Nicole R. Hartnell

Identifying, understanding and overcoming barriers to medication error reporting in hospitals: A focus group study

Objectives The under-reporting of medication errors can compromise patient safety. A qualitative study was conducted to enhance the understanding of barriers to medication error reporting in healthcare organisations. Methods Focus groups (with physicians, pharmacists and nurses) and in-depth interviews (with risk managers) were used to identify medication error reporting beliefs and practices at four community hospitals in Nova Scotia, Canada. Audio tapes were transcribed verbatim and analysed for thematic content using the template style of analysis. The development and analysis of this study were guided by Safety Culture Theory. Results Incentives for medication error reporting were thematised into three categories: patient protection, provider protection and professional compliance. Barriers to medication error reporting were thematised into five categories: reporter burden, professional identity, information gap, organisational factors and fear. Facilitators to encourage medication error reporting were classified into three categories: reducing reporter burden, closing the communication gap and educating for success. Participants indicated they would report medication errors more frequently if reporting were made easier, if they were adequately educated about reporting, and if they received timely feedback. Conclusions Study results may lead to a better understanding of the barriers to medication error reporting, why these barriers exist and what can be done to successfully overcome them. These results could be used by hospitals to encourage reporting of medication errors and ultimately make organisational changes leading to a reduction in the incidence of medication errors and an improvement in patient safety.

Replication of the Weber effect using postmarketing Adverse Event reports voluntarily submitted to the United States food and Drug Administration

Study Objective. To validate or refute a widely accepted epidemiologic phenomenon known as the Weber effect by replicating Webers original observation by using drugs that were marketed in the United States and using reports from a U.S. database.

Adverse Event Reporting with Selective Serotonin-Reuptake Inhibitors

Objective The Weber effect is a phenomenon which states that the number of reported adverse reactions for a drug increases until the middle to end of the second year of marketing. The purpose of this study was to examine the number of adverse event reports associated with specific selective serotonin-reuptake inhibitor (SSRI) use. Methods Data used in this study included voluntary adverse event reports submitted to the US federal government through the Spontaneous Reporting System and Adverse Event Reporting System. Adverse event reports were analyzed for the following SSRIs: citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline. Results Adverse event reporting associated with fluvoxamine demonstrates the Weber effect. Adverse events related to fluoxetine, paroxetine, and sertraline do not exhibit the Weber effect. Fluoxetine-related adverse events peaked at year 3, with peaks also occurring during the 10th and 12th years after market entry. Adverse event reports associated with paroxetine and sertraline use increased 5–8 years after market entry. Conclusions Within 1 class of medications, it is possible for a few agents to exhibit the Weber effect, while there is no definite pattern with others. A new observation in adverse event reporting is introduced and suggests that a peak in adverse event reporting occurs 1–2 years after a medication receives approval for a new indication. Future research is necessary to validate this effect and examine the generalizability to other medications.

Impact of Drug Plan Management Policies in Canada: A Systematic Review

Background/objective: In Canada, pharmaceutical expenditures require an increasing proportion of total health care dollars. Drug plan managers use various policies to manage medication use and control costs, but these policies can have unintended consequences. The objective of this systematic review is to evaluate the impact of drug policies on economic, clinical and humanistic (quality of life or satisfaction) outcomes. Methods: Articles in which the primary objective was to evaluate the impact of a drug policy tool or technique in Canada and that measured one or more economic, clinical or humanistic outcomes were considered for inclusion. Studies were excluded if they were based in institutions or not published in peer-reviewed journals. The search process included searching 9 electronic databases, searching the reference lists of identified articles and working papers and contacting drug policy researchers. Studies were assessed for quality and suitability for meta-analysis. We performed a qualitative synthesis of the study design, study sample and outcomes. Results: Thirty-five articles satisfied the inclusion criteria. Most (n= 25, 71%) determined that drug policies reduced the costs, utilization or both of the studied drug therapy. Only 13 studies (37%) measured the impact of the drug policy on the cost or utilization of medical care, and the impact of the policy was favourable in only 4 of these cases. Six studies (17%) evaluated the impact of the policy on clinical outcomes; none reported a favourable impact. No studies evaluated the impact of the drug policy on humanistic outcomes. Discussion: Although the drug policies in most of the studies included in this systematic review did achieve the desired goal of reducing drug costs, utilization or both, the impact on other outcomes was seldom examined. In the 6 studies in which clinical outcomes were included in the evaluation framework, the impact was inconclusive. Humanistic outcomes have been completely excluded from evaluations to date.

Development of Clinical Indicators for Type 2 Diabetes

Background/Objective:Preventable drug-related morbidity in patients with type 2 diabetes is a major concern. Our objective was to develop a set of Canadian clinical indicators of preventable drug-related morbidity (PDRM) and preventable care-related morbidity (PCRM) for type 2 diabetes.Methods:Each study partner (Dalhousie University, Nova Scotia Department of Health, Diabetes Care Program of Nova Scotia, and Sobeys Pharmacy Group) was asked to identify the priorities of medication-related diabetes care from the Canadian Diabetes Association 2003 clinical practice guidelines using the nominal group technique. Based on the priorities identified, a survey was constructed listing the clinical outcome and pattern of care related to a number of possible PDRMs/PCRMs in patients with type 2 diabetes. Using the Delphi technique, an interdisciplinary panel of 10 experts scored each clinical indicator in an attempt to achieve consensus.Results:Education/reinforcement of targets was identified by the nominal group t...