Year : 2012 | Volume
: 136 | Issue : 2 | Page : 314--316
Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines
National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi 110 029, India
National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi 110 029
|How to cite this article:|
Jain R. Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines.Indian J Med Res 2012;136:314-316
|How to cite this URL:|
Jain R. Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines. Indian J Med Res [serial online] 2012 [cited 2020 Feb 24 ];136:314-316
Available from: http://www.ijmr.org.in/text.asp?2012/136/2/314/100807
Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines (World Health Organization, Geneva) 2011. 72 pages. Price: CHF/US$ 25.00; in developing countries: CHF/US$ 17.50
This document covers the policy guidelines for ensuring balance in national policies on controlled substances, i.e guidance for availability and accessibility of controlled medicines manufactured on a previous set of guidelines published in 2000. The new guidelines cover a wide range of medicines and signal aspects which were not previously covered. Controlled medicines play an important role in several areas of medicine including treatment of pain and opioid dependence, emergency obstetrics, psychiatry and neurology. The availability, accessibility and affordability of controlled medicines are problematic issues for all countries. The objective of the World Health Organization now is to implement the new guidelines to help countries for carrying out assessments of legislation, policies and strategies so as to overcome the current barriers for accessing the controlled medicines. This document has been developed for health benefits that can be derived from medicines containing controlled substances and can be accessible to a large segment of population around the world.
The preface of this publication is written by Hamid Ghodse, President, International Narcotics Control Board (INCB), and the foreword by Dr Carissa F. Etienne, Assistant Director-General, Health Systems and Services, WHO. Introduction to the guidelines covers the purpose, target and the scope. The purpose of these guidelines is to provide an authoritative guidance on policies and legislation with regard to the availability, accessibility, affordability and control of medicines prepared from substances that are controlled under the international drug control conventions.
The guidelines deals with "all controlled medicines" made from substances controlled internationally under the Single Convention on Narcotic Drugs and under the Convention on Psychotropic Substances. It also includes medicines prepared from precursors regulated under the United Nations Conventions against Trafficking in Narcotics and Psychotropics and also other substances controlled under national drug laws and regulations. The guidelines emphasize that all countries have a dual obligation with regard to these medicines based on legal, political, public health and moral grounds. The dual obligation ensures that these substances are made available to those patients who need them for medical purposes and also protect population against abuse and dependence. Thus, countries should aim at a "balanced policy", i.e. minimizing substance abuse and maximizing access for rational medical use.
The document covers 21 guidelines with explana-tion and justification for each guideline for improving the availability, accessibility and affordability of controlled medicines from a policy perspective. The guidelines are as follows: (a) Guidelines 1 and 2 cover national drug control legislation and policy. Guideline 1 suggests that controlled medicines are absolutely necessary for medical and scientific purposes whereas the guideline 2 ensures adequate availability and accessibility of controlled medicines for all medical and scientific purposes through national legislation and drug control policies. The guidelines assume that the governments would comply with their international obligations. (b) Guidelines 3 to 6 emphasise on authorities and their role in the system. Briefly, these cover designating national authorities, developing and implementing policies, co-operation among authorities and ensuring fulfilment of their duties related to a legitimate treatment with controlled medicines. (c) Guidelines 7 to 10 cover policy planning for availability and accessibility which relates to medical uses, benefit to population without discrimination, provisions for optimising health outcomes, corrective actions with clear and unambiguous terminology for national drug control legislation and policies. (d) Guidelines 11 to 14 are for healthcare professionals. These include allowing, prescribing, dispensing these controlled medicines based on their professional skills and license. Moreover, governments should promote medical, pharmaceutical and nursing schools for imparting the knowledge and treatment of pain and substance use disorders by these controlled medicines and also organizing educational initiatives for the countries where controlled medicines are made available and accessible for the first time. (e) Guidelines 15 to 17 discuss estimates, statistics and assessments of the quantities of the controlled substances required for legitimate medical and scientific purposes and submitting reports to the INCB. (f) Guidelines 18 to 20 refer to procurement, manufacture and distribution of controlled medicines in a timely manner with geographical coverage, minimizing negative impact of control and safety measures on the affordability and availability of these medicines. Also drug control authorities should be aware of the existence of the WHO model guidelines for the international provision of controlled medicines for emergency medical care. (g) Governments that decide to bring medicines under national control that are not controlled under the international drug control conventions should apply these guidelines equally to those nationally controlled medicines, is covered in guideline 21.
The document also provides country assessment checklist viz. content of drug control legislation and policy, policy planning for availability and accessibility, estimates and statistics to enable governments to systematically identify and assess policy barriers, and gradually progress towards a situation where controlled medicines are both readily available and accessible.
The document has three annexures. Annex 1: Controlled medicines also listed as WHO Essential Medicines or WHO Essential Medicines for Children; Annex 2: Selected WHO treatment guidelines; and Annex 3: Contents of the CD-ROM Ensuring balance in national policies on controlled substances.
In conclusion, this document has been developed to foster understanding regarding medical and scientific benefits of controlled substances and dispel misconceptions about their medical use. With the publication of this document, the previous guidelines: "Achieving balance in national opioids control policy: guidelines for assessment" (2000) are withdrawn.