Not only had there been a number of concerns raised by coroners highlighting issues with on-line services, but a response from General Pharmaceutical Council Chief Executive, Duncan Rudkin, committed to identify action the regulator could take.
A short consultation took place at the end of 2024.
The first revision to the guidance was back in 2019 where the changes were significant.
Some pharmacies offering an online service went from meeting standards in inspections to standards “not met” and consequent Fitness to Practise proceedings.
Read more: Coroner: Patient dead after ‘tick-box’ online pharmacy prescription
The guidance was still not specific in many areas and even in the second revision in 2022 there was no guidance on weight loss medication. The 2025 iteration provides more clarity to registrants about the standards they have to meet.
Key changes
In many cases the key changes echo the concerns that have already been raised in Fitness to Practise cases.
The changes include, in principle 1 of the new guidance which deals with governance, the following:-
· An emphasis on superintendent pharmacist responsibility - it is the duty of the SI to ensure the safe and effective running of the pharmacy under the Medicines Act 1968 but the responsibilities are now set out in the guidance.
· Requirement for clear, written, service-level agreements between the pharmacy and any third-party provider(s) to be in place.
· Emphasis on keeping auditable records.
Principle 3, dealing with premises and the digital platform, highlights compliance with advertising and promotion of medicines.
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It is in principle 4 though, relating to the health, safety and wellbeing of patients and the public, where the majority of changes have been made.
These include:-
· In relation to conflicts of interest, expressly stating that a conflict includes giving incentives to prescribers to issue prescriptions.
· There is a new section on selecting the appropriate method of consultation to obtain information need to give safe and effective care.
An example given is whether “timely two-way communication can be established.”
It is flagged up that appropriate consultation is particularly important in cases where there is a need for ongoing monitoring, prescription of medicines that are liable to misuse and when the person would be at risk of death or serious harm if they are also getting medicines from another source.
The later is a concern that was raised at a recent inquest.
· There is much more detail on prescriber’s responsibilities, and it is flagged up that some medicines cannot be prescribed by a questionnaire model alone.
· It is clearer that if patients do not have a regular prescriber such as a GP, or if the patient does not consent to share information with a regular prescriber, the online prescriber should carry out, and record, an individual risk-based assessment to decide whether it is safe to prescribe.
· There are new categories of medicines for which prescribing and supply require additional safeguards. These include medicines used for weight management. There is a concept of independent verification: i.e. not relying on information given by the patient. For weight monitoring this means independent verification of the person’s weight, height and/or body mass index which can be by a video consultation, in person, from the person’s clinical records or through another healthcare provider. Verification cannot be by telephone call.
Consultation - what was picked up?
In the consultation on the proposed changes some respondents, such as the PDA, suggested that it was wrong to reverse the 2022 guidance and permit people to give their preferred choice of medicine, for example a preferred brand or formulation, before the clinical assessment. However, the proposed relaxation has been retained.
Read more: GPs warned they could face legal issues if they ‘ignore’ pharmacists
Consultation responses in relation to the language used have been adopted in some cases where mandatory wording has replaced less specific terminology.
Does the update cover everything?
There are still queries; for example, is there enough on what is expected of the capacity assessment? GPhC guidance on consent (which covers capacity) is referenced but that was last revised in 2018.
More generally, it is an issue that the guidance is trying to be a one-size fits all guide for a wide range of remote pharmacy services. However, clarification of what meeting the standards actually entails must be helpful for registrants.
Susan Hunneyball is a partner at Gordons Partnership LLP