Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

OBJECTIVES: To investigate the prescription and dispensation of psychotropic medications through the analysis of the prescriptions/notices kept at various institutions in two cities in the state of São Paulo. METHODS: The prescriptions kept at drugstores, magistral pharmacies, primary care settings and hospitals were collected and analyzed in collaboration with the Sanitary Vigilance agencies in the year of 1999. The information in the prescriptions/notices were typed and tabulated. RESULTS: A total of 108,215 prescriptions were processed, being 76,954 for benzodiazepines, 26,930 for anorexigenic drugs, 3,540 for opiates and 788 for other drugs. The benzodiazepines most frequently prescribed were: diazepam (31,644), bromazepam (16,911) and clonazepam (7,929). Among the anorexigenic drugs, diethylpropion (14,800) and femproporex (10,942) were the most common. When compared to men, women were given more prescriptions, mainly for anorexigenic drugs: the ratio was 10:1 in the prescriptions for diethylpropion and femproporex. The few magistral pharmacies (n=6) handled even more prescriptions than did the drugstores (n=49). A number of errors and inconsistencies were detected in the prescriptions analyzed. CONCLUSIONS: The results confirm the occurrence of an irrational use of such medications and a series of inadequate practices related to their prescription in Brazil. Therefore, they point out to the need of a comprehensive review of the government's control system of these substances.

OBJECTIVES:Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals.METHOD:This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events.RESULTS:One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001) and their knowledge of pharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure.CONCLUSIONS:A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals.

Background & objectivesDifferent algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals.MethodsUsing ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively.ResultsNone of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36).Interpretation & conclusionsAlthough the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.

Our results suggest an association between the use of benzodiazepines and the development of dementia. However, the current evidence lacks the power to infer differences between the effects of Alzheimer's disease and vascular dementias, long-acting and short-acting benzodiazepines, and various exposure loads (duration and dose). Future long-term prospective cohort studies are necessary, with adequate adjustments for confounding variables, strategies to minimize reverse causality, reporting of subgroups aimed at greater homogeneity of findings, adequate statistical power to identify high-magnitude effects, and defined daily dose analyses for dose-response gradient.

Introduction: The use of herbal medicine is on the rise worldwide, and safety issues associated with herbal medicines may have an exacerbated impact in elderly because this population has an increased susceptibility and sensitivity to health complications due to the aging process. Methods: This cross-sectional study was carried out at a primary health care unit in the city of Macapa, Brazil. The herbal medicines used and the sociodemographic characteristics of 123 voluntarily consenting participants were collected using a structured questionnaire. A total of 132 herbal medicines with oral or topical administration were donated by the elderly for microbial analysis before consumption, and 18 water samples used in the preparation of homemade herbal medicines were collected. Bacterial and fungal counts and identification of bacterial pathogens (Escherichia coli, Salmonella spp., Pseudomonas aeruginosa and Staphylococcus aureus) were performed according to the regulations of the Brazilian Pharmacopoeia and World Health Organization. Water analysis for the detection of coliforms and E. coli was carried out using Colilert® according to the manufacturer's instructions and the techniques established by Standard Methods. Results: Of the study participants, 78.8% were women. Bacterial growth was observed in samples from 51.5% of study and 35.6% had fungal growth. A total of 31.8% of the herbal medicine samples exceeded the safety limits (CFU/g ≤ 10 5), including 16.7% of the homemade herbal medicines and 15.1% of the commercial herbal medicines. It was also found that 31.0% of the samples exceeded the safety limit for fungal growth. The microorganisms most commonly isolated from the herbal medicines were S. aureus (49.2%), followed by Salmonella spp. (34.8%), E. coli (25.8%), and P. aeruginosa (14.4%). Of water samples analyzed, 77.8% were positive for total coliforms (1 ml) and in 66.7% water samples E. coli was detected (1 ml), making them unfit for consumption. Conclusions: The use of homemade and commercial herbal medicines is a major risk to the health of elderly who use these therapies due to the lack of microbial quality standards. We observed levels of viable bacteria and fungi that were above safety limits; in addition, we were able to isolate pathogenic bacteria from these herbal medicines.

Non-adherence to recommended treatment can lead to negative outcomes, such as inefficiency (using dosages lower than prescribed), poisoning (using dosages higher than prescribed), and other adverse reactions.