Future Directions for the Yellow Card Scheme

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

The Yellow Card Scheme is operating in a changing environment, particularly with regard to advances in technology, extension of the reporting base, introduction of new regulatory requirements within specific areas and increased use of the data for research.


FUTURE DIRECTIONS FOR THE YELLOW CARD SCHEME

The Yellow Card Scheme is operating in a changing environment, particularly with regard to advances in technology, extension of the reporting base, introduction of new regulatory requirements within specific areas and increased use of the data for research. Many of these initiatives have been described above but it is also worth mentioning two approaches which have been suggested as ways to enhance reporting, but which are not at present under consideration as future directions for the Yellow Card Scheme. The first of these is payment for the completion of Yellow Cards. This issue has been raised with the MHRA by doctors, both directly and through the GP focus groups mentioned above; however, it is not considered that remuneration for the completion of a Yellow Card would result in an increase in high-quality reports of serious reactions. Reporting of suspected ADRs is considered to be part of the profes-sional responsibilities of health professionals and for this reason, payment for the completion of Yellow Cards would be inappropriate. The second approach concerns the voluntary nature of the Yellow Card Scheme. France, Norway, Sweden and Spain have all introduced compulsory reporting of suspected seri-ous ADRs to the regulatory authority (Moore et al., 1985; Wilholm et al., 1994) whereas in the majority of countries, including the United Kingdom, reports are submitted on a voluntary basis by health profes-sionals. Although it would be expected that legisla-tion to make reporting compulsory should increase the number of reports received, reporting rates are not clearly or consistently higher in countries where compulsory reporting has been introduced, compared with the United Kingdom (Griffin, 1986; Wilholm et al., 1994). Furthermore, the introduction of a statu-tory obligation for health professionals to report would be almost impossible to enforce: there is no easy and systematic mechanism for identifying the ADRs that should have been reported, especially since the deci-sion to report depends on the health professional’s suspicion of causation. To date, the MHRA has not identified a case for the introduction of compulsory reporting in the United Kingdom.

Both of these approaches were considered within the Independent Review of Access to the Yellow Card Scheme. The Review recommended that the basic principles of the Scheme, as set out by Sir Derrick Dunlop, should not be changed, as compul-sory reporting and incentive payments would change the Scheme’s fundamental practicalities. The Scheme should remain as a voluntary Scheme and health professionals should consider it to be their profes-sional duty to report ADRs. The Review did, however, recommend that reporters who assist in research based on Yellow Cards should be reimbursed for the time and effort needed to contact a patient and to obtain the patient’s consent to facilitate Yellow Card research. As discussed above, procedures for accessing Yellow Card data for research are in the development phase, but it is anticipated that once these systems are in place, the Yellow Card data collected over the past 40 years will be an important resource for research.

The long-term future of the Yellow Card Scheme will be based on further developing electronic report-ing and information exchange. Although the MHRA has received electronic reports of suspected ADRs from a small group of pharmaceutical companies since 1995, this continues to be a focus for develop-ment. During the late 1990s, EU Competent Author-ities, the EMEA and the European Commission have created a central pharmacovigilance database supported by a system of mandatory electronic ADR reporting between the pharmaceutical industry and the regulators. EudraVigilance has been developed as the European data-processing network and database management system for the exchange, processing and evaluation of Individual Case Safety Reports (ICSRs). From 2005, all pharmaceutical compa-nies within the European Union have been obliged to electronically submit ICSRs for products autho-rised through national, mutual recognition or decen-tralised procedures under Directive 2001/83/EC as amended by Directive 2004/27/EC; likewise Regu-lation EC 726/2004 imposes the same electronic reporting requirements on centrally authorised prod-ucts. The International Conference on Harmonisation (ICH) E2B(M) standard defines the electronic report-ing format that should be used with the Medical Dictionary for Regulatory Affairs (MedDRA) medical terminology for coding the reports. To facilitate ICSR reporting by pharmaceutical companies, the MHRA has amended its database dictionary to MedDRA and the pharmacovigilance systems have been redevel-oped to support electronic transmission of ICSRs.

Of equal importance is the development of elec-tronic communication between regulatory authori-ties and health professionals, including a mechanism for electronic reporting of suspected ADRs. With increasing use of computerised software systems by GP practices, hospitals and pharmacies, the inclu-sion of Yellow Cards on such systems might be one approach, as in the current pilots described above. There are a number of such GP systems; it may be more useful to provide a single method by which all health professionals involved with the Yellow Card Scheme can submit suspected ADR reports, poten-tially via Internet-based reporting. The secure trans-mission of reports, through a widely available system must be assured; it is possible that future develop-ment of National Health Service electronic record systems may provide a suitable medium for reporting of suspected ADR reports.

The nature of pharmacovigilance within the United Kingdom is also evolving with robust methods for signal detection being developed. Spontaneous report-ing systems such as the Yellow Card Scheme are used for signal detection of new drug safety issues or the identification of increased frequencies of recognised ADRs. In the United Kingdom, proportional reporting ratios (PRRs) were introduced as a statistical method for interpreting spontaneous ADR data (Evans, Waller and Davis, 2001). This statistical method compares the proportion of all reactions to a drug which are for a particular medical condition of interest to the same proportion for all drugs in the database. In brief, a high PRR indicates that a potential signal of a drug safety issue has been identified and requires further evaluation. A tool for prioritising signals arising from spontaneous ADR data is known as impact analysis, which considers the strength of evidence for causality and the public health implications (Waller and Evans, 2003). With the use of such tools, for the early detec-tion and prioritisation of drug safety signals, there is an improved capability to home in upon issues that are of importance to public health.The introduction of new concepts, technologies and regulations, optimised use of spontaneous data and the evolving Yellow Card Scheme continues to underpin these processes with the introduction of patient reporting and its future use as an important research tool.

CONCLUSIONS

The Yellow Card Scheme has been in existence for over four decades. Despite its limitations, which are common to all spontaneous reporting Schemes, it has a proven track record in the identification of previ-ously unrecognised safety hazards. The Scheme has undergone continual evaluation and development over the years, and this will continue in the foreseeable future. This will ensure that the Scheme will continue to fulfil its central role in UK pharmacovigilance in the changing climate in which it operates, whilst continuing to adhere to the key principles defined by Sir Derrick Dunlop at the inception of the Scheme-spontaneity and speediness, confidentiality and above all the commitment of health professionals to report their suspicions in the interest of protecting public health. 

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