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Home > English > Communiqués > European expert seminar on appropriate drug donations 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, organized by a European
consortium of NGOs was attended by representatives from 60 organizations in 16 countries.DIFÄM, PIMED and Wemos were the organizers; at the seminar Prosalus was welcomed as a new consortium-member.
Participants from international organizations, development and development education networks as well as medical and pharmaceutical relief networks shared information and best practices and worked together to plan
effective 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 seminar presentations and discussions:
education and communication are key if the quality of drug donations is to be improved and the principles of good drug donation practice upheld. As organizer Mark Raijmakers from Wemos explained at the opening of the seminar, because Western European organizations and governments donate many drugs, the goal of the NGO consortium is to contribute to improving the quality of these donations from the European Community. "Although several organisations in several EU member states are addressing the issue, there has been no consolidated and structural attempt at European level 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 Health Organization 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 urgent need to implement the Guidelines. These have not yet been adopted by most EU member states or by the United
States and have been the subject of much controversy both within the aid community and the pharmaceutical industry.Dr Hans Hogerzeil, fromWHO's Department of Essential Drugs and Other Medicines,
told participants that within one year after their release, governments and organizations 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 study evaluating the guidelines, which made it very clear that, "the idea is not to adapt the Guidelines to the practice, rather it is to adapt the practice to the Guidelines.
Put quite simply, some donors are going to have to change their practices." The study showed that:
90 per cent of respondents thought guidelines for drug donations were very much needed.
40 per cent of organizations have changed their donation practices as a result of the Guidelines.
45 per cent of respondents report an
improvement of the quality of drug donations with respect to relevance of the drugs, remaining shelf life, packaging and labeling.52 per cent of recipients now find it easier to refuse unwanted donations.63 per cent of intermediaries have experienced delays andrefusals of
drug donations, mainly because of the short remaining shelf life of drugsOnly 25 per cent of donors and recipients intermediaries have experienced delays and refusals of drug donations, a remarking difference 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 too strictly. "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 and consolidators to reduce the number and quantities of
short-dated drugs. Speakers Dr Eva Ombaka, from the
Pharmaceutical Program of theWorld Council of Churches (WCC)in Kenya, and Sister Nympha Que from theChristian Health Association of Malawi (CHAM), both pointed out that aid organizations and recipients,
usually desperate for medicines and equipment, are still often reluctant to refuse donations or to complain about their inappropriateness, as it may jeopardise future contributions.
Drug donations at the recipient end - a perspective from Kenya andTanzaniaDr Ombaka noted that in Kenya and Tanzania, the development of the WHO Guidelines per se does not guarantee a
change of behaviour. For this, there is a need to "disseminate, educate, inform and discuss", with both donors and recipients. To facilitate this process, some knowledge of the issues that recipients deal with is necessary.
To this end, a smallstudy was donein 24 rural and urban facilities in the two countries, to identify possible determinants of good drug donation practice in mission hospitals.Mission hospitals receive about four
donation consignments per year. While 75 per cent of the facilities report they send a list to 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 of the donations are antibiotics and about 25 per cent of solicited drugs have a shelf life of less than one
year. The labels on donations in most instances complied with international requirements. When requested, 70.8 per cent of the donations were labeled in a language locally understood by workers in the facility
concerned. The study further revealed that mostly non-pharmaceutically trained health workers are responsible for receipt of donations, e.g. nurses. This poses the need for education at the recipient side.
"Communication
is essential," Dr Ombaka noted. "When drugs are requested, the experience is usually a positive one. We need to work harder to enable the recipient to give the donor full information about what is needed. This
is not exactly an equal partnership at the moment. Recipients need to feel confident enough do this." Donated drugs: the Malawi experienceAs 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 people that
is the ninth poorest in the world with a GNP (Gross National Product) of just $170 per capita and 80 per cent of the labour force employed in agriculture either on small farms or estates. Fifty per cent of the
population is under 15 years with a life expectancy of just 44 years due to AIDs. Just half the population has access to drinking water, 40 per cent of the inpatients are suffering from AIDs and 33 per cent of the
outpatients are afflicted with malaria. Churches deliver about 30 per cent of the healthcare. CHAM is a national health coordinating body overseeing 150 health units in the country. National guidelines for drug donations and an application form for
the importation of drugs were recently developed. CHAM distributed the WHO interagency Guidelines to its units in 1996. In future, all donated drugs need the approval of the Pharmacy, Medicines and Poisons Board.
Most drugs arrive from
individual organizations without prior knowledge by the centers and health facilities. Civic groups sometimes source from their own members, including pharmacists who run small pharmacies. At one point, Sister Que,
convinced that a pharmacy was clearing out its junk items and shipping them to Malawi, wrote the donor a strong letter. The result? No more donations. Church groups, many in Europe, form the majority of donors, sending
container loads of drugs and equipment to be used by sister churches. Some donations are solicited and there has been a "slight improvement noted" in the quality of the consignments. Sister Que and others are
hoping that in future, customs will not clear anything unless the government has approved it. But until then, there is still a fear that donations will stop if the recipients complain. Therein lies the dilemma.
"When confronted
with scarcity, every alternative is justified ifit means saving lives. This is our dilemma. We want good drug donations, but we are afraid these donations will stop. It is a real fear," Sister Que told
participants. "The challenge now is to make an effort to improve donations without hindering people from donating." Post-Mitch reconstruction of the health sectorHurricane Mitch was the worst natural disaster to
hit the Central American isthmus in 200 years, In Honduras, estimates indicate more than 1.5 million people were affected, with more than 8,000 missing, 12,000 missing and 285,000 left homeless and forced to take refuge
in shelters. During the disaster, epidemiological surveillance and control efforts focused on specific diseases considered to pose a public health risk, such as malaria, dengue fever and cholera. As Maria Teresa Gago, from the US-basedPan-American Health Organization (PAHO/WHO) told participants, in Honduras alone, the health infrastructure suffered severe damage affecting 23 of the 28 hospitals, in which their water distribution system was either partially or completely destroyed; 123 health clinics were seriously impaired and 68 were rendered non-operational. Approximately 60 per cent of the country's road infrastructure was destroyed as well as 80 per cent of the water supply system.
There was a massive
response from the international community, she said. However, despite the good intentions of many charitable organizations, many of the donations received were inappropriate. For instance, pharmaceuticals were not in a
familiar language, many donations had expired or were about to expire, and some did not correspond to the country's disease patterns. As a result, in Honduras, drugs and medical equipment are still being stored in a temporary
warehouse. It will take many man-hours to sort through the donations, Ms Gago noted, valuable time that could have been spent more effectively elsewhere: "It was a disaster situation itself."
Post-Mitch reconstruction of the
health sector offers an invaluable opportunity, both politically and socially, to create opportunities to reorient policies and strengthen programs of existing health institutions. An important component of the
reconstruction phase is the improvement of supplies of essential drugs and medical equipment. To facilitate logistics, SUMA, or other supply management software tools should be implemented at the earliest stage possible
to ensure transparency and accountability. One of the valuable lessons learned from Mitch is that countries should adopt the recommendations of the WHO Guidelines and a list of emergency medicines as regional
standards. However, this should not be an isolated or static process. It must involve all sectors and be seen as part of ongoing technical cooperation activities, she said. A Pilot Study for the Evaluation of Policies
and Practices of Donations in Honduras is underway. Kosovo crisis - a grim reminderThe crisis unfolding in Kosovo served as a backdrop for the discussions, and offered a grim reminder of the critical importance of good drug donation practice. As Dr
Gilles-Bernard Forte, an advisor for Central and Eastern Europe for WHO/Euro's Program for Pharmaceuticals pointe dout, tons of drugs and medical supplies are pouring into Albania, the Former Yugoslav Republic of Macedonia and the Federal Republic of Yugoslavia (Serbia and Montenegro). Although exact numbers are hard to come by,
WHO estimates about a third to half of all of the shipments are useless and will likely gather dust in warehouses or eventually have to be destroyed at great expense to the recipient country governments.
Reports indicate
that large quantities of donated medicines are not usable and wasted - about 30 per cent of drugs donated as bilateral aid. For example, tons of medicines to treat cholera and acute diarrhea are stockpiled, while
medicines for non-communicable and chronic diseases are in great need. A recent WHO survey in the Former Republic of Macedonia has highlighted the poor compliance of relief agencies with the interagency Guidelines.
"In one donation, more than 30 different drugs were counted," Dr Forte told a news conference at the seminar. "About 40 per cent of them were considered nonessential or not in line with the national
essential drug references and 30 per cent were expired or had less than one year remaining shelf life." "With the Kosovo crisis, we have the opportunity to bring theproblems of good drug donation
practice to light and underscore the need for appropriate donations," Mr Raijmakers said at the news conference held at the seminar. "We simply cannot afford repeating the mistakes that were made in the
past. We have passed the stage of discussing the Guidelines. We have to explore ways to use the min implementing good drug donation practice."
Who is responsible for disposing of unwanted donations?Despite the positive reception the Guidelines have received from some governments, the problem persists of how to dispose of unwanted drug donations, which nearly always become
hazardous chemical waste. WHO recently issued the interagency Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies, developed after the tremendous problems of accumulated unwanted
drug donations in Croatia and Bosnia-Herzegovina. According to areport in the New England Journal of Medicine, in Bosnia-Herzegovina, possibly as much as
half of the approximately 30,0000 tons of donated medical supplies were of little or no use. The cost of destroying these drugs is estimated to be upwards of US$ 30 million. Conclusions
Education and communication are key if the quality of
drug donations is to be improved and the principles of good drug donation practice upheld.Awareness about good drug donation practice is essential on both sides of the donation process. In donor
countries efforts to promote awareness should be increased.WHO can help host countries by supporting them - and medical aid organizations - to understand the interagency Guidelines and to develop coherent national policies.Organizations active in the field of drug donations should
facilitate in developing a reporting mechanism monitoring drug donations in order to get a clearer picture of where inappropriate donations come from, and to identify donors and recipients that need assistance in
improving donation practices.The
dilemma of recipient refusal resulting in a curtailment of donations must be resolved through education of both recipients and donors about how to communicate with each other and work within the Guidelines.
Educating governments and recipients about
shelf-life is critical. The principle is that all donated drugs should have as half-life of at least one year after arrival in the recipient country. But exceptions are possible, for example in the case of direct
donations to specific health facilities.Local
capabilities should be enhanced, not undermined, by drug donations. For example, local health personnel (especially nurses)should be encouraged to learn about how procurement works, or doesn't. The donor needs to be
aware of the level of training the staff has when giving special products. In emergency situations, donors should support the health care systems of host countries to prevent the development of parallel healthcare systems that eventually undermine
the health of the population.
Rapporteur:Dianna Rienstra, Brussels. |
