The Pharmaceutical Journal
Vol 278 No 7434 p46
13 January 2007

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Changing roles, changing risks — the paradox of pharmacist prescribing

By Anthony Cox and Sarah McDowell

In 1998, three-week-old Matthew Young ingested a preparation of peppermint water for colic, suffered a cardiac arrest and died. The death was a result of confusion between chloroform water in its dilute double-strength form (1:20) and concentrated chloroform water (1:1).

Since this extreme and rare consequence of an error in the dispensing of an extemporaneous preparation, there has been a significant decrease in the number of pharmacists willing to dispense extemporaneous preparations. Many are now sourced from specials manufacturers.¹ This move away from the traditional role of pharmacists reflects modern pharmacy practice, but may also reflect the need to avoid risk due to low levels of sufficient competencies in extemporaneous dispensing.

Errors that lead to criminal prosecution

Another concern that may be driving pharmacists away from extemporaneous dispensing is the possibility of criminal prosecution. The pharmacist and preregistration trainee involved in the peppermint water case were tried for manslaughter, although they were acquitted. This case was the first in 90 years, although the criminal prosecution of pharmacists following the deaths of patients is not a new occurrence.

In the 19th century, more pharmacists were charged with manslaughter than doctors.² Most of these cases were associated with errors in the preparation and dispensing of various medicines. For example, in 1849 a woman died from strychnine poisoning after a pharmacist mistakenly used the dose of strychnine — nine grains (583mg) — appropriate to the dose of salicine in making up a tonic. The pharmacist was charged with manslaughter but later acquitted. In a case from 1864, a man died after taking a medicine. The prescription called for six grains (389mg) of a powder, which was located only one bottle away from the strychnine on the pharmacist’s shelf. The pharmacist was charged with manslaughter but later acquitted.

Rise in prosecutions

Over the past century doctors have been more likely to be charged with manslaughter, and there has been a dramatic rise in prosecutions over the past two decades.³ Most of the cases involving medicines have related to the prescription or administration of the drugs (seven out of 35 were a result of prescribing errors).

For example, in 2001 a surgeon was charged with manslaughter following the death of a patient who had received three times the correct dose of local anaesthetic. The surgeon had failed to ascertain the man’s weight in order to calculate the amount of drug he should be given, and instead had “taken a guess”. The surgeon was acquitted. In the same year, a prison doctor was charged with manslaughter after a prisoner with a long history of heroin abuse died from a methadone overdose. The doctor was alleged to have prescribed too much methadone but was later acquitted by a jury.

Human error — lapses and mistakes

Errors are an inevitable concomitant of human activity.⁴ Most cases of pharmacists and doctors charged with manslaughter involved slips or lapses, which are errors in the execution of an action. These types of error are usually a result of distraction or momentary failure of concentration; they are not intentional. Slips and lapses cannot be prevented through increased vigilance or training.

Cases were also associated with mistakes, which are errors in the planning of an action that occur especially when a task is unfamiliar or when limited knowledge is available. Errors can occur in the prescription, the preparation and the administration of a drug, as illustrated by the cases of pharmacists and doctors charged with manslaughter.

Prescribing — a new role, a new risk?

Paradoxically, as the profession of pharmacy moves away from an area of perceived high risk, pharmacists are moving into the arguably more risky area of prescribing. Prescribing errors are potentially serious and likely to result in patient harm.⁵ Pharmacist prescribers will be prone to the same human cognitive failings as doctors. Although different skill sets, knowledge and areas of practice, specialisation and training may reduce the likelihood of some mistakes, there is also the possibility that different types of errors may evolve for new prescribing groups.

Pharmacists and other professionals taking up new prescribing roles should be aware of the risk of taking on criminal liability for a mere slip or lapse in their practice. Currently, a pharmacist can be charged with gross negligence manslaughter if he or she causes the death of patient. The negligence must be “so gross that it showed such a disregard for the life and safety of others as to amount to a crime against the state and conduct deserving punishment”. This definition was first used in 1925 in the appeal of a doctor charged with manslaughter and was later upheld in 1995 during the case of an anaesthetist convicted of gross negligence manslaughter.

However, recent legal changes proposed by the Government in the Road Safety Bill may change the definition of manslaughter due to negligence. The new law will introduce the offence of causing death by careless driving. A driver will be charged with the offence if his or her driving falls below the minimum acceptable standard. If the manner of driving is far below that which is expected, the driver will be charged with the existing offence of causing death by dangerous driving. The new offence has been criticised because it could make a person criminally liable for up to five years’ imprisonment for the sort of error anyone could make. Because this new offence requires no intent, only human error, this law may set a dangerous precedent whereby health care professionals could be criminally liable for mundane errors that unfortunately have fatal consequences.

Conclusions

The move away from traditional supply-based roles into non-medical prescribing requires that pharmacists accept new professional and legal responsibilities. It will also necessitate an assessment of the new risks involved, and how these risks will be managed. Although the NHS has been making attempts to lessen the blame culture and to develop a more open culture that can learn from errors, this needs to be balanced against the increasing risk of criminal prosecution. Organisations like the Royal Pharmaceutical Society, the British Medical Association and the Royal College of Nursing should be working together in order to create a climate in which the safety of patients is paramount.

References

1. Candlish CA, Worsley AJ, Zaman S. Do pharmacists extemporaneously dispense or do they use specials manufacturers? International Journal of Pharmacy Practice 2003;11(Suppl):R47
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2. McDowell SE, Coleman JJ, Ferner RE. Legal implications of medication errors: Charges of manslaughter against doctors and pharmacists in the UK from 1795 to 2005. Drug Safety 2006;10:962 [abstract].

3. Ferner RE, McDowell SE. Doctors charged with manslaughter in the course of medical practice, 1795–2005: a literature review. Journal of the Royal Society of Medicine 2006;99:309–14.

4. Reason J. Human error. New York: Cambridge University Press; 1990.

5. Dean B, Schachter M, Vincent C, Barber N. Prescribing errors in hospital inpatients: their incidence and clinical significance. Quality and Safety in Health Care 2002;11;340–4.