In December 2004 the Department of Health issued a consultation paper, Making the best use of the pharmacy workforce, which outlined proposals for changes to the personal control and supervision requirements that govern the preparation, sale and supply of medicines from registered pharmacy premises. The purpose of the consultation was to establish ways of providing a more flexible basis for the development of pharmacy services, to allow pharmacists and pharmacies to make the best use of available skills and improve the public’s access to medicines. These aims support the Government’s wider health policy of improving patient choice and experience, increasing access and convenience, improving public health, supporting long-term conditions and ensuring the more flexible use of staff.
Changes to the current legislative requirements will be achieved by a combination of amendments to primary legislation (Medicines Act and NHS legislation), order making powers and new regulations.
Amendments to the Medicines Act 1968 to replace the concept of 'personal control' with that of a 'responsible pharmacist' were announced as part of the Health Bill laid before Parliament on 27 October 2005. The Bill also contained provisions to allow regulations to be made under the Act relating to the supervision of the preparation, dispensing, sale and supply of medicines by pharmacists.
The Health Bill received Royal Assent on 19 July 2006 and became the Health Act 2006. Once brought into force, its amendments to the Medicines Act will establish the overarching requirements for the preparation, sale and supply of medicines from registered pharmacy premises. The detail of the parameters and conditions of the new requirements (parameters for the responsible pharmacist's absence from the pharmacy; restrictions on delegation of supervision) and exceptions to the requirements circumstances where a pharmacist may be responsible for more than one pharmacy) will be contained in regulations to be made under the Act.
In preparation for the work that is still to be undertaken to develop regulations for the responsible pharmacist and supervision requirements, the Society's Council agreed in February 2006 that a small working group of Council members should be formed. The Health Bill Working Group used the Society's existing policy (as outlined in the response to the consultation Making the best use of the pharmacy workforce) as the starting point for its discussions and began to build on this by considering the areas where regulations are expected to be made. Council agreed the recommendations of the Working Group in October 2006 and the consolidated policy was used as the basis for the Society's discussions in both the informal and formal consultations.
For more information click on the links below:
Work began on the regulations to be made under the Act in early 2007. The Department of Health is proposing to have a phased implementation, first developing regulations in respect of the responsible pharmacist, and then developing regulations for the supervision provisions.
Regulations On 29 October 2008, the responsible pharmacist regulations were laid. Click here for a copy of the regulations. The regulations do not come into effect until the 1 October 2009. Over the next 12 months the Society will continue to look at ways the membership needs to be supported.
For a briefing document about the content of the regulations, please click here.
Consultation A series of consultation events about the responsible pharmacist provisions were held during February and March 2007, followed by a formal three-month written consultation. The same approach will be used in due course for consulting on the other provisions of the Health Act 2006 relating to supervision requirements.
The Department of Health consultation on the responsible pharmacist regulations closed on 20 January 2008. For more information click on the link below:
For the Society's response to the consultation, click here.
For the key points of the Society's response to the consultation, consolidated into a concise docment, click on the link below:
Contact:
Priya Sejpal