Inadvertent dispensing errors will no longer be considered a criminal offence across the UK under Government plans revealed earlier this month.

As well as considering inadvertent dispensing errors, the Government consultation (‘Rebalancing Medicines Legislation and Pharmacy Regulation’) also outlines proposals to publish pharmacy inspection reports, deal with breaches of premises standards through registration sanctions meted out by the General Pharmaceutical Council (GPhC), and make provision for the Pharmaceutical Society of Northern Ireland (PSNI) to set standards for registered pharmacy premises in the province.

As the law currently stands, all dispensing errors – regardless of the intent of the individual responsible and the level of impact on the patient – are deemed “strict liability offences” and therefore criminal acts. The change is intended to remove the fear of prosecution that pervades the pharmacy profession and therefore support increased reporting and learning from errors which, in turn, will lead to improved patient safety and better professional practice. Dispensing errors that occur as a result of wilful neglect or with the aim of causing deliberate harm will still be treated as criminal offences.

The proposals around pharmacy standards mark a move towards placing them in a more flexible framework in order to allow them to be reviewed and updated quickly, as and when needed. At the moment, pharmacy standards are set in legislation, which is by nature binding and hence timeconsuming to change. It also means that failure to meet set standards is currently dealt with by means of an enforcement notice, which in turn can lead to criminal or disqualification proceedings.

Big picture

The two draft orders are being made under Section 60 of the Health Act 1999 and will be laid before the Scottish Parliament as well as the UK Parliament once submissions to the 13- week consultation have been analysed, published and any necessary alterations made. The resulting changes will apply across all four UK countries, and will give the GPhC and PSNI – rather than the criminal justice system – the power to deal with matters that have long been considered the remit of regulators.

The work is part of broader rebalancing plans that aim to protect, promote and improve pharmacy services while reducing and removing barriers that impede practice development, and is informed by the efforts of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, which includes representatives from pharmacy and healthcare organisations. An expert advisory group provides insight to the board on changes considered necessary to the regulation of hospital pharmacy. 

Dispensing errors and registered pharmacy standards are the first two areas that the rebalancing programme is trying to tackle. Future work, mentioned in the consultation document, includes:

• Changes to the legislative and regulatory framework relating to pharmacy owners, superintendent pharmacists and responsible pharmacists
• Looking at hospital pharmacy regulation, with the aim of removing criminal sanctions for dispensing errors made by pharmacy professionals working in the sector
• An overhaul of the legislation relating to pharmacist supervision, in order to make full use of the skills of the pharmacy workforce and modern technology while also maintaining patient and public safety.

Have your say

“This is a really important moment in time for pharmacy,” says RPS president Ash Soni, who urges pharmacists to sit up and take notice. A good place to start, he says, is the FAQ document, which is also the place to access the consultation and impact assessment papers. Mr Soni also strongly advises pharmacy professionals to attend one of the many workshops being held around the UK throughout March by organisations including the Department of Health, Royal Pharmaceutical Society, National Pharmacy Association and Association of Pharmacy Technicians UK, or to join the Twitter event being held on March 5 at 8pm.

More details are available at the previously mentioned webpage. Finally, individual as well as organisational responses to the consultation are welcome, and can be submitted online. The deadline for submissions is May 14.

• For more information, email MB-Rebalancing >21@dh.gsi.gov.uk or telephone 020 7210 4850.