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.     

Use of a database computer program to identify trends in reporting of adverse drug reactions

A computerized system for concurrent monitoring and reporting of adverse drug reactions (ADRs) in a university hospital is described. The program, which began in 1988, was developed in collaboration with the hospital's pharmacy and therapeutics committee and quality assurance committee. Quality assurance nurses review patients' charts every three days during hospitalization; if an ADR is detected, the nurse completes an ADR report form. A computer database is used to sort and store 15 data elements taken from each ADR form. Individual pharmacists and hospital review committees evaluate the recorded ADRs. The database can present the data for analysis by different variables such as patient age, clinical service, and implicated drugs. Retrieval of such data permits easier evaluation of trends in ADR reports and identification of reactions that should be reported to FDA. Educational programs for staff members can be targeted to address problems occurring within the institution. During the first nine months of the program 340 ADRs were reported; 15 reports were submitted to FDA, and serious problems were reviewed at medical grand rounds. A bimonthly newsletter that reviews recently reported ADRs was begun. The monitoring program has facilitated rapid detection and evaluation of ADRs.     

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.     

Impact of the development of a multidisciplinary adverse drug reaction committee

A multidisciplinary Adverse Drug Reaction (ADR) committee consisting of pharmacists, nurses, and physician was formed. The committee developed an ADR Reporting Form and a 24-hour ADR Reporting Hotline to simplify ADR Reporting throughout the hospital. An ADR Newsletter and an extensive inservice education program was also implemented. Suspected ADRs are investigated by a pharmacist and presented to committee. A formal report is then forwarded to the Pharmacy and Therapeutics Committee, as well as the clinical departments within the hospital. The establishment of a formalized multidisciplinary ADR committee was successful in generating 2.1 ADR reports per 100 hospital admissions. These ADRs were reported from a variety of healthcare professionals.     

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.     

Multidisciplinary adverse drug reaction surveillance program

Initial experience with a multidisciplinary adverse drug reaction (ADR) surveillance program at a 350-bed community hospital center is described. The pharmacy and quality-review (QR) departments developed a program that was incrementally incorporated into the hospital's overall QR activity. After inservice training, nurses and QR personnel were asked to complete an "alert" card for every suspected ADR and send it to the pharmacy. In addition, medical records were reviewed retrospectively for disease classification codes related to drug toxicity and unspecified adverse effects. Laboratory and utilization-review personnel also conducted retrospective reviews. A pharmacist reviewed all ADR reports and categorized each according to the severity of the reaction and the probability that it was drug related. For each reaction classified as severe, the patient's chart underwent physician peer review for appropriateness of therapy, avoidability of the reaction, and adequate documentation; related patient-care issues were addressed by the medical staff as part of routine quality-review activities. When problems with prescribing were identified, the pharmacy and therapeutics committee intervened with the prescribers or recommended further medical staff review. Drugs repeatedly associated with ADRs became the focus of drug-use reviews. The number of ADR reports increased from 0 to 134 in the first 11 months of the program. A multidisciplinary approach to ADR reporting increased the number and quality of ADR reports.     

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.     

Use of standardized screening procedures to identify adverse drug reactions

The development of an adverse drug reaction (ADR)-monitoring program using standardized screening procedures in a 650-bed hospital is described. A concurrent ADR-reporting system that relied on health-care professionals to report observed ADRs to the pharmacy had generated just two ADR reports during the previous year. The pharmacy developed a program that used standardized procedures to screen for ADRs. The Technicon computer was programmed to screen the previous day's orders for antidotes or "tracer" drugs. In addition, pharmacists screened all laboratory reports of serum drug concentration determinations and positive tests for Clostridium difficile toxin. Spontaneous reporting of ADRs by nurses and physicians was strengthened by use of a revised notification form, newsletters, and inservice-education programs. During the first seven months of the program, 298 ADRs were identified, 15 of which were submitted to FDA. The standardized screening procedures accounted for 149 reports. Pharmacists reviewed an average of 21 reports of high serum drug concentrations each month; on average, 11 of these reports involved ADRs. Screening of microbiology laboratory reports identified 29 ADRs. Physicians reported ADRs infrequently and were likely to report only serious or unexpected reactions. Nurses and pharmacists identified reactions sporadically. Quality assurance auditors were consistent in screening ADRs, but not all reported reactions proved to be ADRs. The use of standardized screening procedures was effective in this pharmacy-based ADR-monitoring program.     

Sensitivity and specificity of three methods of detecting adverse drug reactions

The sensitivity and specificity of three methods of detecting adverse drug reactions (ADRs) were determined. Minimal use of a voluntary ADR reporting program prompted this investigation of three ADR detection methods, as follows: screening of laboratory reports, pharmacist screening of medication orders, and voluntary reporting. A total of 98 patients who were receiving oral or i.v. digoxin therapy, oral or i.v. theophylline therapy, or i.v. gentamicin therapy were randomly selected and monitored for possible ADRs. A physician reviewed the charts of patients with suspected ADRs using the Naranjo algorithm to assess causality. The chart review served as the reference method to which the other three methods were compared. Thirteen "true" (i.e., confirmed by the Naranjo algorithm) ADRs were identified in 11 different patient charts, resulting in a 13.3% ADR incidence rate for the 98 sampled patients. For the three ADR detection methods, the decreasing order for level of sensitivity was screening of laboratory reports, pharmacist screening of medication orders, and voluntary reports; however, only the difference between laboratory reports and voluntary reports was significant. For level of specificity, the decreasing order for the three methods was voluntary reports, pharmacist screening of medication orders, and pharmacist screening of laboratory reports; the differences among all three methods were significant. Screening of laboratory reports and pharmacist screening of medication orders are two detection methods that appear to exhibit an appropriate combination of sensitivity and specificity for identifying ADRs; trials with larger sample sizes are needed to confirm the results of this study.     

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.     

Adverse drug reaction reporting system: developing a well-monitored program.

The spontaneous reporting of adverse drug reactions (ADRs) at the St. John's Hospital and Memorial Medical Center was well below that reported in the literature. After review of procedures for reporting of ADRs at these institutions, the authors developed a system that was approved by their joint P & T Committee. The ADR reporting program developed uses concurrent monitoring of most hospital inpatients and a retrospective review of all emergency room patients. In the year after program implementation, 162 ADR reports were documented. From this program, a group of serious ADRs to one agent was identified and reported, both to the Food and Drug Administration and to the manufacturer. A well-developed ADR monitoring program may lead to heightened physician and nurse awareness and early problem identification, possibly decreasing morbidity for hospitalized patients.     

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     

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 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.     

A successful community hospital program for monitoring adverse drug reactions

All health care professionals are responsible for reporting ADRs. The physician records these events in the patient's medical record. In the monitoring program at Meriter Hospital, pharmacy responsibilities include review and assessment of all reported ADRs. When appropriate, the ADR is reported to the FDA. The pharmacy department maintains ADR statistics, reports quarterly to the P&T committee, and disseminates information to appropriate hospital committees and departments. The P&T committee supports the ADR monitoring program and policy. This committee reviews all ADRs and recommends action plans. The ADR monitoring program has successfully increased the number of ADRs reported, and actions resulting from ADR reports have had a positive impact on patient care.     

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'.     

Community pharmacists’ knowledge,behaviors and experiences about adverse drug reaction reporting in Saudi Arabia

Objective

To assess community pharmacists’ knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia.

Methods

A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia.

Results

The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%).

Conclusion

The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.     

A description of a successful computerized adverse drug reaction tracking program

The University of Illinois Hospital Drug Information Center recently began using a database software program (File Express, Version 4.0, Redmond, WA) for storing and retrieval of reported adverse drug reactions (ADRs). Important features of the software program include the capability of easily generating reports, rapid sorting of data, large storage capability, minimal startup cost, and a user friendly menu system. The number of reported ADRs increased from 24 in 1987 to 124 in 1988 due, in part, to increased educational efforts, revision of the ADR reporting form, and cooperation from the medical records department in identifying reported ADRs during chart review. Overall, pharmacists were found to report most of the ADRs. Retrospective analysis of the ADR reports may help identify trends in ADRs based on the drug and route of administration. A decrease in the incidence of some ADRs and, thus, improved patient care, may result as the information obtained from the computer-based ADR reporting system is shared among healthcare professionals.     

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.