Guidance on interpreting the law relating to dispensing errors, published by the Crown Prosecution Service this week, completely misses the point, according to Joy Wingfield, special professor of pharmacy law and ethics at the University of Nottingham.
The long-awaited guidance sets out how prosecutors should handle dispensing errors pending possible changes to the law that are not expected to come into effect before 2012 following a review of the Medicines Act 1968.
The guidance highlights the rarity of prosecutions under the Medicines Act and the importance of pharmacists recording and reporting dispensing errors. It also sets out points that prosecutors should consider when deciding whether a prosecution is required in the public interest (see Panel).
Panel: What the guidance says
The guidance explains the defences that are available for contraventions of sections 64 (supply of wrong product) and 85.5 (supply of product with misleading label) of the Act.
“To protect the public, a balance needs to be struck between prosecution and incident reporting,” the guidance states. It adds that the routine prosecution of pharmacists for simple dispensing errors would discourage error recording and reporting and adversely affect patient safety.
The guidance explains that prosecutors will usually apply the “full code test” when making decisions. This test has two stages: the evidential stage and the public interest stage. When the evidential stage is met, ie, the prosecutor is satisfied that there is sufficient evidence to provide a realistic prospect of conviction, the prosecutor must go on to consider whether a prosecution is required in the public interest.
The CPS guidance says that, when applying the public interest factors in the code, prosecutors should consider the following points:
- Culpability of those involved in the error
- Seriousness of the error
- Consequences of the error
- Actions of those involved in the incident
- Evidence of other errors
- Regulatory or remedial action taken or likely to be taken against the individual
However, Professor Wingfield told The Journal that the guidance adds little to current interpretation by the CPS and does not remove the threat of prosecution under section 64 of the Medicines Act for self-reporting of dispensing errors. She believes that the public interest would be better served if community pharmacists reported all dispensing errors, and possibly near misses, to a centralised and confidential reporting database without fear of prosecution.
Professor Wingfield argues that errors should first be considered by the pharmacy regulator together with the CPS and the Department of Health using criteria already established for fitness-to-practise referral. “Only where there is prima facie evidence of negligent, reckless or intentional commission of an error should a charge of gross negligence manslaughter be considered,” she said.
The Pharmacists’ Defence Association also believes that the CPS guidance does not go far enough and said that there is nothing within it that would prevent a similar situation to that of Elizabeth Lee arising again. PDA chairman Mark Koziol said that it offers no more than non-obligatory general guidance. The PDA intends to issue advice to its members when it has considered the full implications with its lawyers.
Royal Pharmaceutical Society President Steve Churton said that the guidance is an important step towards protecting pharmacists from prosecution for single dispensing errors. However, he added:“Greater clarity is needed on how [the public interest factors] will be considered, and the consistency with which they will be applied, but the guidance is moving in the right direction.”
He said that the Society is pushing for immediate amendment to the Medicines Act to begin the process of decriminalisation.