Overview of this issue: pharmacovigilance, what is new?
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EDITORIAL
Overview of this issue: pharmacovigilance, what is new? Linda Gore Martin1 · Yolande Hanssens2 · Vibhu Paudyal3
© Springer Nature Switzerland AG 2018
Pharmacovigilance, usually defined with the World Health Organization (WHO) definition of “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems,” [1] is a mandate for the pharmaceutical industry, including Medication Authorisation Holders (MAHs), in most developed countries, but this is not the case for all countries. The International Federation Pharmaceutical Manufacturers & Associations (IFPMA) has a statement on their website regarding the importance of pharmacovigilance [2]. It should also be considered the responsibility of all governments and health care providers (HCPs) in the interest of the public’s health; a clearer role for the public is being established. This special issue of the International Journal of Clinical Pharmacy looks at the current state of pharmacovigilance from different countries and provides some insight into the future. It also explores some special patient populations. Fornasier et al. [3] presents an overview of the history of pharmacovigilance, while Baldo et al. [4] offers a guide to the terminology. The definitions of pharmacovigilance used by the authors are broad or narrow interpretations of the WHO definitions for adverse drug reactions (ADRs) and adverse drug events (ADEs). These definitions can limit pharmacovigilance programs to ADRs or broaden them to include medication errors, inappropriate use, counterfeiting, quality issues and lack of effectiveness. Causality is always an issue; Behera et al. [5] compare different methods of assessment. The European Medicines Agency (EMA) [6], working closely with WHO and the United States’ Food and Drug Administration (FDA), has established good * Linda Gore Martin [email protected] 1
University of Wyoming School of Pharmacy, Laramie Wyoming, USA
2
Hamad Medical Corporation Pharmacy, Doha, Qatar
3
University of Birmingham, Birmingham, UK
pharmacovigilance practices.1 The range of compliance with these guidelines is very good in many developed countries but may be non-existent in the developing nations, representing a large percentage of the world’s population. Eight working groups identified and discussed this and numerous other issues at a 2016 Oman meeting of the WHO Programme for International Drug Monitoring [7]. Olsson comments on the role of the International Society of Pharmacovigilance [8]. Francescon et al. and Baldo et al. [9, 10] comment on pharmacovigilance in oncology and regulations relative to oncology drugs. Al Hail et al. [11] present the progress of a pharmacovigilance system in Qatar while Zhao et al. [12] present on the status in China. No country has a perfect pharmacovigilance system. This is even more true as the system applies to over-the-counter and veterinary drugs as well as the aspects included in the broader interpretation. Elshaf
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