International Journal of Risk & Safety in Medicine - Volume 26, 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: OBJECTIVE: To examine the research on the dependence and abuse potential of zopiclone and the concerns that may be raised for addiction treatment services and General Practice. The focus is on four main areas: Problems that may arise from recommended use; Driving; Issues relating to dependence, and Abuse or recreational misuse. METHOD: Internet-based searches were carried out using the key descriptors of zopiclone and driving, road traffic accidents, dependence, withdrawal, abuse, misuse and overdose. RESULTS: Problems arising from recommended use are rare and almost always confined to common side-effects. Driving-related studies indicate the potential for driving impairment for up to…12 hours following use and this has clear implications for both addiction services and general practice. The likelihood of dependence increases once recommended doses and time-frames are exceeded and vulnerable populations such as psychiatric patients and those with addiction problems are at risk. CONCLUSION: Somewhat contrary to impressions that Zopiclone has little or no abuse potential, there is evidence that this medication is prescribed at higher than recommended doses and for longer than recommended. It can also be obtained readily other than by prescription. The potential for deliberate abuse may now be regarded as established, albeit at low levels compared to the benzodiazepines and this requires a degree of vigilance by prescribers and care managers.
Abstract: BACKGROUND: Patients boarded in the emergency department (ED) with psychiatric complaints may be at risk for medication errors. However, no studies exist to characterize the types of errors and risk factors for errors in these patients. OBJECTIVE: To characterize medication errors in psychiatric patients boarded in ED, and to identify risk factors associated with these errors. METHODS: A prospective observational study conducted in a community ED included all patients seen in the ED for primary psychiatric complaints and remained in the ED pending transfer to a psychiatric facility. An investigator recorded all medication errors requiring an intervention by an emergency…pharmacist. RESULTS: A total of 288 medication errors in 100 patients were observed. Overall, 65 patients had one or more medication errors. The majority of errors (n = 256, 89%) were due to errors of omission. The final severity classification of the medication errors was: Insignificant (n = 77), significant (n = 152), and serious (n = 3). In the multivariate analysis (R-squared 19.6%), increasing number of home medications (OR 1.17, 95% CI 1.01 to 1.36; p = 0.035), and increasing number of comorbidities (OR 1.89, 95% CI 1.10 to 3.27; p = 0.022) were associated with the occurrence of medication errors. CONCLUSION: Psychiatric patients boarded in the ED commonly have medication errors that require intervention.
Abstract: BACKGROUND: Risk assessment is widely used to improve patient safety, but healthcare workers are not trained to design robust solutions to the risks they uncover. This leads to an overreliance on the weakest category of risk control recommendations: administrative controls. Increasing the proportion of non-administrative risk control options (NARCOs) generated would enable (though not ensure) the adoption of more robust solutions. OBJECTIVES: Experimentally assess a method for generating stronger risk controls: The Generating Options for Active Risk Control (GO-ARC) Technique. METHODS: Participants generated risk control options in response to two patient safety scenarios. Scenario 1 (baseline): All participants used current…practice (unstructured brainstorming). Scenario 2: Control group used current practice; intervention group used the GO-ARC Technique. To control for individual differences between participants, analysis focused on the change in the proportion of NARCOs for each group. RESULTS: Control group: Proportion of NARCOs decreased from 0.18 at baseline to 0.12. Intervention group: Proportion increased from 0.10 at baseline to 0.29 using the GO-ARC Technique. Results were statistically significant. There was no decrease in the number of administrative controls generated by the intervention group. CONCLUSION: The Generating Options for Active Risk Control (GO-ARC) Technique appears to lead to more robust risk control options.
Keywords: Healthcare risk management, patient safety, risk control, occupational health
Abstract: BACKGROUND: Since the mid 1990's, Canada has introduced partial direct-to-consumer advertising (DTCA) of prescription drugs through administrative policy shifts. Little documentation exists on how regulation occurs in practice. OBJECTIVE: To evaluate Health Canada's response to complaints about DTCA. METHODS: We use case studies about DTCA spanning from 2000 to 2011 to examine the stringency of regulation by Health Canada. The aim was to identify key themes in Health Canada's approach to regulation from a public health perspective. All of the material related to the cases was independently read by each of the authors and any disagreements in interpretation were resolved…through discussion. RESULTS: We identified six weaknesses in how Health Canada deals with DTCA: failure to act on concerns about promotion for unapproved “off-label” uses, possible financial inducements to use a product, advertisements perceived to stimulate unwarranted fear about disease risks, and advertising of products with serious safety concerns identified in Health Canada safety advisories; ineffective enforcement actions undertaken by Health Canada; and lack of transparency in Health Canada's decision-making. CONCLUSIONS: There is an astonishing degree of discordance between public health priorities and regulation of DTCA in Canada. The current approach to enforcement is notable both for its lack of teeth and lack of accountability and transparency.
Keywords: Direct-to-consumer advertising, Health Canada, pharmaceutical industry, prescription drugs, regulation
Abstract: BACKGROUND: Plaintiffs of the gefitinib (Iressa) lawsuits in Japan started in 2004 were defeated in the Supreme Court in 2013. The Court judged it was not possible to foresee the outbreak of deaths caused by interstitial pneumonia due to gefitinib from death cases before approval of this drug. OBJECTIVE: We attempted to verify validity of this judgment. METHODS: We estimated the 95% confidence interval (CI) of the proportion of onset and death cases among 23 onset and 13 death cases occurring from “within 1 week” to “within 4 weeks” from clinical data before approval of this drug using data admitted…to the Court. RESULTS: For death cases, all of the upper limits of the 95% CI exceeded 50% within 1–4 weeks. This fact suggested that the cases of acute interstitial pneumonia were included in the clinical trial before the approval of gefitinib. CONCLUSION: It was possible to foresee the outbreak of death cases after drug approval. This conclusion showed the Court's ruling was not reasonable and was unscientific.