Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the coming into force of the Preparation and Dispensing Errors (Registered Pharmacies) Order 2018 of the risk of pharmacists being prosecuted as a result of an inadvertent dispensing error.

There have been very few prosecutions in regard to preparation and dispensing errors made by pharmacists to date, and we expect the number to reduce even further. The fundamental premise on which this Order is based is that new defences for offences concerning dispensing errors will reduce the risk of prosecution, leading to an increase in the number of reported errors. Over time, learning from increased numbers of error reports is expected to lead to improvements in training and practices, which should reduce the number of errors made.

An Impact Assessment, published alongside the Order, records that there have only been three prosecutions by the Medicines and Healthcare products Regulatory Agency since 2003 and a similarly very low number by the Crown Prosecution Service and the Public Prosecution Service for Northern Ireland. No specific figure was given for the likely number of prosecutions in future, either for prosecution for the offences to which the defences relate or under the general criminal law. However, the Impact Assessment did seek to put a monetary value on the benefit from a reduced risk of prosecution and estimated a benefit to business of £565,770. The consultation responses supported this part of the analysis.

Whilst it is estimated this policy will result in a reduced risk of prosecution, in the most serious cases, for example where a dispensing error leads to the death of a patient, prosecution will continue to be possible under the general criminal law – for example for gross negligence manslaughter.