Is a pharmacist who sells rapid antibody tests unfit to practise?

 

Responding to the following article:

 

“GPhC tell pharmacies to stop selling rapid antibody tests”

 

Dear PIP editor,

 

The General Pharmaceutical Council (GPhC) is about to mark its first decade as pharmacy regulator. It has published standards and guidance for complying with those standards; but, from its inception, the GPhC has maintained that it was up to pharmacy owners and pharmacy professionals how to comply with those standards.

 

At various times during the pandemic, sales of various items have raised legal and ethical concerns – hydroxychloroquine, face masks and self-testing antibody tests.

 

When it comes to such sales, the GPhC has largely been silent.

 

In May, the MHRA advised pharmacies not to sell COVID-19 self-testing kits (as opposed to tests sent to a lab for analysis) because there were no self-testing kits with a CE marking, and without a CE marking, any sale would be unlawful.

 

The MHRA said:

 

“Using the wrong type of test kit in the wrong setting can lead to inaccurate results, a false sense of protection or recovery and increased pressure on our NHS and social care systems”.

 

The MHRA noted that the position might change if a CE-marked self-testing kit became available.

 

Then, on 21 July, the GPhC wrote to pharmacy owners and superintendent pharmacists, saying:

 

“It is not appropriate for [COVID-19] rapid antibody tests to be sold in community pharmacies”.

 

This statement was made even though such sales are not illegal if the tests have a CE marking. The GPhC acknowledged that it did not have jurisdiction over the legality, safety or efficacy of the kits, but referred to “the wider public health impact”.

 

Despite the rigorous compliance testing required to obtain a CE marking, the GPhC is concerned that false-positive results could lead to behaviour that “could increase the risk of continued transmission”.

 

The GPhC has a role to play in ensuring public protection, but it is notable that it has changed its own behaviour.

 

At the start of the pandemic, when it was being said that face masks did not protect wearers, the GPhC didn’t tell pharmacists they shouldn’t sell them in case they gave wearers a false sense of security and lead them to adapt their behaviour.

 

If the GPhC catches a pharmacist who has sold an antibody test, it can put the pharmacist through its fitness to practise processes if the sale may impair the pharmacist’s fitness to practise.

 

But suppose the pharmacist gave responsible advice at the time of the sale?

 

“There is a risk that this test may give a false-positive result. If you do test positive with this kit, it doesn’t necessarily mean you are immune to the virus. You still have to obey all the restrictions including social-distancing”.

 

Could it really be said that a pharmacist who gives this advice has failed to meet professional standards and is unfit to practise?

 

Not in my book.

 

Yours etc.

 

David Reissner

 

Chair of the Pharmacy Law & Ethics Association

 

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