It is vital that oral antivirals (OAVs) are supplied, stored, prescribed, dispensed and taken correctly, and that systems are in place to ensure that the right patient receives the right dose of the right product at the right time.
Our institutional readiness checklist will help you work to the principles below. Further information can be found on our article on Private: Managing risk when supplying and administering COVID-19 treatments from acute Trusts.
To follow the principles for oral antiviral deployment you should consider these implementation points.
Electronic prescribing systems
Where electronic prescribing is in use, ensure the medication record is set up to allow clinical verification and or prescribing of these OAVs as a free of charge product to ensure replenishment of stock and reporting is accurate. For further details on how to set up can be found in the NHSE SOP.
Authorised prescribers identified
It is expected there is a specified prescriber list for each CMDU. Trusts and their CMDUs will need to identify prescribers who are authorised to prescribe these OAVs. Eligible patients should have been pre-notified of their potential eligibility due to being extremely high risk. Eligible patient cohorts are listed in the clinical policy; prescribers are responsible for checking eligibility before prescribing.
Registration of patients within the hospital
Ensure systems are in place for urgent registration of “new” patients to enable dispensing through pharmacy systems.
Pharmacy stock control systems within hospitals usually take patient demographic fields from the hospital PAS system. Hospital pharmacies will have a system in place to manually add patients to the system. This will require information such as the patient’s full name, date of birth, NHS number, and GP, which must be included on any prescription for COVID-19 oral antivirals and are required as part of the treatment assessment pathway.
The prescription must include the latest date of treatment delivery in order to avoid missing the treatment window.
It is not possible initially to make externally over labelled stock available to trusts. Pharmacies may decide locally that they wish to provide the OAVs as an overlabelled pack, with a space for the patient’s name and date of issue.
Overlabelling batches of antivirals should be undertaken in accordance with the principles of Good Manufacturing Practice. In hospital pharmacies that do not hold a Specials Manufacturing licence from the MHRA, a limited number of packs may be overlabelled by or under the supervision of a pharmacist under the professional exemption from licensing. Chief Pharmacists should consider the implications of overlabelling if supply across a legal boundary is necessary. Stockholding levels of OAVs should be visible on electronic stock holding systems at each stage of the overlabelling process.
Further information is available in our SPS guidance on the overlabelling of small batches in hospital pharmacies.
Trusts should use their normal pharmacy services for receiving a prescription from the CMDU, and dispensing. Pharmacy services must be available every day including weekends and bank holidays, both in hours and out-of-hours if dispensing is clinically necessary. A legal mechanism for prescribing (via paper or using an existing electronic prescribing system) must be agreed with the Chief Pharmacist who is providing oversight to the CMDU. Hospital pharmacies will have such systems in place.
There is no need to confirm that the patient is COVID-positive as part of the clinical check. It is the prescriber’s responsibility to confirm that the patient meets the criteria. The pharmacy must provide the PIL and any other additional information leaflet (unless provided already during the treatment assessment).
Hospital pharmacies have developed mechanisms throughout the COVID-19 period to allow patients to collect their medicines. These must be described in SOPs and take into account the requirements for antivirals to be started promptly. They must be available every day including weekends and bank holidays to ensure patients do not miss the treatment window specified in the clinical policy. Options should include collection by a non-household member or by courier.
Transfer from pharmacy to collection point or site
OAVs should be transported internally within the hospital in accordance with local trust policy.
Those trusts with established arrangements for the transport of medicines to patient homes should utilise those. Delivery services must be available every day including weekends and bank holidays to ensure patients do not miss the treatment window specified in the clinical policy.
In the absence of a validated courier process, trusts will be required to put in place systems for delivery that might include options for using a courier, delivery service, hospital transport or taxi.
Consideration should be given to appropriate security and reliability of the transport method used in addition to any packaging requirements for transport.
Trusts might need to consider additional processes with their logistics provider with regards to the safe and secure transfer of medicines directly to patients.
Collecting data and learning
Collecting real world data
The oral antiviral COVID-19 treatment programme is a high profile initiative and it is essential that MHRA collects real world data on its use. The MHRA’s new guidance on using real-world data contains further information.
Learning from incidents
All incidents should be notified to the designated clinical lead and reported using local governance processes.
Report and suspected adverse reactions via the Coronavirus Yellow Card Reporting site.
Advice for Trusts
Other oral antiviral advice
- Editorial changes. Checklist removed. Minor changes and additions to implementation advice, including change for overlabelled packs to remain on electronic stock holding systems.
- Clinical advice on Molnupiravir moved individual article. Points about data and learning given headings and made clearer.
- Summary text amended.
- Section on breastfeeding added.
- Addition of information leaflet and PIL within dispensing section. Links added and amended.
- Italicisation removed from text on pregnancy and heading added to improve readability. Link to SmPC added. Links checked and tidied. Some other minor editorial amendments.
- Links added and amended. Minor editorial amendments.
- Reference to availability of guidance on use in people with swallowing difficulties added