Adolfo Figueiras

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.

Sociodemographic factors related to self-medication in Spain

To identify the sociodemographic factors associated to self-medication (i.e. use of non-prescription medicines) and undesirable self-medication, a cross-sectional study was carried out using a sample (n = 20,311) representative of the population of adults of 16 years of age and older in Spain. Multivariate Coxs regression was used. The prevalence of self-medication in the sample was 12.7% during the two weeks preceding the interview. Self-medication is more prevalent among women, persons who live alone, and persons who live in large cities. For persons who reported acute disorders, self-medication prevalence was higher among those with higher educational levels. The prevalence of undesirable self-medication in the sample was 2.5% during the two weeks previous to the interview. Undesirable self-medication is twice as common among persons older than 40 years, as compared to persons younger than 27 years. Undesirable self-medication prevalence is 53.0% higher among those who live alone as compared to those who live with their partner (95% confidence intervel (CI): 15.2–103.2) and 36.8% higher among students as compared to full-time workers (95% CI: 1.9–83.5). People over 40 years of age, people living alone, and students should be the priority target populations for public health education programs aimed at improving the quality of self-medication behavior.

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

AbstractObjectives: 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.

Case-Crossover Analysis of Air Pollution Health Effects: A Systematic Review of Methodology and Application

Background Case-crossover is one of the most used designs for analyzing the health-related effects of air pollution. Nevertheless, no one has reviewed its application and methodology in this context. Objective We conducted a systematic review of case-crossover (CCO) designs used to study the relationship between air pollution and morbidity and mortality, from the standpoint of methodology and application. Data sources and extraction A search was made of the MEDLINE and EMBASE databases. Reports were classified as methodologic or applied. From the latter, the following information was extracted: author, study location, year, type of population (general or patients), dependent variable(s), independent variable(s), type of CCO design, and whether effect modification was analyzed for variables at the individual level. Data synthesis The review covered 105 reports that fulfilled the inclusion criteria. Of these, 24 addressed methodological aspects, and the remainder involved the design’s application. In the methodological reports, the designs that yielded the best results in simulation were symmetric bidirectional CCO and time-stratified CCO. Furthermore, we observed an increase across time in the use of certain CCO designs, mainly symmetric bidirectional and time-stratified CCO. The dependent variables most frequently analyzed were those relating to hospital morbidity; the pollutants most often studied were those linked to particulate matter. Among the CCO-application reports, 13.6% studied effect modification for variables at the individual level. Conclusions The use of CCO designs has undergone considerable growth; the most widely used designs were those that yielded better results in simulation studies: symmetric bidirectional and time-stratified CCO. However, the advantages of CCO as a method of analysis of variables at the individual level are put to little use.

Factors that Influence Under-Reporting of Suspected Adverse Drug Reactions among Community Pharmacists in a Spanish Region

Background: The spontaneous reporting system is the most efficient warning system of adverse drug reactions (ADRs). Pharmacists can play an important role in the detection and reporting of ADRs. The factors that affect under-reporting among these professionals are unknown in Spain.Objective: To identify the factors that influence community pharmacists’ ADR under-reporting in Navarra, a Northern Spanish region.Methods: A case-control study was conducted on a population of 802 community pharmacists working in Navarra. Cases were pharmacists who had reported at least two ADRs to the region’s drug surveillance unit between 2003 and 2005 and who agreed to participate in the study (18/20; 90%). A random sample of 60 controls was selected from the 762 pharmacists who had not reported any ADR during the same period of time.Results: Factors positively associated with ADR reporting were age, years of work experience as a pharmacist, participation in educational activities related to the detection and resolution of drug-related problems, the habit of detecting ADRs as part of pharmacists’ duties, having the basic knowledge needed to report ADRs, and disagreement with the common belief among healthcare professionals that ’to report an ADR it is necessary to be sure that the reaction is related to the use of a particular drug’. The most frequently mentioned reasons for not reporting ADRs were the ADR is not serious, the ADR is already known, uncertainty concerning the causal relationship between the ADR and the drug, forgetting to report the ADR and a lack of time.Conclusions: Pharmacists’ knowledge, beliefs, behaviour and motivation play an important role in ADR reporting. Under-reporting might be improved through activities focused on modifying such factors.

Influence of Pharmacists' attitudes on adverse drug reaction reporting : A case-control study in portugal

AbstractIntroduction: 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.

Emergence of asiatic vibrio diseases in south america in phase with El Niño

Background: The seventh pandemic of Vibrio cholerae unexpectedly reached the coast of Peru in 1991, causing an explosive emergence of infections throughout the American continents. The origin and routes of dissemination are as yet unknown. A new Vibrio epidemic arose in 1997 in South America (northern Chile) when the pandemic clone of Vibrio parahaemolyticus was for the fist time detected outside of Asia. These 2 cases were concurrent with 2 episodes of El Niño. Methods: We carried out a survey of records of V. parahaemolyticus infection and of strains existing in the Instituto Nacional de Salud of Peru between 1994 and 2005. Association between the El Niño event and the V. parahaemolyticus disease was analyzed through generalized additive models applied to time-series data with negative binomial response, selecting some oceanographic factors distinctive of the movement of the El Niño waters. Results: Epidemiologic data and laboratory investigations of the strains showed that V. parahaemolyticus infections caused by the pandemic clone emerged in the coasts of Peru linked to the 1997 El Niño episode. The epidemic dissemination of this clone matched the expansion and dynamics of the poleward propagation and the receding of the El Niño waters. This pattern was similar to previously reported onset of cholera epidemic in 1991. Conclusions: These findings identify the El Niño episodes as a reliable vehicle for the introduction and propagation of Vibrio pathogens in South America. The movement of oceanic waters seems to be one of the driving forces of the spread of Vibrio diseases.

Influence of physicians' attitudes on reporting adverse drug events: a case-control study.

BACKGROUND Voluntary physician reporting of adverse drug events (ADEs) in among their patients remains the single most important source of information on serious and rare ADEs. Yet, substantial under-reporting exists and the factors producing its causes are unclear. OBJECTIVES The objectives of the study are to: (1) identify the practitioners demographic and professional characteristics associated with ADE reporting; and (2) identify knowledge, attitudes, and opinions associated with ADE reporting. DESIGN Case-control study. SUBJECTS Physicians within the National Health Service in Galicia (Northwestern Spain). The 194 case doctors are those who reported at least one ADE to the regional drug surveillance center between 1991 and their enrollment in the study. The 498 controls were randomly selected among the remaining physicians. All were interviewed using a mail questionnaire. MAIN OUTCOME MEASURES We used logistic regression to determine the ADE reporting odds ratio. RESULTS The response rate was 63.7%. The probability of reporting ADEs increases with increasing volume of prescriptions and decreases with increasing patient load. The following attitudes are associated with a smaller probability of reporting: (1) belief that really serious adverse drug events are well documented by the time a drug is marketed; (2) belief that it is nearly impossible to determine if a drug is responsible for a particular adverse event; (3) only reporting an adverse drug reaction if one is sure that it is related to the use of a particular drug; and (4) belief that the one case an individual physician might see cannot contribute to medical knowledge. CONCLUSIONS Some physician attitudes regarding ADEs are associated with underreporting.

One-to-one versus group sessions to improve prescription in primary care: a pragmatic randomized controlled trial.

Objectives.The objective of the study was to evaluate the effectiveness of 2 educational strategies aimed at improving prescribing standards in primary care. Methods.A pragmatic controlled trial was designed; the study population included general and family practitioners in Galicia (northwestern Spain) divided into 3 study groups: a one-to-one education group (n = 98), a by-group education group (n = 92), and a control group (n = 405). The educational intervention included explicit recommendations for selecting nonsteroidal anti-inflammatory drugs (NSAIDs) for inflammation signs. Some of the subjects were given reminders. Mixed-effect linear models were applied to data analysis. Analyses were done by intention-to-treat. The dependent variable is a rate with a numerator that is the number of prescribed units of the NSAIDs recommended during intervention; the denominator is the total number of prescribed units of the NSAID total. Results.One-to-one education obtained an average prescribing behavior improvement of 6.5% (P <0.001) in the 9 months after intervention. In the education group, the average improvement was 2.4% (P <0.05) for the same period. Statistically significant differences were observed between the group intervention and one-to-one groups. The reminder increased significantly the effectiveness of the one-to-one intervention. Conclusions.A single, short educational session to primary care doctors can improve their prescribing standards during long periods of ≥9 months. Of the 2 strategies followed in the trial, one-to-one education has shown to be the most effective. Results also show that the effectiveness of these interventions increases when presented together with written material.

Improving the Reporting of Adverse Drug Reactions : A Cluster-Randomized Trial Among Pharmacists in Portugal

AbstractBackground: 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 ISRCTN45 894687. 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.