Alan Crabtree: Prevention of future deaths report 

He was admitted to Macclesfield Hospital on 18 February 2025 as a result of the symptoms of methotrexate induced pancytopenia and was treated for these.

Despite treatment, due to his compromised immune system, he developed pneumonia and died on 1 March 2025

Issues
The issues explored during this inquest related to the dosage range of Methotrexate for treatment of adult patients with rheumatological conditions and the guidance provided to patients as to what actions they should take if they develop signs of Methotrexate toxicity such as sore throat, mouth ulcers and difficulty swallowing; specifically who should they seek advice from in those circumstances. 

As part of the exploration of these issues, evidence was heard in respect of the available local and national guidelines and protocols to assist clinicians in these particular areas including the Shared Care Guideline for Oral Methotrexate in Rheumatological Conditions in Adults (“The Shared Care Protocol”) which was produced by the GMMMG dated 14 September 2017 which was due for renewal on 19 October 2020. According to the evidence at Inquest, this guideline has not been updated since 2017 and remains in place today. 

There are two aspects of the Shared Care Protocol that were revealed as causing potential issues in the course of the evidence at the inquest:

1.  During the inquest, evidence was heard that the dose range referred to within the Shared Care Protocol of 5-15mg for an initial dose, titrated up to maintenance dose of 20-25mg does not reflect current practice; the evidence was that in practice the low dose of 5mg is not routinely prescribed, and is rarely used in clinical practice in rheumatology as it would be considered sub therapeutic. Furthermore, the Shared Care Protocol does not provide any guidance in respect of when doses should be adjusted and factors to take into account to assist clinical decision making when advising on the appropriate starting dose. The suggested dose titration also
requires review to ensure patients reach target dose in a timely manner. The guidelines do not appeared to have recently been reviewed to ensure that they in line with current accepted practice and other national guidance available.

2.  In Mr Crabtree’s case, the family sought advice from a Community Pharmacist when he displayed symptoms of a sore throat, mouth ulcers and difficulty swallowing and treatment was provided as part of the Pharmacy First Scheme.  The concern raised during the inquest was the potentially ambiguous use of term “medical attention” in section 14 which reads:

“Patients should be advised to seek medical attention for the following:
Patient should report all symptoms and signs suggestive of blood disorders
(eg sore throat, bruising and mouth ulcers)

Patients should report all symptoms and signs suggestive of liver toxicity
(eg nausea, vomiting, abdominal discomfort, dark urine and jaundice)
Patient should report any upper abdominal pain as this is an indicator of
development of pancreatis “The Shared Care Protocol was drafted prior to the introduction of the Pharmacy First Scheme and the expanded role of Community Pharmacists which patients may consider could form part of “medical attention”.  This is also not in line with the Arthritis UK Patient Information Leaflet which states patients should inform their “doctor or nurse specialist” if they have signs of a sore throat and/or sores in the mouth.

The Shared Care Protocol is not clear to patients who they should be seeking advice from to ensure they obtain the appropriate care and treatment and as currently drafted does not reference to the expectations surrounding Community Pharmacists under the Pharmacy First Scheme.

The MATTERS OF CONCERN are as follows: (brief summary of matters of 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.

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 ceasing methotrexate or commencing treatment for toxicity for the same.

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