Highlight of 2003?: Well this has to be the extension of ADR reporting to the public via NHS Direct. In the past the concern has been that such reports would lead to increased noise in surveillance systems from poor quality ADR reports. A recent review [van Grooheest K, de Graaf L, de Jong-van den Berg LTW. Consumer Adverse Drug Reaction Reporting: A new Step in Pharmacovigilance? Drug Safety 2003;26(4):211-217] suggests that present data might not demonstrate an additional benefit for consumer reporting. However, perhaps this will be a valuable opportunity to see what benefits can come from a patient reporting scheme and if nothing else it will be seen by the public as increasing openness in regulatory systems. This scheme does seem to make use of a "learned intermediary".
"Patient reporting via NHS Direct will offer an important step in involving patients in monitoring drug safety with the support of our trained staff. I am pleased that the centre here at Beckenham has been chosen as the first centre to pilot this major initiative. We will be able to offer advice to deal with the problems a patient is experiencing as well as completing the Electronic Yellow Card to be sent to the MHRA."
Just as an aside, there is nothing to stop patients reporting adverse drug reactions to the MHRA via their local pharmacist who is well-trained and highly accessible in the community to discuss management of adverse drug reactions face-to-face with the patient. In addition, they may well have better background information on regular patients to their pharmacy within their patient medication record systems.