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CHAPTER 1: INTRODUCTION

1.1 The four UK Health Departments have published strategies for developing NHS pharmaceutical services, which highlight the importance of making the best use of all staff working in pharmacies. These strategies are set out in

• Remedies for Success: A Strategy for Pharmacy in Wales (2002)
• The Right Medicine: A Strategy for Pharmaceutical Care in Scotland (2002)
• A Vision for Pharmacy in the New NHS: (England 2003)
• Making it Better - a Strategy for Pharmacy in the Community (Northern Ireland 2004)

1.2 These plans for NHS pharmacy services, together with the introduction of changes to the NHS community pharmacy contractual arrangements (in England and Wales from 1 April 2005, in Scotland from 1 April 2006 and expected in Northern Ireland in the future), are part of action to improve

• patients' choice and experience through wider access to services that are convenient to modern lifestyles
• public health and how we tackle inequalities
• support in the community for people with long term conditions
• professional advice and support for self care

1.3 If pharmacists are to make full use of their clinical training and expertise in the actions, uses and side effects of medicines and to develop their important role and contribution to professional healthcare teams working in the community and in hospitals, they need to be able to extend the range of services they can offer. For example, in the community, pharmacists have a long and valued tradition of providing the public with readily accessible professional advice in pharmacies on high streets and in shopping centres. Community pharmacies can offer more than the safe and efficient dispensing of NHS prescriptions and the sale of medicines - such as advice on healthy lifestyles (eg stopping smoking), diagnostic testing (eg ensuring the right dose of medicine to slow the clotting rate of blood) and the provision of professional clinical advice to patients experiencing problems in using their medicines.

1.4 To support pharmacists in developing their clinical role and contribution to improving healthcare services, better and more flexible use must also be made of the skills of pharmacy staff (such as pharmacy technicians, dispensing assistants and others) to maintain the safe and effective delivery of dispensing services and the sale of medicines. However, many pharmacists and pharmacy organisations feel that the current legal framework limits the ability of pharmacists to enhance their clinical role and to extend the range of pharmacy services offered, as this will involve pharmacists' ability to be absent from the registered pharmacy premises from time to time.

1.5 Therefore, in 2005, the Government consulted on the scope for changes to the Medicines Act 1968 (the Medicines Act) and related NHS legislation. That is, legislation concerning the requirements on the pharmacist in charge of a registered pharmacy and the requirements on the pharmacist to supervise the preparation, assembly, sale and supply of medicines.

1.6 The consultation paper, Making Better Use of the Pharmacy Workforce, published in England in December 2004 also formed the basis of consultation by the Welsh Assembly Government. Consultation took place in Scotland from February 2005 and in Northern Ireland from April 2005. The paper and a summary of the responses to this consultation are available on the Department of Health website at www.dh.gov.uk/consultations/consultationslibrary.

1.7 The overall response to consultation was strong and clear. The majority of respondents felt there was a need for legislative change to allow pharmacists and pharmacy owners to make better use of the skills and training of all those working in pharmacies to

• underpin the further development of pharmacy services (including pharmacy's contribution to public health), in particular through the NHS community pharmacy contractual arrangements
• improve the public's access to medicines

The Medicines Act 1968: The Personal Control Requirement

1.8 Currently, the Medicines Act, which is UK-wide, requires the business of the retail sale and supply of medicines through registered pharmacies to be under the "personal control" of a pharmacist.

1.9 The Medicines Act does not define "personal control" nor does the Act set out how the pharmacist in charge of the pharmacy is to exercise this requirement. In 1981, the case of R v Logan indicated that some physical presence of the pharmacist in the pharmacy would be required for the pharmacist to exercise personal control. However, that decision also indicated that the sale of General Sales List ( GSL) ( - ie those medicines that other retail premises, as well as pharmacies, may sell,) could take place when the pharmacist was away from the pharmacy. More recently, the Royal Pharmaceutical Society's Statutory Committee advised that if a pharmacist is not in personal control of a pharmacy (for instance, because s/he is not on the registered pharmacy premises), transactions involving the sale or supply of medicines, including the sale of GSL medicines, may not take place.

1.10 This lack of clarity in the Medicines Act - and the availability of limited case law - means that a common interpretation has emerged requiring the pharmacist to be physically present in the pharmacy at all times if s/he is to exercise control and allow the sale and supply of medicines to continue from the pharmacy. This includes the sale of GSL medicines. In order to buy GSL medicines from a pharmacy, if the pharmacist is absent, people must await his/her return or visit another pharmacy where the pharmacist is present. Yet there is no requirement for a pharmacist to be present when people purchase these medicines from retail outlets such as garage shops or newsagents.

1.11 Importantly, there is a view that this interpretation also limits the pharmacist's ability to use fully his/her clinical training in providing services, other than the dispensing and sale of medicines, from pharmacies. Currently, pharmacists are constrained in using their extensive training and expertise in medicines to enhance their clinical role and contribution to improving services for patients in the community and in hospital. Further, there is a need for clarity on what is required of a pharmacist who is in charge of a pharmacy, resulting in an emphasis on the physical presence of the pharmacist in the pharmacy to meet the "personal control" requirement.

1.12 In England, 75% of respondents to the consultation in 2005 called for greater clarity on the Medicines Act requirement that each registered pharmacy must be under the personal control of a pharmacist where this concerns the preparation, assembly, sale and supply of medicines. Of those expressing a view on redefining the "personal control" requirement, around 50% wanted to see this expressed in terms of the pharmacist's professional responsibilities. About 60% of respondents supported the need for legislative changes in relation to the sale of General Sales List ( GSL) medicines to bring pharmacies more into line with other retail outlets selling these medicines.

The Medicines Act 1968 and related NHS Legislation: The Pharmacist Supervision Requirements

1.13 Under the Medicines Act the sale and supply of medicines, other than GSL medicines, is required to be under the supervision of a pharmacist. However, in England, Scotland and Wales, where supplied through a pharmacy via an NHS prescription, current NHS legislation requires a pharmacist to supervise directly the supply of all medicines. The Pharmaceutical Services Regulations (Northern Ireland) 1997 make a similar provision for Northern Ireland.

1.14 The majority of those responding to the 2005 consultation (80%) wanted to see changes to the pharmacist supervision requirements to

• reflect modern pharmacy practice
• take into account the increasing availability of modern technologies
• allow pharmacists more flexibility in using the skills of pharmacy staff
• improve pharmacists' ability to offer services other than the dispensing and sale of medicines

The Health Act 2006

1.15 The Government responded to the call for legislatives changes. The Health Act 2006 (the Health Act) amends the Medicines Act and related NHS legislation in ways that reflect the support for legislative change. However, these changes do not affect the fundamental principle of the Medicines Act - to protect the public in relation to the sale and supply of medicines. Public and patient safety remains paramount.

The Health Act 2006: Key Changes

1.16 The Health Act amends the Medicines Act, and related NHS legislation, in a number of important ways. These are as follows.

"Personal Control" and the Responsible Pharmacist

1.17 The Health Act amends sections 70, 71 and 72 of the Medicines Act replacing "personal control" with a requirement that each pharmacy is to have a responsible pharmacist. Therefore, the Act continues to require a pharmacist to be in charge of each pharmacy. Further, this change does not affect what the Government believes to be the underlying concept of "personal control" - that is, a pharmacist must be in charge of each registered pharmacy to ensure that it is operating safely where this concerns the sale and supply of medicines to the public. It is now more explicit how the pharmacist in charge of the pharmacy is to meet this requirement.

The Superintendent Pharmacist

1.18 There are no changes to the Medicines Act requirement on a pharmacy owned by a body corporate to have a superintendent pharmacist to manage the pharmacy business in relation to the keeping, preparation and dispensing of medicines (other than GSL medicines). Where the superintendent pharmacist is not also in charge of a pharmacy operated by the business, the pharmacy must have a responsible pharmacist who remains subject to the directions of the superintendent pharmacist.

The Responsible Pharmacist: The Statutory Duty

1.19 The Health Act provides further clarification of the responsible pharmacist requirement with the insertion of a new section 72A into the Medicines Act. This new section places a statutory duty on the responsible pharmacist to secure the safe and effective running of the pharmacy. Section 72A makes clear that in exercising his/her statutory duty, the responsible pharmacist must

• establish (where these are not already in place), maintain, and review procedures for safe working in the pharmacy
• keep a record, in the pharmacy, of the pharmacist responsible for the pharmacy at any one time

The Pharmacy Owner: The Statutory Duty

1.20 There is a statutory duty on the pharmacy owner to ensure the responsible pharmacist properly maintains the pharmacy record. The pharmacy owner must also preserve the record for the period specified in regulations.

One Pharmacy/One Responsible Pharmacist

1.21 There is no change in the requirement that a pharmacist must be in charge of each pharmacy. The general "rule" remains that there is to be a pharmacist responsible for each pharmacy and that s/he may only be responsible for one pharmacy at the same time.

1.22 As now, each registered pharmacy (within hospitals and in the community) must have a responsible pharmacist. Where the pharmacy is operating without a responsible pharmacist, it must close for the sale and supply of medicines. Where there is more than one pharmacist working in the pharmacy, only one may be the responsible pharmacist at any one time. Further safeguards introduced through the Health Act are the statutory requirement on the responsible pharmacist to keep a record of the pharmacist responsible for the pharmacy on any date and at any time and the statutory requirement on the pharmacy owner to ensure the responsible pharmacist properly maintains the record. The pharmacy owner must also preserve the record for the period set out in regulations. To be absent from the pharmacy, the responsible pharmacist will also need to comply with conditions for absence set out in the regulations.

1.23 However, recognising the need for some flexibility to respond to future changes in pharmacy practice and the pace of development of modern technologies, Health Ministers may set out in regulations exceptions to this general "rule" - that is, where a pharmacist may be responsible for more than one pharmacy at the same time. During passage of the Health Act, the Government made clear its intention that these regulations tightly define any such exceptions, with a need to comply with the specified circumstances and conditions that will permit a pharmacist to be responsible for more than one pharmacy at the same time.

The Annual Return to the Registrar

1.24 The requirement to keep a record of the responsible pharmacist, in each registered pharmacy, replaces the requirement on the pharmacy owner (in section 77 of the Medicines Act ) to send an annual return to the registrar stating the name of the pharmacist in personal control of the pharmacy. In practice, the annual return provided details of the pharmacist in charge of a pharmacy only on the date it was sent to the registrar, whereas the pharmacy record will provide details of the pharmacist in charge of the pharmacy on any date and at any time.

The Responsible Pharmacist Regulations

1.25 The new section 72A allows Health Ministers to set out, in regulations, further details on how the responsible pharmacist is to exercise the statutory duty to secure the safe and effective running of the pharmacy. In the following chapters, the Government is seeking views on the content of these regulations, which may cover matters such as

• the qualifications and experience that a pharmacist must have to be a responsible pharmacist
• the ability of the responsible pharmacist to be absent from the pharmacy
• the ability of the responsible pharmacist to supervise individual transactions involving the preparation, assembly, sale and supply of medicines in the pharmacy from another location (what is known as "remote supervision)
• the circumstances in which a responsible pharmacist may supervise individual transactions involving the preparation, assembly, sale and supply of medicines in a pharmacy where s/he is not the responsible pharmacist
• the matters to be covered in the pharmacy procedures and the form in which the procedures are to be kept
• the information to be included in the pharmacy record and the form in which the record is to be kept

The Pharmacist's Registration Certificate

1.26 The Government took the opportunity to amend the requirement in sections 70, 71 and 72 of the Medicines Act on the pharmacist in personal control of the pharmacy to display his/her registration certificate conspicuously in the pharmacy. In practice, although not required to do so, most (if not all) pharmacists working in the pharmacy display their registration certificates even when they are not the pharmacist in charge. This can make it difficult for the public and others to identify the pharmacist in personal control of the pharmacy.

1.27 Therefore, sections 27, 28 and 29 of the Health Act amend sections 70, 71 and 72 of the Medicines Act to replace the requirement on the pharmacist in personal control of the pharmacy to display his/her registration certificate. Instead, the responsible pharmacist is required to display a notice, conspicuously, in the pharmacy stating that he/she is the pharmacist in charge of the pharmacy on that particular day and time with details of his/her registration number.

General Sales List ( GSL) Medicines

1.28 Sections 51 and 53 of the Medicines Act relate to GSL medicines (ie medicines sold from retail premises, as well as pharmacies, without the supervision of a pharmacist). The responsible pharmacist requirement clarifies that the exercise of the statutory duty to ensure the safe and effective running of the pharmacy is not dependent on the responsible pharmacist's physical presence in the pharmacy. To meet this requirement, the responsible pharmacist must be sure that effective procedures are in place to support the safe sale and supply of all medicines from the pharmacy, whether or not s/he is present in the pharmacy. Thus, the responsible pharmacist's presence in the pharmacy is not required to permit the sale of GSL medicines - bringing the sale of these medicines more in line with other retail outlets where there is no requirement for a pharmacist to be present on the premises to permit sale.

1.29 However, where GSL medicines are part of an NHS prescription, the pharmacist supervision requirements will continue to apply. This is because the Government continues to believe that it is important to make a clinical assessment of the whole prescription, not just part of the treatment - for example, so the pharmacist can ensure there are no interactions between the different medicines. Therefore, as now, supervision of the dispensing of any GSL medicine, where part of an NHS prescription, is required to be on the same basis as Pharmacy (P) and Prescription Only Medicines ( POM).

The Pharmacist Supervision Requirements

1.30 Amendments to the Medicines Act, made by the Health Act, also provide for regulation making powers to clarify what a pharmacist must do in order to discharge the requirements in Section 10 and Section 52 of the Medicines Act. That is, the requirement on the pharmacist to supervise the preparation, assembly, sale and supply of medicines and the circumstances in which a pharmacist may supervise these activities remotely (eg from a location away from the pharmacy). Section 10 allows pharmacists (and those acting under the supervision of a pharmacist) to prepare and assemble medicinal products, other than in accordance with a licence granted by the Medicines and Healthcare Products Regulatory Authority ( MHRA), in community and hospital pharmacies.

1.31 In tandem with existing powers in the Medicines Act, the changes introduced by the Health Act will allow the pharmacist to permit a suitably trained and registered pharmacy technician (or another suitably trained and registered healthcare professional) to supervise certain aspects of dispensing involving the preparation, assembly, sale and supply of medicines. This will be subject to meeting specified conditions to be set out in regulations. Thus, subject to compliance with these specified conditions, the pharmacist will be able to maintain a safe and effective dispensing service whilst also using his/her clinical expertise to develop and provide other pharmacy services.

Pharmacy Services, other than the Preparation, Sale and Supply of Medicines

1.32 It is important to be clear that these legislative changes relate to requirements in the Medicines Act concerning the preparation, assembly, sale and supply of medicines through pharmacies and the requirements in the Medicines Act and NHS legislation relating to pharmacist supervision of these activities. These changes concern all registered pharmacies - in the community and in hospitals.

1.33 These changes do not concern other activities in the pharmacy unrelated to the sale or supply of medicines. NHS legislation governs wider NHS pharmaceutical services such as those provided through community pharmacy contractual arrangements. For example, these services will include

• health promotion
• support for self-care
• medicines use reviews ( MURs) to improve the way people use their medicines and
• working as part of multi-professional or multi-agency teams to deliver services commissioned by Primary Care Trusts and Local Health Boards to meet specific local health needs, other than the sale or supply of medicines

These do not form part of this consultation paper.

Regulations under the Health Act 2006

1.34 In January 2006, the UK Health Departments published an information paper setting out some initial thinking on how regulations under the Health Act might be developed. The information paper made clear the Government's commitment to consult with all interested parties on work to develop the regulations. It is available on the Department of Health website at www.dh.gov.uk/publicationsandstatistics/publicationsandguidance

Consultation on the Regulations

1.35 These are complex changes. Therefore, the Government has decided to take a phased approach to consultation on the content of the regulations and on the timing of commencement - ie the date for introducing the changes set out in the regulations.

1.36 The statutory requirements relating to the responsible pharmacist are largely mandatory. Every registered pharmacy must have a pharmacist responsible for the safe and effective running of the pharmacy. Those relating to the supervision requirements are enabling, subject to certain circumstances and conditions being in place in the pharmacy.

1.37 As the responsible pharmacist provisions set the framework for the quality assurance system underpinning the safe operation of each pharmacy, the Government believes that it is important to put this regulatory framework in place before introducing the changes relating to pharmacist supervision. Therefore, the Government is starting with consultation on the content of the responsible pharmacist regulations. Consultation on the pharmacist supervision requirements will follow later.

1.38 As a first step, in February and March 2007, the UK Health Departments hosted a series of informal consultation events to allow all interested parties an opportunity to discuss and inform the development of the responsible pharmacist regulations. Those attending these events, and others, also had an opportunity to respond to outline proposals via e-mail or, where requested, further meetings with the Health Departments. The Government thanks all those who contributed to these discussions and, in particular, for providing valuable feedback to inform the preparation of this consultation paper.

1.39 This paper builds on previous consultations and provides a further opportunity to respond to proposals on the content of the responsible regulations setting out how the responsible pharmacist is to discharge his/her statutory duty to secure the safe and effective running of the pharmacy insofar as this relates to the preparation, assembly, sale and supply of medicines.

Timetable for Consultation

1.40 In accordance with best practice on public consultation, the Government has allowed 12 weeks for the receipt of responses, commencing with the date of issue of this paper.

Confidentiality Disclaimer

1.41 Information provided in response to this consultation, including personal information, may be published or disclosed in accordance with access to information regimes (primarily, the Freedom of Information Act 2000 ( FOIA), the Data Protection Act 1998 ( DPA) and the Environmental Information Regulations 2004).

1.42 If you want the information that you provide to be treated as confidential, please be aware that under the FOIA there is a statutory Code of Practice with which public authorities must comply and which deals, amongst other things, with obligations of confidence. In view of this, it would be helpful if you could explain why you regard the information that you have provided to us as confidential. If we receive a request for disclosure of the information, we will take full account of your explanation but we cannot give an assurance that we can maintain confidentiality in all circumstances. The Department will not regard, of itself, any automatic confidentiality disclaimer generated by your IT system as binding on the Department. The Department will process your personal data in accordance with the DPA. In the majority of circumstances, this will mean the Department will not disclose your personal data to a third party.

Compliance with Cabinet Office Code of Practice on Consultation

1.43 This public consultation follows the Cabinet Office Code of Practice on Consultation. This document is available in the consultations section of the Department of Health website. In due course, a summary of views received in response to the consultation will also be available on the website, together with the Government's response and proposals for action. The six consultation criteria set out in the Code of Practice are as follows:

1. Consult widely throughout the process, allowing a minimum of 12 weeks for written consultation at least once during the development of policy
2. Be clear about your proposals, who may be affected, what questions are being asked, and the timescale for responses
3. Ensure that your consultation is clear, concise and widely accessible
4. Give feedback regarding the responses received and how the consultation process influenced the policy
5. Monitor your department's effectiveness at consultation, including through use of a designated consultation co-ordinator
6. Ensure your consultation follows better regulation best practice, including carrying out a Regulatory Impact Assessment, if appropriate

Impact Assessment

1.45 The Government is committed to action to reduce unnecessary regulatory burdens and, therefore, has examined the need to carry out an impact assessment on these regulations. The conclusion is this is not required, as the regulations do not pose any additional burden for the sectors that are likely to be affected. The regulations do not introduce a new policy but continue to support existing principles underlying the Medicines Act 1968 that safeguard the public in relation to the sale and supply of medicines from registered pharmacies. The regulations clarify how the pharmacist is to exercise his/her responsibilities when in charge of a pharmacy to secure safe and effective working in the pharmacy.

Responding to this Consultation

1.46 The Government is allowing extra time for response to this consultation as this includes the Christmas holiday period. In Scotland, responses to the consultation may be e-mailed to mary.waugh@scotland.gsi.gov.uk or sent to

Mary Waugh

1.47 Responses are invited by no later than 20 January 2008. A summary of the response to consultation will be published in due course.

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