The General Pharmaceutical Council (GPhC) has said it is ‘carefully reviewing’ updated guidance from Public Health England (PHE) that allows pharmacies to provide some rapid point-of-care Covid tests.
Previous PHE advice said Covid testing kits that provide ‘very rapid results’ should not be offered in pharmacies, because too little was known about the novel virus to be able to rely on the results.
However, last week (1 February) PHE published new guidance which said that point-of-care or near-person tests (POC/NP) – which provide results in around 30 minutes – may be used in several different healthcare settings including a pharmacy.
‘A POC/NP test may be used within a healthcare setting such as a hospital, a general practice or a pharmacy, or in other settings such as a residential care home, a school, or in a person’s home,’ the document said.
It added that any test provided in pharmacies ‘must have a valid CE mark to ensure its design and manufacture achieves the performance specified for its purpose and is safe to use’.
PHE explained that ‘by making testing more available and having rapid results, additional asymptomatic infectious people can be detected and isolated immediately’.
‘Important distinctions’ between tests
A spokesperson from the GPhC told the Pharmacist that the body was ‘carefully reviewing the PHE guidance and the implications for community pharmacies, recognising that there continue to be important distinctions between the issues around antigen testing on the one hand and antibody testing on the other’.
They added: ‘As highlighted in the PHE guidance, it is essential that all pharmacies that are providing Covid-19 testing become accredited.
‘UKAS has provided comprehensive FAQs for private providers that give further details about how to go about becoming accredited and what minimum standards are expected to be accredited.
‘We strongly recommend that before considering offering testing you should consult this document and the information on their website.’
The GPhC also said it was ‘essential’ for pharmacies already providing testing services to start the process of accreditation ‘imminently’.
Under its existing guidance, the regulator has not taken a position on any Covid testing kit other than rapid antibody tests, which it has said are not ‘appropriate for community pharmacy to be selling and recommending’.
The updated PHE guidance said that there remained ‘great variation’ in the performance of Lateral Flow Device (LFD) antibody tests.
‘The use of LFD antibody POC/NP tests to assist in the diagnosis and management of individual patients is not recommended at present, unless as a formal part of one of the programmes or pilot studies within the National Testing Programme,’ the document said.
It added that the use of these tests to ‘detect vaccine induced antibody’ has not been evaluated and the tests ‘should not be used for this purpose’.
Graham Thoms, chief executive officer of PGD provider Pharmadoctor, has been calling for community pharmacies to be allowed to sell the tests since last year.
‘Pharmadoctor has been calling for PHE’s original guidance to be changed since March last year since we believed it wasn’t founded on any evidence,’ Mr Thoms told the Pharmacist.
He added: ‘It’s great to see that PHE and the GPhC have finally seen sense and will remove any blocks to pharmacies offering valuable Covid testing services which are greatly sought after by members of the public.’