Key information for pharmacy owners and pharmacy professionals
Last updated: 15 February 2021
Our role in relation to COVID-19 testing kits
As the global pandemic progresses, there is an increasing variety of tests being made available to test for current or previous infection with COVID-19.
We set standards that pharmacy professionals and pharmacy owners have to meet at all times, including when offering any type of COVID-19 testing service.
Our overarching aim is the protection of the public, including protecting, promoting and maintaining public health generally, as well as the protection of pharmacy service users specifically.
The role of other regulators and public bodies
Several regulatory and public bodies have leading roles with respect to: the regulation of test kits as medical devices (Medicines and Healthcare products Regulatory Agency); legality of retail sales generally (Trading Standards); regulation of medical services (Care Quality Commission, Healthcare Inspectorate Wales, Healthcare Improvement Scotland) and authoritative public health guidance from the national public health agencies. All private coronavirus test providers are now also required to be accredited by the United Kingdom Accreditation Service (UKAS).
We are aware that this is a fast-changing landscape and there is significant interest across community pharmacy in being able to provide different types of COVID-19 tests to the public.
We are continuing to work closely with other regulators and public health bodies with leading roles in relation to testing to understand their current positions and have been in regular contact with them.
Our approach to COVID-19 testing kits
We do not have the jurisdiction or capability to form our own view on the legality, safety or efficacy of particular types of tests or kits, or the advisability of their use in public health terms.
Our approach therefore has always been to support the positions taken by the relevant authorities, including the MHRA and the public health bodies, on whether it is appropriate to offer particular types of COVID-19 test at the current time, in light of the evidence available.
Supplying COVID-19 testing kits from a pharmacy: what to consider
This is a complex and rapidly changing landscape and so pharmacy owners and pharmacy professionals must take responsibility when deciding whether to offer any type of COVID-19 test within their pharmacies, whether this is a private service managed by the pharmacy, or as part of a national or local initiative.
You should carefully consider the relevant guidance available from the MHRA and public health bodies, UKAS and our regulatory standards and guidance, when deciding whether to offer a particular test within your pharmacy / pharmacies. We have included key links at the end of this page.
Risk assessment for COVID-19 tests: what to consider
We would expect you to consider how you will meet our standards and guidance when offering this service. We would also expect you to consider:
- the wider public health implications of implementing such a service and whether the benefit and value added to patients outweighs the risk
- the evidence available for the efficacy of the test(s) you plan to offer
- relevant guidance and advice from the MHRA and the relevant national public health bodies in each country of Great Britain
- relevant requirements for providing COVID-19 tests, including accreditation with UKAS
- your premises and whether are they suitable to provide this service and support social distancing
- the end to end process and whether all components and parties involved meet the requirements for the service to be safe and quality assured
- whether you would be using the test as intended and detailed by the manufacturer, and whether you have considered the potential limitations of the test in your context and environment (for example its efficacy for asymptomatic patients)
- how the results are fed into the wider surveillance network and/ or part of a clinical study
- whether you have sought appropriate indemnity insurance and been clear with the indemnifier as to what you are offering in comparison to the manufacturer’s intended use
- how you will make sure that suitable training is delivered for all health care professionals and staff members involved in the service so they are aware of their roles and responsibilities, including providing evidence-based information to people using the service in line with government guidelines
- how you will make sure that people using the service understand who is involved in providing the service, including third parties, and how their information may be used
- how you will manage concerns or complaints about the service.
Requirement for pharmacies providing COVID-19 testing: Accreditation with UKAS
In addition, on 15 December 2020, the law changed. Coronavirus testing has been exempted as a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
The new Coronavirus, Testing Requirements and Standards (England) Regulations 2020 require all private coronavirus test providers to become accredited by the United Kingdom Accreditation Service (UKAS).
It is essential that all pharmacies that are providing COVID-19 tests check whether they need to self-declare that they are meeting minimum standards for private-provided testing and if they need to become accredited with UKAS.
Providers of private COVID-19 testing need to self-declare that they meet the minimum standards for private-provided testing when offering services to organisations or members of the public. Providers will then be listed on GOV.UK as a private sector coronavirus (COVID-19) testing provider. Please visit gov.uk to view government guidance and to complete the self-declaration form if necessary.
Pharmacies offering COVID-19 testing for “Test to Release for international travel” should also follow government guidance on Minimum standards for private-sector providers of COVID-19 testing for ‘Test to Release for international travel’.
UKAS has provided comprehensive FAQs for private providers that give further details about which private providers of COVID-19 tests need to be accredited, how to go about becoming accredited and what minimum standards are expected in order to be accredited.
We strongly recommend that before considering offering testing you should consult this document and the information on their website. If you are already providing testing services that require accreditation, then it is essential that you start the process of accreditation imminently.
Rapid antibody tests (point of care or near-person antibody tests) for COVID-19
In July 2020, we wrote to community pharmacy owners to advise them that we did not regard it as appropriate for community pharmacy to be selling and recommending rapid COVID-19 antibody test kits at that point in time. This was based on the guidance and evidence available from the key bodies, including guidance from Public Health England advising that rapid COVID-19 tests (also referred to as point of care (POC) or near-person (NP) tests) should not be supplied from community pharmacies.
Public Health England has since published new guidance: COVID-19: summary guidance for service providers on point of care or near-person tests for diagnosis and management on 1 February 2021. This replaces their previous guidance on the provision of rapid COVID-19 tests from community pharmacies.
This guidance states that “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.”
Section 7 of the PHE guidance sets out a number of key points for providers to note in relation to the use of lateral flow device (LFD) POC/NP antibody tests.
The PHE guidance notes that “Many LFD antibody POC/NP tests are now available and there is great variation in their performance. So far, when compared with high-throughput laboratory ELISA antibody tests, which have a high level of accuracy, independent evaluations of the most promising POC/NP tests have shown each to be less sensitive (study 1, study 2)."
The guidance also notes that:
- “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.”
- “LFD antibody tests to detect vaccine induced antibody has not been evaluated and the tests should not be used for this purpose.”
- “Individuals who test positive by LFD antibody test should be reminded to continue to adhere to all social distancing and public health prevention advice.”
We have reviewed the guidance from the PHE carefully and have updated our previous position on the provision of rapid/ POC/NP antibody tests from community pharmacies in response.
In light of the latest PHE guidance we are no longer asking community pharmacies not to provide POC/NP antibody tests.
Instead, we expect any pharmacy owner or pharmacy professional to carefully consider the PHE guidance and other relevant guidance if deciding whether it is appropriate to offer this type of test, as with any other type of test. Furthermore, it is essential that any patient-facing provider offering COVID-19 testing checks whether they need to be accredited with UKAS. We would also expect them to carry out a full risk assessment considering all key areas, as explained above.
- Public Health England: COVID-19: summary guidance for service providers on point of care or near-person tests for diagnosis and management
- United Kingdom Accredidation Service: Private Providers of COVID-19 testing: Frequently-asked questions
- Medicines and Healthcare products Regulatory Agency: How tests and testing kits for COVID-19 work
- Scottish Government: COVID-19 antibody testing
- Welsh Government: Testing for coronavirus