Guidelines & Codes
WHO Guidelines for Drug Donations
The World Health Organisation has developed guidelines to improve the quality of medicine donations around the world. Donations should maximally benefit the recipient and be based on expressed need - not just sent. Donations should be made respecting the recipient government’s health policies. If a medicine is of unacceptable quality for use in New Zealand it should not be donated.
The World Health Organisation (WHO) says many donated medicines are often not relevant for the emergency situation, the disease, or level of care available. They are often unknown by local health professionals and may not comply with locally agreed medicine policies. Some may even be dangerous.
Citing examples of problems with medicine donations, WHO referred to a case in Lithuania in 1993 where 11 women temporarily lost their eyesight after using a donated medicine which was mistakenly used to treat endometritis. The medicine had been received without product information or a package insert.
After the earthquake in Armenia in 1988, 5000 tons of medicines and medical supplies were donated. It took 50 people six months to gain a clear picture of what had been received and less than half were relevant for an emergency situation.
Core principles of a donation
WHO guidelines
Core principles of a donation
- Donations should benefit the recipient to the maximum extent possible.
- Donations should be given with full respect for the wishes and authority of the recipient and support existing government health policies.
- If the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation.
- There should be effective communications between the donor and recipient - the donation should be based on expressed need and not be sent unannounced.
WHO guidelines
- all medicine donations should be based on expressed need and be relevant to the disease pattern in the recipient country and not sent without prior consent;
- all donated medicines should be approved for use in the recipient country and appear on the national list of essential drugs (or if not available, on the WHO Model List of Essential Drugs). An exception can be made for medicines needed in sudden outbreaks of uncommon or newly emerging diseases, since such medicines may not be approved for use in the recipient country;
- the presentation, strength and formulation of donated medicines should, as much as possible, be similar to those used in the recipient country;
- all donated medicines should be obtained from a reliable source and comply with quality standards in both donor and recipient country;
- no medicines should be donated that have been issued to patients and then returned to a pharmacy, or elsewhere, or given as free samples;
- after arrival in the recipient country, all donated medicines should have a remaining shelf-life of at least one year;
- all donated medicines should be labelled in a language that is easily understood by health professionals in the recipient country and contain information including generic name, batch number, dosage form, strength, name of manufacturer, quantity in container, storage conditions and expiry date;
- as much as possible, donated medicines should be represented in larger quantity units and hospital packs;
- all medicine donations should be packed in accordance with international shipping regulations and be accompanied by a detailed packing list. The weight per carton should not exceed 50kg and medicines should not be mixed with other supplies in the same carton;
- recipients should be informed of all medicine donations being considered, prepared or actually underway;
- in the recipient country the declared value of a medicine donation should be based upon wholesale price of its generic equivalent in the recipient country or the wholesale world-wide market price;
- costs of international and local transport, warehousing, port clearance, and storage and handling should be paid by the donor agency unless otherwise agreed.
To obtain a copy of these guidelines contact your local Regional Medicine Control Office.