Pharmacovigilance and Public Health Ethics
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CURRENT OPINION
Pharmacovigilance and Public Health Ethics Torbjo¨rn Callre´us
Published online: 20 April 2013 Ó Springer International Publishing Switzerland 2013
Abstract Traditionally, bioethics has focused on the obligations of healthcare professionals and the rights of individual patients as well as participants in clinical research. However, in recent years, this center of attention has been questioned and a new ‘‘Public Health Ethics’’ has emerged. It argues that when dealing with ethical issues related to research or interventions, the health of groups and populations should be considered and not only that of individuals. This article reviews the background to the current debate on Public Health Ethics as well as some ethical theories and principles guiding its development. Following a discussion of issues in pharmacovigilance with an ethical dimension, the article explores the potential implications of the emergence of a Public Health Ethics perspective for regulatory pharmacovigilance as a public health activity. In summary it appears that this new perspective may offer a new take on ethical issues in pharmacovigilance and provide guidance as to when public health paternalism is justified or when the public good should take precedence over rights of individuals.
1 Introduction Traditionally, bioethics has focused on the obligations of healthcare professionals and the rights of individual patients as well as participants in clinical research [1]. The origins of this emphasis can be traced back to the Hippocratic oath: ‘‘I will follow that system or regimen which
according to my ability and judgment I consider for the benefit of my patient and abstain from whatever is deleterious and mischievous’’ [2]. However, in recent years, this center of attention has been questioned and a new ‘‘Public Health Ethics’’ has emerged. It argues that when dealing with ethical issues related to research or interventions, the health of groups and populations should be considered and not only that of individuals. Advocates of this new concept argue that there is a range of situations where it would apply and where the interest of the public should be the main concern. Pharmacovigilance has been defined by the World Health Organisation as the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects or any other drug-related problem [3]. The concept is sometimes used synonymously with that of pharmaceutical risk management [4]. Given that the focus of pharmacovigilance is on the health and safety of populations rather than that of individuals, it can be classified as a public health activity. Although decision making related to pharmacovigilance to a large extent should be evidence based and data driven, value judgements are inevitably present, thereby introducing an ethical dimension. However, explicit discussions around the ethical foundation for pharmacovigilance are rare [5]. The aim of this article is to review the current debate on Public Health Ethics and explo
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