Key information for pharmacy owners and pharmacy professionals
Last updated: 14 February 2022
Our role in relation to COVID-19 testing kits
There are now a variety of test 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).
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.
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
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.
UKAS has provided information 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.
- UK Health Security Agency: COVID-19: summary guidance for service providers on point of care or near-person tests for diagnosis and management
- United Kingdom Accredidation Service: Accreditation for Covid-19 testing
- Medicines and Healthcare products Regulatory Agency: How tests and testing kits for COVID-19 work
- Scottish Government: Coronavirus (COVID-19): getting tested in Scotland
- Welsh Government: Testing for coronavirus