Chapter 2: Prescribing and administration of drugs and the deaths that resulted

By the time of the first reported allegations and complaints at the hospital, there was a wealth of published advice and guidance on the safe use of opioids and other drugs acting on the nervous system. The principles of the development and use of clinical guidelines – which may be published internationally, nationally or locally – were well established.

Guidelines are developed through an expert consensus process in which the clinical evidence for treatments is rigorously evaluated. They are invaluable as a reference framework in planning the care of individual patients. They are particularly important in guiding the practice of less experienced clinicians, although experts in particular areas of therapeutics will also use them to underpin their clinical decision making.

As mentioned in paragraph 2.13, the BNF is the authoritative national compendium of advice on drug therapy. It is published jointly by the British Medical Association and the Royal Pharmaceutical Society of Great Britain. The BNF is compiled under the direction of a committee of experts nominated by both organisations, who take additional specific expert advice when necessary. It covers the whole spectrum of therapeutics and is aimed at a broad clinical audience.

The BNF is updated every six months to reflect current practice, and the Department of Health and Social Care funds its distribution free of charge to professionals throughout the NHS and to final year medical and pharmacy students. It is the principal source of general guidance on good prescribing practice in the UK and also in many other countries, and is invariably the first port of call when health professionals wish to check a choice of drug, doses, drug interactions or other aspects of prescribing.

NHS organisations in the locality had adopted regional guidelines on the use of analgesics in palliative care by the time of the events at the hospital examined in this Report. The guidelines – The Palliative Care Handbook: Guidelines on clinical management – are sometimes referred to as the Wessex protocol or Wessex guidelines.¹⁶ They were originally compiled by palliative care clinicians in the Bath District Health Authority, but were subsequently adopted across the Wessex Region of the NHS, including by Portsmouth HealthCare NHS Trust and Gosport War Memorial Hospital.

The concept of the analgesic ‘ladder’ is important in pain management. This is an international guideline introduced by the World Health Organization (WHO) more than 30 years ago, following consensus discussions in response to evidence of poor management of cancer pain in both developing and developed countries. This approach, which has very wide currency, encourages the use of opioids in severe pain but in a logical, stepped process of escalating use of analgesics in response to patients’ symptoms.¹⁷

This approach is widely referred to as one of ‘start low and go slow’ with opioids. It is recommended in the Wessex guidelines. A recurrent criticism of opioid prescribing at Gosport War Memorial Hospital was the systemic failure to adopt the principles of the analgesic ‘ladder’.

Even if there had not been clear guidelines in place, health professionals would have remained subject to their individual responsibility to deliver safe and effective care. Early guidelines issued by the National Institute for Health and Clinical Excellence (NICE) reinforced this point through the following statement:¹⁸

The summary of product characteristics (SPC) is a public document prepared by the manufacturer or distributor of a medicine but agreed by the licensing authority (UK health ministers for medicines licensed in the UK or the European Commission for those licensed on a pan-European basis). The SPC contains information on the dosage, use and side effects of the medicine.

It is unlawful for a manufacturer or distributor to market a medicine anywhere in the European Union without the corresponding SPC and a marketing authorisation (product licence) from the relevant authority. Health professionals may, however, lawfully prescribe and administer an unlicensed medicine, or a licensed one for an unlicensed (‘off-label’) indication (therapeutic use) when this is clinically necessary for their patient. Because the use of unlicensed medicines is often not supported by clinical trials that have been evaluated by regulatory bodies, there is a particular responsibility on prescribers to ensure that such medicines are clinically necessary and used safely.

Accordingly, the third (1995) edition of The Palliative Care Handbook (the Wessex guidelines) notes:

The use of midazolam for terminal agitation was not covered by a marketing authorisation at the time of the events at the hospital, although it is now licensed for this indication in conjunction with an antipsychotic drug.²⁰ Palliative care professionals nevertheless recognised its use for this purpose as a valuable adjunct to end of life care in patients who needed it.

More recent NICE guidelines on strong opioids in palliative care²¹ state:

Guidelines play an increasingly important role in clinical decision making. Although adherence to guidelines is not mandatory, clinicians who, in a patient’s interest, diverge from agreed local or national guidelines should record the reasons for that decision, which they may have to defend if it results in harm to the patient. The Panel found that there were recurrent failures to record the clinical reasoning behind prescribing decisions at the hospital.