International Journal of Risk & Safety in Medicine - Volume 31, issue 3
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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: The emerging COVID-19 pandemic poses a threat to the global health care system. Given the lack of antiviral therapies or vaccines for the disease, the antimalarial drug hydroxychloroquine (HCQ) obtained much attention as a treatment for COVID-19. However, there are limited and uncertain clinical data to support the beneficial effect of this drug in COVID-19 treatment. HCQ has several side effects and warnings, including blindness, heart failure, and renal toxicity, even with recommended doses. For severe cases of COVID-19 or in patients with preexisting conditions, administering such a drug could be fatal, particularly when taken at high doses or in…combination with other antibiotics. However, further well-designed studies that would address the optimal dose, duration of treatment, possible side effects, and long-term usage outcomes are needed to make the final decision. In this paper, we aim to discuss the risk of using HCQ in treating COVID-19 patients, including its possible side effects.
Abstract: The world is currently in the throes of the COVID-19 pandemic which has halted the tourism sector and created an unprecedented global economic crisis. This paper will outline economics pertaining to COVID-19 lockdown, recovery and the inevitable competition that will occur between countries for tourists who will be scarcer and therefore more valuable. Countries are competing with a variety of incentives in order to lure visitors. However, persistent first waves that extend into July will put off tourists, further reducing tourism revenues and accelerate job losses and bankruptcies in affected countries. The example of Sweden’s response to COVID-19 in this…regard will be described. Countries that have COVID-19 relatively under control but experience second waves will also manifest negative tourism effects. Governments and public health must act in unison so as to exit lockdown as speedily and as safely as feasible, with COVID-19 rises that are as low and brief as possible in order to better compete in the tourism sector with other countries. Websites are already online comparing not only safety for travellers vis-à-vis COVID-19 but also the incentives offered by different countries in their attempts to woo tourists in this difficult market.
Keywords: COVID-19, tourism, economics, recession, Internet
Abstract: BACKGROUND: Pharmaceutical compounding allows individuals with special requirements access to medicines. Compounding can also be used to provide cheaper alternatives to commercially produced medicines which may be less strictly regulated than those commercially produced as they do not require marketing authorisation. OBJECTIVE: This review describes the issues and potential risks associated with compounded medicines and equally importantly identifies best practices. METHODS: To establish reports about lack of effectiveness, adverse events and medication errors occurring with compounded pharmaceuticals, a literature search was conducted of PubMed, Embase and MEDLINE databases for relevant cases in European countries which were…published between 2003 and 2018. Case reports/series that described instances of successful use of compounded medicines over the same period were also identified. RESULTS: Overall, 12 case reports/case series describing problems associated with compounded medicines in Europe have been identified. Sources of patient risk associated with compounded medicines include lack of quality, safety and efficacy data, preparation and labelling errors, and improper storage and handling practices. CONCLUSIONS: Several case reports/series describing instances of overdose, medication errors and adverse events associated with compounded medications were reviewed. The number of affected patients was relatively small, but many were children and two adult patients experienced permanent sequelae. The number of incidents associated with compounded medicines is unknown, and so these numbers should be interpreted with caution. When licensed medicines are available, the use of compounded medicines can put patients at unnecessary risk which should be avoided. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. Pharmacists can promote best practices in compounding through professional organisations. Future recommended actions are: 1. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. 2. A comprehensive pan-European survey to gain a greater understanding of compounding procedures and techniques. This would provide valuable information to the benefit of hospital systems and their patients. 3. The results of the survey can then be used to improve the knowledge and quality control of compounded medicines for the good of patient safety.
Abstract: Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the manner in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.
Keywords: Sildenafil, cardiovascular side effects, Ethical Commissions, fetal growth retardation, STRIDER, inadequate patient information, death of patients
Abstract: BACKGROUND: In the case of depression (and other psychiatric disorders), a huge number of scientists have been trying for decades to establish and postulate the disease-based drug concept for antidepressants and these efforts have not born fruits. OBJECTIVE: To show that the discussions about statistical significance of the efficiency of the antidepressants over placebo are non-productive and irrelevant. METHOD: Researching the history of the onset of a chemical imbalance theory in the brain and the launch of antidepressants according to the drug-based disease model was the basis for doubting the appropriateness of using antidepressants in the treatment…of depression. RESULTS: Antidepressants (AD), as their name suggests, are supposed to address a disease-specific model to reverse the neuropathological basis of depression. However, science has not constituted the theory, using various brain imagining techniques or measuring the concentration of serotonin in various body liquids, that depression is characterized by the lack of serotonin in synapses and then created a substance that would block the reuptake of this neurotransmitter or in some other ways elevate its content. CONCLUSION: Even the reductionistic phase of the AD story, the mechanism of action, failed to be consistent so it is unclear how the largest meta-analysis of about 21 antidepressants by Andrea Cipriani et al. appeared in The Lancet.
Abstract: BACKGROUND: Antidepressants are much used and have been tested for many conditions. OBJECTIVE: To investigate the type of diagnoses in placebo-controlled trials apart from depression and anxiety. METHODS: This was a systematic review. RESULTS: We downloaded 5471 records from PubMed and excluded 3017 that contained depression or anxiety . After exclusion of non-eligible studies, meta-analyses and reviews, and records that were unclear, 1273 records remained. We counted 214 unique diagnoses, of which the most common were abuse of drugs or substances (227 records), pain or neuropathy (170), obesity (125), other eating disorders (45),…obsessive compulsive disorder (66), sexual dysfunction (41), gastrointestinal disorders (40), menopausal symptoms/hot flashes (36), premenstrual dysphoric disorder (27), urinary incontinence (21), post-traumatic stress disorder (38), schizophrenia (31), dementia or cognition problems (25), insomnia (19), ADHD (17), autism spectrum disorders (14), and stroke or traumatic brain injury (15). CONCLUSIONS: Trials of antidepressants may be driven mainly by commercial interests, focusing on prevalent diseases and everyday problems. No one can live a full life without experiencing several of the problems for which these drugs were tested. Antidepressants, sometimes called happy pills, could be seen as the modern version of Aldous Huxley’s soma pill intended to keep everyone happy in the “Brave New World”.
Abstract: BACKGROUND: Medicines are an integral part of the health system and the accessibility hugely depends on affordability and availability of medicines. Oral health is an integral component of overall well-being but is ironically often one of the most neglected areas of healthcare. There is paucity of data on the pharmaceutical cost components of dental disease, so this study aims to address this lacuna on the pricing of medicines. OBJECTIVE: This research study can be considered a partial economic evaluation that focuses on an estimation of costs associated with medicines used in the treatment of selected oral diseases to…suggest policy measures to reduce out-of-pocket expenditure on medicines. METHODS: Using cost analysis research design on the PharmaTrac dataset and cross-comparing it with public procurement rates of the Rajasthan Medical Services Corporation (RMSC) indicates that the pharmaceutical cost of treating caries and periodontitis is approximately three times higher if median retail prices are considered instead of RMSC public procurement costs. RESULTS: Medicine cost of treating a single episode of caries or periodontitis using RMSC medicine rates at all levels of care is approximately 1.9–2.5 times lower than retail prices of the same formulations. CONCLUSION: Our results strongly suggest that centralized public procurement of dental medicines with an efficient monitoring and control can reduce the out-of-pocket expenditure.