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CHAPTER 6: THE CONDITIONS APPLYING TO THE RESPONSIBLE PHARMACIST: QUALIFICATIONS AND EXPERIENCE
6.1 The Government recognises that pharmacy owners and pharmacists may need more time to prepare for introduction of certain of the responsible pharmacist regulations. For example, the timing of introduction of regulations relating to qualifications and experience will need to take into account the need to ensure there are sufficient pharmacists available to fulfil the role of the responsible pharmacist, whilst maintaining the public's ready access to pharmacist advice and the medicines they need. In Chapter 9, the Government is seeking views, more generally, on the introduction of the responsible regulations, including the time needed to prepare for changes and the possibility of taking a phased approach to introducing these regulations.
6.2 The Health Act inserts a new section 72A into the Medicines Act that allows Health Ministers to set out in regulations further provisions on how the responsible pharmacist is to exercise the duty to secure safe and effective running of the pharmacy. These will apply to all registered pharmacies, within hospitals and in the community. These regulations may include requirements as to the qualifications and experience needed to be a responsible pharmacist.
6.3 In this chapter, therefore, the Government puts forward and welcomes views on proposals for regulatory requirements relating to the qualifications and experience needed to be a responsible pharmacist.
Qualifications to be a Responsible Pharmacist
6.4 During passage of the Health Act, and during informal consultation in early 2007, the Government confirmed there is no intention to introduce any significant, additional, formal or academic qualification over and above registration as a pharmacist.
6.5 Nevertheless, the Government believes the pharmacist's qualifications and experience to be an important safeguard. These legislative changes will allow the responsible pharmacist greater flexibility in how s/he makes use of pharmacy staff and modern technology. The responsible pharmacist will be able to determine when s/he may be absent from the pharmacy and the use of remote supervision arrangements, provided the circumstances and conditions specified in regulations are met. The responsible pharmacist will also be able to decide, subject to requirements in the regulations, whether supervision of certain aspects of the sale and supply of pharmacy and prescription only medicines may be safely delegated to other registered and suitably trained health professionals, taking into account the particular circumstances of the pharmacy. The responsible pharmacist must be able to fulfil these responsibilities effectively to maintain patient safety and safeguard the public - the key principle underpinning the Medicines Act. Therefore, the Government also believes that the responsible pharmacist should have adequate preparation to take on this role before assuming responsibilities for all activities within the pharmacy and for pharmacy staff
6.6 As a matter of European law, the United Kingdom must recognise the qualifications of pharmacists qualified in other European Community Member States. The Government does not intend that anything in these regulations should be inconsistent with that legal requirement. To qualify to practise as a pharmacist in the UK, it will be sufficient to have undertaken a period of registration as a pharmacist in another Member State in the same way as a period of registration in the UK. For example, working in a community pharmacy in another member state for the specified period would satisfy the "experience" part of the requirement in these regulations. That is, to become a responsible pharmacist someone has to have been qualified as a registered pharmacist for a number of years and - for a community pharmacy - have experience of working in a registered pharmacy in that setting.
An Annotation to the Register
6.7 During passage of the Health Act, and informal consultation, the Government outlined a possible option in relation to qualifications and experience. That is, the Royal Pharmaceutical Society of Great Britain and the Pharmaceutical Society of Northern Ireland might include on the register of pharmacists an annotation against the names of those pharmacists who have the necessary length of registration and the appropriate experience to take on the role of a responsible pharmacist. For example, this could provide transparency for both pharmacy owners and pharmacists when considering appointment as a responsible pharmacist. Such an approach requires the legislation to provide for both the qualifications and the experience required to be a responsible pharmacist.
6.8 In early 2007, the majority view emerging from informal consultation on this option was that any requirement to annotate the register would need careful consideration, including, for example
- that newly qualified pharmacists or those gaining experience to become a responsible pharmacist were not placed at a disadvantage in seeking or gaining posts in the community or hospital pharmacy sectors
- the purpose of the annotation - the majority felt this should make clear a pharmacist was competent to take on the role of a responsible pharmacist rather than just indicating that he or she had undertaken that role in a registered pharmacy in the community or in a hospital.
- Any maintenance arrangements to ensure such information (and the register) remained accurate and up to date
- Use of this information - the majority considered that pharmacy owners should not rely on any annotation to the register alone when considering the appointment of a pharmacist to be responsible for a pharmacy
6.9 The Government is now seeking views, more widely, on whether the Royal Pharmaceutical Society of Great Britain and the Pharmaceutical Society of Northern Ireland might include on the register an annotation against the names of those pharmacists with the necessary experience to be a responsible pharmacist.
Q. What is your view of an option to annotate the register indicating a pharmacist has experience to be a responsible pharmacist? What are your reasons for your view?
Q. Do you think other matters need to be considered, in addition to those outlined above? If so, what are these and what are your reasons for putting them forward?
Pharmacist Experience
6.10 The Government recognises that the Royal Pharmaceutical Society of Great Britain makes clear in the revised Code of Ethics, issued in August 2007, that pharmacists have a professional responsibility to ensure continuing competence and up-to-date knowledge relevant to their field of practice. The Pharmaceutical Society of Northern Ireland Code of Ethics and Practice also makes clear this responsibility on pharmacists. The RPSGB has also issued supporting standards for pharmacists and pharmacy technicians in positions of authority. These include a requirement to ensure that pharmacists and other pharmacy staff are competent to take on their specific role and a requirement to report any concerns relating to professional competence or fitness to practice to the Society .4
6.11 The statutory requirements on the responsible pharmacist are distinct from the requirement on a pharmacist to supervise individual transactions involving the sale and supply of medicines. These requirements extend beyond supervision - the responsible pharmacist has a legal responsibility to ensure that all aspects of the pharmacy's operation are safe and effective where these concern medicines.
6.12 A number of different views on the experience needed to be a responsible pharmacist emerged from informal consultation, including
- The regulations should not specify that a pharmacist must have acquired a period of experience, beyond registration, before taking on the role of a responsible pharmacist. The view is that there is already lengthy and extensive training to qualify as a pharmacist and pharmacists are under a professional obligation to ensure that they, and the pharmacists they may employ, are competent to carry out their responsibilities.
- A view that pre-registration trainee pharmacist training could be developed to provide more relevant experience
- Wide ranging views on any requirement that a pharmacist needs a minimum period of experience, beyond registration, before taking on the role of the responsible pharmacist. For example - these ranged from a requirement of 6 months post registration experience to a requirement on a pharmacist to acquire between two and four years experience to demonstrate competency in this role, undertaken as part of the pharmacist's continuing professional development
- A proposal that any required minimum period of experience might vary. For example, the regulations might specify a requirement for a period of experience where the responsible pharmacist wished to offer services away from the pharmacy (ie to be absent from the pharmacy) and take up his/her ability to permit another suitably trained, registered, healthcare professional working in the pharmacy (eg a registered pharmacy technician) to supervise aspects of the sale and supply of medicines
- A majority view was that any requirement relating to experience should focus on competency to take on the responsibilities of a pharmacist in charge of a pharmacy - not the extent of time a pharmacist may have spent undertaking this role
6.13 The Government welcomes views on the issues raised and discussed during informal consultation. Proposals in relation to a minimum period of experience are set out in the following paragraphs.
Q. What is your view on the issues outlined above and do you think there is also a need to consider other issues? If so, what are these?
A minimum period of experience following registration as a pharmacist
6.14 To allow time for a pharmacist to gain sufficient experience to be a responsible pharmacist, one option might be to include a requirement in these regulations that a pharmacist has a minimum period of experience following registration before he or she may take on this role. For example, this could underpin professional Code of Ethics requirements and pharmacy owners' arrangements (and, as appropriate, those of the superintendent pharmacist) for the assessment of pharmacists wishing to take on this role in their pharmacies. The Government welcomes views on this option, including what the minimum period of experience might be.
Q. Do you think there should be a minimum period of experience, following registration, before a pharmacist may become a responsible pharmacist? If so, what should that minimum period be and what are your reasons for putting this forward?
Q. If you do not agree with this proposal, what do you propose?
Variations to the minimum period of experience
6.15 During informal consultation, one view put forward was that any requirement relating to a minimum period of experience could be an additional condition, for example, for absence from the pharmacy. That is, where a responsible pharmacist wished to be able to be absent from the pharmacy, s/he must comply with a condition that requires him/her to have the minimum period of experience set out in regulations. This approach would allow a recently qualified pharmacist to take on the role of the responsible pharmacist but s/he would need to have a minimum period of experience in that role to meet all the conditions that would allow him/her to be absent from the pharmacy. The ability of the responsible pharmacist to meet his/her statutory requirement to secure the safe and effective running of the pharmacy is not dependent on his or her physical presence in the pharmacy at all times. However, the responsible pharmacist will need to have sufficient experience to judge whether pharmacy staff are able to maintain arrangements for safe working involving the sale and supply of medicines when he or she is away from the pharmacy. The Government welcomes further views on whether the minimum period specified might vary as an additional condition supporting the responsible pharmacist's absence from the pharmacy. Other proposals on conditions relating to absence from the pharmacy are set out in chapter 5.
Q. Do you think a requirement relating to a minimum period of experience might vary? For example, what is your view on the proposal that any minimum period of experience requirement could be an additional condition supporting, for example, the responsible pharmacist's ability to be absent from the pharmacy? What are your reasons for supporting your view?
Recent Experience in the Relevant Pharmacy Sector
6.16 The Government has also sought views, informally, on whether the regulations should specify that a responsible pharmacist should have a minimum period of experience in the relevant pharmacy sector. Overall, the majority view emerging from informal consultation supported the need for a pharmacist to have relevant experience before taking on the role of the responsible pharmacist in a specific pharmacy sector. However, there were a number of views put forward, including:
- That the regulations should not specify a minimum period, including recent experience in the relevant pharmacy sector
- A pharmacist did need recent experience in the relevant pharmacy sector before becoming a responsible pharmacist. For example, a pharmacist who had been responsible for a hospital pharmacy would need time to adapt to the operational needs of a community sector pharmacy (eg volumes of dispensing activity and the sale of medicines) and vice versa. Or a pharmacist who had been working within the pharmaceutical industry, in taking on responsibility for a community pharmacy, would need to be aware of requirements relating to the sale and supply of medicines.
- Where a pharmacist has not practised as a pharmacist for some time (for example, a career break), on return, before taking on the role of the responsible pharmacist s/he should gain experience of working in the relevant pharmacy sector. Different views were put forward on a minimum period of experience - from 3 months to a lengthier period of up to a year where a pharmacist had not practised as a pharmacist for more than three years
Q. What is your view and are there other issues in relation to recent experience in the relevant pharmacy sector? If so, what are these and your reasons for putting them forward?
6.17 In the light of the majority view expressed during informal consultation, the Government proposes that the regulations specify that a responsible pharmacist must have a minimum period of recent, relevant, experience in the pharmacy sector to which he/she wishes to become a responsible pharmacist. For example, the regulations might define the minimum period of experience as "x" period of experience within the last "y" years and might include relevant experience of a specific pharmacy sector gained during pre-registration training. The Government welcomes views on this proposal and, in particular, what the minimum period of recent, relevant, experience might be.
Q. Do you agree with this approach? If so, what are your reasons for supporting this proposal? What do you think should be the minimum period of recent experience in the relevant pharmacy sector and how should this be defined?
Q. If you do not agree, what do you propose instead and what are the reasons supporting your proposals?
A minimum period of relevant experience, where a pharmacist has not practised as a pharmacist for three years or more
6.18 Following informal consultation, the Government also proposes that the regulations specify a minimum period of experience in the relevant pharmacy sector for pharmacists wishing to become a responsible pharmacist where they have not practised as a pharmacist for three years or more. The Government welcomes further views on this proposal and, in particular, what the minimum period might be.
Q. Do you agree that the minimum period of experience might differ where a pharmacist is returning to practise after an absence of three years or more? If so, what should this be?
Q. If you do not agree with this approach, what do you propose instead and what are the reasons for supporting your proposals?
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