Attitudinal survey of voluntary reporting of adverse drug reactions

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.     

Improved reporting of adverse drug reactions

A program using satellite pharmacists to improve adverse drug reaction (ADR) reporting in an 1100-bed teaching hospital is described. Because relying on physicians to report ADRs had met with little success (only six reports in seven years), the pharmacy department proposed that pharmacists in satellite pharmacies on patient-care units be called upon to identify and report ADRs. To begin this program, an ADR team composed of a physician, pharmacist, and nurse made weekly rounds of the satellite pharmacies to assist pharmacists in identifying potential ADRs. The FDA definition of an ADR was adopted. Also, inservice education programs about ADR reporting were conducted for pharmacists and nurses. Currently, suspected ADRs are reported to the satellite pharmacist, who forwards a completed drug reaction report form to the assistant director for clinical pharmacy services. Reports are discussed quarterly by the ADR subcommittee of the pharmacy and therapeutics committee; the sub-committee members determine whether any follow-up action is needed. In the first three years after implementation of this program, 306 ADRs were reported; 90% of the reports were filed by pharmacists. An ADR reporting system based on reporting by staff pharmacists has been effective in increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs.     

A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain.

INTRODUCTION: Since April 1997, UK hospital pharmacists have been invited to submit reports of suspected adverse drug reactions (ADRs) to the Committee on Safety of Medicines (CSM) and Medicines Control Agency. Three studies have investigated the involvement of hospital pharmacists in ADR reporting; however, they did not investigate the possible factors that could affect ADR reporting. OBJECTIVES: (i) To analyse the extent to which hospital pharmacists think that specified factors could affect reporting ADRs; (ii) to identify any additional factors that could hinder reporting; and (iii) to recommend possible methods to improve reporting. METHODS: Piloted questionnaires were sent to 548 hospital pharmacists in Great Britain randomly selected by the Royal Pharmaceutical Society of Great Britain (RPSGB) from their computer database. 346 questionnaires were returned and 280 were included in this study. RESULTS: 46% of the pharmacists had identified ADRs that were considered to be reportable according to the CSM criteria in the 6 months prior to the survey. 39% did not report these ADRs either to the CSM or the manufacturers. Only 8.2% reported that their hospitals had a written policy; conversely, 73.7% agreed that such a policy could enhance ADR reporting. Although not statistically significant, the result showed an increasing tendency to report ADRs by pharmacists who had received training. Furthermore, there was an increasing tendency to report ADRs with increasing seniority. DISCUSSION: The results show that hospital pharmacists say they are more likely to report serious and rare ADRs and ADRs associated with newly marketed drugs. Factors that could reduce ADR reporting included being busy at work, lack of confidence in recognising ADRs and the fear of breaching patient confidentiality. Most common suggestions on methods to improve ADR reporting were to provide ADR training and meetings (34%) and a hospital written policy (24%). RECOMMENDATIONS: ADR training and meetings would be a useful step in improving hospital pharmacist ADR reporting. Therefore, we recommend that the CSM and the RPSGB liaise with regional drug information centres and schools of pharmacy to provide more study days and training programmes for hospital pharmacists. Furthermore, the CSM should write to the 'Drugs and Therapeutics Committee' of each hospital and encourage them to develop a written local policy for pharmacist ADR reporting. Further studies should be conducted to test the recommendations noted here, assessing the response of the pharmacists in terms of absolute numbers of reports made. It would be particularly interesting to study the need for a written hospital policy and education.     

Under-reporting of serious adverse drug reactions in Sweden

INTRODUCTION: Adverse drug reactions (ADR) constitute a major problem, both from a medical point of view and as an economical burden. Spontaneous reporting of ADRs is one of the methods for post marketing surveillance of drug safety. Under-reporting can also provide an important obstacle to rapid and relevant signal detection. AIM: To investigate the rate of under-reporting serious ADRs of selected ICD 10 diagnoses. METHOD: In order to investigate the under-reporting rate we investigated at five hospitals within the county of Norrbotten in Sweden the total number of diagnosed cases during a period of 5 years (1996-2000) with the following diagnoses: cerebral haemorrhage (I 61.0-I 61.9), pulmonary embolism (I 26.0 and I 26.9), embolism or thrombosis (I 74.0-I 74.9), phlebititis, thrombophlebitits or venous thrombosis (I 80.0-I 80.3, I 80.8 and I 80.9) and portal vein thrombosis and other thrombosis or emboli (I 82.0-I 82.3, I 82.8 and I 82.9). The identity of these patients was obtained through a database search. The patients' case records were then scrutinized by a specially trained nurse and the drugs used at the time of the event were noted. An assessment of the possibility of an ADR was performed using standard WHO causality criteria. Later, database search in the Swedish ADR registry was performed in order to investigate whether these suspected ADRs had been reported to the national authority in Sweden or not. RESULTS: In total 1349 case records were found and scrutinized. Of these, 107 patients had received drugs that could have been a probable or possible cause to the diagnoses. Of these 92 cases had not been reported and only 15 patients were found in the database, giving an overall under-reporting rate of all ADRs of 86%.The most commonly occurring diagnoses were cerebral haemorrhage followed by venous thrombosis, 545 and 468 respectively. Among those cases that should have been reported according to the existing rules for spontaneous reporting of suspected ADRs the most frequently occurring diagnosis was cerebral haemorrhage (I 61.0) in connection to treatment with anticoagulants. CONCLUSION: The rate of spontaneous ADR reporting is very low, also for serious and fatal reactions.     

Hospital pharmacy compliance with JCAHO standards and ASHP guidelines for reporting adverse drug reactions.

The extent to which institutional pharmacies comply with the accreditation standards of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the ASHP guidelines for reporting adverse drug reactions (ADRs) was evaluated. A survey was mailed to directors of pharmacy at 444 randomly selected hospitals to collect information on their institutions' ADR programs; the survey addressed each point in the JCAHO accreditation standards and the ASHP guidelines. The 176 usable responses indicated that 89.8% of the institutions met all three of the JCAHO standards and 98.9% met at least two of them; 28.4% of the institutions complied with all 11 of the ASHP guidelines, and 89.2% complied with at least eight of them. Approximately 97% of the institutions had policies for ADR reporting. Respondents reported an average of 70.5 ADRs per hospital during 1989, of which 6.8 per hospital were reported to the FDA. More than 95% of all respondents indicated that they most frequently identified ADRs through voluntary reporting by health-care professionals. Respondents indicated methods and individuals responsible for reporting ADRs, notifying the physician and the FDA, and assessing severity and causality. Sixty-seven percent of the respondents indicated that they did not have a formal ADR committee for monitoring and evaluating ADRs. Almost 90% of the surveyed hospitals complied with all of the JCAHO standards for ADR reporting programs and at least 8 of the 11 ASHP guidelines for ADR monitoring and reporting.     

Incidence of adverse drug reactions in adult medical inpatients

This study was a prospective observational study of ADR occurrence and evaluation in adult internal medicine inpatients conducted over a 120-day period. Clinical pharmacists screened for ADRs at a county hospital in Indianapolis, IN. Patient information was reviewed on admission, every four days during hospitalization, and at discharge. ADRs occurring after hospital admission were assessed for causality, severity, pharmacological type (i.e., augmented pharmacology versus idiosyncratic reaction) and affected organ system. Nurse and pharmacist reports, incident reports, physician consults, patient transfers to critical care units, and serum drug concentration reports were additional means of ADR identification. Overall, 23.1% of patients experienced an ADR while 2.6% of the 11,702 drug exposures resulted in an ADR. Patients aged greater than 65 years (29.6% vs. 20.5% for younger patients) and females (26.2% vs. 20% for males) were at higher risk for ADR development (p < 0.05). Length of hospital stay was longer (13.3 days vs. 6.7 days; p < 0.05) and drug exposures more frequent for patients experiencing ADRs (p < 0.001). Furosemide elicited the most ADRs with 36 in 244 patient exposures (14.7%). Diltiazem, enalapril, heparin, trimterene/hydrochlorothiazide combination and captopril were also frequently implicated. ADRs were classified as mild (35.9%), moderate (52.6%), and severe (10.2%). Organ systems most commonly affected were the metabolic/hematologic (32.9%), gastrointestinal (17.8%), genitourinary (11.8%), and cardiovascular (10.5%). Over 30% of events were idiosyncratic reactions. ADR incidence was consistent with previous literature. Many frequently implicated medications were newer agents and the severity of events was less than previously reported.     

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.     

Do pharmacists' reports of adverse drug reactions reflect patients' concerns?

Aim: The aim of the present study was to investigate whether the concerns patients express to a Drug Information Line about possible adverse drug reactions (ADRs) they have experienced, are sufficiently reflected by the ADR reports submitted by pharmacists to the Netherlands Pharmacovigilance Centre Lareb with regard to the type of ADRs and the drug groups involved. Methods: ADR-related questions patients addressed to the Dutch Drugs Information Line were compared with the ADR reports pharmacists sent in to Lareb in the same period. The similarities and differences between the characteristics of the suspected ADRs and the kinds of drugs mentioned were investigated, as well as the severity of the reported ADRs. To compare the two data sets and to establish whether significant differences were present, a logistic regression analysis was conducted on the reported drugs and ADRs. Results: Analysis of the content of the phone calls yielded 1168 (14.6%) calls concerning possible experienced ADRs. The suspected ADRs pharmacists reported to the Netherlands Pharmacovigilance Centre Lareb in the same period included 1734 reports. There were only slight differences between the queries patients put to the Drug Information Line regarding possible adverse drug reactions and the reports on suspected ADRs pharmacists submitted to the pharmacovigilance centre. With respect to possible ADRs in the psychiatric spectrum and ADRs associated with the use of antidepressants, there seems to be a deficiency in the reporting by pharmacists. Conclusion: The ADRs pharmacists report to the national pharmacovigilance centre reflect patients' concerns about ADRs they experience in relation to the medication they are taking.     

Reporting of adverse drug reactions by hospital doctors and the response to intervention

Aims In Ireland there are relatively fewer adverse drug reaction (ADR/yellow card) reports from doctors in hospital than in general practice. The aim of this study was to review the attitudes to reporting of ADRs of hospital doctors and to determine the effect of making yellow cards freely available.
Methods A postal survey of actively practising doctors with follow-up of non-responders was undertaken. We addressed the single most frequently claimed deterrent to reporting, unavailability of yellow cards, by making cards prominently available and placing one in patient's chart upon admission. In addition, doctors were regularly reminded that ADRs should be reported.
Results Of 118 hospital based doctors, only 45% had ever reported an ADR. Fewer than 5% of pre-registration house officers had reported an ADR and the likelihood of reporting increased with seniority and was greater among physicians than surgeons. We found no evidence that doctors had published case reports in place of submitting ADR reports. Over 3 months, the greater availability of yellow cards and reminders about reporting ADRs led to an approximate five-fold increase in reports but reporting declined rapidly thereafter when verbal reminders were withdrawn, despite continued ready availability of cards suggesting that making cards available alone does not significantly increase reporting.
Conclusions This study indicates there may be more fundamental constraints to reporting than attitudinal surveys would suggest and we need to explore additional avenues to ensure a 'reporting culture'.     

The ambiguity of adverse drug reactions

Summary Three clinical pharmacologists independently evaluated 500 untoward clinical events reported by physicians as adverse drug reactions (ADRs). They often disagreed with the reporting physicians and with each other. They judged 14.4–28.2% of the events to be definite, 26.4–38.0% probable, 21.4–31.0% possible and 15.8–28.2% unlikely ADRs. In their opinion 19.1–32.4% of the drugs blamed were definitely, 29.8–34.4% probably, 24.9–36.7% possibly and 8.4–14.5% not responsible for the adverse reactions. Evaluators disagreed among themselves about the drug most likely to have been responsible in 36.4% of the events, about ADRs causing hospital admission in 56.8%, about severe ADR morbidity in 55.8%, about ADR prolongation of hospitalization in 67.3% and about ADR contribution to death in 71.0%. The divergence of judgements suggests that suspected ADRs are usually ambiguous clinical events, and that incidence, severity, medical consequences and cost of ADRs can only be estimated.     

Characteristics and quality of adverse drug reaction reports by pharmacists in Norway

PURPOSE: To evaluate the characteristics and quality of adverse drug reaction (ADR) reports submitted by pharmacists, and thereby assess the possible contribution of pharmacists to the spontaneous reporting system for ADRs in Norway. METHODS: An open, prospective study was conducted where dispensing pharmacists from 39 pharmacies were encouraged to report ADRs over a 3-month period. The submitted ADR reports were compared to reports by physicians from the same time period. All reports were evaluated for selected characteristics, that is distribution of Anatomical Therapeutic Chemical (ATC) classification codes of suspected drugs, distribution of ADRs according to system-organ classes and the quality of the reports. RESULTS: A total of 118 reports covering 274 ADRs received from the pharmacists were compared to 109 ADR reports with 304 ADRs submitted by physicians. Pharmacists more often reported ADRs related to cardiovascular drugs, alimentary tract and metabolism drugs and respiratory drugs, whereas physicians more frequently reported ADRs related to musculoskeletal drugs and antineoplastic and immunomodulating agents. ADRs reported by pharmacists more frequently described gastrointestinal reactions while physicians reported more ADRs in relation to the cardiovascular and blood system. Whereas 68% of the physicians' reports were classified as serious, only 5% of the pharmacists' reports were serious. More than 50% of the reports submitted by pharmacists concerned ADRs following a generic substitution, in contrast to only 2% of the physicians' reports. The pharmacists' reports were found to be of a lower documentation grade. However, there was no substantial difference in a subjective assessment of the quality of information in the reports submitted by the two categories of health professionals. CONCLUSIONS: Pharmacists submit valuable ADR reports which provide information complimentary to physicians' reports. This emphasises that pharmacist ADR reporting might constitute an important addition to the spontaneous reporting system.     

Spontaneous adverse drug reaction reporting by community pharmacists: preparedness and barriers

BackgroundAdverse drug reactions (ADRs) are undesired, unintended responses to drugs, and are significantly underreported. Pharmacists are drug experts recognized as custodians of drug safety, who are expected to be prepared for and knowledgeable about ADR reporting.ObjectivesTo identify Egyptian community pharmacists’ preparedness for and perceived barriers to spontaneous ADR reporting.MethodsThis cross-sectional study recruited a sample of community pharmacists across Egypt, who were invited to complete a self-administrated questionnaire during April 2020.ResultsA total of 923 pharmacists across Egypt responded to the questionnaire. Most pharmacists were knowledgeable about the definition of ADRs (93.9 %) and indicated they felt reporting ADRs benefits the patients (82.2%). Despite recognizing their public health value, only a small percentage of participants conveyed familiarity with the reporting process for both paper (19.2%) and electronic (30.4%) forms, indeed 56.6% of participants did not remember what the ADR report form looked like. Moreover, 75.4% of respondents said they felt that community pharmacies are not the right place for reporting, with 49% suggesting that reporting was the responsibility of physicians. However, only 32.1% reported having insufficient time being a barrier to ADR reporting.ConclusionsCommunity pharmacists in Egypt are not well prepared for spontaneous ADR reporting due to a lack of knowledge about the formal process and not acknowledging their responsibility, although time was not a major barrier. Therefore, this highlights a clear opportunity for improvement likely involving targeted education.     

Food and Drug Administration monitoring of adverse drug reactions

Food and Drug Administration requirements for reporting adverse drug reactions (ADRs), processing of ADR reports, and actions in response to these reports are described. FDA requires that drug manufacturers report ADRs to the FDA Division of Epidemiology and Surveillance; 90% of the ADR reports received are from manufacturers. Of the remaining 10%, one third are from pharmacists. FDA regulations were revised in 1985 to specifically define reportable ADRs and procedures for reporting; manufacturers are required to report within 15 days reactions that are serious and unlabeled. For newly approved drugs, reports on ADRs must be submitted quarterly for three years; subsequently, annual reporting is required. Any increase in the frequency of serious, labeled reactions must be reported. Serious reactions not listed in the product labeling must be reported for products marketed before 1962 for which new drug applications or abbreviated new drug applications were not filed. ADR information received by FDA is coded into standard terms and entered in a computerized database for evaluation by reviewers. If an important reaction is suspected, the report is entered in a tracking system for further monitoring. ADR reports may result in requirements for changes in product labeling, "Dear Doctor" letters, requirement of further study by the manufacturer, or withdrawal of the product. Information about ADRs is communicated to health-care practitioners in product labeling and in the literature. Pharmacists are encouraged to report suspected serious and unlabeled reactions to FDA so that the medical community and the public can benefit from current information about drug safety.     

Attitudes of community pharmacists in the Netherlands towards adverse drug reaction reporting

Objective — To gain insight into the attitude and behaviour of community pharmacists in the Netherlands with respect to the reporting of adverse drug reactions (ADRs). Method — A questionnaire survey was conducted among a stratified random sample of 200 community pharmacists from the membership list of the Royal Dutch Society for the Advancement of Pharmacy. The structured questionnaire covered knowledge of the Dutch ADR reporting system, attitudes to involvement in reporting ADRs and self‐reported behaviour. Demographic details were requested and used to assess the representativeness of responders in relation to the total population of Dutch community pharmacists. The number of self‐reported ADR reports was compared with those actually received by the nation's ADR centre. Key findings — The response rate was 73 per cent (n=147) after one reminder. Community pharmacists regarded the reporting of ADRs as an integral part of their professional duties and they did not report experiencing any major barriers to reporting. This is reflected in the frequency and number of ADR reports received by the national pharmacovigilance centre. Comparison of pharmacists' self‐reported numbers of ADR reports with actual reports received indicated that pharmacists overestimated the number of reports they made. The most frequently mentioned barriers to reporting were: the adverse effect assumed to be already known (32 per cent), the reporting procedure too time consuming (25 per cent), and uncertainty concerning the causal relationship between ADR and drug (25 per cent). Feedback was mentioned most commonly as the chief impetus for reporting, and this referred both to feedback on the report submitted and general feedback as provided in publications. Although consultation with the attending clinician before submitting a report is not compulsory in the Netherlands, 55 per cent of the pharmacists saw this as an important aspect in the reporting process. Conclusions — Community pharmacists in the Netherlands are knowledgeable about reporting ADRs and highly motivated to do so. This positive attitude towards reporting adverse events is based on the established tradition of pharmacist reporting in the Netherlands.     

Hospital-based survey of doctors' attitudes to adverse drug reactions and perception of drug-related risk for adverse reaction occurrence

Doctors' attitudes to adverse drug reactions (ADRs) and perception of drug-related risk for ADR occurrence were investigated in four hospitals in Northern Italy using an interviewer-administered questionnaire. ADRs were a relevant concern in medical practice for 80% of the respondents and had been observed by 87%. ADRs were perceived to occur in no more than 5% of hospitalized patients and serious ADRs in less than 1%. The response patterns, however, differed according to the ward of work and the year of graduation of the doctors. Antibacterials, NSAIDs and antiarrhythmics were rated as higher risk drugs, while diuretics, lipid lowering agents, antihistamines, antiemetics and antispasmodics were rated as lower risk drugs. Risk perception was dishomogeneous mainly with respect to the ward of work. The estimated frequency of ADR occurrence, the perception of drug-related risk and previous ADR reporting behaviour were clearly correlated. The present results suggest that personal factors affect doctors' attitudes to ADRs, perception of drug-related risk and ADR reporting behaviour and may thus be relevant in developing and targeting educational strategies aimed at increasing awareness of ADRs and at encouraging ADR reporting.     

An introduction to adverse drug reaction reporting systems in different countries

Objective To review adverse drug reaction (ADR) reporting schemes in selected developed countries, with emphasis on identifying community pharmacists' roles in ADR reporting. Setting International comparison between eight developed countries, with respect to ADR reporting systems and developments. Method Review of published articles on ADR reporting by pharmacists. Health and medical sciences databases including International Pharmaceutical Abstracts, MEDLINE and ProQuest were searched for relevant publications from 1993 to 2003. Websites specific to ADR reporting schemes in the selected countries were also searched. Key findings ADRs impact significantly on a nation's healthcare costs. Voluntary reporting by health professionals is currently considered the cornerstone to the detection and management of ADRs and makes a valuable contribution to the safe use of medicines. ADR reporting systems are managed by national ADR or pharmacovigilance reporting centres, and differ internationally. In general, medication‐related problems are reported more commonly in hospitals than in the community. Physicians are the main contributors, except in the Netherlands and Canada, where community pharmacists play the major role in ADR reporting. Time pressure, no remuneration for reporting, and confusion about what to report were identified as some of the main deterrents for reporting by pharmacists. Conclusion Most international reporting systems for ADRs are either hospital based, or physician based. The opportunity therefore exists to further develop reporting systems that are accessible by community pharmacists, as they are in an ideal situation to detect and report ADRs through contact with patients.     

Reporting of adverse drug and biologic reactions in Mississippi hospitals.

There can be no doubt of the therapeutic need for adverse drug reaction (ADR) monitoring in hospitals. In addition, JCAHO requirements mandate the maintenance of concurrent ADR monitoring programs. In order to obtain data pertaining to ADR reporting in hospitals in Mississippi, a survey of statewide hospital-pharmacy directors was conducted. Respondents indicated the average number of ADRs reported to the pharmacy departments was 19.2 ADRs per year. An average of 2.2 ADRs were forwarded to the FDA yearly. Respondents who had recently (since 1984) undergone JCAHO inspection agreed to a greater extent than others that it was the P & T Committee's responsibility to monitor ADRs. The results indicate a need for other health professionals in hospitals to monitor and report ADRs. In addition, submission of ADRs to the FDA must occur to a greater extent than presently is occurring.     

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.