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Medicines shortages cost lives
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Richard Hough and Thorrun Govind provide an update on recent Prevention of Future Deaths (PFD) reports which have been linked to medicines shortages - which have been the cause of tragic deaths…
Medicine shortages are a critical global issue which adversely impact patient care and public health.
These shortages can delay procedures, compromise drug therapy, and increase medication errors. Shortages stem from manufacturing problems, supply chain disruptions and economic challenges.
Production delays, natural disasters, geopolitical events and logistical challenges pose a further threat to the already fragile medicines supply chain.
Tragically, such sorry state of affairs has a human cost, which pharmacy teams encounter every day. In March 2023, the PDA reported that 81 per cent of pharmacists whom they surveyed had experienced patients taking their frustration about medicines unavailability out on them.
The NHS terms of service require pharmacies to dispense medications with "reasonable promptness" to ensure patients receive their prescribed treatments without unnecessary delays.
However, the lack of available information regarding medicines shortages continues to cause pressure on pharmacy teams and impact morale. Many pharmacists report ordering medicines promptly and then only receive notification when the medication does not come in.
The impact of medicine shortages is extensive: patients face delays in receiving essential medicines, leading to worsened health outcomes. Shortages also drive up the cost of alternatives and burden healthcare systems while substitutions can increase the risk of errors.
Serious Shortage Protocols (SSPs) allow the Secretary of State for Health and Social Care to consult with medical experts, and to issue an SSP.
Although legislation permits the issuing of SSPs from 1st July 2019, an SSP will only be considered and issued if there is a serious shortage of a specific medicine.
This results in substitutions and quantity amendments that pharmacists are able to legally fulfil. The problem is that by the time a SSP has been issued, it is often far too late.
The recent inquests into the deaths of David Crompton, Ava Hodgkinson and Charlie Marriage highlight the urgent need for further solutions.
Inquests
An inquest is a judicial inquiry which is conducted to determine the cause of a person's death, particularly when the death is sudden, unexplained, or occurred under suspicious circumstances.
They are typically conducted by a coroner and may involve a jury. The purpose of an inquest is not to assign blame but to establish the facts surrounding the death.
The findings of an inquest can lead to concerns being raised with the aim of preventing future deaths. This in the form of a PFD report, also known as a Regulation 28 report, which is issued by a coroner.
Under Paragraph 7 of Schedule 5 of the Coroners and Justice Act 2009, coroners have a duty to send PFD reports to relevant persons or organisations.
The reports highlight concerns which have been identified during the inquest and their aim is to improve public health, welfare and safety by preventing similar incidents from occurring in the future.
Recent cases linked to medicines shortages
The following three cases have been considered in January 2025 and resulted in a PFD report.
David Crompton, a 44-year-old man with epilepsy, died after a fall that was linked to a shortage of his anti-epileptic medication, Tegretol.
On two occasions, his pharmacy was unable to supply the medication, which led to destabilisation of his condition and ultimately contributed to his fatal fall. The General Pharmaceutical Council will respond to the PFD report.
Ava Grace Hodgkinson, a 2-year-old girl, died from overwhelming sepsis caused by a Group A Streptococcus infection. The pharmacy did not have the prescribed strength of amoxicillin (250mg/5ml) in stock but did have a lower strength (125mg/5ml).
However, current restrictions prevented the pharmacist from issuing the lower strength without an amended prescription, leading to a delay in Ava receiving antibiotics.
The Department for Health and Social Care (DHSC) had not issued a SSP which would have allowed the pharmacist to dispense the correct total dose in a different dose form. The DHSC will respond to the PFD report.
Charlie Marriage, 32, suffered a fatal seizure during the pandemic on 26th June 2021 after he ran out of medication to manage his epilepsy.
It followed a two-day battle to get hold of Fycompa 8mg tablets via his GP, NHS 111, and a pharmacy. NHS England will respond to the coroner’s PFD report.
All these cases emphasise the critical role that pharmacists play in ensuring timely access to medicines and the need for urgent systemic changes to prevent such tragedies.
Community pharmacists have long been campaigning to be allowed to make the same changes to prescriptions as their hospital colleagues.
This is even more important in order to ensure that prescribers’ time isn’t wasted making minor but critically important changes to prescriptions.
We await the PFD report responses from the various organisations and action by the government.
Richard Hough is a partner and head of healthcare at Brabners LLP and a former pharmacist. His co-author Thorrun Govind is a solicitor at Brabners, a pharmacist and TV health expert.