FDA Advisory Committee Hearing on Potential Rescheduling of Hydrocodone: Pharmacist and Pharmacy Issues to Consider

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1 FDA Advisory Committee Hearing on Potential Rescheduling of Hydrocodone: Pharmacist and Pharmacy Issues to Consider January 24, 2013 FDA White Oak Campus Steve Simenson, BPharm, FAPhA, DPNAP APhA President President and Managing Partner, Goodrich Pharmacy, Inc., Anoka, MN Marcie Bough, PharmD Senior Director, Government Affairs, APhA 1

2 American Pharmacists Association (APhA) Largest and oldest national professional society for pharmacists Represents over 62,000 pharmacists, student pharmacists, pharmaceutical scientists and pharmacy technicians APhA members provide care in all practice settings, including: community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings and the uniformed services 2

3 Goal of Presentation As requested, APhA s goal is to provide information to the Advisory Committee on: Pharmacist and pharmacy issues to consider if hydrocodone was rescheduled from C-III to C-II Impact pharmacy issues have on patient access As part of APhA s effort to represent the pharmacy profession, APhA reached out to pharmacists and colleague pharmacy organizations 3

4 Feedback and Sources of Information APhA leadership and members Colleague pharmacy organizations and their members National Association of Chain Drug Stores (NACDS) National Community Pharmacists Association (NCPA) American Society of Consultant Pharmacists (ASCP) Federal pharmacy community representing the uniformed services DEA Pharmacist s Manual and DEA Practitioner s Manual APhA 50-state/DC law review and analysis Search term pharm! /100 c-ii schedule-ii As of October

5 Overview of Pharmacy Issues to Consider Pharmacists support patient access to pain medications for legitimate medical purposes with a balanced approach to address prescription drug misuse/abuse/diversion Support FDA s regulatory process to consider rescheduling hydrocodone from C-III to C-II Questions remain about potential positive or negative impact of rescheduling Variations in how rescheduling could impact different pharmacy practice settings Impact on pharmacy supply chain logistics Ordering, storing, processing and dispensing C-III versus C-II prescriptions Federal C-II requirements versus certain state specific C-II laws 5

6 Rescheduling of Hydrocodone: Pharmacist and Pharmacy Issues to Consider 6

7 Hydrocodone Products: Impact on Pharmacy Examples of the impact of hydrocodone-containing products on pharmacies Represent over 20 different products Estimated several thousand different available combinations based on strength, formulation and manufacturer Millions of prescription orders dispensed per year In some pharmacies, nearly 40% of new hydrocodone prescriptions have a refill Rescheduled to C-II would mean no refills and the patient would need to obtain a new prescription Prescriptions per week per pharmacy may range from a few, to 50, to hundreds Rescheduling would impact the entire pharmacy supply chain and pharmacy operations 7

8 Generalized Overview of Pharmaceutical Supply Chain Finished Product Distribution Raw Materials Suppliers Pharmacies Packaging PATIENTS 8 Raw Materials Sourcing Manufacturing Process Wholesalers, Ware- Houses & Shipping Dispensing Logistics

9 Generalized Process for C-III, IV or V Prescription in a Pharmacy Wholesaler Medication s ordered online by technician or pharmacist and delivered daily Pharmacist Pharmacist verifies Rx. Evaluates clinical need. Pharmacist or technician submits claim. Pharmacist checks drug monitoring program. Inventory added daily updated electronically Inventory Stored alphabetically. Easily accessible. Managed by support staff and pharmacists. Patient brings Rx with up to 5 refills, pharmacist dispenses Rx can be transferred, called in by MD Patient 9

10 Generalized Process for C-II Prescription in a Pharmacy DEA Wholesaler Medications ordered using DEA 222 order form (paper or electronic). Only pharmacists can order. Generally ordered once weekly. Pharmacist Pharmacist verifies Rx. Evaluates clinical need. Pharmacist checks drug monitoring program. Pharmacist or technician submits claim.. Patient brings Rx, no refills allowed. Pharmacist dispenses. Pharmacist orders DEA 222 Forms. No transfers between pharmacies. Cannot be phoned in by prescriber. Inventory generally added once weekly. Inventory Stored in safe if not dispersed. Managed by pharmacist only. Actual physical pillby-pill inventory maintained. Theft/loss reporting. Patient 10

11 Generalized Pharmacy Impact Points to Consider if Hydrocodone Rescheduled to C-II (red boxes) Administrative: Extra steps in process. Wholesaler Medications ordered using DEA 222 form (paper or electronic). Only pharmacists can order. Ordered once weekly. DEA Pharmacist orders DEA 222 Forms. Pharmacist Pharmacist verifies Rx. Evaluates clinical need. Pharmacist checks drug monitoring program. Pharmacist or technician submits claim.. Inventory generally added once weekly. Administrative: Extra steps in the process. Inventory Stored in safe is not dispersed. Managed by pharmacist only. Actual physical pillby-pill inventory maintained. Theft/loss reporting. No transfers Patient Access: Patient brings between Creates need for more Rx, no refills pharmacies. prescriber Administrative: visits for allowed. Cannot be new Increased workload Rx. Access Pharmacist phoned in by changes on pharmacist due to lack of dispenses. prescriber. refill, related to no transfer to other inventory pharmacy, time to Patient management. process Rx, inventory supply, etc. 11

12 Pharmacy Issues to Consider: Administrative 1/2 Order processing and inventory control Separate DEA Form 222 process for C-IIs; C-IIIs ordered with other inventory Real-time perpetual C-II inventory Storage and security Purchase of larger safes to store C-IIs, change in store layout and use of floor space Specific DEA Form 106 theft and loss procedures Record keeping requirements specific to C-IIs Differences in filling and dispensing C-III vs C-II prescriptions Challenges if rescheduled using unique requirements for hydrocodone products only 12

13 Pharmacy Issues to Consider: Administrative 2/2 Pharmacist workload and workflow Pharmacy staff who can participate in C-II activities Time to implement Estimates range from 90 days to over a year Cost to implement Estimates range into the millions for some chains Additional costs for training and administrative/staff cost shifts Impact on pharmacy processes leads to: Impact on overall pharmacy supply chain Impact on patient care and access to pain medications 13

14 Pharmacy Issues to Consider: Patient Access Impact on patient care and access to pain management Capacity of medicine to accommodate increased number of monthly office visits for new C-II prescriptions Capacity of pharmacy to manage increased number of new monthly C-II prescriptions Lack of C-II prescription refills, no C-II fax refill reminders/requests to medical offices Very limited utilization of DEA regulation allowing 90 day supply of C-IIs via post-dated prescription orders 14

15 Additional Considerations for Long Term Care and Assisted Living Practice Settings Impacts on managing C-III vs C-II prescriptions Pharmacy staff contact with medical staff regarding hydrocodone would increase Example: Increase from once every 6 months to monthly Unique prescribing and dispensing process within LTC settings Designated nursing staff transmitting prescriptions as an agent of the prescriber could not authorize C-IIs Physicians not always on location May delay patient care and pain management therapy Failure to treat pain in timely manner may subject facility to citations or state inspections Restrictions on staff allowed to handle C-IIs may be in place Facility capacity for inventory storage/safes 15

16 Rescheduling of Hydrocodone: States with Existing C-II Laws (Based on APhA 50-State/DC Law Review as of October 2012) 16

17 Summary: Federal C-II Pharmacy Requirements Ordering via DEA Form 222 (paper) DEA Controlled Substance Ordering System (CSOS) (electronic) Storage in locked safe or dispersing throughout inventory authorized Perpetual inventory and record keeping requirements Tablet/capsule/liquid inventory DEA Form 106 for inventory theft or loss Separate prescription file required Special labeling Refill prohibited Limited emergency fill procedures Original fax prescription allowed for LTC practice settings 90-day supply via post-dated prescriptions Additional requirements upon dispensing 17

18 States With Laws Requiring Pharmacies to Secure C-IIs Separately Connecticut Delaware Georgia* Idaho* Illinois Maryland* New Hampshire* Nevada New Mexico* Oregon Tennessee* Texas Washington West Virginia *Law applicable to specific types of pharmacies such as hospital or institutional pharmacies. 18

19 States With Laws Authorizing Pharmacies to Disperse C-IIs throughout Inventory Indiana Iowa Louisiana Nebraska New Jersey New Mexico Oklahoma Pennsylvania South Carolina 19

20 States With Laws Requiring Perpetual Inventory Systems for C-IIs Georgia* Iowa Maine Maryland* Massachusetts Minnesota Mississippi* Montana Nevada New Mexico* Oregon Texas* Utah* Vermont* Virginia* Washington State* *Law applicable to specific types of pharmacies such as hospital or institutional pharmacies. 20

21 States With Laws Requiring Pharmacies to Have Separate Prescription Files for C-IIs Alabama Arizona Connecticut Georgia Idaho Louisiana Massachusetts Nebraska Nevada New Jersey New Mexico New York Oklahoma Rhode Island South Carolina Virginia 21

22 States With Laws Requiring Separate Inventory and/or Record Keeping Requirements for C-IIs Alaska Idaho Indiana Louisiana Mississippi Nevada New Mexico South Carolina Texas Virginia 22

23 States With Laws Requiring Special Labeling Requirements for C-IIs District of Columbia Indiana Kansas Louisiana Maryland New Jersey South Carolina West Virginia Wyoming 23

24 States With Laws for Additional Requirements Upon Dispensing C-IIs District of Columbia Georgia Kansas Louisiana Massachusetts Nebraska Vermont Virginia Wisconsin Wyoming 24

25 States with Laws Prohibiting Pharmacies from Refilling C-II Prescriptions 25

26 Additional State C-II Laws of Interest States with C-II laws that would impact pharmacists collaborative practice agreements Iowa North Dakota State with laws requiring pharmacists to check patient ID for C-IIs Georgia North Carolina States with laws concerning C-II prescriptions from outof-state pharmacies Illinois Texas 26

27 Other Activities: Ensuring Patient Access While Addressing Prescription Drug Abuse/Misuse/Diversion 27

28 Support of Other Activities: Patient Access and a Balanced Approach Balanced approach to ensure patient access for legitimate medical need with need to address misuse/abuse/diversion Efforts that are effective and limit burden on patients, providers, medical and pharmacy practice settings, and wholesaler/distributors Focus on other activities that are working well and ensure patient access to appropriate pain therapy Overall efforts driven by ONDCP, HHS agencies, and the National Drug Control Strategy Education, disposal, monitoring programs, enforcement 28

29 Support of Other Activities: Education Increased focus/awareness on opioid safe use and pain management education Importance of patient selection, medication selection, and appropriate steps to taper patient off therapy Need time for current and future programs to have an impact: FDA s REMS programs: long-acting and extended release opioids; transmucosal fentanyl products ONCDP s online training tool Utilization of pharmacy programs on education/outreach Pharmacist continuing education programs on pain management, opioid management, misuse/abuse, etc. Partnerships with community outreach and education programs 29

30 Support of Other Activities: Disposal, Enforcement and Electronic Prescribing Pharmacy participation in medication disposal programs DEA s regulatory efforts to improve options for disposal of controlled substances DEA sponsored National Prescription Drug Take-Back Days Pharmacy, local and/or state specific programs Addressing rogue online drug sellers through FDA s BeSafeRx program and other efforts Enforcement against rogue pain clinics Expanded implementation/utilization of e-prescribing of controlled substances 30

31 Other Activities: PDMPs and Collaboration Between Pharmacy and Medicine Utilization of state authorized prescription drug monitoring programs (PDMPs) by pharmacists and prescribers Support efforts to implement programs in all states, improve programs, and integrate data between states Effective tool for helping to identify appropriate use vs potential misuse/abuse Pharmacists working collaboratively with physicians and others on the medical teams to manage patients with pain: Collaborative practice agreements and other partnerships Review of PDMPs Patient and caregiver education and engagement Team-based approach 31

32 Summary 1/2 Impacts to consider for pharmacy if hydrocodone rescheduled from C-III to C-II Number of patient refills that would become new prescriptions per month Number of new medical office visits required for new prescriptions per month Ordering and storage logistics for pharmacies and their warehouses/wholesalers Time and cost to implement changes in all pharmacy practice settings State C-II laws that may be more restrictive for certain practice settings Overall impact on patient access to appropriate pain medication 32

33 Summary 2/2 Support related efforts to address opioid misuse/abuse PDMPs expansion and utilization Provider and patient education and awareness Medication disposal awareness and improved options E-prescribing of controlled substances utilization Collaboration between pharmacists, physicians and other prescribers for management and care of patients Balanced and fair approach: Ensuring patient access to legitimate pain management therapy Limited burden on patients, providers and the overall health care system 33

34 Thank you 34

35 Contact Information Marcie Bough, PharmD Senior Director, Government Affairs American Pharmacists Association Washington, DC

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