The Anonymised Yellow Card

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

One of the key principles of the Yellow Card Scheme is that reports are submitted and handled in complete confidence.


THE ANONYMISED YELLOW CARD

One of the key principles of the Yellow Card Scheme is that reports are submitted and handled in complete confidence. Concerns about confidential-ity might deter both doctors (Bateman, Sanders and Rawlins, 1992) and pharmacists (Sweis and Wong, 2000) from submitting Yellow Cards; this issue was also highlighted by the GP focus group work.

An anonymised reporting form was first used in the HIV reporting initiative, as described above, because of particular concerns regarding confidentiality in this patient group. However, patients’ rights to privacy are now guarded by data protection legislation based in European legislation; this issue was highlighted by the General Medical Council’s Guidelines on Confi-dentiality (General Medical Council, 2000). This led to the introduction of an ‘anonymised’ Yellow Card in September 2000 (Anon, 2000b,c), which asks for initials and age (rather than name and date of birth) of the patient. In addition, the ‘anonymised’ Card asks reporters to include an identification number or code for the patient; this should enable the reporter, but not the MHRA to identify the patient, and is used in correspondence between the MHRA and the reporter. The use of such an identifier was introduced in order to address concerns that ‘anonymised’ report-ing might lead to a reduction in the ability to detect duplicate reports and to obtain follow-up information from the original reporter. After six months, over 6000 suspected adverse reactions had been reported to the MHRA on the ‘anonymised’ reporting form; of these, around 77% of forms included an entry in the patient ‘identification number’ field.

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