Chapter 2: Prescribing and administration of drugs and the deaths that resulted
Summary of guidance in place at the time
By the time of the events at the hospital examined in this Report, the principles of safe and effective use of opioids, midazolam and other drugs in both palliative and non-palliative care were therefore clearly set out in authoritative international and national guidance. They were also reflected in local guidance issued in the Wessex Region of the NHS. This had been adopted by Portsmouth Hospitals NHS Trust, which provided medicines and associated pharmacy services to Gosport War Memorial Hospital (HCO111155).
The 1997 BNF does not make explicit reference to the WHO analgesic ‘ladder’, but its principles are implicit:
“The non-opioid analgesics aspirin or paracetamol given regularly will often make the use of opioids unnecessary … Morphine is the most useful opioid analgesic … morphine is given by mouth as an oral solution every 4 hours, the initial dose depending largely on the patient’s previous treatment … A dose of 5-10 mg is enough to replace a weaker analgesic … if the first dose of morphine is no more effective than the previous analgesic it should be increased by 50%, the aim being to choose the lowest dose which prevents pain … the equivalent intramuscular (or subcutaneous) dose of diamorphine is only about a quarter to a third of the oral dose of morphine; subcutaneous infusion via syringe driver can be useful.”
It also states that older people, especially the very old, require special care and consideration from prescribers. The 1998 edition of The Palliative Care Handbook (the Wessex guidelines) states: “The WHO analgesic ladder has been adopted to emphasise that it is essential to use an analgesic which is appropriate to the severity of the pain.” It then sets out clearly the three-step approach. Step one uses non-opioid analgesics – paracetamol or non-steroidal inflammatory drugs such as ibuprofen, diclofenac or naproxen. Step two uses weak opioids such as codeine, co-codamol (a combination of codeine and paracetamol) or dihydrocodeine. Step three introduces strong opioids – morphine, diamorphine and fentanyl.
The handbook stresses that accurate and full assessment is essential for both diagnosis and treatment; that appropriate therapies should be used to maintain the best possible quality of life and maximum independence for patients; that patients should be continually reassessed; and that care should be taken that drug side effects do not become worse than the initial problem. When opioids are given, the guidance recommends using continuing pain as an indication to increase the dose, and persistent side effects such as drowsiness, confusion or vomiting as an indication to reduce the dose.
Oral morphine (tablets or liquid) is recommended in a low starting dose of 5 mg every four hours, increasing by 30–50% each day until pain is controlled or side effects prevent further increases. The guidance indicates that only a minority of patients (and this is aimed at people in end of life care) will need more than 30 mg every four hours (equivalent to 60 mg of infused diamorphine per 24 hours). Diamorphine by continuous infusion using a syringe driver is suggested when patients cannot take oral medicines because of dysphagia (difficulty swallowing), vomiting or weakness.
There is no suggestion in the guidance that opioids should be used to treat anxiety, confusion or terminal restlessness. In fact, the sections on confusion and terminal restlessness clearly list opioids as a cause or risk factor, particularly when exacerbated by renal failure.
Pharmacy services at the hospital
Portsmouth Hospitals NHS Trust, the local acute hospital, provided pharmacy services to Gosport War Memorial Hospital under a service level agreement (DOH800198, pp1–21). This included the procurement and supply of medicines required at the hospital, together with advice on their use, security and custody. A senior pharmacist managed the contract and a second pharmacist provided the service. These arrangements appear broadly to have followed standard NHS pharmacy practices for remote non-acute hospitals at the time.
Portsmouth Hospitals NHS Trust and its chief pharmacist therefore had overall responsibility for pharmacy services at Gosport War Memorial Hospital. The chief pharmacist was responsible for oversight of the procurement, control, storage and distribution of drugs for all Portsmouth hospitals; ensuring that there were procedures in place to maintain adequate and safe drug stocks in each ward area; and checking that drugs were stored securely.
The chief pharmacist was also responsible for: ensuring that advice and support was provided to ward staff; training and development of the hospital’s pharmacists; and, with the support of clinical staff and the Drugs and Therapeutics Committee, ensuring that prescribing guidelines were adhered to and that the drug charts being used in the hospital (see paragraphs 2.81 to 2.89) were fit for purpose, safe and in line with national policy and guidance.
The Trust had a Drugs and Therapeutics Committee, of which the chief pharmacist was a key member. The committee had broad oversight of prescribing policy and practice, including the appropriateness and affordability of new drugs introduced in the hospital.
Up until about 1994, the hospital had its own pharmacy department located within the outpatients department on the main hospital site. It had been well established for many years and was staffed several days per week by a pharmacist from Portsmouth Hospitals NHS Trust who made ward visits throughout the hospital, including checks on controlled drugs. This facility was removed in the redevelopment and the on-site pharmacy was replaced by the remote service from Portsmouth.
Portsmouth Hospitals NHS Trust subsequently supplied medicines direct to wards at the hospital in locked boxes, against signed orders from a senior nurse on each ward. In line with universal good practice in the NHS, there was an additional system for signed orders, secure transit, and signed handover and receipt of controlled drugs on the wards.
Pharmacist visits to the hospital continued twice a week and included checks on ward stocks and examinations of patients’ drug charts. The system was primarily aimed at maintaining adequate supplies, but there was also a mechanism for raising concerns. The community services pharmacist for the hospital, said:
“Daedalus ward would have been visited on a Thursday and that visit involves looking through the medical charts and checking for supplies and just generally checking whether things are appropriate … as I go through the charts I would also check for relevance of the medicines that are prescribed.” (HCO109728, p2)
The route for raising concerns was via the senior nurse to the clinical assistant or consultant. There was no systematic process for review of prescribing (HCO109728, p4). In the report of its investigation into the hospital and Portsmouth Hospitals NHS Trust, the Commission for Health Improvement (CHI) described:
“… a remote relationship between the community hospitals and the main pharmacy department at Queen Alexandra Hospital … There were no systems in place in 1998 for the routine review of pharmacy data which could have alerted the trust to any unusual or excessive patterns of prescribing although the prescribing data was available for analysis … it is clear that had adequate checking mechanisms existed in the trust, this level of prescribing would have been questioned.” (CQC100951, p33)
The CHI report, using the Trust’s own medicines usage data, noted the excessive use of diamorphine and midazolam, which reached a peak in 1998/99. Over that period, Dryad, Daedalus and Sultan wards used 1,617 doses of diamorphine and 1,680 doses of midazolam. With a patient population that was in the main not admitted for palliative or end of life care, this was clearly excessive. Even superficial monitoring of pharmacy data should have sounded alarm bells.