International Journal of Risk & Safety in Medicine - Volume 29, issue 1-2
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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: BACKGROUND: Professional medical associations (PMAs) play a crucial role in providing accredited continuing medical education (CME) to physicians. Funding from the pharmaceutical industry may lead to biases in CME. OBJECTIVE: This study examines publicly available policies on CME, adopted by Canadian PMAs as of December 2015. METHODS: Policies were evaluated using an original scoring tool comprising 21 items, two questions about PMAs’ general and CME funding from industry, and three enforcement measures. RESULTS: We assessed 236 policies adopted by Canadian PMAs (range, 0 to 32). Medical associations received summative scores that ranged from 0%…to 49.2% of the total possible points (maximum score = 63). Twenty-seven associations received an overall score of 0%. The highest mean scores were achieved in the areas of industry involvement in planning CME activities (mean: 1.1/3), presence of a review process for topics of CME activities (mean: 1.1/3), content review for balanced information (mean: 1.1/3), and responsibility of distribution of funds (mean: 1.0/3). The lowest mean scores were achieved in the areas of awards (mean: 0.0/3), industry personnel, representatives, and employees (mean: 0.1/3), distribution of industry-funded educational materials at CME activities (mean: 0.1/3), and distinction between marketing and educational materials (mean: 0.1/3). CONCLUSION: These results suggest that Canadian PMAs’ publicly available policies on industry involvement in CME are generally weak or non-existent; therefore, the accredited CME that is provided to Canadian physicians may be viewed as open to bias. We encourage all Canadian medical associations to strengthen their policies to avoid the potential for industry influence in CME.
Keywords: Continuing medical education, Canadian professional medical associations, physician education, pharmaceutical industry, scoring tool, policy evaluation, financial bias
Abstract: BACKGROUND: ‘Off-label use’ is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics. OBJECTIVE: In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety…above all other concerns. METHODS: The article was written from desk research and expert engagement, including a presentation and Q&A in the European Parliament. RESULTS: This article intends to demonstrate that off-label use entails increased risks for patients, especially when it is not underpinned by rigorous clinical studies or the reporting routes for use are not well defined. CONCLUSIONS: Europe is seeing a growing trend the promotion of off-label prescription of medicinal products for reasons other than pure medical need, including motives such as cost-containment. This poses a numer of questions for the ethical and legal framework for medicine prescription and dispensing in Europe.
Keywords: Off-label use, therapeutic freedom, patient safety, patient consent, good practice
Abstract: BACKGROUND: Greatest challenges for clinician is to recognize risk factors for clinically significant drug interactions (CSDIs). There is a lack of awareness about CSDIs among healthcare professionals in India. OBJECTIVE: To recognize all possible risk factors for drug-drug interactions (DDIs) and to identify clinically significant drug interactions (CSDIs), the prevalence, pattern of occurrence of DDIs in People Living with HIV (PLW-HIV) receiving highly active antiretroviral therapy (HAART) and concomitant medications. METHODS: A retrospective medical record review was carried out by clinical pharmacist with ethics committee approval. Case files of HIV patients receiving HAART with concomitant medications…were analyzed for CSDIs using University of Liverpool drug interaction database and CSDIs were classified based on red flag indication (RFI) or contraindicated drug-drug interaction (XDDIs) and orange flag indication (OFI) or DDIs that needs close monitoring. Patients with DDIs (cases) and patients without DDIs (controls) were compared with Chi-square tests. P value <0.05 was considered as statistically significant. RESULTS: A total of 240 HIV patients’ cases were screened. Out of which 267 DDIs were reported in 107 patients. Prevalence of DDIs was higher in male 71 (66.4%) compared to female 36 (33.6%). On zero-inflated poisson regression analysis, factors of polypharmacy, opportunistic infections, comorbid condition like Ischemic heart disease, respiratory tract infections, and psychiatric disorder were found to be predictors of high risk factors for DDIs to HAART. Fourteen XDDIs with RFI and two hundred fifty three DDIs with OFI were reported. XDDIs were atazanavir with fluconazole 4 (28.6%), ritonavir with fluconazole 4 (28.6%), nevirapine with rifampicin 2 (14.4%), ritonavir with quetiapine, atazanavir with pantoprazole. Pharmacokinetic DDIs were highest 238 (89.1%). Sixteen DDIs were reported in a single patient. The majority 97 (90.6%) patients had developed ≤5 DDIs, 8 (7.5%) developed six to eleven DDIs. The highest DDIs were reported with efavirenz 49 (18.4%) and zidovudine 44 (16.5%) based HAART regimen. CONCLUSION: In India, with the increasing access to HAART usage, Clinician must focus to pay attention to recognize possible risk factors for CSDIs associated with HAART regimen and strictly to avoid “Red Flag Indication combinations” while prescribing so as to prevent CSDIs.
Keywords: Human immunodeficiency virus, highly active antiretroviral therapy, clinically significant drug interactions, risk factors for drug-drug interactions
Abstract: BACKGROUND: The use of non-steroidal anti-inflammatory drug (NSAIDs) is deemed a major risk factor for peptic ulcer disease in elderly population that requires concomitant therapy with gastroprotective agents (GPAs). OBJECTIVE: This study evaluated the rational prescribing of NSAIDs and GPAs, and extent of adherence to the guideline recommendations in primary care. METHODS: Nationwide audit of prescriptions issued to elderly patients (≥65 years) with hypertension or diabetic hypertension in primary care. RESULTS: Among 2090 elderly, 45.9% were on low-dose aspirin, and 13.5% on other NSAIDs. Diclofenac-XR was the most frequently prescribed NSAIDs to three-quarter patients whereas…naproxen, the safest NSAID for patients with high cardiovascular (CV) risk, was rarely prescribed. Among those on NSAID, 82.9% were on a scheduled dosing regimen; of these 78.8% received long-term NSAID therapy (3.9±0.9 months). The prescription rate of GPAs was low: 29.2% for aspirin and 33.3% for other NSAIDs. A quarter of the patients on histamine type-2 receptor antagonists received ranitidine at subtherapeutic single-dose for gastroprotection. Approximately half of the patients on proton pump inhibitors (PPIs) were prescribed supra-therapeutic double-dose regimen: omeprazole and esomeprazole accounted for 63.2% of overall prescribed PPIs. CONCLUSIONS: The rational choice of NSAIDs and physicians’ adherence to gastroprotective measures was suboptimal in primary care. The choice of NSAIDs and gastroprotective strategy in elderly be guided by the CV and gastrointestinal adverse events likelihood due to the NSAIDs and risk profile of patients for such adverse events.
Keywords: Elderly, NSAIDs, gastroprotective strategy, hypertension or diabetic hypertension, Bahrain
Abstract: BACKGROUND: Medication errors is a prominent issue on the health policy agenda due to its significant human and financial costs; confusing drug names are one of the most common causes of them. This issue necessitates the adoption of a mechanism to restrict such a confusion before approving drug names. OBJECTIVE: Following the establishment of a committee and developed relevant criteria as mechanisms to address the issue of drug names similarity Iran, there were problems in this process. This study explores the process of adopting this mechanism. METHODS: This qualitative study was conducted using date gathered through…documents, observation and 31 semi-structured interviews. Ethical approval was achieved from the Research Ethics Committee in TUMS. Confidentiality was ensured at all the interviews. The interviews were recorded verbatim, transcribed and coded, using the MAXQDA ver.12 software. Data were analyzed utilizing the Health Policy Triangle Framework. RESULTS: High rate of medication errors and warning from the WHO about drug names in Iran pushed the issue of drug proprietary names to the FDO agenda. A National Drugs Naming Committee was established and relevant criteria were developed by the Food and Drug Organization (FDO). This committee was dissolved for four years; the function was delegated to the General Office of Trademarks Registry. However, the committee was reestablished and resumed functioning. Finings mainly indicated a higher rate of medication errors during dissolving the committee. CONCLUSION: Health policy-makers have a public responsibility for making a decision and the consequences. Regarding the process of naming drugs, it is important for policy makers to consider two issues: patient safety and trademarks rights. However, the Iran FDO adopted an approach to address these issues, a more multifaceted, integrated approach to initial naming of drugs is suggested. The committee’ function is seen to hold the most promise. However the function is partially complete to ensure patient safety. Given the change experienced by altering relevant organizational authorities in the FDO, the sustainability of the committee cannot hope to be guaranteed. Yet, the need for such a guarantee is particularly important.
Keywords: Orthographic similarity, look-alike proprietary drug names, medication errors
Abstract: BACKGROUND: Pharmacovigilance directive 2010/84/EU focused attention on medication errors and encouraged regulators to identify causing and contributing factors. OBJECTIVES: (1) To study opinions of doctors/pharmacists on factors bearing a causal link to MEs as well as ways to minimise MEs (2) to test whether differences in opinion exist between subgroups of doctors and pharmacists working in community, hospital or office settings. METHODS: Different questionnaires were circulated to doctors and pharmacists. Respondents were subdivided according to their primary practice. RESULTS: 320 responses were received (204 doctors/116 pharmacists). Differences in opinion reaching statistical significance were observed…on distractions from staff, overwork and fatigue, availability of technical resources and having more than 1 doctor on duty. For pharmacists’, differences on issues of generic medicine availability and interruptions were found. CONCLUSION: Distractions and interruptions while executing tasks was flagged as an area requiring attention. Issues of overwork and fatigue affect especially doctors in hospital the majority of which are of the opinion that regulatory control on patient numbers could minimize errors. Increasing technical resources and keeping knowledge up-to-date, addressing overwork and high patient workloads have been identified as important areas when looking to reduce MEs.
Abstract: OBJECTIVE: To establish whether the young women (15–24 year old) who committed suicide in Sweden (1999–2013) received antidepressant treatment or not, and to what extent, prior to and/or at the time of suicide. To investigate the belief that increased prescription of antidepressants would drastically reduce the number of suicides. METHODS: An analysis of data from the Swedish Prescribed Drug Register, the Causes of Death Register, with registers cross checked, and from the National Board of Forensic Medicine. RESULTS: This analysis shows a covariance between increased prescription of antidepressants and an increasing trend in the number of…suicides among young women. In the period 1999–2003 antidepressants were found in toxicological analyses done in 23% of the young women who committed suicide, and in 39% of cases for 2009–2013. CONCLUSION: An increasingly larger proportion of young women who later committed suicide, had in the last few years been treated with antidepressants, prior to and at the time of the suicide. The previous assumptions that treatment with antidepressants would lead to a drastic reduction in suicide rates, are incorrect for the population of young women. On the contrary, it was found that an increasing tendency of completed suicides follow the increased prescription of antidepressants.
Keywords: Antidepressants, suicide, young women, toxicology
Abstract: BACKGROUND: Few studies have reported on long-term harms caused by ADHD drugs but they are known to impair growth. OBJECTIVE: To assess whether ADHD drugs impair reproduction in mammals. METHODS: Systematic review of reproduction in studies of animals treated with ADHD drugs. DATA SOURCES: PubMed, Biosis and EMBASE. RESULTS: We included 17 studies. The studies were generally of poor quality or poorly reported. Two studies reported the use of one of three advised randomisation methods. Fifteen studies used placebo which suggested blinding. On clonidine, the ability to produce offspring was reduced for…male rats, which approached two females each. In one study, 10 treated rats produced no offspring while all four controls did. In another study, 10 treated rats impregnated nine females while 10 controls impregnated 16. On methylphenidate, vaginal opening was delayed in two studies (in one, the mean difference was 4.0 days, 95% CI 2.5 to 5.6, and number of estrous cycles was halved; in the other, the minimum delay was 6 days), while in two other studies no difference occurred. Generally, the impairments improved after a drug-free period and were less pronounced when treatment started later in life. CONCLUSION: ADHD drugs impair the reproduction in animals.