|Guidelines for drug donations: Revised 1999 (Caritas - WCC - ICRC - IFRC - FIP - UNAIDS - MSF - UNHCR - Oxfam - PSF - UNICEF - UNDP - UNFPA - WB - WHO/EDM, 1999, 24 p.)|
|VI. How to implement a policy on drug donations|
Define national guidelines for drug donations
It is difficult for a recipient to refuse a donation that has already arrived. Prevention is therefore better than cure. Recipients should indicate to their prospective donors what kind of assistance they need, and how they would like to receive it. If this information is provided in a professional way, most donors will appreciate it and will comply.
Therefore, recipients should first formulate their own national guidelines for drug donations on the basis of the international guidelines. They can also be included in the national drug policy. These national guidelines should then be officially presented and explained to the donor community. Only after they have been presented and officially published can they be enforced.
Define administrative procedures for receiving drug donations
It is not enough for the recipient to adopt and publish the general guidelines on the selection, quality, presentation and management of drug donations. Administrative procedures need to be developed by the recipient to maximize the potential benefit of drug donations. As much as possible such arrangements should be linked with existing drug supply systems, but there are several decisions to be made which apply to donations only. Examples of such important issues, which have to be addressed in each country, are:
· Decide who is responsible for defining the needs, and who will prioritize them.
· Decide who coordinates all drug donations.
· Which documents are needed when a donation is planned; who should receive them?
· Which procedure is used when donations do not follow the guidelines?
· What are the criteria for accepting/rejecting a donation, and who makes the final decision?
· Decide who coordinates reception, storage and distribution of the donated drugs.
· How are donations valued and entered into the budget/expenditure records?
· How will inappropriate donations be disposed of?
Specify the needs for donated drugs
The third important action by the recipient is to specify the needs for donated drugs as much as possible. This puts the onus on the recipient to carefully prepare requests, indicating the required quantities and prioritizing the items. The more information given, the better. Information on donations that are already in the pipeline, or anticipated, is very helpful to other potential donors. Full information from the side of the recipient is greatly appreciated by donors and pays off in the long run.
Manage drugs with less than one-year expiry
Drugs do not become toxic or ineffective on their date of expiry but may slowly deteriorate depending on the product, formulation and storage conditions. Some become toxic but most simply lose their efficacy. An expiry date is the date given on the individual container (usually on the label) of a drug product, up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life period to the date of manufacture. The recommendation that all drugs should have a remaining shelf-life of at least one year upon arrival in a recipient country is to allow for the all too frequent in-country distribution delays. It gives a measure of security that patients will receive drugs of good quality.
A specific exception to the one-year shelf-life requirement can be made for donated drugs provided that: they are direct donations to specific health facilities; the responsible professional acknowledges that (s)he is aware they are short-dated; and the quantity and the remaining shelf-life allow for proper administration, distribution and prescription prior to expiry. Experience has shown that some recipient governments have applied the Guidelines very strictly, without due consideration of the possible exceptions to the general rule. This has resulted in unnecessary impounding and disposal of valuable donations.
Ensure rapid customs clearance of donated drugs
Rapid customs clearance is required for all donated drugs. Customs and health ministry officials managing drug donations covered by the Guidelines have the responsible task of allowing entry for useful donations, while rejecting short-dated donations for which satisfactory distribution provisions have not been made.
Manage donated drugs carefully
The value of donated drugs can be considerable, and the gift should be treated with due expedition and care. On arrival the drugs should be inspected and their receipt confirmed to the donor agency. They should then be stored and distributed in accordance with normal principles of good pharmacy practice, and under the responsibility of adequately trained professionals. There must be due vigilance to ensure that donated products are not diverted for export, commercial sale, or into illicit channels. Good donation management also includes agreed systems of accountability.