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

A number of statutes and policies govern the prescribing and administration of drugs in NHS hospitals. These are: the Medicines Act 1968 and its secondary legislation (more recently the Human Medicines Regulations 2012); the Misuse of Drugs Act 1971 and its regulations; and Department of Health and Social Care and local NHS guidance. Strictly speaking, hospitals are exempt from many elements of medicines legislation – for example, the legal concept of a ‘prescription-only medicine’ applies only in the wider community and not in hospitals. Nevertheless, a body of good practice and guidance has accrued over many years from successive governments and professional bodies that requires NHS hospitals to adhere to the spirit of the legislation in order to protect patients and the wider public interest.

Drugs prescribed for inpatients are written on forms designed specifically for this purpose, often referred to as drug charts. More recently, many hospitals have developed systems of electronic prescribing, but paper-based systems were used almost universally in the 1990s.

Hospitals or groups of hospitals design and source charts to meet their own requirements, including those of specialised units within hospitals. There is no ‘national drug chart’. However, drug charts have evolved over many years to embody good prescribing and recording practice. They follow similar principles and have similar layouts.

Drug charts are filed with each patient’s clinical records. They are both an essential working tool for prescribing and monitoring drug treatment during a patient’s stay, and an important historical record of that treatment, which may be valuable in further episodes of care. When patients are discharged to home or residential care, a ‘to take out’ prescription is usually written. Details of this are included in the discharge summary sent to the patient’s GP, and the drug charts are then archived with other clinical records for that patient. A summary of the drug chart would also accompany the patient if he/she was transferred between hospitals, for example from Queen Alexandra Hospital or Royal Hospital Haslar to Gosport War Memorial Hospital.

A drug chart nearly always has three distinct components, which reflect the three main ways in which drugs are prescribed in hospitals: drugs to be given regularly; drugs to be given when required; and drugs to be given once only. Drugs given regularly comprise the majority of hospital prescribing. The chart records the name and dose of the drug, its route of administration and the times when it is to be given.

In most circumstances, the dose of the drug is fixed and not left to the discretion of the nurse. On occasions some flexibility in dosage is prescribed to allow for changing clinical needs, for example with analgesics or night sedatives. The name of the prescriber is recorded and any subsequent changes (for example, to the dose) are also recorded and signed or initialled by the prescriber. An important feature of a drug chart is that the person administering the drug records the date and time of every dose. This provides a comprehensive record of the patient’s treatment. Instances where the drug is not given are also captured.

Drugs to be given on an ‘as required’ basis are recorded in a separate area of the chart. They are often still referred to as ‘PRN’ medications, an abbreviation of the formerly used Latin term pro re nata (as circumstances require). The prescriber again records the drug, dose, route of administration and frequency of dosing. The decision to administer the PRN therapy is then left to the discretion of nursing staff responsible for that patient. Any changes to the prescription are recorded and signed or initialled, and the date and time of each dose is recorded.

This is an example of ‘anticipatory prescribing’; that is, prescribing a drug in advance to meet a possible future clinical need. Anticipatory prescribing is now well established in palliative care medicine and there is an extensive body of literature on its safe and effective use to benefit patients. However, its use was not well established in the 1990s. At the heart of the families’ concerns are the scale and extent of this practice at the hospital; the dose ranges prescribed; the degree of delegation to nurses to start treatment and increase doses; and the dangers inherent in this practice.

Drugs that are given only once are recorded in the third part of the drug chart. These might include, for example, a single dose of a drug to treat an epileptic fit, or a dose of a tranquilliser to settle a disturbed patient.

The records show that the drug charts in use at the hospital reflected the principles and design outlined above. In addition to the detailed records created in the drug charts, notes of the initiation of drug treatment and/or any changes were usually made in the narrative recorded in the clinical notes and the separate nursing notes.

For controlled drugs such as diamorphine there was an additional set of records. All hospital wards and departments are required to keep a controlled drug register. This is a hardback book (electronic registers are also now permitted in some settings) with separate sections for each drug and dosage form. All controlled drugs received by the ward must be entered, and every dose administered to a patient and the name of the person giving it (as well as any wastage) is also recorded. A running balance is maintained so that any discrepancies or diversion of controlled drugs can be readily identified.

There are therefore four discrete sources of information on the drugs given to individual patients at the hospital. The Panel has found that, from the data it has been able to access, one or more of these sources is often incomplete or missing altogether. But wherever possible, all these sources have been used in the analysis.

Panel members, supported by expert nurses recruited for the purpose, have reviewed the clinical records of the Initial Group of patients and the Wider Group of patients (see paragraphs 2.3 and 2.4).

The Panel considered 45 questions as part of the drug analysis. These were answered by reviewing the contemporaneous clinical and nursing notes, along with those drug charts and controlled drug registers that were available. The Panel addressed the questions for all 163 patients in the Initial Group of patients and 30 patients in the Wider Group of patients, as described in Appendix 1.

The Panel was concerned by the use of opioids at the hospital – as were some experts whose work will be covered in later chapters of this Report. The Panel’s analysis was independent of those earlier expert reports. Indeed, the Panel decided not to consider the earlier expert witness statements until it had completed its own clinical analysis.

The nature of what the Panel found can be seen in Table 1, which summarises the treatment and cause of death of the Initial Group of patients. This is published with the permission of the families.