International Journal of Risk & Safety in Medicine - Volume 25, issue 4
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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: INTRODUCTION: One of the important pillars of an efficient pharmacovigilance system is contribution by healthcare professionals in the form of spontaneous reporting. This study was aimed at investigating the knowledge, attitude and practice of spontaneous ADR reporting among doctors in a teaching hospital in Pune, and to analyze the effect of an informative lecture about Pharmacovigilance on the same. METHODOLOGY: This was an interventional study conducted among 220 doctors at a tertiary care teaching hospital, Pune. Each participant was explained the purpose of study and asked to fill in a questionnaire about their knowledge, attitude and practice of pharmacovigilance. Only…80 of them attended the interventional lecture on Pharmacovigilance and again filled up the questionnaire after a period of one month from this intervention. RESULTS: Merely 7.5% of the participants knew ADR reporting system in India. Majority of the respondents (95%) knew that, as doctors, they could report ADRs but were unaware about the methodology to report (92.5%) which affected their practice of Pharmacovigilance. All (100%) the participants expressed that proper training should be provided to clinicians for ADR reporting & 81% felt ADR reporting should be made mandatory. Only 80 participants (36.4%) attended the interventional lecture which reflected a poor response. Intervention improved their (96%) knowledge about ADR reporting system and now majority of them (92%) agreed that all sort of ADRs should be reported (p < 0.001). CONCLUSION: Attitude towards ADR reporting was positive but knowledge about ADR reporting system was inadequate among doctors working in a teaching hospital in Pune. Education helped in improving knowledge and had an impact on attitude of participants regarding pharmacovigilance.
Abstract: BACKGROUND: There is an increasing use of herbal products and herbal medicines globally with the belief that herbal medicines are always ‘safe’ and carry no risk because they are from natural sources. However, there are concerns regarding medicinal plants and their ability to produce adverse effects. The growing herbal medicine usage has increased the need to monitor the safety of herbal medicines. Thus, the recommended approach by the World Health Organization (WHO) is to include herbal medicines in existing national pharmacovigilance systems. OBJECTIVE: This study aimed to determine the knowledge of pharmacovigilance of herbal medicines amongst herbal medicine practitioners. METHODS:…The study was carried out in Lagos West Senatorial District of Lagos State, Nigeria. Three categories of practitioners (378 respondents) were engaged and they include Traditional Herbal Sellers, Natural Health Practitioners and Pharmacists. RESULTS: The results showed that herbal medicines are commonly recommended for malaria, typhoid, diabetes and fever. 281 (74.3%) of the respondents claimed that herbal medicines have no adverse effects and only 91 (24.1%) of the respondents said there were some adverse effects reported by the users. Adverse effects reported include nausea, diarrhoea and weight loss. Amongst those that received reports of adverse effects, only 19 (20.9%) documented these reported adverse effects; none of these documentations were forwarded to the regulatory bodies or national pharmacovigilance centre in Nigeria. CONCLUSIONS: These results showed inadequate adverse effects monitoring (Pharmacovigilance) amongst the practitioners and underscore the necessity to educate and enlighten herbal medicine practitioners on the need for pharmacovigilance activity of herbal products.
Keywords: Herbal medicine, adverse effects, pharmacovigilance, herbal medicine practitioners, Nigeria
Abstract: BACKGROUND: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation of the healthcare practitioners. Poor knowledge and practice of pharmacovigilance has necessitated training of healthcare professionals in different parts of Nigeria. OBJECTIVES: The objectives of this study are to determine the knowledge and practice of pharmacovigilance amongst health professionals in Nigeria and the impact of previous training in pharmacovigilance on their knowledge and practice. METHODS: In this descriptive cross sectional study, purposive and systematic random…sampling method was used in selecting health facilities and health care practitioners respectively. Data were collected using a three-part peer-reviewed structured questionnaire administered through electronic mail (25) and self administration by healthcare professionals (316). RESULTS: Respondents who had received training on pharmacovigilance had better knowledge of correct definition of pharmacovigilance (P = 0.001) and better theoretical knowledge and practice scores of pharmacovigilance (P = 0.001). Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of pharmacovigilance. Overall, knowledge and practice of pharmacovigilance in Nigeria was still below average. The main challenges faced in the reporting and detecting of ADR were lack of awareness, poor communication, lack of continuity in training and poor funding. CONCLUSION: Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthened awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program.
Keywords: Pharmacovigilance, adverse drug reaction, knowledge and practice, spontaneous reporting, health care practitioner
Abstract: OBJECTIVE: Identify factors that predict fall-related injury in hospitalized adults. DESIGN: Retrospective records review. SETTING: 435-bed university hospital. PARTICIPANTS: Inpatients with reported falls in 2010. RESULTS: Medical records were available for 286/293 (98%) of reported falls in 251 patients. 25% (63/286) of falls were associated with injury, 4% (11/286) with serious injury. Compared to all fallers, patients with injury did not differ by gender or age. In univariate analysis, patients who reported hitting their head, had pre-fall confusion, or who received narcotics within 24 hours before falling were more likely to suffer injury (estimated odds ratios 6.04, 2.00 and 5.1,…respectfully). In multivariate analysis, receiving a narcotic prior to falling was the strongest predictor of injury (estimated odds ratio 5.38; 95% confidence intervals 2.07–13.98, p < 0.001). CONCLUSIONS: In this single-institution study, 25% of patients who fell suffered injury and 4% serious injury. Neither age nor gender predicted fall-related injury. Recent narcotic administration was the strongest predictor of injury. Strategies to prevent fall-related injury in the hospital should target patients receiving narcotics. When evaluating inpatients who have fallen, providers should be especially vigilant about injury in patients who have pre-fall confusion, hit their head, or have received recent narcotics.
Keywords: Falls, hospital, injury, narcotics, patient safety
Abstract: BACKGROUND: With globalization and signing of WTO GATT treaty, the market in India has expanded. This has necessitated important regulatory decisions. OBJECTIVE: This study aims to determine the gap in introduction and withdrawal of drugs in India and EU. METHODS: For drugs prohibited for manufacture and sale(withdrawn) in India during 1983–1998 and 1999–2012 periods, data on year of introduction and withdrawal in India and EU/internationally was extracted from Central Drugs Standard Control Organization (CDSCO), European Medical Agency (EMA) websites and Google search engine and compared. RESULTS: The gap in introduction of drug in India compared to EU/internationally during 1999–2012 period…is shorter than 1983–1998 period, while the gap in withdrawal has not changed much. CONCLUSION: Regulatory authority in India has approved drugs in recent year more quickly than the past but gap in withdrawal has not shortened, indicating need for strengthening postmarketing studies and review process.
Keywords: Drug approval, drug withdrawal, CDSCO, EMA
Abstract: BACKGROUND: Regulatory decision for withdrawal of a drug from market in European Union (EU) or other developed countries poses a challenge to authorities in developing countries specially when decision varies from different countries, such as for nimesulide. OBJECTIVES: To compare and evaluate, benefit and risk data for regulatory action, of nimesulide in India and EU. METHODS: Data on Nimesulide from EU available from Report on EMA website and Indian data from published literature (SCOPUS data base), WHO Vigibase and International Medicines Statistics (IMS) was compared. RESULTS: Publications from India on Adverse drug reactions (ADRs) are case reports (10) and case…series (14). Drug Utilization Research (DUR) studies (17) are mostly from tertiary centres. Data in the WHO Vigibase is meagre, data from IMS is not easily available and there is regional variation in prescriptions. Thus incidence of ADRs per sale, prescription or defined daily does (DDD) cannot be calculated, as has been done for EU. CONCLUSION: Limited and varying data in post marketing studies on ADRs and drug utilization for nimesulide from India made regulatory decision difficult. India and other similar countries could contribute to post marketing data for local and global regulatory decisions by systematically planned studies and networking within country and across countries in region.
Keywords: Benefit risk, drug withdrawal, drug regulation, nimesulide