Archived: WMA Statement on the Prescription of Substitute Drugs in the Outpatient Treatment of Addicts to Opiate Drugs Print PDF Send

Adopted by the 47th General Assembly Bali, Indonesia, September 1995
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006


A large number of regions throughout the world currently are faced with the frequent tragedies generated by addicts to opiate drugs. These tragedies occur in the following four spheres:

  1. health: the physical and psychological condition of the addict; propagation of viral infections such as HIV and hepatitis B or C through the sharing of infected syringes and unprotected sexual intercourse;
  2. decay of the family, professional and social environment;
  3. degeneration of the individual: incitement of both sexes to prostitution to pay for the drug, hospitalization, imprisonment, etc…
  4. public safety: resorting to criminal behavior to obtain either the drug or the money to buy the drug.
    The World Medical Association, concerned by such a widespread medico-psycho-social calamity, must formulate recommendations for physicians involved in the treatment of addicts to opiate drugs. This subject has already been addressed briefly in the WMA Statement on the Use and Misuse of Psychotropic Drugs (Doc. 20.30). However, the current situation requires more specific and elaborate guidelines than those presented in that Statement.


The addict to opiate drugs is a full citizen who has rights and duties. His/her drug dependence indicates suffering that leads to physical, psychological and social difficulties; even prolonged drug dependence should be considered a temporary situation. The help to which addicts should have access should respect their dignity. They must be cared for with the same consideration as any other patient. The objective of the treatment always should be to re-establish addicts in a free and responsible life.

Treating addiction to opiate drugs is often very difficult. Among the many programmes proposed in different countries concerned by the increase in the number of such addicts, two trends are revealed: “therapeutic communities” (external protection) and the prescription of substitute drugs (internal protection).

The use of substitute drugs in outpatient treatment is certainly not the ideal solution (which should be sought through further research and scientific evaluation) to the problem of drug dependence. However, this method as a “therapeutic tool” exists, is used in many places throughout the world, and may contribute in part – until a better solution is found – to containing the problem. The standard ambition of the method is the weaning of the patient and his/her reintegration into his/her family, professional, and social environment, without improper maintenance of his/her dependence. A decrease in dosage should always be sought by the prescribing physician.

Whatever we do, drug dependence is a phenomenon for which we know no “miracle solution”. The medical use of substitute products for heroin (diacetylmorphine), and opiate drugs of synthesis (and in particular but not only methadone, which has been known for about fifty years), creates fundamental problems (weaning, pharmacology, etc…), clinical problems (treatment programs, prescription, delivery, surveillance), legal problems (laws and regulations) and ethical problems.

Consequently, in outpatient treatment, substitute drugs should be subjected to a set of evidence-based guidelines, the formulation of which would stem from experience acquired during the last quarter of this century by those treating drug dependence, namely in North America and Europe. Many countries have established legal procedures for the treatment of addicts to opiate drugs. The National Medical Associations should seek, if necessary, to improve inadequate legal texts.


  1. The physician shall abstain from prescribing at the sole request of the patient any drug that is not medically justified by his/her condition.
  2. In the outpatient treatment of addicts to opiate drugs, substitute drugs shall be prescribed according to evidence-based guidelines.
  3. The ultimate goal of the treatment always shall be the weaning of the patient, which may be achieved only after a long period of time.
  4. The use of substitute drugs will allow the patient to be medically, psychologically or socially stabilized and therefore reintegrated without delay into his/her family and professional environments. It will also serve to reduce the risk of contracting viruses such as HIV or hepatitis B or C through the use of infected syringes. In addition, the crime induced by the use of heroin can only diminish.
  5. Any treatment using substitution drugs shall be prescribed only after accurate diagnosis. It should be supervised by a competent and trained physician with an appropriate support team.
  6. The physician shall limit the number of patients addicted to opiate drugs that he/she will treat, with a view to ensuring attentive and conscientious care to each of them. In every case, he will keep a detailed medical record concerning the treatment provided to the patient, and audit the results.
  7. The prescription and administration of substitute drugs should be organized in such a way as to avoid any stocking by the patient, resale or other illicit usage.
  8. Subject to the provisions of national law, the patient, in order to receive drug substitution must agree to comply regularly with unscheduled, supervised biological tests, (urine for instance) to ensure that he/she is not taking other drugs simultaneously and/or accepting simultaneous treatment from another physician, without the knowledge of both practitioners.