SIMulation of Medication Error induced by Clinical Trial drug labeling: the SIMME-CT study.

OBJECTIVE: To assess the impact of investigational drug labels on the risk of medication error in drug dispensing. DESIGN: A simulation-based learning program focusing on investigational drug dispensing was conducted. SETTING: The study was undertaken in an Investigational Drugs Dispensing Unit of a University Hospital of Lyon, France. PARTICIPANTS: Sixty-three pharmacy workers (pharmacists, residents, technicians or students) were enrolled. INTERVENTION: Ten risk factors were selected concerning label information or the risk of confusion with another clinical trial. Each risk factor was scored independently out of 5: the higher the score, the greater the risk of error. From 400 labels analyzed, two groups were selected for the dispensing simulation: 27 labels with high risk (score ≥3) and 27 with low risk (score ≤2). Each question in the learning program was displayed as a simulated clinical trial prescription. MAIN OUTCOME MEASURE: Medication error was defined as at least one erroneous answer (i.e. error in drug dispensing). For each question, response times were collected. RESULTS: High-risk investigational drug labels correlated with medication error and slower response time. Error rates were significantly 5.5-fold higher for high-risk series. Error frequency was not significantly affected by occupational category or experience in clinical trials. CONCLUSIONS: SIMME-CT is the first simulation-based learning tool to focus on investigational drug labels as a risk factor for medication error. SIMME-CT was also used as a training tool for staff involved in clinical research, to develop medication error risk awareness and to validate competence in continuing medical education.

Administration of anticancer drugs: exposure in hospital nurses.

BACKGROUND: Even though anticancer drugs are prepared in dedicated pharmaceutical units, nurses remain exposed to cytotoxic agents during administration to patients. OBJECTIVE: The aim of this study was to assess this occupational exposure during the intravenous line-purging procedure at the patient's bedside before administration in oncology departments. METHODS: This prospective study was conducted over a 4-week period in the hematology and oncology departments at a university hospital. Amounts of doxorubicin and cyclophosphamide on the surface of nurses' gloves were measured after the intravenous line purge of the infusion bag and the connection to the patient. For this purpose, gloves were washed with sterile water, following a validated procedure. Quantification of the 2 drugs into the water was performed using LC-MS/MS. RESULTS: After 59 chemotherapy administrations, 30.5% of gloves were contaminated. Despite extremely low volumes of contamination (0.08-6.28 µL), amounts collected ranged from 190 to 2500 ng per pair of gloves that tested positive for doxorubicin (median, 1600 ng) and from 130 to 32,600 ng with cyclophosphamide (median, 2700 ng). CONCLUSIONS: The intravenous line purge preceding antineoplastic infusion bag administration is a potential source of contamination in nurses. Contaminations appear to be invisible but frequent (in >30% of cases). Therefore, intravenous line purging performed under appropriately safe conditions should be mandated in pharmaceutical units dedicated to injectable-drug preparation. This measure should be included as a standard hospital practice as a matter of urgency.

Hypersensitivity to oxaliplatin: clinical features and risk factors.

BACKGROUND: Oxaliplatin-based regimens induce a potential risk of hypersensitivity reaction (HSR), with incidence varying from 10% to 25% and lack of clearly identified risk factors. The present study aimed to assess incidence and risk factors in HSR. METHODS: All patients treated with oxaliplatin in the Medical Oncology Department of the Lyon Sud University Hospital (Hospices Civils de Lyon, France) from October 2004 to January 2011 were enrolled. Incidence and severity of HSR were analyzed retrospectively and the potential clinicopathological covariates were tested on univariate and multivariate analysis. RESULTS: A total of 1,221 doses of oxaliplatin were administered for 191 patients, 8.9% of whom experienced an HSR. Seventeen HSRs were observed, with 1.6% grade 3 and no grade 4 events. The first reaction appeared after a median of 3 oxaliplatin infusions. Using univariate analysis, HSR was associated with younger age (mean age, 56.2 years; p = 0.04), female gender (p = 0.01) and prior exposure to platinum salts (p = 0.02). No increased risk was associated with mean dose or with presence of atopic background. Multivariate analysis confirmed that women were at higher risk of oxaliplatin HSR than men (p < 0.05). Reintroduction of oxaliplatin was effective in 64.7% of hypersensitive patients using an appropriate premedication strategy. Patients who experienced a grade 3 HSR were not rechallenged. CONCLUSION: The risk of developing oxaliplatin HSR should not be underestimated (8.9% of patients). The medical team's vigilance should be increased with women, younger patients and patients with prior exposure to platinum salts.

Improving cancer patient care with combined medication error reviews and morbidity and mortality conferences.

BACKGROUND: To reduce the occurrence of medication errors, a systemic approach was developed combining anti-neoplastic medication error reviews and morbidity and mortality conferences (M&MCs). We report the first experience of implementing this strategy in oncology. METHODS: The case reports submitted to combined reviews were prepared by physicians and pharmacists, and medication error(s) were described and chronological and root-cause analyses were performed. RESULTS: Ten combined reviews were conducted, which involved the departments of haematology, medical oncology, pneumology, gastroenterology and clinical oncology pharmacy. A total of 91 errors were analysed, of which 3 had reached the patient. Thirty-four corrective actions were proposed; 53% consisted of changes in practice, 35% in procedural reminders and 12% in on-ward education sessions. CONCLUSIONS: The combination of medication error reviews and M&MCs appears to be an efficient means of improving cancer patient safety and personnel proficiency. This multidisciplinary work is indispensable to improve future patient management through the critical analysis of past medical errors.

[Clinical pharmacy and pharmacovigilance over a period of nine years in hospital]. / Pharmacie clinique et pharmacovigilance à l'hôpital : bilan et perspectives après 9 ans d'expérience.

INTRODUCTION: Underreporting is the main limit in any pharmacovigilance system relying on spontaneous notification. Available data emphasize that pharmacists report few adverse drug reactions (ADRs) in France. OBJECTIVE: To report how the integration of pharmacists in health care units contributes to reporting of ADRs and to study the validity of the reports. METHOD: Over a period of nine years we have prospectively collected and analyzed all ADRs collected by pharmacists in a university hospital setting and notified to the regional center of pharmacovigilance. RESULTS: Over the study period 2017 notifications were sent. Over the past four years the annual number of reports varied between 250 and 350. This amount is approximately ten times the number referred by physicians during the year preceding the beginning of this work. Only 8.6% of the submitted notifications were rejected by the pharmacovigilance center for various reasons: no causal link between the adverse event and taking medication, problem of timing, lack of data... CONCLUSION: The integration of the adverse reaction reporting in the daily activities of the pharmacist is a mean to increase very significantly the number of reports (factor of increase of 9.6 to 13.4).