Ethical challenges in designing and conducting medicine quality surveys

Poor quality medicines and medical products jeopardize national, regional and global attempts to improve access to effective treatment and health care. Both poor quality manufacture and deliberate falsification of medicines are widespread and many examples have been highlighted globally. Ethically designed surveys are essential for an in-depth understanding of this phenomenon to ensure corrective actions. Objectives: In this paper we identify and discuss the main ethical challenges related to the conduct of surveys and make suggestions on how to address them. Methods: 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 upholds moral and ethical obligations and analyses the ethical implications and consequences of such work, i.e. 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 concerned national Medicine Regulatory Authorities (MRA). An international, but contextually sensitive, model of good ethical practice for such surveys is needed.