Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme; the Yellow Card Scheme. Approximately 20,000 reports of ADRs are reported to the MHRA/CHM through this scheme each year. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines. Reports for adverse incidents with medical devices are not collected by the Yellow Card Scheme.
With regard to a breakdown of suspected drugs reported via the Yellow Card Scheme, due to the sheer volume of data, we refer the hon. Member to the MHRA website at:
http://www.mhra.gov.uk/daps.
At this website, Drug Analysis Prints (DAPs) can be found. DAPs are freely available in the public domain and list all suspected reactions reported for a particular medicinal active substance. A breakdown of total numbers of reports received for a particular medicinal active substance and the number of suspected reactions are also stated on a DAP.
Table 1 shows the number of suspected ADRs received by the MHRA between 1997 and 2007. The second column shows the total number of ADR reports submitted including those from marketing authorisation holders through their legal obligations. Columns three and four provide the number of reports received directly from patients and health care professionals via the Yellow Card Scheme.
Year received by MHRA Total number of spontaneous suspected ADR reports received (including company ADR reports) Number of spontaneous UK suspected ADR reports submitted directly by patients Number of spontaneous UK suspected ADR reports submitted directly by healthcare professionals 1997 16,627 0 14,181 1998 18,047 0 14,908 1999 18,484 0 14,938 2000 33,147 0 29,229 2001 21,454 0 17,256 2002 17,604 0 12,890 2003 19,218 0 13,951 2004 19,973 0 13,494 2005 21,925 949 12,585 2006 22,021 3,598 10,913 2007 21,767 1,651 10,469
Medical device related adverse incident reports are not submitted via the Yellow Card system. The MHRA operates a separate, voluntary reporting system for all medical device users. The numbers of such reports received from patients and health care professionals in the United Kingdom is given in table 2.
Year received by MHRA Total number of adverse incident reports Total number of adverse incident reports submitted directly by patients/members of the public Total number of adverse incident reports submitted directly by health care professionals 1997 5,383 Not applicable 3,653 1998 6,298 Not applicable 5,007 1999 6,610 Not applicable 4,297 2000 7,249 Not applicable 4,613 2001 7,896 Not applicable 5,660 2002 8,756 Not applicable 4,927 2003 8,803 Not applicable 4,204 2004 8,840 Not applicable 4,546 2005 7,862 Not applicable 3,806 2006 7,975 117 3,708 2007 8,634 103 3,429 Notes: 1. ‘Patients’ are included under the heading ‘Patients/Members of the Public’. 2. The first full year in which reports from patients/members of the public were identified separately was 2006. Therefore for the years 1997 to 2005, this has been identified as “Not applicable”. 3. MHRA records for 1979-99 contain the total number of adverse incident reports received and the percentage for each recorded report source. The figures for reports received from health care professionals for these years have been calculated using those percentages.