On 28 April 2020, the Government announced that care homes would now be permitted to reuse medicines to ensure that residents receive the medicines they require.
Under usual circumstances, the reuse or recycling of patient medicine is not permitted.
CQC updated its website also on 28 April 2020, stating:
“Prescription-only medicines (POMs) must only be supplied on prescription to a named person. Once prescribed, the medicines become the property of that named person. The person must not supply the POM to anyone else. Therefore prescribed medicines cannot be used for anyone else. Due to Coronavirus pressures, you might need to make sure people receive timely access to essential prescribed medicines. You need to act in a way that is pragmatic and safe, and focus on what is in the best interests of your patients and the wider system. Local schemes or medicines reuse may already be in operation to support this.”
Regrettably, this is not the clearest of statements from CQC. However, further guidance has also been issued by the Government which has been prepared jointly by the NHS and the Department of Health & Social Care. This guidance confirms that, the reuse or recycling of another person’s medicine is not recommended and that any unused medicines would normally be disposed of by returning them to a contracted external company or community pharmacy. However, in light of the increasing concerns about the pressure on medicine supply chains which could be caused by the COVID-19 pandemic, a medicines reuse scheme for care homes and hospices could help ease some of that pressure.
Although the usual rules around reuse of medicines remain good practice, the guidance introduces a new Standard Operating Procedure which is designed to help care providers manage situations where the best interest of residents may mean it is not appropriate to follow that good practice recommendation. Medicines reuse schemes already operate successfully within NHS hospitals and there does not seem to be any reason why they could not also do so within care homes. Having said this, however, providers need to be careful how they deal with such matters and ensure that they keep proper records.
It is intended that the Standard Operating Procedure will be time limited and will only apply for the period of the COVID-19 pandemic.
When might this process be used?
The guidance recommends that consideration be given to whether the situations amount to “a crisis”. Each individual care home or hospice must carry out a risk assessment on an individual medicine basis. The risk assessment and subsequent decision should be informed by three key indicators:
- No other stocks of the medicine are available in an appropriate timeframe (as informed by the supplying pharmacy) and there is an immediate patient need for the medicine;
- No suitable alternatives for an individual patient are available in a timely manner (i.e. a new prescription cannot be issued and the medicines supplied quickly enough);
- The benefits of using a medicine that is no longer needed by a person for whom it was prescribed, outweigh any risks for an individual patient receiving that unused medicine.
Is a medicine suitable for reuse?
Before reusing medicine it must be checked against the criteria set out in Tables 1 to 3 of the guidance by a registered healthcare professional. Where no registered healthcare professional is on site (for example in a care home which only offers residential care) registered healthcare professionals from other organisation can perform that check (such as pharmacists, GPs, community nurses etc from clinical commission groups or GP practices). These checks can take place ‘virtually’. Clear records must be kept, including details of the medicine and details of the registered healthcare professional who performed the check on suitability for reuse. If the medicine is a controlled drug, it must remain in the possession and control of an organisaton authorised to do so and appropriate records (e.g. controlled drugs register) must be maintained in respect of controlled drugs.
The Standard Operating Procedure applies to medicines that have been supplied to residents whilst in a care home or hospice and which have not been removed from that setting (other than for short periods, e.g. at an outpatient appointment) and which have been stored in accordance with good practice guidance on storing medicines in a managed setting. It can apply to all medicines, including liquid medication, injections (for example analgesics or insulin), creams and inhalers that are in sealed or blister packs and provided the criteria in Table 1 of the guidance is met. Table 1 sets out a number of criteria including that the medicine is unopened or within a blister pack which has not been tampered with, that it is in date and that it is has been stored appropriately (including refrigeration if required).
Table 2 of the guidance sets out action and considerations to minimise the risk of cross contamination, including circumstances where the medicine is from a patient which has been diagnosed COVID-19 positive or who is showing symptoms. Table 3 sets out requirements around ensuring permission is obtained and that patients’ families and carers are fully involved.
In circumstances where providers may have particular difficulty in accessing certain medicines, the guidance also suggests providers should assess whether the normal assumption of allowing patients to keep their own supplies of medication for self-administration remains appropriate, or whether other storage arrangements would better facilitate their reuse, if the patient no longer needs them.
Reuse should only be within a single care home/hospice setting and medicines identified for reuse should not be transferred to another care home or hospice, even within the same organisation.
What action should providers take?
To ensure that reuse of medicines is an option that can be used as flexibly as possible if required, the guidance suggests that care homes actively seek written permission from all residents in respect of the following:
- That their medicines (if no longer needed) can be made available to other residents; and/or
- Their agreement to receive a reused medicine, provided it is deemed safe for reuse.
Annex B of the guidance provides some further helpful information, including suggested content of discussions which should be taking place now with residents.
Providers must also maintain a log of all reused stock, including the generic drug name, batch number, strength, formulation, expiry date, quantity and details of the registered healthcare professional who assessed the medicine, as a minimum. When stock is reused the quantity used must be entered on the log. Annex B also contains an example log. Any reused medicine would need to be administered according to the direction of a relevant prescriber and recorded in the care home MAR charts.
The Standard Operating Procedure sets out a number of detailed requirements which must be followed for the medicines to be reused and we would recommend that the guidance is read in full.
It is most important for registered providers to ensure that these matters are handled safely and carefully and fully documented. This includes the risk assessments referred to above and clear documentation regarding authorisation for reuse of specific medicines and ensuring that the reuse of all medicines is properly logged as referred to above and in the Standard Operating Procedure and Annex B. Particular attention will need to paid to issues such as dosage of medicines where the strength or dosage of certain tablet medicines may vary. Inevitably, CQC will be expecting to see clear records of use of medicines and a clear audit trail.
CQC has also highlighted that, due to capacity and infection control measures, some community pharmacies are not accepting medicine returns. Risk assessments should be updated to reflect this and providers should make appropriate records in respect of waste medicines and ensure that medicines are stored securely with access restricted to authorised staff only.
We envisage that issues such as medicine use, which are often considered to be matters which may present a risk to the safety of service users, will be a particular focal point for CQC on future inspections and maintaining clear and accurate records is therefore essential and providers and managers should undertake checks to ensure appropriate records are being maintained in this respect.
If you require any assistance, our CQC solicitors are available to help. Contact us on 01202 786178 or Laura.Guntrip@LA-Law.com.