Guidelines for Drug Donations - Revised 1999
(1999; 24 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoChanges incorporated into the 1999 edition
Ver el documentoI. Introduction
Ver el documentoII. The need for guidelines
Ver el documentoIII. Core principles
Cerrar esta carpetaIV. Guidelines for drug donations
Ver el documentoSelection of drugs
Ver el documentoQuality assurance and shelf-life
Ver el documentoPresentation, packing and labelling
Ver el documentoInformation and management
Abrir esta carpeta y ver su contenidoV. Other ways donors can help
Abrir esta carpeta y ver su contenidoVI. How to implement a policy on drug donations
Ver el documentoAnnex: Examples of problems with drug donations
Ver el documentoAcknowledgements
Ver el documentoReferences
Ver el documentoBack Cover
 

Quality assurance and shelf-life

4. All donated drugs should be obtained from a reliable source and comply with quality standards in both donor and recipient country. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce7 should be used.

Justification and explanation

This provision prevents double standards: drugs of unacceptable quality in the donor country should not be donated to other countries. Donated drugs should be authorized for sale in the country of origin, and manufactured in accordance with international standards of Good Manufacturing Practice (GMP).

Possible exceptions

In acute emergencies the use of the WHO Certification Scheme may not be practical. However, if it is not used, a justification should be given by the donor. When donors provide funds to purchase drugs from local producers, those which comply with national standards should not be excluded on the sole grounds that they do not meet quality standards of the donor country.

5. No drugs should be donated that have been issued to patients and then returned to a pharmacy or elsewhere, or were given to health professionals as free samples.

Justification and explanation

Patients return unused drugs to a pharmacy to ensure their safe disposal; the same applies to drug samples that have been received by health workers. In most countries it is not allowed to issue such drugs to other patients, because their quality cannot be guaranteed. For this reason returned drugs should not be donated either. In addition to quality issues, returned drugs are very difficult to manage at the receiving end because of broken packages and the small quantities involved.

6. After arrival in the recipient country all donated drugs should have a remaining shelf-life of at least one year. An exception may be made for direct donations to specific health facilities, provided that: the responsible professional at the receiving end acknowledges that (s)he is aware of the shelf-life; and that the quantity and remaining shelf-life allow for proper administration prior to expiration. In all cases it is important that the date of arrival and the expiry dates of the drugs be communicated to the recipient well in advance.

Justification and explanation

In many recipient countries, and especially under emergency situations, there are logistical problems. Very often the regular drug distribution system has limited possibilities for immediate distribution. Regular distribution through different storage levels (e.g. central store, provincial store, district hospital) may take six to nine months. This provision especially prevents the donation of drugs just before their expiry, as in most cases such drugs would only reach the patient after expiry. It is important that the recipient official responsible for acceptance of the donation is fully aware of the quantities of drugs being donated, as overstocking may lead to wastage. The argument that short-dated products can be donated in the case of acute emergencies, because they will be used rapidly, is incorrect. In emergency situations the systems for reception, storage and distribution of drugs are very often disrupted and overloaded, and many donated drugs tend to accumulate.

Additional exception

Besides the possible exception for direct donations mentioned above, an exception should be made for drugs with a total shelf-life of less than two years, in which case at least one-third of the shelf-life should remain.

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