§ Mr. BurstowTo ask the Secretary of State for Health what assessment he has made of the validity of criticisms of the Yellow Card scheme published in the "International Journal of Risk and Safety of Medicine" (2003, 16, 3–17); what account he has taken of the view of the Medicines and Healthcare Products Regulatory Agency on the matter; and what steps he has taken(a) to ensure that there has been no significant miscoding and misinterpretation of Yellow Card adverse drug reaction reports for paroxetine and (b) to ensure that there has been effective follow-up of reports relating to suspected paroxetine-induced suicidal behaviour. [178431]
§ Tim LoughtonTo ask the Secretary of State for Health what assessment he has made of the Medicines and Healthcare Products Regulatory Agency criticisms of the Yellow Card scheme published in the "International Journal of Risk and Safety of Medicine" (2003, 16, 3–17); and what assessment he has made of(a) the adequacy of the coding and interpretation of Yellow Card adverse drug reaction reports for paroxetine and (b) the effectiveness of the follow-up of reports relating to suspected paroxetine-induced suicidal behaviour.[178696]
§ Ms Rosie WintertonThe Yellow Card scheme was recently subject to an independent review led by Dr. Jeremy Metters and the recommendations of the review are out to consultation, apart from the recommendation to introduce direct patient reporting, which has been accepted in principle.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has carefully reviewed the criticisms made in the article by Medawar and Herxheimer in relation to follow up and coding of reports of suspected adverse reactions associated with paroxetine (Seroxat) received through the yellow card scheme. Professor Herxheimer and Mr. Medawar contributed to the Metters review.
Yellow cards submitted by health care professionals are held as scanned images and coded data are transposed onto the adverse drug reactions online information tracking (ADROIT) system. This is a relational database of around 500,000 reports, which enables complex analyses to be performed to detect new or changing drug safety hazards. Data from the yellow 371W card scheme cannot be used to quantify the risk of an adverse reaction. Standard operating procedures are in place which ensure quality control of data.
Errors in transposition onto the database occur at a low rate and are kept to a minimum by quality checks. These transposition errors do not impact on signal detection and risk evaluation.
The standardised terms used for coding were based on what has become the internationally adopted standard in drug regulation, MedDRA—the medical dictionary for regulatory activities. The ADROIT classification procedure reflects as closely as possible the words used by the reporter rather than introducing further interpretation of the reporter's words. The image of the original yellow card is available alongside the electronic record. This enables the MHRA to assess the totality of the yellow card data, which are routinely examined when risk assessment is undertaken, along with other data sources.
The MHRA will respond directly to the authors of the article and a copy of that reply will be placed in the Library.