An investigation into adverse drug reaction monitoring by United Kingdom hospital pharmacy departments

Prior to the nationwide introduction of the Committee on Safety of Medicines “yellow card” adverse drug reaction reporting for hospital pharmacists, a study was carried out to investigate the activities undertaken by hospital pharmacists in adverse drug reaction (ADR) reporting. A survey of 200 United Kingdom hospitals was conducted and 172 (86 per cent) questionnaires were returned. Local ADR reporting schemes were in operation in 26 (15.1 per cent) surveyed hospitals. The majority used locally designed cards to report ADRs. The most common reasons for the lack of a local ADR scheme (n=141) were staffing, the fact that a scheme had never been considered, time factors and the lack of perceived need to operate a scheme. Of these 141 departments, 80.1 per cent said they would consider implementing schemes in their hospital. With the inclusion of pharmacists in the CSM “yellow card” scheme, there is an incentive for them to become officially and further involved in the management and reporting of ADRs. Local ADR reporting schemes encourage pharmacovigilance and could allow pharmacists to take a leading role in this area of clinical practice.     

A survey of adverse drug reaction reporting by hospital pharmacists to the Committee on Safety of Medicines — the role of pharmacy departments

Objectives — To identify: (1) how adverse drug reaction (ADR) reporting by hospital pharmacists is managed, (2) the education of pharmacy personnel on ADR reporting, (3) pharmacy personnel with a specific role in ADR reporting, (4) the numbers of ADR reports sent to the Committee on Safety of Medicines (CSM) and (5) barriers to reporting Method — Postal questionnaire survey of 250 hospital-based drug information (DI) departments Setting — All hospital-based DI departments listed in the United Kingdom Drug Information Pharmacists' Group directory Key findings — A total of 185 questionnaires was returned (74 per cent response). Thirty-five per cent of respondents had a procedure for the reporting of ADRs by pharmacists; 62 per cent of departments actively promoted reporting; 44 per cent of departments reviewed reports before they were sent to the CSM. DI pharmacists were frequently involved in the review of the reports and were usually the designated ADR person. Education on ADR reporting was provided by 69 per cent of departments. Few specialist pharmacists (n=9) were identified as having established a direct link with the CSM. The majority of departments had submitted five or fewer ADR reports to the CSM. The presence of a procedure, promotion of reporting, education and the presence of a designated ADR person were found to be associated with above average rates of ADR reporting (chi-square test) Conclusion — The survey showed that the role played by pharmacy departments in the area of hospital pharmacist ADR reporting varied considerably but in most cases was insufficiently developed     

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.     

The role of hospital and community pharmacists in pharmacovigilance

In this paper, we give an overview of the role pharmacists actually have and could have in collecting reports of adverse drug reactions (ADRs) and more widely in pharmacovigilance.In the literature, several ways are mentioned in which the pharmacist, both the community pharmacist and the hospital pharmacist, can contribute to the safe use of drugs. In addition to their responsibilities regarding drug dispensing and compliance, they can have a substantial role in ADR reporting.Especially, hospital pharmacists can play a significant role in ADR reporting because the most serious adverse drug events occur in hospitals, and ADRs account for a substantial proportion of hospital admissions.Community pharmacists, however, can also play an important role in ADR reporting. This is, for example, the case in the Netherlands where community pharmacists contribute substantially, both in numbers and in quality of ADR reports.The contribution of the pharmacist to pharmacovigilance should, however, not be limited to ADR reporting. The various pharmaceutical disciplines could also greatly enhance our understanding of the nature of ADRs. If those involved in pharmaceutical disciplines can rise to this challenge, they will significantly help deepen our insights into ADRs.     

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway

BACKGROUND: In Scandinavian countries, pharmacists have not reported adverse drug reactions (ADRs), either due to legislative restrictions or because of lack of tradition. From 1 January 2005, Norwegian pharmacists have been encouraged by the Norwegian Medicines Agency to take a larger role in the reporting of ADRs. OBJECTIVE: To explore pharmacists' attitudes towards pharmacovigilance and their experiences with ADR reporting, to evaluate the effect of an educational programme and to compare these findings to the attitudes in a control group. METHODS: From September 2004, pharmacies in two of Norway's five health regions were invited to attend a 3-month ADR reporting study, and 39 pharmacies were recruited. One pharmacist from each pharmacy participated in a 1 day pre-study educational programme and a 1 day post-study evaluation meeting. Pharmacists involved in the study answered a questionnaire (A) regarding their attitudes to ADR reporting (active group). A control group answered the same questionnaire. One reminder was sent. The active group evaluated the study by answering questionnaire A once more and an evaluation questionnaire (B). Qualitative aspects of ADR reporting were discussed with the active group post-study. RESULTS: The response rate for questionnaire A was 97% (n = 158) in the active group, 74% (n = 184) in the control group and the response rate for questionnaire A and B post-study was 68% (n = 105) in the active group. Pharmacists in the active group had more positive attitudes to ADR reporting after taking part in the study than the control group (p < 0.001). Lack of time, confidence and knowledge of reporting rules could potentially prevent them from reporting ADRs. CONCLUSIONS: The pharmacists had positive attitudes towards pharmacovigilance, but very little experience with reporting. The educational programme clarified their role and increased their knowledge about the reporting requirements.     

Adverse drug reaction reporting by general medical practitioners and retail pharmacists in Harare--a pilot study

OBJECTIVE: The pilot study was undertaken to investigate whether doctors and pharmacists in the private sector are willing to undertake Adverse Drug Reaction (ADR) reporting, to analyse their perceptions with regard to ADR reporting and to determine whether the concept of sentinel reporters could be of value in Zimbabwe. DESIGN: An open, prospective study where a selected group of private general medical practitioners and community pharmacists were asked to report any suspected ADRs over a six month period and to complete a structured self administered questionnaire. SETTING: Private medical and pharmacy practices in Harare. SUBJECTS: General medical practitioners and community pharmacists. MAIN OUTCOME MEASURES: Number of ADR reports received at Medicines Control Authority (MCA) and questionnaire responses. RESULTS: 19 reports were received from participants (eight pharmacists and five doctors) accounting for 79.2% of ADR reports to the MCA, during the study period. Seventeen (89.5%) of the reports generated from the study came from doctors. The 19 reports involved 15 different drugs, three (20%) of which had been registered in the last three years. Twelve questionnaires were completed. Serious and unexpected reactions were more likely to be reported. Most respondents knew what was expected and were willing to report, although five (41.7%) felt they were too busy. Seventy five percent of the doctors had not known that a reporting scheme existed in Zimbabwe and none of the participants had ever sent in a report prior to the study. Medical journals and the drug manufacturers were the most important sources of information about ADRs. CONCLUSION: Simply having interested pharmacists and doctors on the look out for ADRs and increased reporting of ADRs to the MCA. There are willing health care personnel but there is a need for larger studies to see if sentinel reporting of ADRs is applicable on a country wide basis.     

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.     

Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran

Objective Adverse Drug Reactions (ADRs) are a major cause of patient morbidity and mortality. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance and is important in maintaining patient safety. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was performed in Shiraz. Setting: The pharmacies in Shiraz, capital of Fars province in Iran. Methods A questionnaire was prepared to investigate knowledge and attitude of pharmacists regarding ADR reporting. The questionnaire was given to 200 pharmacists who participated in a pharmacist association meeting. Main outcomes measured: The knowledge of pharmacovigilance practice, reasons for not reporting ADR, and perceptions of the Iranian pharmacists on pharmacovigilance practice were evaluated Results The response rate was 55% (n = 110). 29% of the respondents were not aware of the Iranian Pharmacovigilance Center. More than half of those responding felt that ADR reporting should be voluntary, while 26% felt it was a professional obligation. As for the purposes of ADR reporting scheme, 60% of the pharmacists falsely believed that monitoring ADR spontaneous reports aims at measuring the incidence of ADR. 42% of the pharmacists indicated that they have suspected an ADR without reporting it. Doubt about causality was the major reason for not reporting an ADR. Although our ADR center states that all suspected reactions to any drug on the market must be reported, only 17% of the respondents seemed to be aware of this responsibility. Conclusion Our pharmacists have little knowledge regarding the operation, purposes, and usefulness of ADR spontaneous reporting system. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.     

Multidisciplinary program for detecting and evaluating adverse drug reactions

An adverse drug reaction (ADR)-reporting program involving detection of charted ADRs by quality assurance nurses and data collection and causality assessment by staff pharmacists is described. The voluntary ADR-reporting mechanism used in a 900-bed, university-based hospital complex produced less than one ADR report per month. The newly implemented system depends on nurses to detect and report documented ADRs through concurrent chart review. Staff pharmacists are then responsible for follow-up chart review, data collection, and causality assignment based on two published algorithms. An inservice education program designed to increase the awareness and understanding of ADRs was provided to the department of pharmacy and the quality assurance nurses. The clinical staff provides quality assurance through weekly ADR committee meetings. Drug information center personnel complete the causality algorithms by using the data collected by the staff pharmacists. The ADR committee then compares the algorithm results of the two assessors. Discrepancies in scoring are evaluated to determine whether a change in the system is necessary. An FDA report is generated if the staff pharmacist assessor and the drug information center assessor obtain results of "probable" for both algorithms. An ADR-reporting program that relies on quality assurance nurses to detect charted ADRs and on staff pharmacists to evaluate reported ADRs increased the average number of ADRs reported from 0.4 to 20 per month.     

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.     

Pharmacy-coordinated program that encourages physician reporting of adverse drug reactions

A pharmacy-coordinated program for encouraging physician reporting of adverse drug reactions (ADRs) is described. The ADR surveillance program at the Medical Center Hospital of Vermont, a 500-bed tertiary-care hospital, is in its fifth year. Key elements are close interaction between physicians and pharmacists, feedback, program promotion, and financial incentive. The program is promoted chiefly to house staff physicians. A physician may identify a suspected ADR, or he or she may be alerted by a pharmacist. The physician completes the first part of a form, which requests information on the patient, the severity of the reaction, the actions taken, and any predisposing factors. A pharmacist reviews the incident independently and in consultation with the reporter and then completes the second part of the form, which asks the pharmacists to assess the probability that the drug caused the ADR and to classify the reaction. A summary is sent to the physician and may be reported to the FDA and the manufacturer. Each report earns the reporter a $5 stipend. Information from the ADR forms is entered into a dBASEIII PLUS computer program for later retrieval and analysis. During a 12-month period, 175 ADR reports (out of a total of 249 reports) were received from house staff members, compared with about 4 voluntary reports received annually before the program began. The ADR surveillance program has increased physician reporting of ADRs and produced a reliable database that can be used to influence hospital policy and promote education.     

Attitudes of hospital pharmacists to adverse drug reactions and the “yellow card” scheme: a qualitative study

Objective — To elicit the views of hospital pharmacists towards adverse drug reaction (ADR) reporting. Method — Qualitative, semi-structured interviews were conducted on a face to face basis using a prepiloted questionnaire. Analysis was carried out using Winmax Pro, content analysis and comparison of interpretation by two independent reviewers. Setting — All major hospitals in one Committee on Safety of Medicines/Medicines Control Agency (CSM/MCA) regional monitoring centre in England. Key findings — It was considered that introduction of reporting had been poorly publicised and promoted. Only 42 per cent of those interviewed had submitted more than one “yellow card” report and a similar percentage had reported none. The CSM/MCA has a poor image in terms of accessibility and its perceived opinion of pharmacists' role in reporting. Feedback from the CSM/MCA was satisfactory and Current Problems in Pharmacovigilance was highly regarded. Several factors appear to be dissuading pharmacists from participation in the scheme, including lack of clinical knowledge, pressure of work and a lack of time. The absence of a fee did not appear to be a deterrent to reporting; in fact, a fee was considered inappropriate. Initial schemes for education and training were perceived as having been successful. However, ongoing training needs had not been fully addressed. Conclusion — While hospitals pharmacists acknowledge ADR reporting as part of their professional role, it is not yet considered as part of their daily practice and requires more vigorous promotion. Further investigation and quantitative work are required to investigate fully this aspect of pharmacy practice.     

Program coordinated by a drug information service to improve adverse drug reaction reporting in a hospital

A program coordinated by a drug information service to improve adverse drug reaction (ADR) reporting in a hospital is described. At a 520-bed teaching hospital, the drug information service was asked to design a new adverse drug reaction reporting system that would encourage clinicians to report ADRs. A new system was implemented on a general medical unit: A physician, pharmacist, or nurse telephoned the drug information service when an adverse drug reaction was suspected, and drug information personnel followed up on the report, completing all subsequent investigation and documentation. A standard algorithm was used to evaluate causality of the reported reactions. Pertinent data were entered on a form and retained in the drug information service. The primary physician's approval was obtained before a reaction could be reported on an FDA drug-experience form. Drug information service personnel reviewed the ADR data monthly to detect any trends that clinicians should be aware of and to prepare a report for the pharmacy and therapeutics committee. Nurses, physicians, and pharmacy personnel were oriented to the new system before its implementation and were subsequently informed about reported ADRs and use of the system through newsletters and meetings. In the initial three-month period, 23 ADRs involving 19 drugs were reported from the medical unit; in a six-month period before development of the new system, no ADRs had been reported. This ADR reporting system developed and implemented by the drug information service was effective in improving reporting of adverse drug reactions.     

Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting

AIMS: To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of adverse drug reaction (ADR) reporting. METHODS: A postal questionnaire survey of 600 randomly selected hospital pharmacists was conducted. RESULTS: The response rate was 53.7% (n = 322). A total of 217 Yellow Cards had been submitted to the CSM/MCA by 78 (25.6%) of those responding. Half of those responding felt that ADR reporting should be compulsory and over three-quarters felt it was a professional obligation. However, almost half were unclear as to what should be reported, while the time available in clinical practice and time taken to complete forms were deemed to be major deterrents to reporting. Pharmacists were not dissuaded from reporting by the need to consult a medical colleague or by the absence of a fee. Education and training had a significant influence on pharmacists' participation in the Yellow Card Scheme. CONCLUSIONS: Pharmacists have a reasonable knowledge and are supportive of the Yellow Card spontaneous ADR reporting scheme. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.     

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.     

Pharmacists' role in reporting adverse drug reactions in an international perspective

INTRODUCTION: The participation of the pharmacist in national spontaneous reporting systems for adverse drug reactions (ADRs) has not always been a matter of course. Even today, there are a number of countries, in particular the Scandinavian countries, where pharmacists are not authorised to report ADRs. In those countries in which they are allowed to report, they do not always use this opportunity. METHODS: We have conducted a review of the literature to investigate the involvement of pharmacists in ADR reporting. In addition, we evaluated the pharmacists' actual contributions in 2001 by means of an international questionnaire-based survey among the countries participating in the WHO Drug Monitoring Programme in September 2002. Apart from the numbers of pharmacists' reports, respondents were asked to indicate their assessment of both the quality and the significance of the contribution. Of the 68 participating countries, 41 responded by returning the questionnaire. RESULTS AND CONCLUSIONS: The appreciation of pharmacists' ADR reports is high in those countries that have more experience with greater numbers of pharmacists' reports. The countries that received fewer reports from pharmacists gave lower scores to their contribution. If the specific contribution pharmacists can make to the quantity and quality of ADR reports were to be exploited to a greater extent, this could lead to a substantial improvement of the international adverse drug reactions reporting system.     

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.     

Adverse drug reaction monitoring by United Kingdom hospital pharmacy departments: impact of the introduction of “yellow card” reporting for pharmacists

Objective — To assess the impact of the introduction of hospital pharmacist “yellow card” adverse drug reaction (ADR) reporting on the operation of local schemes. Method — Prepiloted postal questionnaire sent to hospitals in 1998 following up a previous survey two years earlier. Setting — Clinical services managers for 200 hospital pharmacies that had been randomly selected for the previous survey. Key findings — One hundred and fifty usable questionnaires (75 per cent) were returned. Twenty-eight departments (18.9 per cent), compared with 26 departments (15.1 per cent) in 1996, operated ADR reporting schemes. Of a total of 440 local ADR reports made to participating departments, 70.0 per cent (312) were forwarded to the Committee on Safety of Medicines, a significantly higher percentage than the 14.9 per cent in the previous study (P=0.001). Only eight hospitals (5.4 per cent) had schemes for monitoring newly marketed or “black triangle” drugs. Ninety-four departments (62.3 per cent) had supported education and training activities. Of the hospitals without a scheme, 15 (12.5 per cent) said they had definite plans to introduce one in their hospital, 40 (33.3 per cent) had probable plans to introduce one and 65 (54.2 per cent) had no such plans. Conclusion — Pharmacists' involvement in the CSM yellow card scheme appears to have had little impact on local initiatives. In areas where these local schemes have been implemented and educational activities provided, drug information pharmacists appear to have a significant role. From the results of this study, even in hospitals with local or in-house schemes, gross under-reporting of ADRs remains a major problem.