PQMD Principles and Standards Background by niusheng11


									PQMD Principles and Standards

The Partnership for Quality Medical Donations (PQMD) is a unique alliance of non-profit and corporate
organizations committed to bringing measurable health impact to underserved and vulnerable people
through active engagement with global partners and local communities. The Partnership for Quality
Medical Donations includes manufacturers of pharmaceuticals, medical devices, medical equipment, and
the non-profit organizations that use and distribute donated products in developing countries. PQMD
members commit to raising medical donation standards, promoting effective donation practices and
informing policy makers and the public on quality donation practices. We accomplish this through setting
and promoting quality standards, conducting research, disseminating knowledge and influencing policy.

PQMD members and their partners combine product contributions with cash, volunteers, training and
other services to support a wide range of global health programs. Members work together with
multilateral, national and sub-national governments, other companies and INGOs, to pursue disease
eradication, develop healthcare infrastructure, build the capacity of in-country healthcare workers, and fill
gaps in local health services.

PQMD Members: Abbott, Alcon, AmeriCares, AstraZeneca, Baxter, BD, Boehringer Ingelheim
Pharmaceuticals, Inc., Bristol-Myers Squibb, Catholic Medical Mission Board, Direct Relief International,
Eli Lilly and Company, Genzyme, GlaxoSmithKline, Heart to Heart International, Henry Schein, Inc.,
Hospira, Inc., IMA World Health, International Health Partners (UK), International Medical Corps, Johnson
& Johnson, MAP International, Medical Teams International, MediSend International, Merck & Co, Inc.,
Mercy Ships, National Cancer Coalition, Pfizer Inc., Project HOPE, sanofi-aventis US, Tulipe, U.S. Fund
for UNICEF and World Vision.

2011                                  PQMD Principles and Standards                               Page 1 of 5

                            Advancing Quality Medical Donations Worldwide
                                     PRINCIPLES AND STANDARDS


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

   2.1. 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.
   2.2. Strengths/dosages/formulation s policy.
   2.3. Dosages, strength and formulations should fit the needs of specific populations to be treated,
         e.g., infants.

2011                                 PQMD Principles and Standards                                  Page 2 of 5

                            Advancing Quality Medical Donations Worldwide
   3.1. 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.
   3.2. 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.
   3.3. 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
   3.4. 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.
   3.5. Prescribing information in a language likely to be understood by recipients must accompany
         every donation.
   3.6. Returned drugs, whether from consumers or others, must not be donated, given the uncertainty
         of conditions under which such products are stored.
   3.7. Quantities donated should fit the documented need, so that the donation is neither wasted nor
        becomes an environmental problem.

   4.1. 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.
   4.2. Packaging must take account of any climatic conditions encountered in the recipient country.
   4.3. Glass syringes, bottles, etc. must be packed to avoid breakage.
   4.4. Products requiring refrigeration and/or maintenance of a cold-chain must be prominently labeled
         to that effect and should contain control thermometers.
   4.5. Protective packing should take account of the mode of transportation chosen.
   4.6. Cases, bagged or boxed units should be small and light enough to be managed by hand.
   4.7. 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.
   4.8. Labeling and packaging should be in a language easily understood by most health care
         professionals in the recipient country.

2011                                PQMD Principles and Standards                               Page 3 of 5

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

   6.1. Personnel involved in packing and transporting drugs should have knowledge of field conditions.
   6.2. The labeling must clearly identify the product's generic name, the expiration date and other
         relevant information, to facilitate proper sorting, storage and utilization.
   6.3. Recipients should be provided with the name(s) of responsible contacts at the donor agency in
         the event questions arise.
   6.4. 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.

2011                                PQMD Principles and Standards                               Page 4 of 5

                           Advancing Quality Medical Donations Worldwide
   7.1. 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.
   7.2. When appropriate, reports and recommendations on post-donation evaluations should be made
        public in order to share lessons learned as well as progress made.
   7.3. Evaluations should include site inspections and dispensary record keeping.

   8.1 Compliance An organization’s valuation framework should be compliant with generally accepted
   accounting principles.
       8.1.1 The organization’s valuation framework should be internally consistent in application.
       8.1.2 Financial reviews should be conducted to ensure compliance with generally accepted
       accounting principles.
   8.2 Transparency An organization’s valuation framework should be clear and transparent.
       8.2.1. A concise description of the valuation framework should be available to the public upon
       8.2.2. Audited financial statements should be available to the public upon request.
   8.3. Explicit Documentation An organization’s process used to determine product or service values
   should be explicitly documented through written practices or procedures.
       8.3.1. The organization should maintain regular internal documentation demonstrating
       compliance with its practices or procedures.
   8.4. Applicability Valuation frameworks for products or services should use methods that are
   practical and reasonable.
       8.4.1. The value should accurately reflect the attributes of the products or services.
       8.4.2. Product or service values should be determined by verifiable, active market data where

2011                                PQMD Principles and Standards                               Page 5 of 5

                           Advancing Quality Medical Donations Worldwide

To top