The Pharmaceutical Journal
Vol 272 No 7291 p349
20 March 2004

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· Community pharmacy
· Obesity
· Prescription fraud
· ADR reporting
· Careers supplement

Letters to the Editor

ADR reporting

Do not forget about the yellow card scheme

From Mr A. R. Cox, MRPharmS, and others

The National Patient Safety Agency has recently announced its reporting scheme. We would like to use this opportunity to remind pharmacists of another reporting scheme that has been in place for nearly 40 years: the yellow card scheme. Hospital pharmacists were accepted as reporters in 1997 and community pharmacists were invited to participate in 1999, after successful trials of both groups. Pharmacists should report any suspected reaction, no matter how trivial, to the following groups of agents:

1. Drugs and vaccines that are being closely monitored (indicated by a black triangle in the British National Formulary)
2. Any drug used in a child
3. Any herbal preparation

For established products, any suspected serious reactions should be reported. Serious reactions include those that are fatal, life-threatening, disabling, incapacitating or which result in admission to hospital or prolong hospital stay or are medically significant. Congenital abnormalities following drug use are also classified as serious.

Adverse drug reactions arising as a result of error should also be reported using the yellow card scheme. Such reports have informed important decisions about the licensing of medicines and drug safety messages provided to health care professionals. For example, Current Problems in Pharmacovigilance described how the Committee on Safety of Medicines (CSM) had received 74 reports of seizures associated with bupropion (Zyban). In half of these reports, individuals had a past history of seizure or other risk factors that clearly contraindicated the use of bupropion.¹ In the same issue, Current Problems gave guidance on the prescribing of alfacalcidol drops in children following 13 reports of accidental overdose which had resulted in hypercalcaemia or nephrocalcinosis.²

One of the founding principles of the yellow card scheme was that reports could be made, and would be treated, in strict confidence. This important principle continues to be upheld by the CSM, so reporters may be reassured that they can report in confidence. The future success and capability of the yellow card scheme to perform its valuable public health role depends on the continued participation of reporters.

Anthony Cox
ADR Pharmacist

Nigel Langford
Locum Consultant Physician

Christopher Anton
Administrative Co-ordinator
West Midlands Centre for Adverse Drug Reaction Reporting,
Sandwell and West Birmingham Hospitals NHS Trust,
Dudley Road,
Birmingham B18 7QH

References

1. Committee on Safety of Medicines. Zyban — safety reminder. Current Problems in Pharmacovigilance 2001;27:5.
2. Committee on Safety of Medicines. Accidental overdose with alfacalcidol
(One-Alpha drops). Current Problems in Pharmacovigilance 2001;27:3.

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