HL Deb 03 December 2001 vol 629 cc106-7WA
Lord Clement-Jones

asked Her Majesty's Government:

Whether degeneration into autism is now recorded by the Medicines Control Agency as a potential adverse event after vaccination. [HL1449]

Lord Hunt of Kings Heath

The United Kingdom's spontaneous adverse drug reaction (ADR) reporting scheme (the Yellow Card Scheme), operated by the Medicines Control Agency (MCA) and Committee of Safety of Medicines, receives reports of suspected ADRs directly from doctors, dentists, coroners, pharmacists and indirectly via pharmaceutical companies. Any reported cases of autism suspected by the reporter to be associated with medicine or vaccine are routinely recorded on the MCA's ADROIT (Adverse Drug Reaction Online Information Tracking) database.

Lord Clement-Jones

asked Her Majesty's Government:

What guidance the Department of Health has given to general practitioners and other health professions on filing Yellow Card reports to the Medicines Control Agency on degeneration into autism after vaccination, including slow degeneration after months or years. [HL1450]

Lord Hunt of Kings Heath

Health professionals are requested to report all suspected adverse drug reactions (ADRs) associated with the newer "black triangle" medicines and all serious suspected ADRs to established medicines regardless of any uncertainty they may have about a casual relationship. They are also strongly encouraged to report all suspected ADRs which occur in children, regardless of whether the drug is "black triangle" or established. This includes any suspected ADRs associated with childhood vaccines. The guidance specifically mentions delayed effects to medicines that may manifest months or years after exposure and asks that any suspicion of such an association be reported. Guidance is included in the British National Formulary distributed to health professionals twice yearly and in the United Kingdom Health Department's memorandumImmunisation against Infectious Disease which is supplied to health professionals involved in immunisation. Guidance is also given on the Medicines Control Agency website at www.mca.gov.uk. No specific guidance has been given on reporting suspected cases of autism associated with vaccines and it is the responsibility of individual reporters to use their clinical judgement in reporting if they suspect there is an association between an adverse event and any medicine given.