Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA) - Bahrain, 10-13 November 1996
(1996; 111 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuOpening ceremony
Ouvrir ce répertoire et afficher son contenuInternational harmonization of regulatory requirements Plenary: 10 November 1996
Ouvrir ce répertoire et afficher son contenuGlobal harmonization
Ouvrir ce répertoire et afficher son contenuTripartite harmonization - International Conference on Harmonization (ICH)
Ouvrir ce répertoire et afficher son contenuRegional harmonization activities
Ouvrir ce répertoire et afficher son contenuAgreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Ouvrir ce répertoire et afficher son contenuThe mission of drug regulatory authorities
Ouvrir ce répertoire et afficher son contenuCounterfeit drugs
Ouvrir ce répertoire et afficher son contenuComputer-assisted drug registration
Fermer ce répertoireUpdates
Afficher le documentUse and future of the International Pharmacopoeia - Professor T. Paal, Hungary
Afficher le documentDrug donations: the Eritrean experience - Kidane Woldeyesus
Afficher le documentReport on diethylene glycol poisoning in Haiti - Dr E. Fefer, WHO/AMRO
Afficher le documentRegulatory measures to allow timely provision of controlled medicines in emergency situations - Mr T. Yoshida, WHO
Afficher le documentRecommendation
Ouvrir ce répertoire et afficher son contenuThe challenge of biotechnology
Ouvrir ce répertoire et afficher son contenuPharmacovigilance
Ouvrir ce répertoire et afficher son contenuWHO Certification scheme: current developments
Ouvrir ce répertoire et afficher son contenuRegulatory control and assessment of herbal medicines
Ouvrir ce répertoire et afficher son contenuRegistration requirements for multisource products (generics)
Afficher le documentList of participants
 

Drug donations: the Eritrean experience - Kidane Woldeyesus

Two distinct periods in Eritrean history shape our experience with donations. The first covers the thirty years war for liberation and the second period covers the time since liberation in 1991.

During the war, assistance was not received from international organizations or governments because this was considered as interference in the internal affairs of a sovereign state. Thus, the liberation front had to find ways of providing its own drugs and medical supplies, and one was to establish its own drug manufacturing plant. The plant was set up in 1984 and produced IV infusions, tablets, capsules and topical preparations to satisfy about 40% of our needs. Funds to pay for supply of the remaining medicines came from nongovernmental organizations, solidarity groups and other humanitarian organizations. Occasionally, support was received from a government.

The health services of the liberation front were dispensed at 8 hospitals as well as a large number of community-level health facilities. These services were provided under particularly difficult situations. The liberated areas were subject to recurrent droughts and there were frequent episodes of famine. The situation was further aggravated because the health facilities, including the drug manufacturing plant, had to be placed underground or deeply hidden in the bush to escape aerial bombardment.

The Eritrean Relief Association had offices in many parts of the world and was responsible for requesting donations. Lists of requirements would be sent from the field and appeals were made to encourage support. Financial assistance was preferred because this made it possible to purchase supplies from appropriate sources but, where this was not possible, humanitarian organizations and other private donors were informed of our requirements and handed our essential drugs list. For many years, useful donations of drugs and medical supplies were sent by dedicated supporters and sympathetic humanitarian organizations. These donations contributed immensely to the success of our struggle. Thousands of lives were saved - especially at the height of the war when there were many grave injuries among combatants and civilians. Because of the dislocation of populations from the places of conflict, epidemics such as cholera and meningitis occurred frequently.

Although many types of problem were encountered in Eritrea concerning inappropriate donations, we see these merely as side effects to a useful product. None the less, from among many of the situations we encountered, the following advice may be useful for future donors of emergency situations.

Unsolicited drugs and medical supplies

On many occasions during the war, items that were not solicited and often not relevant to our needs were received. For example, in 1984 at the height of the terrible drought and famine in the region, a whole shipment of appetite depressants, cardiovascular drugs, anabolics and central nervous system drugs, plus tons of unusable medical supplies such as rubber and plastic tubes or oversized hypodermic needles, were received. On another occasion, more than one million tablets of nicotinamide 500 mg and an equal amount of propranolol 80 mg were received. Such items had to be disposed of and the logistical problems of moving these items from place to place and destroying them was almost insurmountable.

Donations of drugs and medical supplies in quantities far exceeding needs

Some organizations collected huge quantities of drugs and medical supplies and despatched them to Eritrea as donations. Although a few of these items could be used, the quantities received were sometimes far in excess of our needs, and this created enormous problems of storage. To cite an example, thousands of injectable lincomycin and ampicillin products and more than ten thousand tubes of corticosteroid topical ointment were received in 1987. They had to be kept for a long time, way beyond the expiry date, as there was great reluctance to dispose of such valuable necessities until they could be replaced by fresh supplies.

Expired drugs

Expired drugs were donated so often that this was taken for granted. In 1985, for example, we received seven truckloads of acetylsalicylic acid 650 mg amounting to millions of expired tablets which took more than a month to sort out and six months to burn. In 1989, we received 36 000 half-litre bottles of expired amino acid intravenous solution which could not be disposed of anywhere near a settlement because of the smell. It took months to deal with of this consignment - with the pharmacists carrying it on their backs to far away places for disposal. In 1994, we received over 100 000 tablets of loperamide which expired on the day of arrival.

Inadequately packed and labelled

Some of the donated drugs had brand names with labelling in languages that was not understandable, or indicating the chemical structure names rather than the generic (INN) name. Another example of a similar problem was the donation of drugs that had been issued and returned to pharmacies, or free samples collected from doctors clinics. Because the consignments were often not accompanied by a packing list, each had to be opened to see what was in the box or carton. All types of drugs were found in the same box. It took many people several days to sort, repack and relabel them. This created an extra workload on already overstretched and precious human resources.

The need for a policy on donations

The cause of these problems could usually be traced to poor understanding of the situation, poor communication links between recipient and donor, and lack of awareness by those conducting appeals. Our experience on irrational and inappropriate donations therefore raised the issue of the urgent need for specific guidelines for both recipients and donors.

In the interim period after the war, before locally manufactured Pharmaceuticals were available, the country continued to depend on donations. However, experience gained during the war led to a number of developments concerning appeals and careful attention was paid to criteria and guidelines.

A national list of drugs was established in 1993 and is applied to the procurement of Pharmaceuticals and requests for donations. Donors are now informed of requirements, and only items on the national list are accepted. The Ministry of Health has circulated a letter to all embassies abroad requesting them to pass this information on to potential donors.

The following protocol has been established by our country:

1. The Ministry of Health must give approval before drugs or medical supplies are shipped to Eritrea.

2. All donations should comply with the national list, including supplies from church-related organizations.

3. Hospitals and health facilities are not allowed to make individual arrangements. All requests should be pooled through the government and individual collection of drugs is actively discouraged.

4. Donations of generic drugs are encouraged. All labelling should be in English.

5. Except for those cases where drugs have a short shelf-life, all donated drugs should have a 50% remaining shelf-life on arrival. Donations of free samples or drugs that have been partially used and returned to pharmacies are not allowed in the country.

6. Financial contributions are preferred.


Inspection on arrival ensures compliance, and materials that are not on the national list are not accepted. All individual donations, or those from private associations which comply with specifications, will be pooled at the Central Medical Store.

Although improvement has been made, efforts to further rationalize should continue. The recent publication of the Guidelines for Drug Donations should have a significant impact on awareness of the situation. I hope that our country's experience will be of help to others in similar circumstances. In conclusion, I should like to give thanks to the various groups and organizations concerned by our plight. Their support has been invaluable and we shall always remember their generosity with gratitude.

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Dernière mise à jour: le 3 mai 2013