Widening the Yellow Card Reporting Base

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

The RMCs played a key role in conducting pilot studies into the potential contribution of hospital and community pharmacists to the Yellow Card Scheme.


Pharmacist Reporting

For many years, pharmacists have been recognised as reporters to national spontaneous reporting Schemes in a number of countries (Griffin, 1986), and there is published evidence suggesting a valuable role for both hospital and community pharmacists in the monitoring and reporting of ADRs (e.g. Roberts, Wolfson and Booth, 1994; Smith et al., 1996).

The RMCs played a key role in conducting pilot studies into the potential contribution of hospital and community pharmacists to the Yellow Card Scheme. A pilot Scheme for hospital pharmacist reporting, conducted by the Northern RMC, showed that, in comparison with hospital doctors, hospital pharma-cists submitted a higher proportion of reports of serious ADRs, and reports from the two groups of reporters were of similar quality. Additionally, a survey of consultants whose patients had been the subject of a pharmacist report during the pilot study showed a high level of support for the continuation of the Scheme (Lee et al., 1997). This study led, in April 1997, to the extension of the Yellow Card Scheme nationwide to include reporting by hospital pharmacists (Anon, 1997a). A subsequent evaluation of hospital pharmacist reports made in the first year following this extension generally confirmed the find-ings of the pilot study, and indicated that reports received from hospital pharmacists expanded on those received from hospital doctors, rather than simply replacing them (Davis, Coulson and Wood, 1999). Following the nationwide extension, by the end of 2001, an excess of 4800 reports had been received directly from hospital pharmacists; in 2001, approx-imately 6.2% of Yellow Cards were submitted by this group.

A pilot study of community pharmacist reporting was conducted by four RMCs; an evaluation of reports received during the first 12 months of the pilot showed that community pharmacists submitted reports which were comparable to those received from GPs, with regard to both the quality of the reports and the seri-ousness of reactions reported. Furthermore, commu-nity pharmacists submitted a higher proportion of reports for herbal products compared with GPs (Davis and Coulson, 1999). An attitudinal survey carried out in Wales, one of the areas in which the pilot study was conducted, demonstrated a high degree of support among both GPs and community pharmacists for a role of the latter group in reporting suspected ADRs to the Yellow Card Scheme (Houghton et al., 1999). In the light of these findings, and the assump-tion that community pharmacists are well placed to inform patients about, and be made aware of, any ADRs experienced in association with ‘over the counter’ products, nationwide reporting by commu-nity pharmacists was introduced in November 1999 (Anon, 1999).

In recent years, the role of pharmacists has changed with the introduction of supplementary prescribing for pharmacists in April 2003. This voluntary prescribing partnership between an independent prescriber and a supplementary prescriber allows pharmacists to implement an agreed patient-specific clinical manage-ment plan with the patient’s agreement. In addition, pharmacists along with other health professionals can now supply and administer medicines through patient group directions (PGDs) (Health Service Circular 2000/026). With these new prescribing powers, both hospital and community pharmacists are nowadays important contributors to the Yellow Card Scheme and in 2004, over 3000 ADR reports originated from pharmacists, representing 17% of all ADR reports received by the Agency.

Nurse Reporting

In the past five years the role and responsibilities of nurses have rapidly developed. Nurses have had a more active role in the provision of medicines to patients. This is illustrated by the introduction of inde-pendent nurse prescribing from the Nurse Prescribers’ Formulary for district nurses and health visitors and the Nurse Prescribers’ Extended Formulary (NPEF). Along with pharmacists, nurses are empowered to provide medicines under PGDs, and supplementary prescribing was introduced in April 2003.

With their increased responsibilities it soon became apparent that nurses should be responsible for report-ing their suspicions of ADRs experienced by patients in their care and there was some published evidence to support this (Hall et al., 1995; Smith et al., 1996; Van den Bemt et al., 1999), although a lack of knowledge about adverse effects of medicines was identified in one study as a major constraint to their participation (Hall et al., 1995).

During the UK campaign to vaccinate chil-dren against meningitis C, school nurses were the main body of health professionals administering the vaccine. When the campaign began, nurses began to submit spontaneously significant numbers of Yellow Card reports; the CSM subsequently recommended that nurses should be allowed to report suspected ADRs for meningitis C vaccine for the duration of this important public health campaign. Nurse reports received during the vaccination campaign have been used by the MHRA to evaluate the potential contri-bution which this group might make to the Yellow Card Scheme. This evaluation also considered the findings of a pilot study of nurse reporting which has recently been conducted by the RMC in Merseyside (Morrison-Griffiths, 2000).

An evaluation of nurse reporting by the MHRA suggested that nurses report similar levels of seri-ous reactions to other health professionals, that their reports are of similar quality to those received from doctors and that, with appropriate formal training, they could be important contributors to the Yellow Card Scheme. As a result, the Scheme was extended to all nurses, midwives and health visitors in October 2002 and an analysis of the role of community and hospital nurses in ADR reporting demonstrated that the proportion and quality of reports received from nurses were similar to those received from doctors (Morrison-Griffiths et al., 2003). In 2004, over 2000 ADR reports were received from nurses comprising 11% of all health professionals who reported via the Scheme that year.

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