Community pharmacists' attitudes to adverse drug reaction reporting

Objective — A “demonstration” scheme for adverse drug reaction (ADR) reporting by United Kingdom community pharmacists began in April, 1997. The objective of this study was to investigate community pharmacists' attitudes to and knowledge of ADR reporting and the “yellow card” scheme. Method — Structured face-to-face interview with community pharmacists, using a prepiloted questionnaire. Setting — Randomly selected community pharmacies within one demonstration scheme area. Key findings — Almost all of the pharmacists (28, 93 per cent) were aware that they were able to report ADRs but only one had done so. Just under half recalled receiving the official information pack and half of these had read it. Reasons given for not submitting reports were lack of information or time, and that most reactions seen were already well-recognised. Although most pharmacists knew that serious reactions to established drugs should be reported, fewer recognised the need to report unusual reactions to established drugs and reactions to herbal medicines. Few participants knew the reporting criteria for “black triangle” drugs. Reporting on over-the-counter (OTC) products was an area specifically identified where it was expected that community pharmacists could “add value” to the previous, yellow card, scheme. It was thus of some concern that 21 pharmacists (70 per cent) agreed that they would be unlikely to report an ADR to a product they had counter-prescribed for a patient. Few respondents had negative attitudes to the scheme. Most agreed that ADR reporting is important, and a professional role in which pharmacists should be involved. Conclusion — Community pharmacists are supportive of their involvement in ADR reporting. Their concerns about reporting need to be addressed and further publicity given to the scheme if reporting is to increase. Our findings suggest that more research is needed to identify the factors which encourage and inhibit reporting, and that further efforts may be needed to promote ADR reporting.     

The pharmacist and adverse drug reaction reporting

During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.     

Increased adverse drug reaction reporting through wall-mounted ADR reporting cards

To increase adverse drug reaction reporting, the Pharmacy Department Quality Assessment and Improvement Committee at the University of Iowa Hospitals and Clinics created an abbreviated wall-mounted adverse drug reaction card on "tear-off" pads. This report discusses strategies the Committee identified in order to attain its goal.     

141例药品不良反应报告分析

目的:探讨我院药品不良反应(ADR)的特点,促进临床合理用药。方法:对2011年141份药品不良反应报告进行分类统计分析。结果:涉及ADR的药品11大类84种,其中以抗微生物药为主,其次是抗肿瘤药物;严重及新的ADR分别是35例、11例;临床表现以皮肤及其附件损害最常见。结论:重视新的及严重的ADR监测,充分发挥护士在ADR报告的积极性。     

Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden

Objectives  This study was designed to investigate attitudes to and incentive for reporting adverse drug reactions (ADRs) in general and towards nurses as reporters of ADRs in particular in a sample of hospital physicians. Method  A questionnaire was sent to 1,201 randomly selected hospital physicians. Results  The main factors for the decision to report an ADR were the severity of the reaction, a reaction to a new drug, and an unusual reaction. The most important factor for refraining from reporting was that the reaction was well known. There were no significant differences between males and females or between age groups in these aspects. A majority were positive or neutral to nurses as reporters. Only 6% stated that their willingness to report ADRs would be affected in a negative way if nurses were involved in the program for reporting. Conclusions  The results of this survey showed that inclusion of hospital nurses as reporters will not decrease the reporting rate from the physicians.     

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.     

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.     

A continuous quality improvement team approach to adverse drug reaction reporting

Crossfunctional teams can generate more new ideas, concepts, and possible solutions than does a department-based process alone. Working collaboratively can increase knowledge of teams using CQI approaches and appropriate tools. CQI produces growth and development at multiple levels resulting from involvement in the process of incremental improvement.     

完善医院ADR监测系统的探讨

目的:探讨完善医疗机构ADR监测与报告体系及其运作机制的必要性。方法:对我国医疗机构ADR报告与监测体系提高运作效率进行分析,并提出建议。结果与结论:我国医疗机构现有的ADR报告与监测体系尚不完善,必须进行优化。     

Making the most of spontaneous adverse drug reaction reporting

The primary purpose of spontaneous adverse drug reaction reporting is to provide early warnings or "signals" of previously unrecognized drug toxicity. The method was developed in the 1960s in response to the thalidomide tragedy and is now well-established throughout the developed world. Health professionals are the key original source of reports, the value of patient reporting is yet unclear. Electronic transmission of all reports is likely to become the norm within a few years. This is well-advanced between pharmaceutical companies and regulatory authorities but still in its infancy for health professionals in many parts of the world. Considered globally, the process may be inefficient and movement towards centralization of databases with appropriate access controls is logical. Alternative methods for capturing clinical suspicions of adverse drug reactions should be investigated and could provide more systematic data. However much it can be improved, spontaneous adverse drug reaction reporting is unlikely to identify all important unrecognized drug safety hazards. Complementary approaches therefore still need to be identified and developed.