Highest level of drug reaction reports for 12 years
MHRA yellow card data has revealed a correlation between national vaccination campaigns and high numbers of drug reactions reported
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The number of adverse drug reactions (ADRs) reported to the MHRA last year was the highest for more than a decade, C+D has learned. Almost 17,000 suspected ADRs were reported electronically or on paper in 2013, a 23 per cent rise on the previous year and the highest level of reports since 2001. The MHRA attributed the "significant increase" to the expansion of its Yellow Card reporting scheme into GP IT systems last year and its ongoing efforts to improve awareness of the scheme. The highest recorded volume of reports was in 2000 - the first year for which the MHRA holds data - when almost 30,000 paper reports were sent to the MHRA. The medicines watchdog said this could "largely be accounted for" by reports of suspected reactions to the meningitis C vaccine, which was administered to children in a nationwide immunisation campaign that year. "An estimated 18.5 million doses of vaccine were distributed in just over a year and nurse reporting was permitted for the first time during the immunisation campaign," the MHRA told C+D. Reports of ADRs dropped to more than 17,000 the following year and fell again to less than 13,000 in 2002. Vaccination campaigns generated "significant volumes" of reports and the "dramatic drop" by 2002 marked a return to typical reporting levels prior to the meningitis campaign, it said. More than 212,000 ADRs were reported to the MHRA through the Yellow Card scheme between 2000 and 2013. ADRs could first be reported electronically in 2002 and the number of electronic reports overtook those submitted on paper in 2009. The MHRA was unable to provide details of which reported reactions were most common for each year as this information would be "difficult to pull out", it added. Patients and health professionals can use the Yellow Card website to report ADRs, which are evaluated along with additional information to identify medicine safety issues. If a new side effect is detected then the use of the medicine is reviewed by the MHRA.
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