Ethical challenges in designing and conducting medicine quality surveys.

OBJECTIVES: In this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them. METHOD: Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented. RESULTS AND CONCLUSIONS: It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed

Fake anti-malarials: start with the facts.

This meeting report presents the key findings and discussion points of a 1-day meeting entitled 'Fake anti-malarials: start with the facts' held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium's drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting

Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?

Fake artesunate could compromise the hope that artemisinin-based combination therapy offers for malaria control in Africa and Asia

Guidelines for Field Surveys of the Quality of Medicines: A Proposal

Paul Newton and colleagues propose guidelines for conducting and reporting field surveys of the quality of medicines

A Collaborative Epidemiological Investigation into the Criminal Fake Artesunate Trade in South East Asia

Paul Newton and colleagues' international, collaborative study found evidence that counterfeit artesunate was being manufactured in China, which prompted a criminal investigation

6 - The ‘demand’ for poor quality medicines

When supplies of a product continue to be available, it is a clear indication that there is a continued ‘demand’ for that product. Why, then, do people in the Mekong Subregion ‘demand’ poor quality medicines which might cause harm to their health? Most of the studies on medicines with poor quality focus on their supply. There have not been adequate concrete studies that help provide relevant insights into the demand side of this issue. Supply and demand meet at a given price. ‘Demand’ can be ..

Introduction

As waves of emerging and re-emerging diseases send repercussions around the world time and again, the global community has come to realize the interconnectedness of our world, of its countries, peoples, and activities. Today, what happens in one place can have an impact far beyond the boundary of a geographical locale. The world community pulls together to examine the many interrelated factors causing epidemics that are difficult to contain, and to re-examine old issues in a new light. Medici..

1 - The Mekong Subregion and Medicine Quality

1.1 - Legal Framework for Medicine Quality in the Five Countries Substandard and counterfeit medicines exist in the Mekong Subregion despite the existence of legal frameworks and regulatory systems designed to control them. Although legal definitions and requirements of substandard and counterfeit medicines under the laws in each country might differ, these two categories of medicines both fall within the realm of regulation. The following sections provide brief reviews of the legal d..