International Journal of Risk & Safety in Medicine - Volume 26, issue 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: INTRODUCTION: Acute pain service (APS) ensures provision of effective and safe postoperative pain relief. The following cases describe a potentially fatal error in managing patients who receive epidural analgesia postoperatively. CASE REPORT SUMMARY: Three patients who received 6–8 ml/hr epidural infusion of 0.1% levobupivacaine with 2 μg/ml fentanyl (cocktail) developed poor arousal, hypopnoea and hypercarbia 16–18 hrs postoperatively. They required mechanical ventilation in the Intensive Care Unit (ICU) and exclusion of neurological and cardiac causes. Haemodynamically, they remained stable at the time of referral and throughout their ICU stay. All 3 patients were extubated within 24 hours uneventfully. DISCUSSION: Following…an inquiry, it was found that all three epidural cocktails came from the same batch of preparation. Analysis of the contents revealed high concentrations of morphine without traces of levobupivacaine. The epidural cocktail infusion and patient-controlled analgesia (PCA) morphine syringes were prepared in identical 50-ml syringes at the same setting but were labeled separately by different personnel. CONCLUSION: A defined APS protocol should ensure patients' safety. If the protocol is strictly adhered to and with regular audits, preventable errors can be avoided. The acute pain service provider must be alert and responsive to warning signs of any protocol errors.
Abstract: BACKGROUND: Off-label use of drugs is widely prevalent in children mainly due to a limited data generated in children during drug development process. Parents play a critical role in giving consent for their child to participate in clinical trials. Very few studies have assessed the opinion of the parents regarding such use and permitting their child to participate in clinical trials. OBJECTIVE: In view of lack of information about the awareness among parents regarding both off-label drug use in children as well as about allowing their child to participate in clinical research especially from a developing country, this study was…conducted. METHODS: Adults accompanying patients in a tertiary care hospital were administered a validated, structured questionnaire following written informed consent. The questionnaire consisted of 18 items broadly divided into 5 themes - parental views on safety and labelled use of drugs in children, awareness of off-label drug use in children, communication from healthcare worker about it, parental views on off-label drug use in children and willingness to allow their child to participate in a clinical trial. Chi-square or Fisher's exact probability test and McNemar's test were used for analysis. RESULTS: Initially, a majority of the participants felt that the drugs used in children in hospital (89.5%) and prescribed by a family physician (80.3%) were either safe or extremely safe while after the concept of off-label drug use is explained, a significant reduction in the proportion (59.3% in hospital and 59.8% by family physician) of parents felt the same. Only 30% parents were aware of off-label drug use in children. Ninety-three percent of the parents wanted to be informed whenever a doctor prescribes a drug in an off-label manner and a similar percentage felt the off-label drug use would increase the side-effects. Seventy three percent parents felt the off-label drug use is illegal and 57% would ask for change to a labelled drug in case of such prescription in their children. A majority of the parents would allow their child to participate in case of a life-threatening condition (59.8%) or in case of a chronic illness (51.3%) but significantly less when their child is healthy. CONCLUSION: The present study has found a low level of awareness regarding the concept of off-label drug use in children amongst the public. Our study also shows that parents expect that the doctor explains the fact to them, although they appear to vest a large amount of trust in the doctor's judgement in doing the best for their sick child. Parents were more willing to allow their child's participation in clinical research if their child was seriously ill than if healthy, indicating the need to educate the society about the need for clinical research so that they could take more informed decisions.
Keywords: Awareness, children, clinical trials, off-label drug use, parents
Abstract: Adverse effects of treatment on cardiac QT intervals were first reported 50 years ago. A clear link to sudden death was established, but the problem remained relatively unknown. The issue of treatment related effects on the heart, and the contribution this might make to sudden cardiac deaths in general, came more clearly into focus 20 years ago, linked to regulatory actions. In an era of polypharmacy, and mixing of prescribed and non-prescribed pharmacologically active agents it is now becoming increasingly clear that unanticipated cardiac effects may be common and a significant cause of mortality. There is likely underreporting and also…underdiagnosis, as recognition requires a timely ECG. This paper proposes two methods to handle the problem.
Abstract: BACKGROUND: In 2010, the Affordable Care Act (ACA) was signed into law. The Act seeks to improve the access of Americans to improved quality health care, while controlling the nation's escalating health care expenditures. The Act is scheduled for further implementation in 2014. OBJECTIVE: This article elucidates the opportunities and challenges that the ACA presents for constructive, innovative collaboration between the legal and medical professions in contributing to the quest for a more affordable and accessible high quality health care system. METHODS: The author analyzed the text of the Act, as well as secondary sources in the areas of law,…medicine, and public health. This allowed for the creation of a comprehensive conceptual and empirical framework through which the Act could be properly analyzed and understood. RESULTS: The research described the pitfalls inherent in the Act, but demonstrated that the ACA presents more opportunities than challenges if lawyers and doctors are willing to work together to bring about needed social change. CONCLUSION: The article qualified these findings by emphasizing that doctors must learn to advocate on behalf of their profession if the potential benefits of the ACA are to be realized.
Keywords: Affordable Care Act, medical-legal partnership
Abstract: BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies. OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product characteristics (SPC) of recently approved medicinal products. METHODS: Drug labels of products centrally approved in Europe between 2006 and 2012 were screened. Of drugs including the term ‘QT’ in the SPC, the message on QT-prolongation (‘no prolongation’/‘unclear drug-QT association’/‘possibly QT-prolongation’/‘QT-prolongation’) and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association.…RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC (‘no QT-prolongation’: 23%, ‘unclear drug-QT association’: 43%, ‘possibly QT-prolongation’: 16%, ‘QT-prolongation’: 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC (‘no prolongation’: 10% and for the category ‘QT-prolongation’: 100%). CONCLUSIONS: The extent and content of information on QT-prolongation varies considerably between SPCs, and in almost half of the drugs a clear message on QT-prolongation was lacking in the SPC.
Keywords: Cardiovascular agents/adverse effects, drug approval, torsades de pointes/chemically induced, drug labeling/legislation & jurisprudence, communication
Abstract: BACKGROUND: There have been recent reports linking serotonin reuptake inhibitor use with increased alcohol consumption. A syndrome of alcoholism precipitated by a common treatment has clear implications for both research and treatment if it is a common phenomenon. OBJECTIVE: To explore the profile of people affected, and drugs that might trigger the syndrome. METHODS: We have selected reports to RxISK.org reporting the problem and cases linked to a blog posting outlining the syndrome and mined these for data on age, gender, drug of use, pattern of outcome on treatment, and impact of the problem. RESULTS: The data make it clear…that all treatments with significant effects on the serotonin reuptake system are likely to cause this problem. Both sexes, and all ages are affected and reports have come from a range of countries. While stopping treatment can lead to the problem clearing, a failure to stop can result in death. CONCLUSIONS: SSRI induced alcoholism is likely to be a relatively common problem. Recognizing the problem can lead to a gratifying cure. A failure to recognize it can be fatal.
Abstract: BACKGROUND: There have been reports for over a decade linking serotonin reuptake inhibitors, finasteride and isotretinoin with enduring sexual dysfunction after treatment stops. OBJECTIVE: To explore the clinical pictures linked to all 3 drugs. METHODS: We have selected 120 reports to RxISK.org reporting the problem and mined these for data on age, gender, drug of use, and impact of the problem. RESULTS: The data make it clear that the three drugs show extensive overlap in symptom profile, regardless of sex or country of origin. CONCLUSIONS: The availability of 120 reports from over 20 countries add to the case for the…validity of the syndrome. This is severe and enduring condition can result in death. An understanding of its physiology and an approach to treatment are needed.
Keywords: SSRIs, finasteride, isotretinoin, erectile dysfunction, loss of libido, genital anesthesia