Risks and responsibilities raised by Pharmacy First

As pharmacists step into a more prominent clinical role through Pharmacy First, a recent prevention of future deaths report highlights the risks, responsibilities and grey areas surrounding patient advice in community settings. Saša Janković reports

A coroner’s report has highlighted issues over outdated dosage guidance and ambiguities around who patients should be seeking advice from since the launch of the Pharmacy First scheme, raising concerns that new practice requirements may be putting pharmacists’ professional safety on the line.

In a prevention of future deaths report, assistant coroner for Cheshire, Elizabeth Wheeler, raised two concerns following the death of Alan Crabtree in March 2025 from methotrexate induced pancytopenia (a decrease in red and white blood cells and platelets) and pneumonia. The report said Mr Crabtree’s family had sought advice from a community pharmacist when he displayed symptoms of a sore throat, mouth ulcers and difficulty swallowing – signs of methotrexate toxicity – and treatment was provided under the Pharmacy First scheme.

However, the report noted that the Shared Care Guideline for Oral Methotrexate in Rheumatological Conditions in Adults had been produced in 2017, before the Pharmacy First scheme had come into effect in January 2024. The guideline states that 'patients should be advised to seek medical attention' for all signs and symptoms suggestive of blood disorders such as a sore throat, which Ms Wheeler said made it unclear who patients should be seeking advice from to ensure they obtain the appropriate care and treatment. The report said that in light of the expanded role under the Pharmacy First scheme 'patients may consider community pharmacists could form part of 'medical attention'.

These worries are especially relevant now that pharmacies are set to become a ‘first point of contact’ for more patients to reduce pressure on general practice, according to the government’s new neighbourhood health framework, published in March.

Professional practice requirements

Of course, community and GP practice pharmacists – and pharmacy technicians – don’t have to scrabble in the dark to work out their professional practice requirements when giving medical advice.

The GPhC sets standards for pharmacy professionals, which have to be met at all times, to ensure safe, effective, evidence based care. These are that pharmacy professionals must:

1. provide person-centred care
2. work in partnership with others
3. communicate effectively
4. maintain, develop and use their professional knowledge and skills
5. use professional judgement
6. behave in a professional manner
7. respect and maintain the person’s confidentiality and privacy
8. speak up when they have concerns or when things go wrong
9. demonstrate leadership

Additionally, the GPhC’s Guidance for Pharmacist Prescribers states that pharmacist prescribers must make sure their prescribing is evidence-based, safe and appropriate. The Pharmacy Order 2010 also requires every pharmacist and pharmacy technician to have appropriate professional indemnity, which is why the GPhC requires this as part of their initial registration and subsequent renewal.

‘Pharmacists and pharmacy technicians have to meet the GPhC standards for pharmacy professionals, at all times. Pharmacy teams must take particular care when supplying high risk medicines, and ensure they have all the necessary information to check the medicine is safe and suitable for the person,’ says Roz Gittins, chief pharmacy officer at the GPhC, adding ‘Relevant service specifications and evidence-based, best practice guidance should also be considered when medicines are supplied, including via Pharmacy First.’

For pharmacists wanting a ‘legally digestible’ handbook to refer to alongside the GPhC standards, Thorrun Govind – pharmacist and solicitor at Brabners regulatory and professional conduct team – says: ‘The Royal Pharmaceutical Society (RPS) Medicines, Ethics and Practice (MEP) guide offers guidance on legislation, ethics and professional standards, and helps pharmacists make sound decisions on dispensing, prescribing, and ethical issues on a day-to-day basis.’

Ms Govind also highlights the importance of ‘working within your competencies, and keeping up to date,’ which she says is why ‘you can't just do your revalidation once a year for the GPhC and think that's enough. You've got to have insight into where you need to develop, and do the work to improve your practice, as well as raising concerns where care falls outside your scope, and identify red flags and escalate when necessary.’

Pharmacy First competencies

The case of Mr Crabtree raises the important concern of how well these long-standing practice competencies tie in with offering Pharmacy First consultations.

NHS England’s Community Pharmacy advanced service specification for the NHS Pharmacy First Service sets out clear guidelines for contactors offering the service, including that:

• The pharmacy contractor must ensure that pharmacists and pharmacy staff providing the service are competent to do so, and be familiar with the clinical pathways, clinical protocol and PGDs.
• The pharmacy contractor must keep documentary evidence that pharmacy staff involved in the provision of the service are competent and remain up to date with regards to the specific skills and knowledge that are appropriate to their role, and to the aspects of the service they are delivering.
• The contractor is required to report any patient safety incidents in line with the Clinical Governance Approved Particulars for pharmacies.

Alongside this, Alima Batchelor, head of policy at The Pharmacists’ Defence Association (PDA), says there is a ‘comprehensive collection’ of resources including clinical pathway documents and patient group directions which have been devised to support pharmacists (and in some cases now, pharmacy technicians) providing Pharmacy First consultations.

‘These set out the conditions to be treated, questions to be asked and situations where the patient needs to be referred elsewhere’, says Batchelor, ‘and aim to help pharmacists identify red flags and those patients who need to be referred to a doctor, or in some cases to A&E rather than receiving a medicine under Pharmacy First.’

Nonetheless, Batchelor warns there are still ‘occasions when patients are inappropriately referred to Pharmacy First introducing unnecessary delay to them receiving the care they require, and we believe that in Mr Crabtree’s case, the community pharmacy and Pharmacy First was not the correct setting for the care he required.’

‘Inappropriate’ queries

So what should pharmacists do if a patient’s medical advice query is inappropriate? And will they always be aware it’s not appropriate?

Batchelor says: ‘As with any query which lies outside of routine practice for the pharmacist concerned, the patient should be signposted to a more appropriate healthcare professional, and as noted above, the clinical pathway documents for Pharmacy First provide guidance on where patients should be directed.’

In the case of Mr Crabtree, Batchelor says: ‘The Shared Care Agreement (SCA) which the hospital clinic should have been following, stated that patients needed to be advised to seek medical attention if they developed sore throat, bruising or mouth ulcers after starting methotrexate. Mr Crabtree and his family should have been told that if he developed any of these symptoms, they would need to urgently seek medical attention from his general practitioner, consultant or advanced nurse specialist.’

Liability and protection

Ms Govind says community and GP practice pharmacists may find themselves falling under a range of liabilities if a mistake is made: ‘There's the risks of failing to act within your competence, or inappropriately acting or not acting, and you could find yourself subject to GPhC fitness-to-practice or civil negligence claims, or even employer disciplinary action.’

To mitigate this, legal protection is required. Kate Ryan, RPS Patient Safety Manager, says: ‘Like other regulated healthcare professionals, pharmacists practise within a clear professional and regulatory framework and are required to have appropriate professional indemnity arrangements in place for their scope of practice.’

Batchelor goes a step further, advising: ‘Having personal indemnity cover which is independent of the employer is advisable (a contingent indemnity policy is not truly independent as it only comes into play should the employer’s indemnity scheme fail).’

Clinical overload

With a retention crisis in the sector, and contractors pushed often beyond their limits by a lack of funding, does the tragic case of Mr Crabtree highlight the pitfalls of pharmacists being pushed to do more clinical work?

Batchelor says the PDA has had feedback from members ‘which shows that there has been no increase in staffing to accommodate the increase in clinical consultations, and despite this, the range of clinical services and quantity of those delivered has increased. Pharmacists are entirely capable of doing the work under Pharmacy First, independent prescribing and other clinical services. To best deliver these, the appropriate governance processes must be in place, together with suitable staffing levels.’

For Ms Govind, the key to patient safety is working collaboratively. ‘Ultimately, we need to work together to make sure that patients don't suffer’, she says. ‘It's not about trying to save the world. It's about making sure that everyone is working within their level of competence and knows where to go to get more support, if needed.’