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CHAPTER 9: OTHER MATTERS RELATING TO THE RESPONSIBLE PHARMACIST REGULATIONS
9.1 In addition to proposals on the content of the responsible regulations, this paper sets out a number of related matters. These are
- enforcement of the responsible pharmacist regulations
- the timing of introduction of these regulations - for example, the time needed by pharmacists, pharmacy owners and others to prepare for change
- the availability of guidance to support introduction of the regulations
Enforcement of the Responsible Pharmacist Regulations
9.2 The Health Act inserts a new section 72B into the Medicines Act and amends other sections relating to enforcement of Medicines Act requirements. These amendments place a specific duty on the Royal Pharmaceutical Society of Great Britain ( RPSGB) and the Pharmaceutical Society of Northern Ireland ( PSNI) to enforce statutory requirements relating to the responsible pharmacist where failure to comply is a matter of professional misconduct. For example, the requirement that pharmacy procedures include matters specified in the regulations. The duty on the RPSGB and the PSNI extends to registered pharmacies located in hospitals or in the community.
9.3 The amendments also give the appropriate Health Minister a right of entry to inspect and investigate in relation to provisions in section 72A of the Medicines Act. This reflects current arrangements in Northern Ireland, where the PSNI works with the Department of Health, Social Services and Public Security, Northern Ireland (the DHSSPSNI), which has responsibility for the inspection of pharmacies and action to ensure compliance with statutory requirements.
9.4 The new Section 72B in the Medicines Act makes clear that breach of certain provisions in relation to the responsible pharmacist is an offence, subject to the payment of a fine on conviction. This includes failure by the responsible pharmacist to keep and maintain the pharmacy record as required, failure of the pharmacy owner to ensure the responsible pharmacist properly keeps the record and failure of the pharmacy owner to preserve the record for the period set out in the regulations.
Introduction of the Responsible Pharmacist Regulations: Preparing for Change
9.5 In relation to enforcement, it will be important to ensure there is a consistent approach to the implementation of the statutory changes with adequate time allowed for pharmacists, pharmacy owners and pharmacy organisations - such as the professional regulatory bodies and others - to prepare for change. In addition, the Government recognises that, at this time, the professional regulatory bodies and others are engaged in a challenging work programme to establish a General Pharmaceutical Council. Therefore, the Government is consulting on the time needed to prepare for the introduction of the responsible pharmacist regulations.
Introduction of the Majority of the Responsible Pharmacist Regulations
9.6 Given the responsible pharmacist requirements replace and clarify the current personal control requirement, and that pharmacists and pharmacy owners are already operating under systems supporting safe operation of the pharmacy (eg Standard Operating Procedures), the Government believes there is scope to introduce the majority of the responsible pharmacist regulations at the same time. These are the regulations providing the statutory framework that underpins the safe and effective running of the pharmacy - the professional and other quality assurance systems that safeguard pharmacy operations and the delivery of safe services to the public. That is regulations in relation to
- the pharmacy procedures
- the pharmacy record
- the ability of the responsible pharmacist to be absent from the pharmacy - recognising that this will be limited to where another pharmacist is present in the pharmacy until introduction of the pharmacist supervision regulations at a later date
- requirements relating to recent experience in the relevant pharmacy sector for a pharmacist wishing to be responsible for a pharmacy in that sector (eg hospital or community) or where a pharmacist has not practised as a pharmacist for a period of, for example, three years
9.7 The Government welcomes views on the proposal to introduce the majority of the responsible pharmacy regulations at the same time and what might be a reasonable time period to allow pharmacists, the professional regulatory bodies and others to prepare. During informal consultation, the general view was that it would be unhelpful to have a prolonged preparatory period but that at least 12 months was required to prepare for change. Others thought there was a need for more time to support implementation of change.
Q. How long do you think pharmacy owners, pharmacists, and others need to prepare for the introduction of the majority of the responsible pharmacist regulations? What are your reasons for putting forward your view?
A phased approach to the Introduction of other Responsible Pharmacist Regulations
9.8 A view emerging from informal consultation is a need for more time to prepare for introduction of some of the responsible pharmacist regulations - for example, those closely linked to the pharmacist supervision regulations. Therefore, in response to views expressed during informal consultation, the Government is consulting more widely on whether it may be more appropriate to consult on the introduction of certain of the responsible pharmacist regulations in the context of the later consultation on the pharmacist supervision regulations.
9.9 The Government has made clear its intention to consult on remote supervision as part of that later consultation. However, the Government also welcomes views on whether consultation on introduction of regulations relating to the ability of a responsible pharmacist to supervise activities in a pharmacy where s/he is not the responsible pharmacist ( see chapter 8) should also be part of the later consultation, given the link to the pharmacist supervision regulations.
9.10 Section 72A of the Medicines Act provides for regulations specifying the exceptional circumstances and conditions that will allow a pharmacist to be responsible for more than one pharmacy at the same time. In addition to compliance with exceptional circumstances and specified conditions, the responsible pharmacist will need to comply with conditions relating to the pharmacist's ability to be absent from the pharmacy and the pharmacist supervision requirements. The responsible pharmacist must be able to meet his/her statutory duty for safe and effective running of the pharmacy and ensure that s/he is meeting all the conditions that will allow him/her to be responsible for more than one pharmacy at the same time.
9.11 At this stage, the Government is seeking views on two possible examples of exceptional circumstances that may prompt consideration of an exception to the one pharmacy/one responsible pharmacist "rule" ( see Chapter 7). One example is dependent on the responsible pharmacist's ability to supervise transactions remotely using appropriate new technologies. Therefore, subject to other examples being put forward in response to this consultation, the Government welcomes views on whether it may be more appropriate to seek views on these again (and other examples that may be put forward) in the context of the later consultation on the pharmacist supervision regulations, in particular remote supervision. For example, it may be more appropriate to look at the timing of introduction of these regulations at the same time or following the introduction of the pharmacist supervision regulations.
9.12 During informal consultation, the Government sought views on the time needed to prepare for introduction of the regulatory requirements relating to the qualifications and experience needed to be a responsible pharmacist. As made clear in chapter 6, the Government recognises that the timing of introduction of these regulations must 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.
9.13 The response indicated that it may take some time to develop arrangements to meet some of the proposed requirements but any firmer view on a timetable for change depended on the outcome of public consultation on the proposed content of these regulations and the approach adopted. Therefore, subject to the outcome of consultation on the proposals outlined in chapter 6, the Government welcomes further views on the time needed to prepare for the introduction of regulations relating to the qualifications and experience to be a responsible pharmacist. In particular, the Government is seeking views on the possibility of introducing some of these regulations before others - for example, those relating to the minimum period of recent experience in the relevant pharmacy sector.
9.14 Given views expressed during informal consultation, and subject to the response to consultation on proposals set out in this paper, the Government welcomes views on whether it may be more sensible and appropriate to introduce some of the responsible pharmacist regulations either following or at the same time as introduction of the pharmacist supervision regulations. For example, this may allow pharmacists and pharmacy owners more time to ensure that key responsible pharmacist requirements are in place to enable the responsible pharmacist to exercise the statutory duty (eg pharmacy procedures and the pharmacy record). It will also allow them further time to consider how the specific regulations, for example those relating to the one pharmacy/one responsible pharmacist "rule", fit with other regulations relating to absence and pharmacist supervision, including remote supervision.
Q. Do you think it would be helpful to take a phased approach to introduction of other responsible pharmacist regulations?
Q. If so, what are your views on the proposal that an option might be to
- Consult on the timing of introduction of regulations relating to the circumstances and conditions that will allow a pharmacist to be responsible for more than one pharmacy at the same time as part of later consultation on the pharmacist supervision regulations
- Consult on the timing of regulations, relating to the ability of a pharmacist responsible for one pharmacy to supervise activities in a pharmacy where s/he is not the responsible pharmacist, as part of later consultation on the pharmacist supervision regulations
- Introduce some of the regulations, relating to the qualifications and experience needed to be a responsible, with the majority of the responsible pharmacist regulations ( see chapter 6) - for example, those relating to recent, relevant, experience
Q. What are the reasons supporting your view?
Q. If you do not agree with this approach, what do you propose and why?
Guidance Supporting the Introduction of the Responsible Pharmacist Regulations
9.15 During informal consultation, many felt that it would be more appropriate to look to guidance rather than the regulations to provide further details on meeting the responsible pharmacist requirements. For example, earlier in this consultation paper, there are views outlined on a possible need for guidance providing detailed information and advice on developing pharmacy procedures and how the responsible pharmacist is to maintain contact and provide advice to pharmacy staff when absent from the pharmacy.
9.16 Some guidance is already available from the professional regulatory bodies, other pharmacy organisations, pharmacy owners (and superintendent pharmacists) on professional and ethical standards and operational systems that need to be in place to assure safe working in the pharmacy (eg Standard Operating Procedures). The Government's view is that, wherever possible, pharmacists and pharmacy owners, should continue to use current guidance and best practice in preparing for the introduction of the responsible pharmacist regulations.
9.17 However, the Government welcomes views on the need for further guidance to support introduction of the responsible pharmacist regulations. In particular, the Government is seeking views on the matters that should be included in guidance and who should develop and publish such guidance. For example, for some matters it may be more appropriate for the professional regulatory bodies to provide further guidance or to update current guidance available where these concern professional standards and requirements.
Q. Do you think there is a need for specific guidance to support introduction of the responsible pharmacist regulations? If so, what should this cover and what are your reasons for proposing this?
Q. Do you think, for example that the professional regulatory bodies should provide guidance on certain matters? Or is there scope for a joint approach to developing guidance by, for example, the Health Departments and the regulatory bodies? What are your reasons for supporting your view?
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