Best Safety Practices Now and in the Future
Since July 2012, much EU pharmacovigilance regulation has been published so an outsider might rationally conclude that it would be easy to define what ‘best safety practices are’ now. However, what constitutes the global ‘best practice’ and whether we hav
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Best Safety Practices Now and in the Future Brian Edwards
Since July 2012, much EU pharmacovigilance regulation has been published so an outsider might rationally conclude that it would be easy to define what ‘best safety practices are’ now. However, what constitutes the global ‘best practice’ and whether we have achieved a consensus depends on your point of view within the system both hierarchically and geographically. As of 2012, it seems the harm from medicines in the EU has serious public health implications as the European Medicines Agency (EMA) repeatedly stated the following to justify revision of the pharmacovigilance (PV) legislation [1]: • • • • •
5 % of all hospital admissions are for adverse drug reactions (ADRs). 5 % of all hospital patients suffer an ADR. ADRs are the fifth most common cause of hospital death. An estimated 197,000 deaths occur each year in EU attributed to ADRs. EU societal cost of ADRs amounts to 79 billion euros per year.
It is uncertain, and maybe it is too early to judge, whether and how the pharmacovigilance EU legislation in 2012 will impact these figures although the EMA plans to perform an impact assessment. The public health situation in the USA, however, shows continuing unacceptable levels of harm from medicines most notably opioids and warfarin [2–5]. For example, in February 2014, the US Office of the Inspector General reported that a third of patients were harmed by a treatment adverse event in the first 35 days of their stay in a skilled nursing facility, a third of which were related to medication [6]. Even product quality in the USA cannot be assured. The USA is recovering from a scandal whereby compounding pharmacies were producing and commercialising poor quality medicines which caused an outbreak of meningitis from contaminated
B. Edwards NDA Regulatory Science Ltd, Grove House, Guildford Road, Leatherhead, Surrey, UK e-mail: [email protected] © Springer International Publishing Switzerland 2017 I.R. Edwards, M. Lindquist (eds.), Pharmacovigilance, DOI 10.1007/978-3-319-40400-4_5
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methylprednisolone injected epidurally, sadly, often for reasons which were poorly evidenced based. The FDA has subsequently inspected many such pharmacies but has received pushback from about 12 compounders stating that they are not subject to FDA GMP requirements and instead are subject to oversight of their state pharmacy boards. In general, compounded drugs are exempt from GMP requirements if the products are for a specific patient with a prescription or are produced in limited quantities by a pharmacist. But this means variable quality standards for medicines for patients in the USA dependent on origin [7, 8]. How have patients themselves been performing? Studies have consistently shown that 20–30 % of medication prescriptions are never filled and that approximately 50 % of medications for chronic diseases are not taken as prescribed [9]. There is further evidence of global systematic dysfunction [10, 11]. The economic consequence of harm from medicine
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