The "yellow card" scheme for adverse drug reaction reporting has been updated to ensure that patients' privacy is protected. In addition, the Medicines Control Agency says that the new yellow card will make reporting of suspected reactions easier.
The main change to the yellow card is that a patient's name and date of birth are no longer requested. Instead, a patient's age and sex are required. In addition, their initials and an identification code are asked for to allow the reporter to identify the patient in any future correspondence with the MCA.
Professor Alasdair Breckenridge (chairman, Committee on Safety of Medicines) said at a press briefing on September 7 that as a result of data protection legislation and the recent General Medical Council guidelines on confidentiality, no personal information could be released without the consent of the person involved. This posed a problem for the yellow card scheme because 50 per cent of reports were submitted up to two weeks after a patient had been seen by a doctor. If a patient had to be contacted at the time the card was completed, it would be a deterrent against reporting. By "anonymising" the yellow card, there was no need to obtain patient consent. Dr June Raine (director, post-licensing division, MCA) added: "We are not saying don't talk to the patient." The overriding aim of the changes was that reporters should have no concerns about confidentiality. Patients should be told about reports but this should not delay the reporting, she said.
The MCA suggests that a hospital number or general practitioner practice number could be used as a local identification number. Alternatively, reporters could make up their own system of numbering, for instance in a file specifically for yellow cards. A patient's National Health Service number would not be appropriate because it was traceable. Dr Raine said that it was important that reporters were able to identify the patient because 50-55 per cent of yellow card reports were for serious reactions and for 20-30 per cent of these needed to be followed up. Duplicate reporting would be identified from information such as the drug, timing of reaction and patient's initials and age, she added.
A number of other revisions have been made to the yellow cards which the MCA says will help reporters to provide more precisely the type of information it requires. These changes include a series of tick boxes about the suspected reaction and, in particular, questions about the severity of the reaction. In addition, information on herbal remedies is also requested in the "other drugs" section.
The new 40th edition of the British National Formulary (September, 2000) will contain the updated yellow cards. The yellow cards sent to pharmacists last week by the MCA/CSM contain an error in the section for additional information. The final sentence reads: "For congenital abnormalities please state all other drugs taken during pregnancy and the last menstrual period" and should state "and the date of the last menstrual period". The cards in the new BNF are correct.
New "yellow care" protects patients' privacy |