PQMD PRINCIPLES AND STANDARDS
The PQMD Principles and Standards (Standards) serve to inform and guide medical donation practices while allowing for the flexibility needed to operate in diverse operating environments around the world. PQMD members donate, deliver, distribute and use donated medical products in 150 countries, including the United States. Products support relief camps, field clinics, and community clinics, small and large hospitals. The infrastructure, regulations, customs, and operating environments vary, and a one-size-fits all standards are not feasible or desirable. Overly prescriptive standards can result in unintended consequences that undermine the ability of an organization to carry out their mission and prevent essential medicines from reaching patients.
The Standards complement, rather than replace, each organization’s existing quality program management and service delivery policies and procedures. The criteria outlined in the Standards help users identify the key elements of a quality donation program. Donations should be determined by in-country assessments, requested product type and quantity, properly packaged and transported, familiar, readable and usable by local healthcare workers and suitable for the current needs and culture of the community. The Standards also serve to educate donors on how to identify appropriate donations and more importantly, how to choose an experienced nonprofit partner that is able to effectively and strategically deploy donations.
PQMD’s Resource Library and website provide a range of information and tools that offer guidance for both donors and humanitarian organizations. PQMD provides the materials at no cost and can be downloaded or viewed online. The case studies and PQMD forum presentations examine all components of medical donation practice as well as explore the issues shaping global health, corporate contribution programs and cross sector collaboration. Please contact us for additional assistance, provide material for the library or suggest how to improve the site.
PQMD Principles and Standards
PQMD Principles and Standard - Download PDF Version
History of the PQMD Principles and Standards
Mission Possible: Training Video and Standards Resource
History of the PQMD Principles and Standards
In 1996 the World Health Organization (WHO) published Inter-agency Guidelines intended to ensure future donations would be both appropriate and effective. However, the guidelines raised several concerns among relief and humanitarian agencies and healthcare firms. Foremost was the concern that much needed medical donations might either be reduced or discouraged. Additionally, many asked that the benefits of donations be more fully elaborated upon in future editions of the Guidelines.
It was against this backdrop that an informal alliance of private voluntary agencies and pharmaceutical and medical device companies was formed in 1996 and formally incorporated in 1999 as the Partnership for Quality Medical Donations (PQMD). Its membership shared a common commitment to address these concerns and advance effective and appropriate medical donations.
Working with Temple University and after interviews with several PQMD members, PQMD published The Seven Key Components in the Comprehensive Management of Medical Product Donations. The Guidelines provided some practical advice for organizations considering the management of drug and medical donations in a manner consistent with the WHO Guidelines on Drug Donations.
In 2010 PQMD renamed the Guidelines the Principles and Standards to reflect a commitment to developing quality voluntary standards using the American National Standards Institute’s cardinal principles of consensus, due process and openness. PQMD then applied the ANSI principles and procedures to guide the development of the eighth standard - Valuation.
We aren't finished yet. PQMD is further expanding its commitment to quality practices by seeking ANSI accreditation for its standards activities and determining the feasibility of a certification program designed to build the capacity of medical donation management programs.
Mission Possible Training Video
Mission Possible, a partially animated, 30-minute film discusses the professional standards, networks and basic knowledge required to enable effective, efficient supply chain management for the delivery of health care supplies. The main character, Agent Rex, guides the viewer on a secret mission to deliver the right amount of product on time to patients everywhere. Specifically designed to fit within established training curricula, the video, on its own, provides a basic primer in the field of health care logistics, highlighting the opportunities of this growing profession. It provides a foundation for Principles and Standards implementation.
To learn how to implement PQMD Principles and Standards order the free training video and materials, click here for more information, to watch the video online or to order.
PRINCIPLES AND STANDARDS IN THE COMPREHENSIVE MANAGEMENT OF MEDICAL PRODUCT DONATIONS
Appropriateness of the Donation
Quality and Quantity
Utilization of Human Resources
1. NEEDS ASSESSMENT
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 medication;
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. APPROPRIATENESS OF THE DONATION
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.
3. QUALITY AND QUANTITY
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 expiry.
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.
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 governments.
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. UTILIZATION OF HUMAN RESOURCES
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.
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 request.
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 available.
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