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CHAPTER 7: ONE PHARMACY/ONE RESPONSIBLE PHARMACIST
7.1 Sections 27, 28 and 29 of the Health Act amend section 70, 71 and 72 of the Medicines Act, replacing personal control with a requirement that each pharmacy is to have a responsible pharmacist. During passage of the Health Act through Parliament, the Government made clear its view that to discharge fully and effectively the statutory duty on the responsible pharmacist to secure safe and effective running of the pharmacy, the general "rule" remains that each pharmacy is to have a responsible pharmacist. Thus, a registered pharmacy must have a responsible pharmacist if it is to remain open for the sale and supply of medicines to the public and that pharmacist may only be responsible for one registered pharmacy at any one time. If there are two pharmacists working in a pharmacy at the same time, only one will be the responsible pharmacist. However, one or both of them may be the pharmacist supervising individual transactions involving the sale and supply of pharmacy and prescription only medicines.
7.2 If a registered pharmacy does not have a responsible pharmacist (as now with the personal control requirement), the pharmacy may not remain open for the sale and supply of medicines to the public. This applies to registered pharmacy premises within hospitals and in the community.
Exceptional Circumstances Permitting a Responsible Pharmacist to be Responsible for more than One Pharmacy at the Same Time
7.3 However, during passage of the Act, the Government also made clear its view that it was sensible for the legislation to allow sufficient flexibility to make exceptions to this general "rule" where there was a need to give a considered response to any exceptional circumstances that may arise in the future. The new section 72A, inserted into the Medicines Act, allows Health Ministers to specify such circumstances in regulations. The Government is seeking views on what circumstances might be considered to be exceptional and thus set out in the regulations.
Conditions Permitting a Responsible Pharmacist to be Responsible for more than One Pharmacy at the Same Time
7.4 As an added safeguard, section 72A also requires compliance with certain specified conditions before a pharmacist may be responsible for more than one pharmacy at the same time. The Government believes the need to comply with requirements relating to exceptional circumstances and specified conditions will ensure the responsible pharmacist is able to fulfil his/her responsibilities for the safe sale and supply of medicines in each of the pharmacies for which s/he is responsible. Public safety is paramount. The Government's view is that the responsible pharmacist will need to be sure that s/he does not overstretch both his/her capacity and ability to exercise the statutory duty in relation to each pharmacy.
7.5 Therefore, in this chapter, the Government is seeking views on proposals relating to the specific circumstances and conditions that will permit a pharmacist to be responsible for more than one pharmacy at the same time.
7.6 Before a responsible pharmacist may take on responsibility for more than one pharmacy, s/he will need to comply with the specified circumstances and conditions, with the regulations relating to absence from the pharmacy ( see Chapter 5) and with the pharmacist supervision regulations (on which the Government is consulting later). Therefore, the Government recognises that it may be appropriate to take a phased approach to the introduction of regulations relating to the ability of a pharmacist to be responsible for more than one pharmacy at the same time. In chapter 9, the Government welcomes views on this possible approach.
Possible Exceptional Circumstances
7.7 The Government believes that, by their nature, exceptional circumstances will be unusual and will require careful consideration when deciding if these require making an exception to the general "rule" of one pharmacy/one responsible pharmacist.
7.8 The Government does not believe that circumstances such as sickness, holidays, and "emergencies" (eg an accident, problems at home, and disruption to travel) should be included in the regulations as exceptional circumstances. For example, where a responsible pharmacist plans to be away on holiday for two weeks, this would not be an exceptional circumstance prompting consideration of an exception to the one pharmacy/one responsible pharmacist "rule". As now, with the personal control requirement, where a pharmacy is without a responsible pharmacist, the pharmacy owner must appoint another pharmacist to be in charge of the pharmacy until the usual responsible pharmacist returns from his/her holiday. This will also be the case where the responsible pharmacist's holiday involves only a short period, as there will need to be compliance with regulations relating to absence from the pharmacy ( see Chapter 5).
7.9 During passage of the Health Act and as part of informal consultation in early 2007, the Government put forward two possible examples of circumstances for consideration as exceptions to the one pharmacy/one responsible pharmacist "rule". These are set out below. The Government is now seeking wider views on the examples given.
Example 1: A temporary pharmacy
7.10 Possible exceptional circumstances might be where a large number of people attend an event (such as a festival or agricultural show) held over a several days, with a temporary pharmacy available at the site to meet their needs during this period. Trained pharmacy staff (such as registered pharmacy technicians) would be available at the pharmacy with the pharmacist responsible for the main pharmacy in a nearby town or village also becoming responsible for the safe running of the temporary pharmacy. The pharmacist responsible for the main pharmacy would set out the temporary pharmacy's procedures, and decide which staff may undertake certain activities in that pharmacy. Such arrangements would also need to comply with the pharmacist supervision regulations on which the Government is consulting later.
7.11 The majority view emerging from informal consultation was this scenario did not present a strong enough case for consideration as an exception to the general "rule". However, the Government welcomes any further views.
Example 2: Pharmacist operated dispensing machine located in separate registered pharmacy premises
7.12 Developing technologies are already making available machines, controlled and operated by a pharmacist, to dispense medicines to patients who are unable to visit the pharmacy where the pharmacist is located. Although located in separate registered pharmacy premises, the machine supports "tele-link" face-to-face interaction between the pharmacist and the patient to provide advice, the pharmacist can see and receive the prescription, choose and label the medicine required and deliver this to the patient via the machine. As the pace of developing technologies continues to advance, such circumstances are likely to arise in the near future - the technology described is already under development in countries such as Australia.
7.13 As an exception to the general "rule", the same pharmacist would be responsible for the registered premises where the machine is located as well as the main pharmacy. A pharmacist undertakes extensive clinical training. Therefore, the Government does not believe it is sensible or appropriate to require him/her to be responsible for a registered pharmacy where s/he only stands guard over a machine operated by a pharmacist from another pharmacy. In such circumstances, the Government's view is that is more appropriate for the pharmacist responsible for the main pharmacy, who also controls the dispensing machine, to be responsible for the safe and effective operation of such technology and the registered pharmacy premises where the machine is located.
7.14 Whilst those responding to informal consultation recognised that such a scenario may already be possible (and increasingly so in the future), no firm view emerged on this as a possible exception to the general "rule" that each pharmacy is to have a responsible pharmacist. Therefore, the Government welcomes wider views on whether the increasing availability of such technologies might support consideration of these circumstances as exceptional, thus allowing a pharmacist to be responsible for more than one pharmacy at the same time.
Q. What is your view of the two examples in providing a possible case for an exception to the one pharmacy/one responsible pharmacist "rule"?
Q. Are there other exceptional circumstances where you think a pharmacist might be responsible for more than one pharmacy at the same time?
7.15 Subject to receipt of further views on the examples given, and any other examples of possible exceptional circumstances that might be put forward, the Government recognises that it may be more appropriate to seek views on the second example in the wider context of consultation on the regulations relating to pharmacist supervision ( see Chapter 9). The Government is consulting on the content of these regulations later, including the ability of the responsible pharmacist to supervise individual transactions remotely, using appropriate technologies.
Compliance with conditions that will allow a pharmacist to be responsible for more than one pharmacy at the same time
7.16 In addition to specifying exceptional circumstances that will allow a pharmacist to be responsible for more than one pharmacy at the same time, there will also be a need to comply with conditions specified in the regulations. During informal consultation, the Government put forward proposals on what these conditions might be. These proposals, together with initial views emerging from informal consultation, are set out below.
Capacity to Exercise the Statutory Duty
7.17 The Government believes that the responsible pharmacist must be able to meet his/her statutory responsibilities fully and effectively in each of the pharmacies for which s/he is responsible. For example, the responsible pharmacist will need to assess his/her capacity to ensure the safe and effective sale and supply of medicines and his/her capacity in relation to other services provided in each of the pharmacies (for example, medicines use reviews, advice on self-care). During informal consultation, the majority view was that this was an important condition and should be included in the responsible pharmacist regulations. As part of this consultation, the Government is seeking further views on this proposal.
Q. Do you agree the regulations should include, as a condition, the responsible pharmacist's capacity to be in charge of more than one pharmacy at the same time?
Staff employed in the pharmacies
7.18 This proposed condition supports the condition set out above. For example, the responsible pharmacist's capacity and ability to ensure the safe and effective running of each pharmacy for which s/he is responsible will depend, to some extent, on the availability of suitably trained, competent and experienced pharmacy staff (eg a registered pharmacy technician). Thus, the regulations might specify the employment of certain pharmacy staff where a pharmacist is to be responsible for more than one pharmacy at the same time. Informal consultation in early 2007 supported this view but, as part of this consultation, the Government welcomes further views, including whether certain specified staff should be available in one or all of the pharmacies for which a pharmacist is responsible.
Q. Do you agree with the proposal to include in the regulations, as a condition, that certain staff should be available in the pharmacy? What are your reasons for your views?
Q. If you agree, which trained pharmacy staff (eg a registered pharmacy technician) do you think will need to be available in the pharmacy where the pharmacist is responsible for more than one pharmacy at the same time? What are the reasons supporting your view?
Q. Should this be all the pharmacies concerned or, for example, as a minimum one of the pharmacies? What are the reasons supporting your view?
The period for which a responsible pharmacist may be responsible for more than one pharmacy at the same time
7.19 Depending on the nature of the exceptional circumstances involved, the Government proposes a limit to the period during which a pharmacist might be responsible for more than one pharmacy at the same time. For example, such a limit could support re-assessment of the need for such arrangements and if these continue to comply with the regulations.
Q. Do you agree that, subject to the exceptional circumstances, the regulations should specify a limit to the period for which a pharmacist may be responsible for more than one pharmacy at the same time? If so, what are your reasons for supporting this?
Q. What do you suggest that period might be and what are your reasons for this?
Notification that a pharmacist is responsible for more than one pharmacy at the same time
7.20 The Government is seeking views on a proposal that the pharmacy owner or the responsible pharmacist notifies the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland where the responsible pharmacist is to be in charge of more than one pharmacy at any one time. Such a notification would not require the professional regulatory bodies' agreement before a pharmacist became responsible for more than one pharmacy at the same time. The Government recognises that such an arrangement will need to fit with the programme of routine visits to pharmacies by the RPSGB pharmacy inspectors and, in Northern Ireland, the Department of Health, Social Services and Public Safety ( DHSSPSNI) inspectors. However, notification would enable pharmacy inspectors to plan their visits to pharmacies in order to check compliance with the circumstances and conditions specified in the regulations.
7.21 A majority view on this proposal did not emerge during informal consultation. For example, one view is that the responsible pharmacist should be required to note the pharmacy record of each pharmacy concerned when s/he takes on responsibility for the pharmacies at the same time. Another related view put forward is that, as pharmacy inspectors are able to check the pharmacy record when visiting the pharmacies concerned, there should be no requirement to notify the professional regulatory bodies. As no clear view has emerged on this proposal, the Government welcomes further views.
Q. What is your view on the proposal that the professional regulatory bodies are notified of any arrangements where a responsible pharmacist takes on responsibility for more than one pharmacy at the same time? If you agree, who should be required to notify the arrangements - the responsible pharmacist or the pharmacy owner?
Q. If you do not agree, what do you propose and why?
Each pharmacy concerned should be owned and managed by the same company, partnership or individual
7.22 The RPSGB and the PSNI Code of Ethics place a professional requirement on pharmacists to comply with their legal and professional obligations. For example, that the pharmacist's workload or working conditions do not compromise patient care or public safety or prevent others from meeting their legal or professional requirements, particularly in relation to safeguarding patients and the public. In addition, where a pharmacist is employed (ie not under locum pharmacist arrangements) by a pharmacy business to be responsible for a pharmacy, the contract of employment agreed between the pharmacist and the pharmacy owner may set out that s/he may not be employed as a responsible pharmacist for a pharmacy owned by another business.
7.23 However, the Government welcomes views on a proposal that, as an added safeguard, that the regulations specify that the same body corporate, partnership or individual must own each pharmacy concerned where a pharmacist is responsible for more than one pharmacy at the same time. Possibly, such a condition might further support the responsible pharmacist in his/her capacity to exercise the statutory duty in respect of each pharmacy for which s/he is responsible, as the responsible pharmacist will be working within the same governance framework for that pharmacy business.
Q. Do you think the regulations should include a condition that the same company, partnership or individual should own each pharmacy where a pharmacist is responsible for more than one pharmacy at the same time? What are your reasons for taking your view?
The number of pharmacies for which a pharmacist may be responsible at the same time
7.24 The Government proposes that the regulations specify, as one of the conditions, the maximum number of pharmacies for which a pharmacist might be responsible at the same time. The Government believes that such a condition will further support the important condition that the responsible pharmacist must have the capacity and the ability to meet his/her statutory duty in each of the pharmacies for which s/he is responsible. During informal consultation, the majority view was, given the need to meet the exceptional circumstances requirement and the additional need to comply with other specified conditions (eg absence from the pharmacy), the maximum number should be set at two pharmacies.
Q. Do you agree that the regulations specify the maximum number of pharmacies for which a pharmacist may be responsible at the same time? If so, what are your views on the number of pharmacies (eg two)?
7.25 In addition to views on the proposals for the individual conditions set out above, the Government also welcomes views on whether all or only some of these should be included in regulations. The Government also welcome views on whether there is a need to include further conditions and, if so, what these might be.
Q. Do you think the regulations need to include all or only some of the conditions outlined above? What are your reasons for this?
Q. Are there any gaps - for example, do you propose that other or further conditions need to be set out in the regulations? If so, what are your reasons for this?
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