Executive Summary: Proposals for the Responsible Pharmacist Regulations
1. This consultation paper is seeking views on
- proposals on the content of the responsible pharmacist regulations
- the timing of introduction of the responsible pharmacist regulations and the time needed to prepare for change
- the need for guidance to support introduction of the regulations
2. A summary of proposals for the content of the regulations and other matters raised in the paper are set out below. Appendix A summarises questions posed in the following chapters and provides a format that you may wish to use in responding to the consultation. Appendix B lists some frequently asked questions from the informal consultation events held in early 2007 and other meetings.
Pharmacy Procedures ( Chapter 3)
3. The responsible pharmacist is required to establish (if these are not already established), maintain and review pharmacy procedures designed to secure the safe and effective running of the pharmacy. The Government is seeking views on
- Allowing the responsible pharmacist to use his/her professional judgement in ensuring pharmacy procedures support safe working in the pharmacy for which s/he is responsible and the need for review or amendment of the procedures
- The minimum areas to be covered by the pharmacy procedures, including a requirement that pharmacy procedures should include arrangements for the sale of General Sales List ( GSL) medicines from the pharmacy
- That, over and above the matters specified in the regulations on pharmacy procedures, any further matters to be included in the pharmacy procedures are a matter for the pharmacy owner, the superintendent pharmacist, and the responsible pharmacist, as appropriate.
- The regulations should allow the responsible pharmacist to set out the written pharmacy procedures on paper or electronically, provided these are readily available and accessible to those who need to consult the procedures
- The regulations should not prescribe a format for pharmacy procedures
- A proposal that regulations should require the format used for pharmacy procedures to allow the responsible pharmacist to "sign off" the procedures in a way that indicates that, on taking responsibility for the pharmacy, s/he is content that the procedures support safe working in the pharmacy.
- Proposals relating to the review of the pharmacy procedures, including the role of guidance
- The role of the responsible pharmacist, the superintendent pharmacist, the pharmacy owner and the professional regulatory bodies
The Pharmacy Record ( Chapter 4)
4. The responsible pharmacist is required to keep a record, in the pharmacy, of the pharmacist responsible for the pharmacy on any date and at any time. The Government is seeking views on
- A proposal that the regulations specify the minimum information to be included in the pharmacy record
- That, over and above meeting these minimum requirements, the inclusion of additional information in the record will be a matter for the pharmacy owner
- A proposal that the regulations allow the responsible pharmacist to keep the record in paper form or electronically, provided the record is readily available and accessible to those wishing to consult the record
- It is proposed that the regulations do not prescribe the format of the pharmacy record but specify the fields of information to be included in the record
5. The pharmacy owner has a statutory duty to ensure the responsible pharmacist properly keeps the record and to preserve the record for the period set out in regulations. The Government welcomes views on
- The required minimum period for which the pharmacy owner must preserve the record - the Government is proposing that this is five years from the date of the last entry to the record
- That, over and above the requirement to meet this minimum requirement, the preservation of the record for a longer period is a matter for the pharmacy owner
Absence from the Pharmacy ( Chapter 5)
6. The statutory duty on the responsible pharmacist now makes clear that s/he must secure the safe and effective running of the pharmacy - setting out procedures designed to ensure safe operation of the pharmacy and keeping a record of the pharmacist responsible for the pharmacy at any time and on any date. These explicit requirements and added safeguards make clear that safe working is not dependent on the responsible pharmacist's physical presence in the pharmacy at all times when it is operating. Subject to certain conditions, the responsible pharmacist will be able to leave the pharmacy. For example, the pharmacist will be able to use his/her clinical training to offer services other than the sale and supply of medicines in the same building, adjacent to the registered pharmacy premises (such as a consulting room) or to provide clinical services away from the pharmacy (eg in health centres and patients' homes).
7. However, the Government has made clear its view that the pharmacist should consider the pharmacy to be his/her main place of work, when responsible for the pharmacy, to ensure that s/he is able to meet the statutory duty fully and effectively.
8. The Government is seeking views on how the regulations should define absence from the pharmacy and the conditions that will allow the responsible pharmacist to be absent.
9. To define absence from the pharmacy, the Government proposes
- That the regulations specify the minimum proportion of time, during any one period in which s/he is responsible for the pharmacy and the pharmacy is operational, the responsible pharmacist should spend in the pharmacy. Further, this should be the majority of that time (ie more than 50% of each period for which s/he is responsible for the pharmacy and the pharmacy is operating).
- The regulations also specify three hours as the maximum time the responsible pharmacist may be away from the pharmacy in any one period of absence.
- In addition, the Government is seeking views on whether this maximum time might vary - for example, where another pharmacist or certain other pharmacy staff (eg a registered pharmacy technician) remain present in the pharmacy during the responsible pharmacist's absence - and, if so, how this should vary.
10. The Government welcomes views on proposals that the responsible pharmacist must comply with the following conditions in order to be absent from the pharmacy for the maximum time specified in the regulations. The Government also welcomes proposals for any further conditions in relation to the responsible pharmacist's absence from the pharmacy.
- A proposal that, as a condition supporting absence from the pharmacy, the responsible pharmacist should be required to return to the pharmacy with reasonable promptness where requested/required to do so. The Government's view is that it will be difficult to define in the regulations all circumstances that may arise to prompt a return to the pharmacy. The Government also believes that the responsible pharmacist must be able to use his/her professional judgement in deciding how to meet this condition, taking into account the circumstances concerned. Therefore, the Government does not propose to define "reasonable promptness" in the regulations.
- That, as necessary, the responsible pharmacist maintains contact with pharmacy staff to provide professional advice or to respond to a request to return to the pharmacy. For example, where s/he is absent and there is no other pharmacist working in the pharmacy. The Government does not propose to specify in the regulations the ways in which the responsible pharmacist is to maintain readily contactable by pharmacy staff but welcomes views on the role of guidance as a more appropriate way of advising the responsible pharmacist in this respect.
- As another condition supporting absence from the pharmacy, that where s/he is unable to maintain contact with pharmacy staff whilst away from the pharmacy. the responsible pharmacist is required to arrange for another pharmacist to provide advice. Again, the Government does not propose that the regulations specify how the responsible pharmacist is to make such arrangements, as this will also involve professional judgement. The Government is also seeking views on whether the other pharmacist providing advice should be a responsible pharmacist or eligible to take on this role.
Qualifications and Experience ( Chapter 6)
11. The regulations may set out the qualifications and experience needed to be a responsible pharmacist. The Government has no intention to introduce a qualification over and above registration as a qualified pharmacist. However, given the statutory duty on the responsible pharmacist and changes in the pharmacist supervision requirements, the Government welcomes views on, for example, the experience needed to take on this important role and the proposals set out in the consultation paper. These include
- A proposal that an annotation to the register be made against the names of those pharmacists with the necessary experience to be a responsible pharmacist
- A proposal that regulations specify that before taking on responsibility for a pharmacy, a responsible pharmacist is required to have a minimum period of experience following registration as a pharmacist. Alternatively, that this requirement might only apply, for example, as a further condition enabling the responsible pharmacist to be absent from the pharmacy or to allow a suitably trained and registered healthcare professional (eg a pharmacy technician) to supervise certain aspects of the sale and supply of medicines
- A proposal that a pharmacist wishing to take on the role of a responsible pharmacist is required to have recent experience in the pharmacy sector concerned (eg community or hospital). The Government is also seeking views on what the minimum period of relevant experience might be and how this might be set out in the regulations - for example "x" period of experience in the last "y" years.
- A proposal that, where a pharmacist has not practised as a pharmacist for a specified period (eg three years) that s/he has a minimum period of experience in the relevant pharmacy sector before taking on the role of a responsible pharmacist.
12. The Government is also seeking views on the time needed to prepare for the introduction of the regulations relating to the qualifications and experience needed to be a responsible pharmacist - in particular whether some of these regulations might be introduced before others. See also Chapter 9.
One Pharmacy/One Responsible Pharmacist ( Chapter 7)
13. The general "rule" remains - that each registered pharmacy must have a responsible pharmacist. The new section 72A in the Medicines Act makes clear that a pharmacist may only be responsible for one pharmacy at the same time, except in circumstances specified in regulations and then only subject to compliance with certain conditions. During passage of the Health Act, the Government stated its intention to draw these regulations tightly to maintain public safeguards in relation to the sale and supply of medicines.
14. The Government welcomes views on two possible examples of such exceptional circumstances and invites others to be put forward. Subject to the response to consultation, the Government also puts forward a view that it may be more appropriate to introduce regulations allowing a pharmacist to be responsible for more than one pharmacy later. For example, these might be introduced as further exceptional circumstances arise or following introduction of the pharmacist supervision regulations and those permitting a responsible pharmacist to supervise remotely. ( See chapter 9). Again, views are welcome on this proposal.
15. The Government is seeking views on proposals relating to the required conditions that, together with specified exceptional circumstances, will allow a pharmacist to be responsible for more than one pharmacy at the same time. These are
- A proposed requirement that the responsible pharmacist must be able to meet the statutory duty in relation to each of the pharmacies for which s/he is responsible
- A proposal that, subject to specified circumstances, a pharmacist may be responsible for more than one pharmacy at the same time only for the limited period specified in the regulations - views are also sought on what that period might be
- A proposal that the pharmacy owner or the responsible pharmacist notify the Royal Pharmaceutical Society of Great Britain (in Northern Ireland, the Pharmaceutical Society of Northern Ireland) of any arrangements in which the pharmacist is responsible for more than one pharmacy at the same time
- A proposal that a condition allowing a pharmacist to be responsible for more than one pharmacy is that each pharmacy concerned should be owned and managed by the same company, partnership or individual
- A proposal that certain pharmacy staff (eg another pharmacist or a registered pharmacy technician) are employed in at least one or all of the pharmacies concerned
- A proposal that the regulations specify, depending on the nature of the exceptional circumstances concerned, the maximum number of pharmacies for which a pharmacist may be responsible at the same time - the Government proposes that the maximum number should be two pharmacies.
Supervision by the Responsible Pharmacist of activities in a pharmacy where s/he is not the Responsible Pharmacist ( Chapter 8)
16. The responsible pharmacist regulations may set out the circumstances in which a pharmacist responsible for one pharmacy may supervise the preparation, assembly, sale and supply of medicines in a pharmacy where s/he is not the responsible pharmacist. To do so, the pharmacist will need to meet the conditions for absence.
17. The Government also recognises that these regulations link with regulations relating to remote supervision and, more generally, the pharmacist supervision regulations on which the Government is consulting later. Therefore, in responding to this consultation, there may be a view that it is more appropriate to consider the content of these regulations within the context of that later consultation. The Government welcomes views on this. ( See chapter 9).
18. In the meantime, the Government welcomes views on the following proposals for conditions relating to the ability of a pharmacist responsible for one pharmacy to supervise individual transactions involving the sale and supply of medicines from another pharmacy where s/he is not the responsible pharmacist. The Government also welcomes proposals for any further conditions that might be included in these regulations.
- A proposal that a condition should be that certain pharmacy staff (eg a registered pharmacy technician) should be employed in one or both of the pharmacies concerned
- A proposal that both pharmacies have the same pharmacy owner
Other Matters Relating to the Responsible Pharmacist ( Chapter 9)
19. In chapter 9, the Government sets out other matters relating to the responsible pharmacist regulations. That is
- enforcement of the regulations
- the time needed to prepare for the introduction of the majority of the responsible pharmacist regulations
- taking a phased approach to the introduction of other responsible pharmacist regulations
- the role of guidance in supporting introduction of these changes
20. The Government welcomes views on a proposal to introduce the majority of the responsible pharmacist regulations at the same time and the time needed to prepare for introduction.
21. The Government welcomes views on introducing some of the responsible pharmacist regulations later - for example, at the same time or following introduction of the pharmacist supervision regulations.
22. At this stage of consultation, the Government is not consulting on the responsible pharmacist regulations relating to remote supervision. The Government intends to consult on these proposals later, as part of wider consultation on the pharmacist supervision regulations .
23. The Government welcomes views on the need for guidance to support introduction of the responsible pharmacist regulations, in particular what the guidance should cover and whether certain matters are more appropriate for guidance issued by the professional regulatory bodies and others (eg updating existing guidance on pharmacy standard operating procedures ( SOPs).