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CHAPTER 5: CONDITIONS RELATING TO THE RESPONSIBLE PHARMACIST: ABSENCE FROM THE PHARMACY
Absence and the "personal control" requirement
5.1 Sections 70, 71 and 72 of the Medicines Act require the business of the retail sale and supply of medicines to be under the "personal control" of a pharmacist. However, the Medicines Act does not define "personal control" nor does the Act define how the pharmacist is to meet this requirement. The concept of "personal control" derives from the Pharmacy and Poisons Act 1933 but this provision did not attract extensive debate in the passage of that legislation or the Medicines Act 1968. In 1981, the case of R v Logan indicated that some physical presence on the pharmacy premises was required if a pharmacist was to be considered in control of the pharmacy. However, that decision also indicated that the sale of GSL medicines could take place when the pharmacist was not in the pharmacy. A more recent statement by the RPSGB Statutory Committee indicated that if a pharmacist is not in personal control (for instance because s/he is not on the registered pharmacy premises) transactions involving the sale or supply of medicines, including GSL medicines, could not take place.
5.2 In response to the continuing debate about the exercise of the personal control requirement, the Government proposed a fresh look at this requirement in the light of modern pharmacy practice. The response to the 2005 public consultation paper, Making the Best Use of the Pharmacy Workforce confirmed strong support for clarification of the personal control requirement with some 75% of respondents calling for changes to the legislation.
5.3 The Health Act amends sections 70, 71and 72 of the Medicines Act to replace "personal control" with a requirement that each pharmacy is to have a responsible pharmacist. The new section 72A inserted into the Medicines Act, by the Health Act, provides further details on this requirement. The pharmacist in charge of a pharmacy now has an explicit statutory duty to secure the safe and effective running of the pharmacy. S/he will be responsible for ensuring that all activities involving the preparation, assembly, sale and supply of medicines are undertaken safely. The responsible pharmacist is required to set down pharmacy procedures for working in the pharmacy, including the training and experience required of pharmacy staff with specific responsibilities within the pharmacy. The responsible pharmacist must also keep a record of the pharmacist responsible for the pharmacy on any date and at any time.
5.4 The Government believes these explicit requirements on the responsible pharmacist ensure safeguards are in place to maintain patient safety whilst allowing the responsible pharmacist to be absent from the pharmacy. These changes also make clear that the presence of the pharmacist is not required to permit the sale of GSL medicines.
5.5 Section 72A provides for regulations on how the responsible pharmacist is to exercise the statutory duty, including the ability of the responsible pharmacist to be absent from the pharmacy. Again, it is important to be clear that these regulations concern the Medicines Act requirements relating to the preparation, assembly, sale and supply of medicines from registered pharmacies. Wider NHS legislation and the NHS pharmaceutical services contractual frameworks in the four countries of the United Kingdom relate to other services available from the pharmacy - for example, any requirement to be available in the pharmacy in core hours in order to provide NHS services. Amendment of NHS regulations can address the availability of a pharmacist in the pharmacy to provide the full range of NHS services. The Government will be looking at possible amendments to NHS regulations later, as part of proposals for the pharmacist supervision regulations.
Absence and the responsible pharmacist requirement
5.6 The Government's view is that the responsible pharmacist should be able to leave the pharmacy - for example, to use his/her training and clinical expertise in working with other healthcare professionals (such as GPs) to provide a wider range of health services in the community and in patients' own homes. Many share this view, believing that, in particular, this will enhance the pharmacist's clinical role and the pharmacist's contribution to improving health and healthcare services in the community. In hospitals, pharmacists work within the pharmacy and on hospital wards, as members of the clinical team responsible for the care and treatment of patients.
5.7 In the majority of community pharmacies, there is only one pharmacist working in the pharmacy. The Government recognises concerns raised that allowing the responsible pharmacist to be absent may lead to circumstances where a pharmacy is without a pharmacist. However, it remains a statutory requirement that each pharmacy is to have a pharmacist in charge of the pharmacy - that is a responsible pharmacist with a statutory duty to ensure that the pharmacy is operating safely. Where a pharmacy is without a responsible pharmacist, it must close to the public for the sale and supply of medicines.
5.8 There are other safeguards. The requirement to keep the pharmacy record will provide details of the pharmacist who is responsible for a pharmacy at any time and on any date. There is also the requirement on the responsible pharmacist that s/he must display a notice conspicuously in the pharmacy stating that s/he is the pharmacist in charge of the pharmacy at that time, together with details of his/her registration number.
5.9 The Government also recognises concerns that the pharmacist's ability to be absent from the pharmacy may mean that members of the public will be unable to rely on seeing a pharmacist when they visit a pharmacy. This direct access to professional advice on medicines and self-care is greatly valued by the public and, like others, the Government wishes to see this continue.
5.10 During passage of the Health Act, the Government stated clearly its view that, in order to fulfil the statutory duty fully and effectively, a responsible pharmacist should consider the pharmacy to be his/her main place of work whilst s/he is responsible for the pharmacy. The Government believes the responsible pharmacist will need to spend the majority of his/her time in the pharmacy during the period in which s/he is in charge of the pharmacy. The responsible pharmacist must be able to maintain his/her knowledge and experience of the pharmacy's activities and the skills and competencies of pharmacy staff and to ensure adherence to pharmacy procedures for safe working.
5.11 Where a pharmacist is responsible for a pharmacy, s/he is under a statutory duty to secure the safe running of the pharmacy, including during any period of absence from the pharmacy. Therefore, the Government's view is that, during any period of absence, the responsible pharmacist will need to remain available to provide professional advice to pharmacy staff, patients and the public and to respond to any request to return to the pharmacy.
5.12 However, the ability to be absent from the pharmacy will provide the responsible pharmacist with opportunities to use his/her clinical training to provide pharmacy services elsewhere. For example, this may be in another part of the same building adjacent to the registered pharmacy (eg a consulting room) or away from the pharmacy (eg in clinics, nursing homes or in patients' own homes). Therefore, the Government believes the regulations relating to the responsible pharmacist's absence from the pharmacy will need to achieve a balance. These must be consistent with the responsible pharmacist's overall statutory duty to secure safe and effective running of the pharmacy, whilst allowing sufficient time and flexibility for him/her to offer pharmacy services, other than the dispensing and sale of medicines, in the pharmacy itself or away from the pharmacy. In this way, the responsible pharmacist will be able to develop his/her clinical role and contribute to pharmacy's developing role in local health service planning and service delivery.
Defining Absence from the Pharmacy
5.13 To achieve this balance, and given the primary aim of the Medicines Act to safeguard the public, the Government proposes that the regulations define absence from the pharmacy in a number of ways. That is
- the extent to which the responsible pharmacist must be present in the pharmacy during any one period for which s/he is responsible for that pharmacy and the pharmacy is operational
- the maximum time that the responsible pharmacist may be away from the pharmacy during any one period of absence
The extent to which the responsible pharmacist must be present in the pharmacy during any one period for which s/he is responsible for that pharmacy and the pharmacy is operational
5.14 The Government proposes that the regulations specify the minimum proportion of time that the responsible pharmacist should spend in the pharmacy in order to exercise the statutory duty to secure safe and effective running of the pharmacy. That is,
- as a minimum, the responsible pharmacist should be in the pharmacy for the majority of his/her time when the pharmacy is operating
- the majority of time should be more than 50% of each period for which he/she is the responsible pharmacist when the pharmacy is operating
Most of those responding to informal consultation on this proposal agreed that the responsible pharmacist should spend the majority of his/her working time in the pharmacy when it is operating but the Government welcomes wider views on this proposal.
Q. If you do not agree that the regulations should specify the minimum proportion of time the responsible pharmacist should spend in the pharmacy and this should be the majority of the time s/he is responsible for the pharmacy, what do you propose and what are your reasons for supporting your proposal?
The minimum proportion of time set out in regulations
5.15 During informal consultation, no majority view emerged on a minimum proportion of time to be set out in the regulations. One view put forward was the minimum requirement should be that the proportion of the responsible pharmacist's time spent in the pharmacy should be 75-90%. However, there is an argument that, as a minimum proportion of time, this may not allow the responsible pharmacist sufficient time or flexibility to allow him/her to work outside the pharmacy with healthcare professionals and others in the planning and delivery of services. Another view was that any specified minimum proportion of time should support safe working but should not hamper service development or the better use of the pharmacist's clinical skills and those of pharmacy staff.
5.16 A number of people also felt there was a need to consider the minimum proportion of time specified in these regulations in the context of changes in the pharmacist supervision requirements. The Government agrees with this view. Changes in the pharmacist supervision requirements will permit a responsible pharmacist, subject to conditions set out in the regulations, to allow a suitably trained registered healthcare professional (such as a pharmacy technician) to supervise certain aspects of individual transactions involving the sale and supply of medicines from the pharmacy. Where there is compliance with the pharmacist supervision regulations, the responsible pharmacist will be able to be absent from the pharmacy provided specified, suitably trained and registered pharmacy staff are available to supervise certain aspects of dispensing, supported by other competent pharmacy staff, working to pharmacy procedures set down by the responsible pharmacist. However, the Government is not consulting on proposals for the pharmacist supervision regulations until later.
5.17 In the meantime, the Government recognises that many responsible pharmacists will be limited in their ability to be absent from the pharmacy until the introduction of the pharmacist supervision regulations. However, at this stage, a responsible pharmacist may be able to meet the specified conditions for absence where more than one pharmacist is working in the pharmacy at the same time. The other pharmacist working in the pharmacy will continue to be present in the pharmacy to meet the current pharmacist supervision requirements. Meanwhile, the Government welcomes views on the minimum proportion of time the responsible pharmacist is required to spend in the pharmacy in any one period for which s/he is in charge of the pharmacy and the pharmacy is in operation. In addition, views are welcome on how the responsible pharmacist regulations should specify this requirement. The Government has already stated its view that this will need to be the majority of the responsible pharmacist's time - ie more than 50% of his/her time during any one period in which s/he is responsible for the pharmacy and the pharmacy is operating.
Q. What do you think should be the minimum proportion of time that the responsible pharmacist should be required to be present in the pharmacy during each period that s/he is the responsible pharmacist? What are your reasons for this?
A maximum period of absence from the pharmacy
5.18 During informal consultation, a majority view was that the regulations should specify a maximum time of between two to three hours for any one period of absence, during which a responsible pharmacist may be away from the pharmacy. The majority also felt this period could vary for a number of reasons, including
- in some rural areas, the responsible pharmacist would need time to take into account distances between different localities to enable him/her to offer services outside the pharmacy
- the presence of another pharmacist in the pharmacy
- the presence of another suitably trained registered healthcare professional (eg a pharmacy technician) in the pharmacy
- the volume and range of the pharmacy's main business activities
However, the view was also taken that any conditions supporting any variation should be considered in the context of the maximum period specified. Following informal consultation, the Government proposes that the regulations specify three hours be specified as the maximum time for any one period of absence when the pharmacy is operating but welcomes further views on this proposal. The Government also welcomes views on whether the maximum period might vary, subject to certain conditions - for example, where another pharmacist remains present in the pharmacy when the responsible pharmacist is absent.
Q. Do you agree that regulations should specify the maximum time that the responsible pharmacist may be absent from the pharmacy during any one period of absence? If so, should this be set at three hours?
Q. Do you think the specified maximum time could vary - subject to specified conditions set out in the regulations? For example, where another pharmacist or certain other pharmacy staff (eg a suitably trained and registered pharmacy technician) are present in the pharmacy? If so, how might this vary and what are your reasons for supporting that view?
Q. If you do not agree with these proposals, what do you propose and what are your reasons for supporting your proposal?
Other Conditions relating to the Responsible Pharmacist's Absence from the Pharmacy
5.19 Further, the Government proposes that the pharmacist's ability to be absent from the pharmacy should be subject to a number of other conditions specified in the regulations. That is:
- the responsible pharmacist must be able to return to the pharmacy with reasonable promptness
- during any period of absence, as necessary, the responsible pharmacist should remain readily contactable so that pharmacy staff are able to seek advice or request his/her return to the pharmacy
- where the responsible pharmacist is unable to remain contactable, he or she must arrange for another pharmacist to be available to provide advice (who may not need to be present in the pharmacy) until s/he is able to return to the pharmacy
Returning with Reasonable Promptness
5.20 The responsible pharmacist's absence from the pharmacy will be subject to the maximum time specified in the regulations that s/he is able to be away from the pharmacy during any one period of absence. However, as a further safeguard, the Government proposes that regulations require the responsible pharmacist to be able to return to the pharmacy with reasonable promptness.
5.21 The Government's view is that it will be difficult to define "reasonable promptness" in the regulations in a way that meets all possible circumstances. The Government also believes that the responsible pharmacist should be able to use his/her professional judgement to decide, in individual circumstances, what might be "reasonable promptness" in returning to the pharmacy - having regard to the maximum time that s/he is able to be away in any one period of absence.
Q. Do you agree that the responsible pharmacist be required to return to the pharmacy with "reasonable promptness" and the approach taken? If not, what do you propose and what are your reasons for this?
Contacting the Responsible Pharmacist when absent from the pharmacy
5.22 The responsible pharmacist is required to set down written procedures for safe working in the pharmacy, which will continue to support pharmacy staff in working under the responsible pharmacist's authority when s/he is absent from the pharmacy. The procedures should set out clear arrangements relating to the responsible pharmacist's absence from the pharmacy, including the circumstances in which pharmacy staff must seek advice from the responsible pharmacist. However, as a further safeguard, the Government believes the regulations should require the responsible pharmacist to ensure that, as necessary, pharmacy staff may readily contact him/her during his/her absence to obtain advice or to request his/her return to the pharmacy. For example, where another pharmacist is not also working in the pharmacy or where the responsible pharmacist has not arranged for another pharmacist to be available to provide advice.
5.23 The Government does not propose that the regulations should set out the ways in which the responsible pharmacist is to maintain contact with pharmacy staff when absent from the pharmacy. Nevertheless, the Government believes that it is important to consider some of the practical implications before placing too much reliance on, for example, telephone contact because of possible mobile telephone network failure (as occurred during the terrorist attacks in London in July 2005) or poor quality or lack of reception in some areas.
5.24 During informal consultation, the Government sought views on the kind of arrangements that a responsible pharmacist will need to consider. A number proposed a requirement that details of the responsible pharmacist's location and contact(s) at that location should be included in the pharmacy procedures or the pharmacy record. The Government's view is that it may not be practical to specify in regulations that pharmacy procedures include such detail - for example, this may result in the need for frequent amendment of procedures each time the responsible pharmacist is away at a different location. Another proposal was that it would be more appropriate to provide advice on maintaining contact with pharmacy staff in guidance rather than in the regulations. The Government welcomes further views on maintaining contact with pharmacy staff and the need for guidance.
Q. Do you agree the regulations should require the responsible pharmacist, as necessary, to remain readily contactable by pharmacy staff?
Q. What is your view on the proposal that it may be more practical and appropriate to offer advice on this in guidance?
Q. If you do not agree with these proposals, what do you propose and what are your reasons for putting your proposals forward?
Arrangements where the responsible pharmacist may be unable to maintain contact with pharmacy staff during his/her absence from the pharmacy
5.25 In some circumstances, the responsible pharmacist may be unable to maintain contact with pharmacy staff. For example, where for the whole of the period of absence the responsible pharmacist is engaged in required activities to maintain his/her professional skills or s/he is engaged in a number of consultations with patients. In such circumstances, the responsible pharmacist may not be in a position to respond quickly to a call from pharmacy staff to provide advice. Again, as an additional safeguard, the Government sought views informally on whether the regulations should require the responsible pharmacist to arrange for another pharmacist to provide professional advice where s/he is unable to maintain contact with pharmacy staff during any period of absence from the pharmacy. The Government also sought views on whether the responsible pharmacist should be required to make such arrangements only with another responsible pharmacist or a pharmacist that is eligible to be a responsible pharmacist.
5.26 Where a responsible pharmacist is unable to maintain contact with pharmacy staff during any period of absence, the majority considered the regulations should require him/her to arrange for another pharmacist to provide professional advice. However, this requirement should not specify that the other pharmacist must be a responsible pharmacist or eligible to take on this role. The Government is now seeking wider views on these proposals.
Q. Do you agree the regulations should require the responsible pharmacist to arrange for another pharmacist to provide advice where s/he is unable to maintain contact with the pharmacy during his/her absence?
Q. Further, do you agree that it is unnecessary for the regulations to specify that the other pharmacist should also be a responsible pharmacist or a pharmacist eligible to take on this role?
Q. If you do not agree with one or either of these proposals, what do you propose and what are your reasons for putting this view forward?
5.27 Again, the Government does not propose the regulations should specify how the responsible pharmacist is to ensure another pharmacist is available to provide advice where s/he is not contactable by pharmacy staff during his/her absence. This is because the responsible pharmacist will need to take into account the other proposed conditions for absence. In addition, the responsible pharmacist and the other pharmacist with whom s/he makes such arrangements will need to exercise professional judgement in assessing how these arrangements will maintain safe working in the pharmacy.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for this?
5.28 It may be helpful to set how the responsible pharmacist will meet the proposed conditions supporting absence from the pharmacy. For example:
Scenario 1
The responsible pharmacist is the only pharmacist working in a pharmacy. If wishing to be absent from the pharmacy, s/he must take into account the specified maximum time for absence and this will include the pharmacist's journey time from and back to the pharmacy. The responsible pharmacist must also judge how journey time will affect the requirement to return with reasonable promptness as, in these circumstances, the period of absence may be significantly less than the proposed maximum of three hours. In addition, the responsible pharmacist must set out arrangements for pharmacy staff to contact him/her during that absence, taking into account any time within that period when s/he is not contactable and whether this requires arrangements with another pharmacist (who will not be present in the pharmacy) to provide advice during that time. Both pharmacists will need to use their professional judgement in agreeing that arrangements made will continue to support the safe running of the pharmacy.
Scenario 2
There are two pharmacists working in the pharmacy. The responsible pharmacist will be absent from the pharmacy, leaving the other pharmacist present in the pharmacy whilst s/he is away. As another pharmacist remains present in the pharmacy, the maximum time might vary - allowing a longer time for absence. However, the responsible pharmacist must still take into account the specified maximum time for absence, which will include journey times from and to the pharmacy and, in doing so, the requirement to return to the pharmacy with reasonable promptness if required to do. Again, the responsible pharmacist must also set out arrangements for pharmacy staff to contact him/her during that absence (eg to request return) taking into account any time within that period when s/he is not contactable.
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