Education and debate

Guidelines for drug donations

^a Action programme on essential drugs, World health organisation, 1211 Geneva, Switzerland, ^b Division of drug management and policies, WHO, ^c Division of emergency and humanitarian action, WHO

Correspondence to: Dr Hogerzell

	Abstract

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Drug donations are usually given in response to acute emergencies, but they can also be part of development aid. Donations may be given directly by governments, by non-governmental organisations, as corporate donations (direct or through private voluntary organisations), or as private donations to single health facilities. Although there are legitimate differences between these donations, basic rules should apply to them all. This common core of "good donation practice" is the basis for new guidelines which have recently been issued by the World Health Organisation after consultation with all relevant United Nations agencies, the Red Cross, and other major international agencies active in humanitarian emergency relief. This article summarises the need for such guidelines, the development process, the core principles, and the guidelines themselves and gives practical advice to recipients and donor agencies.

	The need for guidelines

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International humanitarian relief efforts in natural or other disasters can greatly benefit from donations of appropriate drugs. Unfortunately, there are also many examples of drug donations which cause problems instead of being helpful. For example, after the 1988 earthquake in Armenia, 5000 tons of drugs and medical supplies worth $55m (£36m) were sent, which took 50 people six months to sort out. Only 30% of the drugs were easy to identify and only 42% were relevant for an emergency situation. Most were labelled with only brand names.¹ Eritrea received seven truck loads of expired aspirin tablets that took six months to burn; a container full of unsolicited cardiovascular drugs with two months to expiry; and 30 000 bottles of expired amino acid infusion that could not be disposed of anywhere near a settlement because of the smell.² War torn southern Sudan received donations of contact lens solution, appetite stimulants, drugs against hypercholesterolaemia, and expired antibiotics, all labelled in French.³ In 1992 11 women in Lithuania temporarily lost their eyesight after taking a donated drug. The drug, closantel, was a veterinary anthelmintic but was mistakenly given to treat endometriosis. It had been received without product information and doctors had tried to identify the product by matching its name with those on leaflets of other products.⁴ Of all drugs received by the World Health Organisation field office in Zagreb in 1994, 15% were completely unusable and 30% were not needed.⁵ By the end of 1995, 340 tons of expired drugs were stored in Mostar. Most of these were donated by European nations, and the mayor has written to the European Union requesting international help to have them destroyed.

View larger version (76K): [in this window] [in a new window]   Fig 1 Voluntary worker trying to sort out donated medicines in Mexico, 1991. WHO/PAHO

The main problems that occur with donations are as follows:

• Donated drugs are often not relevant for the emergency situation, for the disease pattern, or for the level of care available. They are often unknown by local health professionals and patients and may not comply with locally agreed drug policies and standard treatment guidelines; they may even be dangerous, as the case in Lithuania illustrates

• 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 non-proprietary name (generic name) on the label (fig 1)

• 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 samples returned to pharmacies by patients or doctors

• 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 policies and wishes of national authorities

• Donated drugs may have a high declared value–for example, the market value in the donor country rather than the world market price for the generic equivalent. Import taxes and overheads for storage are usually charged as a percentage of the declared value and may then become unnecessarily high. In some recipient countries the ministry of finance considers a donation removes their obligation to fund the necessary drug budget of the ministry of health, which is then reduced accordingly

• 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; moreover, stockpiling unused drugs encourages pilfering and black market sales.

There are several underlying reasons for these problems. Probably the most important factor is the common but mistaken belief that in an acute emergency, or for developing countries, any drug is better than none at all. Another important factor is a general lack of communication between donors and recipients, 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 human and transport resources. Often the total handling costs (duties, storage, transport) are higher than the value of the drugs.

	Developing guidelines for drug donations

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In the early 1980s the first guidelines for drug donations were developed by international humanitarian organisations such as the Christian Medical Commission of the World Council of Churches.⁶ 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,⁷ later refined by the WHO expert committee on the use of essential drugs.⁸ In 1994 the WHO office in Zagreb issued specific guidelines for humanitarian assistance to former Yugoslavia.⁹

It soon became clear that one comprehensive set of core principles and guidelines was needed that would be endorsed and used by all major international agencies active in emergency relief. For this reason WHO started a global consultative process to reach consensus with the United Nations High Commissioner for Refugees and Unicef, the Red Cross, and other non-governmental organisations (see acknowledgements). Comments from over 100 humanitarian aid organisations and experts were taken into consideration. The guidelines were issued in May 1996 and have been well received. Many countries have adopted them wholesale and others have adapted them to their specific situation. The guidelines will be reviewed after one year, but it seems that they are already having a significant impact on donation practice.

View larger version (87K): [in this window] [in a new window]   Fig 2 Distribution of standardised kits of essential drugs in former Yugoslavia. All boxes are labelled with a packing list on the outside. Green is the international colour code for emergency medicines B OBERSON/ICRC

Box box gives the four core principles. The first is that a drug donation should benefit the recipient to the maximum extent possible. This implies that all donations should be based on an expressed need and that unsolicited drug donations are to be discouraged. The second principle is that a donation should be given with full respect for the wishes and authority of the recipient, and support existing government health policies and administrative arrangements. The third is that there should be no double standards in quality: if the quality of an item is unacceptable in the donor country it is also unacceptable as a donation. The fourth principle is that there should be effective communication between the donor and the recipient; donations should never be sent unannounced.

Box box summarises the guidelines for drug donations; the full text and explanatory notes are available elsewhere.¹⁰

	Other ways donors can help

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New emergency health kit
Immediately after an emergency, or when refugees have no medical care, it is better to send standardised kits of drugs and medical supplies that are specifically designed for this purpose (fig 2). For example, the new emergency health kit,^{7 11} which has been widely used since 1990, contains drugs, disposable supplies, and basic equipment needed for general medical care for a population of 10 000 for three months. It is permanently stocked by several major international suppliers and can be available within 48 hours. It is especially relevant in the absence of specific requests.

Donations in cash
After the initial phase of the emergency is over a cash donation to buy drugs locally or regionally is usually much more welcome than further drug donations.

Drug donations as part of development aid
When drug donations are given as humanitarian support to long lasting complex emergencies or as regular development aid there is more time to consider the recipient's specific demands. Drugs should not arrive in an administrative vacuum; drug donations should not create an abnormal situation which may obstruct or delay the building of national capacity to select, procure, distribute, and rationally use drugs. Special care should be taken to ensure that the donated drugs respond to an expressed need, comply with the national drug policy, and meet national treatment guidelines. Administratively, the drugs should be treated as if they were bought. This means that they should be authorised for use in the country through the same registration and quality assurance procedures that are used for government tenders. If cost sharing procedures are operational, donated drugs should not automatically be distributed free of charge.

	How to implement a policy on drug donations

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Actions required from recipients
It is difficult for a recipient to refuse a donation that has already arrived; prevention is therefore better than cure. Recipients should indicate to prospective donors what kind of help they need and how they would like to receive it. To this end recipients should first formulate their own national guidelines for drug donations, on the basis of the WHO guidelines, and present them to their donors.

Recipients should also develop administrative procedures to maximise the potential benefit of drug donations. The following important questions have to be addressed in advance:

• Who coordinates all drug donations?

• Which documents are needed when a donation is planned; who should receive them?

• What are the criteria for accepting/rejecting a donation; who makes the final decision?

• Which procedure is used when donations do not follow the guidelines?

• Who coordinates reception, storage, and distribution of the donated drugs?

• How are donations valued and entered into the budget/expenditure records?

• How will inappropriate donations be disposed of?

The third important action by the recipient is to specify its needs as much as possible, indicating the required quantities and prioritising the items. Information on other donations that are already in the pipeline is helpful to potential donors. Full openness by the recipient is greatly appreciated by donors and pays off in the long run.

Finally, the value of donated drugs can be considerable, and the gift should be treated with due care. On arrival the drugs should be inspected and their receipt confirmed to the donor agency. They should then be stored and distributed in accordance with normal principles of good pharmacy practice. There must be vigilance to ensure that donated products are not diverted for export, for commercial sale, or into illicit channels.

Action required from donor agencies
Donors should always respect the four core principles for drug donations. Donors should also respect any national guidelines for drug donations and respond to the priority needs indicated by the recipient. Unsolicited donations should be prevented as much as possible. Ask for full information from the recipient about requested and approved donations. Donors should also inform the recipient well in advance and in great detail about which donations are coming, and when. This will help the recipient country to plan for the proper reception of the donations, to inform other donors, and to identify any additional needs.

	Acknowledgements

The guidelines for drug donations were issued by the WHO Action Programme on Essential Drugs as an interagency statement by WHO, Unicef, the Office of the United Nations High Commissioner for Refugees, the International Committee of the Red Cross, the International Federation of Red Cross and Red Crescent Societies, Churches' Action for Health of the World Council of Churches, Médecins sans Frontières, and Oxfam. The valuable comments and contributions by all other organisations and individuals are gratefully acknowledged.

	References

Top Abstract The need for guidelines Developing guidelines for drug... Other ways donors can... How to implement a... References

1. Autier P, Férir M-C, Hairapetien A, Alexanian A, Agoudjian V, Schmets G, et al. Drug supply in the aftermath of the 1988 Armenian earthquake. Lancet 1990;335:1388-90.
2. Woldeyesus K, Snell B. Eritrea's policy on donations. Lancet 1994;344:879. [Medline]
3. Cohen S. Drug donations to Sudan. Lancet 1990;335:745.
4. Hoen E, Hodgkin C. Harmful use of donated veterinary drug. Lancet 1993;342:308-9.
5. Forte GB. An ounce of prevention is worth a pound of cure. The Hague: International Conference of Drug Regulatory Agencies, 1994.
6. Christian Medical Commission. Guidelines for donors and recipients of pharmaceutical donations. Geneva: World Council of Churches, 1990.
7. World Health Organisation. The new emergency health kit. Geneva: WHO, 1990:5. (WHO/DAP/90.1.)
8. World Health Organisation. The use of essential drugs. World Health Organ Tech Rep Ser 1992;825:13.
9. World Health Organisation. Medical supplies donor guidelines for WHO humanitarian assistance for former Yugoslavia. Zagreb: WHO, 1994.
10. World Health Organisation. Guidelines for drug donations. Geneva: WHO, 1996. (WHO/DAP/96.2.)
11. Hogerzeil HV. Emergency health kits. Lancet 1990;336:1194.

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