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19 Apr 2004 : Column 163W—continued
Zebra Fish
Mr. Watson: To ask the Secretary of State for Environment, Food and Rural Affairs (1) what plans she has to prohibit the sale of genetically modified (a) zebra fish and (b) other species in the UK; [165035]
(2) what assessment her Department has made of the possible future market for genetically modified pets. [165036]
Mr. Morley: Sales of genetically modified fish and other GM animals are already prohibited within the European Union unless specifically authorised under Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms or kept in secure containment under the terms of Directive 90/219 (as amended by Directive 98/81/EC) on the contained use of Genetically Modified Micro-Organisms. To date no applications have been received in the EU to release either GM fish or GM pets. The Department has not undertaken any assessment of the future market for genetically modified pets.
HEALTH
Heroin Addicts
Simon Hughes: To ask the Secretary of State for Health how many registered heroin addicts there were in (a) Greater London and (b) each London borough in each of the last five years. [162339]
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Miss Melanie Johnson: This information is not available because there is no longer a register of heroin addicts. The Home Office register of heroin addicts ceased in 1997 as resistance to register by heroin users meant the data were so inaccurate they were unusable.
Adverse Drug Reactions
Mr. Burstow: To ask the Secretary of State for Health (1) what proportion of inpatients had their hospital stay prolonged by adverse drug reactions in the last 12 months; [163488]
(2) what his latest estimate is of the proportion of hospital admissions caused by adverse drug reactions; and if he will make a statement. [163497]
Mr. Hutton: The Department of Health collects information on all hospital admissions (Hospital Episode Statistics data). These data contain primary and secondary reasons for hospital admissions, which includes data on 'external causes' such as adverse drug reactions (ADRs).
In the year 2002–03 about 0.5 per cent. of admissions were identified as caused by ADRs. However, this proportion is likely to be an under-estimate because only admissions specifically identified as caused by ADRs will have been included.
United Kingdom wide data are not available to allow estimation of the proportion of in-patients who had their hospital stay prolonged by adverse drug reactions in the last 12 months.
Mr. Burstow: To ask the Secretary of State for Health if he will place in the Library a copy of the (a) Committee on Safety of Medicines' policy on the disclosure of information about adverse drug reactions and (b) Medicines and Healthcare Products Regulatory Agency's policy on disclosure of information. [163490]
Ms Rosie Winterton: A copy of the publication scheme of the Committee on the Safety of Medicines (CSM) has been placed in the Library. The CSM does not routinely publish information about suspected adverse drug reactions (ADRs). However, the Medicines and Healthcare products Regulatory Agency (MHRA) currently responds on behalf of the CSM to individual requests for ADR data under the Code of Practice on Access to Government Information. Anonymised ADR data are released on this basis.
An independent review of access to data from the yellow card scheme is currently considering whether, and if so under what conditions and for what purposes, data collected on suspected ADRs should be made more widely available. The review is expected to be published later this year.
The MHRA is committed to making available as much information as is compatible with the provisions of the current Code of Practice on Access to Government Information. A copy of the MHRA's approved publication scheme has been placed in the Library.
Mr. Burstow: To ask the Secretary of State for Health if he will list the 10 types of drug most commonly involved in adverse drug reactions reported to the yellow card scheme. [163491]
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Ms Rosie Winterton: The following table lists the 10 drugs most commonly associated with suspected adverse drug reactions reported to the yellow card scheme in 2003. The figures provided relate to the number of reports received. Some reports may contain more than one reaction.
| Drug(63) | Number of reports |
|---|---|
| Clozapine | 1,075 |
| Rofecoxib | 367 |
| Venlafaxine | 359 |
| Bupropion | 348 |
| Celecoxib | 341 |
| Paroxetine | 294 |
| Risperidone | 290 |
| Aspirin | 275 |
| Infliximab | 265 |
| Etoricoxib | 239 |
(63) Stated as drug substance
Total number of reports received in 2003: 18,060.
The total number of reports received for a particular drug does not reflect the effects of factors such as an individual's medical history, concomitant medication and age, nor do they reflect the total usage of a drug (aspirin has a very high usage), whether a particular drug has a monitoring scheme (clozapine) or is being intensively monitored due to it being a new drug on the market (infliximab, bupropion, etoricoxib). These factors may result in an increased number of reports submitted via the yellow card scheme.
Mr. Burstow: To ask the Secretary of State for Health (1) what his Department's estimate is of the percentage of adverse drug reactions which are reported by (a) general practitioners, (b) hospital doctors, (c) nurses and (b) pharmacists via the yellow card system; and if he will make a statement; [163492]
(2) what the nurse reporting figures for adverse drug reactions were for each month since the scheme started, broken down by those under the (a) e-yellow card and (b) paper based yellow card scheme; [163494]
(3) how many calls NHS Direct has received from callers reporting adverse drug reactions since 1 January 2003. [163496]
Ms Rosie Winterton: In the United Kingdom, the yellow card scheme allows health professionals to report suspected adverse drug reactions (ADRs) on a voluntary basis to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM). Alongside doctors, pharmacists, dentists and coroners, the scheme was extended to allow nurses, health visitors and midwives to report suspected ADRs on 31 October 2002. An electronic version of the yellow card was launched on the same date.
To date, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 2,992 reports of suspected adverse drug reactions from nurses, from both paper and electronic versions of the yellow card. The following table provides a breakdown of reports received from nurses, for both paper and electronic yellow cards (table 1).
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In 2003, the MHRA received a total of 18,060 yellow card reports from health professionals broken down as in table 2.
A pilot scheme enabling patients to contribute to the yellow card scheme via NHS Direct was launched in a single NHS Direct area on 25 April 2003. NHS Direct nurses and health information advisors submit reports of suspected adverse drug reactions via an electronic yellow card. All calls from patients reporting suspected ADRs at the Beckenham call centre have been reported to the MHRA and, to date, we have received 39 reports from patients via NHS Direct.
| Received date (month/year) | Number of reports (paper) | Number of reports (electronic) | Total number of reports |
|---|---|---|---|
| October 2002 | 8 | 0 | 8 |
| November 2002 | 253 | 3 | 256 |
| December 2002 | 85 | 1 | 86 |
| January 2003 | 60 | 2 | 62 |
| February 2003 | 295 | 0 | 295 |
| March 2003 | 239 | 10 | 249 |
| April 2003 | 146 | 6 | 152 |
| May 2003 | 129 | 13 | 142 |
| June 2003 | 167 | 9 | 175 |
| July 2003 | 211 | 11 | 222 |
| August 2003 | 154 | 4 | 158 |
| September 2003 | 126 | 7 | 133 |
| October 2003 | 202 | 8 | 210 |
| November 2003 | 218 | 2 | 220 |
| December 2003 | 173 | 4 | 177 |
| January 2004 | 171 | 3 | 174 |
| February 2004 | 158 | 4 | 162 |
| March 2004 | 106 | 4 | 110 |
Total number of reports received to date: 2,992.
| Report source | Number of reports | Percentage(64) |
|---|---|---|
| General Practitioner | 5,564 | 31 |
| Hospital Doctor | 4,388 | 24 |
| Nurse | 2,196 | 12 |
| Pharmacist | 3,434 | 19 |
| Other | 2,477 | 14 |
(64) Percentage of total number of reports received in 2003.
Total number of reports received in 2003 was 18,060.
Mr. Burstow: To ask the Secretary of State for Health what evaluation has been made of the (a) impact and (b) quality of information received on electronic yellow cards. [163495]
Ms Rosie Winterton: The Medicines and Healthcare products Regulatory Agency (MHRA) and Committee on Safety of Medicines (CSM) launched a new electronic yellow card on 31 October 2002, to provide a rapid and convenient way to report suspected adverse drug reactions (ADRs) for healthcare professionals. To date, the MHRA has received 386 reports of suspected adverse drug reactions (ADRs) via the Internet.
A working group of the CSM and its Subcommittee on Pharmacovigilance (SCOP) was formed to advise on
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strategies for electronic reporting and the criteria for evaluation of its contribution to pharmacovigilance. The working group proposed a questionnaire for electronic reporters to obtain their opinions on the usefulness of the electronic yellow card. A one-year evaluation has been carried out to assess the impact of, and the nature and quality of, information received on electronic yellow cards in comparison with the paper counterparts.
Electronic reports were comparable with paper reports with respect to the proportion of serious ADRs reported and reports associated with new, intensively monitored drugs. In general, there was little difference in the quality of core information (patient, reporter, suspect drug and reaction details) provided via electronic and paper yellow cards. A significant proportion (93 per cent.) of electronic reporters intend to continue reporting via the Internet. The working group and the MHRA are currently assessing method's to promote and increase the awareness and usability of the electronic yellow card amongst health professionals.
A new website providing rapid and direct access to the electronic yellow card is at www.yellowcard.gov.uk. This was launched on 19 February 2004 and the working group MHRA are in the process of linking this with other health-related websites. The findings from the evaluation will be presented to CSM for consideration and to inform future enhancements to the electronic yellow card.
Mr. Burstow: To ask the Secretary of State for Health (1) how many people, broken down by age, suffered from adverse drug reactions, in (a) England, (b) each region and (c) each strategic health authority in each year since 1997; and how many of those reactions were fatal; [163498]
(2) how many children suffered from adverse drug reactions, in (a) England, (b) each region and (c) each strategic health authority in each year since 1997; and how many of those reactions were fatal. [163499]
Ms Rosie Winterton: Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the yellow card scheme. Approximately 20,000 reports of ADRs are reported to the MHRA/CSM through this scheme each year, of which approximately 3 per cent. report a suspected ADR with a fatal outcome.
There are five regional monitoring centres (RMCs) that act locally on behalf of the CSM to collect reports of ADRs and to stimulate ADR reporting through local initiatives. These are Mersey, Wales, Northern, West Midlands and Scotland, which was established in 2002.
The attached tables contain the total number of suspected ADR reports and ADR reports with a fatal outcome received via the yellow card scheme from 1997 to 2003 inclusive. The figures are broken down by age groups: 16 years and under, 17 to 59 years and 60 years and above. Included in the tables are the numbers of suspected ADR reports and reports with a fatal
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outcome received from the five RMCs. A breakdown of ADR data by health authority is not available, as this information is not collected as part of the yellow card scheme. Data from the yellow card scheme cannot be used to measure the frequency of an ADR in a particular region or health authority, as spontaneous ADR reporting is associated with an unknown and variable degree of under-reporting.
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 temporal association, the possible contribution of concomitant medication and the underlying disease. Additionally, the use of medicines may vary between different age groups. Use of medicines in the elderly, for example, is higher than in other age groups and elderly patients are more likely to be using combinations of medicines.
Table 1: Total number of adverse drug reaction (ADR) reports and reports with a fatal outcome, broken down by age group, from 1997 to 2003 received by the Medicines and Healthcare products Regulatory Agency (MHRA) from the Adverse Drug Reactions On-line Tracking (ADROIT) database. Figures include reports received from the regional monitoring centres (RMCs).
| Age group | ||||
|---|---|---|---|---|
| 16 years and under | 17 to 59 years | 60 years and above | Total 1 | |
| 1997 | ||||
| Total | 1,360 | 8,706 | 5,536 | 16,627 |
| Fatal | 22 | 168 | 227 | 446 |
| 1998 | ||||
| Total | 1,395 | 9,358 | 6,024 | 18,054 |
| Fatal | 11 | 212 | 246 | 521 |
| 1999 | ||||
| Total | 2,387 | 8,734 | 5,943 | 18,483 |
| Fatal | 26 | 225 | 249 | 563 |
| 2000 | ||||
| Total | 11,986 | 11,491 | 7,304 | 33,151 |
| Fatal | 36 | 252 | 283 | 629 |
| 2001 | ||||
| Total | 1,629 | 11,556 | 6,669 | 21,466 |
| Fatal | 35 | 261 | 295 | 643 |
| 2002 | ||||
| Total | 1,477 | 8,289 | 5,875 | 17,174 |
| Fatal | 31 | 274 | 295 | 657 |
| 2003 | ||||
| Total | 2,169 | 8,161 | 6,077 | 18,060 |
| Fatal | 25 | 289 | 323 | 722 |
(65) Includes reports where the patient age has not been specified (10,889 reports in total since 1997 inclusive).
Table 2: Total number of adverse drug reaction (ADR) reports and reports with a fatal outcome, broken down by age group, from 1997 to 2003 received by the five regional monitoring centres (RMCs) from the Adverse Drug Reactions On-line Tracking (ADROIT) database.
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| Wales | Scotland 2 | |||||
|---|---|---|---|---|---|---|
| Age range | ||||||
| 16 years and under | 17 to 59 years | 60 years and over | 16 years and under | 17 to 59 years | 60 years and over | |
| 1997 | ||||||
| Total | 57 | 366 | 318 | — | — | — |
| Fatal | (66)— | 7 | 17 | — | — | — |
| 1998 | ||||||
| Total | 71 | 429 | 351 | — | — | — |
| Fatal | 0 | 14 | 9 | — | — | — |
| 1999 | ||||||
| Total | 136 | 406 | 319 | — | — | — |
| Fatal | 0 | 6 | 9 | — | — | — |
| 2000 | ||||||
| Total | 781 | 790 | 567 | — | — | — |
| Fatal | (66)— | (66)— | 13 | — | — | — |
| 2001 | ||||||
| Total | 67 | 722 | 456 | — | — | — |
| Fatal | 0 | 7 | 12 | — | — | — |
| 2002 | ||||||
| Total | 92 | 431 | 403 | 6 | 79 | 66 |
| Fatal | 0 | 9 | 113 | 0 | (66)— | (66)— |
| 2003 | ||||||
| Total | 122 | 361 | 334 | 89 | 406 | 365 |
| Fatal | 0 | (66)— | 6 | 0 | 6 | 17 |
(66) Small number of cases. Data withheld to protect patient confidentiality.
(67) CSM Scotland began to receive yellow cards on 10 October 2002.
Sandra Gidley:
To ask the Secretary of State for Health pursuant to his answer of 22 March, Official Report, column 599W, on older people, how many
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adverse drug reactions occurred in individuals aged (a) 60–79 years, (b) 70–79 years, (c) 80–89 years and (d) over 90 years in each year since 1997. [164256]
Ms Rosie Winterton: Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the Yellow Card scheme. Approaching 20,000 reports of ADRs are reported to the MHRA/CSM through this scheme each year.
The table shows the total number of suspected ADR reports received via the yellow card scheme from 1997 to 2003 inclusive. The figures are broken down by age group: 60–69 years, 70–79 years, 80–89 years and 90 years and above.
| Age group | |||||
|---|---|---|---|---|---|
| Year | 60–69 | 70–79 | 80–89 | More than 90 | (68)Total number reports |
| 1997 | 2,627 | 2,050 | 776 | 83 | 16,627 |
| 1998 | 2,754 | 2,348 | 833 | 89 | 18,054 |
| 1999 | 2,781 | 2,271 | 815 | 76 | 18,483 |
| 2000 | 3,473 | 2,706 | 1,012 | 113 | 33,151 |
| 2001 | 3,071 | 2,440 | 1,023 | 135 | 21,466 |
| 2002 | 2,339 | 2,214 | 1,133 | 189 | 17,174 |
| 2003 | 2,401 | 2,239 | 1,241 | 196 | 18,060 |
(68) Total number of reports received for all ages through the yellow card scheme (includes reports where the patient age has not been specified)
It is important to note that a report of an adverse reaction does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal
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association, the possible contribution of concomitant medication and the underlying disease. Additionally, the use of medicines may vary between different age groups. Use of medicines in the elderly, for example, is higher than in other age groups and elderly patients are more likely to be using combinations of medicines.
Mr. Burstow: To ask the Secretary of State for Health if he will make a statement on his Department's review of the Yellow Card scheme for reporting adverse drug reactions. [164611]
Ms Rosie Winterton: On 21 July 2003, my noble Friend the Parliamentary Under Secretary of State for Health announced an independent review into the access to and use of data collected by the Medicines Healthcare products Regulatory Agency on suspected adverse drug reactions (ADRs). The review is being led by Dr. Jeremy Matters, CB. The primary purpose of the review is to consider whether, and if so under what conditions and for what purposes, the data should be made more widely available.
A 12 week public consultation exercise ended on 9 January 2004. The report of the Review is expected to be published later in the year.
Mr. Burstow: To ask the Secretary of State for Health how many cases of adverse reactions relating to herbal medicines were reported to the yellow card scheme in each year since 1997. [164681]
Ms Rosie Winterton: Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the yellow card scheme. By 30 March 2004, the CSM and MHRA had received 527 reports of suspected adverse drug reactions (ADRs) associated with herbal medicines since 1997. A breakdown of the number of reports received per year is shown in the table.
Year | Number of ADR reports associated with herbal medicines |
|---|---|
| 1997 | 46 |
| 1998 | 41 |
| 1999 | 65 |
| 2000 | 142 |
| 2001 | 79 |
| 2002 | 69 |
| 2003 | 66 |
| 2004 (part)(69) | 19 |
| Total | 527 |
(69) Figures to date
It is important to note that the submission of a suspected adverse reaction does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships, including temporal association, the possible contribution of concomitant medication and the underlying disease.
The number of reports received via the yellow card scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as this scheme is associated with an unknown and variable level of under-reporting. Reporting through the yellow card scheme has been low for products used in self-medication as health professionals
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may not be aware of their use. ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use of a particular drug and promotion and publicity about a drug. Data from the yellow card scheme cannot be used as a basis for determining the incidence of an ADR as neither the total number of reactions occurring, nor the number of patients using the drug is known.
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