August 18, 2001: Inappropriate drug donations: the need for reforms. Article by Beverley Snell published in The Lancet, Volume 358, Number 9281, on Inappropriate Drug Donations and the Need for Reforms Individuals and organisations tend to respond to humanitarian emergencies with an urgent desire to help those in need. The media often highlight shortages of medicines, and donating medicines can seem a tangible way to express concern and solidarity. Drug donations do play an important part in humanitarian relief efforts, but they are not always the most effective way to help. After an earthquake, the first needs are usually shelter and earth-moving equipment. In refugee settings, priorities are clean water, sanitation, shelter, food, and vaccines. The requirement for drugs is determined with a comprehensive assessment of health problems. Surplus drugs from hospitals and pharmacies in donor countries are rarely what is most needed in emergency settings. If the medical needs of the affected population are not clearly specified, responses from hospitals and pharmacies are unlikely to be helpful. Surplus drugs often include free samples or drugs returned by patients or health professionals, such as cardiovascular drugs, gastrointestinal drugs, hormones, and anti-rheumatic remedies. Some drugs have reached or are near their expiry date. Antimalarials and vitamin A are commonly needed in an emergency, but are unlikely to be among the medicines donated by western hospitals. In 1991, Pharmaciens Sans Frontières found that only 20% of 4 million kg of drugs collected from 4000 pharmacies in France for international aid programmes could be used--the rest had to be burnt. Guidelines for drug donations were produced by several organisations during the 1980s in response to inappropriate donations in emergency situations. They formed the basis for internationally endorsed drug donation guidelines.1 The 12 articles of these guidelines are based on a set of core principles. First, there should be maximum benefit for the recipient. Second, there should be respect for the wishes and authority of the recipient, and support for existing government policies. Third, 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. Fourth, there should be effective communication between the donor and the recipient. After arrival in the recipient country all donated drugs should have a shelf-life of at least 1 year. Drugs may lose their active properties after their expiry date, and distribution through different storage levels (eg, central store to provincial store to district facilities) can take 6-9 months. Although some drugs may continue to be safe and effective after the expiry date, their use would not be allowed in the donor country and so they should not be donated. Many countries have developed a national standard drug list based on treatment guidelines for the most common diseases, to ensure safe and reliable treatment and optimal use of resources. The criteria for selection of drugs are appropriateness, efficacy, safety, and cost-effectiveness. Donations of drugs on the standard list, in consultation with recipients, can be helpful. Donations of products not on the list should be made only if there is a strong rationale, and after consultation with the recipient country. At the community level, donation of inappropriate drugs can interfere with management of common problems and can undermine a system based on rational prescribing from standard drug lists, treatment protocols, and trained national health workers. Governments can buy essential generic drugs from reputable non-profit procuring agencies at lower prices than brand-name drugs from large multinational companies.  Furthermore, medicines identified by international non-proprietary names make training easier by overcoming the confusion caused by different brand names. The use of non-proprietary names also facilitates ordering and storage of drugs. Despite the existence of published guidelines since the 1980s, every emergency produces new examples of inappropriate donations. In eastern Zaire in 1994, for example, one relief organisation chartered an aeroplane to deliver a huge shipment of a commercial soft drink used by athletes, in the false belief that it could be used to treat people with cholera. In fact, this product can be dangerous if given to infants. In addition, the product was not only bulky and difficult to store, but caused considerable waste and was not cost-effective when compared with standard oral rehydration therapies used to treat diarrhoea. There are many documented cases1,2 of relief organisations, private companies, governments, and individuals providing culturally unacceptable and nutritionally inadequate foods; inappropriate, expired, poorly packaged, and even dangerous drugs; and other useless relief supplies. Donations by pharmaceutical companies can be used to obtain tax deductions on unused stock or to stimulate a market for certain products. In April, 1999, growing concern about the appropriateness and the quality of the drugs donated to Albania during the Kosovo refugee crisis caused the WHO to voice its concern. Albania was assisted by a WHO consultant to develop national guidelines for drug donations and a standardised list of drugs. The WHO audit of Albania during May, 1999, noted that about 50% of the donated drugs were inappropriate or useless and would have to be destroyed. 65% of drugs were due to expire within 1 year, and 32% were identified only by brand-names that were unfamiliar to Albanian health professionals. None of the short shelf-life donations were requested, and aid workers reported that they could not be distributed and used before the expiry date. Donations need to be properly thought out before they leave the donor. Transport to the recipient country can cost more than the value of the drugs. Packages must be clearly labelled in a language that can be read in the region and units of drugs, such as blister packs, should not have been opened or used. Sometimes consignments remain at the point of entry for months because arrangements were not made for distribution on arrival. Storage costs and taxes may also be demanded. If drugs are not appropriate then the recipient has to ensure their safe disposal, which also poses difficulties. Between 1992 and mid-1996 in Bosnia and Herzegovina, about 17 000 tonnes of inappropriate donations cost US$34 million to destroy. There were neither high temperature incinerators nor specialist chemical waste treatment centres necessary for safe drug disposal. An incinerator supplied to Macedonia by the UK at the time of the Kosovo refugee crisis did not comply with British or EU emission standards. In response to such difficulties WHO have developed and published guidelines for the disposal of drugs. In most humanitarian emergencies, a financial contribution is more appropriate than donation of medicines. Such aid allows purchase and transport from specialist procuring agencies, at a fraction of the cost of supplying products from another country. The frustration of waiting for consignments of donated medicines, only to find that most were useless, led the Eritreans to develop their own manufacturing plant for commonly used medicines during their war for independence. By the end of 1987, this plant was able to prepare all intravenous fluids and 40% of the tablets and capsules needed in Eritrea. The plant formed the basis of the national manufacturing programme which has developed since independence. Inappropriate donations need to be prevented and recipients must be able to refuse unwanted gifts. Ideally, the government of a disaster-affected country should monitor the quality of the assistance and ensure that inappropriate aid is rejected. Without government controls, the lead aid agency in a relief programme should exert its authority on monitoring the quality of donations. Well-informed media could play a part in exposing agencies, companies, and governments that persist in sending useless drugs to countries facing humanitarian crises. In the long-term, the problem of inappropriate drug donations needs to be resolved by relief agencies through education of the public and by maintaining a commitment to high standards through consultation with the media, policy makers, and the drug industry. On a positive note, the world's newest nation, East Timor, has already developed a national standard drug list to cover all health facilities, and procurement policies that preclude drug donations. Beverley Snell International Health Unit Macfarlane Burnet Centre for Medical Research PO Box 254, Fairfield, Victoria 3078, Australia 1. WHO. Guidelines for drug donations. Geneva: WHO, 1999. 2. Forte G, Alderslade B. Inappropriate drug-donation practices in Bosnia and Herzegovina. N Engl J Med 1998; 338: 1473. 3. WHO. Guidelines for safe disposal of unwanted pharmaceuticals in and after emergencies. Geneva: WHO, 1999. Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Information and archive http://satellife.healthnet.org/programs/edrug.html Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to:`owner-e-drug@usa.healthnet.org'. [back]