Decriminalisation of dispensing errors for pharmacists

Currently both the Royal Pharmaceutical Society of Great Britain’s Council and the Pharmacists’ Defence Association are pressing the government for an urgent change in legislation to decriminalise dispensing errors. At present under the Medicines Act 1968, pharmacists automatically commit a criminal offence each time they make a dispensing error or a labelling error.

Experts on medical safety all agree that this is a disproportionate response to human errors, making systems less safe. It leads to pharmaceutical practice becoming more defensive with errors driven underground. Consequently effective clinical governance and risk management is significantly affected.

The issue has once again been thrust into the spotlight following the case of Mrs Lee. In 2007, Mrs. Lee dispensed propranolol instead of prednisolone to 72-year-old lady, who later died.

The Courts were told that Mrs. Lee bore no legal or factual responsibility for Mrs. Sheller’s death. However, she was sentenced under terms of the 1968 Medicines Act that classified a dispensing error as a criminal offence.

Mrs Lee was eventually allowed to take voluntary erasure by the RPSGB and no disciplinary action was taken against her on the basis:

1. Her error had been extensively investigated, far more so than would have been done by the RPSGB.
2. There is a formal court finding.
3. Mrs. Lee had received far harsher punishment than anything that the Society could impose.
4. The case had received very wide publicity, far wider than anything that the RPSGB tends to organise for pharmacists that it has disciplined.
5. Permanent records exist for the entire proceedings and also formal correspondence on the matter with the Society.
6. Mrs. Lee had behaved in an open, honest and thoroughly professional way throughout.
7. After the experiences that she has undergone, she has no intention of returning to the practice.

The RPSGB is currently surveying pharmacists on its register to explore their views on recording dispensing errors in a dispensing error log. The early results show the outcome in the case of Mrs. Lee has made pharmacists reluctant to record dispensing errors with 42.8 per cent of pharmacists are now seriously concerned about recording dispensing errors. Pharmacists are torn between doing the right thing – recording and learning from mistakes – and the risk of incriminating themselves by making a record of a potential criminal offence.

It is evidence that a balance needs to be struck in maintaining public confidence in the pharmaceutical profession whilst recognising and addressing the ever present risks involved in dispensing. The PDA have highlighted that the increase in work attributed to the rise in prescriptions, coupled with the expansion of the pharmacists role, has not been matched with an increase in funding. This clearly raises issues both within the profession and a risk to patients.

The key issue in this scenario is whether this provisions in the Medicines Act are archaic and outdated with this area being better serviced by the regulator who understands profession and has a statutory function to maintain standards and protect patients.

by Deborah Nicholson, Richard Nelson Solicitors