Reporting Adverse Drug Reactions: A guide for healthcare professionals
May 2006
Why is the rate of spontaneous reporting so low?
The main strength of the Yellow Card spontaneous reporting scheme is that it enables continual monitoring of the use of a product throughout its life span and by all patients (see reference 46). Despite the fact the scheme is well-established and Yellow Cards have become more widely accessible in recent years, ADRs are greatly under-reported and the number of reports received annually by the MHRA has remained fairly consistent at around 20,000 since the mid-1980s (see figure 1 for number of reports from 1992-2004).
The exception to this was in 2000, when a significant increase in the number of reports was associated with a mass meningitis C vaccination campaign for all children under 18 years of age (see reference 29). Compared to other countries the number of spontaneous reports submitted in the UK is relatively high and reporting rates in relation to prescription volumes are also among the best in Europe (see reference 2). It is estimated, however, that only 10 per cent of serious reactions and between 2 and 4 per cent of non-serious reactions are reported (see reference 2). It should be noted that such a high level of under-reporting will necessarily lead to bias in the data collected via the Yellow Card Scheme.
PEM data collected by the DSRU also raise the question about whether healthcare professionals are fully aware of the need to monitor black triangle drugs more closely and to report all ADRs caused by them. One PEM analysis of 15 newly marketed drugs, showed that while ADRs were five times more likely to be reported if the reaction was serious rather than non-serious, only 9 per cent of the ADRs found by PEM had been reported to the Committee on Safety of Medicines (CSM), indicating significant under-reporting via the Yellow Card Scheme (see reference 47).
A 1976 discussion by Dr Bill Inman, who pioneered the Yellow Card Scheme, highlighted ‘Seven deadly sins’ that might cause the low reporting rate of ADRs among healthcare professionals (see reference 48). As the scheme has become better established and accessible most of the problems identified by Inman have been overcome. One more recent survey of UK healthcare professionals showed that the only ‘sin’ still affecting reporting of ADRs was ‘lethargy’ (see reference 49).
Doctors and other healthcare professionals have many demands on their time and it is appreciated that they are required to carry out many tasks during the working day and thus finding the time to complete Yellow Cards may be difficult. It is important, however, that healthcare professionals recognise the importance of spontaneous reporting of suspected ADRs and the vital contribution that this can make to pharmacovigilance and maximising drug safety.
In order, therefore, to enhance patient care it is crucial that healthcare professionals make every effort to submit a Yellow Card in accordance with the relevant guidelines whenever appropriate. As well as time pressures, the above survey identified both a lack of available Yellow Card forms and a belief that ADRs should only be reported if causality was certain as other reasons for the low reporting rate.
While the introduction of electronic Yellow Cards should have improved access to the scheme, other studies have also highlighted a disinclination among healthcare professionals to report an ADR if they are uncertain of the link between the reaction and a medication (see references 50, 51 and 52). The beliefs that serious adverse reactions will be identified in clinical trials (see reference 51) and that there is no need to report a well known reaction (see references 16 and 52 ) are also noted in the literature. Box 3 shows the reasons given in an attitudinal survey of Dutch physicians for not reporting ADRs. Anecdotal evidence points to a fear by professionals that reporting
a suspected ADR via the Yellow Card Scheme may result in them being legally liable for any consequences of the reaction.11 This fear can be particularly pertinent when medicines that are unlicensed for use by children have been prescribed to a patient under the age of 18. Healthcare professionals should be reassured that the MHRA would never allow Yellow Card data to be used for legal or disciplinary purposes.
Box 4: Results of an attitudinal survey of Dutch physicians regarding voluntary reporting of ADRs
- Only 26% knew which ADRs to report.
- 93% thought the reaction was too well known.
- 75% thought the reaction was trivial.
- 72% were uncertain whether the reaction was caused by a drug.
- 38% did not have enough time.
- 36% thought that reporting was too bureaucratic.
- 22% did not know how to report.
- 18% were not aware of the need to report ADRs.
Although it is true that many adverse reactions may be well documented, it is important that all serious ADRs and those occurring with black triangle products are always reported so that the benefit/harm profile of a medication can be kept up to date and so that comprehensive advice about prescribing and drug safety can be communicated to all healthcare professionals. Healthcare professionals should be reminded that if they are in any doubt as to the causality of a reaction or whether or not they should submit a Yellow Card, then it is best practice that they should submit a report.
Improving reporting rates of ADRs is primarily about improving awareness of the need to report and the mechanisms used to submit a Yellow Card. In areas that are served by an RMC, which engage in work with the local reporting population and in awareness raising activities, reporting rates are higher than in areas where there is no regional centre (see reference 29). Doctors and other healthcare professionals have a duty to keep their knowledge and skills up to date, which can be done by participating in continuing professional development (CPD). As pharmacovigilance is an area where awareness and participation levels can be poor, there could be an expansion of CPD activities which explore the importance of reporting ADRs.
One controlled study (2005) looked at the impact of a distance-learning package in pharmacovigilance which was linked to educational credits on the rate and quality of reporting (see reference 53). The results showed that at least in the short term Yellow Card reports from those that passed the course assessment increased in number and improved in quality compared to those who had not taken the course. This indicates that CPD could have a crucial role to play in improving the collection of Yellow Card data.
The need for improved and more consistent teaching at undergraduate level of the need to report ADRs, as well as the wider importance of pharmacovigilance is also identified in one study as being crucial if a reporting culture within the medical profession is to develop (see reference 54). This research also advocates a more involved role for the MHRA in promoting the Yellow Card Scheme to undergraduate medical, pharmacy and nursing students. In 2003 a paper which discussed the teaching of safe and effective prescribing in UK medical schools highlighted the importance of incorporating clinical pharmacology into the core curriculum (see reference 55). It states that the core knowledge and understanding of medical students should include the following about ADRs:
- types and mechanisms of ADRs
- the frequency of ADRs in primary and secondary care
- recognition of the predisposing factors and how risks can be minimised
- the importance of reporting ADRs and the role of the Yellow Card scheme.
It is vital that patient records and correspondence are both accurate and thorough so that all healthcare professionals are well informed and there is consistency in the care that is provided. Communication between doctors and patients is also critical in identifying suspected ADRs and can also help prevent some ADRs occurring (see reference 12). Research published in 2004 also showed that health professionals rarely record the use of complementary and alternative medicines in a patient’s history (see reference 57).
It is crucial that patients are asked what medications they are taking, and that particular reference is made to OTC medications and all other non-prescribed therapies, such as herbal remedies or those purchased over the internet. Further, when presented with unexpected or unexplained symptoms consideration should be given to the fact that the patient may have experienced an adverse reaction to one or more medications that they have been taking.
When prescribing or administering medications it is also vital that the prescriber gives clear instructions about taking the medication, requests that the patient reads the patient information leaflet which includes information about side effects that they may experience, and also finds out whether the patient is taking any other medication that may interact with the proposed treatment. Effective communication is needed so that the healthcare professional has as much information as possible and that the patient is fully informed about their medications and any possible side effects. Healthcare professionals may find the British Heart Foundation’s factfile on Communicating Risk to Patients, a useful resource (see reference 58). It can be downloaded from its website, www.bhf.org.uk.
General practitioners (GPs) have traditionally submitted the highest proportion (around 60 per cent) of Yellow Cards (see Figure 2), and it is often accepted that GPs may be best placed to report ADRs. It can be seen from the graph, however, that in recent years the proportion of reports being submitted by nurses and pharmacists has been increasing (also see appendix E). This increased participation by other healthcare professionals is valued by the regulatory authorities and analysis of reports made by nurses and pharmacists has shown that their involvement can be very useful (see references 19 and 20). The contribution that nurses can make to the Yellow Card scheme was particularly evident during the meningitis C vaccination campaign in 2000.
It should be noted, however, that given the high incidence of ADRs in hospitalised patients, hospital doctors could make a greater contribution to ADR reporting. Doctors should be reminded that the introduction of nurse and pharmacist reporting was meant to supplement the reports made by doctors and not be a substitute for them. Figure 2 shows that the number of reports received from GPs in the last few years has been significantly lower than in previous years. There has not yet been any research into why this has occurred although speculation might pin point increased workload and administration or a presumption that others are reporting as possible reasons for this decline.
Source: Data supplied by the MHRA
While it is not considered that making reporting of ADRs mandatory would combat under-reporting (see reference 50), the development of the national NHS IT system NPfIT represents an opportunity for information on ADRs to be collected through centrally held patient records (see reference 16). The technology office of NHS Connecting for Health has been in discussions with the MHRA about ways in which electronic Yellow Cards can be incorporated into the new system and about the interaction between the GPRD and the Secondary Uses Service (SUS) of NPfIT (see reference 59).
In relation to the GPRD a broader discussion about the capture of primary care data is anticipated, while prescription data should be brought into the SUS when the electronic transmission of prescriptions is rolled out, starting in early 2007. Such developments could prove significant for the future effectiveness of pharmacovigilance, particularly in secondary care where monitoring at present is underdeveloped. While this could transform ADR reporting in England, it is equally important that similar mechanisms for capturing such information are developed in the other devolved nations.