Patient-centered pharmacovigilance: A review

Purpose: To determine through a literature review, the current status of patients’ involvement in adverse drug reactions (ADRs) reporting.Methods: Eighteen (18) studies which were published within the period from 2010 to 2016 were reviewed. The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete “EBSCO”, Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library.Results: The review revealed that although the reports by patients were of good quality, the patients’ awareness of, and attitude towards, ADR reporting were generally poor.Conclusion: The results of this review suggest the need for patients’ enlightenment on ADRs reporting. Information on how to improve ADRs reporting is provided.Keywords: Adverse drug reaction, Patients’ reporting; Systematic review, Patient-centeredpharmacovigilanc

Incidence and Characteristics of Benzodiazepine Use in an Elderly Cohort: The EVA Study

Objective: The aim of this study was to estimate the incidence of benzodiazepine use in an elderly population and to identify associated factors. Methods: Data were collected in four self-report questionnaires on the use of sedatives and sleeping drugs. These questionnaires were sent every 6 months, over a 2-year period, to the 1272 elderly subjects interviewed at the first follow-up examination of the EVA (Epidemiology of Vascular Aging) Study. Results: The incidence rate of benzodiazepine use was 4.7 per 1000 person-months (95% confidence interval [CI] 3.6, 5.8). In multivariable analyses (logistic regression model), incident use of benzodiazepines was significantly associated with depressive or anxious symptoms (odds ratio [OR] = 3.3; 95% CI 1.7, 6.4), high use of non-psychotropic drugs (≥ 3; OR = 1.8; 95% CI 1.1, 3.1) and female gender (OR = 1.9; 95% CI 1.1, 3.3). Conclusion: Simultaneous use of benzodiazepines and other medications should be carefully assessed in elderly patients, considering the risk of adverse drug reactions and drug-drug interactions

Spontaneous Reporting System Modelling for the Evaluation of Automatic Signal Generation Methods in Pharmacovigilance

International audiencePharmacovigilance aims at detecting adverse effects of marketed drugs. It is generally based on a Spontaneous Reporting System (SRS) that consists of the spontaneous reporting, by health professionals, of events that are supposed to be adverse effects of marketed drugs. SRS supply huge databases, the human-based exploitation of which cannot be exhaustive. Automated signal generation methods have been proposed in the literature but no consensus exists concerning their efficiency and applicability due to the difficulties in evaluating the methods on real data.The objective is to propose SRS modelling in order to simulate realistic data sets that would permit completion of the methods’ evaluation and comparison. In fact, as the status of the drug-event relationships is known in the simulated data sets, generated signals can be labelled as “true” or “false.”The spontaneous reporting is viewed as a Poisson process depending on: the drug’s exposure frequency, the delay from the drug’s launch, the adverse events’ background incidence and seriousness, and the reporting probability. This reporting probability, quantitatively unknown, is derived from the qualitative knowledge found in the literature and expressed by experts. This knowledge is represented and exploited by means of a set of fuzzy rules.Then, we show that the SRS modelling permits to evaluate the automatic signal generation methods proposed within pharmacovigilance and contribute to generate a consensus on drugs’ postmarketing surveillance strategies

Antipsychotic use and myocardial infarction in older patients with treated dementia

Background Antipsychotic agents (APs) are commonly prescribed to older patients with dementia. Antipsychotic use is associated with an increased risk of ischemic stroke in this population. Our study aimed to investigate the association of AP use with the risk of acute myocardial infarction (MI). Methods A retrospective cohort of community-dwelling older patients who initiated cholinesterase inhibitor treatment was identified between January 1, 2000, and December 31, 2009, using the Quebec, Canada, prescription claims database. From this source cohort, all new AP users during the study period were matched with a random sample of AP nonusers. The risk of MI was evaluated using Cox proportional hazards models, adjusting for age, sex, cardiovascular risk factors, psychotropic drug use, and propensity scores. In addition, a self-controlled case series study using conditional Poisson regression modeling was conducted. Results Among the source cohort of 37 138 cholinesterase inhibitor users, 10 969 (29.5%) initiated AP treatment. Within 1 year of initiating AP treatment, 1.3% of them had an incident MI. Hazard ratios for the risk of MI after initiation of AP treatment were 2.19 (95% CI, 1.11-4.32) for the first 30 days, 1.62 (95% CI, 0.99-2.65) for the first 60 days, 1.36 (95% CI, 0.89-2.08) for the first 90 days, and 1.15 (95% CI, 0.89-1.47) for the first 365 days. The self-controlled case series study conducted among 804 incident cases of MI among new AP users yielded incidence rate ratios of 1.78 (95% CI, 1.26-2.52) for the 1- to 30-day period, 1.67 (95% CI, 1.09-2.56) for the 31- to 60-day period, and 1.37 (95% CI, 0.82-2.28) for the 61- to 90-day period. Conclusion Antipsychotic use is associated with a modest and time-limited increase in the risk of MI among community-dwelling older patients treated with cholinesterase inhibitors

Prescription du célécoxib (Célébrex

Objectif : L'objectif de cette étude est de décrire les sujets débutant un traitement par célécoxib et l'évolution de ce traitement au cours des 6 mois suivant son initiation. Méthode : Elle a été conduite sur 14 323 sujets ayant eu une première délivrance de célécoxib en décembre 2000, identifiés dans la base de sécurité sociale d'Aquitaine. L'âge moyen est de 61,9 ans et le sex ratio homme/femme de 0,45. Soixante et un pour cent sont d'anciens consommateurs d'autres anti-inflammatoires non stéroïdiens (AINS) et 38 % d'anti-ulcéreux. Résultats : Sur la même ordonnance que célécoxib ou dans les 30 jours suivants, 23 % ont une délivrance d'anti-ulcéreux et 15 % d'autres AINS. Au cours des 6 mois suivant l'inclusion, le célécoxib a été renouvelé par 41 % des sujets. En cas de renouvellement, au cours des 6 mois avant et après l'inclusion, la délivrance d'anti-ulcéreux est respectivement de 40,9 % et de 44,1 %. En cas de non-renouvellement, ces proportions sont de 32,2 % et de 33,7 %. Discussion : La prescription de célécoxib s'adresse essentiellement à des sujets anciens consommateurs d'autres AINS. Elle ne modifie pas ou peu la prise en charge des sujets traités et, en particulier, ne fait pas diminuer l'utilisation des anti-ulcéreux

Are traditional NSAIDs prescribed appropriately among French elderly with osteoarthritis? Results from the CADEUS cohort

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Patterns of selective serotonin reuptake inhibitor use andrisk of falls and fractures in community-dwelling elderly people. The Three-City cohort

International audiencePurpose: Increased risk of falls and fractures has been reported in elderly users of selective serotonin reuptake inhibitors (SSRIs). However, biases were insufficiently addressed notably temporality between exposure and outcome and confounding by residual depression. Our objective was to examine the associations between SSRIs and fall or fracture incidence focusing on their chronic use and different types of SSRIs.Methods: The population-based cohort included participants aged 65 years and above, who had not fallen before inclusion (n=6,599) or free of recent fracture (n=6823) and followed-up twice over 4 years. New fall and fracture events were self-reported and defined as at least two falls and one fracture, respectively, during the previous 2-years. SSRI users were compared with those taking no antidepressants. Hazard ratios (HR) were estimated using Cox models with delayed entry and adjusted for many confounders including residual depressive symptoms.Results: Incidence of falls was 19.3% over 4 years and that of fractures 9.5%. After multi-adjustment, SSRI intake was significantly associated with a higher risk of falls (HR, 95% CI = 1.58, 1.23-2.03) and fractures (HR, 95% CI = 1.61, 1.16-2.24). The risks were significantly increased by 80% in those continuing the treatment over 4 years. Citalopram intake only was at significant risk for falls and fluoxetine for fractures. Conclusions: In this large community-dwelling elderly sample, SSRI users were at higher risk of falls and fractures. This association was not due to reverse causality or residual depressive symptoms. Different SSRI drugs may have specific adverse effects on falls and fractures

Antidepressant use and cognitive decline in community-dwelling elderly people – The Three-City Cohort

International audienceAbstractBackgroundCognitive impairment is very common in late-life depression, principally affecting executive skills and information processing speed. The aim of the study was to examine the effect of antidepressant treatment on cognitive performances over a 10-year period.MethodsThe community-based cohort included 7381 participants aged 65 years and above. Five cognitive domains (verbal fluency, psychomotor speed, executive function, visuospatial skills and global cognition) were assessed up to five times over 10 years of follow-up. Treatment groups included participants under a specific antidepressant class at both baseline and the first follow-up and their follow-up cognitive data were considered until the last consecutive follow-up with a report of antidepressant use of the same class. Linear mixed models were used to compare baseline cognitive performance and cognitive decline over time according to antidepressant treatment. The models were adjusted for multiple confounders including residual depressive symptoms assessed by the Center for Epidemiologic Studies-Depression scale.ResultsAt baseline, 4.0% of participants were taking antidepressants. Compared to non-users, tricyclic antidepressant users had lower baseline performances in verbal fluency, visual memory and psychomotor speed, and selective serotonin reuptake inhibitor users in verbal fluency and psychomotor speed. For the two other cognitive abilities, executive function and global cognition, no significant differences were found at baseline irrespective of the antidepressant class. Regarding changes over time, no significant differences were observed in comparison with non-users whatever the cognitive domain, except for a slight additional improvement over the follow-up in verbal fluency skills for tricyclic antidepressant users.ConclusionsIn this large elderly general population cohort, we found no evidence for an association between antidepressant use and post-treatment cognitive decline over 10 years of follow-up in various cognitive domains