Alan Crabtree

E: quality.nhsgm@nhs.net  

Date: 8 April 2026 

Private & Confidential 
Elizabeth Wheeler 
Assistant Coroner for Cheshire 
Cheshire Coroner’s Court 
Museum Street 
Warrington WA1 1JX 

Sent by email to: 

Dear Elizabeth 

Re: Regulation 28 Report to Prevent Future Deaths – Mr. Alan Crabtree  

Thank you for your Regulation 28 Report dated 20th of February 2026 regarding the sad death of Mr. 
Alan Crabtree. On behalf of NHS Greater Manchester (NHS GM), we would like to begin by offering our 
sincere condolences to Alan’s family for their loss. 

Thank you for highlighting your concerns during the inquest, which concluded on the 26th of January 
2026. On behalf of NHS GM, we apologise that you have had to bring these matters of concern to our 
attention, and we recognise it is very important to ensure we make the necessary improvements.   

During the inquest, you identified the following causes for concern:  

1.  The dose regime referred to in the “Shared Care Guideline for Oral Methotrexate in 
Rheumatological Conditions in Adults” does not reflect current practice and the initial dose 
recommended is a sub-therapeutic dose. 

The Shared Care Protocol (SCP) includes a section that explains how methotrexate doses should be 
managed once a hospital specialist has started treatment. It sets out a range of doses that may be used, 
starting at a lower dose and increasing gradually over time. The protocol states that methotrexate should 
be prescribed at 7.5–25 mg once weekly according to hospital instructions, with an initial dose of 5–15 
mg once weekly, titrated upwards by 2.5–5 mg every 2–6 weeks according to response, with a typical 
maintenance dose up to 20 mg per week, and in some circumstances up to 25 mg per week. The 
protocol also specifies that only 2.5 mg tablets should be prescribed, which is a recognised national 
safety measure intended to minimise the risk of dosing errors with methotrexate. 

The dose range described in the Shared Care Protocol is consistent with information contained within 
the Summary of Product Characteristics (SmPC) for Methotrexate, which describes typical dosing 
ranges for rheumatoid arthritis and states that dosing should be adjusted gradually in order to obtain an 
optimal therapeutic response. This approach is designed to allow clinicians to balance effectiveness with 

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 safety. Methotrexate is a powerful medicine, and starting at a lower dose helps reduce the risk of serious 
side effects, particularly in people who are older, frail, or who have kidney or liver disease. 

The dosing range described in the protocol also reflects earlier national rheumatology guidance available 
when the document was developed. For example, the 2008 guidance from the British Society for 
Rheumatology and British Health Professionals in Rheumatology for the prescription and monitoring of 
non-biologic disease-modifying antirheumatic drugs describes a typical methotrexate dose range of 7.5–
25 mg once weekly, with an initial dose of 5–10 mg once weekly, increasing by 2.5–5 mg every 2–6 
weeks until the disease is stabilised. The dosing range described in the Shared Care Protocol, therefore, 
allows specialist doctors to adjust treatment based on the individual needs of each patient. 

It is important to note that within the shared care model, methotrexate treatment is initiated and titrated 
by the specialist rheumatology team, and the starting dose is a specialist clinical decision made in 
consultation with the patient. This decision takes into account multiple factors, including disease severity, 
comorbidities, renal function, age, and the overall treatment strategy. Methotrexate may also be 
prescribed in combination with other disease-modifying antirheumatic drugs (DMARDs) as part of the 
overall management plan for inflammatory arthritis, and therefore, the starting dose and titration 
schedule may be adjusted by the specialist clinician to reflect the overall therapeutic regimen. 

There has been a recent update to specialist guidance to methotrexate monitoring, following publication 
of the British Society for Rheumatology guideline in 2025. National medicines information resources, 
including guidance published by the Specialist Pharmacy Service, have not yet fully updated their 
publicly available monitoring guidance to reflect these newer recommendations. In response to these 
developments, a review of the monitoring requirements within the Shared Care Protocol has already 
been scheduled, and the dosing wording will also be reviewed as part of the next update of the protocol 
to ensure alignment with contemporary rheumatology practice and national guidance. 

Overall, the Shared Care Protocol provides a framework that ensures methotrexate therapy is initiated, 
dose-optimised, and monitored under specialist supervision, with clear safety safeguards and structured 
monitoring arrangements in place before prescribing responsibility is transferred to primary care. 

The concerns raised by this report have highlighted that some Shared Care Protocols have passed their 
planned review dates. NHS Greater Manchester has addressed this by the implementation of immediate 
and long-term actions. 

Immediate actions: 

•  Formally recognise the risk associated with out-of-date SCPs at the system level via a risk 

• 

register. 
Introduce regular reporting through existing governance routes, including Greater Manchester 
Medicines Management Group (GMMMG) and GM Clinical Effectiveness Group (CEG). 

•  Add a statement to the GMMMG website to clarify when protocols have passed their review date 

and are awaiting formal review. 

•  Continue to make urgent safety-related amendments through existing clinical governance 

processes where required. 

•  Prioritise review of those protocols considered to present the greatest clinical risk. 
•  Preparation and dissemination of a ‘7-minute briefing’ to share the learning from this issue across 
the GM health care sectors, including primary and secondary care and community pharmacy 
teams.  

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 Long-term plan: 

•  Develop and implement a formal process for risk rating and prioritising review of all out-of-date 

SCPs. 

•  Establish clear ownership, responsibilities and timescales for coordinated review and updating of 

overdue protocols. 

•  Embed the SCP review programme within the NHS GM Pharmacy and Medicines Team with a 

responsibility for clinical guidance, including SCP's workplan.  

•  Maintain oversight through the NHS GM Pharmacy and Medicines Team with routine progress 

updates to GMMMG. 

•  Strengthen assurance arrangements so that shared care protocols are reviewed in a timely way 

and future backlog risk is reduced. 

•  Ensure there is a robust communication mechanism to inform all involved and to maintain future 

knowledge of any improvements. 

2.  The “Shared Care Guideline for Oral Methotrexate in Rheumatological Conditions in 

Adults” was produced in September 2017. Since then, the “Pharmacy First” scheme 
has come into effect. The guidance, therefore, does not reflect the changes in the 
relevant responsibilities between secondary care, GPs and community pharmacists 
leading to ambiguity as to what type of healthcare professional a patient should 
consult and potentially fatal delay in increasing methotrexate or commencing treatment 
for toxicity for the same. 

The SCP was written in 2017, before the introduction of the Pharmacy First scheme, which expanded 
the role of community pharmacists in treating some minor conditions. 

The SCP clearly advises patients taking methotrexate to seek medical advice if they develop symptoms 
such as sore throat or mouth ulcers, as these can be signs of serious side effects. Patients are directed 
to contact their GP or specialist team, who are responsible for their ongoing care and monitoring. 

Community pharmacists are not part of the formal shared care arrangements for methotrexate 
prescribing and monitoring. While pharmacists play an important role in supporting patients, symptoms 
that may indicate methotrexate toxicity require assessment by the clinicians overseeing the patient’s 
treatment. 

As part of the planned review, NHS Greater Manchester will consider whether the guidelines could be 
clearer for patients about who to contact if they develop concerning symptoms.  

This learning relates particularly to the importance of clear communication and the timely recognition of 
immunosuppression and its potential effects. While methotrexate is widely and appropriately used, the 
case has reinforced how critical it is that signs of possible infection or toxicity are recognised early and 
acted upon, and that patients know who to contact for advice. 

Additionally, NHS GM has undertaken a review of the community pharmacy involvement in this case, in 
conjunction with NHS Cheshire & Merseyside ICB, where the community pharmacy involved is situated. 
We have linked with the regional pharmacy lead to share learnings and escalate to the national team 
regarding feedback on the pathway design for sore throat, and specifically around patients who are 
immunosuppressed. NHS GM is also liaising with the Community Pharmacy Greater Manchester 
(CPGM) to raise awareness across GM community pharmacies to share learning. This includes ensuring 

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 pharmacists delivering the Pharmacy First service are aware of local and national resources to support 
Pharmacy First consultations.  

We have raised issues presented in the PFD at the March GMMMG and CEG meetings and agreed to 
monitor progress of the improvements through the updates to the groups and the organisational risk 
register.   

The GMMMG and CEG are grateful for the improvement opportunities that have been identified and 
would like to formally acknowledge them, providing assurance that actions are being taken locally to 
address these areas. A review of the circumstances around out-of-date SCP was conducted and 
although the document had passed its scheduled review date, the clinical content remained aligned with 
current guidelines and standard clinical practice. Importantly, the patient was not managed under the 
SCP at the time of the incident, as they remained on a consultant-led titration regimen. It was concluded 
that the status of the SCP did not influence the patient’s care and did not contribute to the patient’s 
death. 

We believe there is a clear need to provide feedback to NHS England, as the commissioner of the 
Pharmacy First Service, to highlight the wider challenges associated with the delivery of the service.  
The PDF report review has identified that the patient should not have been managed through the 
Pharmacy First Service, as they did not meet the eligibility criteria for this service. This highlights the 
need for strengthened pathway exclusions and clearer safeguards to ensure that patients with complex 
clinical needs or specialist oversight requirements are appropriately identified and excluded from 
Pharmacy First pathways. 

We also recognise the need for further work with the Trust to better understand the Patient Information 
Leaflet (PIL) provided at the point of prescribing, including how it is selected, issued, and explained to 
patients. Ensuring that patients receive clear, accurate, and comprehensible information at the time of 
prescribing is an important additional safety net and may support earlier identification of risk or 
deterioration. NHS GM will be seeking assurance from providers that appropriate patient consultation is 
consistently undertaken when patients are commenced on new treatment.  

We consider that addressing these challenges at both national and provider levels could help prevent 
similar incidents in the future. In addition, we are planning to develop a local 7-minute briefing to share 
further learning and reinforce good practice across relevant teams. 

Thank you for bringing this matter to our attention.  

I trust this information is useful. Please contact me should you require further information. 

Best wishes 

Chief Medical Officer 
Caldicott Guardian  
NHS Greater Manchester 

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 References: 

•  Summary of Product Characteristics, Methotrexate 2.5mg Tablets, Accessed at 

https://www.medicines.org.uk/emc/product/9945/smpc  

•  The British Society For Rheumatology, BSR/BHPR guideline for disease-modifying anti-

rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists, 
2008, Accessed at: https://pubmed.ncbi.nlm.nih.gov/16940305/  

•  The British Society For Rheumatology, The 2025 British Society for Rheumatology guideline for 

the prescription and monitoring of conventional synthetic disease-modifying anti-rheumatic drugs, 
2025, Accessed at https://academic.oup.com/rheumatology/article/65/2/keaf522/8322743  

•  Visser K. Katchamart W., Loza E., et al., Multinational evidence-based recommendations for the 
use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating 
systematic literature research and expert opinion of a broad international panel of 
rheumatologists in the 3E Initiative, Ann Rheum Dis Diseases 2009 Jul;68(7):1086-93, Accessed 
at : https://pubmed.ncbi.nlm.nih.gov/19033291/  

•  Specialist Pharmacy Service, Methotrexate monitoring, July 2021 ( last updated Jan 2026), 

Accessed at: https://www.sps.nhs.uk/monitorings/methotrexate-monitoring/  

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