The government issued guidance on running a medicines re-use scheme in a care home or hospital setting on its updating service on 28 April 2020. This is a significant development in the way medicines can be used in a pandemic situation.
Key points
- The guidance only applies to care homes or hospices and for the duration of the pandemic.
- The patient receiving the re-used medicine still needs a direction (usually a prescription) for the supply of medicines.
- A risk assessment must be carried out.
- The integrity of the medicines needs to be checked.
- The reuse should be authorised by a registered healthcare professional.
- Records should be kept.
- The re-used medicines can include Controlled Drugs.
- Medicines for re-use should not be transferred between homes/hospices.
- Permission for reuse should be obtained.
So how do care homes manage this?
The guidance recommends that medicines should only be re-used in accordance with a medicines re-use scheme, set out in an SOP. Interestingly it does not make this mandatory. But given the guidance suggests using the SOP will offer “a framework to run a safe and effective medicines re-use scheme that is in the best interest of patients” it would be wise for care homes to adopt this recommendation unless there are significant circumstances that could justify not adopting it.
Key elements in the re-use of medicines are:
- Risk assessment
Care homes will have to conduct a risk assessment. There are three factors to take into account:
- No other stocks of the medicine are available in an appropriate timeframe and there is immediate patient need. Ascertaining stock level will be the result of a discussion between care home and pharmacy but there is no guidance about what an appropriate time frame will be. It would be sensible to treat it as a case by case assessment. There does not seem to be an obligation to phone around a number of pharmacies.
- No suitable alternatives for an individual patient are available in a timely manner i.e. a new prescription cannot be issued, and the medicine(s) supplied against it in the conventional manner quickly enough.
- The benefits of using a medicine that is no longer needed by the person for whom it was originally prescribed or bought, outweigh any risks for an individual patient receiving that unused medicine.
- Suitability of medicine for re-use.
All medicines no longer needed by the person for whom they were originally prescribed and intended for re-use must be under the supervision of a registered healthcare professional and appropriate records kept, including details of the registered healthcare professional who performed the check on suitability for reuse. The healthcare professional can be in the home or an individual working externally and checking virtually. They must be satisfied the medicine is:
- In an unopened pack
- In date
- Has been stored appropriately
- Is a prescribed or OTC medicine
- Risk of contamination has been addressed
The record keeping obligations are set out in the guidance but in addition it would be sensible to document all decision-making processes.
- Obtaining permission
The permission that should be obtained is two way: (1) from the person for whom the medicine was originally prescribed (or if the person lacks capacity, from a person with power of attorney or if the person has died, from their next of kin ) and (2) from the person who will use the medicine (or if the person lacks capacity from a person with power of attorney, although the guidance is silent on this point). In the second category, if there is no person with a power of attorney, a best interest decision would need to be made to include next of kin. Again, the guidance is silent on this point but the care home and hospice will have to follow the Mental Capacity Act 2005. The guidance suggests that written permission could be sought in advance for medicines to be re-used.
It is highly likely that the implementation of this guidance will give rise to legal issues given its technical nature.
About the Author
Susan Hunneyball
Healthcare Regulatory Lawyer
D.D: 01483 366064
Tel: 01483 451900
Email: susan@gordonsols.co.uk