVE THE RXYC IS AND THE RX NORM NAMES. WHAT WE CAN DO ALSO IS A GIVEN DRUG MIGHT HAVE CLASSES IN SEVERAL CLASSIFICATION SYSTEMS. WE CAN SEE WHICH CLASSES A PARTICULAR DRUG BELONGS TO SO IF YOU LOOK AT A ATORVASTATIN, WE CAN SEE THE INHIBITORS AND YOU CAN SEE IT'S ALSO AN AGENT IN MESH, AND IT IS ALSO STATED IN THE EPC, PHARMACOLOGIC CLASSES WHICH IN THIS CASE WE GET THE RELATION FROM THE DATA MET INDEX OF FIVE. WE CAN ALSO SEARCH WE CAN ALSO SEARCH AND LET'S DO A--WE CAN SEARCH BY DRUGS AND WE CAN SEARCH BY CLASS, ALSO, SO LET'S DO A SEARCH BY DRUGS FOR EXAMPLE, LET'S SAY I'M SEARCHING FOR--FOR [INDISCERNIBLE]. SO HERE IT IS LISTED AS AN INHIBITOR IN ATC AND ALSO IN THE EPCs. AND AGAIN IF I LOOK AT IT AS I LOOK AT THIS CLASS WITHIN THE EPCs. I WILL FIND THE SAME THING I WILL FIND IN THE INDEXING FILE FROM DAILY MED WHICH MEANS THAT THE DRUGS, ARE GOING TO BE IDENTIFIED BY THEIR UNITS BECAUSE THAT'S HOW THEY'RE IDENTIFIED IN THE DAILY MEDS CONVICTION SIZE BUT WE CONVERT THESE WHO THROUGH RX NORM INTO THE CORRESPONDING RX CUI, SO I AM GOING TO STOP HERE AND I WILL BE HAPPY TO TAKE ANY QUESTIONS. THANK YOU. OR NOT. [LAUGHTER] [ APPLAUSE ] >> OKAY, WELL, THANKS FOR INVITING ME BACK, IT'S NICE TO BE INVITED SOME PLACE AND WHEN YOU'RE INVITED BACK, IT'S STILL REALLY GOOD AND HOPEFULLY MY TALK WILL BE INTERESTING TO YOU AFTER LUNCH WHICH SINCE WE CAN'T HAVE DRINKS FROM HERE, I'M SUFFERING FROM A CAFFEINE DROP MYSELF HERE BUT WHAT WE'RE GOING TO TALK ABOUT IS IN A SIMILAR VAIN TO WHATEE HEARD A WHILE AGO FROM ED AND JERRY ABOUT THE REMS, IN THE SENSE THAT WE'RE TALKING ABOUT SOMETHING THAT'S IMPORTANT CLINICALLY THAT IS PRESENT THAT WE WOULD LIKE TO STRUCTURE BECAUSE IT WOULD BENEFIT A LOT OF STAKEHOLDERS SO THAT THING WE'LL TALK ABOUT THAT'S UNSTRUCTURED THAT'S CURRENTLY IN THE PRODUCT LABEL SUGGEST IS PHARMACOKINETIC MENTIONS AND WHAT I WILL TELL YOU ABOUT IS, OUR INITIAL EXPLORATION AT THE UNIVERSITY OF PITTSBURGH OF TRYING TO USE NONEXPERTS TO ANNOTATE THAT INFORMATION, I CAN SEE IF I CAN FIGURE OUT HOW TO GO HERE. I HAVE NO FINANCIAL RELATIONSHIPS OR COMMERCIAL INTEREST TO DISCLOSE FOR THIS TALK. AND THE TAKE HOME MESSAGE IS THIS: STRUCTURED PRODUCTS CONTAIN A LOT OF EVIDENCE AROUND DRUG INTERACTION BUT IT'S ALL UNSTRUCTURED. IF YOU LOOK AT SAY THE THOUSAND OR SO DRUG PRODUCT LABELS THAT HAVE TABLES THAT'S SIMILARLY NOT HELPFUL. THERE'S NO SEMANTICS. STRUCTURAL EVIDENCE WOULD BE HELPFUL TO SEVERAL STAKEHOLDERS AND WE WILL GET INTO CONCRETE EXAMPLES OF THAT IN SLIDES BUT IT'S COSTLY AND DIFFICULT AND I DON'T THINK THIS IS A SURPRISE TO THIS AUDIENCE AND I STARTED LEARNING ABOUT PRODUCT LABELS I WENT THROUGH THE DOCUMENTS THAT ARE STRUCTURED PRODUCT LABEL AND I THOUGHT THERE WERE LOTS OF DISCUSSIONDOING A WHOLE LOT MORE STRUCTURING THAN WHAT WE HAVE NOW. SO IT'S A NEW ISSUE, AND WHAT WE ARE--WE SEE THERE'S A LOT OF EXCITEMENT AND GROWING AND TOOLING AROUND CROWD SOURCING, AND WE THOUGHT THIS STUDY MIGHT HELP US MOVE THAT OR SEE IF WE CAN MOVE THAT DIRECTION SO THAT'S THE TAKE HOME POINT, NOW I AM PROBABLY ONE OF THE FEW FEMME IN THIS ROOM WHO IS NONAPOPTOTIC THE A SCIENTIST, I AM A BIOINNORMATTIST WITH A Ph.D. BUT I WORK WIDE FARM SUITS AS I GOT INTO GRADUATE SCHOOL SO I THINK IT'S IMPORTANT TO FOCUS ON WHAT THEY MEAN WHEN THEYUC ABOUT A DRUG INTERACTION. AND THAT IS A CLINICALLY MEANINGFUL ALTERATION OF THE EFFECT OF A DRUG THAT OCCURS AS A RESULT OF CO ADMINISTRATION OF ANOTHER DRUG. MY INFORMAT CYST COLLEAGUES AND MYSELF HAVE GOTTEN THIS WRONG SOMETIMES AND WE'VE WRITTEN PAPERS WHERE WE REPORTED PREDICT THE INTERACTIONS IN THE 10S OF THOUSANDS AND SAID THIS WOULD BE IMPORTANT TO CLINICIANS AND WE'RE TALKING ABOUT VIGILANT SIGNALS OR OFTEN TIMES WE'RE TALKING ABOUT POTENTIAL DRUG INTERACTION, AND THAT MEANS EVIDENCE EXISTS PERHAPS IN A CASE REPORT THAT'S ANALYZED FOR CAUSALITY OR PERHAPS A PERSPECTIVE DRUG INTERACTION STUDY THAT SHOWS FARM CO KIN ETICSIC DATA THAT INDICATES THAT TWO DRUGS CAN ACT AND NOW HAVE YOU A PATIENT, POPULATION OF PATIENTS THAT ARE EXPOSED TO THAT PAIR THAT.'S A POTENTIAL DRUG INTERACTION, IT DOESN'T MEAN SOMEONE'S GETTING HARMED NECESSARILY. BUT AT THE SAME TIME PEOPLE DO GET HARMED FROM THESE, IN FACT A GOOD EPIDEMIOLOGIC STUDY THAT WAS COMPLETED A FEW YEARS AGO SHOWED THAT 1. 1.9-5 MILLION IN PATIENTS PER YEAR, IT'S A BIT OF A CONUNDERLYING ASSUMPTIONS - -CONUNDRUM. IT NEEDS TO INCLUDE A DESCRIPTION OF CLINICALLY SUG95 CANT INTERACTIONS, SO IT SOUNDS SIMPLE ENOUGH BUT IT'S VERY CHALLENGING BECAUSE AGAIN WHAT DO YOU MEAN WHEN YOU SAY CLINICALLY SIGNIFICANT AND IT ALSO TALKS ABOUT IF YOU LOOK IN THIS TEXT HERE, EITHER OBSERVED OR PREDICTIVE SO THERE'S TONS AND TONS OF THINGS THAT ARE PREDICTED OR INFERRED MECHANISMS FOR THE DRUGS FOR WHICH THERE'S NEVER BEEN A STUDY CONDUCTED NOR WILL THERE EVER BE WHICH WILL ESTABLISH THE ACTUAL MEAN NOTHING PATIENTS, AND SO THIS BECOMES A REALLY INTERESTING INFORMATION PROBLEM TO LOOK AT. I LOOKED AT THIS A COUPLE YEARS AGO BY CONDUCTING A REVIEW WHAT WE WANTED TO KNOW IS FOCUSING IN ON SPECIFIC KIND OF INTERACTION, THESE ARE INTERACTIONS THAT ARE OCCUR BY METABOLIC INHIBITION, SO HAVE YOU A DRUG, THAT HAS THE POTENTIAL TO INHIBIT THE METABOLIC ENZYMES THAT ANOTHER DRUG MIGHT YOU KNOW BE CLEARED FROM THE BODY, THROUGH, SO WE WANT TO FOCUS ON THOSE INTERACTIONS SO THOSE ARE THE ONES WHICH WE SAY STUDIES ARE DONE THEY HAVE PHARMACOKINETIC DATA SO FOR THAT SUBSET OF DRUGS AND FOR A SUBSET OF DRUG CLASSES, WE FOCUSED ON HYPNOTICS AND ANTIDEPRESSANTS AND ANTIPSYCHOTICS WHICH WE CALL PSYCHOTROPIC, HOWEVER OFTEN AND THIS MENTIONED IN PRODUCT LABELING WHICH MEANS WE HAD TO LOOK IN THE LITERATE AND YOU ARE TO GET A REFERENCE SET AND THEN WE ALSO SAID CAN WE SEE ANY INFLUENCE OF THE LOCATION OF THIS INFORMATION SO EXTERNAL SOURCES THAT SAY PROVIDE PEOPLE ON THE INTERNET WITH A WAY TO CHECK THEIR DRUGS FOR INTERACTIONS, DO THEY SEEM TO AGREE MORE OFTEN IF THE INFORMATION IS LOCATED IN BOTH THE LITERATURE AND THE PRODUCT LABELING OR IF IT'S ONLY IN THE LABELING, OR ONLY IN LITERATURE. THAT WAS THE OBJECTIVES WHAT WE ACCOMPLISH. AND GANG THIS WAS A COMPREHENSIVE REVIEW. WE DID IT IN A SORT OF SYSTEMATIC REVIEW STYLE, IF YOU WILL AND WE INVOLVE THREE DIFFERENT DRUG INFORMATION RESOURCES: SO I'LL SHOW YOU TWO TABLES OF RESULTS, THE FIRST TABLE IS REALLY JUST LOOKING AT THE LOCATION OF THE INTERACTIONS THAT WE FOUND, THESE ARE METABOLIC PSYCHOTROPIC DRUGS AND THERE'S A TOTAL OF 44, 13 WERE IN THE LITERATURE SO THERE WAS SOME SORT OF PUBLISHED SCIENTIFIC ARTICLE THAT TALKED ABOUT THE PAIR. 18 WERE EXCLUSIVELY IN THE PACKAGE INSERT. AND THIS SORT OF MAKES SENSE THERE'S AN OVERLAP OF 13. YOU CAN SEE THERE'S VARIOUS DEGREES OF COVERAGE. SO THE SECOND TABLE IS INTERESTING, WE SAID THERE WE KNOW THERE'S DISAGREEMENT. IT'S BEEN REPORTED OVER AND OVER AGAIN THAT THESE SOURCES OF DRUG INFORMATION DISAGREE WITH EACH OTHER ABOUT WHICH DRUGS INTERACT AND ABOUT THEIR SEVERITY. BUT DO WE SEE ANY GREATER AGREEMENT IF WE PAY ATTENTION TO THE SOURCE OF THE INFORMATION. AND I THINK THIS IS THE MOST INTERESTING THING TO ME IS THAT IF WE LOOK AT WHERE THE RED BOX IS, DRUG INTERACTIONS, MENTION EXCLUES OFLY IN LABELS WITH 3.2 TIMES MORE LIKELY TO BE AGREED UPON BY SCREENING TOOLS. BUT 50% OF THE INTERACTIONS THAT WERE MENTIONED IN PROUCT LABELING WERE AGREED UPON AND I THINK IT'S--WE CAN PROPOSE REASONABLE EXPLANATIONS FOR THAT. MOSTLY, IT'S A ONE STOP SHOP. YOU GO TO THE PRODUCT LABEL. YOU GO TO THE DRUG INTERACTION SECTION AND YOU PULL OUT THE INFORMATION. IF YOU HAVE TO GO TO THE LITERATURE, YOU HAVE TO DEVELOP A SEARCH STRATEGY, ALSO WHEN YOU GET BACK THE LITERATURE YOU GET INFORMATION WHICH ALLOWS TO YOU ASSESS THAT INTERACTION, SO SOME OF THESE SOURCES DEPENDING ON EDITORIAL BOARD AND APPROACH TO ASSESSING THESE INTERACTIONS WOULD THROW THINGS OUT WHICH KHI IS WHY THE INTERACTIONS THAT ARE IN BOTH ARE PROBABLY LESS THAN THE INTERACTIONS THAT ARE MENTION INDEED ONLY ONE. SO WE THOUGHT THIS WAS REALLY INTERESTING AND I THINK IT DOES--IT IS A TELLING THING, IT SAYS WHAT IS PUBLISH INDEED THE PRODUCT LABEL MATTERS. IT'S OUT THERE, INFLUENCING DRUG INTERACTION, CHECKING AND SCREENING TOOLS AND WHAT'S BEING PROVIDED BY VENDORS TO HOSPITALS AND PHYSICIANS. WE'RE NOT THE ONLY ONE TO DO THESE KINDS OF STUDIES THIS, IS AN INTERNATIONAL STUDY THAT LOOKED AT LABELING AND U. K. AND UNITED STATES AND GERMANY AND AMONG THE QUESTIONS THAT I ASKED IS IF YOU SAW A DRUG INTERACTION REPORT INDEED ONE LABEL. LET'S SAY KETOCONO VOWEL AND YOU WENT TO THE COMPLIMENTARY LABEL, HOW OFTEN WAS THE INTERACTION MENTIONED IN BOTH? AND THEY FOUND THAT WAS PRETTY SPOTTY. IT VARIED ACROSS THE COUNTRIES BUT NOT VERY MUCH, SO 40% OF THE LABELS THAT THEY LOOKED AT IN THE UNITED STATES HAD THIS SITUATION WHERE ONLY WOB LABEL MENTIONED THE INTERACTION. SO WE CAN KIND OF GO ON AND ON AND WITH THE STORY. CLEARLY WELL THEIR ARE ISSUES THAT NEED TO BE ADDRESSED. I THINK IT'S ALL FIXABLE IF WE COULD STRUCTURE THAT DRUG INTERACTION INFORMATION. IDEALLY AT THE TIME THAT WE WRITE THE DOCUMENT, IT WOULD BE GREAT, STRUCTURED PUBLISHING THE INTERACTION, AND IF IT WAS STRUCTURE INDEED THAT WAY IT WOULD BE SIMPLE FOR SOMEONE TO SCRIPT UP THE ANALYTICS AND SAY ACROSS LABELING THERE'S DISCORDANCE ACROSS THE LABEL. ALSO FROM AN INFORMATION RETRIEVAL PERSPECTIVE IF THIS WAS NOT DONE IN LABELING BUT DONE IN OTHER RESOURCES LIKE FOR EXAMPLE MEDLINE, YOU COULD LINK ACROSS THE SOURCES AND IF WE WENT BACK TO THE TABLE LIKE THE SECOND ONE IN THE BOTTOM HERE, WHEN SOMEONE WAS LOOKING AT THE PACKAGE INSERT WHY WOULDN'T THERE BE A LINK OUT TO MEDLINE THAT SAYS BY THE WAY THIS HAS BEEN STUDIED TWO OR THREE TIMES THIS IS THE PUBMED DIFFICULTY D. CHECK IT OUT. BUT THERE ARE PAIRIERS AND AGAIN THIS AUDIENCE IS FAMILIAR WITH THIS AND THIS KIND OF FORMALIZATION IS TIME CONSUMING AND THERE ARE A LOT OF DRUG PRODUCTS. WE'RE ACTUALLY, YOU KNOW IF WE STARTED TODAY TO STRUCTURALLY THUR INFORMATION WE COULD STILL HAVE THOUSANDS AND THOUSANDS AND THOUSANDS OF PRODUCT LABELS THAT DON'T HAVE ANY STRUCTURE TO THEM. ALSO BECAUSE OF THE WAY THAT THINGS HAPPEN WITH STRUCTURE PRODUCT LABELING THEY'RE WRITTEN BY DIFFERENT ORGANIZATION SO HOW DO YOU INSURE CONSIST ENSEL SCHETHIS IS A PROBLEM THAT SPL PROJECT EXPERIENCED EARLY ON WHEN THEY TRY TO STRUCTURE MOIRE OF THE PRODUCT LABELING AND FINALLY WHAT ARE THE INCENTIVES, WHAT ARE THE INCENTIVES THAT THE PHARMACEUTICAL COMPANY TO DO THIS. HOW WILL WE MAKE THIS WORTH WHILE. SO I'M NOT GOING TO ANSWER THE LAST QUESTION TODAY. THOUGH I WILL PUT IN A PLUG THAT IN A FEW WEEKS, THERE IS GOING TO BE A SYMPOSIUM HERE FROM THE OBSERVATIONAL HEALTH DATA SCIENCES AND INFORMATICS COLLABORATIVE, OHDSI. IF YOU GO TO OHDSI.ORG, YOU WILL SEE THAT. AND WE MAY SHOW SOME TECHNOLOGY THAT MAY ANSWER SOME OF THEM. WHAT I WILL FOCUS ON ON MORE AND CAN WE MAKE IT MORE FEASIBLE? SO WHAT IF ANNOTATION CAN BE CROWD SOURCES TO INDIVIDUALS WITH BASIC CHEMISTRY BACKGROUND. THAT'S ALL I HAVE. I LOVE THE SUBJECT, WE GOT INTO GRAT YOD SCHOOL AND STARTED WORKING WITH PHARMACIST AND IT WAS ABLE TO READ THESE DOCUMENTS FAIRLY WELL. THERE'S A LOT, LOT OF RETIREES AND THAT NUMBER'S NOT GOING DOWN AND THESE ARE SMART PEOPLE. AND THERE'S A NEW SORT OF THING CALLED CITIZEN SCIENTISTS AND YOU MIGHT LOOK INTO THIS, WHERE THERE'S A LOT OF PEOPLE WHO ARE REALLY INTERESTED IN SCIENCE BUT THEY DON'T HAVE A Ph.D., THEY WANT TO PARTICIPATE AND THEY'RE GREATER ROLE PEOPLE TO ENGAGE IN ALL THINGS. IT'S BEEN VERY SUCCESSFUL IN ASTROLOGY, ORNOPHOLOGY, AND ALL THAT. SO HERE'S THE QUESTION CAN PEOPLE WITH LITTLE TO NO TRAIN NOTHING THE FIELD OF DRUG INTERACTIONS ANNOTATE BLUING PRODUCT LABELING? SO WE DID A PILOT SIDE TO ANSWER THAT QUESTION SO WE COULD LEARN HOW TO DESIGN THE STUDY EVEN BETTER FOR THE NEXT GO AROUND AND BUILD A LARGER SCALE SCENARIO, WE SET UP DIFFERENT ANNOTATION SCENARIOS WE THOUGHT, OKAY, WE WILL PROVIDE A SCENARIO, WHERE THE PEOPLE WHO WE ENGAGE HAVE NO ASSISTANCE AT ALL. THEY'RE JUST THROWING THE LABEL SECTION. A--BITS OITATE OUT THE DRUG INTERACTION. WE DOLL A LITTLE HEALTH IN ANOTHER SCENARIO, WE WILL GO THROUGH AND TAG THE DRUGGENTITYS SO WE'LL HIGHLIGHT FOR THEM, THICKS LIKE KETOCONO VOWEL SO IT STANDS OUT A BIT MORE AND HOPEFULLY THOSE SENTENCES WILL DRAW THEIR ATTENTION AND THEN WE'LL TRY TO APPLY NATURAL LANGUAGE PROCESSING. SO WE'LL ACTUALLY HAVE NLP COME ALONG AND SAY, I THINK THIS SENTENCE IS STAYING A POTENTIAL PHARMACOKINETIC DRUG INTERACTION AND THE ANNOTATOR CANS MAKE A DECISION TO ACCEPT THAT OR DISMISS IT AND MAYBE THAT WOULD ASSIST THEM ALSO. SO THOSE ARE THE SCENARIOS WE SET UP AND THIS IS WHAT IT LOOKED LIKE. SO UP ON THE TOP, I SEE THE GREEN DOT, THIS IS HIGHLIGHTED THIS IS WHAT THE USER WOULD SEE, THIS IS ACTUALLY ONE WHERE THE USER SAID, THIS WOULD HAVE SOMETHING TO ANNOTATE OR IT'S PREANNOTATED FOR THEM T. SAYS HERE A PUBLISHED STUDY SHOWS THAT THE CO ADMINISTRATION, THREE AA FOURA INHIBITOR WOULD INCREASE THE OXYCODONE. WE DIDN'T ASK TOO MUCH, JUST A BIT OF FORMALIZATION HERE. CAN YOU HIGHLIGHT FOR US THE TWO DRUGS, OR CAN YOU ACCEPT WHAT THE--WHAT THE PREANNOTATION SUGGESTED ARE THE TWO DRIVES. CAN YOU TELL US ENACTIVE INGREDIENT, METABOLITE OR PRODUCT? WE MIGHT NOT KNOW THAT. IF CAN YOU INDICATE IF THE DRUG IS THE OBJECT OF THE INTERACTION, SO THE VICTIM OR IF IT'S THE PER TAS PANT OR THE DRUG CAUSING THE INTERACTION. IS THERE QUANTITATIVE DATA IN THAT STATEMENT. CAN YOU TELL US THAT ISHT ACTIVE STATEMENT IS AN INTERACTION OR THERE'S EVIDENCE THAT THERE'S NO INTERACTION SO CAN YOU HAVE DRUG INTERACTION STUDIES THAT SHOW NO CHANGE IN PHARMACOKINETIC PARAMETERS SO THAT'S NEGATIVE MODALITY DRUG INTERACTION STATEMENT. PRETTY EASY, WE THOUGHT NOT TOO COMPLICATED SO AFTER THAT ANNOTATION IS COMPLETE, CAN YOU LOOK AND SUMMARIZE, AND SEE A SUMMARY OF WHAT HAS BEEN ANNOTATED THEY HAVE THE OPPORTUNITY TO EDIT IT OR DELETE IT AND THIS WAS A WEB BASED SYSTEM BECAUSE WE'RE TRYING TO MOVE INTO THE CROWD SOURCING SPACE SO WE HAVE A WESTBOUND SYSTEM, ANYBODY IN THE WORLD COULD HAVE PARTICIPATED. A LITTLE MORE ABOUT THE ARCHITECTURE HERE. THIS IS WHERE WE GOT THE STRUCTURE MODEL. WE CONVERTED IT AND I KEEP SLAPPING THE MIC, SORRY. SO THIS ALLOWED US TO QUERY UP A SECTION WE CAN FOCUS ON, AND WE WERE ONLY GOING TO FOCUS ON SPECIFIC SECTIONS AND THEN WE RAN TWO DIFFERENT ALLEGOR EIGHT HOURS IMPEDIMENTSES AND THESE ARE IN HOUSE ALGORITHMS WE REPORT OFFICE OF DIVERSITY THE METRICS PREVIOUSLY. ONE WAS A DRUG NAMED IN THE DRUG RECOGNITION PROGRAM AND IT'S THE BIOPORTAL IN THE PROCESSING TO IMPROVE THE PRECISION TO RECALL. AND THEN WE HAD AN IN-HOUSE NLP PER PHARMACOKINETIC DRUG INTERACTION MENTION IDENTIFICATION AND IN OUR PRIOR WORK IT DID GOOD. IF YOU GAVE IT A BLOCK OF TEXT FROM A PRODUCT LABEL, IT WOULD IDENTIFY IF THERE THERE WAS A CONNECTION AROUND 80% OF THE TIME AND 80% OF THE TIME THAT IDENTIFIED THE INTERACTION THERE, IT WAS ACTUALLY REALLY THERE. IF YOU GIVE IT A BLOCK OF TEXT, THAT'S IMPORTANT BECAUSE WE WILL SEE LATE OR THE EVALUATION THAT WE DID ON OUR OWN WASN'T THE EVALUATION WE'VE DONE IN ORDER TO DO THIS. SO WE LEARNED A LESSON THAT NONETHELESS WE HAD THOSE TWO TOOLS THERE AND THEN WE HAD ALL OF THIS PUT IN AND PART I WON'T GO OVER HERE IS A LOT OF DETAIL AND WE WENT IN A WEB BASED PLATFORM, AND THEY COULD LOOK AT THE PRODUCT LABEL BUT THEY COULD ANNOTATE IT. NOW OUR STUDY DESIGN. WE HAD OUR REFERENCE PURPOSE, 208 SECTIONS, THAT WERE FOR POTENTIAL DRUG INTERACTIONS FOR THE FARM COIN DINETTIC VARIETY AND WE HAD A SET OF GUIDELINES THAT THEY WOULD BE FAMILIAR WITH FORRAN OITATION AND WE HAD A TRAINING SESSION WHERE WE WENT THROUGH THE GUIDELINES WITH THEM. SO THE PARTIC PANNED WHO IS AGREED TO HELP USOUS WERE GIVEN 52 LABELS IN THE SCENARIO WHERE THERE'S NO ASSISTANCE, ABOUT THE SAME NUMBER OR EXACTLY THE SAME NUMBER WHERE WE DID PREANNOTATIONOT NAME IDENTITIES 53 WHICH IS ABOUT THE SAME AGAIN, WE DID PRAN OITATION AND NLP PREANNOTATION AND THEN JUST TO SEND WHERE WE COULD SEE, WERE THERE ANY LEARNING EFFECTS, THE INTERACTION HELP THESE PEOPLE PERHAPS YOU DIDN'T FEEL COMFORTABLE IDENTIFYING DRUG INTERACTION STATEMENTS THAT HELPED THEM IMPROVE, WE THROW IN A SCENARIO, WHERE THERE'S NO AFTER THE ACCIDENT CYSTANCE. SO THESE FOLK WHO IS PARTICIPATE CAN DID A LOT OF WORK AND WE ASKED THEM, YOU KNOW HOW USEABLE WAS THE TOOL. WE LOOK AT THEIR TIMING, SELF-REPORTED TIMING AND THEN WE USE THE TRADITIONAL MEASURES THAT PEOPLE USE AND A LOT OF INFORMATION RETRIEVAL STUDY WHICH IS IS PRECISION AND RECALL. MOTHER WORDS, PRECISION WOULD BE THE PROPORTION OF THE TIME THAT OUR PARTICIPANT IS SAYS THIS IS A SENTENCE OR SENTENCE SPAN TAKEN--THEY TALKS ABOUT PHARMACOKINETIC INTERACTION AND IT MATCHED OUR REFERENCE STANDARD AND THEN FOR RECALL IF OUR REFERENCE STANDARD IN THE PRODUCT LABEL SECTION TALKED ABOUT FIVE OR SIX POTENTIAL DRUG INTERACTIONS WHAT PROPORTION DID THE USER IDENTIFY AND THE KEY MEASURE TO BALANCE THESE OUT IS THE FONE AND BALANCES PRECISION AND RECALL. SO OUR RESULTS. WE HAD TWO EXPERTS AND WHEN WE MEAN BY EXPERTS HERE THESE ARE PEOPLE WHO SERVED IN AN EDITORIAL CAPACITY AROUND DRUG INTERACTIONS THEY WERE REALLY, REALLY KNOWLEDGEABLE ABOUT THIS STUFF. THEIR DAILY PART OF LIFE, OUR WORK WAS, AND WE HAD FOUR STUDENT FIST YOU WERE WHO HAD CHEMISTRY BACKGROUND. SO THAT'S WHAT WE HAD ENROLLED WE HAD ONE DROP OUT BECAUSE OF THE TOOL THAT WE BUILT, THEY COULDN'T GET USED TO USING IT. EARLY ON THEY SAID IT WAS TOO HARD FOR THEM AND THEN WE HAD A NONEXPERT BECAUSE LIFE WAS TOO BUSY THEY COULDN'T PARTICIPATE AFTER A CERTAIN PERIOD OF TIME. NOW THE THREE NONEXPERTS THE TIMING WAS ROUGHLY SIMILAR, I WON'T SHOW THAT DATA BUT IF YOU WANT TO SEE IT FIND ME AFTERWARDS. WHAT I WILL SHOW YOU IS THE RESULT. THIS IS THAN OITATION RESULTS, SO THIS IS THE WORK, THE BATTERY IS DIEING ON IT, YOU WILL HAVE TO LOOK YOURSELF OR MAYBE THE MOUSE WILL WORK. HERE WE GO. THERE'S THE SCENARIOS WE MENTION BEFORE, SO NO ASSISTANCE, PREANNOTATION THAT DRUG MENTIONS, PREANNOTATIONS DRUG MENTIONS DRUG IRPT ACTION AND AGAIN THIS COLUMN WILL AVERAGE THINGS OUT ACROSS THE SKEANORIOS, SO WRITE AWAY, CAN YOU SEE THE NONEXPERTS ARE ARE PERFORMING UP THERE. OKAY. NOW THIS IS NOT STATISTICALLY POWERED TO DO ACROSS EXPERT, NON-EXPERT PAIRS. THIS IS A PILOT STUDY. BUT YOU CAN SEE THAT THEY'RE FAIRLY CLOSE. THE NLP IS DOING VERY BAD. THIS IS WHAT I MENTIONED BEFORE. THE WAY WE EVALUATE THE NLP, IS WE, DENTIFY TODAY IN A SECTION ATTACK. SO THE WAY THIS PERFORMANCE WE'RE SHOWING YOU HERE IS DID THE NLP ACTUALLY MATCH WHAT THE PERSON ANNOTATED SO A SENSE LEVEL MATCH AND THIS ACTUALLY POOR PERFORMANCE HAD A HUGE IMPACT ON OUR STUDY. SO WE'LL MAKE THAT UP FRONT AND CLEAR. OKAY? WHEN WE PREANNOTATED. WE SEE THAT THE--IT DIDN'T SEEM TO MATTER TO THE EXPERT TOO MUCH AND WE DON'T KNOW REALLY, WE CAN'T CLAIM ANY EFFECT WITH THE NONEXPERTS. ABOUT YOU WE--YOU KNOW WE STILL SEE--LOOK AT THIS ONE OF THE NONEXPERTS DOING EQUALLY WELL, IF NOT BETTER OR THE OR THE NEW EXPERT IN THIS CASE. WHAT'S INTERESTING IS WHEN WE DO THE PREANNOTATION OF THE NLP, EVERYBODY'S PERFORMANCE GOES DOWN INCLUDING THE EXPERT. IT JUST DROPS DOWN AND THEN AGAIN TO LOOK AT THE SCENARIO WHERE THERE'S NO ASSISTANCE THAT WE THROUGH IT AT THE END. THINGS GO UP AGAIN BUT OVERALL WE SEE THAT THE NONEXPERT AND THE EXPERT, YOU KNOW ROUGHLY WERE EQUIVALENT. AGAIN THE NLP DID A TERRIBLE JOB, OVERALL AND WE'LL TALK ABOUT THAT IN A SECOND. SO LOOKING CLOSELY AT RESULTS WHAT DID WE LEARN? LEARNED THAT DRUG INTERACTIONS WAS SIMILAR BETWEEN THE EBBS PETTERS AND NONEXPERTS. SO IF WE THROUGH THE TEXT AND SAID SHOW US THE DRUG INTERACTION, THAT SEEMED TO GO FAIRLY WELL FOR EVERYBODY. THE EXPERT HAD MORE FALSE-NEGATIVES THAN THE NONEXPERTS SO WHAT THIS MEAN SYSTEM THAT COMPARED TO THE REFERENCE STANDARD WHERE WE HAD TWO EXPERTS GO THROUGH AND REACH CONSENSUS, THE ONE EXPERT WAS AVOIDING OR NOT ANNOTATING LOTS OF THINGS AND I'VE WORK WIDE THESE EXPERTS BEFORE SO MY HYPOTHESIS IS THAT SHE HAD SOME BIAS, SHE READ THAT STATEMENT AND SAID, I WILL NOT READ THAT, I I'M NOT GOING IT ANNOTATE IT I DON'T BELIEVE IT. WHERE THE NONEXPERTS DESCROANT THAT BIAS SO THAT COULD BE A GOOD THICK FOR THIS KIND OFANO TASK TASK THAT WE'RE TALKING ABOUT. THAT'S WHY I SAID IS THERE A HYPOTHESIS TO STUDY DOWN THE ROAD. DOES PRIOR EXPERIENCE CAUSE IMPLICIT REJECTIONS. SHOULD WE DESIGN IT SO YOU HAVE TO HAVE TWO PEOPLE LOOKING AT THE THING? OT OTHER HAND THE NONEXPERTS SLEEP APNEA AND OBESITY TO BE SLIGHTLY MORGUE LIKELY WITH THE FALSE-POSITIVES BY THE NATURAL PROCESSING THIS, TWO I SINGLE REASONABLE IF THE CASE, NONEXPERTS SEEING THE TEXT IS INTIMIDATED AND IS MORE WILLING TO EXCEPT WHAT THE NLP SAYS EVEN IF IT'S WRONG BECAUSE THEY'RE NOT AS COMFORTABLE WITH THE DOMAIN SO THIS IS A SMALL PILOT STUDY BUT WE WE CONCLUDE SIDE RELIABLE PDI INTERACTIONS WITH THE SIMILAR TO THOSE OF EXPERTS. WE THINK THIS MEANS CROWD SOURCING COULD BE FEASIBLE, COULD BE FEASIBLE OPTION FOR COMPREHENSIVE ANNOTATION OF THE PDIs ACROSS THE BROADER RANGE OF PRODUCT LABELING SO WE HAVE TO TEST THIS BUT THERE'S MORE RESEARCH NEEDED ALSO WE NEED NATURAL LANGUAGE PROCESSES AND THERE IS NLT AVAILABLE NOW THAT WE USE IN FUTURE WORK. BUT ALSO HOW DO WE PRESENT THE NLP TO USERS SO WE TOSS IT IN THEIR FACE AND THE FEEDBACK WAS WE FELT COMFORTABLE ANYTHING TO THE LABEL AND ANNOTATING THINGS. THE NLP MIGHT BE HELPFUL TO COME BACK AFTER I DO MY ANNOTATIONS AND SAY, BY THE WAY, I THINK YOU MIGHT HAVE MISSED ONE HERE. PRESENTING IT AFTER THEY HAVE TIME TO LOOK INSTEAD OF JUST THEM TRYING TO STRUGGLE AND THEN OKAY, I FIX THAD AND NOW I NEED TO FIND WHAT I NEED TO FIND SO THE PRESENTATION OF NLP COULD BE A FACTOR TO LOOK AT CLOSELY. I THINK I'VE TAKEN TIME TODAY. THIS STUDY INVOLVED A LOT OF PEOPLE. I WANT THIS WAS A STUDENT'S MASTER'S WORK DOWN IN COLUMBIA AND WE HAD A LOT OF RECOLLECT PEOPLE INVOLVED WITH THIS, AND THE GRANT VS BEEN PART OF THIS WORK. SO HOPEFULLY I HAVE EXPLAINED IT WELL ENOUGH TO MAKE IT CLEAR AND GET A QUESTION OR TWO? >> YES? >> SO EXCUSE ME AT NCPDP'S LAST WORK GROUP, THE POINT OF DISCUSSION THAT CAME UP WAS THE INCREASING USE OF DRUG-DRUG INTERACTION DATA WITHIN LABELING IN THE FORM OF FOREST PLOTS SO THOSE TRULY ARE GRAPHICAL REPRESENTATIONS OF THE DRUG NAMES,ED SIZE, MODIFYING DOSAGE IS NOT CAPTURED IN ANY DIGESTIBLE FORM THAT WOULD ALLOW NATURAL LANGUAGE PROCESSING. SO THE QUESTION DID YOU USE THOSE LABELS AND HOW DID YOU DEAL WITH DATA THAT WERE EMBED INDEED A FOREST PLOT AS TO BEING WITHIN THE ACTUAL TEXT OF THE LABEL. >> IT'S A VERY, VERY RELEVANT QUESTION. WE DID NOT FOCUS ON FIGURE BUT THIS BRINGS UP ANOTHER THING THAT WE DID PAY ATTENTION TO THOUGH, IT WASN'T INCLUDE INDEED IN ANNOTATION STUDY AND THAT WAS TABLE BECAUSE--I RECOGNIZE THE FOUR PLOTS BUT THERE'S LABELS THAT HAVE TABLES IN FACT WE HAVE A SUMMER STUDENT WHO IDENTIFIED OVER A THOUSAND LABELS IN THE DRUG INTERACTION SECTION THERE, 'S A TABLE. NOW NOT ALL THE TABLES REPORTED TABLE INTERACTION, AND THEY'RE DETAILED AROUND OTHER KINDS OF INFORMATION BUT THAT IS NOT SOMETHING THAT THIS PARTICULAR KIND OF NLP APPROACH OR ANNOTATION APPROACH TARGETED RIGHT NOW. MY HYPOTHESIS IS THAT, WELL, THERE'S TWO THINGS HERE, ONE THERE'S A QUESTION AROUND MOVING FORWARD THE TABLE OR A FOURTH PLOT YOU MIGHT LOSE INFORMATION THAT'S REALLY IMPORTANT TO COMMUNICATE. SO THERE SHOULD BE FURTHER STOOD ON A GOOD WAY TO GO. ARE THEY MOVING BECAUSE IT'S CONCISE BUT IT'S ALSO PRETTY AWFUL FROM THE LINKING PERSPECTIVE. WE CAN BUILD ANALYTICS OFF A STRUCTURED FORMAT THAT CAN PRESENT THE DATA IN A VIEW BUT THE DAT ITSELF SHOULD BE--YOU KNOW AS FORMALIZED A STRUCTURE AS POSSIBLE PRIOR TO PRESENT TAG DEAL SO MY APPROACH WOULD BE THE REFERENCE LABEL COMPLETELY ANNOTATES THE DAT FOR THE DRUG PROD AND YOU COULD GENERATE THAT VIEW OFF A STYLE SHEET SOMETHING LIKE THAT SO WHEN WE PROCESS THE LABEL IN THE BACK END, YOU KNOW LIKE YOU DID FOR THE ROUNDS, YOU WOULD PULL THOSE ANALYTICS OUT. >> THAT IS THE CONTEXT IN WHICH IT CAME UP THAT FDA'S ENCOURAGING THE USE FOR FORM KACCT KINETICS COMPARATIVE, EFFICACY TRIALS AND IN SO DOING WE'RE LOSING THE VALUE OF THE STRUCTURE PRODUCT LABELING BECAUSE THE INFORMATION YOU WANT TO CAPTURE IS NO LONGER STRUCTURED. IT'S A GRAPHICAL REPRESENTATION OF DATA AND THE DATA THEMSELVES HAVE DISAPPEARED FROM WHAT YOU CAN DIGEST ELECTRONICALLY. >> I TOTALLY AGREE AND I THINK BECAUSE OF THE LABEL ITSELF IS A FAIRLY STATIC DOCUMENT, WE HAVE TO RETHINK THIS SO I APPRECIATE THAT COMMENT QUITE A BIT. ANY OTHER QUESTIONS OR COMMENTS? YES? >> I'M WITH THE NLM, SO THANK FIST AN INTERESTING PRESENTATION, WE DID SOMETHING VERY SIMILAR A WHILE AGO USING NNLP TO EXTRACT LABELS AND WE WENT THROUGH THE PROCESS OF HUMAN ANNOTATION AND OUR EXPERIENCE IS THAT IT TOOK MANY HOURS OF MEETING AND WE HAD TWO WHICH YOU CALL AS KIND OF SEMIEXPERT LABELERS, ONE IS M. D. AND ONE THE OTHER HAS A HISTORY--DEEP UNDERSTANDING OF MEDICAL TERMINOLOGY SO IT IS A VERY PAIN STAKING PROCESS, CONSISTENT ANNOTATION SO I APPLAUD YOU FOR JUST PULLING IT OFF WITH NO ASSISTANCE. WITH THE TRAINING AND EVERYTHING, GET A REASONABLE RESULT. SO MY QUESTION IS, YOU ASK THE ANNOTATORS TO GIVE YOU SEVERAL CLASSES OF INFORMATION, LIKE WHETHER THE DRUG IS AN ACTIVE INGREDIENT OR IS IT A METABOLITE AND ALSO IN THAT CLASS IS WHETHER IT IS QUANTITATIVE OR QUALITATIVE SO DID YOU BREAK DOWN RESULTS OF AGREEMENT OR PERFORMANCE ANNOTATION AND DIFFERENT CATEGORIES OF INFORMATION. WE DID HAVE THAT DATA, BUT, BECAUSE OF THE NUMBERS OF PARTICIPANT WEES HAD, IT WASN'T MEANINGFUL ACROSS PARTICIPANTS IF WE LOOK AT THE AGGREGATE LEVEL, THE POTENTIAL DRUG INTERACTION AND BUT YEAH, WE DID LOOK AT THAT LOWER LEVEL FOR PILOT DATA. THERE'S NO SIGNATURES 95 95--SIGNIFICANCE, THAT WASN'T A PROBLEM THAT WE REPORTED EMPLOY SO IF WE WERE GOING TO FORMALLY ANNOTATE WHICH IS PART OF A PROBLEM PART OF MY RO-1 GRANT, THERE'S A DROP DOWN, THERE'S DROP DOWN THAT POPS OPEN IF THERE'S DAT ON THE AUC CHANGE, THE DOSING RENAL CANCER MEN AND A LOT MORE DETAIL TO THERE, ABSOLUTELY REALLY IMPORTANT IF WE'RE GOING TO CROWD SOURCE THAT TO BE ABLE TO KNOW AT WHAT THEY CALL THE MICRO OR HORIZONTAL LEVEL. >> SO JUST THREES CATEGORIES OF THE PRECIPITATING DRUG THAT WOULD BE A MORE TRICKY CATEGORY BECAUSE WE GET A DISCREPANCY IN THAT CATEGORY. >> I THINK THE LESSONS LEARNED FROM THE OTHER STUDIES IN THE SCIENTIFIC FIELD HAVE BEEN THAT YOU HAVE TO DESIGN THINGS IN A WAY THAT CAN YOU USE METRICS TO SEE HOW ARE PEOPLE PERFORMING OVER ALL SO YOU DON'T JUST THROW IT OUT THERE AND TRUST THEY'RE GOING TO DO THE WORK THE RIGHT WAY. YOU'LL YOU'LL END UP FINDING IS THAT THERE'S PEOPLE TWO OR THREE THAT ARE GOOD AT THIS, THE PEOPLE WHO WANT TO PARTICIPATE AND A LOT OF PEOPLE COME ALONG FOR THE RIDE. AND THOSE TWO OR THREE PEOPLE, THAT'S GREAT. SO YOU BRING THEM IN AND THEY COULD BE LIKE WE SAW WITH THE WON RESULT HERE, THERE WAS ONE NONEXPERT WHO WAS CONSISTENTLY LIKE BETTER ACROSS ALMOST ALL THE SCENARIOS OR AS GOOD AS THE EXPERT, NOT SIGNIFICANCE SENSE BUT THE PERFORMANCE WAS GREAT. SO I DON'T KNOW. WE HAVE TO LEARN MORE ABOUT THIS BUT WHAT I THINK YOU'RE SAY SUGGEST THAT ENTER INTO THIS CAUTIOUSLY. DON'T BE NAIVE, YOU HAVE TO HAVE GUIDELINES AND METRICS AND INCENTIVES ALINE PROPERLY TO AKOCHLISH THIS. BUT THEN I WOULD ASK THE QUESTION BACK TO YOU, DO YOU THINK THERE WILL EVER BE ANYWAY OTHER THAN THE SORT OF BROAD CROWD SOURCING TO GET THIS INFORMATION STRUCTURED BECAUSE I DON'T THINK THE NLP WILL EVER BE GOOD ENOUGH TO DO IT FOR US? >> CAN YOU TALK TO ME OFFLINE. >> THANK YOU VERY MUCH. [ APPLAUSE ] >> I WISH WE HAD MORE TIME BUT I GOTTA SAY THE LAST HOUR IS LIKE THE COOLEST HOUR, I THINK. NOW, WE'VE GOT A CHOICE HERE, WE'RE SUPPOSED TO HAVE A BREAK 11 MINUTES AGO BUT WE ALSO NEED TO FINISH ABOUT FIVE. SO WHAT I THINK AND I HAD ENOUGH CAFFEINE, BUT NOT SO MUCH THAT I NEED TO DID SHE OUT BUT I WONDER IF WE COULD START NOW BUT IF PEOPLE NEED TO COME CAN GO A BIT, THAT WOULD BE OKAY BECAUSE I REALLY WANT TO HAVE THIS LAST HOUR FULL OF DISCUSSION THAT WE HAVE SO THAT'S MY PRE'S FASAND MY CONCLUSION IS--PREFASAND I WE WILL PLENCH ON FORWARD AND IF THEY NEED TO STEP OUT QUICKLY THEN THEY WILL MISS THE VERY BEGINNING OF THIS SO LET ME GET THE COMPUTER SET UP HERE. >> GOOD AFTERNOON AND THANK YOU JOHN FOR INVITING ME TO MY FIRST JAMMEREE AND OF COURSE JOHN IS TRUSTING ME TO HAVE HAD ENOUGH CAFFEINE TO GIVE THE TALK SO I'M HOPING YOU WON'T BE DISAPPOINTED. FOR THOSE OF WHO YOU DON'T KNOW ME, AND MANY OF YOU I HAVEN'T MET YET I'M TINA MORRIS, I'M THE SCIENTIFIC HEAD OF THE BIOLOGICS UNIT AT USP AND WE--OUR BUSINESS IS STANDARDS, WRITTEN STANDARDS AND REFERENCE MATERIALS. AND I'M GOING TO TALK TO YOU ABOUT OUR ROLE IN STANDARDS, SOME OF WHICH HAS BEEN TALKED ABOUT IN THE NOMENCLATURE LABELING AREA AND THERE--BIOLOGICAL MEDICINES HAVE MANY CHALLENGES, SCIENTIFICALLY SPEAKING AND THERE ARE VERY DIVERSE AND COMPLICATED PRODUCT GROUP ESPECIALLY IF YOU LOOK AT THEM IN THE COMPENDIO CONTEXT, SO IN THE CONTEXT, OF USP AS THE OFFICIAL COMPENDIUM, WE LOOK AT THE WHOLE WATER FRONT OF BIOLOGICS BLOOD AND BLOOD PRODUCTS GENE AND CELL THERAPIES, THERAPEUTIC PROTEINS, VACCINES SO OUR DEFINITION OF BIOLOGICS IS MUCH BROADER THAN SOME OF THE VERY MUCH NARROWER REGULATORY DEFINITIONS, MUCH MORE OF A SCIENCE DEFINITION. MANY BIOLOGIC VS MULTIPLE COMPONENTS AND THAT'S IMPORTANT TO KEEP IN MIND WHEN WE TALK ABOUT IDENTITY. AND OF COURSE, YOU PROBABLY HEARD ABOUT THE PARADIGM OF THE PROCESS, THE PRODUCT, SO HOW MUCH OF THE COMPLEX MANUFACTURING PROCESS IMPACTS THE QUALITY ATTRIBUTES THAT WE MEASURE AND SO IN MANY REGARDS INCLUDING FOR IDENTITY WE HAVE TO APPLY VERY SOPHISTICATED ANALYTERAL METHODS TO UNDERSTAND WHAT THE PRODUCT IS, AND WHAT ITS STRUCTURE IS BECAUSE ALL OF THAT MAY HAVE AN IMPACT ON HOW IT WORKS. NOW WHY DOE WE CARE ABOUT THIS AT USP AND THIS IS WHAT I CALL OUR WHY YOU SHOULD CARE SLIDE. USP AS A STATUTORY ROLE AND IN WRITTEN INTO THE LAW TO BE PRECISE IN THE FOOD, DRUG AND COSMETIC ACT AND THAT'S THE DIRECT LINK OF OUR ROLE AND THE APPLICABILITY OF OUR STANDARDS IS LINKED THROUGH IDENTITY SO IF AN ARTICLE MEETS THE IDENTITY CRITERIA, PRESCRIBE INDEED A MONOGRAPH, THE MONOGRAPH IS APPLICABLE, AND THAT'S THE WHOLE LINK, ALSO LINKS BACK TO THE NAMING BECAUSE THE USP IS WRITTEN INTO THE MISLABELING AND MISBRANDING PROVISIONS EVER THE LAW AND YOU SEE THAT HERE ON THE SLIDE UNDER NAMING, A DRUG SHALL BE MISS BRANDED UNLESS IT'S LABELED BEARS TO THE EXCLUSION OF ANY OTHER NONPROPRIETARY NAMED THE ESTABLISH NAME, OFFICIAL TITLE IN THE USP-NF UNLESS FDA SPECIFIES NAME, A DIFFERENT NAME VIA REGULATION AND THAT'S RULE MAKING FROM VIA 508. SO BIOLOGICAL PRODUCTS ARE INCLUDE INDEED THAT REGARDLESS OF LICENSING PATHWAY THAT IS USED TO PUT THEM ON THE MARKET. SO I WILL TALK ABOUT A BIT COMPENDIAL IDENTITY AND IT'S IMPORTANT TO UNDERSTAND WHAT THAT MEANS. THE USP MONOGRAPH CONTAINS ONE OR MORE TESTS THAT IS USED TO ESTABLISH WHETHER AN ARTICLE IS WHAT IT IS AND WHAT IT'S NAMED FOR IN THE USPNF. AND THE IDENTITY TEST IS USED TO ESTABLISH WHICH DRUGS ARE BIOLOGICS A PARTICULAR USPNF MONOGRAPH, APPLIES TO AND WHEN YOU HAVE MULTIPLE BIOLOGICS THAT FALL UNDER THE SAME IDENTITY TEST, THEY MUST CONFORM TO ALL THE TESTS THAT ARE IN THE MONOGRAPH AND I'LL EXPLAIN THAT MORE LATER. WHEN TWO OR MORE OF THESE BIOLOGIC VS THE SAME COMPENDIAL IDENTITY THAT DOESN'T MEAN THEY HAVE THE SAME REGULATORY STATUS. THAT'S IMPORTANT TO UNDERSTAND. SO COMPENDIAL IDENTITY AND REGULATORY STATUS ARE TWO SEPARATE THINGS. ONLY THE FDA RELEVANT REGULATOR LAS THE AUTHORITY UNDER VARIOUS LAWS TO CLEAR A DRUG FOR MARKETING OR TOO DETERMINE THAT TWO DRUGS ARE THE SAME SIMILAR IDENTICAL OR INTERCHANGEABLE THAT,'S VERY, VERY IMPORTANT. SO OUR STANDARDS ARE NOT DIRECTLY PERTINENT TO THE ASSESSMENT OF CLINICALLY MEANINGFUL PRODUCT ATTRIBUTES BUT THEY MAY HELP THE REGULATOR TO EVALUATE QUALITY ATTRIBUTES TO ASSESS SIMILARITY. SO THAT'S THE LINK THERE AND AGAIN, IF THEY HAVE THE SAME COMPENDIAL IDENTITY, THAT DOESN'T MEAN THEY HAVE THE SAME REGULATORY STATUS. THAT'S A VERY IMPORTANT DISTINCTION TO REMEMBER. SO HOW DO WE SET OUR STANDARDS. OUR STANDARDS ARE SET BY EXPERT COMMITTEES AND YOU SEE HERE ON THE CURRENT STRUCTURE OF THE COUNCIL OF EXPERTS FOR THE NEXT FIVE YEARS. THIS IS THE WORLD THAT I WORK IN, THOSE ARE THE FOUR EXPERT COMMITTEES THAT SET--THAT WORK ON MONOGRAPH AND CHAPTERS FOR THE DIFFERENT PRODUCT CLASSES AND WE'VE DIVIDED THEM UP BY PEPTIDES, PROTEINS AND COMPLEX BIOLOGICS AND THEN WE A DEDICATED EXPERT COMMITTEE THAT WRITES GENERAL CHAPTERS, THAT CONTAIN GENERAL TEST METHODS, WE ALSO COLLABORATE VERY CLOSELY WITH THE NOMEN CLEATURE AND EXPERT COMMITTEE AND THE NOMENCLATURE EXPERT COMMITTEE DOES EXACTLY WHAT THE MAIN SAYS, THEY LIBERATEOT OFFICIAL TITLES OF THE MONOGRAPHS AND THEY DELIBERATE ON LABELING. BECAUSE BIOLOGIC SYSTEM COMPLICATED THEY WORK WITH THE COMMITTEE THAT WORKS ON THE ACTUAL STANDARD TO DELIBERATEOT NAMING AND IT ACTUALLY IN THIS NEW REVISION CYCLE, THE TWO GROUPS HAVE DECIDED TO FORM A JOINT SUBCOMMITTEE ON BIOLOGICS NAMING SO THEY CAN WORK EVEN CLOSER TOGETHER. SO WE HAVE QUITE A FEW BIOLOGICS MONOGRAPH ALREADY THAT ARE WHAT WE WOULD CALL MULTIMANUFACTURING PRODUCT UNDER THE SAME NAME. MANY OF THESE ARE TRADITIONAL BIOLOGICS THAT HAVE BEEN AROUND FOR A LANGUAGE TIME SO THE INSULIN, GLUCAGON SOMATROPIN, HEPARIN, ENOXAPRIN AND THAT BECAME OFFICIAL IN 2008 AND IT'S ALREADY A MULTIMANUFACTURED PRODUCT. SOY HOW DO WE NAME THE LINKAGES? WE HAVE AN OFFICIAL TITLE OR ESTABLISHED NAME AND WE WRITE BOTH DRUG SUBSTANCE OR DRUG PRODUCT MONOGRAPHS OR DOSAGE FORM MONOGRAPHS AND THE ARTICLE IDEBT DENTITY IS CAPTURED AT THE MONOGRAPH LEVEL, BOTH FOR THE DRUG SUBSTANCE AND DRUG PRODUCT. WHY IS THAT IMPORTANT TO UNDERSTAND? THERE'S ALSO THE CONCEPT OF THE PROPER NAME WHICH IS WRITTEN INTO THE 21 CFR AND THE 600.3 K, AND THAT SAYS THE NAME AS APPLIED TO A PRODUCT MEANS THE NAME DESIGNATED IN THE LICENSE FOR USE UPON EACH PACKAGE OF THE DRUG PRODUCT. SO THIS WAS USED FOR TRADITIONAL BIOLOGICS THAT ARE VACCINES AND BLOOD PRODUCTS SO A LOT OF THE ORIGINAL SEEKER PRODUCT NAMES. SO MORE IMPORTANTLY THE FDA HAD DRAFT GUIDANCE WHERE THE PROPER NAME IS COMPOSED OF A CORE NAME AND THEN A SUFFIX AND THAT'S ATTACHED BY A HYPHEN. SO THE QUESTION S&P I CORE NAME CONCEPT HERE, THE PRIMARY SUBSTANCE IDENTITY LINK. TAKEN--THEY'S IMPORTANT TO US ALSO BECAUSE USP IS TIED INTO THE USA N MECHANISM FOR NONPROPRIETARY NAMING AND THE WHOLE USA N IS SUBSTANCE BASED. NOW JILLIAN WHO WILL SPEAK AFTER ME AND MEMBER OF OUR NOMENCLATURE EXPERT COMMITTEE WILL TALK TO YOU A LOT ABOUT THIS. I'M JUST MENTIONING THAT HERE BECAUSE BASICALLY THERE'S A CHAIN OF LINKAGES ININVOLVED AND IT'S IT'S IMPORTANT ABOUT THE DRUG PRODUCT LABEL OR THE DRUG SUBSTANCE, WHAT ARE WE TALKING ABOUT? SO WHY IS THIS IMPORTANT? THIS IS AN EXCERPT FROM A DRUG SUBSTANCE MONOGRAPH, FOR THE SOMATROPEIN SO YOU HAVE THE TITLE OF THE MONOGRAPH, THE AMINO ACID SEQUENCE, IT'S A SMALL PROTEIN AND THE FORMULA AND THEN THE IDENTITY TEST IN THIS MONOGRAPH ARE TWO IDENTITY TESTS CHROMEATOGRAPHIC PURITY BY HPLC AND PEPTIDE MAPPING AND THERE'S A ALSO A BIOIDENTITY TEST WHICH IS COMMON FOR BIOLOGICS. AND AGAIN HERE YOU SEE THE CONCEPT THAT'S SEVERAL ORTHOGONAL PROCEDURES PROBE DIFFERENT IDENTIFYING ATTRIBUTES OF THE ARTICLE INCLUDING THE PRIMARY SEQUENCE. SO ORTHOGONAL AND THEY LOOK AT THINGS SO THEY ARE COMPLEX AND THEY HAVE TECHNIQUES THAT PROBE DIFFERENT ATTRIBUTES. AGAIN, ANOTHER LINKAGE THAT IS IMPORTANT HERE IS THE LINKAGE WITH THE UNICODE WHICH ALSO SPEAKS SUBSTANCE, USP COLLABORATES WITH THE FDAOT SRS SYSTEM, THE SUBSTANCE REGISTRATION SYSTEM. AND A LOT OF THIS INFORMATION IS CAPTURED--I WILL SHOW YOU IN THE USP USE AND DICTIONARY BUT HERE YOU CAN SEE THAT FOR SOMA TROPEIN THERE UNICODE, ALL THE INFORMATION ABOUT THE MANUFACTURES THAT MAKE TTHE CAS NUMBER, THE DIFFERENT OTHER NONPROPRIETARY NAMES, THE I. N. N. WHICH BECOMES BEFORE THE USAN, THAT'S AN IMPORTANT THING TO UNDERSTAND THE I. N. N. NAME WHICH IS ASSIGNED BY THE W. H. O. COMMITTEE IS ASSIGNED VERY, VERY EARLY IN THEUCT DEVELOPMENT LIFE CYCLE, MUCH, MUCH, EARLIER BEFORE THAN WE COME ALONG AND HERE YOU SEE WHAT A--USP USE AND DICTIONARY ENTRY WOULD LOOK LIKE AND IT COVERS AND DID CAPTURES ALL THESE DIFFERENT PIECES OF INFORMATION THIS, IS FOR A DIFFERENT DRUG, BUT IT HAS THE NAMES THAT THE I. N. N., THE UNICODE, OTHER NONPROPRIETARY NAMES, BRAND NAMES MANUFACTURE THERAPEUTIC CATEGORY, BASICALLY A LOT OF INFORMATION THAT HAS TO BE LINKED TOGETHER TO UNDERSTAND WHAT THE MOLECULE IS, WHAT IT'S BEEN CALLED AND WHAT IT IS BASICALLY AT A STRUCTURAL LEVEL. NOW THIS IS A--THIS IS A SMALL MOLECULE, BUT, AS CAN YOU SEE, GOING BACK TO THE SOMA TROPEIN THAT IS MORE COMPLICATED, YOU HAVE AN AMINO ACID SEQUENCE FOR A LARGER PROTEIN. YOU COULD HAVE--YOU COULD HAVE NONSEQUENCE DRIVEN STRUCTURAL ELEMENT TGETS MORE COMPLICATED AS I WILL SHOW YOU AND THAT'S ACTUALLY A BIG DEAL, NOT JUST FOR NEW BIOLOGICS BUT ACTUALLY SOME OF THE MOST CHALLENGING MOLECULES, IN TERMS OF DESCRIBING WHAT THEY ARE. SOME OF THE LEGACY BIOLOGICS. AND THIS IS AN EXAMPLE FOR HEPARIN THAT IS NOW ONE OF OUR MOST MODERN STANDARDS INCLUDING FOR IDENTITY. IT HAS FIVE IDENTIFICATION TESTS INCLUDING A VERY SOPHISTICATED SPECTROSCOPY TEST, PROTON NMERROR FOR SUBSTANCE IDENTITY. HAS A CHROMATOGRAPHY TEST. BY BIOASIGNIFY RATSIO, ANOTHER CHROMATOGRAPHY TEST AND THEN IT ALSO HAS ONE OF THE TRADITIONAL TESTS TO TEST FOR THE COUNTER ION SODIUM. AND THIS IS A SPECTRUM OF THE PROTON NMR ANALYSIS FOR REP RIN SODIUM. VERY, VERY SOPHISTICATED IDENTIFICATION TOOL TO ANALYZE A VERY COMPLEX TOTALLY DISPURSE MATERIAL THAT REALLY CAN'T BE DESCRIBED BY A SEQUENCE OR ANYTHING. SO, IT IS DIFFICULT BUT IT IS POSSIBLE TO BY MODERN ANALYTICAL TECHNOLOGY TO DESCRIBE WHAT AN ARTICLE IS. IN MANY CASES FOR BIOLOGICS THE FUNCTIONALITY IS AN IMPORTANT PART OF THE IDENTITY AND THAT'S TRUE EVEN FOR SMALL BIOLOGICS THAT HAVE BEEN AROUND FOR A LONG TIME LIKE GLUCCA GONE THIS, IS AN EXAMPLE HERE WHERE THE BIOLOGICAL POTENCY MEASURE IS PART OF THE MOLECULE IDENTITY AND THEN WE CALL THAT BIOIDENTITY. IN THIS PARTICULAR CASE, THERE ARE--THE TEST IS CAPTURED IN THE USP CHAPTER AND YOU CAN SEE THAT FROM A POTENCY OR AIAN DOSE ASSIGNMENT WE'VE MOVED TO PHYSICAL CHEMICAL MEASUREMENT AND ASSIGNMENT OF DOSING ON A MASS BASIS BUT THE IDENTITY TEST IS STILL REQUIRED AND IT IS A VERY SOPHISTICATED INVITIO BIOASSAY. --AND THERE EVERYTHING IS AGAIN LINKED TO THE REQUIREMENTS IN THE ASSAY AND YOU CAN SEE THAT THE DEFINITION OF THE MONOGRAPH IS QUITE EXTENSIVE IN TERMS OF DESCRIBING WHAT THE PRODUCT IS, WHAT IT DOES AND OF COURSE, EVERY SINGLE DOSE IS DIFFERENT BECAUSE EVERY PATIENT IS DIFFERENT AND THE MATERIAL COMES FROM THE PATIENT. AND I MENTIONED MANY LEGACY BIOLOGICS ARE MIXTURES AND I'M TOLD VERY RECENTLY, THEY WERE VERY DIFFICULT TO DESCRIBE. AND IN THOSE CASES, MANY OF OUR TRADITIONAL MONOGRAPHS HAVE HAD VERY, VERY LONG, WHAT WE CALL DEFINITIONS BUT THE IDENTITY TESTS WAS MUCH MORE DIFFICULT. BECAUSE WE JUST DID NOT HAVE THE ANALYTICAL TECHNOLOGY TO DO THAT. VERY RECENTLY ACTUAL THREE THIS WEEK, I WAS ASKED TO GIVE A TALK ON THE DEVELOPMENT OF BIOLOGICAL STANDARDIZATION AND I CAME ACROSS AN ARTICLE, AN EARLY ARTICLE BY MILES ON INTERNATIONAL STANDARDS FROM 1952, THIS WAS SHORTLY AFTER THE WORLD HEALTH ORGANIZATION EXPERT COMMITTEE FOR BIOLOGICAL STANDARD EYATION WAS FORMED AND HE HAS THE HIERARCHY OF STANDARDS THAT GOES FROM AN AUTHOR'S PREPARATION WHICH IS VERY POORLY DESCRIBED PROVISIONAL MATERIAL WITH AN AUTHOR'S UNIT THEY GO TO AN INTERNATIONAL--TO A PROVISIONAL UNIT AND INTERNATIONAL UNIT WHICH IS STILL BY THE WAY THE W. H. O. INTERNATIONAL UNIT MANY BIOLOGIC SYSTEM THE WAY TO MEASURE POTENCY BUT THE DREAM BACK THEN WAS TO SAY, OKAY, THE HIGHEST LEVEL OF CHARACTERIZATION AND THE HIGHEST LEVEL OF DESCRIBABILITY IS THE PURE CHEMICAL AND YOU JUST CAN DESCRIBE IT BY WEIGHT. WELL WHAT I CAN SAY IS THAT WE ARE NOT THERE, AND FOR MANY BIOLOGICS I'VE TOLD YOU, WE WON'T GET THERE BECAUSE MANY BIOLOGICS ARE CELLS. THEY ARE VERY, VERY COMPLICATED, TO DESCRIBE IN TERMS OF IDENTITY, IN TERMS OF THE AMOUNT OF SUBSTANCE, SO I THINK TO A CERTAIN EXTENT THIS WILL REMAIN A DREAM BUT, IT'S ALSO IMPORTANT TO UNDERSTAND THAT OUR KNOWLEDGE AND OUR UNDERSTANDING KEEPS EVOLVING. AND SO, WE--KEY STILL HAVE MANY PRODUCTS THAT ARE AROUND, THAT OUR LEGACY PRODUCTS. HEPARIN UNFRACTIONATED HEPARIN HAS BEEN ON THE U.S. MARKET SINCE 1938,OOSE STILL THERE, P A NCREALIPASE IS STILL THERE, AND MANY OF THESE WE'RE JUST NOW GETTING TO THE ABILITY OF BEING ABLE TO DESCRIBE THEM VERY WELL AND THATIA IMPORTANT TO UNDERSTAND. SO THE STANDARDS THAT WE APPLY TO THEM INCLUDING FOR IDENTITY KEEP EVOLVING AS WELL. SO FOR MANY OF THE LEGACY PRODUCTS, ALSO THE CONCEPT OF DRUG SUBSTANCE VERSES DRUG PRODUCT REALLY DIDN'T EXIST. AND THAT ALSO IMPACTED OUR UNDERSTANDING OF THE ARTICLE IDENTITY, AS I MENTIONED IN THE BEGINNING IDENTITY USUALLY LINKS DIRECTLY BACK TO A CHEMICAL DEFINITION OF WHAT A SUBSTANCE IS. NOW WHEN WE TALK ABOUT MODERN SYNTHETIC OR BIOTECHNOLOGY DERIVED THERAPEUTICS THEY MUCH, MUCH, MORE FOLLOW THE ESTABLISHED PARADIGM OF DRUG SUBSTANCE FOR DRUG PRODUCT. AND FOR MANY OF THESE ARTICLES, WE CAN DESCRIBE THEM TO A VERY, VERY SOPHISTICATED LEVEL WITH MODERN ANALYTICAL TECHNOLOGY ESPECIALLY WITH REGARD TO THE SUBSTANCE IDENTITY AMINO ACID SEQUENCE, A LOT OF ATTRIBUTE WHAT'SY CAN PROBE WITH MANIAN LITICAL TECHNIQUES AND THENOT OTHER SIDE OF THE SPECTRUM WE HAVE THESE ADVANCED THERAPIES LIKE CELL THERAPIES, THAT WILL CONTINUE TO CHALLENGE OUR ANALYTICAL AND REGULATORY UNDERSTANDING OF WHAT IDENTITY MEANS FOR THOSE TYPES OF PRODUCTS. AND THAT'S ALL I HAVE AND I WILL BE HAPPY TO TAKE QUESTIONS. THANK YOU. [ APPLAUSE ] >> GRAD TO BE HERE, ONE COMMITTEE I DIDN'T VOLUNTEER TO BE IN WAS THE PRONOUNCEIATION COMMITTEE, SO I'M COMING LATE IN THE DAY, I WILL SKIP THROUGH SLIDES THAT WILL BE AVAILABLE TO EVERYBODY BECAUSE I DIDN'T KNOW QUITE WOULD HAVE ALREADY BEEN SAID SO I'M LOOKING AT BIOLOGICS AND BY O SIMILARS, I MADE CHANGEABLE BIOLOGICS WRITTEN LARGE ONE THING THAT'S IMPORTANT IS THIS NATURE OF EVIDENCE AND WHO'S USING WHAT FOR WHAT PURPOSE AND SO ONE THING WE SEE AT AVALERE BECAUSE WE WORK FROM THE LIFE SCIENCES COMPANIES PROVIDED THROUGH THE PATIENTS THAT PERCEPTION OF EVIDENCE, WHAT IT IS AND WHAT THEY USE S&P WHAT WE CALL THE EVIDENCE ARMS RACE BECAUSE IT IS SEEN VERY, VERY DIFFERENTLY BY DIFFERENT COHORTS AND GETTING THAT INTEROPERABILITY, THAT CONNECTIVITY AND SOME SORT OF ABILITY REFERENCE BACK TO SOME SORT OF BED ROCK AND CLEARLY REALLY IMPORTANT. SO THEN I WANT TO ADDRESS THOSE WHERE WE'VE COME FROM, I THINK WE'RE SEEING A SORT OF LOT OF RHETORIC AROUND THE CURRENT NAMING DEBATE FOR BIOLOGICS AS IF THEY KNEW. SO TO START OFF WITH THE MY DEFINITION FOR OPERATIONAL PURPOSES AND I'LL JUMP TO THE SHORT HAND IS THAT BIOSIMILARS ARE TO BIOLOGICS WHAT GENERICS ARE TO DRUGS. THAT WAS THE REASON THEY WERE ADDAD TO THE STATUTE AND THEY'RE ATTEMPT IN REGULATORY FORM TO HAVE COMPETITION IN THE SPECIALTY MARKET, THERE'S THEMENDOUS ECONOMIC INCENTIVES, A BIOLOGIC ESSENTIALLY IS COMING FROM A LIVING SYSTEM, AND A SIMILAR THEREFORE IS REFERRING BACK TO THE PRIOR DECISION MADE BY THE SAME REGULATORY AUTHORITY IN THIS CASE, THE FDA, ON THE SAFETY PURITY AND POTENCY OF THAT PRODUCT. SO THE BIOSIMILAR DOES NOT HAVE TO ESTABLISH IT A PRIORI BUT THEREFORE WHERE ARE THEY ESTABLISHING IT FROM, THEY'RE ESTABLISHING IT BASED ON HAVING AN INVERTED THE SAME ACTIVE INGREDIENT AND THEN UNIQUELY IN THE U.S. WE HAVE THIS OPPORTUNITY FOR INTERCHANGEABLE BIOLOGICS THAT CAN BE SUBSTITUTED BY THE PHARMACIST WITHOUT THE INVOLVEMENT OF THE ORIGINAL PRESCRIBER. SO IF WE LOOK AT THIS BIOLOGICS ARE NOT NEW, I'LL NOT GOING TO GO THROUGH IN DETAIL, THERE'S OBVIOUSLY BEEN A LOT OF ACTIVITY BUT EVEN MAPS, MONOCLONAL ANTIBODIES ARE 40 YEARS OLD. SO I THINK AGAIN WE'RE HEARING A LOT OF RHETORIC, I GO BACK TO 1796 FOR THE FIRST RELIABLE VACCINE, THERE'S A LOT OF EXPERIENCE AND OBVIOUSLY THE REGULATORS HAVE A LOT OF EXPERIENCE WITH THESE PRODUCTS THAT'S HOW THEY GOT TO THE MARKET IN THE FIRST PLACE. AND THERE'S ALSO THIS TREMENDOUS VARIATION IN COMPLEXITY WE'RE GOING FROM ASPIRIN ON THE LEFT OF A TO MONOCLONAL WE THINK OF AS BIG BUT THEN WE HAVE THE SOUP WHICH IS SOME OF THE THINGS THAT TINA REFERRED TO WHICH AS I PUT IT ARE BIGGER THAN THIS ROOM AND HISTORICALLY WE HAD SOUPS BECAUSE WE DIDN'T HAVE THE ABILITY TO CHARACTERIZE. IT'S WORTH BEAR NOTHING MIND, YES BY COMPLEX MIXTURES, THEY ALSO VARY BATCH TO BATCH AND THE SAME PRODUCT VARIES OVERTIME SO THAT'S GOING TO BE A VERY, VERY CRITICAL POINT TO CONSIDER WHEN WE LOOK TO WHAT WE'RE INCLUDING WITHIN IDENTITY. SO WHERE ARE WE NOW? THE U.S. IS BIG, I ADMIT IT, BUT IT IS BUT ONE COUNTRY IN THE WORLD AND IT REPRESENTS FIVE% OF THE WORLD'S POPULATION BUT 50% OF THE BIOLOGICS MARKET BY VALUE, NOW THE ICH COUNTRIES THAT ARE HIGHLY REGULATED WE LARGELY HAVE, WE LARGELY EXPECT ACCESS. 45% OF THE WORLD IS THE BRICK TM. THESE ARE THE COUNTRIES THAT THEY BASICALLY SEE AND THEN THEY WANT ACCESS AND THEN THEY HAVE THE REST OF THE WORLD WHICH IS LARGELY THOSE COUNTRIES THAT RECEIVE VACCINES IN DONATION PROGRAMS THEY DESCROANT A LOT OF THE SOPHISTICATED BIOLOGICS WE EXPECT IF THE U.S. SO IT'S WORTH PUTTING THIS IN CONTEXT THAT WHEN YOU'RE TALKING ABOUT SORT OF GLOBAL STANDARDS, GLOBAL MARKETS AND ACCESS TO PRODUCTS USUALLY MADE AT A SINGLE FACILITY BY A COMPANY, WELL'S A GREAT VARIATION IN THIS THAT ACSESSION AFFORDABILITY PRICE. AND THE GLOBAL NONPROPRIMATESETY NAMING PREVENTIONS I PUT SINCE 1959 ADMINISTERED BY W. H. O. IS AN EFFORT THAT YOU UNDERSTAND WHAT ONE PRODUCT IS ACROSS THE GLOBE. THAT WAS THE VALUE OF A NONPROPRIETARY, IT'S CALLED NONPROPRIMATESETRY FOR THAT REASON BUT THE ACTIVE NAME OF THE INGREDIENT AND THE CHEMICAL. I'LL QUICKLY SKIP THROUGH, VUBSLY WE HAVE A SYSTEM OF GENERICS WHERE WE EXPECT A LEVEL OF OBLIGATIONS SALLIES ENSEL AND YOU'RE EXPECTING COMPUTATION ON PRICE BUT THE ARGUMENT PARTICULARLY THE U.S. INNOVATION IS DRIB BY COMPETITION BUT THE SEMANTICS DOESN'T CHANGE THE SCIENCE AND THERE'S BEEN A TREMENDOUS DISTRACTION IN THE BIOLOGICS DEBATE, SOME OF NEM NOT THE SAME VERSIONS OF THAT THAT MEAN WE HAVE TO FIND THIS BED ROCK IN TERMS OF WHAT WE'RE TALKING ABOUT IN TERMS OF ACTIVE INGREDIENTS, HOWEVER WE CODE TDESCRIBE IT, WHATEVER WORDS WE USE. THEN WE'VE ALSO GOT THIS ISSUE OF ALTERNATIVE BIOLOGICS NOT BEING BIAS SIMILAR SO THERE'S A LOT OF PRODUCTS ELSEWHERE IN THE WORLD THAT DO SERVE A FUNCTION BUT THEY'RE NOT OF THE QUALITY AND CALIBER WE WOULD ACCEPT IN THE U.S. AND THOSE SHOULD NOT BE CONFUSED AND THOUGHT OF AS BIOSIMILARS AND THEY'RE DEVELOPED ANALYTICALLY HEAD-TO-HEAD WITH A SINGLE REFERENCE PRODUCT THAT'S BEEN APPROVED BY THE SAME REGULATORY AUTHORITY. ALSO WE HAVE TO ACCEPT THAT MANUFACTURING CHANGES ARE A REGULATORY NORM, THEY'RE SUBJECT TO REVIEW BY THE SAME REGULATORY AUTHORITY AND THE STANDARD IS HIGHLY SIMILAR PRODUCT QUALITY ATTRIBUTES. IF YOU LOOK HERE THIS INSTANCE IS 38 MANUFACTURING CHANGES SINCE INITIAL APPROVAL, THESE ARE ALL APPROPRIATE AND THEY'RE CAREFULLY MANAGE BUT IT IS ESSENTIAL BY AND BASED ON THIS STANDARD THERE'S COMPLETE EXTRAPOLATION BETWEEN INDICATIONS, THE PRODUCTS ARE INTERCHANGEABLE, THE LABEL OF THE PRODUCT DOES NOT CHANGE AND CERTAINLY THE NONPROPRIETARY NAME DOES NOT CHANGE. SO THE GOOD NEWS IS THERE'S HUGE EXPERIENCE WITH THESE PRODUCTS BY MULTIPLE STAKEHOLDERS. SO WHAT DO WE EXPECT? JUST BY WAY OF REFERENCE, THE THIS IS THE SAME 30 OR SO YEARS, THE PRODUCT BLAs BY THE FDA AND THEN THOSE IN DEVELOPMENT AS IN BEING PUT INTO PEOPLE, NOW THE--YOU CAN LOOK AT THIS DATA IN VARIOUS WAYS, I COULDN'T PLOT THEM ON THE SAME GRAPH BECAUSE THE APPROVALS DO NOT LEAVE THE X-AXIS SO THE PROSPECTS FOR THOSE IN DEVELOPMENT WOULD APPEAR TO BE HUGE. OT OTHER HAND TELL TAKE A CENTURY TO APPROVE WHAT WE ARE CURRENTLY PUT NOTHING PEOPLE. SO THERE'S A BIT OF A CHALLENGE THAT WE'RE PUTTING THE WRONG THINGS IN PEOPLE OR NOT APPROVING THINGS AT THE APPROPRIATE PACE. HOWEVER THE PIPELINE OF THOSE BIOLOGICS IN DEVELOPMENT WHICH ARE NOW ABOUT 15% OF THE PRESCRIPTION DRUG BUDGET, CLEARLY THE SCIENCE IS THE BEST IT'S EVER BEEN, THE PROSPECTS ARE VERY GOOD, THOSE WILL ALSO BE THE CANDIDATES FOR THEM, AND THEN WE NEED LEVEL OF STANDARD, SOME LEVEL OF DESCRIPTION, SOME WAY OF MATCHING THESE PRODUCTS. THIS IS A SUMMARY JUST SO HAVE YOU THE REGULATORY PATHWAYS, THE BLACK ONES ARE THE ORIGINAL FOOD AND DRUG AND COSMETIC ACT, THE PH S ACT BACK FROM 1903. THE BLUE ONES ARE THE HATCH HATCH ONES, THE GREEN ARE DEVICES AND THEN IN 2010 ALONG CAME THE SOPHISTICATED CALLED 351 K PATHWAY FOR BIOSIMILARS AND THAT INCLUDES INTERCHANGEABLE BIOLOGICS AS WELL. THE REGULATORY CONCEPT OF BIOSIMILARRITY. AGAIN THIS IS ONE WAY OF VISUALIZING THE SQUARE OF THE GREEN, YOU HAVE TO DEVELOP THE INITIAL CANDIDATE, THE R&D SELECTION FOR AN INNOVATIVE PRODUCT AT THE VERY BOTTOM, EVERY STAGE IS STAND ALONE IT'S COMPLETE DEVELOPMENT PATHWAY FOR A BIOSIMILAR, EVERY STAGE IS HEAD-TO-HEAD WITH YOUR REFERENCE AND ANALYTICS ARE ABSOLUTELY FUNDAMENTAL. YOU HAVE DO ACHIEVE THE STATUTORY STANDARD OF HIGHLY SIMILAR AND THIS IS WHERE I DRAW THE COMPARISON TO THE HIGHLY SIMILAR OF COMPARABILITY, IT MAY BE--IN EUROPE, THE EUROPEAN AGENCY SAID THEY'RE HIGHLY SIMILAR COMPABILITY AND BIOSIMILARRITY ARE THE SAME. THE FDA HAS NOT SAID THEY'RE THE SAME NOR DOES THE AGENCY SAY THEY ARE DIFFERENT AND IT'S DIFFICULT FOR ME TO SCIENTIFICALLY TO SEE HOW THEY'RE DIFFERENT BECAUSE YOU COULDN'T HAVE ONE A HIGHER STANDARD THAN THE OTHER. BUT BASICALLY IF YOU CAN'T SHOW THAT YOU'RE ANALYTICALLY HIGHER, THEN YOU CAN'T BE SIMILAR,--SO WHILE THE SCIENCE IS THE SAME WORLD WIDE, THE FACT THAT THE CONSTITUTEUTES ARE DIFFERENT DOES MEAN THE REGULATORS ARE LIMP ELEMENTING THE PATHWAY IN A SLIGHTY DIFFERENT MANNER. AND THIS IS ANOTHER WAY OF LOOKING AT A BIOSIMILAR AND LOOKING AT THE ELEMENTS THAT HAVE YOU AS A SMALL MOLECULE GENERIC VERSES THOSE THAT YOU HAVE AS A NOVEL MOLECULARRENTITY AND ESSENTIALLY A BIOSEMESTERULAR HAS SOME ATTRIBUTES OF A GENERIC BUT IT ALSO HAS CRITICAL ASPECTS FOR ITS RESPONSE TO CONSIDER THAT APPLY TO NOVEL MOLECULAR ENTITIES AND AND I WON'T GO THROUGH AGAIN IN DETAIL AND IT REFERS TO A PUBLICATION. INTERCHANGEABILITY UNIQUE TO THE U.S., AS I MENTIONED, IT'S BASICALLY ALLOWING A PHARMACIST TO SUBSTITUTE WITHOUT INVOLVING THE ORIGINAL PRESCRIBER. BUT ALSO GAINED A LIFE OF ITS OWN AS IF YOU'RE NOT INTERCHANGEABLE THEN SOMEHOW YOU'RE LESS GOOD. THE ONLY THING I EMPHASIZE HERE AND WE HAVE NO DESIGNATIONS YET IN THE U.S., BUT IN INTERCHANGEABLE BIOLOGIC WILL BE A BIOSIMILAR ON WHICH ADDITIONAL STUDY VS BEEN DONE ALTHOUGH IT'S THE SAME PRODUCT AND I THINK IF YOU FAIL TO SHOW INTERCHANGEABILITY NOT AS IF UNPROVEN BUT IF YOU SHOW YOU'RE NOT INTERCHANGEABLE, YOU WILL HAVE SHOWN YOU WEREN'T BIOSIMILAR IN THE FIRST PLACE BUT THIS GETS INTO THE NOMENCLATURE BECAUSE ARE YOU SOMEHOW GETTING THE ACTIVE INGREDIENT, MORE THE SAME IF YOU GOT AN INTERCHANGEABILITY DESIGNATION AND IF YOU'RE THE SAME PRODUCT, YOU HAVE THE SAME ACTIVE INGREDIENT ALL THE WAY THROUGH. SO WE HAVE THE FIRST APPROVAL OF ZARXIO ON MARCH THE SIXTH AND IT HAS A PLACE HOLDER NONPROPRIETARY NAME WE WILL DISCUSS, IT'S THE ONLY PRODUCT WITH THIS FORMAT OF NAMING, IT WAS LAUNCHED ON THE THIRD OF SEPTEMBER, SO IT IS NOW A U.S. MARKETED PRODUCT. IN EUROPE, THE SAME PRODUCT IS ZARZIO WITH TWO ZS AND THE NONPROPRIETARY NAME IS FILGRASTIM, BACK IN 2009 WITH ABOUT 7.5 MILLION PATIENTS IN TREATMENT. THESE ARE THE APPLICATIONS THAT ARE IN WITH THE REFERENCE PROD AND YOU CAN THIS IS WHERE WE GET INTO THE FDA'S PROPOSED RULE BECAUSE THE NAMING CONVENTIONS FOR THE REFERENCE PRODUCTS ARE THOSE FOR WHICH FDA IS PROPOSING TO ACTUALLY CHANGE THE CURRENT NONPROPRIETARY NAME. NAMELY FILGRASTIM, EVEN IF - IT AS UNIQUE PROPRIETARY NAME IT REFERS TO TWO SEPARATE BRAND NAMED PRODUCTS. SO THE SO CALLED UNIQUE PROPRIETARY NAME STILL WILL NOT IDENTIFY WHICH PRODUCT IS IN PLAY AND BEEN USED FOR THE PATIENT. SO I THE NAMING---I PUT TO THIS DUDE UP, HE MAY BE ABLE TO PRONOUNCE A 58 LETTER TOWN NAME BUT THE WELSH I CAN SAY IS LLOYDS BANK SO HE ACTUALLY DOES GIVE THIS NAME BUT THE IDEA OF WORDS THAT ARE PRONOUNCEABLE, MEMORY RESPONSIBLE I THINK IS CRITICALLY IMPORTANT. SO THE NAMES OF DRUGS, LET'S BE REAL HAVE ALWAYS HAD A PRICE HISTORICALLY IT WAS THE BRAND NAME ISSUE, BUT THE NAME HERE IS THE ACTIVE INGREDIENT BACK TO TINA'S POINT ON THE IDENTITY WHERE THE BRAND NAME IS THE NAME OF THE PRODUCT AND THE BRAND NAME DOES VARY BETWEEN COUNTRY BECAUSE IF IT'S DESIGNED TO BE SHORT, WRITABLE, RECOGNIZABLE IN THE LOCAL LANGUAGE. NOW FOR BIOLOGICS MOST BIOLOGICS, NOT ALL HAVE BRAND NAMES, AND ALL BIOSIMILARS ARE ANTICIPATED TO HAVE BRAND NAMES. WE ALSO KNOW THE HANDOUT HAVE A LOT OF BIOLOGICS ON THE U.S. MARKET, 77OT TABLE THAT WAS HANDED OUT TO 25 REFERENCED PRODUCTS, SO CAN YOU HAVE UNIQUE BRAND NAMES THAT REFER TO THE SAME REFERENCE PRODUCT AND AS FAR AS I KNOW THERE'S NOT BEEN A MAJOR PROBLEM WITH CONFUSION. AND THEN WE HAVE TO MENTION THE STATE LAWS AND THE FDA IS WANTING AN ORANGE BOOK. HERE WE HAVE THE BIOSIMILARS, ALL OF THE NONPROPRIETARY NAMES, THE I. N. INTERNATIONAL NONPROPRIETARY NAMES MATCH THAT OF THE REFERENCE AND THERE HASN'T BEEN A PROBLEM WITH ANY KIND OF TRACK AND TRACE LARGELY BECAUSE MOST OF THESE PRODUCTS ARE PRESCRIBED BY THE NAME BY WHICH THEY'RE MARKETED, WHICH IS THE BRAND NAME. BUT THEN WE HAD A INTERESTING SITUATION WITH ZARXIO, FOR NAMING CONVENTIONS AND WE HAVE THIS PLACE HOLDER NONPROPRIETARY NAME FOR THE NONBIOSIMILAR AND WE HAVE CURIOUS CASE AND FDA AGREED THAT THE MONOGRAPH DOES NOT APPLY BUT THERE'S NO QUESTION THAT THE PRODUCT DOES COMPLY WITH THE MONOGRAPH USP NF. SO I TRIED TO FRAME THESE NAMES BECAUSE I COULDN'T KEEP TRACK OF WHAT WAS HAPPENING. SO THIS A REFERENCE TABLE ON THE LEFT AND I JUST HAPPEN TO CHOOSE ZARZIO AS THE EXAMPLE. SO, IN FACT I'VE ALREADY SEEN A TYPO IN THE TABLE BECAUSE WE HAVE THE ZARXIO WITH THE U.S. AND WITH TWO Zs IN THE EUROPE. BUT THE NAME FILGRASTIM IS COMMON THROUGHOUT, AND THAT'S IN THE REFERENCE PROD AND YOU CAN THERE'S PROPOSALS OUT THERE, ONE IS THAT WE WOULD HAVE A RANDOM NAME, OF FOUR CONSONANTS, IT LOOKS LIKE A W. H. O. PROPOSAL, HENS THE OTHER, THE W. H. O. PROPOSAL HAS THE FOUR CONSONANTS ENTIRELY INDEPENDENT OF THE NONPROPRIETARY NAME, IT IS UNLINKED UNHYPHEN EIGHTED, SEPARATE DATA FIELD. PUT THE W. H. O., PROPOSAL OUT THERE, AS COMPLETELY SEPARATE, IT'S NOT IMPLEMENTED, NOT AVAILABLE. HOWEVER FOR US TO HAVE A SUFFIX IN THE U.S. THAT IS DIFFERENT DISTINCT FROM OBVIOUSLY THE P. H. O. DOES MEAN THE GLOBE AT SYSTEM STARTS TO FALL APART. SO FDA HAS A PROPOSAL OUT THERE, PROPOSED RANK, THE COMMON PERIOD THROUGH NOVEMBER 11th . ON VARIOUS WAYS TO HAVE SUFFIXS, TO 16 PARTICULAR PRODUCTS, SO FAR, ONE COULD BECOME COMPANY RELATED SUCH AS AMGN, OR THE PLACE HOLDER, SNDZ, AND THEN THERE'S THE IDEA OF RANDOM CONSONANTS AND THEN THE USAN WOULD BE THE CORE NAME TO WHATEVER THE SUFFIX IS AND CLEARLY FOR EVERYTHING WE'VE HEARD TODAY THE QUESTION IS CAN THE DATA SYSTEM ACCOMMODATE A CHANGE IN NAME TO INITIALLY THE SIX PRODUCTS, POTENTIALLY THE 77OT HANDOUT YOU GOT ALLA BIOLOGICS IN ORDER TO BE CONSISTENT AND FURTHER CAN THOSE PRODUCT VS TWO DIFFERENT IDENTITIES ON THE MARKET AT THE SAME TIME. AS INVENTORY IS MANAGED AND RUN THROUGH BY THE SPONSORS SO YOU DON'T HAVE TO THROW OUT OBVIOUSLY PRODUCT WITHIN ITS SHELF LIFE. SO REALLY WE DON'T HAVE TO GO IN DETAIL IN THE INTEREST OF TIME BUT THE TITLE SAYS IT ALL: IS THERE SUCH A THING AS A MEANINGLESS FOUR-LETTER WORD? [LAUGHTER] THE ASPIRATION STRAIGHT FROM THE REG IS THAT FDA IS PROPOSING TO TAKE ACTION WITH RESPECT TO THESE SIX PRODUCTS WHICH ARE THE FILGRASTIN, ALPHA AND EFLICKSA MACK WHERE WE HAVE APPLICATIONS IN, BECAUSE OF THE NEED TO ENCOURAGE, EMPHASIS ON ENCOURAGE, ROUTINE USAGE OF DESIGNATESSED SUFFIXS IN ORDERING, PRESCRIBING, DISPENSING, RECORD KEEPING, AND FORM CO VIGILANCE PRACTICES FOR THE BIOLOGICAL PRODUCTS SUBJECT TO THIS RULE MAKING. THE ASPIRATION IS SOUND, THE QUESTION IS CAN THE SYSTEMS ACCOMMODATE A CHANGE IN NAMES FOR THESE SIX PRODUCTS AND POETIC TESHTIALLY ALL OF THE PRODUCTS THAT ARE ON THE MARKET. NOW JANET HEAD OF CDER SAYS THIS SUFFIX HAS TO BE PART OF THE NONPROPRIETARY NAME SO THAT'S WHERE THIS CONNECTION AND THAT THEY ALWAYS STAY CONNECTED THE NONPROPRIETARY NAME AND THIS SUFFIX IS OR ISN'T WHATEVER POINT IT BECOMES IT IS CRITICALLY IMPORTANT BECAUSE IF WE CAN'T HAVE THE SYSTEMS MANAGE IT, THEN WE'RE NOT GOING TO HAVE A NAME THAT WORKS IN ORDERING PRESCRIBING DISPENSING, RECORD KEEPING AND FARM CO VIGILANCE. JUST SO HAVE YOU IT, I'VE INCLUDED THE EXAMPLES OF THE NAME. WELL IS A CERTAIN IRONY IN TERMS OF THE MEANINGLESS FOUR LETTER WORD BECAUSE THE WAY IT'S PROPOSED THE BIOSIMILAR WOULD BE ALPHABETICALLY ABOVE THE RANDOM NAME OF J. C. W. P. THAT WOULD BE ASSIGNED TO THE REFERENCE PRODUCT. THERE ARE CLEARLY CONSEQUENCES TO ANY RANDOM LETTERS AND YOU HAVE TO PRESUME THEREFORE THAT AMGEN WOULD PREFER AMGEN, AND MAYBE IT WON'T WHEN IT MAKE ITS TO GENENTECH AS PRODUCTS AND IS ABOVE ON DROWN MENUS THAT ARE BASED ON ALPHABETICAL ORDER, SO THERE'S MASSIVE CONSEQUENCE SPECIALIZATION OF SPECIFIC ENDOTHELIAL I WOULD DRAW YOUR ATTENTION TO THIS PROPOSAL AND CONSIDER IT ENLIGHTEN SELF-INTEREST, WHAT HAPPENS ALL THE WAY THROUGH THE SYSTEM. AND REALLY IS THERE SUCH A THING AS A UNIQUE NONPROPRIETARY NAME THAT IN AND OF ITSELF HAS A BRAND NAME. SO HERE'S GANNA A SUMMARY OF THE GUIDANCE OUT THERE, THE GUIDANCE HAS A COMMENT PERIOD NOT THAT THAT TECHNICALLY EVER ENDS BUT THE GUIDANCE PERIOD IS THROUGH THE 27th OF OCTOBER AND THAT WOULD BE PROPOSING SOME SORT OF SYSTEM TO BE APPLIED TO ALL BIOLOGICS AND ONE HAS TO IMAGINE THAT ALL THE BIOLOGICS ON THAT TABLE AS CURRENTLY MARKETED WOULD NEED THEREFORE TO CHANGE THEIR NAMES. SO HERE'S THE DOCKET TODAY LINES AND THE QUESTION IS, THEN, DOES IT END UP WITH FINAL GUIDANCE WHICH IS NOT BINDING BUT IF A FINAL RULE IS ISSUED, THEN THOSE SPONSOR DOS HAVE TO CHANGE THE NAMES AND DATA SYSTEMS HAVE TO ACCOMMODATE. SO IN CONCLUSION WE HAVE A WHOLE MODEL, I HAVE ONE WHICH IS LAUNCHED IN THE U.S., AND THE QUESTION IS WHAT IS THIS BIOSIMILAR MODEL, IS IT MORE OF A BRANDED MODEL. IS IT MORE OF A GENERIC MODEL AND AT THIS POINT I HAVE TO SAY WITH ALL CANDOR I THINK IT'S AN IMPOSSIBLE MODEL. IT'S COSTING TOO MUCH TO GET APPROVED FOR A QUESTIONABLE COMMERCIAL VALUE. AND IRONICALLY ONE OF THE PRODUCTS THAT WAS APPROVED, AND IS SUBJECT TO THE NAME CHANGE IS APPROVED AS A BIOSIMILAR AND APPROVED HERE AS A STAND ALONE 351 A JUST BECAUSE THE PATHWAY IS QUITE CHALLENGING. SO BIOSIMILARS OPEN TO QUESTION. >> THANK YOU. >> ANYBODY HAS ANY QUESTION. F THIS IS COMING FROM A POSITION OF IGNORANCE, YOU MENTIONED THAT MANUFACTURING CHANGES, YOU MENTIONED A DRUG EARLY ON THAT HAD 18 OR HOW MANY MANUFACTURING CHANGES AND THAT EFFECTIVELY IT USES BIOSIMILAR TO ITSELF, RIGHT? SO, FROM--OTHER THAN A BRANDING DIFFERENCE HERE IN EFFECT, THE BIOSIMILAR THOUGH IT'S MADE IN A DIFFERENT PLANT BY SOME OTHER CORPORATENTITY IT WAS MADE IN A PLANT BY THE CORPORATENTITY, IT KEEPS ONE NAME BUT IF IT'S MADE BY ANOTHER CORP RANT ENTITY IN A DIFFERENT PLANT IT NEEDS DISTINCTION BECAUSE IT'S-- >> IT'S PURELY SPONSOR BASED NOT SCIENCE BASED AND IN FACT SOME ORIGINATOR VS CHANGED CELL LINES ON THEIR OWN PROD AND YOU CAN ENDED UP WITH THE SAME NAME AND IF YOU LOOK AT THE TO WHICH THE LIST ON THAT HANDOUT, MYZYME, LUMAZYME FAILED COMPARABILITY, FDA REQUIRED A NEW BLA AND YET IT WAS GIB THE SAME NAME BECAUSE IT'S BASED ON THE SAME ACTIVE INGREDIENT. SO HISTORICALLY THE NONPROPRIETARY NAME IS A GROUPING, IT'S A BUNDLING, CATEGORY. A WAY TO CONNECT A SERIES OF PRODUCTS AND THEN BASED ON ACTIVE INGREDIENTS AND THEN THE BRAND NAME WITH THE PRODUCTS SPECIFIC. SO TO ME YOU NEED NONPROPRIETORY AS AN OXYMORON NAND THATEE EFFECTIVE FOR THE PROPRIETARY, YOU LOSE THE BUNDLING CAPACITY AND IT'S ALL YOU GUYS YOU DO YOUR DATA BANK CANS CODE IT TO BUNDLE FOR YOUR SAFETY. AND MY CONCERN IS THIS COMES FROM MY MAD COW BACKGROUND TO REPLACE SOMETHING THAT'SA KNOWN. >> IT CAN BE TAKEN IN A NUMBER OF WAYS BUT I CAN'T GIVE BLOOD. >> BUT SOMETHING--SO THE WHOLE EPREX STORY WHEN WE REFORMULATED THE PRODUCT TO EVADE MAD COW LED TO THE PRCA BECAUSE WE WERE REPLACING SOMETHING OF KNOWN BUT INFIN TESS MALLY SMALL RISK. SO MY WORRYY IS WE HAVE A SYSTEM IN WHICH THERE MAY BE SOME RECORD KEEPING PROBLEMS. BUT TO REPLACE IT WITH A NEW SYSTEM IS NOT GOING TO GUARANTEE GREATER RELIABILITY. I'M NOT SURE THE PROBLEM WE'RE FIXING. >> I WANT TO GIVE FDA THEIR FULL-TIME. >> YES, SURE, ABSOLUTEY. >> [ APPLAUSE ] >> CAN EVERYONE HEAR ME? I'M VADA PERKINS, DEPUTY ASSOCIATE DIRECT DIRECTOR FOR REVIEW MANAGEMENT THERE, AND MYSELF AND MY COLLEAGUE WILL TALK ABOUT THE BIOLOGICAL DRUG SUBSTANCE CATEGORIZATION AND INDEXING WE'VE BEEN WORKING CLOSELY WITH OUR COLLEAGUES FROM NLM TO COME UP WITH AN INDEXING FILE OR A WAY TO IDENTIFY DRUG SUBSTANCE IN ASSOCIATION WITH NONPROPRIETARY NAMES IN ORDINANCE NUMBER TORE SUPPORT THE CURRENT STATE OF THE MARKET WHEN IT COMES TO BIOSIMILARS. SO MANY OF YOU OF COURSE ARE QUITE FAMILIAR WITH THE UNIQUE INGREDIENTS OR THE UNIQUE AND WE'VE BEEN USING UUNIS SINCE 2008 FOR OUR LABELING TO ASSOCIATE THAT TO THE ACTIVE VOGT THAT YOU SEE IN SPL FILES THAT ARE PUT ON DAILY MED AND AT THE TIME THAT WAS THE BEST, I WOULD SAY VALUE SET THAT WE HAD. THOSE ACTIVE INGREDIENTS IS OVER TIME AND IT DOESN'T GIVE YOU EVERYTHING YOU NEED TO KNOW WHAT AN ACTIVE INGREDIENT IS FOR A DRUG PRACTICEDUCT, SO THE WAY WE IDENTIFY INGREDIENTS IDENTIFIER SYSTEM THAT IT'S BASED ON SCIENTIFIC IDENTIFICATION SO THINK PERIODIC TABLE OF ELEMENTS SO IT'S ABOUT WHAT IT IS, IT'S NOT ABOUT HOW IT'S MADE OR WHAT IT'S USED FOR. SO IDENTIFICATION AT THE SUBSTANCE LEVEL WITH RESPECT TO UNIQUE INGREDIENTS IDENTIFIER AS INDEPENDENT OF PROD AND YOU CAN MANUFACTURING INFORMATION AND HOWEVER AS I SAID, THAT WAS THE BEST WAY TO ASSOCIATE AND CODE THAT TO ACTIVE INGREDIENTS AND ACTIVE INGREDIENTS, ET CETERA. OVER TIME AND I DON'T KNOW HOW MANY ARE FAMILIAR WITH THE ISO IDENTIFICATION OF PRODPRODUCTS, OF THOSE STANDARDS, WE HAVE PRODUCT IDENTIFICATION, OTHER'S FOR PHARMACEUTICAL IDENTIFICATION, DOZAGE FORM ROOTS, UNITS OF MEASUREMENT AND ULTIMATELY SUBSTANCES AND IN TERMS OF HOW WE'RE IDENTIFYING SUBSTANCES UNIQUELY IN TERMS WHAT HAVE THEY ARE, THIS IS CONSISTENT WITH THE INTERNATIONAL STANDARD 1123ATE SUBSTANCE IDENTIFICATION, SO HOW WE'VE BEEN ADDRESS THANKSGIVING IS AS I MENTIONED BEFORE IS SCIENTIFIC SPECIFIED SUBSTANCE, IS SIN ONLY MOUSE WITH THE BIOLOGICAL DRUG SUBSTANCES AND WHAT A COMPANY OR MANUFACTURE DOES WITH THAT PARTICULAR SUBSTANCE AND WE FOUND IT TO BE VERY IMPORTANT ON AN INTERNATIONAL STUDY TO DO THE MAINING SO EVEN THOUGH PEOPLE WANT TO THESE CONCEPTS WE SHOULDN'T ACTUALLY COMPROMISE THE INTEGRITY OF HOW WE IDENTIFY IT SCIENTIFIC ME THAT SHOULD BE DONE SOMEWHERE ELSE. SO IN THE CASE OF THE IDENTIFICATION, WE IDENTIFY THAT BY ITS PROTEIN SEQUENCE SO AS CAN YOU SEE HERE THIS, IS AT THE SUBSTANCE LEVEL OF HOW WE PROVIDE THAT UNI. SO WITH RESECT TO THAT UNII, THE DRUG SUBSTANCE RELATIONSHIP IN OUR DOSSIER, THIS IS THE IH TO FIND THIS IN THE COMMON TECHNICAL DOCUMENT THERE WAS A SECTION 3.2. S, THERE'S ANOTHER ONE SOPHISTICATED DRUG SUBSTANCE AND THEN DRUG PRODUCT AND IN THIS PARTICULAR RELATIONSHIP, WE WANT TO MAINTAIN THE IDENTIFIER FOR THE SUBSTANCE, AND IT'S IDENTIFIED BY THE PROTEIN SEQUENCE, AND THERE'S MULL PEL MANUFACTURES OUT THERE THAT WILL TAKE THAT AND THEY DOLL ADDITIONAL THINGS TO IT, VERY SPECIFIC TO A PARTICULAR COMPANY WILL DO AND THAT'S REAL LE WHAT WE'RE CAPTURING AT THE DRUG SUBSTANCE LEVEL AND WE HAVE THE NAME AND MANUFACTURE AND THERE'S COMPANY OR LABORATORY CODE, OTHER NONPROPRIETARY NAME AND THE MANUFACTURING PROCESS THAT ARE SPECIFIC TO THAT MANUFACTURE WITH RESPECT TO THAT SUBSTANCE OR HOW WE'RE IDENTIFYING IT IN THE U.S. AS THE UNII. SO WHAT WE'VE ULTIMATELY CREATED WITHIN THE STANDARD AS I SAID, THE ISO STANDARDS THAT HAVE BEEN UNDER DEVELOPMENT INTERNATIONALLY WE ARE CAPTURING, WE'RE CALL TAG THE SPECIFIED SUBSTANCE BUT WE'VE DONE HERE IS WE'VE MADE A SPECIFIC CATEGORY CALL THE BIOLOGICAL DRUG SUBSTANCE CATEGORY SO STARTING TO THE RIGHT AND MOVING FORWARD THE LEFT, WE HAVE THE SUBSTANCE, THE UNIIIDENTIFIER WHICH REMINES OWN CHANGED LIKE I SAID IT DOESN'T MATTER HOW IT'S USED OR WHAT THEY'RE USING IT FOR OR HOW IT'S MADE, WE HAVE THAT IDENTIFIER THERE, WHEN IT COMES TO MULTIPLE MANUFACTURES, THE BIOLOGICAL DRUG SUBSTANCE WHICH IS CONSISTENT IN WHAT YOU SEE AND THE COMMON TECHNICAL DOCUMENT, THAT'S WHERE WE MAKE THE DIFFERENTIATION SO HAVE YOU THE SAME NAME BUT AND IN ALSO AND SO IN THE CASE THAT WAS MENTIONED TODAY WE HAVE THE BEAUTY---IN SNDZ, SO WHAT YOU SEE IN THAT SEGMENT IS A VERSION. SO THROUGHOUT THE PRODUCT LIFE CYCLE THERE ARE THINGS THAT ACTUALLY CHANGE THE MANUFACTURE MAKES DIFFERENCE DIFFERENCES AND THE SUBSTANTIVE ENOUGH YOU CAN IN FACT VERSION THIS TO SAY THIS IS THE SECOND AND THIRD VERSION OF THIS PARTICULAR BIOLOGICAL DRUG SUBSTANCE FOR THIS DRUG MANUFACTURE. THE BIOLOGICAL DRUG SUBSTANCE TERMS WILL BE ASSOCIATED TO THE UNI BUT NOT SINON MOUSE WITH SO WE DON'T WANT TO SAY, WELL ISSUE, SUBSTANCE IS SINON MOUSE WITH FILGRASTIM,-ANY OTHER TYPE OF SUFFIX, WE WANT TO MAKE THAT DISTINCTION AT THE BIOLOGICAL DRUG SUBSTANCE LEVEL SO THEY'RE SINON MOUSE, THEY'RE NOT SINON MOUSE, BUT YOU HAVE THAT WAY TO LINK BACK TO IT. IT ALLOWS EACH BIOLOGICAL DRUG SUBSTANCE TO BE IDENTSIFY AND AS CAN YOU SEE FOR THE BIOLOGICAL DRUG SUBSTANCE AND WORKING WITH OUR COLLEAGUES, IT WAS VERY IMPORTANT THAT WE ACTUALLY DID ASSOCIATE WITH O THAT WITH THE NONPROPRIETARY NAME SO WHAT YOU SEE HERE ISN'T CO INCIDENCE, WHAT WE'RE DOING OR PUTTING TOGETHER IS YOU SEE THIS FOR THE BIOLOGICAL DRUG STUB STANCE NAME, UNII-CODE IS LISTED THERE WITH THE SUFFIX AND THAT CORRESPONDS TO THE NONPROPRIETARY NAME THAT'S LISTED FOR THIS PRODUCT. IT DOESN'T ADDRESS THE SYNONYMS AT THE SUBSTANCE LEVEL SO AT THE PAST THAT NONPROPRIETARY NAME WAS ASSOCIATED TO THE UNI AND AS I SAID THERE WAS A GAP THERE BECAUSE IT'S THE DRUG SUBSTANCE THAT WE ARE TRYING TO FOCUS ON AND FILLS THAT VOID AND ALLOWS TO BE MORE SPECIFIC ABOUT WHAT WE'RE TALKING ABOUT WHEN WE TALK ABOUT DRUG SUBSTANCES OR ACTIVE INGREDIENTS IN THIS THE MEDICINAL PRODUCTS AND IT DOES SUPPORT THE BIOLOGIC DRUG SUBSTANCE RELATIONSHIP THROUGHOUT THE LIFE CYCLE SO AS I SAID, THERE'S A VERSION OF THIS, THEY THIS IS SOMETHING THEY WILL BE ABLE TO CONTINUE TO TRACK THROUGHOUT THE LIFE CYCLE OF A PRODUCT. THAT'S ESSENTIALLY HOW WE'RE ASSOCIATING SUBSTANCE. AS I SAID, SCIENTIFICALLY IDENTIFYING THAT, IN THIS CASE, APPROACHING SEQUENCE TO A BIOLOGICAL DRUG SUBSTANCE OR THE SPECIFIED SUBSTANCE WHICH IS IS SPECIFICALLY WHAT A MANUFACTURER IS GOING TO DO WITH THAT SUBSTANCE ULTIMATELY TO PUT IT INTO A MEDICINAL PRODUCT. THOSE ARE THE RELATIONSHIPS THAT CAN BE MANAGED OVER TIME, IT'S EXTENSIBLE TO MANY OTHER THINGS. SO THAT CONCLUDES MY PORTION OF THE TALK. I'M GOING TO TERN IT OVER TO MY COLLEAGUE, LONNIE SMITH, BECAUSE HE'S GOING TO TALK ABOUT THE INDEXING FILE THAT CAN BE PROVIDED IN ORDER TO CONTINUE TO HAVE THAT ASSOCIATION TO THE PRODUCTS THAT RON THE MARKET, SO LONNIE, IF YOU WANT TO TAKE IT FROM HERE. >> THANKS. I'M A POLICY ANALYST IN THE FDA'S NEW OFFICE OF HEALTH INFORMATICS THAT'S IN THE FDA'S OFFICE OF THE CHIEF SCIENTIST. SINCE 2013, FDA HAS BEEN -- WITH DATA SUCH AS THE PHARMACOLOGIC CLASS. THE PROVISION OF THESE INDEXING FILES ALLOWS FDA TO PROVIDE ADDITIONAL PRODUCT INFORMATION WITHOUT ALTERING THE COMPANY'S PRODUCT FILE POSTED ON DAILY MED. THE NEXT TWO SLIDES CONTAIN THE FPL REPRESENTATION OF THE DATA ELEMENTS WHICH HE JUST COVERED. A LOT OF THESE DATA ELEMENTS HAVE BEEN REPURPOSED FROM OTHER A.D.A.'S SPL INITIATIVES SO THEY SHOULD SEEM FAMILIAR TO MOST OF YOU. ONE KEY DATA ELEMENT IN THIS IS THE RELATED DOCUMENT ELEMENT. THE INCLUSION OF THE COMPANY'S PRODUCTS SET I.D. IN RELATED DOCUMENT AFFORDS AN OPPORTUNITY FOR THE HEALTHCARE INFORMATION PROVIDERS TO AUTOMATICALLY LINK AND INDEX THE FILE TO THE PRODUCT FILE ON DAILY MED. FOR THOSE WHO PREFER NOT TO AUTOMATICALLY LINK THE DATA BUT TO DO SO MANUALLY, WE HAVE INCLUDED THE PROPRIETARY NAME SO YOU CAN QUICKLY IDENTIFY THE APPROPRIATE PRODUCT SPL FILE POSTED ON DAILY MED. THE SUBSTANCE, UNI AND NAME HAS BEEN EUSD FOR QUITE SOME TIME. SO YOU SHOULD BE FAMILIAR WITH THAT. IN THIS INDEXING FILE, WE INCLUDED THE TIME FRAME FOR USE. WE WILL INCLUDE A START DATE, INDICATING THE DATE THAT FDA STATES THAT THIS BIOLOGIC DRUG SUBSTANCE NAME IS TO BE USED, IN CASES WHERE WE WANT TO STATE THAT THERE IS AN END DATE, WE WILL INCLUDE AN END DATE DATA ELEMENT AND INCLUDE THE DATE AS THAT VALUE. IN AN INDEXING SPL FILE WITH END DATE, THERE WILL ALSO BE ANOTHER INDEXING DATA ELEMENT SECTION WHICH WILL HAVE A START TIME FOR THE NEW NAME FOR THE BIOLOGIC DRUG SUBSTANCE. THIS DATA ELEMENT OR SET OF DATA ELEMENTS CAPTURES THE CODE AND NAME OF THE BUY LO JIJ TRUG SUBSTANCE NAME. THE CODE SYSTEM IS NEW, WE JUST IMPLEMENTED IT, IT SPECIFICALLY STATES THAT THIS CODE AND NAME IS ASSOCIATED WITH THE BIOLOGIC DRUG SUBSTANCE. WE ALSO INCLUDE IN THIS FILE THE BIOLOGIC LICENSING APPLICATION SO THAT THE USER KNOWS THAT THE INFORMATION IN THIS FILE IS ASSOCIATED WITH A PARTICULAR BIOLOGIC LICENSE APPLICATION OR BLA. WE ALSO DEFINITELY WANT TO INCLUDE THE DOCUMENT ELEMENT WHICH STATES THAT IT IS FDA WHICH IS PROVIDING THIS INFORMATION AND WE INCLUDE BOTH THE NAME AND A -- NUMBER. WE USE AN EXISTING SYSTEM INFRARE THAT WE'VE HAD FOR YEARS REGARDING THE TRANSMISSION OF SPL FILES TO NATIONAL LIBRARY OF MEDICINE, THE INDEXING FILES, THE PHARMACOLOGIC CLASS BUILDING IN AS WELL AS THE NEW BIOLOGIC DRUG INDEXING FILES ARE SUBMITTED THROUGH A SECURE FTP PORTAL TO NATIONAL LIBRARY OF MEDICINE ONE OUR AFTER NATIONAL LIBRARY OF MEDICINE RECEIVING THE FILE, IT IS MADE AVAILABLE TO THE HEALTHCARE INFORMATION SYSTEM TO PROVIDERS WHO WISH TO IMPORT THIS DATA. IN FACT, IN THIS PARTICULAR FILE, IT WAS POSTED ON THE DAILY MED WEBSITE LAST NIGHT. THANK YOU, I'LL TURN IT BACK OVER TO JOHN. [APPLAUSE] >> SO I GUESS WE'RE AT THE END. DOESN'T QUITE FEEL LIKE THE END. MAYBE WE COULD ASK -- YOU ALL HAVE SOME QUESTIONS, MAYBE. >> SO I GUESS THE MOST BASIC QUESTION THAT I HAVE IS THAT IN THE PAST -- >> YOU'RE ASKING ME OR THEM? >> THIS IS FOR LONNIE IN PARTICULAR. IN THE PAST, WHEN FDA HAS HAD PROPOSALS FOR INDEXING, THEY'VE ENGAGED STAKEHOLDERS AS PART OF THAT CONVERSATION SO THE HL7 -- TERRY, WHAT'S THE NAME OF YOUR GROUP? OH, TERRY HAD TO LEAVE. THE GROUP THAT ED IS INVOLVED WITH, THEY'VE BEEN PART OF THOSE DISCUSSIONS AND I'M WONDERING, HAVE THEY BEEN PRIVY TO THESE DISCUSSIONS AND HAVE THEY PROVIDED YOU ANY STAKEHOLDER INPUT BEFORE THIS IT FILE WAS POSTED LAST NIGHT? >> ACTUALLY THAT'S PARTIALLY TRUE. IN THE INDEXING GUIDANCE THAT WE PUBLISHED, WE DO PROVIDE -- WE DO STATE WE WILL PROVIDE THE FILES ON A WEBSITE FOR COMMENT, AND THIS FILE IS PROVIDED FOR COMMENT. WE HAVE NOT STATED -- AS USUAL, WE ACCEPT FEEDBACK FOR ANY TYPE OF SPL FILE. IF YOU NOTICE THAT OVER THE YEARS, WE MAY CHANGE IT TO THE DIFFERENT SPL FIEMS TO ACCOMMODATE COMMENTS MADE BY THE COMPANIES AND THE USERS ON DAILY MED. AS I STATED EARLIER, A LOT OF THESE DATA ELEMENTS, IN FACT, ALL THE DATA ELEMENTS ARE BEING RE-USED. THEY'RE ALREADY IN SPL FILES ARE ALREADY PUBLISHED ON DA DAILY MED, EVEN THE SUBSTANCE SPECIFICATION, WHICH IS PROBABLY THE MOST NEWEST DATA ELEMENT WE USE, WE STARTED USING THOSE IN THE HUMAN COMPOUNDED DRUG SPL FILES, WHICH CDER IMPLEMENTED LAST FALL. SO THEY'RE THE ELEMENTS WE'VE ALWAYS USED. >> BUT THE CONSTRUCT IS DIFFERENT. >> THE TERMINOLOGY IS DIFFERENT. >> RIGHT, SO IT'S NOT REALLY SOMETHING THAT'S BEEN USED BEFORE. >> YOU MEAN THE DATA ELEMENTS OR THE DATA? >> THE WAY THAT THE DATA ARE REPRESENTED. I MEAN, THAT YOU'RE ADDING -- BASICALLY WHAT YOU'VE DONE IS YOU'VE TAKEN THE SUFFIXES AND PREFIXES THAT ARE CURRENTLY IN EFFECT FOR THOSE DRUGS AND JUST APPENDED THEM TO THE UNI CODE AND THEN MY ASSUMPTION IS THAT IF FDA'S CURRENT PROPOSAL GOES FORWARD, THAT YOU WOULD THEN SWITCH THOSE AND ADOPT WHATEVER SUFFIX IS ADDED TO THOSE PRODUCTS TO THE UNI CODE TO COME UP WITH THAT CODE, RIGHT? >> RIGHT. THAT QUESTION IS MORE OF A POLICY QUESTION. ALL I PROVIDED WAS THE XML REPRESENTATION, AND YOU CAN PROVIDE COMMENT THROUGH THE APPROPRIATE POLICY MECHANISMS. >> WHAT WE CAN SAY IS WHAT WE PRESENTED IS THAT IT ALLOWS ITSELF -- IT'S FLEXIBLE, AND IT'S EXTENSIBLE SO WHATEVER THE DECISION IS, IT ALLOWS US TO BE ABLE TO ACCOMMODATE THAT. I DO WANT TO IT ADD ONE THING ABOUT HL7 BECAUSE I DO PARTICIPATE IN THAT, AND AS LONNIE WAS SAYING, HL7 IS ABOUT MESSAGE EXCHANGE, MESSAGE EXCHANGE STANDARDS. EVERYTHING WE'RE TALKING ABOUT HERE IS ALREADY ACCOMMODATED IN THE CURRENT STANDARDS. WHEN WE START TALKING ABOUT CONTENT, WE DON'T TAKE CONTENT TO HL7. OBVIOUSLY WE HAVE TO MODIFY THE STANDARD OR THE MODEL TO DO SOMETHING, THEN CERTAINLY WE WOULD BASICALLY GO THROUGH HL7, BUT AS LONNIE SAID, IT'S AVAILABLE FOR COMMENT BUT WITH RESPECT TO THE QUESTION ABOUT HL7, THERE'S NOTHING HERE THAT'S INCONSISTENT WHAT'S ALREADY AVAILABLE IN THE STANDARD FOR HL7. >> SO CAN I JUST CLARIFY HOW THIS ACCOMMODATES TWO DIFFERENTLY NAMED PRODUCTS THAT ARE THE SAME ON THE MARKET AT THE SAME TIME? BECAUSE HOW ARE YOU GOING TO RECORD IF THERE'S A DATE CERTAIN THAT YOU'RE SWITCHING TO THE NEW DESIGNATION, BUT YOU'VE STILL GOT OLD INVENTORY RUNNING THROUGH ALLOWS THE GUIDANCE WHICH COULD BE ANYTHING FROM MONTHS TO A YEAR OR WHATEVER, HOW DOES THE SYSTEM, IF YOU'VE GOT A DATE CERTAIN IF THE SWITCH -- ACCOMMODATE THOSE TWO DIFFERENTLY NAMED PRODUCTS THAT AE BOTH LEGITIMATELY ON THE MARKET? >> WHAT WE HAVE HERE ALLOWS FOR VERSIONING, SO ANY VERSION THAT'S AVAILABLE, IF IT'S NAMED ONE THING AND ULTIMATELY SOMETHING HAS TO CHANGE FROM A STANDARDS PERSPECTIVE, WE CAN ACTUALLY ASSOCIATE THOSE AND LINK THOSE AND UPDATE IN AN INDEXING FILE TO SAY HERE WAS A NAME AT A CERTAIN POINT IN TIME AND NOW THE NAME HAS CHANGED AND THE TWO THINGS ARE RELATED. NOW FROM A LABELING STANDPOINT, THIS IS NO DIFFERENT THAN WHEN WE HAVE CERTAIN THINGS IN LABELING AND THEN WE HAVE TO COME UP WITH SOMETHING NEW, SO RIGHT NOW CURREN CURRENTLY PUTTING THIS ASIDE, YOU CAN HAVE A LABEL THAT'S OUT THERE, THERE'S SOMETHING THAT'S CHANGED BUT YOU STILL HAVE PRODUCT ON THE MARKET WITH A CERTAIN NAME. BASICALLY WHAT COMPANIES DO TODAY IS THAT UNTIL THAT OTHER PRODUCT REACHES ITS LAST LOT OF EXPIRY, THEN YOU HAVE TO MAINTAIN THAT LABELING ON DATELY MED ANYWAY, AND THEY BASICALLY CAN PULL THAT DOWN SO WE DO HAVE PROVISIONS TO ALLOW FOR THOSE THINGS TO BE ON THERE AND TO ASSOCIATE THEM AND MAKE THAT INFORMATION AVAILABLE TO THE GENERAL PUBLIC. >> STEVE EMRICK FROM NLM. I WAS WONDERING, DOES THE VERSION OF THE NAME -- I THINK IT WAS THE NON-PROPRIETARY NAME, DOES THAT HAVE ANY CLINICAL SIGNIFICANCE? >> I'M SORRY, IN TERMS OF THE VERSION OF THE NON-PROPRIETARY NAME HAVE ANY CLINICAL SIGNIFICANCE? >> WHAT DOES THE VERSION MEAN? >> SO YOU'RE NOT TALKING ABOUT THE NON-PROPRIETARY, YOU'RE TALKING ABOUT THE CODE? >> I DON'T KNOW. I JUST SAW -- >> RIGHT, SO WHAT I MENTIONED ABOUT VERSIONING AT THE BIOLOGICAL DRUG SUBSTACE LEVEL, DASH ONE, WE'RE NOT TALKING ABOUT THE NON-PROPRIETARY NAME. I THINK TO THE OTHER QUESTION BEFORE, THAT NAME CHANGES, CAN YOU ASSOCIATE THOSE AS SYNONYMS SO YOU CAN TRACK EVERYTHING TOGETHER, AND THE ANSWER IS YES. FOR THE BIOLOGICAL DRUG SUBSTANCE, THE REASON WHY WE HAVE THE VERSIONING IS BECAUSE I BELIEVE SOMEONE HAD MENTIONED IT EARLIER, YOU CAN HAVE A COMPANY DO MULTIPLE THINGS, IT MAY CHANGE THEIR MANUFACTURING PROCESS IF YOU DO OTHER THINGS AND YOU MAY HAVE A REASON WHY YOU WANT TO TRACK ONE PARTICULAR VERSION OF THE DRUG SUBSTANCE THAT WAS MANUFACTURED, THEN WHEN THEY CHANGED THE PROCESS AS AN EXAMPLE, YOU COULD HAVE A DASH 2 TO SAY THIS IS A VERSION OF THE DRUG SUBSTANCE WITH THIS FORMULATION OR THIS PART OF THE PRODUCT WHEN THEY CHANGE THE MANUFACTURING. SO THAT'S JUST ONE EXAMPLE. FOR WHATEVER REASON YOU MAY HAVE THAT YOU WANT TO VERSION IT, IT LENDS ITSELF TO THAT SO YOU CAN KEEP TRACK IN ANY INSTANCE IN TIME OF WHAT WAS THE VERSION OF THE DRUG SUBSTANCE AT THIS POINT IN TIME AND ULTIMATELY IT HAS CHANGED OVER TIME, WHAT IS THE VERSION OF IT CURRENTLY. >> I HAD A QUESTION REGARDING LET'S SAY ONE OF THESE BRAND NAMES HAS A VERSION CHANGE, IS THAT GOING TO GET A NEW NDC CODE? CURRENTLY THAT'S KIND OF HOW WE TRACK THINGS. IF IT DOES GET AN NDC CODE, I'M CURIOUS HOW YOU'RE GOING TO TRACK THE VERSION. >> RIGHT. SO RIGHT NOW FOR VERSIONING, AND THIS IS ACTUALLY NOT SPECIFIC TO BIOSIMILARS, THIS IS JUST WITH PRODUCTS IN GENERAL, THERE CAN BE VERSIONS OR INSTANCES WHERE A COMPANY CHANGES SOMETHING IN THE MANUFACTURING PROCESS SO IT'S DEPENDS IF IT'S SIGNIFICANT ENOUGH AND YOU DON'T THINK THAT IT'S COMPARABLE, THEN YOU MAY SAY I NEED TO GO AHEAD AND SAY THIS IS A DIFFERENT FORMULATION OF THIS PRODUCT AND GIVE IT A DIFFERENT NDC. IF YOU THINK IT IS, THEN YOU MAY NOT HAVE TO CHANGE THE NDC SO JUST TO BE CLEAR IT HAS NOTHING TO DO WITH BIOSIMILARS. IT MAY OR MAY NOT CHANGE THE NDC DEPENDING ON WHAT'S BEING SUBMIT AND WHAT THEY'RE CHANGING. >> TOM -- WITH -- THAT STATEMENT IS CONFUSING TO ME. BECAUSE I THOUGHT THE ISSUE HERE WAS TO IDENTIFY THE PRODUCT TO THE PARTICULAR MANUFACTURER. SO IF SOMETHING CHANGES, YOU HAVE TO REVERSION THE NAME, YOU DO WANT TO TRACK THAT THROUGH THE SYSTEM FOR PHARMACOVIGILANCE OR WHATEVER ELSE YOU WANT TO DO. >> CORRECT. >> IF YOU DON'T CHANGE THE NDC, YOU'RE NOT GOING TO BE ABLE TO DO THAT IN A PRACTICAL MATTER. >> SO THE WAY YOU CAN CAN ACTUALLY VERSION WITH NDC IS THAT THAT CURRENTLY HAPPENS TODAY, SO REGARDLESS IF IT'S A BIOSIMILAR, WE DO HAVE WAYS THAT WE ACTUALLY TRACK THE NDC -- TRACK THE PRODUCT EVEN IF THE NDC DOESN'T CHANGE BECAUSE WE HAVE OTHER IDENTIFIERS ASSOCIATED WITH THAT, BUT TO YOUR POINT, YOU'RE EXACTLY RIGHT, THAT CAN MAKE IT A LITTLE MORE DIFFICULT, BUT I BELIEVE HIS QUESTION WAS MORE ALONG THE LINES OF IF YOU VERSION THE DRUG SUBSTANCE, HOW DO YOU TRACK IT. WE HAVE ALL OF THE INFORMATION SO WE'RE ABLE TO -- AT LEAST FOR THOSE VERSIONS TODAY. PUBLICLY, IT MAY BE A LITTLE BIT MORE DIFFERENT, SO THERE MAY BE INSTANCES WHERE THE NDC DOESN'T CHANGE AND THE LABELING DOESN'T CHANGE, BUT INTERNALLY, IF WE DON'T THINK THAT CHANGE IS SIGNIFICANT ENOUGH TO CHANGE LABELING THEN WE HAVE A WAY TO TRACK THAT OURSELVES INTERNALLY. IF IT'S SIGNIFICANT ENOUGH, THEN WE WOULD CHANGE THE NDC BUT TO BE CLEAR, WHEN THE NDC CHANGES, IF IT'S A PRODUCT OR A PACKAGING ISSUE, IT'S JUST SOMETHING THAT'S FUNDAMENTAL TO ALL PRODUCTS THAT WE REGULATE. >> I THINK THE DIFFERENCE IS A POLICY ISSUE, SOMETHING YOU CAN ANSWER WOULD BE SOMETHING THAT WOULD BE DIRECTED TO YOU, BUT THE FDA IS STATING THERE'S A DIFFERENCE IN THESE PRODUCTS, IN THESE BIOSIMILARS, SO TO IDENTIFY THAT DIFFERENCE, WE HAVE TO HAVE A DIFFERENT NON-PROPRIETARY NAME. IF WE'RE GOING TO DO THAT, IF THAT'S A TRUE STATEMENT, THERE'S A CHANGE THAT YOU'RE DESCRIBING HERE, NO MATTER WHETHER IT CHANGES THE EFFECTIVENESS OF THE DRUG OR ANY OF THOSE OTHER THINGS, IT SEEMS TO ME YOU COULD HAVE TO WANING CHAING TH TO CHANGE THE NDC NUMBER. >> THERE'S SOME POLICY THINGS WE'RE NOT HERE TO ADDRESS, THE WEBSITE HAS PLENTY OF INFORMATION IF PEOPLE WANT TO ADDRESS IT. WE'RE HERE TO BASICALLY SAY WHATEVER THE DECISION IS, IF TH IS FLEXIBLE ENOUGH TO BE ABLE TO ACCOMMODATE THAT DECISION. >> JONATHAN, THIS IS THE LAST QUESTION. >> THOMAS FROM -- I JUST WANT TO COMMEND YOU FOR TAKING AN INTERESTING AND INNOVATIVE APPROACH TO TRYING TO TRACK THESE MEDICATIONS AND KEEP MANUFACTURERS ACCOUNTABLE FOR THEIR PRODUCTS, WHICH IS SOMETHING THAT WE'VE BEEN ADVOCATING FOR AS A BIOSIMILAR MANUFACTURER. THE BIOLOGICAL DRUG SUBSTANCE AND THE VERSION THAT YOU SAY CAN BE ACCOMMODATED IN SYSTEMS, IT'S INTERESTING BECAUSE IT'S ONE STEP CLOSER TO A BATCH LEVEL TRACEABILITY FOR PRODUCTS. IT'S NOT EXACTLY A BATCH LEVEL TRACEABILITY BUT AT LEAST IT'S A FORMULATION TRACEABILITY. CLOSE TO IT. HOW DO YOU SEE THAT BEING INCLUDED IN AN ADVERSE EVENT REPORTING PROCESS SO THAT YOU COULD ACTUALLY POTENTIALLY LINK SOMETHING THAT HAPPENS WITH A NEW FORMULATION OR VERSION TO ADVERSE EVENTS THAT ARE IDENTIFIED IN THE COMMUNITY AND REPORT IT? RIGHT NOW BIOLOGICAL DRUG SUBSTANCE IN THAT CODE IS IN A FIELD THAT'S INCLUDED IN, SAY, THE MED WATCH 3500 REPORT FORM. SO HOW DO YOU SEE THAT BEING LINKED TOGETHER IN TERMS OF MEASURING QUALITY, EFFICACY, SAFETY? >> WHAT I'LL SAY IS -- THAT MIGHT BE A LONGER ANSWER -- INTERNATIONALLY, AS WE MENTIONED, WE'VE BEEN WORKING ON THESE IDENTIFICATION OF MEDICINAL PRODUCT STANDARDS, THESE ISO STANDARDS, TO GET DOWN TO A VERY GRANULAR LEVEL OF BASICALLY HOW WE CAN DIFFERENTIATE AND IDENTIFY THINGS. WITHIN THAT SAME ISO PROCESS, WE HAVE INDIVIDUAL CASE -- REPORTING. THOSE THINGS ARE LINKED. SO THE WAY YOU DO ICSRs AND -- ARE THREE, IT HAS ASSOCIATION WITH THE ISO STANDARDS TO BE ABLE TO IDENTIFY MEDICINAL PRODUCTS AT A VERY GRANULAR LEVEL SO IT CAN GO DOWN TO THE LOT LEVEL, TO THE BULL, SO THERE'S SOME TRACEABILITY THERE, SO OFFLINE, WE CAN SPEAK AND I CAN GIVE YOU MORE INFORMATION ABOUT HOW WE'RE FORWARD THINKING WITH THOSE STANDARD AND HOW WE NT THOSE, BUT IT GOES TO THE POINT THAT YOU'RE MAKING. [APPLAUSE] >> ALL RIGHT, I THINK CLASS IS DISMISSED, SO THANK YOU ALL FOR COMING, AND THIS WAS A LOT OF FUN.