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RCGP calls for NICE guidance and MHRA regulation for self-testing kits

RCGP calls for NICE guidance and MHRA regulation for self-testing kits

The RCGP has set out its position on self-testing kits in a new position statement, which calls on MHRA to produce regulation and NICE to set out guidelines to protect patients.

The College is calling for a meeting with regulators to discuss concerns around the information patients are given when buying self-testing kits.

It follows an announcement in March by Tesco that it would be selling a range of self-diagnostic products in some of its stores including for thyroid, bowel health, menopause and male fertility.

There has also been a boom in recent years in companies providing self-test kits to purchase online, often panels of biomarkers that are sent off to a lab for processing based on a finger-prick blood sample.

Two months ago the Advertising Standards Agency upheld a complaint made by a GP against a company that advertised an at-home blood test to help people manage their health as ‘free if we don’t find anything’.

In the new position statement setting out its view on self-testing kits, the College said it had also raised the issue with NICE who agreed a national policy would be useful.

But in order to do this, NICE would have to be commissioned by NHS England, the Department of Health and Social Care or the UK National Screening Committee to carry out a review of the available evidence on self-testing, it said.

The RCGP is requesting a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) over particular concerns it has on the quality of information patients are provided with when purchasing self-testing kits.

All tests should come with information on disease risk, the benefits of testing, chances of false positives and false negatives and how to interpret the results, the statement said.

Non-symptomatic self-test kits are sold to look for suspected conditions or ‘check ups’ regardless of symptoms or what the evidence for screening is.

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Yet the efficacy, validity and accuracy of these tests are not guaranteed and many do not come with clear and supported informed choice, interpretation of results, and help for individuals afterwards, the position statement notes.

‘In many cases testing is not warranted under NHS guidance and potentially increases the already overwhelming workload of overstretched GPs,’ it continues.

It is ‘crucial’ such tests are independently validated, only used in line with national guidance, and do not promote general practice as the default provider for aftercare, the RCGP added.

‘It is not acceptable for providers to expect GPs to interpret, explain, discuss, or give feedback on non-evidenced screening tests, especially if they are not in routine use in general practice,’ it concluded.

The College also called on the NHS to provide more information on self-tests and what the evidence and harms are.

RCGP chair Professor Kamila Hawthorne, said: ‘Manufacturers can market self-testing kits as medical ‘check ups’, irrespective of the evidence base behind the product, and regardless of a patient’s symptoms.

‘We are seeing patients in our surgeries, who are distressed because of misleading or inaccurate results from self-testing, which they could have been spared if unevidenced tests were properly regulated.’

‘Taking a test can provide peace of mind for a patient. But it can also cause worry, if they’re not sure about how to interpret the result – or if they get a positive result that they weren’t necessarily expecting. For some conditions, this could be really distressing, and people may not have the appropriate support in place.’

She added that it was putting pressure on GPs already stretched to the limit: ‘It isn’t a good use of our time to be explaining the results of unnecessary tests with patients.

‘Manufacturers of self-testing kits should be responsible for providing patient aftercare, they are making money from selling these tests, the NHS must not be left to pick up the pieces.’

An MHRA spokesperson told Pulse: ‘Whilst home self-testing kits can bring significant benefits to patients, through diagnosis and ongoing monitoring, we recognise the need to ensure continued, effective regulation that takes into account the impact on general practice and the wider health system.’


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Please note, only GPs are permitted to add comments to articles

Anonymous 15 May, 2023 6:24 pm

NICE has no control over your average Sharon or Bob. They will want everything done regardless of what the guidelines say.
At least the GPs will be protected when there is a lawsuit.

Richard Greenway 15 May, 2023 6:57 pm

Perhaps for once the USA gets it right with most medical kit licenced by the FDA and only available through a doctor