(2) how many people in each age cohort experienced an adverse drug reaction in (a) England, (b) each region, (c) each strategic health authority and (d) each primary care trust area in each year since 2003; and how many such reactions in each category were fatal;
(3) how many people aged between (a) 50 and 64-years-old, (b) 65 and 74-years-old and (c) over 75-years-old (i) died and (ii) were injured by adverse drug reactions in each year since 2003.
Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission for Human Medicines through the spontaneous reporting scheme; the yellow card scheme.
Table 1 shows the number of suspected ADR reports received by the MHRA in the specified time periods where an anti-psychotic drug was listed by the reporter as being suspect. The total number of ADR reports for all antipsychotics is not equal to the sum of both atypical and traditional antipsychotics since an individual ADR report may provide more than one drug as suspect.
All antipsychotics Atypical antipsychotics Traditional antipsychotics 2003 1,812 1,694 140 2004 2,060 1,963 105 2005 2,614 2,473 160 2006 2,127 1,920 226 2007 2,327 2,172 173
The numbers of antipsychotic prescription items from the Prescription Cost Analysis (PCA) database are shown in table 2.
All antipsychotics Atypical antipsychotics Traditional antipsychotics 2002 5,167.0 2,471.6 2,695.3 2003 5,513.2 3,088.7 2,424.4 2004 5,687.8 3,333.9 2,353.8 2005 5,872.9 3,597.7 2,275.2 2006 6,196.1 4,049.1 2,147.0 1 Prescriptions items—prescriptions are written on a prescription form. Each single item written on the form is counted as a prescription item.
Table 3 gives the numbers of suspected adverse reaction reports received for the three age cohorts each year since 2003. Reports of suspected ADRs do not always specify the original reporter’s address; therefore data on ADRs cannot be provided by region, strategic health authority or primary care trust area.
Age group 50-64 65-74 75+ 2003 3,832 2,633 2,595 2004 4,242 2,904 2,503 2005 4,280 2,896 2,585 2006 4,414 2,919 2,374 2007 4,692 2,693 1,998
The number of suspected adverse reaction reports associated with a fatal outcome each year for the last five years is shown in table 4. It is important to note that the submission of a suspected ADR report does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including the possible contribution of concomitant medication and the patient's underlying disease.
Age group 50-64 65-74 75+ 2003 139 117 172 2004 180 146 196 2005 242 174 186 2006 201 191 160 2007 220 177 184