Access to Controlled Medications Programme

Willem Scholten HQ/EMP/QSM/ACMP

Technical Briefing Seminar

19 November 2008

Drug Control

Currently 3 UN drug conventions:

● Single Convention on Narcotic Drugs (1961)● Convention on Psychotropic Substances

(1971)● Convention against Illicit Traffic in Narcotic

Drugs and Psychotropic Substances (1988)

Drug conventions are public health law

1961 and 1971 Conventions:

Two objectives:1. Prevention of harm from drug dependence2. Availability for rational medical use

Public health interests are best served if all control measures aim at the optimum between medical availability and abuse prevention

Controlled medicines on the WHO EML

– Opioid analgesicsmoderate to severe pain

– Opioids for substitution treatment

opioid dependence

– Ergometrine and ephedrine

emergency obstetrics

– Benzodiazepines

anxiolytics, hypnotics, anti-epileptics

– Phenobarbital

anti-epileptic

Morphine consumption per capita

Graphic: New York Times

Drug conventions

Why does drug control impede medical access?

- Excessive fear for dependence

- Excessive fear for diversion

- Attention for medical needs neglected

Drug conventions

Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes …

(Preamble Single Conv. on Narcotic Drugs)

Conventions are a minimum

● Countries may apply stricter measuresExamples:– Licence requirement for community and hospital

pharmacies – Dispensing restricted to major hospitals– Government monopoly on morphine trade– Special prescription forms

● Stricter measures usually decrease medical availability

International Covenant on Economic Social and Cultural

Rights (ICESCR)

Article 12:1. The States Parties to the present Covenant

recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

(…) the creation of conditions which would assure to all medical service and medical attention in the event of sickness.

Right to Health includes:

● Access to Essential Medicines ● Chronically and terminally ill

– Spare avoidable pain– Die with dignity

● Non-discrimination – Women, children, prisoners, HIV-patients, people with heroin

dependence et cetera

● Protection against drug abuse● States, treaties and UN-bodies should promote right to

health internationally

General Comment 14 to the International Covenant on Economic, Social and Cultural Rights

Untreated pain patients(annually, globally)

All avoidable with controlled

medications

Cause Number of untreated pain patients

Cancer around 4 million

HIV/Aids 0.8 million

Emergencies 8 - 40 million

Surgery 8 - 40 million (overlap with emergencies)

Other 10 million (estimated)

Total 30 – 86 million (officially according to WHO: "tens of millions")

Undue medical effectsof drug control

Untreated pain patients tens of millions

Preventable HIV infections > 250,000

Mortality from post-partal haemorrhage

75,000

Effect on mortality among patients with opioid dependence

2-3% 0.2–0.3%

Antiepileptics, anxiolytics ?(first three: annual prevalence)

Substitution therapyeffects

● Prevents transmission of HIV and Hepatitis C– Reduction HIV seroconversion in IDU's:

55% - 85% (= 230,000 – 360,000)

● Reduces death rate of dependence patients to about normal– Reduction 90 – 95%

● Reduces public nuisance and petty crime– $ 1 investment yields $ 5 for society

Barriers for access

At the fundamentals is:

● Fear for abuse● Fear for dependence● Fear for diversion

Often exaggerated

Barriers for access

● Legislative barriers● Policy barriers● Knowledge barriers● Attitude barriers

General for all medicines:● Economical and procurement barriers

Legislative barriers● Inappropriate laws and regulations

– Rules often not preventing abuse, dependence and diversion– Rules often a barrier for medical access

● Limitations on prescriptions and administration– Duration– Maximum dosage– Administration of medicines restricted

● Special prescription forms● Limitation of outlets

Policy Barriers

● Access to controlled medicines not included in national policy plans– National Pharmaceutical Policy Plan– National Cancer Control Plan– National HIV/AIDS Plan

● Too much red tape– Malfunctioning of estimate system (Important for

importing opioids)– Speed of licensing

Knowledge Barriers

● Medical Schools– Many do not teach opioid analgesia

● Physicians– Fear for dependence– Unfamiliarity with prescribing– Learned "not to treat symptoms, but disease"

Attitude Barriers

● Patient and family– Association morphine impending death– Conviction that suffering chastens

● Health-care and other professionals– Continuing use of obsolete or counter-productive

terminology– Seniors not allowing juniors to introduce new

techniques

Resolutions

● ECOSOC 2005/25– On treatment of pain using opioid analgesics

● World Health Assembly 58.22 (25-05-2005)– on Cancer Prevention and Control

"…..to examine jointly with the International Narcotics Control Board the feasibility of a possible assistance mechanism that would facilitate the adequate treatment of pain using opioid analgesics"

Access to Controlled Medications Programme (ACMP)

● To assist countries to improve access to controlled essential medicines

● Developed in consultation with the International Narcotics Control Board (INCB)

● Operated by WHO

Access to Controlled Medications Programme (ACMP)

Programme info on www.who.int/medicines:

- Framework - Briefing notes - Pain guideline development

ACMP Activities (1)

Step 1:Developing tools

Monitoring and planning tools- International Opioid Consumption Database

(interactive on-line database) (on-line by end of 2009) - methods for need estimation (ready for publication)

WHO Treatment Guidelines for all types of pain Focussed on opioid availability

ongoing; available by 2010-2012

Update of Guidelines on Opioid availability ("Achieving balance in national opioid control policies")

available by 2010

ACMP Activities (2)

Step 2: Direct country support

Policy analysis

Analysis of legislation and support for amendment process

Procurement of controlled substances (advice)

Estimates training

Support for training of health care professionals

ACMP Methods

6-country workshops - policies analysed by 3 government officials and 3 health

care workers - lectures

- national plans drafted

National workshops 50 – 200 stakeholders invited

Estimates training workshops for civil servants responsible for estimates

and statistics submission to INCB

Counseling

Other areas of work involved

Not a pharmaceutical topic exclusively:- HIV- Palliative care/cancer care- Surgery and emergency care- Child and adolescent health- Substance abuse

ACMP priority countries

EURO● Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech

Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Moldova, Poland, Romania, Serbia & Montenegro, Slovenia, Slovakia.

AFRO● Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi,

Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania, Zambia.EMRO● Egypt, Iran, Morocco, Oman, Pakistan, Sudan.PAHO● Argentina, Colombia, Panama.SEARO● Indonesia, Bangladesh, IndiaWPRO● Vietnam, China, Philippines

Programme Duration and Cost

● Over 150 countries to go to● Expected to take over 15 years● Action Plan Phase I (2008 -2013)

– Needed budget: US$ 55.5 million● Funds to be raised from Members States and

donor organizations

Willem Scholten

Manager Access to Controlled Medications Programme

Quality Assurance and Safety: Medicines

Department of Essential Medicines and Pharmaceutical Policies

scholtenw@who.int

+41 22 79 15540

More information: