|Model Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care, (WHO - OMS, 1996, 14 p.)|
A sudden rise in the need for medical care in emergency situations following natural or man-made disasters creates an acute shortage of medical supplies. Several international organizations and nongovernmental organizations (NGOs) are actively involved in the provision of humanitarian assistance by delivery of medical supplies in emergency situations. However, they are often faced with serious difficulties in providing several essential medicines containing narcotic drugs or psychotropic substances partly because of the regulatory requirements concerning their importation and exportation. The lack of these medicines results in additional human suffering by depriving those in need of adequate pain relief and sedation.
In order to improve the provision of medical care for disaster-stricken peoples, there is an urgent need to work out a practical solution to this problem.
Cause of the Problem
Based on operational experiences, humanitarian aid agencies perceive the problem as follows:
The international transportation of humanitarian supplies containing narcotic drugs and psychotropic substances is regarded by the control authorities as "exportation" requiring prior import authorizations from the authorities of the receiving country. As such, the import/export authorization system makes the quick international transportation of controlled drugs to sites of emergencies virtually impossible. In addition, the rigorous application of the estimate system can further complicate the procedure. While the International Narcotics Control Board (INCB) has advised control authorities that emergency humanitarian deliveries are considered as being consumed in the exporting country and included as such in the estimate of the exporting country, in reality, authorities had often followed the procedure for normal import/export transactions. This procedure often takes too long to meet the acute need for relief in some emergency situations, particularly when the control authorities in the receiving country are rendered dysfunctional, or are not in a position to issue import authorizations for the inhabitants in the disaster-stricken area of the country.
As a consequence, all humanitarian aid agencies have abandoned the provision of narcotic drugs in their emergency medical supplies. Instead, pentazocine or buprenorphine (in Schedule III of the Convention on Psychotropic Substances, 1971) has been provided as an alternative for narcotic analgesics. Even this has become increasingly difficult, as more and more Governments have introduced the export/import authorization and the "assessment" systems for Schedule III and IV psychotropic substances in response to the resolution adopted by the Economic and Social Council (ECOSOC). The same applies to diazepam and phenobarbital in Schedule IV of the 1971 Convention. Furthermore, difficulty has been encountered even with ephedrine, ergometrine, ketamine, tramadol, thiopental, and chlorpromazine as some national control authorities apply similar export/import control systems to these medicines.
Search for a Solution
WHO brought this issue to the attention of the INCB in an effort to find a practical solution. The INCB, in its report for 1994, recommended that control obligations could be limited to the authorities of exporting countries in emergency situations. This principle was endorsed at the 38th session of the UN Commission on Narcotic Drugs in 1995, and was further reinforced by its resolution entitled "Timely provision of controlled drugs for emergency care" adopted at the 39th session in 1996 (Annex 1). This and a similar resolution adopted by the 49th session of the World Health Assembly (Annex 2) request WHO to prepare model guidelines to assist national authorities with simplified regulatory procedures for this purpose, in consultation with the relevant UN bodies and interested governments.
These model guidelines are prepared in response to the above resolutions. In essence, the procedures proposed would allow certain suppliers to make international shipments of controlled medicines at the request of recognized agencies providing humanitarian assistance without prior export/import authorizations in emergency situations, following defined procedures acceptable to the control authorities and the INCB.