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GPhC changes position on sale of COVID-19 rapid antibody tests

GPhC: Contractors selling these tests are expected to carry out risk assessments
GPhC: Contractors selling these tests are expected to carry out risk assessments

The General Pharmaceutical Council (GPhC) is no longer telling pharmacists not to sell rapid antibody tests, it has said in an update.

The regulator sent a letter to contractors in July last year, in which it said it was “not appropriate” for community pharmacies to sell or recommend COVID-19 rapid response antibody tests, based on the public health advice that was issued at the time.

Earlier this month (February 1), Public Health England (PHE) updated its guidance on the sale of COVID-19 tests to state that a point-of-care or near-person test can be used within a healthcare setting such as a hospital, a general practice or a pharmacy.

In a statement published yesterday (February 15), the GPhC said that following the updated PHE guidance, it has also reconsidered its position on the sale of rapid antibody tests for COVID-19 from community pharmacies.  

Consider relevant guidance

While the GPhC is no longer discouraging pharmacies from selling COVID-19 rapid response antibody tests, it expects contractors to “consider the PHE guidance and other relevant guidance if deciding whether it is appropriate to offer this type of test or other types of COVID-19 test”.

Pharmacists should also check whether they need to be accredited with the United Kingdom Accreditation Service and should carry out a risk assessment considering, among other things, how the results of the tests can be shared with “the wider surveillance network”.

“A clear anomaly”

In October last year, the National Pharmacy Association (NPA) called on PHE to allow community pharmacies to conduct rapid COVID-19 tests in compliance with regulations set out by the Medicines and Healthcare products Regulatory Authority (MHRA).

Commenting on the GPhC’s U-turn on the sale of these tests by pharmacies, NPA CEO Mark Lyonette said yesterday that the NPA is “delighted that the GPhC has joined PHE in updating guidance on COVID-19 testing, following repeated representations by the NPA”.

“Community pharmacies are no longer explicitly prohibited from providing COVID tests, which was a clear anomaly in the initial position.

“We believe our persistence helped bring about this levelling of the playing field in relation to testing, as well as a big dollop of common sense,” he added.

The Association of Independent Multiple Pharmacies CEO Dr Leyla Hannbeck also welcomed the GPhC’s change in position regarding the sale of rapid COVID-19 antibody tests.

“As highly trained and responsible healthcare professionals, pharmacists should be trusted by decision-makers and our regulator to make the same type of professional judgement over COVID-19 tests, [a judgement] we all know they exercise hundreds of times every day in their daily practice,” Dr Hannbeck added.

Superdrug relaunched its at-home COVID-19 antibody testing service in October last year because it said it is confident it complies with guidance issued by the MHRA. The test kits were first launched in May, but the service was paused following an MHRA alert advising providers of laboratory-based COVID-19 antibody testing services using capillary blood collected by a finger prick “temporarily” suspend this service.

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