International Journal of Risk & Safety in Medicine - Volume 22, issue 1
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: This case report describes an episode of acute hepatotoxicity with liver injury after citalopram use in an 83-year old female. Drug intake was stopped immediately on admission. A biopsy of the liver showed extensive liver cell damage and inflammation consistent with drug-induced injury. After cessation of drug intake, the patient fully recovered within a couple of days. Recommencing of medication, with the exception of citalopram, did not cause liver abnormalities during one year of follow-up.
Abstract: In recent years, a number of authors have advocated the merits of conducting randomised controlled trials (RCTs) of antidepressants in women with nervous disorders during the prenatal period. However, a critical review of the literature indicates RCTs are not justifiable. At a time when it has become clear that a significant proportion of the existing literature on the use of pharmaceutical agents is ghostwritten, ethicists and others making assertions that RCTs are needed risk becoming part of an apparatus that plays down the hazards of treatment and promotes the use of treatments that may be harmful.
Abstract: Safety is one of the very important elements of medicines, especially in daily practice. It is expected that the medicines listed by the Thai Essential Medicine Lists (EML) and their market products registered by the Thai Food and Drug Administration (FDA) should be comparable with respect to practical safety. The objective was to investigate if there are differences in practical safety between anti-infective essential medicines and their products assigned by the two authorities in Thailand. Data were based on Thai EML, Thai FDA registration, and Thailand Index of Medical Specialities 2008. Results showed that Thai EML and Thai FDA divided…anti-infective items (n = 101) and their products into groups varying in practical safety. Two thirds of the items and their products were comparable with respect to practical safety, but one third of them were not. The products of the latter were defined as having a lower practical safety compared to their corresponding items. This study has demonstrated that there are differences in practical safety between several essential medicines and their products. Consistent practical safety is very necessary for safe use of anti-infective products. Thus, there should be deliberations between the two authorities to reconsider the practical safety of these items and their products.
Abstract: A second wave of blockbuster products will go off-patent between 2012–2016 in Europe and USA, triggering a rush for the approval of biosimilars or follow-on biologics. Biosimilars are approved through an abbreviated route which relies on a limited safety and efficacy data enabling biogeneric companies to develop these products at lower cost giving a price benefit to the payer. This advantage needs to be weighed against the potential risk that any variation could have with respect to safety and efficacy, especially from long-term use. The paper attempts to rationalize the current “risk” perceptions regarding biosimilars, which have been in existence…over a decade in the Indian market. The differences from the Reference product are substantial yet their safety record over a long use warrants a more “realistic” rather than “speculative” assessment, keeping cost-to-benefit as an important criteria and identify ways of mitigating potential risk that are perceived for biosimilar products.
Keywords: Biosimilars, follow-on-biologics, EMEA, India, aggregates, PRCA, risk, cold-chain
Abstract: The Food and Drugs Act theoretically gives Health Canada considerable authority in dealing with safety issues but there are also significant limitations in the legislation. Furthermore, the priorities of Health Canada are skewed in favour of rapid approval of new drugs at the expense of the postmarketing pharmacosurveillance system as judged by how much money and many personnel are allocated to each activity. Health Canada has explicitly rejected developing quantitative standards for evaluating its postmarketing pharmacosurveillance system. In addition to lacking standards in this area, it does not monitor whether or not its communications to professionals and the public have…had the desired effect in terms of changing the way that drugs are prescribed and used. Health Canada continues to treat safety information that companies submit as confidential business information. What safety information it does release is insufficient to allow an adequate independent assessment of a drug’s safety. Progressive licensing is a new regulatory model that would allow Health Canada to retain control over a drug throughout the product's entire lifecycle. In its initial incarnation progressive licensing would have actually further strengthened Health Canada’s reliance on the industry for information and would have worked to enhance regulatory secrecy.
Keywords: Adverse drug reactions, drug regulation, drug safety, pharmaceutical industry, user fees