Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions (original) (raw)
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Physicians??? Attitudes and Adverse Drug Reaction Reporting
Drug Safety, 2005
medical drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledgeand 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
International Journal of Advances in Medicine
Background: Contribution of physicians, in adverse drug reaction (ADR) reporting and monitoring, to develop a global database is enormously significant to ensure safety of medicine. But, in reality, due to lack of awareness among the healthcare providers, under-reporting of suspected ADRs is a major problem, especially in countries like India. Present study aimed to evaluate the knowledge, attitude, and practices (KAP) of the physicians regarding self-reporting of ADR in a tertiary care hospital in Kolkata, West Bengal, India.Methods: This was a cross-sectional, observational and questionnaire-based study involving physicians of different clinical departments. This questionnaire-based study was conducted to obtain the demography as well as information on knowledge, attitude and perception of physicians towards ADR reporting. Ethical clearance was obtained prior to start the study.Results: 50 doctors were included in the study after their verbal consent. It was revealed that average ...
British Journal of Clinical Pharmacology, 2007
AimsTo synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients.To synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients.MethodsStructured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts.Structured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts.ResultsSeven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data reported by four. Patient reports identified possible new ADRs that had not previously been reported by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process.Seven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data reported by four. Patient reports identified possible new ADRs that had not previously been reported by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process.ConclusionsOverall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence.Overall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence.
Journal of Evaluation in Clinical Practice, 2004
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 knowledgeattitudes-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.
Influence of Pharmacists??? Attitudes on Adverse Drug Reaction Reporting
Drug Safety, 2006
(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 = Herdeiro et al. 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.
Underreporting of recognized adverse drug reactions by primary care physicians: an exploratory study
Purpose This study evaluated the magnitude of underreporting of adverse drug reactions (ADRs) and investigated possible reporting patterns according to patient characteristics and the type of reaction based on the integration of information obtained from primary care electronic medical records (EMRs) and the Spanish Pharmacovigilance System. Methods This investigation was a descriptive retrospective study analysing ADRs recorded in 2005 in the EMRs from six health centers in Zaragoza (Aragon, Spain) with a covered population of 126,838 subjects. The associations between the probability of reporting and the reaction and drug type were studied using logistic regression models adjusted by age and sex. Results The total number of ADRs recorded in the EMRs was 543, of which 65.7% were reported to the Spanish Pharmacovigilance System. Positive associations were found between the probability of reporting an ADR and advanced age of patients (OR for ≥76 years = 2.0; 95%CI 1.1-3.6), involvement of the reproductive system (OR = 7.9; 95%CI 1.02-60.2) and involvement of psychiatric disorders (OR = 4.0; 95%CI 1.4-11.6). Negative associations were found between reporting an ADR and early age of patients (OR for 0-14 years = 0.2; 95%CI 0.1-0.6) and the use of antimicrobial drugs (OR = 0.6; 95%CI 0.4-0.9). Conclusions This study tackles an important public health problem directly related to patients' safety and highlights the utility of EMRs for investigating the current significance of ADR underreporting. It also makes us think that primary care physicians seem to have selective reporting patterns based on their familiarity with the reaction type and the drug causing the reaction as well as on the age of patients. Copyright