Reporting Adverse Drug Reactions: A guide for healthcare professionals
May 2006
Conclusion
Given the limitations of clinical trials in identifying rare and delayed ADRs, and the need for comprehensive drug safety profiles, the importance of reporting of ADRs cannot be overemphasised. The pharmacovigilance systems in place in the UK are well established and present excellent opportunities for generating signals about potential drug hazards. These systems can only be successful, however, if they are utilised effectively and if awareness of their importance is continually highlighted. Under-reporting of ADRs via the Yellow Card Scheme is one area where significant improvements are needed in pharmacovigilance. The following recommendations are suggested ways in which healthcare professionals can build on good work that is already being done.
Recommendations
- It is the professional duty of all healthcare professionals to report all suspected ADRs associated with black triangle products and all serious ADRs associated with established products using the Yellow Card Scheme. If there is any uncertainty about whether a report should be submitted it is best practice to report the ADR. The experts assessing the report can then decide if further investigation is needed.
- All reports should be as comprehensive as possible, as quality data are essential in order to inform drug safety analysis. To improve the quality of online reports, an applicable pre-populated template should appear when either a healthcare professional or a patient fills out an electronic Yellow Card.
- All healthcare professionals should be vigilant to the status of medicines, particularly those labelled as black triangle medications which are under intensive monitoring, and changes to the classification of such medications such as pharmacy availability of former prescription only medicines.
- Healthcare professionals should not be deterred from reporting by the recently introduced provision for patients to report suspected ADRs via the Yellow Card Scheme. It should be noted that the database used by the MHRA can identify and deal with any duplicate reports.
- When prescribing medication, doctors should inform patients that should they suffer any reaction to a medication, they should inform the prescribing doctor and/or complete a patient Yellow Card which is available on the MHRA website.
- Patient information (leaflets etc) should be widely available in clinics in primary and secondary care explaining how patients can report ADRs.
- It is important that prescribers routinely ask patients about OTC medicines or herbal remedies they are using. This is particularly important in avoiding interactions which are a significant cause of ADRs.
- Effective communication between healthcare professionals is essential, as are comprehensive medical notes in order that doctors in different care settings have access to all the relevant information about a patient’s medical history.
- NPfIT represents a significant opportunity to systematically gather information on ADRs and improve pharmacovigilance. Collection of ADR data should form part of the SUS of the IT systems being developed for the NHS. Similar mechanisms for capturing such data should be developed in the devolved nations.
- The methods and importance of pharmacovigilance should be covered more comprehensively and systematically in the undergraduate medical curricula. CPD courses relating to pharmacovigilance should be offered to healthcare professionals. Patient experiences, as captured by the MHRA database of patient reports, could be used to inform this training.
- Given the intensive monitoring of black triangle medications, it is particularly important that the importance of reporting ADRs is reinforced within all CPD courses relating to new drug developments.
- The MHRA should commission research to improve the understanding of the barriers to reporting ADRs and how they may be overcome. Specifically, research should be carried out to understand why Yellow Card reporting by GPs has fallen over the last 10 years.