Outpatient atorvastatin use and severe COVID-19 outcomes: A population-based study.

Evidence of the effect of statins on patients with coronavirus disease (2019) COVID-19 is inconsistent. The aim of this study was to evaluate the association between chronic use of statins-both overall and by active ingredient-and severe outcomes of COVID-19 (risk of hospitalization and mortality), progression to severe outcomes, and susceptibility to the virus. We conducted a population-based case-control study with data from electronic records to assess the risk of (1) hospitalization: cases were patients admitted due to COVID-19 and controls were subjects without COVID-19; (2) mortality: cases were hospitalized patients who died due to COVID-19 and controls were subjects without COVID-19; (3) progression: cases were hospitalized COVID-19 subjects and controls were nonhospitalized COVID-19 patients; and (4) susceptibility: cases were patients with COVID-19 (both hospitalized and nonhospitalized) and controls were subjects without COVID-19. We collected data on 2821 hospitalized cases, 26 996 nonhospitalized cases, and 52 318 controls. Chronic use of atorvastatin was associated with a decreased risk of hospitalization (adjusted odds ratios [aOR] = 0.83; 95% confidence interval [CI]: 0.74-0.92) and mortality (aOR = 0.70; 95% CI: 0.53-0.93), attributable in part to a lower risk of susceptibility to the virus (aOR = 0.91; 95% CI: 0.86-0.96). Simvastatin was associated with a reduced risk of mortality (aOR = 0.59; 95% CI: 0.40-0.87). The wide degree of heterogeneity observed in the estimated odds ratios (ORs) of the different statins suggests that there is no class effect. The results of this real-world study suggest that chronic use of atorvastatin (and to a lesser degree, of simvastatin) is associated with a decrease in risk of severe COVID-19 outcomes.

Colchicine and risk of hospitalization due to COVID-19: A population-based study.

Colchicine is one of the most widely studied and best-known anti-inflammatory treatments. This study aimed to assess the effect of colchicine on risk of hospitalization due to COVID-19; and its effect on susceptibility to and severity of the virus in patients with COVID-19. We carried out a population-based case-control study. The following groups were applied: (1) to assess risk of hospitalization, cases were patients with a positive PCR who were hospitalized due to COVID-19, and controls without a positive PCR; (2) to assess susceptibility to COVID-19, cases were patients with a positive PCR (hospitalized and non-hospitalized), and the same controls; (3) to determine potential severity, cases were subjects with COVID-19 hospitalized, and controls patients with COVID-19 nonhospitalised. Different electronic, linked, administrative health and clinical databases were used to extract data on sociodemographic variables, comorbidities, and medications dispensed. The study covered 3060 subjects with a positive PCR who were hospitalized, 26 757 with a positive PCR who were not hospitalized, and 56 785 healthy controls. After adjustment for sociodemographic variables, comorbidities and other treatments, colchicine did not modify risk of hospitalization due to COVID-19 (adjusted odd ratio [OR] 1.08 [95% confidence interval (CI) 0.76-1.53]), patients' susceptibility to contracting the disease (adjusted OR 1.12 (95% CI 0.91-1.37)) or the severity of the infection (adjusted OR 1.03 [95% CI 0.67-1.59]). Our results would neither support the prophylactic use of colchicine for prevention of the infection or hospitalization in any type of patient, nor justify the withdrawal of colchicine treatment due to a higher risk of contracting COVID-19.

Impact of infectious disease epidemics on xenophobia: A systematic review.

Background Globally, xenophobia towards out-groups is frequently increased in times of economic and political instability, such as in infectious disease outbreaks. This systematic review aims to: (1) assess the xenophobic attitudes and behaviors towards migrants during disease outbreaks; and (2) identify adverse health outcomes linked to xenophobia. Methods We searched nine scientific databases to identify studies measuring xenophobic tendencies towards international migrants during disease outbreaks and evaluated the resulting adverse health effects. Results Eighteen articles were included in the review. The findings were grouped into: (1) xenophobia-related outcomes, including social exclusion, out-group avoidance, support for exclusionary health policies, othering, and germ aversion; and (2) mental health problems, such as anxiety and fear. Depending on the disease outbreak, different migrant populations were negatively affected, particularly Asians, Africans, and Latino people. Factors such as perceived vulnerability to disease, disgust sensitivity, medical mistrust individualism, collectivism, disease salience, social representation of disease and beliefs in different origins of disease were associated with xenophobia. Conclusions Overall, migrants can be a vulnerable population frequently blamed for spreading disease, promoting irrational fear, worry and stigma in various forms, thus leading to health inequities worldwide. It is urgent that societies adopt effective support strategies to combat xenophobia and structural forms of discrimination against migrants.

[Operationalisation for Portugal of the EU(7)-PIM List for Identification of Potentially Inappropriate Medicines in Older Adults]. / Operacionalização para Portugal da Lista EU(7)-PIM para Identificação de Medicamentos Potencialmente Inapropriados nos Idosos.

INTRODUCTION: In 2015, the EU(7)-PIM List was published, which identifies potentially inappropriate medicines in older patients and resulted from a consensus of experts from seven European countries. Portugal was not part of this group, so it was not originally adapted to the Portuguese reality. With this work, we intend to elaborate a list of potentially inappropriate medicines adapted to the reality of medicines marketed in Portugal, through the operationalization of the EU(7)-PIM List for the national reality and to evaluate the adequacy of its use for clinical practice. MATERIAL AND METHODS: Search, in INFARMED's Infomed database, of drugs that are included in the EU(7)-PIM List that have marketing authorization, and analysis of possible new drugs for inclusion in the list. The tool adapted to the Portuguese reality was applied to a sample of 1089 outpatient, polymedicated older patients from 38 primary care units in Central Portugal. RESULTS: The final PIM list adapted to the Portuguese reality includes 184 potentially inappropriate medicines (from these, 178 are active substances, five are classes of drugs, and one corresponds to the sliding scale therapeutic scheme used in insulin therapy). Of 1089 polymedicated older patients, 83.7% took at least one drug included in the final potentially inappropriate medicines list or belonging to one of the groups included in the list, and, on average, each patient took 1.74 (IQR 1 - 2). DISCUSSION: Even though the availability of drugs on the market is quite diverse, the EU(7)-PIM List has been used in several European countries. With this study, we operationalized the European list for the Portuguese reality, which will enable its application in clinical practice. CONCLUSION: The list drawn up is a useful tool for the identification of potentially inappropriate medicines, easy to use in clinical practice and research.

Introdução: Em 2015 foi publicada a lista EU(7)-PIM, que identifica medicamentos potencialmente inapropriados na população idosa e resultou de um consenso de peritos de sete países europeus. Portugal não fez parte deste grupo, pelo que na sua origem não foi adaptada para a realidade portuguesa. Com este trabalho pretendemos elaborar uma lista de medicamentos potencialmente inapropriados adaptada à realidade dos medicamentos comercializados em Portugal, através da operacionalização da lista EU(7)-PIM para a realidade nacional, avaliar a adequabilidade do seu uso na prática clínica.Material e Métodos: Pesquisa, na base de dados Infomed do INFARMED, dos medicamentos incluídos na lista EU(7)-PIM que apresentam autorização de introdução no mercado, e análise de possíveis novos medicamentos para inclusão na lista. A ferramenta adaptada para a realidade Portuguesa foi aplicada a uma amostra de 1089 idosos polimedicados não institucionalizados, utentes de 38 unidades de cuidados de saúde primários da região centro.Resultados: A lista final adaptada para a realidade portuguesa inclui 184 medicamentos potencialmente inapropriados (dos quais 178 são substâncias ativas, cinco são classes de medicamentos e um corresponde ao esquema terapêutico sliding scale usado nas insulinas). Dos 1089 idosos polimedicados, 83,7% tomavam pelo menos um fármaco incluído na lista final de medicamentos potencialmente inapropriados ou pertencente a um dos grupos incluídos na lista e, em média, cada doente tomava 1,74 (IQR 1 ­ 2).Discussão: Apesar da disponibilidade de fármacos no mercado ser bastante diversa, a lista EU(7)-PIM tem sido utilizada em vários países europeus. Com este estudo operacionalizamos a lista europeia para a realidade portuguesa, facilitando assim a sua aplicação na prática clínica.Conclusão: A lista elaborada apresenta-se como uma ferramenta útil para a identificação de medicamentos potencialmente inapropriados, de fácil utilização na prática clínica e em investigação.

Does the problem begin at the beginning? Medical students' knowledge and beliefs regarding antibiotics and resistance: a systematic review.

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.

Type B adverse drug reactions reported by an immunoallergology department.

OBJECTIVE: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). METHODS: An observational, descriptive and retrospective study was conducted, based in a spontaneous report system. Participants were all the patients from the IAD, with suspected ADR, reported to NPC by specialists after the study was completed. RESULTS: Studied population had a median age of 41 years, with the predominance of the female gender (73.2%). Allergic rhinitis and asthma were the most frequent comorbidities. All studied ADR were type B, 89.6% were serious, 86.4% unexpected and 2.6% associated with drugs that presented less than 2 years in the market. The most represented drug classes were the non-steroidal anti-inflammatory drugs (NSAIDs) (52.6%) and antibiotics (25.2%). Skin symptoms represented 61.2% of the reported complaints. About 52.9% of these ADR occurred in less than one hour after intake. The most frequent ADR treatment at the time of the reaction was drug interruption (86.2%), followed by the prescription of anti-histamines (42.2%). CONCLUSIONS: Reported ADR to NPC by the Drug Alert Unit were mainly serious, unexpected, associated with NSAIDs and antibiotics and related with marketing authorization medicines older than two years. These results could be very useful to develop strategies to prevent the clinical and economic consequences of ADR.

Impact of rosiglitazone safety alerts on oral antidiabetic sales trends: a countrywide study in Portugal.

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.

Determinants of physician antibiotic prescribing behavior: a 3 year cohort study in Portugal.

Objectives Antibiotic 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. Methods A 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. Results The 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]). Conclusions The 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.

Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

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.

PERSYVE - Design and validation of a questionnaire about adverse effects of antihypertensive drugs.

OBJECTIVE: The aim of this study was to design and validate a questionnaire to measure perceived symptoms associated with antihypertensive drugs (PERSYVE). METHODS: THE PERSYVE DEVELOPMENT AND VALIDATION INCLUDED FOUR STAGES: 1) item development (bibliographic review and questionnaire elaboration); 2) face and content validation; 3) field testing (pre-test); and 4) test-retest validation, assessment of internal consistency (Cronbach's alpha) and reproducibility over time (intraclass correlation coefficient and Cohen's kappa coefficient). RESULTS: PERSYVE IS DIVIDED INTO SIX SECTIONS ACCORDING TO RESULTS OBTAINED FROM THE LITERATURE REVIEW: (1) drug adherence, (2) perceived symptoms and how they affect quality of life (five-point Likert scale), (3) communication with health professionals, (4) perception of symptoms as adverse reactions, (5) influence on therapy compliance, and (6) adoption of non-pharmacological methods for blood pressure control. Content and face validation of the questionnaire led to some vocabulary changes and the introduction of section 2.1. Field-testing (n=26) revealed high comprehensibility of the questions. The Cronbach's alpha, calculated for section 2 (five-point Likert scale) was 0.850. PERSYVE was reproducible (n=167): kappa values presented fair to substantial reproducibility and, in section 2, ICC values resulted in good to excellent reproducibility. CONCLUSION: Results showed that PERSYVE is a well-structured, objective, patient-friendly, valid and reliable questionnaire. PERSYVE can be a very useful instrument in hypertensive patients' monitoring and in the screening of adverse effects.

Strategies to improve adverse drug reaction reporting: a critical and systematic review.

BACKGROUND: Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting. OBJECTIVE: We aimed to conduct a critical review of papers that assessed the effectiveness of different strategies to increase ADR reporting, regardless of the health professionals or patients included. DATA SOURCES: Scientific papers were selected after a search of the MEDLINE-PubMed and EMBASE scientific databases up to 7 December 2010. STUDY SELECTION: We included papers in English, French or Spanish that analysed an intervention aimed at increasing the number of reported ADRs, and quantify the results of the intervention in terms of number of reports. DATA EXTRACTION: The abstracts retrieved in both computerized searches were reviewed independently by two of the authors. Initially selected papers were thoroughly read to evaluate if they met inclusion and exclusion criteria. Data in finally selected papers were independently extracted by both authors and set in pre-designed tables. A third author took the final decision in case of disagreement. For each study, we analysed study design, type of intervention, assessment period, and results of the intervention. RESULTS: Of the 4,221 papers located that fulfilled the search criteria, 43 met the selection criteria. With the exception of one study, the interventions assessed were deemed to be effective. The vast majority of papers displayed methodological and formal limitations that lowered the grade of evidence. Multiple interventions seem to have had more impact than did single interventions. There were very few cases in which interventions were designed on the basis of inappropriate attitudes and mistaken beliefs about ADRs. CONCLUSIONS: In general, there is a need for studies of better methodological quality in this topic, so that more evidence of the effectiveness of the respective strategies can be collected for the purpose of improving ADR reporting by health professionals. It is probable that multiple interventions cause greater increases in the ADR reporting rates than single.

Determinants of under-reporting of adverse drug reactions: a systematic review.

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.

Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal.

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.

An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial.

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.

Influence of pharmacists' attitudes on adverse drug reaction reporting : a case-control study in Portugal.

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.

Physicians' attitudes and adverse drug reaction reporting : a case-control study in Portugal.

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.

Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional.

RATIONALE, AIMS AND OBJECTIVES: The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. METHODS: The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. RESULTS AND CONCLUSIONS: The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.