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Pharmacovigilance systems are important to monitor the safety of on-market drugs after approval. The aim of this study was to assess the impact of rosiglitazone safety alerts on trends in the sale of rosiglitazone and other oral antidiabetic drugs. An ecological study was conducted, using temporally aggregated data and linking safety alerts to countrywide sales of all oral antidiabetic drugs in Portugal from January 2002 to December 2012. Sales figures for oral antidiabetic drugs marketed in Portugal were supplied by IMS Health Portugal with a breakdown by active substance and fixed combinations. The number of defined daily doses per 1000 inhabitants per day (DIDs) of each oral antidiabetic drug sold to the estimated diabetic population using oral antidiabetic drugs in Portugal was calculated. Particular attention was paid to the case of rosiglitazone, with the results being adjusted for changes in rosiglitazone reimbursement policies. A total of four safety alerts were issued about rosiglitazone. Rosiglitazone sales registered an increase of 32.9% (0.202 DIDs; P < 0.001) after the first alert (risk of macular oedema or worsening of pre-existent macular oedema) in January 2006. After subsequent alerts about cardiovascular risks, this trend was not, however, repeated and sales fell. Following the January 2006 and January 2008 safety alerts, rosiglitazone sales described a long-term downward trend, with decreases of 3.75% (−0023 DIDs; P > 0.05) and 0.24% (−0.001 DIDs; P > 0.05), respectively. It is important to promote the dissemination and publication of drug safety alerts. [ABSTRACT FROM AUTHOR]

Background: The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs).Objectives: To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system.Methods: A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months.Results: Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55).Conclusions: Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas. A high baseline notification rate could account for the educational program having a moderate effect. [ABSTRACT FROM AUTHOR]

The article provides the findings of a research study on the effectiveness of educational outreach visits meant to improve the reporting of adverse drug reactions (ADR) by physicians. The article reports that because drug safety information tends to be limited when a new drug is licensed and marketed, previously unidentified ADRs may occur. Voluntary reporting of these cases by physicians can aid postmarketing surveillance of the drugs. The study shows that a targeted outreach program to physicians may improve the reporting of ADRs.

INTRODUCTION: Pharmacists can play a fundamental role in adverse drug reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists’ ADR reporting in northern Portugal. METHODS: We conducted a case-control study on a population of pharmacists employed in hospital and community pharmacies across Portugal’s Northern Regional Health Authority catchment area in 2003. Cases (n = 34) comprised pharmacists who had reported at least one ADR to the northern region’s drug surveillance unit, and controls (n = 280) were randomly sampled from pharmacists who had never reported an ADR. All were interviewed using a mail questionnaire. Most attitudes were based on Inman’s ‘seven deadly sins’ and were measured using a continuous visual analogue scale. Answers were recorded in a range from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to determine the ADR reporting adjusted odds ratio (OR) for a change in exposure corresponding to the interquartile range for each attitude. RESULTS: The response rate was 86.8%. Reporting probability proved higher among hospital versus community pharmacists (adjusted OR 20.0; 95 CI 3.3, 125.0; p < 0.001). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by (i) 223% (95% CI 51, 595; p < 0.05) for “Really serious ADRs are well documented by the time a drug is marketed”; (ii) 240% (95% CI 89, 508; p = 0.002) for “I would only report an ADR if I were sure that it was related to the use of a particular drug”; (iii) 316% (95% CI 44, 1104; p = 0.010) for “It is only necessary to report serious or unexpected ADRs”; and (iv) 171% (95% CI 13, 549; p = 0.020) for “I do not have time to think about the involvement of the drug or other causes in ADRs”. CONCLUSIONS: ADR under-reporting is strongly associated with certain attitudes, possibly indicating that under-reporting could be minimised through educational interventions targeted at changing such attitudes. Pharmacists’ ADR education must be improved and educational programmes should be focused on altering attitudes identified by the study as being associated with under-reporting. Our data also indicate that community pharmacists must be a priority target for this intervention. [ABSTRACT FROM AUTHOR]

Objectives: Voluntary adverse drug reaction (ADR) reporting is fundamental to medical drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge- and attitude-related factors associated with ADR reporting by physicians in Northern Portugal. Methods: Case-control study covering a population of National Health Service medical practitioners. The 88 cases comprised physicians who had reported at least one ADR to the drug surveillance unit from the year 2000 to the date of enrolment in the study. The 771 controls were randomly selected from among the remaining physicians. All interviews were conducted using a self-administered questionnaire. Knowledge and attitudes regarding spontaneous ADR reporting were based on Inman’s ‘seven deadly sins’. Agreement with the questions included in the questionnaire was measured using a horizontal, continuous visual analogue scale, which was unnumbered. Recorded answers were read in a range from zero (total disagreement) to ten (total agreement). We used logistic regression to determine the ADR reporting adjusted odds ratio (ORadj) for a change in exposure corresponding to the interquartile range for each attitude. Results: A total of 397 questionnaires were received from 731 eligible practitioners (54.3%). Physicians who worked in primary versus hospital care (ORadj 7.74 [95% CI 1.85, 32.30]) and in general medicine (ORadj 1.05 [95% CI 0.30, 3.69]) versus medical specialities were more likely to report ADRs. In contrast, physicians working in the medical-surgical/surgical fields were significantly less likely to report ADRs compared with medical specialists (ORadj 0.10 [95% CI 0.02, 0.46]). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by: (i) 87% (p < 0.05) for complacency (the belief that really serious ADRs are well documented by the time a drug is marketed); (ii) 109% (p < 0.01) for insecurity (the belief that it is nearly impossible to determine whether a drug is responsible for a particular adverse reaction); (iii) 143% (p < 0.001) for diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug); (iv) 220% (p < 0.001) for indifference (the belief that the one case an individual doctor might see could not contribute to medical knowledge); and (v) 71% (p < 0.05) for ignorance (the belief that it is only necessary to report serious or unexpected ADRs). Conclusion: This study shows that there are attitudes strongly associated with under-reporting. The implementation of purpose-designed educational interventions based on the attitudes identified in this study may serve to improve reporting substantially. [ABSTRACT FROM AUTHOR]

ObjectivesAntibiotic misprescription is a major driver of resistance, which is a worldwide public health problem. Therefore, our aim is to assess the influence of the determinants of physician prescribing on the quality of antibiotic use. MethodsA 3 year cohort study including all primary-care physicians working in Portugal’s Central Regional Health Administration (n = 1094) was conducted. We assessed the determinants of prescribing using a pre-validated, personally addressed, reply-paid, self-administered questionnaire (sent four times to non-responders, between September 2011 and February 2012) designed to collect information on physicians’ attitudes to and knowledge of antibiotic prescribing as well as their socio-demographic and professional data. To evaluate antibiotic prescribing, we’ve calculated ESAC 12 quality indicators per physician per year, allowing us to stratify them as good or poor prescribers according to their performance on those indicators. Associations between determinants and outcomes were fitted with generalized linear mixed models. ResultsThe overall response rate was 46.1%. Emergency activity (OR [95% CI] = 0.29 [0.16–0.54];p < 0.05) and workload (number of patients seen per day: OR [95% CI] = 0.97 [0.94–1.00];p < 0.05; number of patients seen per week in emergencies: OR [95% CI] = 0.98 [0.97–0.99];p < 0.05) were both related to poor quality of antibiotic prescribing. Statistically significant odds ratios were also obtained for ignorance (IqOR [95% CI] = 2.14 [1.31–3.52]), complacency (1/IqOR [95% CI] = 1.19 [1.01–1.41]) and responsibility of others (1/IqOR [95% CI] = 1.78 [1.10–3.06]). ConclusionsThe above results serve to emphasize workload, working at emergency departments and physicians’ attitudes identified as critical factors affecting antibiotic prescribing. This provides new insights for clinicians, researchers and policy makers when it comes to developing and improving the clinical and economic outcomes of antibiotic use. Key limitations of the study included the difficulty of results extrapolation and the limitations of the stratification method based on the antibiotic prescribing quality indicators. [ABSTRACT FROM PUBLISHER]

The aim of the present study was to determine the bioactive photochemical contents presented in three native species of Portugal, Melissa officinalis L., Matricaria chamomilla L., Tilia cordata Mill. by UV-Vis spectrophotometric quantification of total phenolics, flavonoids, proanthocyanidins (tannins total) and total of carotenoids. It was also analysed the possible correlation between antioxidant activity ( in vitro) and the synergistic effect between the different phytochemicals, using the free radical DPPH assay. The aqueous extracts showed significant differences (p < 0.05) among all phytochemicals studied. The lemon balm showed higher concentrations of total phenolics (258.1 mg.100g-1) and total flavonoids (686.4 mg.100g-1), verifying a positive correlation between those compounds and their antioxidant capacity (65%). Chamomile was the medicinal herb with higher concentrations of tannins (37.0 mg.100g-1), recognized for its astringent and digestive properties. All medicinal herbs showed antioxidant activity, significantly higher than control sample, with values varying between 8.5% and 65% for lime and lemon balm, respectively. This study proves that Portuguese medicinal plants are a rich source of bioactive compounds which may be useful for application in food and pharmaceutical industries. [ABSTRACT FROM AUTHOR]

A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting. A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman's 'seven deadly sins') associated with reporting. Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies. While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors. [ABSTRACT FROM AUTHOR]

Background: Adverse drug reaction (ADR) reporting systems are the basic component for comprehensive postmarketing surveillance of the risk of drug-induced adverse effects. The aim of this study was to evaluate the effectiveness of educational outreach visits aimed at improving ADR reporting by pharmacists.Methods: The study population comprised all pharmacists working in a catchment area covered by Portugal's Northern Regional Health Authority. Using unequal randomization, four spatial-clusters were assigned to the intervention group (n = 342) and eleven to the control group (n = 1091). The intervention took the form of 1-hour long educational outreach visits tailored to training needs detected in a previous study, with a 13- to 16-month follow-up period (March-June 2004 through June 2005). This study is registered as an international standard randomized controlled trial, number ISRCTN45894687.Results: At baseline, ADR reporting rates (per 1000 pharmacist-years) did not differ significantly between the intervention and control groups (32.28 vs 29.16). The adjusted increase in ADR reporting attributable to the intervention was 275.63 per 1000 pharmacist-years (95% CI 162.15, 389.12; relative risk [RR] = 5.87, 95% CI 1.98, 17.39). The intervention succeeded in multiplying the reporting rate of: serious ADRs, 10-fold (RR = 9.79; 95% CI 2.24, 42.66); unexpected ADRs, 4-fold (RR = 4.41; 95% CI 1.11, 17.53); high-causality ADRs, 9-fold (RR = 8.67; 95% CI 2.12, 35.42); and new drug-related ADRs, 9-fold (RR = 9.33; 95% CI 2.53, 34.40). While the greatest effect was registered during the first 4 months post-intervention, differences remained statistically significant for 8 months.Conclusions: Educational outreach visits improve ADR reporting by pharmacists in terms of quantity and relevance. [ABSTRACT FROM AUTHOR]

Context: Data on the adverse effects of newly marketed drugs are limited. Voluntary reporting is an important part of postmarketing surveillance but is underused by physicians.Objective: To evaluate the effectiveness of educational outreach visits for improving adverse drug reaction (ADR) reporting by physicians.Design, Setting, and Participants: A cluster-randomized controlled trial covering all National Health System physicians in the north of Portugal, with intervention in March 2004 through July 2004, and 13 to 16 months of follow-up. A total of 1388 physicians were assigned in 4 spatial clusters to the intervention group, and 5063 were assigned in 11 clusters to the control group.Intervention: One-hour educational outreach visits tailored to training needs identified in a previous study.Main Outcome Measures: Change in total number of reported ADRs and number of serious, high-causality, unexpected, and new-drug-related ADRs, using generalized linear mixed models adjusted for baseline ADR reporting, age, specialty, and work setting.Results: At baseline, ADR reporting rates (per 1000 physician-years) did not differ significantly between the intervention groups and the control groups in reporting ADRs overall (7.6 vs 11.3), nor did they differ significantly by category: serious, 4.3 vs 6.0; high-causality, 5.4 vs 7.6; unexpected, 1.6 vs 3.5; and new-drug-related ADRs, 3.7 vs 3.8. (P>.05 for all comparisons). The control group had no significant increase in ADR reports during follow-up. The adjusted increase in ADR reporting rates attributable to intervention was 90.19 for total ADRs (95% confidence interval [CI], 54.51-125.87; relative risk [RR], 10.23; 95% CI, 3.81-27.51), 30.16 for serious ADRs (95% CI, 18.84-41.47; RR, 6.32; 95% CI, 2.09-19.16), 64.90 for high-causality ADRs (95% CI, 38.38-91.42; RR, 8.75; 95% CI, 3.05-25.07), 28.04 for unexpected ADRs (95% CI, 16.25-39.83; RR, 30.21; 95% CI, 4.54-200.84), and 42.17 for new-drug-related ADRs (95% CI, 21.58-62.76; RR, 8.05; 95% CI, 2.10 -30.83). The greatest difference occurred during the first 4 months after intervention, but differences remained statistically significant for 12 months.Conclusion: A targeted outreach program may improve high-quality reporting of ADRs among physicians. [ABSTRACT FROM AUTHOR]

Background: Studies have detected that prescribers display gaps in knowledge and inappropriate attitudes regarding antibiotics and resistances, but it is not known whether these are generated during professional practice or derive from the undergraduate stage of their education. Accordingly, the aim of this study was to identify medical students' knowledge, beliefs and attitudes regarding antibiotic use and antibiotic resistance, and whether these change over the course of their time at medical school. Methods: We conducted a search of the MEDLINE and EMBASE databases, and included studies that measured knowledge and/or beliefs and/or attitudes regarding antibiotic prescribing and/or resistance, among medical students. Results: Of the 509 studies retrieved, 22 met the inclusion criteria. While medical students perceived resistance as posing a major public health problem, both worldwide and in their own countries, students in the last two course years were more aware of overprescription of antibiotics in general, and of broad-spectrum antibiotics, at their teaching hospital. There was a considerable lack of knowledge about the treatment of high-incidence infections, and upper respiratory tract infections in particular (41–69% of participants believed antibiotics to be useful for treating these), without any differences by course year. Students were conscious of their personal shortcomings and thus showed willing to improve their education. Conclusions: Future physicians display important gaps in knowledge, particularly in terms of treatment of high-incidence infections. This finding may be of use when it comes to designing more effective training in antibiotic stewardship for undergraduates. [ABSTRACT FROM AUTHOR]