Development of canadian safety indicators for medication use.

Reports of preventable illness due to medication errors are widespread in Canada. However, quantifying the magnitude of the problem has been hampered by a lack of measurement tools. Canadian-specific indicators, or performance measures, of safe medication use do not exist. The objective of this study was to develop a set of Canadian consensus-based indicators for the safe use of medication for both in-patient and outpatient settings. A panel of 20 national experts was established from a convenience sample of experts representing medicine, nursing, pharmacy, research and decision-makers in hospitals and community settings across Canada. After creating a list of potential indicators from the literature, the final consensus set was chosen by the panel using a Delphi survey process via e-mail. After three rounds, consensus was obtained on 20 medication-use safety indicators: seven indicators were related to systems of care, five to prescribing/ordering, three to monitoring/assessment, three to medication administration, one to preparation and dispensing and one to purchasing/inventory management. Seventeen of the indicators measure a process of care (in contrast to health outcome); at least 10 have applications outside the in-patient setting. The resulting 20 medication-use safety indicators are diverse in scope and should be applicable in a variety of practice settings. These indicators may provide clinicians and decision-makers with valuable tools to assess the safety of medication-use systems.

Use of gastrointestinal preventive therapy among elderly persons receiving antiarthritic agents in Nova Scotia, Canada.

BACKGROUND: Two different strategies, referred to as gastrointestinal (GI) preventive therapy (GIPT), have been recommended for high-risk patients to prevent GI complications associated with antiarthritic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs): (1) use of a gastroprotective agent (GPA) along with the NSAID or (2) use of a cyclooxygenase-2-selective inhibitor (COX-2SI). The COX-2SIs rofecoxib and celecoxib have been shown to be as effective as traditional NSAADs for pain relief, but with an improved GI safety profile. OBJECTIVE: The purpose of this study was to examine the utilization of GIPT by elderly persons in Nova Scotia who were taking antiarthritic medications and to identify the factors associated with their use of GIPT. METHODS: A retrospective, cross-sectional study was conducted using administrative data from the Nova Scotia Seniors' Pharmacare Program database. Study participants were aged >or=65 years and had filled a prescription for a COX-2SI, a traditional NSAID, or high-dose aspirin at some point between January 1, 2001 and August 31, 2002. Subjects with at least 1 risk factor (as defined by our study) who received GIPT were classified as receiving appropriate therapy. Subjects with risk factors who did not receive GIPT were classified as potential underutilizers of GIPT. Subjects without risk factors who received GIPT were classified as potential overutilizers of GIPT. Descriptive statistics were presented, and factors independently associated with receiving GIPT were assessed using logistic regression. RESULTS: The study included 14,587 seniors: 3647 used COX-2SIs, 9412 used traditional NSAIDs alone, and 1528 used traditional NSAADs plus a GPA. Subjects were predominantly female (age range, 65-74 years). In subjects with at least 1 risk factor, 63% were classified as potential underutilizers of GIPT. Thirty-three percent of subjects with no risk factors were classified as potential overutilizers of GIPT. Factors significantly associated with receiving a GIPT included Female gender, annual income >$50,000, urban residence, age >or=75 years, GI complication in the previous year, and concomitant use of warfarin or corticosteroids. CONCLUSION: Potential under utilization of GIPT in this subject population was more prevalent than potential overutilization of GIPT. Although all hypothesized risk factors were significantly associated with receiving GIPT, physician education on GI risk factors might improve prescribing of GIPT for elderly persons in Nova Scotia.

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 Weber's original observation by using drugs that were marketed in the United States and using reports from a U.S. database. DESIGN: Retrospective analysis of adverse event databases. SETTING: University research center. DRUGS: The original nonsteroidal antiinflammatory drugs studied by Weber that were approved by the U.S. Food and Drug Administration (FDA) and marketed in the United States: diclofenac sodium, diclofenac potassium, diflunisal, sulindac, flurbiprofen, and piroxicam. INTERVENTION: Reports of adverse events submitted to the FDAs Spontaneous Reporting System and the Adverse Event Reporting System from January 1969-December 2000 for these drugs were analyzed according to the number of adverse events reported for each drug per year from the time the drug was approved until December 2000. MEASUREMENTS AND MAIN RESULTS: Reporting patterns were considered to demonstrate the Weber effect if the highest peak in reports during the first 5 years after product approval occurred during year 2. All five drugs analyzed in this study demonstrated the Weber effect. CONCLUSION: The Weber effect was replicable by using drugs marketed in the United States and using reports that were submitted to a U.S. database. Various other factors affected spontaneous reporting of adverse events, as peaks in the number of reports were seen numerous times for each drug after the initial 5-year marketing period.

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.