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Previous studies have pointed out the question of effective training and information to health professionals on pharmacovigilance. The lack of training is known to induce inadequate use of drugs and noncompliance of patients. Pharmacology teaching is performed in the third year of medical studies at the Toulouse Faculty of Medicine. The aim of the study was to investigate the perception of risk of adverse drug reactions (ADRs) by medical students at the end of the one year pharmacology course and two years later, after clinical training period. Sixty-seven students were interviewed in May 2005 and in October 2007. Visual analogue scales were used to define a score of perceived risk of ADRs associated with each drug class (ranking from 0 to 10) before and after pharmacology training. The drug classes evaluated were antibiotics, anticoagulants, antidepressants, aspirin, contraceptive pill, corticosteroids, drugs for arterial hypertension, drugs for diabetes (other than insulin), hypnotics, hypocholesterolaemic drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), postmenopausal hormone replacement therapy and tranquilisers. After pharmacology courses (May 2005), antidepressants were ranked as the most dangerous drugs by medical students [median score (25th-75th centiles): 7.7 (6.3-8.6)], followed by anticoagulants [7.6 (6.6-8.4)] and hypnotics [7.4 (6.1-8.1)]. Contraceptive pills was listed in the last position [median score [4.7 (2.2-6.7)]. Two years later (October 2007), anticoagulants moved into the first position [8.3 (7.3-9.2)], followed by NSAIDs [6.9 (5.0-8.4)] and aspirin [6.8 (5.8-8.4)]. Contraceptive pills remained in the last position. No change was observed for NSAIDs and aspirin, still ranked as dangerous drugs by medical students after clinical training. Values of perceived risk were significantly increased for anticoagulant (+9.2%, P < 0.01) and hypoglycemiant drugs (+27.7%, P < 0.0001). The perceived risk significantly decreased for hypocholesterolaemic (-14.3%, P < 0.0001) and antidepressant drugs (-19.5%, P < 0.0001), but not for hypnotics. The study shows that the perception of risk of ADRs by medical students was modified after clinical training. They were still aware of potentially serious ADRs associated with anticoagulants, aspirin or NSAIDs, but they remained less cautious for drugs such as antidepressants. Additional pharmacology training at the end of medical studies will be useful.

Aims: To investigate how adverse drug reactions (ADRs) to several classes of drugs are perceived by young medical students before and after a 1 year pharmacology course., Methods: The whole cohort of 92 medical students (63 females and 29 males) was questioned during their third year. A visual analogue scale was used to define a score (ranging from 0 to 10) of perceived risk of ADRs associated with each drug class before and at the end of the pharmacological training period., Results: Before the pharmacology course, hypnotics were ranked as the most dangerous drugs by the medical students, followed by antidepressants and anticoagulants. Contraceptive pills were listed in the last position. After pharmacological training, antidepressants moved into the first position, followed by anticoagulants and hypnotics. When all different drug classes were taken as a whole, the mean (+/-SD) of median scores of the perceived risk were 4.8 (+/-1.3) before and 5.8 (+/-1.5) at the end of the pharmacology course (P < 0.0001). Except for antidiabetics, antihypertensive drugs, tranquillizers, corticosteroids and hypnotics, the perceived risk significantly increased after the pharmacology course for the other drugs. The highest increases were observed for contraceptive pills (+104%, P < 0.01), NSAIDs (+86%, P < 0.01) and aspirin (+56%, P < 0.01)., Conclusions: Pharmacological training allows young medical students to be aware of potentially serious ADRs associated with drugs, in particular with drugs considered relatively safe (such as NSAIDs and aspirin) by nonhealth professionals.

Purpose: The aim of the study was to detect adverse drug reactions (ADRs) in pediatric inpatients using the medical administrative database 'Programme de Médicalisation des Systèmes d′Information' (PMSI) and to compare these cases ADRs with those spontaneously reported to a regional PharmacoVigilance (PV) Centre. Methods: The study was conducted from January 2008 to December 2011 in the Children University Hospital of Toulouse (Midi-Pyrénées, South-west France). From PMSI database, all discharge summaries including selected ICD-10 codes (10th International Classification of Diseases) were analyzed. All ADRs spontaneously reported by the Children Hospital of Toulouse and registered in the French PV Database (FPVDB) were included. The capture-recapture method was applied to estimate the incidence of ADRs. Results: During the study period, we identified 60 reports from the PMSI database and 200 from the FPVDB. The rate of 'serious' ADRs was higher in PMSI reports (74.6 % vs 38.9 %, p < 0.0001). The most frequent ADRs reported were musculoskeletal (12.4 %) and central (11.3 %) ADRs in PMSI database versus cutaneous (22.4 %) and general (17.5 %) ADRs in FPVDB. The most frequently suspected drugs were antineoplastic drugs (31.1 %) in PMSI database versus anti-infectives (38.2 %) in FPVDB. The estimated number of ADRs was 717 [95 % confidence interval (CI) 513, 921], and the incidence of ADRs among admissions was 0.6 % (95 % CI 0.4, 0.8). Conclusions: Use of PMSI database improves from around 30 % detection of ADRs in children. In comparison with classical pharmacovigilance database, it also allows to detect different ADRs and drugs, thus enhancing safe medicine use for pediatric patients. [ABSTRACT FROM AUTHOR]

Nefopam is widely used for the relief of moderate acute pain. Its safety profile remains to be specified. The objective of the study was to review adverse reactions to nefopam spontaneously reported to the French Pharmacovigilance system. All cases of adverse drug reactions (ADRs) associated with nefopam, registered in the French Pharmacovigilance database from January 1, 1995 to December 31, 2004, were reviewed. For each reported ADR, information about patient (age, gender, medical history), drug exposure (suspected and concomitantly used drugs), characteristics of ADRs (imputability score, time of onset, seriousness, outcome) were collected. A total of 114 ADRs with an imputability rated from ‘plausible’ (I2) to ‘likely’ (I3) and ‘very likely’ (I4) was analysed. The most frequent ADRs included ‘expected’ ADRs such as sweating, nausea, tachycardia, malaise or vomiting; 61 ADRs were ‘unexpected. No overdose was reported; 26 ADRs (23%) were considered as ‘serious’. Most of them were ‘unexpected’, including neuropsychiatric (hallucinations, convulsions) or cutaneous (pruritus, erythema, urticaria) ADRs. Six cases of anaphylactic ADRs (two angioedema and four anaphylactic shocks) were reported, all occurring shortly after use of nefopam during the post-operative period. Physicians should be aware of the possible occurrence of some serious ADRs when using nefopam such as convulsions and anaphylactic shocks, especially when the drug is used in special medical conditions, like post-operative periods. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented on anatomical localizations of bleedings between vitamin K antagonists and direct oral anticoagulants.