International Journal of Risk & Safety in Medicine - Volume 26, issue 4

Authors: Curreen, Merlin | Lidmila, Jed

Article Type: Research Article

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. Show more

Keywords: Zopiclone, abuse, dependence, overdose, driving, road traffic accidents

DOI: 10.3233/JRS-140633

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 183-189, 2014

Authors: Bakhsh, Hussain T. | Perona, Stephen J. | Shields, Whitney A. | Salek, Sara | Sanders, Arthur B. | Patanwala, Asad E.

Article Type: Research Article

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. Show more

Keywords: Medication errors, safety, emergency department, boarding

DOI: 10.3233/JRS-140634

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 191-198, 2014

Authors: Card, Alan J. | Simsekler, Mecit Can Emre | Clark, Michael | Ward, James R. | Clarkson, P. John

Article Type: Research Article

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. Show more

Keywords: Healthcare risk management, patient safety, risk control, occupational health

DOI: 10.3233/JRS-140636

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 199-211, 2014

Authors: Lexchin, Joel | Mintzes, Barbara

Article Type: Review Article

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. Show more

Keywords: Direct-to-consumer advertising, Health Canada, pharmaceutical industry, prescription drugs, regulation

DOI: 10.3233/JRS-140635

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 213-225, 2014

Authors: Katahira, K. | Yoshikawa, T. | Enoki, H. | Teraoka, A. | Tsuchiya, Y.

Article Type: Research Article

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. Show more

Keywords: Gefitinib, acute interstitial pneumonia (AIP), lawsuit, predictability, estimation

DOI: 10.3233/JRS-140637

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 227-233, 2014

Article Type: Other

Citation: International Journal of Risk & Safety in Medicine, vol. 26, no. 4, pp. 235-237, 2014