Man’s death linked to Tegretol shortages; Epilepsy Society calls for supply chain review

The deceased, who had epilepsy, was left without his prescribed medication on two occasions as his pharmacy was unable to supply it   

The Epilepsy Society has called on health secretary Wes Streeting to initiate a comprehensive review of the medicine supply chain following the tragic death of a 44-year-old man with epilepsy, who was left without his essential anti-seizure medication.

David Joseph Crompton from Yorkshire died on December 13 after falling down the stairs, reportedly due to a lack of access to his prescribed Tegretol (carbamazepine).

An inquest revealed that Midway Pharmacy in Pudsey had issued an 'IOU' for his prescribed medication - as they were unable to supply it.

West Yorkshire senior coroner Kevin McLoughlin reported that Crompton was left without Tegretol on two occasions.

The first incident occurred in April 2024, leaving him without the medication for approximately ten days, which led to a fall.

The second, fatal fall happened in December after the pharmacy had “left a manuscript ‘IOU’ in relation to Tegretol at his home when other medicines were delivered,” said the coroner.

The inquest concluded that Crompton’s death was caused by hypoxic ischaemic encephalopathy (brain damage due to lack of oxygen), cardiac arrest, a spinal injury from the fall, and epilepsy.

“Without his medication his epileptic condition was likely to destabilise and give rise to fits,” the coroner said.

Both the pharmacy involved and the General Pharmaceutical Council have been notified and are required to respond by February 27 with proposed actions or explanations for inaction.

The Epilepsy Society stated that Crompton’s death has added urgency to their call for a full review of the medicines supply chain.

In a letter to Streeting, Epilepsy Society chief executive Clare Pelham highlighted the critical need to resolve global supply chain complexities swiftly to prevent another family from experiencing a tragic bereavement.

Pelham stated, “This is not a request for additional funding. It can be tackled with a handful of people applying their skills and expertise. The Epilepsy Society stands ready to help-as I know do many others.”

Addressing medicine shortages

The government has confirmed its commitment to consider an independent review of the medicines supply chain in its response to the Health and Social Care Committee’s pharmacy inquiry report.

Considering the impact that shortages are having, the Committee recommended that the review should be commissioned as soon as possible and completed within six months of starting.

The government stated that a range of actions are being taken to improve to mitigate and manage shortages and strengthen resilience. However, it emphasised that medicine shortages are a complex and global issue, requiring involvement of everyone in the supply chain in addressing them.

The Committee had recommended that the government review the effectiveness of Serious Shortage Protocols (SSPs), with a focus on their timing and their administrative burden.

The government partially accepted the recommendation, noting that it will keep this policy under review.

It acknowledges that an SSP enables community pharmacists to supply “a specified medicine or device in accordance with a protocol rather than a prescription, with the patient’s consent and without needing to seek authorisation from the prescriber.”

“The administrative burden on pharmacy contractors of SSPs is balanced with the need to find an alternative way of dealing with the shortage each time an SSP is developed,” it adds.

Another recommendation from the Committee was to ensure that regulations are updated within three months to allow pharmacists in community settings to make dose and formulation substitutions for out-of-stock items, subject to the safeguards set out in the Royal Pharmaceutical Society’s Medicines Shortage Policy.

The government expressed concerns that allowing pharmacists to take local action to alter prescriptions and supply an alternative without an SSP in place and without the full oversight from  the DHSC Medicines Supply Team could have “the effect of creating a ‘knock-on’ shortage of the alternative and could thereby have the potential to exacerbate rather than mitigate a supply problem.”

However, it recognised there may be occasions where it is appropriate to enable further flexibility to supply an alternative dose or formulation to what was prescribed without going back to the prescriber.

The government added that it is currently exploring options with stakeholders to assess where and how this could be appropriate, and how any associated risks could be managed.

Nevertheless, the government rejected the recommendation for allowing generic substitution for out-of-stock medication, citing potential impacts on patient safety.

The government clarified that the Human Medicines Regulations 2012 (HMRs 2012) require pharmacists to dispense “in accordance with a prescription” and 81 per cent of all drugs in primary care are already prescribed generically.

It also acknowledged that there could be “good clinical reasons” why a patient must be maintained on a specific manufacturer’s product, such as issues of bioequivalence (e.g. anti-epileptics) or cases where patients suffer from side effects or are allergic to a particular excipient.

The All-Party Parliamentary Group (APPG) on Pharmacy recently launched an inquiry into the ongoing issue of medicines shortages in England, calling for written evidence from key stakeholders across the healthcare sector, including pharmacists and pharmacy teams.