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GPhC: 'Not appropriate' for pharmacies to sell certain antibody tests

Pharmacies should stop "any current provision” of COVID-19 rapid response antibody tests
Pharmacies should stop "any current provision” of COVID-19 rapid response antibody tests

It is “not appropriate” for community pharmacies to sell or recommend COVID-19 rapid response antibody tests, following current public health advice, the GPhC has said.

Pharmacies should “support public health” by “stopping any current provision” of these tests, the General Pharmaceutical Council (GPhC) warned in a letter to contractors yesterday (July 21).

The regulator said it is aware that several pharmacies across Great Britain are selling rapid response antibody testing kits privately, which might be legal to sell if they have a CE mark, meaning a product meets European quality assurance.

“This does not necessarily mean that it is appropriate for a health professional to supply it to a patient or member of the public,” the GPhC said, as there is “conflicting evidence in relation to the use and efficacy of these tests”.

“During this ongoing national public health crisis, any activity that may contribute to false results or assurances that then impact on public behaviour should not be supported,” the regulator said.

A Department of Health and Social Care spokesperson told C+D today (July 22) that “no privately available antibody test has been approved for national rollout, although we continue to work with the industry”.

​A GPhC spokesperson told C+D today that the organisation wrote to pharmacy owners and superintendents setting out our concerns and asking them to support public health by not offering COVID-19 rapid antibody testing services.

If enforcement action is needed, as always we have a range of options, which we consider on a risk-informed case by case basis,” they added.

Protect public health

The GPhC does not have powers to determine the “legality, safety or efficacy” of these tests, it said.

However, as the regulator of pharmacy professionals, it needs to ensure that registered pharmacy professionals and pharmacy owners “work to protect public health as well as the health of individuals using pharmacy services”.

It invited pharmacy teams to comply with any recommended national guidance available to them.

“We are asking that you ensure your pharmacies support public health by not offering such services and stopping any current provision,” the GPhC said.

In April, the GPhC wrote to seven online pharmacies to ask them to remove illegal COVID-19 home testing kits from sale.

The Medicines and Healthcare products Regulatory Agency asked pharmacies in May to stop selling COVID-19 antibody testing using a finger-prick blood sample, “until home collection of this sample type has been properly assessed and validated for use with these laboratory tests.”

This request prompted Lloydspharmacy and Superdrug to remove their home sampling tests from sale.

What do you make of the GPhC's statement?

dilesh vyas, Pharmaceutical Adviser

The question here is who is pulling who's strings. As a supplier of the INNOVITA brand of antibody testkits, used during the Chinese pandemic in Wuhan hospitals, authorised for use in several countries, used by a multinational bank to test 45,000 employees and most recently an order to supply 3 million tests to Chile. Independently Lab verified and the subject of several Peer reviewed studies....Can you tell me of any other POC test that has this type of provenance?.....and they are CE marked. The UK is lagging far behind many other countries, test, test, test...the idea of antibody tests will allow the population to keep themselves ALERT, and having the freedom, as in the case of asymptomatic cases, to test themselves regularly and take precautions even if positive based on Government guidelines. There are so many spurious products sold, like homeopathic, pharmaceuticals, even vitamins with no real medicinal benefit, here is a product that is proven and tested. These policy makers make me wonder as to their real reasons behind making such decisions. Propharma-UK

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

This is so much nonsense it isn't true! Our shelves are stacked with non-efficacious medicines that have no real use (homoeopathy, vitamins, chesty cough medication, simple linctus, the list is endless) but the GPhC has nothing to say on those. If something is legal to sell, as our over-regulatory body, they have no right to say if we should or shouldn't sell it. Where is the much trumpeted 'professional judgement' here? It should be the role of the LAW to decide. It isn't illegal for a pharmacy to sell alcohol or cigarettes, just not within the pharmacy premises - I have come across pharmacies that also have sidelines as offies, newsagents or post offices selling all sorts of things that aren't necessarily what you would think of as appropriate for a pharmacy, but they can still do it. The much vaunted Boots makes a fortune out of spurious claims for cosmetics for vain people yet nothing is said about this either. Where is the consistency?

Mike Bereza, Community pharmacist

Maybe we should rethink selling 400-year-old medicines which originally were intended for expectorating evil spirits from the body?

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

Depends on what the profit margin is......

On Break, Community pharmacist

Does this mean all types of antibody testing is suspended including Superdrug’s phlebotomy based service and the nhs testing for staff and carers. Or has the GPhC seen some pharmacies identify a service that is actually profitable and they feel the need to stop us “profiteering” again.

I think if the tests have a CE mark they are legal to sell and if members of the public want to spend their money on a test it is not for the GPhC to stop them. If someone gets a positive result they will be advised appropriately about following COVID requirements as it is unknown about long term antibody protection. If there are concerns/evidence the test don’t work then the CE mark should be removed and it would be illegal to sell the service.

Mike Bereza, Community pharmacist

Superdrugs new phlebotomy tests are based upon the governments gold standard PCR technology which has proven accuracy.

Richard MacLeavy, Dispenser Manager/ Dispensing Assistant

Whats the point in the CE mark if it doesn't indicate a product is safe and effective to use?

Mike Bereza, Community pharmacist

CE marking does not provide any specific information to the consumer. It is not a quality assurance declaration, it does not show evidence of third-party testing, and it should not be confused with any independent certification mark of the type issued by international or European notified test bodies - from a Google search:

Richard Judge, Manager

Stay at home, don't stay at home, don't go to work, go to work, don't wear a mask, wear a mask, supply antibody tests, don't supply antibody tests.
Pharmacies have been listed as a “target setting” for COVID-19 antibody tests under specifications published by the Medicines and Healthcare products Regulatory Agency (MHRA).

Mike Bereza, Community pharmacist

Yes, 100%, pharmacy is a fantastic place for these tests to be administered, this is not under debate. The issue is one of protecting the public from third party, clinically unverified POCT accuracy claims.

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