by Ms Victoria Steele
The National Pharmacy Association (NPA) has warned that medicine shortages in the UK are now among the most severe ever experienced, with a record number of shortages in recent months for commonly dispensed medicines.
Serious Shortage Protocols (SSPs) for medicines including Creon, used by patients with pancreatic cancer and cystic fibrosis, and Estradot, a commonly prescribed hormone replacement therapy (HRT) preparation, have now been in place for record periods. The NPA says shortages are becoming more frequent, lasting longer and posing a serious risk to patient safety.
The issue is also receiving attention in the national and healthcare press, with coverage focusing not only on the scale and duration of the shortages, but also on the potential implications for patient safety.
A number of coroners inquests have now referred to medicine shortages in their findings, identifying either the inability to commence treatment because of a lack of available medication, or interruptions to a consistent supply of medicines, as significant contributory factors. Coroners have also highlighted the importance of having clear and robust systems in place to manage medicine shortages when they arise.
Coverage
The Times
The Guardian
The Telegraph
Medico-legal implications of medicine shortages
Medicine shortages are rarely the fault of individual clinicians. Global supply chains, manufacturing difficulties, geopolitical events and fluctuations in demand are often outside the control of GPs, pharmacists and hospital specialists.
However, shortages may nevertheless raise important medico-legal questions.
If a patient suffers harm after being unable to access medication, expert evidence may be required to consider issues such as:
- whether clinicians responded appropriately once a shortage became apparent;
- whether reasonable alternatives were considered;
- whether communication between pharmacists, GPs and specialist teams was timely and effective;
- whether national guidance or Serious Shortage Protocols were followed; and
- whether any harm could realistically have been avoided.
- Whether there is sufficient documentation to evidence all of the above points
As healthcare professionals face increasing pressure to manage medicine shortages, courts and regulators may increasingly be asked not whether the shortage itself was negligent, but whether the clinical response to the shortage met the standard expected of a reasonably competent practitioner.
In England, NHS pharmacies are required to supply prescriptions within a reasonable timeframe. However, recent reports suggest that one in eight patients experience difficulty obtaining their medication within 3-4 days, with approximately 10% of patients waiting up to a week
Healthcare professionals must continue to adhere to the standards expected by their professional regulators and work collaboratively across primary and secondary care to achieve the best outcomes for patients. In primary care, it is particularly important to maintain clear evidence of collaborative and professional communication with other healthcare professionals, documenting the discussions and the medical considerations relevant to each patient.
Best practice in community pharmacy includes appointing a designated lead for medicine shortages, maintaining up-to-date contact details for wholesalers, local pharmacies and GP practices, and ensuring that staff are able to explain clearly:
- The nature of the shortage
- How long this issue is likely to continue,
- What alternative treatments or options are available; and
- Who is affected.
Ms Victoria Steele
Victoria Steele is a Director of Clinical Governance & Superintendent Pharmacist (BPharm (hons) FRCPharm) and expert witness at McCollum Consultants.
Victoria Steele is a highly experienced pharmacist and clinical governance leader with more than 25 years’ experience across community, primary and secondary care pharmacy.
She has extensive medico-legal experience in cases involving dispensing and prescribing errors, clinical negligence, risk management and safeguarding, acting for both claimant and defendant law firms.
To Instruct Victoria, please contact us on:
t: +44 (0)161 218 0223
e: info@exp-w.com