Review: medicines reuse guidance
In a significant development in the way medicines can be used in a pandemic situation and as a way of easing pressure in the supply chain, the government has issued guidance (April 28) on running a medicines reuse scheme in a care home or hospice setting, writes solicitor Susan Hunneyball.
In circumstances where there is a short supply of a particular medicine, community pharmacists will need to consider elements of the new guidance as part of their liaison role if care homes wish to set up a reuse scheme, and if they are the checking healthcare professional under a scheme.
The standard advice, of course, is that medicine prescribed and supplied for one patient cannot be used for another. The revised guidance states that for the specific purposes of the human medicine regulations it is not relevant how medicines are sourced and skirts round the gray area of when the supply to a patient is completed. It only applies to medicines in care homes or hospices and for the duration of the pandemic only.
The guidance states that if a medicine is out of stock and there is no suitable alternative, community pharmacy teams should ask the care home or hospice if they run a medicines reuse scheme and whether they have a stock of the required medicine. If the answer is yes to both queries, then the pharmacy must share a copy of the prescription with the home and update the MAR chart.
The key points of the guidance are:
- The patient receiving the reused medicine still needs a direction (usually a prescription) for the supply
- A risk assessment must be carried out by the care home/hospice
- The integrity of the medicine needs to be checked
- Reuse should be authorised by a registered healthcare professional
- Records should be kept
- Controlled Drugs can be reused in these circumstances
- Medicines being reused should not be transferred between institutions
- Permission for reuse should be obtained.
How pharmacists will be involved
The guidance recommends that medicines should only be reused in accordance with a 'medicines reuse scheme', set out in a standard operating procedure (SOP). Interestingly, it does not make this mandatory, but says using an SOP is in the best interests of the patient so there would have to be extremely good justification to depart from a framework set out in the SOP.
Key elements in the re-use of medicines scheme will involve pharmacy professionals:
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 an immediate patient need. The pharmacist/care home dialogue will be important here as it will be through a conversation with the supplying pharmacy that the care home can be satisfied that medicines cannot be obtained through the standard supply chain. Care homes do not seem to have an obligation to check with a range of pharmacies so the pharmacy that normally deals with supply to a care home will need to convey the information about short supply of medicines. It would be good practice for a pharmacy to make a record of any discussion that will lead to the adoption of a reuse protocol.
- 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 reuse
All medicines no longer needed by the person for whom they were originally prescribed and intended for reuse must be under the supervision of a registered healthcare professional. A registered healthcare professional in this context includes a pharmacist and/or pharmacy technician. There is a requirement that appropriate records are kept, including details of the registered healthcare professional who performed the check on suitability for reuse. If the pharmacist is working with the home externally, the checks of medication can be made virtually. The healthcare professional must be satisfied the medicine:
- Is in an unopened pack
- Is in date
- Has been stored appropriately
- Is a prescribed or OTC medicine
- Has been risk assessed for contamination.
The SOP applies to all medicines, including liquid medicines, injections (analgesics, insulin), creams and inhalers, that are in sealed or in blister packs. The guidance includes Controlled Drugs which is understandable as the possibility of reuse in end-of-life care is clear.
The requirement for the medicines for reuse to be under the supervision of the healthcare profession seems to be a continuing obligation. This may pose difficulty in some cases if a pharmacist did the medicine check virtually if they are not usually present in the home or hospice. The guidance does not suggestion how this might be resolved in practice.
These are set out in the guidance, but it would be sensible to document all decision-making processes, and possibly for the checking health professional to have copies.
The care home or hospice will have to obtain relevant permissions. The obligation to do this lies with the care home or hospice, so it is unlikely a pharmacist would be involved.
This is a general overview. Independent legal advice should be sought for any specific queries of concerns.
Susan Hunneyball is a solicitor at Gordons Partnership LLP email@example.com
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