Background
COVID-19 treatments may be supplied by multiple organisations working together, with clinical assessment, prescribing, medicine supply and administration functions spread across each. As a consequence, there may be no integrated electronic prescribing system in place and insufficient time to obtain hard copy prescription at the dispensary or treatment centre to ensure timely treatment.
Risks and their mitigation
Each supply model may pose slightly different risks. Below you can find example risks and management approaches for each model. These can be used to help inform local governance arrangements relating to medicines supply and administration. Note, however, that our lists are not necessarily exhaustive and other risks may need to be considered depending on local circumstances.
Supply via emailed prescription: risks and mitigations
Supply against an emailed copy of a prescription (dispensing) either to a patient (OAV) or to a healthcare professional who will administer the medicine to the patient (nMAB). Risks and their mitigations are as follows.
Prescription supply uncertainty risk
Risk definition
Risk of uncertainty that the supply has been made in accordance with a legally valid prescription.
Mitigation
Ensure system governance measures in place. Roles and responsibilities for all tasks/functions clear and documented.
Poor legibility risk
Risk definition
Poor legibility of prescriptions.
Mitigation
Ensure there is a system in place to refer legibility issues to prescriber.
Non-receipt of original prescription risk
Risk definition
Non-receipt of original prescription, leading to inability to demonstrate a supply had been made in accordance with a prescription.
Mitigation
Ensure there is a reconciliation procedure in place and regularly audited.
Prescription amendment risk
Risk definition
Original prescription is subsequently amended by the prescriber.
Mitigation
- Ensure treatment is given in line with national commissioning framework.
- Ensure systems in place to confirm treatment when clerking patient into treatment centre or under care provider.
Fax/email risk
Risk definition
Fax/email is sent to multiple pharmacies, leading to duplicate supplies being made.
Mitigation
- Supply from single approved dispensary for each place/ICS boundary. (Commissioners may prefer Local Delivery System (LDS) due to local geography.)
- Patient postcodes mapped to nominated registered pharmacy
Prescription not genuine risk
Risk definition
The prescription is not genuine.
Mitigations
Prescription from unknown prescriber are validity checked as part of usual process.
Send and receive risk
Risk definition
System for sending and receiving is not secure
Mitigations:
- Emailed copies sent and received via secure NHS email
- Prescriptions only to pre-defined addresses
- Recipient will accept messages/prescriptions only from pre-defined senders
Supply of stock to healthcare professional: criteria and compliance rationale
Supply of stock to a healthcare professional who will administer the medicine to a patient under a Wholesaler Distribution Authorisation (WDA) or from a pharmacy under a WDA exemption. This may be either through wholesale supply via WDA, which is acceptable if in accordance with GDP, or may be through pharmacy supply under WDA exemption (within hospital or community).
Small quantity
Criterion definition
The quantity of medicines supplied is small.
Compliance rationale
- Medicines are limited to pre-specified nMABs and OAVs for treatment against NICE Technology Appraisal Guidance
- Supply will be distributed by Alliance Healthcare UK in England
Not-for-profit
Criterion definition
The supply is made on a not-for-profit basis.
Compliance rationale
- No profit involved
- The supply is not for onward wholesale distribution
- No onward wholesale distribution will occur
Administration from stock: risks and mitigation
Administration of a medicine from stock held in a treatment centre against an emailed authorisation (nMABs). Risks and mitigations are as follows:
Prescription supply uncertainty risk
Risk definition
Risk of uncertainty that the supply has been made in accordance with a legally valid prescription.
Mitigation
Ensure governance measures in place and that roles and responsibilities for all tasks/functions clear and documented.
Non-receipt risk
Risk definition
Non-receipt of original prescription, leading to inability to demonstrate a supply had been made in accordance with a prescription.
Mitigation
Reconciliation procedure in place and regularly audited.
Prescription amendment risk
Risk definition
Original prescription is subsequently amended by the prescriber.
Mitigation
- Ensure treatment is given in line with national commissioning framework and NICE Technology Appraisal Guidance
- Ensure systems in place to confirm treatment when clerking patient into treatment centre or under care provider
Send and receive risk
Risk definition
System for sending and receiving is not secure.
Mitigations:
- Ensure emailed copies sent and received via secure NHS email
- Ensure prescriptions only to pre-defined addresses
- Ensure recipient will accept messages/prescriptions only from pre-defined senders
Bibliography
- MHRA, 2012. Guidance for pharmacists on the repeal of Section 10(7) of the Medicines Act 1968.
- RPS, 2022. Medicines, Ethics and Practice (MEP), 45th ed. Available online: Medicines, Ethics and Practice – MEP | RPS
Update history
- Updated in line with commissioning framework to provide access to COVID-19 treatments in the community. Editorial changes throughout. Webpage status amended to be publicly available.
- General update in line with changes in service provision. Removal of links to other resources.
- Published