Abstract

ObjectivesIn this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them.MethodMost 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 conclusionsIt 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.

Highlights

  • Medicines are of vital importance in modern health systems, and access to quality-assured medicines is part of the basic right to health [1, 2]

  • As a first step to address this problem, we identify and discuss the major ethical issues related to the design and conduct of medicine quality surveys

  • We suggest that ethical scrutiny may be required if (i) the survey goes beyond medicine regulatory authorities (MRA) routine surveillance, and/or (ii) if the risk assessment shows that there is more than minimal risk to surveyors, the surveyed or the community, and/or (iii) if it is required by regulations in the country(ies) where the survey is carried out

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Summary

Ethical challenges in designing and conducting medicine quality surveys

Existing research ethical guidelines do not provide specific guidance for medicine quality surveys. 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. Keywords ethics, poor quality, medicines, surveys, falsified and substandard medicines, counterfeit

Introduction
The regulatory context
Impact on the local availability of and access to medicines
Confidentiality and privacy risks to surveyors
The issue of deception
What to do with the information once it has been collated?
Dissemination of findings
The need for ethical and regulatory approval
Conclusions
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