Global Hand recommends the WHO Guidelines for Drug Donations as summarised here. By describing “good donation practice”, these guidelines aim to improve the quality of drug donations.

The following is designed to be read in light of Principles and Cross-referential Issues.

Feedback? We would be grateful to hear from you if you have:

• Relevant resources
• Comments or suggestions or stories
• Stories of product unwisely/wisely placed.

Please email us at enquiries@globalhand.org

1.2. Drugs & pharmaceuticals

Global Hand recommends the WHO Guidelines for Drug Donations as summarised here. By describing “good donation practice”, these guidelines aim to improve the quality of drug donations.

Please note that, while the Guidelines are specific about issues such as selection of drugs, quality assurance, and presentation and packaging, they often allow for “Possible exceptions”. For example, while Guideline 6 says that “all donated drugs should have a remaining shelf-life of at least one year”, it does go on to say that"an exception may be made for direct donations to specific health facilities."

Member comments:
It was pointed out that the section on Drugs & Pharmaceuticals (1.2.) covers donated drugs, but does not cover purchased drugs, which are of equal importance in terms of usefulness and appropriateness. The GH member said that we need to ensure these standards are applicable to both donated and purchased items. A suggested solution could be to replace “drug donations” with “drug procurements”.

1.2.1.The four core principles are:

Core principles, WHO Guidelines for Drug Donation revised 1999

1.2.1.1.

“Maximum benefit to the recipient”.

1.2.1.2.

“Respect for wishes and authority of the recipient”.

1.2.1.3.

“No double standards in quality”.

1.2.1.4.

“Effective communication between donor and recipient.”

The 12 guidelines for drug donations are:

Guidelines for Drug Donations, WHO Guidelines for Drug Donation revised 1999

1.2.2

Selection of drugs

1.2.2.1.

“All drug donations should be based on an expressed need and be relevant to the disease pattern in the recipient country. Drugs should not be sent without prior consent by the recipient.”

1.2.2.2.

“All donated drugs or their generic equivalents should be approved for use in the recipient country and appear on the national list of essential drugs, or, if a national list is not available, on the WHO Model List of Essential Drugs, unless specifically requested otherwise by the recipient.”

1.2.2.3.

“The presentation, strength and formulation of donated drugs should, as much as possible, be similar to those of drugs commonly used in the recipient country.”

1.2.3.

Quality assurance and shelf-life

1.2.3.1.

“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 Commerce should be used.”

1.2.3.2.

“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.”

1.2.3.3.

“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.”

Member comments:
In section 1.2.3.3., the WHO Guidelines state that “all donated drugs should have a remaining shelf-life of at least one year”. The guidelines do allow for exceptions for"specific health facilities", but do not allow exceptions for health bodies, such as regional health offices or the local Ministry of Health. One Global Hand member regularly sends goods to such umbrella bodies, who would prefer to have short-shelf or extend-life drugs, rather than nothing. This member would like this guideline to be extended to include such official health umbrellas.

1.2.4

Presentation, packing and labelling

1.2.4.1.

“All drugs should be labelled in a language that is easily understood by health professionals in the recipient country; the label on each individual container should at least contain the International Nonproprietary Name (INN) or generic name, batch number, dosage form, strength, name of manufacturer, quantity in the container, storage conditions and expiry date.”

1.2.4.2.

“As much as possible, donated drugs should be presented in larger quantity units and hospital packs.”

1.2.4.3.

“All drug donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list which specifies the contents of each numbered carton by INN, dosage form, quantity, batch number, expiry date, volume, weight and any special storage conditions. The weight per carton should not exceed 50 kilograms. Drugs should not be mixed with other supplies in the same carton.”

Member comments:
In reference to 1.2.4.3, it was requested that Global Hand extend this standard to allow shipments with homogeneous pallets to list the contents of each pallet, rather than individual boxes. It was also requested that a box count is not enforced when goods are received on pallets from the manufacturer, especially for shipments that are sent directly from manufacturer to the field.

1.2.5.

Information and management

1.2.5.1

“Recipients should be informed of all drug donations that are being considered, prepared or actually under way.”

1.2.5.2.

“In the recipient country the declared value of a drug donation should be based upon the wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale world-market price for its generic equivalent.”

1.2.5.3.

“Costs of international and local transport, warehousing, port clearance and appropriate storage and handling should be paid by the donor agency, unless specifically agreed otherwise with the recipient in advance.”

See the WHO Guidelines for Drug Donations revised 1999 for further detail.

Member comments:
One member has informed Global Hand that costs are often met by a third party, such as a local Rotary club, or a humanitarian partner organisation. Therefore, they have requested that other potential payees, such as these, be listed under section 1.2.5.3.