European expert seminar on appropriate drug donations. June 11, and 12 1999, Oegstgeest, The Netherlands Summary of proceedings of the first plenary day (June 11) Organised by the NGO-consortium on Appropriate Drug Donations by DIFÄM - Germany, PIMED - France, Prosalus - Spain, and Wemos - The Netherlands. Contents online The need for implementation of the guidelines Drug donations at the recipient end - a perspective from Kenya and Tanzania Donated drugs: the Malawi experience Post-Mitch reconstruction of the health sector Who is responsible for disposing of unwanted donations? Kosovo crisis - a grim reminder Conclusions The seminar, organised by a European consortium of NGOs wasattended by representatives from 60 organisations in 16 countries. DIFÄM, PIMED and Wemos were the organisers; at the seminar Prosaluswas welcomed as a new consortium-member. Participants frominternational organisations, development and development educationnetworks as well as medical and pharmaceutical relief networksshared information and best practices and worked together to planeffective strategies to improve the quality of drug donations.  For more information on the seminar click here.  The need for implementation of the guidelines A single message resonated throughout the various seminarpresentations and discussions: education and communication are keyif the quality of drug donations is to be improved and the principles of good drugdonation practice upheld.  As organiser Mark Raijmakers from Wemos explained at the opening of the seminar, because Western Europeanorganisations and governments donate many drugs, the goal of theNGO consortium is to contribute to improving the quality of thesedonations from the European Community. "Although severalorganisations in several EU member states are addressing the issue,there has been no consolidated and structural attempt at Europeanlevel to share knowledge and learn from each other's experiences,"he told participants. Nor has there been a concerted effort to effectively implement theinteragency Guidelines for Drug Donations, issued by the World HealthOrganisation in 1996 and revised in 1999. To this end, WEMOS, DIFÄMand PIMED have launched a Europe-wide awareness campaign to inform donors and national governments that donate drugs of the urgentneed to implement the Guidelines. These have not yet been adopted by most EUmember states or by the United States and have been the subject ofmuch controversy both within the aid community and thepharmaceutical industry. Dr Hans Hogerzeil, fromWHO's Department of Essential Drugs and Other Medicines, toldparticipants that within one year after their release, governmentsand organisations in more than 40 countries, ranging from Australiato Zimbabwe, have adopted or adapted the Guidelines and are usingthem.  Dr Hogerzeil presented preliminary results of a 1997 studyevaluating the guidelines, which made it very clear that, "the idea is not to adaptthe Guidelines to the practice, rather it is to adapt the practiceto the Guidelines. Put quite simply, some donors are going to haveto change their practices."  The study showed that:  90 per cent of respondents thought guidelines for drug donationswere very much needed. 40 per cent of organisations have changed their donationpractices as a result of the Guidelines. 45 per cent of respondents report an improvement of the qualityof drug donations with respect to relevance of the drugs, remainingshelf life, packaging and labelling. 52 per cent of recipients now find it easier to refuse unwanteddonations. 63 per cent of intermediaries have experienced delays andrefusals of drug donations, mainly because of the short remainingshelf life of drugs Only 25 per cent of donors and recipients intermediaries haveexperienced delays and refusals of drug donations, a remarkingdifference with the above-standing results with the intermediaries.  These preliminary results are encouraging, he told participants,and things appear to be changing, albeit slowly. On the other hand,there are also some problems when the Guidelines are applied toostrictly.  "We have to make it clear to governments that they should bereasonable and not blindly apply some of the rules," Dr Hogerzeilsaid. "A special education effort is needed to convince donors andconsolidators to reduce the number and quantities of short-dateddrugs.  Speakers Dr Eva Ombaka, from the Pharmaceutical Programme of theWorld Council of Churches (WCC)in Kenya, and Sister Nympha Que from theChristianHealth Association of Malawi (CHAM), both pointed out that aid organisations andrecipients, usually desperate for medicines and equipment, arestill often reluctant to refuse donations or to complain abouttheir inappropriateness, as it may jeopardise future contributions.   Drug donations at the recipient end - a perspective from Kenya andTanzania Dr Ombaka noted that in Kenya and Tanzania, the development of theWHO Guidelines per se does not guarantee a change of behaviour. Forthis, there is a need to "disseminate, educate, inform anddiscuss", with both donors and recipients.  To facilitate this process, some knowledge of the issues thatrecipients deal with is necessary. To this end, a smallstudy was done in 24 rural and urban facilities in the two countries, to identifypossible determinants of good drug donation practice in mission hospitals. Mission hospitals receive about four donation consignments peryear. While 75 per cent of the facilities report they send a listto donors, only 50 per cent receive what they requested. Overall,with both requested and unsolicited drug donations, just 41.7 percent were "always appropriate." Among other things, the findings indicate that about 25 per cent ofthe donations are antibiotics and about 25 per cent of soliciteddrugs have a shelf life of less than one year. The labels ondonations in most instances complied with internationalrequirements. When requested, 70.8 per cent of the donations werelabelled in a language locally understood by workers in thefacility concerned. The study further revealed that mostlynon-pharmaceutically trained health workers are responsible forreceipt of donations, e.g. nurses. This poses the need foreducation at the recipient side.  "Communication is essential," Dr Ombaka noted. "When drugs arerequested, the experience is usually a positive one. We need towork harder to enable the recipient to give the donor fullinformation about what is needed. This is not exactly an equalpartnership at the moment. Recipients need to feel confident enoughto do this."    Donated drugs: the Malawi experience As one of the poorest countries south of the Sahara, Malawi has along history of drug donations from individuals, civic groups,church groups, bilateral donations and cash donations for drugs.  Sister Que painted a picture of a country of 9.8 million peoplethat is the ninth poorest in the world with a GNP (Gross NationalProduct) of just $170 per capita and 80 per cent of the labourforce employed in agriculture either on small farms or estates.Fifty per cent of the population is under 15 years with a lifeexpectancy of just 44 years due to AIDs. Just half the populationhas access to drinking water, 40 per cent of the in-patients aresuffering from AIDs and 33 per cent of the outpatients areafflicted with malaria. Churches deliver about 30 per cent of the healthcare. CHAM is anational health co-ordinating body overseeing 150 health units inthe country.  National guidelines for drug donations and an application form forthe importation of drugs were recently developed. CHAM distributedthe WHO interagency Guidelines to its units in 1996. In future, alldonated drugs need the approval of the Pharmacy, Medicines andPoisons Board. Most drugs arrive from individual organisations without priorknowledge by the centres and health facilities. Civic groupssometimes source from their own members, including pharmacists whorun small pharmacies. At one point, Sister Que, convinced that apharmacy was clearing out its junk items and shipping them toMalawi, wrote the donor a strong letter. The result? No more donations.  Church groups, many in Europe, form the majority of donors, sendingcontainer loads of drugs and equipment to be used by sisterchurches. Some donations are solicited and there has been a "slightimprovement noted" in the quality of the consignments. Sister Queand others are hoping that in future, customs will not clearanything unless the government has approved it. But until then,there is still a fear that donations will stop if the recipientscomplain. Therein lies the dilemma. "When confronted with scarcity, every alternative is justified ifit means saving lives. This is our dilemma. We want good drugdonations, but we are afraid these donations will stop. It is areal fear," Sister Que told participants. "The challenge now is to make aneffort to improve donations without hindering people fromdonating."    Post-Mitch reconstruction of the health sector Hurricane Mitch was the worst natural disaster to hit the CentralAmerican isthmus in 200 years, In Honduras, estimates indicate morethan 1.5 million people were affected, with more than 8,000missing, 12,000 missing and 285,000 left homeless and forced totake refuge in shelters. During the disaster, epidemiologicalsurveillance and control efforts focused on specific diseasesconsidered to pose a public health risk, such as malaria, denguefever and cholera.  As Maria Teresa Gago, from the US-basedPan-American Health Organisation (PAHO/WHO) told participants,in Honduras alone, the health infrastructure suffered severe damageaffecting 23 of the 28 hospitals, in which their water distributionsystem was either partially or completely destroyed; 123 healthclinics were seriously impaired and 68 were renderednon-operational. Approximately 60 per cent of the country's roadinfrastructure was destroyed as well as 80 per cent of the watersupply system.  There was a massive response from the international community, shesaid. However, despite the good intentions of many charitableorganisations, many of the donations received were inappropriate.For instance, pharmaceuticals were not in a familiar language, manydonations had expired or were about to expire, and some did notcorrespond to the country's disease patterns.  As a result, in Honduras, drugs and medical equipment are stillbeing stored in a temporary warehouse. It will take many man-hoursto sort through the donations, Ms Gago noted, valuable time thatcould have been spent more effectively elsewhere: "It was adisaster situation itself." Post-Mitch reconstruction of the health sector offers an invaluableopportunity, both politically and socially, to create opportunitiesto reorient policies and strengthen programmes of existing healthinstitutions. An important component of the reconstruction phase isthe improvement of supplies of essential drugs and medicalequipment. To facilitate logistics, SUMA, or other supplymanagement software tools should be implemented at the earlieststage possible to ensure transparency and accountability.  One of the valuable lessons learned from Mitch is that countriesshould adopt the recommendations of the WHO Guidelines and a listof emergency medicines as regional standards. However, this shouldnot be an isolated or static process. It must involve all sectorsand be seen as part of ongoing technical co-operation activities,she said. A Pilot Study for the Evaluation of Policies andPractices of Donations in Honduras is underway.    Kosovo crisis - a grim reminder The crisis unfolding in Kosovo served as a backdrop for thediscussions, and offered a grim reminder of the critical importanceof good drug donation practice. As Dr Gilles-Bernard Forte, anadvisor for Central and Eastern Europe for WHO/Euro's Programme for Pharmaceuticals pointedout, tons of drugs and medical supplies are pouring into Albania,the Former Yugoslav Republic of Macedonia and the Federal Republicof Yugoslavia (Serbia and Montenegro). Although exact numbers arehard to come by, WHO estimates about a third to half of all of theshipments are useless and will likely gather dust in warehouses oreventually have to be destroyed at great expense to the recipientcountry governments.  Reports indicate that large quantities of donated medicines are notusable and wasted - about 30 per cent of drugs donated as bilateralaid. For example, tons of medicines to treat cholera and acutediarrhoea are stockpiled, while medicines for non-communicable andchronic diseases are in great need. A recent WHO survey in theFormer Republic of Macedonia has highlighted the poor compliance ofrelief agencies with the interagency Guidelines. "In one donation,more than 30 different drugs were counted," Dr Forte told a newsconference at the seminar. "About 40 per cent of them wereconsidered non-essential or not in line with the national essentialdrug references and 30 per cent were expired or had less than oneyear remaining shelf life."  "With the Kosovo crisis, we have the opportunity to bring theproblems of good drug donation practice to light and underscore theneed for appropriate donations," Mr Raijmakers said at the newsconference held at the seminar. "We simply cannot afford repeatingthe mistakes that were made in the past. We have passed the stageof discussing the Guidelines. We have to explore ways to use themin implementing good drug donation practice."   Who is responsible for disposing of unwanted donations? Despite the positive reception the Guidelines have received fromsome governments, the problem persists of how to dispose ofunwanted drug donations, which nearly always become hazardouschemical waste. WHO recently issued the interagency Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies, developedafter the tremendous problems of accumulated unwanted drugdonations in Croatia and Bosnia-Herzegovina. According to areport in the New England Journal of Medicine, inBosnia-Herzegovina, possibly as much as half of the approximately30,0000 tons of donated medical supplies were of little or no use.The cost of destroying these drugs is estimated to be upwards ofUS$30 million.    Conclusions Education and communication are key if the quality of drugdonations is to be improved and the principles of good drugdonation practice upheld. Awareness about good drug donation practice is essential on bothsides of the donation process. In donor countries efforts topromote awareness should be increased. WHO can help host countries by supporting them - and medical aidorganisations - to understand the interagency Guidelines and todevelop coherent national policies. Organisations active in the field of drug donations shouldfacilitate in developing a reporting mechanism monitoring drugdonations in order to get a clearer picture of where inappropriatedonations come from, and to identify donors and recipients thatneed assistance in improving donation practices. The dilemma of recipient refusal resulting in a curtailment ofdonations must be resolved through education of both recipients anddonors about how to communicate with each other and work within theGuidelines. Educating governments and recipients about shelf-life iscritical. The principle is that all donated drugs should have ashelf-life of at least one year after arrival in the recipientcountry. But exceptions are possible, for example in the case ofdirect donations to specific health facilities. Local capabilities should be enhanced, not undermined, by drugdonations. For example, local health personnel (especially nurses)should be encouraged to learn about how procurement works, ordoesn't. The donor needs to be aware of the level of training thestaff has when giving special products. In emergency situations, donors should support the health caresystems of host countries to prevent the development of parallelhealthcare systems that eventually undermine the health of thepopulation.  Rapporteur:Dianna Rienstra, Brussels.  [back]