Designing a drug control system that balances access with prevention and

control of misuse: What should it look like?

Martha Maurer, MSSW, MPH, PhDPain & Policy Studies Group

University of Wisconsin

Making Oral Opioids Available in Eastern Europe and Central Asia6 March 2013

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

Definition of Diversion

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

Diversion Sources SchematicDISTRIBUTION

SYSTEM (lawful)

Level 3: Manufacturers,

Distributors

Level 4: Retail•Pharmacies•Hospitals/Clinics•Internet w/Rx•Nursing homes•Hospices

Level 6. PatientsLawful 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

DrugDealers

PeersRelatives

REDISTRIBUTION(illicit industry)

NON MEDICAL USES

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

“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

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

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

Level 1: International Narcotics Control Board

Ensure Availability / Prevent Diversion

Confirm estimated requirements Confirming supplementary requests Ensure adequate international supply Monitor imports/exports

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

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

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

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.

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

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

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 gramsStock Record on MSP Warehouse

Morphine solution production labStock Record on Production in LabConverted from grams to mls

Prescriptions in mls

Dispensary

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.

• 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

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

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

Level 6. PATIENTSEnsure Access Prevent 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

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

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

UN Guidance for ensuring access/ preventing diversion and abuse

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

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