Underreporting of recognized adverse drug reactions by primary care physicians: an exploratory study (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
A study on determinants of underreporting of adverse drug reactions among resident doctors
International Journal of Research in Medical Sciences, 2018
Background: Adverse Drug Reactions (ADRs) are global problem with significant morbidity and mortality. Health care providers/professionals (HCPs) play a critical role in ADR surveillance. However, only 6% of all ADRs are reported and under-reporting acts as great impedance in exchange of drug information. Thus, spontaneous reporting of suspected adverse drug reactions requires greater commitment from healthcare professionals. The aim was to determine the reasons of underreporting of ADRs among resident doctors.Methods: This was a cross-sectional observational study with self-administered questionnaire assessing the reasons for underreporting of ADRs among resident doctors.Results: Very low level of awareness about ADR reporting was found among doctors. Eighty eight percent of doctors did not know the authority and the procedure for ADR reporting. About 32.8% were not sure with the reaction and the drug, while 46.3% doctors felt that there is no need of reporting the recognized react...
Journal of Clinical Epidemiology, 2002
The spontaneous reporting system (srs) is the most important early warning system of adverse drug reactions. As there is serious under-reporting we studied the respective knowledge and attitudes of two samples of physicians in Germany. Five hundred randomly sampled physicians and 815 physicians who had actually reported an ADR were included; the response rate to the mail questionnaire was 51.4 and 43.9%, respectively; 61.3% said to have reported at least one case in their life. As many as 75-85% of physicians said never to have sent an ADR report to the governmental or professional reporting systems. Reporting to pharmaceutical companies, on the other hand, has been substantially better. Sixty-eight and two-tenths percent indicated to have suspected an ADR without reporting it. Major reasons for not reporting were: ADR well known (75.6%), too trivial (71.1%), causality uncertain (66.3%). The ADR with the highest probability of being reported were serious unknown adverse reactions of a new drug (81.1%) or an established drug (72.9%) and serious known reactions to a new drug (65.2%). Almost 20% of the physicians admitted to not know the spontaneous reporting system and 30% to not know how to report; 54% would rather report an ADR if therapeutic advice was offered. The results indicate that the traditional ways of advertising the srs and communicating with physicians could be improved. Proactive services and professional marketing of srs are needed to reduce underreporting.
Objectives: To measure awareness about adverse drug reaction (ADRs) reporting among doctors, pharmacists and nurses and to determine reasons of ADRs under‑reporting in Pakistan. Methods: In present study, a self‑administered questionnaire was used to measure the awareness level about ADRs reporting among health care professionals (HCPs) of Pakistan. This was a cross sectional study. Results: Out of the respondents 51 % were physicians, 29.7 % pharmacists and 19.3 % were nurses. 65.5 % of HCP population observed ADRs, out of which only 57.4 % reported these in their respective hospitals. About 77.3 % of population understood the importance of reporting ADRs while 67.3 % of population agrees that pharmacists are chief personnel for the development of system. 71.8 % of HCPs agrees that ADRs are not reported because Commu‑ nity pharmacy lacks legally qualified pharmacists. Only 14.3 % of HCPs population knows that there is any ADR report‑ ing organization in Pakistan. Conclusion: The study recommends the need of such reporting system and more than half of the studied popula‑ tion agreed that pharmacists are required in developing such system.
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 ...
Under-reporting of adverse drug reactions in general practice
British Journal of Clinical Pharmacology, 2003
Aims In post-marketing setting, spontaneous reporting by physicians is a mode of surveillance of adverse effects associated with drug use. The objective of this study was to quantitatively assess under-reporting of adverse drug reactions (ADRs) in general practice. Methods A random sample of 100 general practitioners (GPs) practising in the region of the Bordeaux pharmacovigilance centre were surveyed to obtain data on adverse effects observed. Overall, 81 GPs agreed to record during 3 non-consecutive working days any effect they believed to be associated with drug use. The types of effects, regardless of their seriousness and labelling, and the drugs suspected were characterized and compared to spontaneous reports received from GPs by the Bordeaux pharmacovigilance centre during the reference period. Results The average number of ADRs observed per day per GP was 1.99. The estimate of the under-reporting coefficient ( U) was 24 433 (95% confidence interval: 20 702-28 837) which indicates that, as a whole, GPs might be expected to report only 1 out of every 24 433 ADRs to the pharmacovigilance centre. Under-reporting was lowest for serious and unlabelled effects ( U=4610; 95%CI: 2514-8454) and for drugs marketed recently (U=12 802; 95% CI: 8174-20 050). Conclusions Adverse effects due to drugs are part of GPs routine activities. According to the observed trend in under-reporting, there appears to be a selection process which indicates that spontaneous reporting in general practice is not conducive to an exhaustive description of the safety profile of a drug. However, our findings are consistent with greater efficacy of spontaneous reporting in detecting serious and unlabelled effect.
Reporting Adverse Drug Reactions in a Tertiary Care Hospital in İstanbul
Turkish thoracic journal, 2018
The World Health Organization (WHO) defines adverse drug reactions (ADR) as "response to a drug that is noxious and unintended and occurs at doses normally used in men for prophylaxis, diagnosis or therapy of disease, or for modification of physiological function" [1]. Reactions can be caused by any therapeutic agent, such as antibiotics, analgesics, blood products, vaccines or radiographic contrast media [2]. The reaction may be a well-known side effect of the drug or an undefined new reaction. Initially, many ADRs are unpredictable; they are mostly described after the post-marketing widespread usage [2]. Age, polypharmacy and additional diseases are the main risk factors for ADRs [3]. A study by Pirmohamed et al. [4] showed that patients admitted with ADRs were significantly older than patients without ADRs (76 versus 66 years). Therefore, ADRs pose a considerable burden among hospitalized patients who are more likely to be older and taking multiple medicines. ADRs are more common than expected among hospitalized patients; they may occur in up to 16.8% of patients during hospitalization, and 16% of these reactions may be fatal [5,6]. Spontaneous ADR reporting systems are used for surveillance of drug associated risks, and in many countries, the adverse drug reporting form is the standard of care for detecting the annual rate of ADRs in inpatient or outpatient settings. Additionally, a computer software and database for case report management have been designed for monitoring ADRs at some centers in Europe [2]. Questionnaires are an inexpensive and simple method for identifying new ADRs occurring in hospitals. The adverse drug reporting form can be filled by pharmacists, hospital doctors, nurses, and other healthcare professionals. However, many physicians are not aware of this form and are not reporting ADRs. According to the results of a survey, only 26% of physicians know which ADRs to report, 36% think that reporting is too bureaucratic, 22% do not know how to report and 18% are unaware of the need to report ADRs [7]. Doctors and other healthcare professionals also declare that they do not have enough time to report ADRs [7]. Nevertheless, in recent years, an increase in the proportion of reports, filled and sent by nurses and pharmacists, has been noticed [2]. At our institutions, we systematically monitor ADRs occurred during inpatient care. The ADR reporting forms are completed by our inpatient nurses immediately after an unwanted drug reaction has been detected. These forms include patients' demographic details, culprit drug, details of the reaction and the management of ADR (Figure 1) [8]. The ADR team at our hospital, which comprises a pharmacist, an allergist, a pulmonologist, and a nurse, is responsible for collecting data from the forms and organizing educational activities for improving ADR management. The allergist arranges training activities according to the needs of the staff and the pharmacist submits data to our national pharmacovigilance data system. Two training sessions are organized each year for inpatient nurses; these trains consist of updated education about drug interactions, ADRs, allergic drug reactions, and methods for appropriately filling out the ADR reporting form. Our reporting system provides valuable information to our healthcare professionals and helps them to be aware of the factors related to ADRs and prevention strategies to reduce the occurrence of unwanted drug reactions, accurate diagnosis, and effective management of ADRs, such as adrenaline use in anaphylaxis. Our computer based data collecting system will also be available in the near future and will help improve the service we provide.
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.