GPhC tell pharmacies to stop selling rapid antibody tests

In a letter to pharmacy owners and superintendent pharmacists in the UK, the General Pharmaceutical Council (GPhC) has said that it is inappropriate for community pharmacies to sell COVID-19 rapid antibody tests.

The GPhC has stated that:

“At this point in time, we do not regard it as appropriate for community pharmacy to be selling and recommending rapid antibody test kits.”

The letter says that although the GPhC does not have jurisdiction over the legality, safety or efficacy of particular types of tests or kits, it does have a responsibility as the regulator of pharmacy professionals, in relation to the standards that must be met by pharmacists and pharmacy technicians in all settings in which they work, and the standards that must be met by the owners of registered pharmacies.

The GPhC has drawn attention to the fact that they expect pharmacists and pharmacy technicians, and those who own pharmacy premises, to protect public health at all times. This includes following guidance from bodies like Public Health England and others.

Chief Executive and Registrar of the GPhC Duncan Rudkin commented:

“I want to highlight our position concerning the provision and sale of COVID-19 rapid antibody tests from community pharmacies: in the light of current public health advice, it is not appropriate for them to be sold in community pharmacies or recommended by pharmacy professionals at this point in time.

“We are aware that there are manufacturers selling and supplying COVID-19 rapid antibody testing kits and that these tests are being offered privately in several community pharmacies across Great Britain.

“Although it may be legal to sell or supply a product, for example, it may have a CE mark this does not necessarily mean that it is appropriate for a health professional to supply it to a patient or member of the public. We would expect all pharmacy professionals to consider the wider public health impact. 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.

“Both the World Health Organisation and SAGE, the Scientific Advisory Group for Emergencies, have advised there are potentially negative impacts on public health if individuals assume immunity from a positive result and adapt their behaviour in a way which could increase the risk of continued transmission.

“To date we have:

• Worked closely with other regulators and public health agencies which have leading roles to play in relation to testing and test kits, to identify the latest guidance and information in this fast-moving area.

• Shared this guidance and information with stakeholders, members of the public, pharmacy professionals and pharmacy owners, including through our coronavirus Q&A.

• When made aware that a pharmacy is providing tests which do not adhere to guidance from the public health agencies in Great Britain, written to the pharmacy to tell them to stop providing these tests. Our inspectors have been signposting pharmacy owners, superintendent pharmacists and pharmacy professionals to relevant guidance and reiterating our position on this.

“Overall, we want to reiterate that, at this point in time, we do not regard it as appropriate for community pharmacy to be selling and recommending rapid antibody test kits. The UK Government as well as the Scottish and Welsh Governments, alongside the key public health bodies, WHO and SAGE have all intimated that:

• Their use in the response to COVID-19 has not yet been established.
• That that there is conflicting evidence in relation to the use and efficacy of these tests.
• The public health consequences potentially outweigh any benefit a patient or member of the public may gain from this type of.

“We are asking that you ensure your pharmacies support public health by not offering such services and stopping any current provision. We are aware that this is a fluid landscape and we will continue to work closely with other regulators with leading roles in relation to testing and provide an update if the situation changes.”

Chief Executive of PharmaDoctor™ Graham Thoms commented:

“As the leading provider of antibody tests to community pharmacy, we are not aware of any pharmacies selling test kits to members of the public.

“Over 510 pharmacies are however offering a clinically robust Antibody Testing SERVICE using CE Certified tests which were approved for sale by the MHRA for healthcare professional use on the 5th March.

“PharmaDoctor™ wrote to Public Health England (PHE) three months ago so far with no response. We asked them to update their advice (not updated since first published 25th March) which states that they can’t be sure of the ‘accuracy of antibody tests to diagnose COVID-19 infection’.

“We all know that antibody tests don’t ‘DIAGNOSE’ COVID infections, that’s the job of the antigen tests, not the antibody tests. The antibody testing service being offered in over 510 UK pharmacies with the support of PharmaDoctor™ ensures customers using the service understand the limitations of the tests and that a positive result doesn’t equate to immunity against COVID.

“The service also enforces the need to continue following government advice with regards to social distancing and isolating if appropriate.

“Come on PHE and GPhC.. let’s have a constructive discussion…?”

You can read the letter in full here.

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