Adverse drug reaction rate up

The introduction of the Meningitis C vaccination has increased feedback from doctors, writes Dr Muiris Houston , Medical Correspondent…

The introduction of the Meningitis C vaccination has increased feedback from doctors, writes Dr Muiris Houston, Medical Correspondent

Adverse drug reactions (ADRs) are reported by doctors to the Irish Medicines Board (IMB) using a voluntary system of reporting.

Historically, the level of reporting would, at best, have been moderate; recently, the ADR feedback from all specialities has increased significantly.

Meningitis C vaccination was introduced as part of the free national immunisation scheme on a phased basis, starting in 2000. It was the subject of an especially vigorous campaign by the Department of Health, the Office for Health Gain and the National Disease Surveillance Centre. The new vaccine's introduction was supported by the Royal College of Physicians in Ireland, and the Irish College of General Practitioners.

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While the vaccine itself was new, its constituents (various proteins and polysaccharides) had been used separately in other vaccines for a number of years. Nevertheless, doctors were specifically asked to fill in ADRs on the Meningitis C vaccine - this is undoubtedly one of the reasons for the high level of reports, especially those from 2001.

The Meningitis C vaccine is not a "live" vaccine. This immediately renders it even safer than other types. Prior to its introduction in the Republic, approximately 13.5 million doses of Meningococcal C vaccine were administered in the UK. Almost 5,000 adverse reactions were reported, giving a reaction rate of less than 1: 10,000.

Without a figure for the total number of vaccines given in the Republic per annum, it is impossible to assess whether the ADR rate here is high, low or merely average in comparison with other countries.

Doctors are encouraged to report all side-effects, no matter how mild, to the IMB.

In general, ADR reporting is highest with newly introduced treatments. This is due to increased clinical vigilance, and reminders from health agencies to doctors, asking that they report even the most innocuous association described by patients.