Case series in drug safety: a review to determine characteristics and quality.

Case series and case reports are a cornerstone of drug safety research; however, the characteristics of case series published in the literature remain poorly examined. A narrative review of case series addressing drug safety, published in the literature between 1 January 2003 and 15 July 2009, and identified through a PubMed search, was conducted in order to determine their characteristics and quality according to the criteria found in the US FDA Pharmacovigilance Guidance 2005. Of 130 publications that met the search criteria, 11.5% included an analytical component and 88.5% were descriptive. The median number of cases included in a given case series was 7 (range 2-2195) and the median time period for recruitment of the cases was 23 months (range 0.5-96). Overall, 43.1% of case series consisted of individual case reports, while 24.6% originated from cohorts and 21% from pharmacovigilance databases. Of the case series, 65.1% concerned adults (age ≥18 years), 11.6% elderly (age ≥65 years) and 8.5% youth (<18 years). Adverse effects involved mainly the skin (18.5%) and the circulatory system (13.8%). The main suspected drug classes (Anatomical Therapeutic Chemical classification) were nervous system drugs (23.1%) and antineoplastic and immunomodulating agents (20.0%). On average, six out of the possible nine US FDA Pharmacovigilance Guidance Criteria were fulfilled, with 27% of publications fulfilling at least seven criteria. Only 10% reported data on co-morbidity. In conclusion, this review highlights the reporting gaps and heterogeneity in published case series with respect to size, recruitment period and quality.

Factors associated with persistence of cholinesterase inhibitor treatments in the elderly.

PURPOSE: To identify factors associated with one-year persistence of cholinesterase inhibitor (ChI) treatments. METHODS: A retrospective cohort study was performed using the reimbursement database of the Echantillon Généraliste des Bénéficiaires, a 1/96(e) representative sample of subjects affiliated to the French National Healthcare Insurance System. Among this, patients who initiated a ChI treatment between 1 January 2004 and 31 December 2005 and for whom 1 year of follow-up in the database after treatment initiation was available were identified. One-year persistence of ChI treatment was defined as an ongoing treatment without dispensing interval exceeding 60 consecutive days during the 12 months following treatment initiation. Drug switches were not considered as treatment discontinuation. A multivariate logistic regression was conducted to identify, among patients characteristics (sociodemographic, drug uses), factors associated with one-year persistence of ChI treatments. RESULTS: Among the 942 patients who initiated a treatment with ChI during the study period, 72.4% were women; mean age was 79.6 years (SD = 7.4). Patients used eight other different drugs in median (Inter-Quartile Range: 5-11); 63.7% used psychotropics, 63.6% used cardiovascular drugs. One-year persistence of ChI treatments was estimated at 45.3%. Persistence of ChI treatments was lower in patients aged 80 years and over (OR = 0.74, 95%CI: 0.57-0.96); it was higher in patients using antidepressants at ChI treatment initiation (OR = 1.38, 95%CI: 1.05-1.82). CONCLUSIONS: One-year persistence of ChI treatment was estimated at 45.3% in this French sample. To optimize persistence of ChI treatment in the demented, patients poorly symptomatic and/or aged over 80 years should be especially monitored.

Adherence to anti-inflammatory treatment for asthma in clinical practice in France.

OBJECTIVES: This study evaluated adherence to anti-inflammatory controller medication for asthma in a French population. METHODS: This was an observational cohort study that employed data from the health insurance database for the Aquitaine region of France. Eligible subjects were aged between 15 and 45 years and had > or = 1 reimbursement claim for anti-inflammatory controller medication between December 1, 2003, and December 31, 2003. Data were collected from June 1, 2003, to May 28, 2005. New users were defined as those having no reimbursement claim for any asthma controller medication in the 6 months preceding the index date; all others were considered previous users. All subjects were followed for 17 months. Continuous multiple-interval measures of medication availability and medication gaps, treatment persistence, and time to first renewal were calculated for users of inhaled corticosteroids (ICS) alone, users of ICS combined with a long-acting beta2-agonist (LABA) in a single inhaler (ICS/LABA) or in separate inhalers (ICS + LABA), and users of oral leukotriene antagonists. RESULTS: The study population contained 12,502 new and previous users of anti-inflammatory controller medication for asthma. Their mean (SD) age was 32.0 (8.9) years and 58.3% were female. Previous users had better adherence to treatment than new users with respect to all measures. Adherence was best in previous users of leukotriene antagonists. However, only 40.2% of previous users of leukotriene antagonists had sufficient medication (95% CI, 37.6-42.9), compared with 56.8% of previous users of ICS + LABA (95% CI, 50.7-62.8), 65.5% of previous users of ICS only (95% CI, 63.1-67.9), and 69.8% of previous users of ICS/LABA (95% CI, 68.2-71.4). The rate of persistence over a 1-year period was 44.3% for previous users of leukotriene antagonists (95% CI, 41.7-46.8), compared with 27.1% for previous users of ICS only (95% CI, 25.1-29.1), 32.1% for previous users of ICS/LABA (95% CI, 30.5-33.6), and 44.1% for previous users of ICS + LABA (95% CI, 38.2-50.0). CONCLUSION: Adherence to treatment was poor (< or = 44%) in these users of anti-inflammatory controller medications for asthma.