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The 130th Annual Meeting of APHA |
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The 130th Annual Meeting of APHA |
David Lee, MD, Center for Pharmaceutical Management, Management Sciences for Health, 4301 North Fairfax Drive, Suite #400, Arlington, VA 22203, 703-248-1612, dlee@msh.org
Access to pharmaceuticals is not achieved if the quality of products and services do not meet established standards that ensure their safe and effective use. In many developing countries retail pharmaceutical outlets are often the most important sources of health care advice and treatment. Although clients may perceive otherwise, there are significant concerns about drug product quality and the quality of service delivery.
Some recent studies have shown that between 0% and 27% of a small sample of essential medicines available at retail pharmaceutical outlets in several countries have been found to be substandard. Indicator-based assessments have also documented the need for improving the quality of pharmaceutical services (information and advice given, product availability, setting and materials for dispensing).
Efforts to ensure pharmaceutical product quality require effective involvement of the national drug regulatory authority, suppliers (manufacturers, importers, wholesalers, and distributors), and retailers. A priority-based approach to product testing needs to be an essential component of overall pharmaceutical product quality assurance programs that include supplier and product documentation evaluation, inspections (e.g., Good Manufacturing Practices, product compliance with specifications), product problem reporting and monitoring, evaluation, and standards enforcement.
A limited number of strategies to improve quality of pharmaceutical services have been evaluated recently. Examples include face-to-face training on diarrhea treatment in Kenya and Indonesia, and constructive inspection and enforcement of regulations in Laos. Initiatives that combine business incentives with education, supervision and standards enforcement are currently being explored. There are no simple solutions to enhance quality of pharmaceutical services. The most effective strategies will likely be multi-faceted, combining sustainable approaches that effectively address regulatory enforcement/ compliance, provider incentives, and education of providers, patients and communities.
Learning Objectives:
Keywords: Access to Care, Prescription Drug Use Patterns
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.