Information for Pharmacists
Helping your patients decide whether to self-test
The pharmacy team can play a pivotal role in helping your patients decide whether a self-testing kit would benefit them.
You can help by informing your patient;
- That a medical test result by itself is not a diagnosis but can provide useful information towards a diagnosis by a pharmacist or doctor
- To consider what impact a positive or negative test result could mean to them before deciding to test
We have a dedicated section of our website for HCPs, providing performance and regulatory information for pharmacists and doctors for each of our medical devices for home use.
Professional customer care
It is essential that your patients are able to use their test and interpret their results correctly.
Although all SELFCHECK instruction leaflets have been written in easy-to-read English, we know from experience that a minority of patients will not follow the instructions and consequently will not get a result. In our experience over 20 years, device failures by themselves are almost non-existent, due to the extensive quality control points necessary to manufacture a regulated medical diagnostic.
In the event that your patient does not get a result, the instruction leaflet directs them to contact us for help. Our technical experts will ensure that your patient understands what may have gone wrong, and then send them a replacement test. It is exceptionally rare for us to have to send more than one replacement.
Post self-test advice
Although we do not provide medical advice, information on the next steps to be taken following a positive or negative test result is clearly explained in the instruction leaflet provided with the test. It is currently a legal requirement for self-test manufacturers to encourage users to speak with their doctor to discuss their result.
Regulation of self-test medical devices in the UK
Direct-to-consumer tests are strictly regulated in the UK through the in vitro diagnostic directive (IVDD) and the in vitro diagnostic regulations (IVDR). All self-test diagnostics have to be independently reviewed by scientists, clinicians and regulatory specialists from a Notified or Approved Body which answers to the Competent Authority - which is MHRA in the UK, before they can be certified, registered, and used. Despite these regulations, there are many devices available to patients online that are unsafe and unfit for purpose.
All SELFCHECK medical self-test devices meet the current UK requirements either IVDD or IVDR for self-test devices. In addition to CE certification and registration with MHRA, SELFCHECK medical tests are assembled in the UK at an ISO13485:2016 certified medical device facility, where new diagnostics are developed for hospital laboratories and intensive care wards.
How to contact SELFCHECK
Your pharmacy team and patients can contact our technical experts by phone Monday to Friday between 9am and 4pm on 01745 535 169, or through our online contact form anytime. During working hours, we normally respond within 1 hour. Outside these hours we will respond the next working day.