|Guidelines for Drug Donations (WHO - OMS, 1999, 24 p.)|
In the face of disaster and suffering there is a natural human impulse to reach out and help those in need. Medicines are an essential element in alleviating suffering, and international humanitarian relief efforts can greatly benefit from donations of appropriate drugs.
Unfortunately, there are also many examples of drug donations which cause problems instead of being helpful. A sizeable disaster does not always lead to an objective assessment of emergency medical needs based on epidemiological data and past experience. Very often an emotional appeal for massive medical assistance is issued without guidance on what are the priority needs. Numerous examples of inappropriate drug donations have been reported (see Annex). The main problems can be summarized as follows:
· Donated drugs are often not relevant for the emergency situation, for the disease pattern or for the level of care that is available. They are often unknown to local health professionals and patients, and may not comply with locally agreed drug policies and standard treatment guidelines; they may even be dangerous.
· Many donated drugs arrive unsorted and labelled in a language which is not easily understood. Some donated drugs come under trade names which are not registered for use in the recipient country, and without an International Nonproprietary Name (INN) or generic name on the label.
· The quality of the drugs does not always comply with standards in the donor country. For example, donated drugs may have expired before they reach the patient, or they may be drugs or free samples returned to pharmacies by patients or health professionals.
· The donor agency sometimes ignores local administrative procedures for receiving and distributing medical supplies. The distribution plan of the donor agencies may conflict with the wishes of national authorities.
· Donated drugs may have a high declared value, e.g. the market value in the donor country rather than the world market price. In such cases import taxes and overheads for storage and distribution may be unnecessarily high, and the (inflated) value of the donation may be deducted from the government drug budget.
· Drugs may be donated in the wrong quantities, and some stocks may have to be destroyed. This is wasteful and creates problems of disposal at the receiving end.
There are several underlying reasons for these problems. Probably the most important factor is the common but mistaken belief that in an acute emergency any type of drug is better than none at all. Another important factor is a general lack of communication between the donor and the recipient, leading to many unnecessary donations. This is unfortunate because in disaster situations and war zones inappropriate drug donations create an extra workload in sorting, storage and distribution and can easily overstretch the capacity of precious human resources and scarce transport volume. Often, the total handling costs (duties, storage, transport) are higher than the value of the drugs. Stockpiling of unused drugs can encourage pilfering and black market sales.
Donating returned drugs (unused drugs returned to a pharmacy for safe disposal, or free samples given to health professionals) is an example of double standards because in most countries their use would not be permitted owing to quality control regulations. Apart from quality aspects, such donations also frustrate management efforts to administer drug stocks in a rational way. Prescribers are confronted with many different drugs and brands in ever-changing dosages; patients on long-term treatment suffer because the same drug may not be available the next time. For these reasons this type of donation is forbidden in an increasing number of countries and is generally discouraged.
In the early 1980s the first guidelines for drug donations were developed by international humanitarian organizations, such as the Christian Medical Commission of the World Council of Churches, later called Churches Action for Health1 and the International Committee of the Red Cross. In 1990 the WHO Action Programme on Essential Drugs, in close collaboration with the major international emergency aid agencies, issued a first set of WHO guidelines for donors,2 later refined by the WHO Expert Committee on the Use of Essential Drugs.3 In 1994 the WHO office in Zagreb issued specific guidelines for humanitarian assistance to former Yugoslavia.4
In view of the existence of these different drug donation guidelines, the need was felt for one comprehensive set of guidelines that would be endorsed and used by all major international agencies active in emergency relief. For this reason a first draft was prepared by the WHO Action Programme on Essential Drugs and further refined in close collaboration with the Division of Drug Management and Policies and the Division of Emergency and Humanitarian Action, major international relief organizations and a large number of international experts. The final text represented the consensus between WHO, Churches Action for Health of the World Council of Churches, the International Committee of the Red Cross, the International Federation of Red Cross and Red Crescent Societies, Médecins Sans Frontières, the Office of the United Nations High Commissioner for Refugees, OXFAM and the United Nations Childrens Fund. In the process comments by over 100 humanitarian organizations and individual experts were taken into consideration.
The examples of inappropriate donations described here constitute ample reasons to develop international guidelines for drug donations. In summary, guidelines are needed because:
· Donors intend well, but often do not realize the possible inconveniences and unwanted consequences at the receiving end.
· Donor and recipient do not communicate on equal terms. Recipients may need support in specifying how they want to be helped.
· Drugs do not arrive in a vacuum. Drug needs may vary between countries and from situation to situation. Drug donations must be based on a sound analysis of the needs, and their selection and distribution must fit within existing drug policies and administrative systems. Unsolicited and unnecessary drug donations are wasteful and should not occur.
· The quality requirements of drugs are different from those for other donated items, such as food and clothing. Drugs can be harmful if misused; they need to be identified easily through labels and written information; they may expire; and they may have to be destroyed in a professional way.