Guidelines

In this section, PQMD highlights resources that focus on advancing medical product donation standards.

These resources are provided to help humanitarian organizations, church groups, individuals and other donors better understand the basic tenets of high quality medical donation practices.

Medical product donations are not and should not be promoted as the solution to the global healthcare crisis. However, appropriate donations do serve as an effective, sustainable mechanism for providing access to needed medical supplies not available by any other means.

To review the WHO Guidelines for Drug Donations, visit http://whqlibdoc.who.int/hq/1999/WHO_EDM_PAR_99.4.pdf. For general information on drug policy, please visit Essential Drugs and Medicines Policy site at WHO.

SEVEN KEY COMPONENTS IN THE COMPREHENSIVE MANAGEMENT OF MEDICAL PRODUCT DONATIONS

The outline that follows was compiled by colleagues at Temple University after interviews with several PQMD members and serves as some practical advice for organizations considering the management of drug and medical donations in a manner consistent with the WHO Guidelines on Drug Donations.

1. NEEDS ASSESSMENT

Whether donations are related to disaster relief efforts or are a component of long-term development projects, the following considerations should be reviewed prior to making an offer to donate:

• The nature of the event, its impacts, expected duration, expected amount of time the population will be displaced or affected;
• Demographics and Socio-economic status of affected populations;
• Status of the existing health care infrastructure and availability of transportation to existing healthcare sites;
• Human resources available to take responsibility for and to appropriately dispense prescription medication;
• Recipients' customary modes of treating diseases that are likely to be encountered;
• Affected area's location, accessibility, climatic conditions and security status;
• Rules and regulations of local recipient governments;
• Contacts for key MOH/other country personnel;
• Receptivity of local authorities to foreign humanitarian operations in their country.

2. APPROPRIATENESS OF THE DONATION

• The donated products should be on the recipient's documented list of requested products. If not, shipment should not be made without the recipient's explicit written approval.
• Strengths/dosages/formulations of donated products should be comparable to those with which recipients are familiar and consistent with the country's health policy.
• Dosages, strength and formulations should fit the needs of specific populations to be treated, e.g., infants.

3. QUALITY AND QUANTITY

• The quality of the product must be foremost, whether demonstrated by evidence of conformance to compendial standards supplied by the donor, ascertained by an independent laboratory or past experience with the donating company's products. Similarly, the availability of proper storage and inventory controls must be assured.
• The product's generic name must appear on the package and shipping documents, along with other relevant information, e.g., quantity, expiration date, lot and control numbers and storage/temperature requirements.
• Drugs with less than 12 months dating must not be shipped without prior acceptance, and the donor should gain absolute assurance in such cases that the product will be utilized before expiry.
• To avoid creating excess inventory problems, donor non-governmental organizations (NGOs) should have procedures in place to ensure that any excess or expired donations are destroyed in accordance with the manufacturer's/donor's prescribed procedures and applicable government regulations/WHO guidelines. Drugs requiring special equipment for use, such as injectables, should not be shipped before the recipient confirms the availability of the needed equipment in writing or such equipment is made available as part of the donation.
• Prescribing information in a language likely to be understood by recipients must accompany every donation.
• Returned drugs, whether from consumers or others, must not be donated, given the uncertainty of conditions under which such products are stored.
• Quantities donated should fit the documented need, so that the donation is neither wasted nor becomes an environmental problem.

4. PACKAGING

• Shipping documents should be clear and readily understandable by persons operating in the field. To that end, PQMD and Essential Drugs and Medicines (EDM) should collaborate to develop a uniform recommended format.
• Packaging must take account of any climatic conditions encountered in the recipient country.
• Glass syringes, bottles, etc. must be packed to avoid breakage.
• Products requiring refrigeration and/or maintenance of a cold-chain must be prominently labeled to that effect and should contain control thermometers.
• Protective packing should take account of the mode of transportation chosen.
• Cases, bagged or boxed units should be small and light enough to be managed by hand.
• If more than one product is packed in one box, there must be a content list for each box with all the required instructions/inserts enclosed per each unique unit.
• Labeling and packaging should be in a language easily understood by most health care professionals in the recipient country.

5. TRANSPORTATION

• The means of transportation should be appropriate to the circumstances of the donation, whether by air or surface, taking costs into consideration.
• Costs of transportation should be addressed in advance and should not be borne by the recipient governments.
• The shipping documents should be clear and should contain all the data and information agreed to be essential by PQMD and EDM.
• Arrangements to pay required duties must be made in advance or Duty Free Clearance Status must be obtained before shipment arrives in country.
• Shipping should be in accordance with the receiving country's policies.
• Drug donations for emergency use should be sent by the most expeditious means available, depending on the proximity of the recipient to the donor.
• The consignment should be insured.
• Arrangements for any necessary storage should be made prior to shipping.
• Only qualified, licensed (where needed), reliable transport companies should be employed to transport donated pharmaceuticals.

6. UTILIZATION OF HUMAN RESOURCES

• Personnel involved in packing and transporting drugs should have knowledge of field conditions.
• The labeling must clearly identify the product's generic name, the expiration date and other relevant information, to facilitate proper sorting, storage and utilization.
• Recipients should be provided with the name(s) of responsible contacts at the donor agency in the event questions arise.
• Prior to shipping, the donor must ascertain the extent of human resources/staffing available in the recipient country to handle the product and whether the recipient has reviewed its existing inventory to ensure that the donation is needed.

7. EVALUATION

• The donor company and its Non-governmental Organizational Partners (NGO) should have a plan in place to evaluate donations periodically and as needed, so as to measure the effects of donations, both long- and short-term, and to learn from successes and missteps. The plan should provide ready access to recipients so as to facilitate feedback.
• When appropriate, reports and recommendations on post-donation evaluations should be made public in order to share lessons learned as well as progress made.
• Evaluations should include site inspections and dispensary record keeping.