Title: Multi-Country Participatory Evaluation of the Implementation of the WHO Ethical

Title: Multi-Country Participatory Evaluation of the Implementation of the WHO Ethical Criteria for Medicinal Drug Promotion: Networking Tools for Monitoring and Evaluation

Author Name: NiyadaKiatying-Angsulee

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Presenter Name: NiyadaKiatying-Angsulee

Authors: Kiatying-Angsulee N, Pham HD, Hidayati S, Khotsay K

Institutions: Social Pharmacy Research Unit and College of Public Health, Chulalongkorn University, Bangkok; Institute for Health and Development, Vietnam; INRUD/Indonesia; Food and Drug Department, Lao PDR

Problem Statement: The World Health Organization’s Ethical Criteria for Medicinal Drug Promotion (WHO-EC) was initiated and published in 1988, but implementation lags behind. There are scattered reports on this issue world-wide. A trend toward free trade in the Asia Pacific region might lead to increased unethical use of medicines.

Objective: To improve the health of people in Asian Pacific countries by decreasing unethical drug promotion via the implementation of networking tools among these countries.

Design: Time-series studies were conducted by devising tools with the consensus of six countries and then implementing the first phase in each country. After that the tools were revised for the second phase. Changes in situations were observed and analyzed.

Methods: Networking was set up by working together on the same research concept and protocol, communicated via sets of workshops and information sharing on intervention means and current status. Results from member countries were compared and used in each country as interventions, depending on local perspectives.

Setting and Study Population: Regulatory agencies, professional associations, universities, industry, and the media in six countries in the first phase and in four countries (Thailand, Vietnam, Indonesia, Lao PDR) in the second phase.

Intervention: A data collection study was devised as the first tool for intervention, followed by various methods such as an educational strategy by communicating the situation to stakeholders in drug policy making including drug authorities, industry, professionals, university personnel, and the media.

Outcome Measures: Changes in illegal and/or unethical promotional practices (drug advertisement and symposia), regulatory status (laws, regulations and codes of professionals and industry associations), and awareness of WHO-EC among stakeholders in all countries during the second phase of the study.

Results: The study created awareness and brought about changes in regulations and professional association codes. Thailand had greater awareness of the WHO-EC and more use of generic names in advertising than the other countries. The intervention study in Vietnam was successful in using research evidence to inform stakeholders in drug policy making. The study suggests the development of a monitoring mechanism for identification of unethical aspects of drug promotion; improvement of drug promotion practices may also increase rational drug use. In Indonesia, it was found that despite the growing number of drug ads in all media, the quality of information in the ads was better during the second phase of the study. Laos has promulgated regulations concerning ads, which has improved the situation in that country.

Conclusions: Networking—several countries working together from situation analysis to intervention tools and evaluation—can be a vital tool for monitoring drug promotional practices.

Study Funding: AusAID; Commonwealth Department of Human Services and Health, Thailand; Swedish International Development and Cooperation Agency; WHO (for Multi-Country WHO-EC Project)