1. Designing a drug control system that balances access with prevention and control of misuse: What should it look like? Martha Maurer, MSSW, MPH, PhD Pain & Policy Studies Group University of Wisconsin Making Oral Opioids Available in Eastern Europe and Central Asia 6 March 2013

2. Drug Distribution System Model Level 6. PATIENTS Level 2: National Competent Authority Level 3. Importer/Manufacturers/Distributors Level 1: International Narcotics Control Board Level 4. Hospitals/Pharmacies/Hospice/PC programs Level 5. Physicians/Pharmacists/Other

3. Definition of Diversion “Diversion” is the transfer of a drug from a licit to an illicit channel of distribution or use.

4. Diversion Sources Schematic DISTRIBUTION SYSTEM (lawful) Level 3: Manufacturers, Distributors Level 4: Retail Pharmacies Hospitals/Clinics Internet w/Rx Nursing homes Hospices Level 6. Patients Lawful medical use Level 5: Practitioners Prescribers Dispensers PRIMARY DIVERSION (unlawful) Theft from manufacturers and distributors Theft in transit Theft from hospitals Pharmacies/robbery Employee/customer Pilferage Unlawful prescribing Inappropriate prescribing Internet sales without Rx Theft / forgery of Rx forms Theft from home Patient sells or gives Theft from patient Improper disposal People with addictive disease, impaired health care professionals use diverted controlled substances Used for reward, high, recreation compulsive use due to dependence syndrome Self -treatment of withdrawal Self medication for mood, sleep, pain Drug Dealers Peers Relatives REDISTRIBUTION (illicit industry) NON MEDICAL USES

5. Single Convention on Narcotic Drugs Ensure availability of drugs for medical and scientific use ▫ “the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering… adequate provision must be made to ensure the availability of narcotic drugs for such purposes.” Preamble, p. 13 Prevents against diversion and abuse ▫ “addiction to narcotic drugs constitutes a serious evil for the individual and is fraught with social and economic danger to mankind…” Preamble, p. 13

6. “The Board has always emphasized that the efforts to limit the use of narcotic drugs and psychotropic substances to medical and scientific purposes must not adversely affect their availability for such purposes. On the other hand, increasing the use of certain controlled drugs for legitimate medical purposes needs thorough monitoring. Careful attention has to be given to ensuring the legitimate absorption capacity of countries and the proper functioning of safeguard mechanisms in order to minimize misuse and leaks into the system…” International Narcotics Control Board

7. Single Convention Control Measures Closed System - All entities must be authorized and accountable to government for security and records Governments limit annual import and manufacture to amounts required for medical and scientific use Medical prescription required to prescribe/dispense Schedule I controlled substances

8. Single Convention Control allows Flexibility “legal authority” undefined, left to discretion of countries No guidance about who may obtain licenses, for how long licenses should be valid Tremendous discretion in creating classifications of drugs Prescriptions: Silent on appearance of prescription, who can prescribe, in what amounts and for what period of time “Pharmacist” undefined

9. Level 1: International Narcotics Control Board Ensure Availability / Prevent Diversion Confirm estimated requirements Confirming supplementary requests Ensure adequate international supply Monitor imports/exports

10. Level 2: National Competent Authority Ensure Availability / Prevent Diversion Submit estimates, statistics to INCB Authorize import, manufacture, distribution of drugs Authorize those who handle controlled medicines Monitor drug distribution Develop, disseminate guidelines for handling opioids

11. Guidelines for Ensuring Patient Access to, and Safe Management of, Controlled Substances Facilitates access and prevents diversion Tool for implementation Defines roles and responsibilities ▫ Record-keeping ▫ Forms to use Reassures government

12. Level 3. Importers/Manufacturers/Distributors Ensure Availability / Prevent Diversion Procure adequate amounts Distribute promptly – avoid shortages Report of amounts distributed should be accurate / timely Follow rules for secure storage, records, reports Distribute only to authorized entities Records should be complete

13. Colombia: Distribution to Pharmacies Poor distribution of morphine supply from warehouses in capital city to pharmacies in 32 states National workshop held 2007 ▫ Resulted in new MoH resolution ordering regional offices to ensure availability of morphine 24/7 in at least one institution per state ▫ Engaged the regional competent authorities and sensitized them about the importance of adequate availability of opioids in their regions Leon, De Lima, Florez, et al. Improving Availability of and Access to Opioids in Colombia: Description and Preliminary Results of an Action Plan for the Country. Journal of Pain and Symptom Management, 2009; 38(5):758-766.

14. Georgia: Amount and formulation In 2008, total Estimated Requirement for morphine sufficient to meet needs, but only importing injectable; no oral morphine available since 2005 2009 Parliament Committee meeting to discuss importing oral morphine ▫ Developed estimated amounts of various morphine formulations: immediate release vs. sustained release vs. injectable Georgia MoH and Parliament requested guidance from palliative care advocates as to the amount of each formulation to import

15. Level 4.Hospitals/Pharmacies/Palliative Care programs Ensure Availability / Prevent Diversion Obtain licenses, make pain a priority, support training Anticipate needs, procure adequate amounts, maintain stocks Maintain secure storage, inventory, records; report theft Dispense based on medical prescription Know and adhere to regulatory requirements

16. Sierra Leone: New supply and no diversion In 2008, Shepherd’s Hospice received first-ever shipment of oral morphine powder from low- cost supplier in Scotland Pharmacist trained in Uganda to learn how to manufacture oral morphine solution Hospice staff tracked morphine amounts from import to prescription /administration to patients Hospice developed safekeeping procedures for how to manage and use the morphine Second shipment of 1 kg of morphine powder arrived in 2011 Morphine powder imported (500 grams) Shepherd’s hospice drug store beginning stock balance = 500 grams Stock Record on MSP Warehouse Morphine solution production lab Stock Record on Production in Lab Converted from grams to mls Prescriptions in mls Dispensary

17. India: Medical Use, Misuse, and Diversion Two-year study of medical use of oral morphine at home in rural India 1,723 patients received palliative care and oral morphine Staff noted quantity of morphine received in each shipment; recorded morphine dispensing in stock register, reconciling daily; return of left-over medication No instances of abuse or diversion were identified Rajagopal MR, Joranson DE, Gilson AM. Medical use, misuse, and diversion of opioids in India. The Lancet. 358:139-143.

18. Development of a draft policy “Policy for Patient Access and the Safe Management of Controlled Drugs” Coordinated with Jamaica Legislation, MoH guidance Controlled drugs topics covered: ordering, storage, prescription (in-patients and out-patients), record-keeping, stock reconciliation, transfer of controlled drugs between wards, and disposal/waste Jamaica: Guidance for Hospitals

19. Level 5. Physicians/Pharmacists/Other Ensure Availability / Prevent Diversion Identify hospitals / pharmacies in patient’s area able to dispense opioids Recognize that as disease progresses patients may need increased amounts of opioids Prescribe and Dispense according to laws, regulations Recognize and avoid use of opioids for nonmedical purposes Manage stocks and records according to legal requirements

20. Drug control and healthcare responsibilities: Essential and compatible HEALTH CARE PRACTITIONERS DRUG CONTROL OFFICERS Pain Know about pain control; Assess and treat pain Avoid interfering in pain control Allow for adequate availability Diversion Comply with regulations Understand diversion and avoid contributing to it Manage control system, monitor for diversion Understand legitimate need for pain treatment

21. Level 6. PATIENTS Ensure AccessPrevent Diversion Know about their pain; report unrelieved pain Understand differences between physical dependence, tolerance, and dependence syndrome Take medications as directed only for medical reasons Store medications safely Acquire opioids only from licensed pharmacies Follow national requirements for disposing or returning unused medication

22. Serbia: Educate Patients/Families Brochure for health care professionals, regulators concepts of tolerance current WHO definition of dependence syndrome (“addiction”) adverse effects of opioids current regulatory framework for prescribing opioids in Serbia Brochure for patients / families presents real-life statements reflecting their fears of opioids and addressing them Recognized by the MoH as official educational material for palliative care

23. United States: Medication take-back Office of National Drug Control Policy Initiative Secure and Responsible Drug Disposal Act 2010 ▫ Developing Regulations to implement Act Drug Enforcement Administration National Take-Back days ▫ Safe, convenient, responsible means of disposal ▫ Education opportunity Public education campaign for patients ▫ Appropriate use, secure storage, disposal of controlled medicines

24. UN Guidance for ensuring access/ preventing diversion and abuse

25. UN Guidance: Common Themes ▫ Review / Revise national legislation  Implementation, enforcement ▫ Inter-agency cooperation within Gov’t ▫ Training, education of health care professionals / law enforcement ▫ Reinforce or establish monitoring systems ▫ Internet/postal diversion

26. Take-away messages ▫ Diversion can occur at any point in the system ▫ Single Convention establishes general framework  Allows for latitude in designing national systems ▫ Stakeholders at all levels of the system have responsibilities to ensure balance ▫ Examples of countries developing balanced approaches ▫ Medical use of opioids and drug control can be compatible; in fact, they can strengthen each other