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Appendix 1 - Staff Expertise in the Delivery of Medicines
| WHO Guidelines | Staff Knowledge | Staff Ability |
|---|---|---|
| For all donations activities | A professional with a degree in pharmacy should supervise the management of drugs used in Donations of Medicines programs. The applicant should submit evidence of this professional qualification, including: a copy of their degree in pharmacy obtained from a recognized university in Canada or abroad. Foreign graduates should also provide a letter of document evaluation from the Pharmacy Evaluation Board of Canada in order to ensure their degree program is acceptable to the board. The candidate should have reasonable experience in their field. | |
| Guideline 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. | Ability to assess if requested medicines are appropriate for relevant disease pattern. | |
| Guideline 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. | Knowledge of the commercial and generic naming conventions for drugs. Knowledge of the WHO Model List of Essential Drugs. | Ability to analyze national drug policies and essential drug programs in less-developed countries. |
| Guideline 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. | Knowledge of conventions and considerations concerning the presentation, strength, and formulation of drugs. | Ability to assess if the presentation, strength, and formulation of donated drugs are sufficiently similar to those of drugs commonly used in recipient country. |
| Guideline 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 Commerce should be used. | Knowledge of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Knowledge of current good manufacturing practices (GMPs) for drugs. | Ability to assess potential drug donors. |
| Guideline 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. | Knowledge of considerations around returned drugs and drug samples. | |
| Guideline 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. | Knowledge of safety and policy issues related to the shelf life of drugs, including Health Canada policies on shelf life extension. | |
| Guideline 7 - All drugs should be labelled in a language that is easily understood by health professionals in the recipient countryhe 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. | Knowledge of conventions related to the labelling of drugs and of the WHO Guidelines. | Ability to ensure donated drugs delivered outside of Canada are labelled in accordance with the WHO Guidelines. |
| Guideline 8 - As much as possible, donated drugs should be presented in larger quantity units and hospital packs. | Ability to ensure that drugs are presented in larger quantity units and hospital packs, appropriate to the specific needs of the recipient country. | |
| Guideline 9 - 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. | Knowledge of considerations related to appropriate packing of drugs for delivery for use in charitable activities outside of Canada. | |
| Guidelines 10, 11, 12 Guideline 10 - Recipients should be informed of all drug donations that are being considered, prepared, or actually under way. Guideline 11 -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.) Guideline 12 - 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. |
Ability to manage the delivery of donated drugs and for use in charitable activities outside of Canada, including providing proper notification to recipients; conducting valuations of drugs; and managing local transport, warehousing, port clearance, storage, and handling in the recipient country. (This ability applies to Guidelines 10, 11 and 12) |
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| Guideline 12 - 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. | Knowledge of the best practices, requirements, and considerations for maintaining the safety and quality of drugs in the transportation, storage, handling, and distribution of those drugs, both internationally and locally. |
