One of the key principles of the Yellow Card Scheme is that reports are submitted and handled in complete confidence. Concerns about confidentiality might deter both doctors (Bateman et al., 1992) and pharmacists (Sweis and Wong, 2000) from submitting Yellow Cards; this issue was also highlighted by the GP focus group work.
Until 2000, patient names/dates of birth, as requested on the Yellow Card and recorded on the ADROIT database, were used in correspondence only with the original reporter to enable them to identify the patient—for instance, letters acknowledging receipt of, or requesting additional information on a suspected ADR reported to the Yellow Card Scheme. Additionally, this information was also useful in the identification of duplicate reports. Names and dates of birth were not used for any other purposes.
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 recently highlighted by the General Medical Council's Guidelines on confidentiality (General Medical Council, 2000). This has led to the introduction of an "anonymised" Yellow Card in September 2000 (Anon, 2000b, 2000c), which asks for the 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 MCA to identify the patient, and is used in correspondence between the MCA and the reporter. The use of such an identifier was introduced in order to address concerns that "anonymised" reporting might lead to a reduction in our 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 MCA on the "anonymised" reporting form; of these, around 77% of forms included an entry in the patient "identification number'' field.
Was this article helpful?