Drugs: Labelling

(asked on 15th July 2015) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what plans he has to amend section 85 of the Medicines Act 1968, as it relates to medicines labelling, in legislation to decriminalise errors made by pharmacists.


Answered by
Alistair Burt Portrait
Alistair Burt
This question was answered on 22nd July 2015

The programme board for “rebalancing” medicines legislation and pharmacy regulation is tasked with examining the respective scope of legislation and regulation, and the interface between them, with a view to ensuring these are optimally designed to provide safety for users of pharmacy services, while facilitating and reducing the barriers to responsible development of practice, innovation and a systematic approach to quality in pharmacy. Members of the board, from across the United Kingdom, include representatives from the pharmacy regulators, the professional bodies for pharmacists and pharmacy technicians, pharmacy owners, pharmacists and pharmacy technicians from the various sectors of practice and patients and the public.

A UK wide consultation, issued on behalf of the four UK Health Departments, ran from 12 February to 14 May 2015. It sought comments and views on two pharmacy related draft Orders being made under the powers in section 60 of the Health Act 1999. The two pharmacy-related draft Orders are:

- The Pharmacy (Preparation and Dispensing Errors) Order 2015

- The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2015

The responses to the consultation were supportive of the proposals and included many from individual pharmacy professionals (registered pharmacists and registered pharmacy technicians), as well as pharmacy representative bodies, health organisations, patients and the public and others. A report will be published in due course and recommendations made to ministers on next steps.

While retaining the criminal sanction the draft section 60 Order entitled ‘The Pharmacy (Preparation and Dispensing Errors) Order 2015’ provides:

- a defence to prosecution under section 63 (adulteration of medicinal products) of the Medicines Act 1968, in cases of errors where medicines are prepared by a registered pharmacist or a registered pharmacy technician, or under the supervision of a registered pharmacist;

- a defence to prosecution under section 64 (medicinal products not of the nature or quality ordered) of the Medicines Act 1968, in cases of errors where medicines are dispensed by a registered pharmacist or registered pharmacy technician, or under the supervision of a registered pharmacist; and

- the conditions to be met if the new defences are to apply.

Criminal sanctions will remain in place for dispensing errors falling outside the proposed defences, for example, where pharmacy professionals do not act in the course of their profession by using their professional skills for an improper purpose or deliberately failing to have due regard for patient safety. General criminal law may also apply.

A draft impact assessment was published alongside the consultation on dispensing errors. This will be updated, taking account of the consultation responses.

There was an error made in the transposition of section 85 of the Medicines Act 1968 in part into regulation 269 of the Human Medicines Regulations 2012 during consolidation of medicines legislation. A legislative amendment has now been made, which came into force on 1 July 2015, to restore the effect of the original provisions which existed in section 85(5) of Medicines Act 1968, such that the labelling offence applies to businesses and not individuals, such as pharmacists and pharmacy technicians.

Reticulating Splines