American Society for Automation in Pharmacy

1. American Society for Automation in Pharmacy The Role of Government and Technology in the Emerging BTC Class

2. Objectives Following this presentation, attendees should be able to: Discuss the requirements for dispensing non-prescription products that are kept behind the pharmacy counter Evaluate technology that allows the pharmacy to comply with current requirements for these products while maintaining the efficiency of dispensing and allowing sufficient time for patient care Review classes of drugs most likely to be considered for behind the counter (BTC) class Understand the challenges that may be associated with BTC products

3. Over-the-Counter Drugs (OTC) Defined by Durham-Humphrey Amendment Must be labeled with directions for the layperson that indicate their safe and effective use Advertising is regulated by FTC Today we only have two “regulated” classes of drugs, prescription and over-the-counter. Prescription drugs differ from over-the-counter drugs in a number of ways. Today we only have two “regulated” classes of drugs, prescription and over-the-counter. Prescription drugs differ from over-the-counter drugs in a number of ways.

4. Rx Only Drugs/Legend Drugs Durham-Humphrey Amendment Restricted the sale of Rx drugs (drugs that could not be used without medical supervision) to people with a valid prescription written by a licensed practitioner Defined as A drug that because of its toxicity or other harmful effect requires supervision of a licensed medical professional Is FDA approved Dispensed only by a licensed practitioner and written by a licensed practitioner Dispensed only by a licensed practitioner (RPh) and written by a licensed practitioner (MD, DO, PA, NP, OD) So how do drugs go from being a prescription only product to an over-the-counter product? Dispensed only by a licensed practitioner (RPh) and written by a licensed practitioner (MD, DO, PA, NP, OD) So how do drugs go from being a prescription only product to an over-the-counter product?

5. Rx to OTC Switch Process There is a defined process for Rx drugs to be considered for a switch to OTC status There is a defined process for Rx drugs to be considered for a switch to OTC status

6. Rx to OTC Switch Drug Price Competition and Patent Term Restoration Act Provides up to 3 additional years of marketing exclusivity for the makers of drugs switched from prescription to over-the-counter status if the FDA has required additional clinical trials deemed essential to evaluate the switch

7. Many Products Have Made theRx to OTC Switch NSAIDs H2 blockers Proton pump inhibitors Non-sedating antihistamines Topical dermatological agents Anti-diarrheals Nicotine replacement therapy Hair growth products Weight loss products

8. Rx to OTC Switch Criteria Similar criteria could be used to guide a potential Rx to BTC switchSimilar criteria could be used to guide a potential Rx to BTC switch

9. Status of Drugs Currently Available Behind the Pharmacy Counter Two types of non-prescription products are currently available behind the pharmacy counter Products containing pseudoephedrine (PSE) Plan B® Not a true third class of drugs because not established by regulation Also products containing phenylpropanolamine, and ephedrine, but only PSE is currently on the market in U.S. Later in the presentation we will discuss the FDA’s consideration of a third class of drugs, but first let’s look at the non-prescription drugs currently kept behind the pharmacy counterAlso products containing phenylpropanolamine, and ephedrine, but only PSE is currently on the market in U.S. Later in the presentation we will discuss the FDA’s consideration of a third class of drugs, but first let’s look at the non-prescription drugs currently kept behind the pharmacy counter

10. Products Containing Pseudoephedrine (PSE) Combat Methamphetamine Epidemic Act (CMEA) Intended to limit the amount of pseudoephedrine available to individuals using it to create methamphetamine Established requirements for selling PSE to consumers Signed into law on March 9, 2006

11. CMEA Requirements Requires retailers selling PSE to Store products behind the pharmacy counter or in a locked cabinet Limit the quantity of PSE sold to an individual consumer Daily sales not to exceed 3.6 grams Monthly sales not to exceed 9.0 grams Some states may have stricter regulations on this, but this is what the CMEA requiresSome states may have stricter regulations on this, but this is what the CMEA requires

12. CMEA Requirements Also requires retailers selling PSE to Keep record of purchases for 2 years Record purchaser’s name, address, name of product sold, quantity sold, date and time of the sale, and purchaser’s signature Consumer must show picture identification so that seller can verify that information provided is correct Submit a self-certification to the Attorney General stating that all employees involved in the sale of PSE have undergone training to ensure they understand these requirements The record keeping requirement in particular has posed some logistical challenges for pharmacies. Pharmacies are using a variety of methods to comply with the record keeping requirement How many of you work in pharmacies that use a paper based logbook to record this information? How many of you work in pharmacies that keep PSE purchase records in pharmacy dispensing software? How many of you work in pharmacies that use a POS system to keep these records? Just as there are many methods of capturing this information, the information captured may be in a variety of formats These types of differences can make it challenging to keep track of PSE purchases among multiple retailers and can make it more difficult for law enforcement to identify and crack down on potential meth cooks To help alleviate some of these challenges, ASAP has created a standard for recording this information The record keeping requirement in particular has posed some logistical challenges for pharmacies. Pharmacies are using a variety of methods to comply with the record keeping requirement How many of you work in pharmacies that use a paper based logbook to record this information? How many of you work in pharmacies that keep PSE purchase records in pharmacy dispensing software? How many of you work in pharmacies that use a POS system to keep these records? Just as there are many methods of capturing this information, the information captured may be in a variety of formats These types of differences can make it challenging to keep track of PSE purchases among multiple retailers and can make it more difficult for law enforcement to identify and crack down on potential meth cooks To help alleviate some of these challenges, ASAP has created a standard for recording this information

13. ASAP Standard Creates uniformity among various electronic PSE-tracking programs Facilitates sharing of PSE purchase data Does not dictate what information a PSE-tracking system should collect beyond what the CMEA requires ASAP has developed the PSE-tracking standard as a result of a meeting of law enforcement officials and others in March 2007 that was sponsored by the National Alliance for Model State Drug Laws (NAMSDL), with support from the Office of National Drug Control Policy and the Bureau of Justice Assistance, Office of Justice Programs, United States Department of Justice. The meeting resulted in the formation of the NAMSDL Methamphetamine Precursor Tracking Advisory Committee. “Law enforcement doesn’t have to reinvent the wheel, and pharmacies don’t have to comply with multiple standards.” “The ASAP standards simply say that if you decide to collect a certain piece of information — a driver’s license number, for example — then here is the technical format you should use.” ASAP has developed the PSE-tracking standard as a result of a meeting of law enforcement officials and others in March 2007 that was sponsored by the National Alliance for Model State Drug Laws (NAMSDL), with support from the Office of National Drug Control Policy and the Bureau of Justice Assistance, Office of Justice Programs, United States Department of Justice. The meeting resulted in the formation of the NAMSDL Methamphetamine Precursor Tracking Advisory Committee. “Law enforcement doesn’t have to reinvent the wheel, and pharmacies don’t have to comply with multiple standards.” “The ASAP standards simply say that if you decide to collect a certain piece of information — a driver’s license number, for example — then here is the technical format you should use.”

14. ASAP Standard Flexibility Works with systems that simply collect data and pass it along Also works with systems that collect data in real time to stop sales above legal limits Accepts Batch-file transmissions of PSE purchases Web-based reporting through portals or servers Reporting through company-specific POS systems Applies to pharmacies and non-pharmacy retailers that sell PSE Regardless of whether the data is collected in real time or on a periodic basis The ASAP PSE-tracking standard is available on a CD or as a PDF to ASAP members for $125. The cost for nonmembers is $620. So ASAP has helped address one of the challenges with PSE. Another product kept behind the counter that presents challenges for retailers is Plan B. Regardless of whether the data is collected in real time or on a periodic basis The ASAP PSE-tracking standard is available on a CD or as a PDF to ASAP members for $125. The cost for nonmembers is $620. So ASAP has helped address one of the challenges with PSE. Another product kept behind the counter that presents challenges for retailers is Plan B.

15. History of Plan B Time sensitive treatment Rx introduces barriers to access Since becoming available BTC, 40,000 Units sold weekly in U.S. 16% are dispensed as a prescription Statistics from transcript of Food and Drug Administration Behind the Counter Availability of Certain Drugs. Public Meeting. Wednesday, November 14, 2007. Available http://www.fda.gov/oc/op/btc/transcripts11_14_07.html. Speaker: Kirsten Moore, Reproductive Health Technologies ProjectTime sensitive treatment Rx introduces barriers to access Since becoming available BTC, 40,000 Units sold weekly in U.S. 16% are dispensed as a prescription Statistics from transcript of Food and Drug Administration Behind the Counter Availability of Certain Drugs. Public Meeting. Wednesday, November 14, 2007. Available http://www.fda.gov/oc/op/btc/transcripts11_14_07.html. Speaker: Kirsten Moore, Reproductive Health Technologies Project

16. Plan B Requirements for Pharmacies Only licensed pharmacies or other licensed healthcare clinics may sell Plan B Must be kept behind the counter May only sell without a prescription to consumers age 18 and older Proof of Age Photo ID Must have prescription to dispense to patients age 17 and younger What about gender of purchaser? Plan B Stocking Sheet states that “Government-issued ID required for age verification.” This is also mentioned in an FDA memo published the day that Plan B was approved for non-prescription status. This is not mentioned in the prescribing information or in the FDA’s approval letter To be safe, I would recommend always checking ID. Plan B Stocking Sheet states that “Government-issued ID required for age verification.” This is also mentioned in an FDA memo published the day that Plan B was approved for non-prescription status. This is not mentioned in the prescribing information or in the FDA’s approval letter To be safe, I would recommend always checking ID.

17. Plan B Requirements for Manufacturer Monitor trends in the use of emergency contraception to evaluate the effectiveness of the CARE program Conduct a market research survey(s) of healthcare professionals annually To determine whether the Rx requirement for those ages <17 is being adhered to To provide signals of program effectiveness and potential problems associated with consumers’ understanding of the purpose and proper use of Plan B Potential areas of monitoring and reporting include evaluating possible correlations between increases in sexually transmitted infections (STIs) based on geographic areas and data and trends in pregnancy and/or abortion rates based on geographic areas. Potential areas of monitoring and reporting include evaluating possible correlations between increases in sexually transmitted infections (STIs) based on geographic areas and data and trends in pregnancy and/or abortion rates based on geographic areas.

18. Plan B Requirements for Manufacturer Use survey data regularly collected by other groups to monitor for potential inappropriate use Conduct a “Point-of-Purchase Monitoring Program” to track how it is being sold, including using anonymous shoppers who visit locations where Plan B is available and purchase the product Use data to document and analyze retailers’ comprehension of age requirement and how it is handled at the point of sale Report repeat violators to the relevant State Board(s) of Pharmacy Report to FDA on the results of these activities every 6 months Other groups include: Centers for Disease Control’s Behavioral Risk Factor Safety Surveillance (CDC BRFSS) Youth Risk Behavior Safety Surveillance (YRBSS) Anecdotal evidence suggests that retailers have been lax in enforcing the ID requirement. Nothing requires retailer to document that they have checked the customer’s ID. Some pharmacies have opted to swipe customers’ ID to verify age, similar to the process for verifying age for a tobacco or alcohol sale. This would certainly help the pharmacy defend itself if accused of not verifying a customer’s age before selling Plan B. This presents another situation where technology can help pharmacies handle BTC product sales.Other groups include: Centers for Disease Control’s Behavioral Risk Factor Safety Surveillance (CDC BRFSS) Youth Risk Behavior Safety Surveillance (YRBSS) Anecdotal evidence suggests that retailers have been lax in enforcing the ID requirement. Nothing requires retailer to document that they have checked the customer’s ID. Some pharmacies have opted to swipe customers’ ID to verify age, similar to the process for verifying age for a tobacco or alcohol sale. This would certainly help the pharmacy defend itself if accused of not verifying a customer’s age before selling Plan B. This presents another situation where technology can help pharmacies handle BTC product sales.

19. New Technology for Non-Prescription Drugs Kept Behind the Pharmacy Counter Plan B and PSE each have their own requirements related to restrictions on purchaser. Both take up extra time on the part of the pharmacist or pharmacy technician in order to dispense in compliance with these requirements. Some companies have recognized this and developed technology solutions to address this. Plan B and PSE each have their own requirements related to restrictions on purchaser. Both take up extra time on the part of the pharmacist or pharmacy technician in order to dispense in compliance with these requirements. Some companies have recognized this and developed technology solutions to address this.

20. Need for Technology Solution Record keeping requirement of CMEA Manual logbooks Time consuming for the patient and the pharmacy Creates challenges in tracking and preventing illegal sales - not able to be tracked or shared in real time States have developed legislation to require electronic tracking of PSE sales Intended to make the CMEA more enforceable in real time Several companies have answered their call with PSE tracking devices, software, and databases Tie in previous speaker’s comments on states, pending legislation, etc. New technologies are designed to allow the pharmacy to comply with current requirements while maintaining the efficiency of dispensing and allowing sufficient time for patient care. They may help make sure that the rules are enforced efficiently. Some of these technology vendors, such as Optimum Technology and Appriss, participated in the development of the ASAP PSE Tracking Standard. Since there are a variety of products that each have their own attributes, but also share many attributes, I have listed here the general attributes of PSE tracking products. If you are interested in more information about specific products, you can check out the ComputerTalk buyers guide or I’d be happy to discuss Tie in previous speaker’s comments on states, pending legislation, etc. New technologies are designed to allow the pharmacy to comply with current requirements while maintaining the efficiency of dispensing and allowing sufficient time for patient care. They may help make sure that the rules are enforced efficiently. Some of these technology vendors, such as Optimum Technology and Appriss, participated in the development of the ASAP PSE Tracking Standard. Since there are a variety of products that each have their own attributes, but also share many attributes, I have listed here the general attributes of PSE tracking products. If you are interested in more information about specific products, you can check out the ComputerTalk buyers guide or I’d be happy to discuss

21. PSE Tracking Technology Attributes Format Integrated POS Solution Stand-Alone Solution Product Info Capture UPC Scanning Purchaser Info Capture Drivers License Barcode Scanner Drivers License Magnetic Stripe Scanner Manual data entry Signature Capture All of the PSE tracking products marketed to pharmacies have UPC scanning and signature capture. Some products offer POS, stand-alone, or both. Purchaser data capture varies among the different products; some products may allow for more than one method of data capture.All of the PSE tracking products marketed to pharmacies have UPC scanning and signature capture. Some products offer POS, stand-alone, or both. Purchaser data capture varies among the different products; some products may allow for more than one method of data capture.

22. Record Keeping Maintain log 2 years Enforcement Alert Reports Enforcement Calculate quantity purchased per person per day and per person per month Check/restrict purchase if above legal limit Tracking National Database Report to centrally managed state database Some technology products can help pharmacies keep track of records, submit records to national and state databases Can also help law enforcement identify offenders and enforce CMEASome technology products can help pharmacies keep track of records, submit records to national and state databases Can also help law enforcement identify offenders and enforce CMEA

23. Need for Technology Solution Plan B is only allowed to be dispensed without an Rx to individuals >18 years old Need to verify purchaser’s age using photo identification Anecdotal evidence suggests that pharmacies may be lax in enforcing Some PSE tracking products can prompt for age verification at POS Technology to verify purchaser age, like those used to restrict alcohol and tobacco purchases, may be useful for this product also Many of the electronic tracking products out there focus on PSE tracking and sales limits However, some products do have an age verification function to remind the seller to check the purchaser’s ID, prevent the sale without ID, and/or track the purchaser’s ID swipe Many of the electronic tracking products out there focus on PSE tracking and sales limits However, some products do have an age verification function to remind the seller to check the purchaser’s ID, prevent the sale without ID, and/or track the purchaser’s ID swipe

24. Future of Behind The Counter Drugs The FDA is currently looking into creating a third class of drugs, also known as “behind the counter” or “BTC” classThe FDA is currently looking into creating a third class of drugs, also known as “behind the counter” or “BTC” class

25. Status of FDA Action on BTC Meeting held November 14, 2007 FDA is still reviewing the comments from the meeting and those submitted after the meeting Exploring next steps Only some of the comments submitted in writing or electronically are currently available Several hundred documents associated with this docket The FDA has also not determined if it can create a new behind-the-counter drug class on its own, or whether Congress would have to pass a new law to do it. The FDA requested public comment on the issue of a BTC class Posed specific questions about the transition of drugs to BTC status, the dispensing process for BTC products, and the pharmacist’s professional role Still in the process of reviewing the public comments in response to these questions One of their questions asked, “If safety concerns arise, should there be criteria or standards for a drug to transition out of BTC status to prescription status? Or from OTC status to BTC status? If so what should these criteria or standards be for each scenario?”   The transition of products from Rx to BTC status is one part of the discussion.  This type of switch is designed to increase patient access to medications. It may be guided by the current Rx to OTC switch process. However, there could be switches in the opposite direction, designed to ensure patient safety and/or public health.  OTC to BTC or BTC to Rx switches may also be necessary.  We have seen PSE products moved behind the pharmacy counter. It would be easy to imagine other drugs that could fall into this category. For example, the potential for abuse of OTC products containing dextromethorphan and the risks it poses to the public health may warrant restriction of these products to behind the counter availability.The FDA has also not determined if it can create a new behind-the-counter drug class on its own, or whether Congress would have to pass a new law to do it. The FDA requested public comment on the issue of a BTC class Posed specific questions about the transition of drugs to BTC status, the dispensing process for BTC products, and the pharmacist’s professional role Still in the process of reviewing the public comments in response to these questions One of their questions asked, “If safety concerns arise, should there be criteria or standards for a drug to transition out of BTC status to prescription status? Or from OTC status to BTC status? If so what should these criteria or standards be for each scenario?”   The transition of products from Rx to BTC status is one part of the discussion.  This type of switch is designed to increase patient access to medications. It may be guided by the current Rx to OTC switch process. However, there could be switches in the opposite direction, designed to ensure patient safety and/or public health.  OTC to BTC or BTC to Rx switches may also be necessary.  We have seen PSE products moved behind the pharmacy counter. It would be easy to imagine other drugs that could fall into this category. For example, the potential for abuse of OTC products containing dextromethorphan and the risks it poses to the public health may warrant restriction of these products to behind the counter availability.

26. Regulatory Challenges Facing BTC Class FDA Authority Rx to BTC Switch Process Experiences from other countries Additional considerations Record keeping Liability Licensure Advertising HIPAA

27. BTC Technology Considerations Technology solutions may be needed to address Purchase restrictions DUR Record keeping “Refills” Reimbursement Continuity of care Depending on drug, diagnostic technologies may be needed Dispensing process for BTC products is unclear. Processing transactions for BTC products through the pharmacy computer system is definitely an option to consider.  This would help pharmacists serve a clinical role, by conducting a DUR including the patient’s prescription and BTC products.  It could also be a way to facilitate reimbursement for BTC products.  (The topic of reimbursement for BTC products was not specifically raised by the FDA, but it would also need to be considered in creating a BTC class.)  Looking at the non-prescription products that are currently available behind the pharmacy counter, PSE and Plan B, there is no identifiable trend towards processing these products through the pharmacy computer system.   ·         PSE - Electronic devices, like those we discussed earlier, are commonly used to process PSE transactions, though some pharmacies may choose to manually record the information in a log book, or to process these transactions through the pharmacy computer system.  ·         Plan B - Pharmacies are only required to process Plan B transactions through pharmacy systems if they are dispensed pursuant to a prescription, i.e. for patients age 17 or younger.  Some pharmacies may choose to process Plan B transactions through their system for patients age 18 and over also, for clinical or reimbursement reasons.  POS devices, like those used for PSE transactions, may also be used to verify the patient’s age when dispensing Plan B.  Electronic tracking devices like these could be used as an alternative to pharmacy computer systems as a way to process and record BTC product transactions. Dispensing process for BTC products is unclear. Processing transactions for BTC products through the pharmacy computer system is definitely an option to consider.  This would help pharmacists serve a clinical role, by conducting a DUR including the patient’s prescription and BTC products.  It could also be a way to facilitate reimbursement for BTC products.  (The topic of reimbursement for BTC products was not specifically raised by the FDA, but it would also need to be considered in creating a BTC class.)  Looking at the non-prescription products that are currently available behind the pharmacy counter, PSE and Plan B, there is no identifiable trend towards processing these products through the pharmacy computer system.   ·         PSE - Electronic devices, like those we discussed earlier, are commonly used to process PSE transactions, though some pharmacies may choose to manually record the information in a log book, or to process these transactions through the pharmacy computer system.  ·         Plan B - Pharmacies are only required to process Plan B transactions through pharmacy systems if they are dispensed pursuant to a prescription, i.e. for patients age 17 or younger.  Some pharmacies may choose to process Plan B transactions through their system for patients age 18 and over also, for clinical or reimbursement reasons.  POS devices, like those used for PSE transactions, may also be used to verify the patient’s age when dispensing Plan B.  Electronic tracking devices like these could be used as an alternative to pharmacy computer systems as a way to process and record BTC product transactions.

28. Drug Classes to Consider

29. Possible BTC: Statins Rationale for BTC Status Widely prescribed therapeutic class Effective in lowering cholesterol Well tolerated aside from potential for rhabdomyolysis Dispensing Challenges Need to know patient’s cholesterol level to assess need for treatment Can be measured at a physician’s office and shared with the pharmacy or measured on-site at the pharmacy Technology Considerations If provided by physician’s office, may be communicated via email or EMR Need to have technology to measure on-site

30. Possible BTC: Triptans Rationale for BTC Status Migraine is a symptomatic condition that patients can identify and triage Many patients may be missing opportunity for therapy due to access barriers Dispensing Challenges Need to differentiate migraine from other types of headache Technology Considerations Possible electronic screening tool to help assess headache type

31. Possible BTC: Antifungals Rationale for BTC Status Relatively minor symptomatic condition Patient may not feel need to visit doctor to treat Pharmacist can triage and refer serious infections to physician Dispensing Challenges Vary depending on specific product Technology Considerations If patient needs to be referred to physician, could communicate information via email or EMR

32. Possible BTC: Dermatological Anti-inflammatories Rationale for BTC Status Relatively minor symptomatic condition Patient may not feel need to visit doctor to treat Pharmacist can triage and refer serious infections to physician Dispensing Challenges Often difficult to pinpoint true cause of dermatological conditions – challenging to recommend appropriate treatment Technology Considerations If patient needs to be referred to physician, could communicate info via email or EMR

33. Possible BTC: Smoking Cessation Treatments Rationale for BTC Status Widespread use of tobacco has led to many preventable illnesses and deaths Barriers to access may prevent people from seeking treatment to help them quit Dispensing Challenges Need to monitor for adverse events Will likely require proof of age in order to purchase Technology Considerations Current technology available to verify age to sell Plan B and other age restricted products could be used

34. Additional Possibilities Tamiflu Oral contraceptives EpiPen Proton pump inhibitors Antibiotics Antihypertensives

35. Conclusions Non-prescription products currently available behind the pharmacy counter have presented opportunities and challenges for all involved Appropriate use of technology is helping The future a third class of drugs is unclear The products selected for this status could greatly influence the outcome Pharmacist involvement will be vital for BTC to be successful

36. Questions? Thank You! Melissa Sherer msherer@phsirx.com