Quality of UK consumer health tests to be scrutinised
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《英国医生杂志》
Concerns that consumer health tests offered by UK retail outlets fail to meet quality standards routinely used in NHS laboratories have prompted calls for regulations to be tightened to guarantee public safety.
The move follows a small amount of anecdotal evidence on cholesterol testing submitted to the Royal College of Pathologists and the National Patient Safety Agency amid fears that this might signal a wider problem.
Cholesterol testing has joined the range of point of sale tests, since the government made the cholesterol lowering drug simvastatin available over the counter in England and Wales in July 2004.
National figures are not available, but a spokesperson for Boots, a leading chain of UK high street chemists, told the BMJ that its outlets had done some 300 000 such tests since July.
The Medicines and Healthcare Products Regulatory Agency and the Royal Pharmaceutical Society of Great Britain have both issued comprehensive guidance on cholesterol testing.
Internal and independent external quality controls to assure standards are both recommended. But, unlike in the NHS, no statutory regulations force retail outlets to comply, and external quality assurance can be costly.
Dr Graham Marshall, medical director for Boots, told the BMJ that the company follows a strict protocol for cholesterol testing but that it does not have external quality assurance because the test is intended as only an initial screening test rather than a formal cardiovascular risk assessment.
Dr Mike Penney, consultant chemical pathologist at the Royal Gwent Hospital in Newport, however, countered that screening programmes in the NHS were all required to have rigorous quality checks, including external quality assurance. "An instrument is not like a ruler," he said, "You need to know if gives the same reading in position A as it does in position B."
He cited the example of a man who contacted him after twice receiving cholesterol readings from the same high street chemist, which varied by about 2 mmol/l from the result given by the local NHS laboratory within the same time frame.
This was a substantial variation and indicated an instrumentation bias, suggested Dr Penney, who wants the same NHS quality standards to apply to commercial laboratories.
College vice president and chair of its chemistry advisory committee, Dr Graham Beastall, said that the many elements involved in cholesterol testing meant there was "a lot of scope for error."
Point of sale testing was likely to grow, in view of the government抯 agenda to improve access to diagnostics, he said, "But there are not enough checks and balances in the system."
Dr Beastall stressed that there was no evidence that anyone had come to any harm, but added, "It抯 only a matter of time before something untoward occurs." The Medicines and Healthcare Products Regulatory Agency is to convene a meeting of key parties early next year, he added.(London Caroline White)
The move follows a small amount of anecdotal evidence on cholesterol testing submitted to the Royal College of Pathologists and the National Patient Safety Agency amid fears that this might signal a wider problem.
Cholesterol testing has joined the range of point of sale tests, since the government made the cholesterol lowering drug simvastatin available over the counter in England and Wales in July 2004.
National figures are not available, but a spokesperson for Boots, a leading chain of UK high street chemists, told the BMJ that its outlets had done some 300 000 such tests since July.
The Medicines and Healthcare Products Regulatory Agency and the Royal Pharmaceutical Society of Great Britain have both issued comprehensive guidance on cholesterol testing.
Internal and independent external quality controls to assure standards are both recommended. But, unlike in the NHS, no statutory regulations force retail outlets to comply, and external quality assurance can be costly.
Dr Graham Marshall, medical director for Boots, told the BMJ that the company follows a strict protocol for cholesterol testing but that it does not have external quality assurance because the test is intended as only an initial screening test rather than a formal cardiovascular risk assessment.
Dr Mike Penney, consultant chemical pathologist at the Royal Gwent Hospital in Newport, however, countered that screening programmes in the NHS were all required to have rigorous quality checks, including external quality assurance. "An instrument is not like a ruler," he said, "You need to know if gives the same reading in position A as it does in position B."
He cited the example of a man who contacted him after twice receiving cholesterol readings from the same high street chemist, which varied by about 2 mmol/l from the result given by the local NHS laboratory within the same time frame.
This was a substantial variation and indicated an instrumentation bias, suggested Dr Penney, who wants the same NHS quality standards to apply to commercial laboratories.
College vice president and chair of its chemistry advisory committee, Dr Graham Beastall, said that the many elements involved in cholesterol testing meant there was "a lot of scope for error."
Point of sale testing was likely to grow, in view of the government抯 agenda to improve access to diagnostics, he said, "But there are not enough checks and balances in the system."
Dr Beastall stressed that there was no evidence that anyone had come to any harm, but added, "It抯 only a matter of time before something untoward occurs." The Medicines and Healthcare Products Regulatory Agency is to convene a meeting of key parties early next year, he added.(London Caroline White)