Layer 1

Legal view: The new MUR record-keeping obligations for pharmacies

“Verbal consent must be obtained and a record of it made by the pharmacy”

Keeping detailed records is an important part of pharmacies providing MURs remotely, says lawyer Susan Hunneyball

New medicine service (NMS) consultations from the comfort of your armchair? This became possible from September 1, following amendments to pharmaceutical services legislation. The directions, which contractors need to consider, relate to the method of obtaining patient consent and the way the services are run.

Permanent change

The amendments apply to 2013 directions that set out the framework for advanced services – meaning the changes to patient consent are not limited to the duration of the pandemic.

It is now possible for a pharmacist providing the NMS to do so from a location outside the pharmacy. This is clearly useful if a pharmacist is having to self-isolate due to COVID-19.

The changes smooth out the logistics of remote service provision by removing the obligation to obtain written patient consent for the flu vaccination service, medicines use reviews (MURs), NMS and appliance use reviews (AURs). Instead, verbal consent must be obtained and a record of it made by the pharmacy.

A further means of running remote consultations by video is now permitted for MURs, NMS and AURs. MURs and telephone consultations no longer need prior approval from NHS England & Improvement. All NMS consultations can now take place by telephone or video call, whereas previously only follow-up consultations could be carried out in this way.

The directions say safeguards for the provision of advanced services at a distance are:

● Prior consent from patients to the method of service delivery

● The pharmacist must undertake the consultation “in circumstances where the telephone or video link conversation cannot be overheard (except by someone whom the patient wants to hear the conversation, for example a carer)”

● It has to be “clinically” appropriate to conduct the service in this way.

Legal implications

There is a significant amount of public money involved in providing advanced services. Claims made in January this year for the NMS alone amounted to over £2 million for the month. It follows that there is a post-payment verification of claims made by contractors and the possibility of further scrutiny after that.

Experience from fraud investigations and General Pharmaceutical Council (GPhC) enquiries relating to services show that one of the most important factors in defending challenges is whether there has been diligent record-keeping. A compliant service needs to be evidenced as compliant. So, what are the record-keeping obligations here?

In relation to patient consent, the directions say that consent has to be recorded in the “pharmacy’s clinical record for the service”. There are important issues here: who gives consent? Are there doubts about mental capacity that have to be resolved?

The scope of the consent will also have to be noted. This is consent to share information and for data collection, as well as the process and the method of carrying out the service. Pharmacies no longer have to collate signed consent forms, but the work that needs to be done is still there and should be evidenced.

In relation to the method and location of service delivery, the guidance and service specifications have not yet caught up with the changes in the advanced services directions.

However, for the NMS, the unamended guidance from 2013 says a pharmacist should record the date and method of the intervention and date and method of the follow-up consultation, with the latter showing whether it was face-to-face or over the phone.

As set out above, there are now mandatory requirements to be met before the provision of the services by video or telephone call can be carried out. These are consent, appropriateness and privacy.

Clearly, the basic recording guidance here is simplistic. A pharmacy’s sensible recording system will document pharmacists’ compliance with the NHS directions. Ideally, as well as documenting consent, the system would show that the appropriateness of the venue was considered, and privacy checks were carried out.

The records, of course, are not only for external scrutiny but for internal governance. The pharmacy’s own audit processes will need to ensure compliance with the revised directions. Standard operating procedures will need to be revised to take account of the changes.

Practical implications

Studies have looked at the impact of “telepharmacy” – the delivery of pharmaceutical care remotely – in various incarnations before and during the pandemic. One study by the Utrecht Institute for Pharmaceutical Sciences published in July showed that, unsurprisingly, the pandemic had a “considerable impact” on pharmaceutical services in the Netherlands regarding patient education and counselling. It concluded there was a need for more “telepharmacy”, such as video calling, to optimally support patients.

Outside the pandemic, the picture may be more nuanced. Although the increased access to services – especially for vulnerable groups – is a positive factor, there will be many other considerations such as the context of the service and whether it is a replacement or enhancement of existing services.

In January, the NHS long-term plan set out the future aim for digitally-enabled primary care. The new directions are a step towards that goal.

It is clear that even before the outbreak of COVID-19 there was a drive to offer more services digitally. This will not be appropriate for all patients, but in an environment where everyone is concerned about face-to-face contact, with the right legal framework and guidance, the changes should be useful for all pharmacies.

Susan Hunneyball is consultant solicitor at Gordons Partnership law firm.

1 Comments

J. Locum, Locum pharmacist

This article asked the question " who gives consent" but then didn't answer its own question. It has been my view that only the patient can give consent and that such consent should be informed but observing working practices in many pharmacies over the years leads me to assume that I am in a small minority. Frequently the representative collecting a prescription is asked to give consent or patients are asked to " sign here" with no explanation that they have given permission for their information to be stored or shared with their GP . The last time I recall this issue being raised was with the introduction of access to summary care records so anyone who did that training should be aware of the concept of obtaining informed consent, shouldn't they ?

Job of the week

General Practice Pharmacist
Armagh, Dungannon, Newry
Up to £40,894