CHAPTER 2: THE RESPONSIBLE PHARMACIST
The Medicines Act: The "Personal Control" Requirement
2.1 Currently, sections 70, 71 and 72 of the Medicines Act require each registered pharmacy premises, operated by individual pharmacists, partnerships, bodies corporate or a representative of a pharmacist, to be under the "personal control" of a pharmacist.
The Medicines Act: The Pharmacist Supervision Requirements
2.2 Section 10 and Section 52 of the Medicines Act place a requirement on the pharmacist to undertake or supervise individual transactions involving the preparation, assembly, sale and supply of medicines, other than those on the General Sales List ( GSL medicines).
Interpretation of these separate statutory requirements
2.3 The Medicines Act does not define "personal control" nor does it set out how the pharmacist in charge of the pharmacy is to exercise this requirement. This lack of clarity and limited case law has meant that, over the years, a common interpretation has emerged requiring the pharmacist to be physically present in the pharmacy at all times when it is operating in order to meet both of these separate and different Medicines Act requirements - ie the personal control and the pharmacist supervision requirements.
2.4 Many community pharmacies operate with a single pharmacist. As such, s/he is the pharmacist in personal control of the pharmacy and the pharmacist supervising individual transactions. The Government believes this contributes to the perceived requirement on the pharmacist in charge to be present in the pharmacy at all times in order to exercise "personal control" and to permit the sale and supply or medicines from the pharmacy.
2.5. Many pharmacists, pharmacy organisations and others have made clear the need for changes to the current statutory framework to remove constraints on pharmacists' ability to offer services other than the dispensing or sale of medicines in the pharmacy, including where this might be in partnership with other healthcare professionals. In addition, it has resulted in an anomaly in relation to the sale of GSL medicines from pharmacies and from other retail outlets. People are unable to buy a GSL medicine from a pharmacy unless a pharmacist is present in the pharmacy at the time of sale. If the pharmacist is absent, the purchaser must go elsewhere to buy the medicines or await the return of the pharmacist. However, the sale of GSL medicines from other retail outlets (eg a corner shop or newsagents) is not dependent on the presence of a pharmacist in order to permit sale. Thus, pharmacies are out of line with other retails outlets with regard to the sale of GSL medicines, which limits the public's access to these medicines.
2.6 Following the response to consultation in 2005, which indicated strong and clear support for change, the Government brought forward legislation in 2006 to clarify the "personal control" requirement in the Medicines Act. The Health Act 2006 amends the Medicines Act in a way that makes explicit that "personal control" relates to the day-to-day management of the pharmacy with the pharmacist in charge (the responsible pharmacist) ensuring the pharmacy operates safely and effectively in relation to the sale and supply of medicines to the public. Further, the duty on the responsible pharmacist to secure the safe and effective running of the pharmacy makes clear that his/her responsibilities extend beyond the requirement to supervise individual transactions involving the sale and supply of medicines. These include, for example, arrangements for the safe ordering, storage and disposal of medicines (including controlled drugs) and for ensuring the availability of trained, competent, pharmacy staff to undertake specific tasks in the pharmacy.
2.7 If the pharmacy is to operate safely and effectively, the pharmacist in charge must set out arrangements that continue to support safe working whether or not s/he is physically present in the pharmacy. Either the pharmacy is operating safely or it is not and this is not dependent on the pharmacist in charge of the pharmacy being physically present in the pharmacy at all times whilst it is operating.
Personal Control and the Responsible Pharmacist
2.8 Sections 27, 28 and 29 of the Health Act amend sections 70, 71 and 72 of the Medicines Act to replace "personal control" with a new requirement for each registered pharmacy premises to have a responsible pharmacist, whether operated by an individual pharmacist, a partnership, a body corporate or a representative of a pharmacist. He or she will be the pharmacist in day-to-day charge of the business insofar as this relates to the retail sale or supply of medicines. This role is distinct from that of the superintendent pharmacist, who has overarching responsibilities within a body corporate to ensure that a pharmacist is in charge of each pharmacy owned by the company and the company meets statutory, ethical and professional requirements and standards.
The Responsible Pharmacist: Statutory Duty
2.9 To provide further clarification on the responsible pharmacist requirement, section 30 of the Health Act inserts a new section 72A into the Medicines Act to place a statutory duty on the responsible pharmacist to secure the safe and effective running of the pharmacy and to set out how the responsible pharmacist is to carry out that duty.
2.10 Each pharmacy is to have a responsible pharmacist. Only one pharmacist may be responsible for a pharmacy at any one time. The responsible pharmacist
- may not be responsible for more than one pharmacy at any one time except in specified circumstances set out in regulations and then only if certain conditions are met
- must establish (where these are not already established), maintain and review procedures (eg Standing Operating Procedures ( SOPs)) that determine how activities are to be carried out in the pharmacy
- must maintain a record, at the pharmacy premises, of the pharmacist responsible for that pharmacy on any date and at any time.
2.11 There is also a statutory duty on the pharmacy owner to ensure that the responsible pharmacist properly maintains the pharmacy record. The pharmacy owner is required to preserve the record for the period specified in the regulations
2.12 The new section 72A also allows Health Ministers to set out in regulations further detail as to how the responsible pharmacist is to exercise the duty, including
- 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 Government believes that this regulatory framework will underpin quality assurance systems in the pharmacy that support the responsible pharmacist in exercising the statutory duty to secure safe and effective operation of the pharmacy.
Pharmacy Businesses Carried on by a Body Corporate: The Superintendent Pharmacist and the Responsible Pharmacist
2.13 The Health Act amendments to section 71 of the Medicines Act do not affect the role and responsibilities of the superintendent pharmacist of a body corporate. The pharmacy business is required to ensure that the sale and supply of medicines is under the management of a superintendent pharmacist. Where the superintendent pharmacist is not the pharmacist responsible for a pharmacy operated by the business, another pharmacist must be available to meet this requirement. The superintendent pharmacist continues to have overall management accountability and the pharmacist responsible for a pharmacy will remain subject to the directions of the superintendent pharmacist.
2.14 The Government considers it is important to ensure clarity on the different statutory role of the superintendent pharmacist and that of the responsible pharmacist. The Government's view is that the superintendent pharmacist has an overall governance and monitoring role - for example,
- within the pharmacy business, to ensure a company's policies and governance framework, within which pharmacists and other pharmacy staff work, support safe, effective and professional pharmacy practice
- to ensure that pharmacists employed by the company are able to meet legal, ethical and professional standards
- to monitor the service quality and professional standards set for the pharmacy business, ensuring that processes are in place to maintain standards and to act to improve standards further
2.15 The superintendent pharmacist, as part of his/her statutory and professional responsibility, has a duty to ensure that all the company's pharmacies operate within the legislative framework, to ensure that pharmacists and other staff employed by the company understand these requirements, and that each company pharmacy operates safely. The Government believes this role is distinct from, but complementary to, the responsible pharmacist's role to secure the safe and effective day-to-day operation of the individual pharmacy.
Pharmacy Businesses Carried on by Individuals or Partnerships or a Representative of a Pharmacist: The Responsible Pharmacist
2.16 The legislation addresses the need to ensure the safe and effective operation of all registered pharmacies. Not all registered pharmacies are part of a body corporate with a requirement to have a superintendent pharmacist. Section 70 of the Medicines Act relates to pharmacy businesses carried on by individuals or partnerships and Section 72 to businesses carried on by a representative of a pharmacist (for example, someone who carries on the business following the death of a pharmacist).
2.17 As with bodies corporate, there is a need to ensure clarity of the role of the responsible pharmacist in relation to a pharmacy business carried on by an individual owner, a partnership or someone representing a pharmacist. There will be a number of possible arrangements. For example,
- A individual pharmacy business owned and operated by a pharmacist who is both the pharmacy owner and the responsible pharmacist for that pharmacy
- A pharmacist with three pharmacies operating as part of his business, who has appointed responsible pharmacists for two of these pharmacies at any one time, will be the pharmacy owner and responsible pharmacist for only one of the pharmacies. For the other two pharmacies, he is the pharmacy owner
- A partnership, in which only one partner is a pharmacist, owns two pharmacies. Both have responsibilities as pharmacy owners but only the partner who is a registered pharmacist may be responsible for one of the pharmacies at any one time. They will need to appoint another pharmacist as the responsible pharmacist for the second pharmacy.
- A pharmacy business carried on by a representative of a pharmacist. Again, if that representative is not a pharmacist, he must appoint a responsible pharmacist to be in charge of each of the pharmacies carried on by that business. He may not be in charge of any of the pharmacies and, in representing the pharmacy owner, must carry out the owner's statutory responsibilities.
For each of these, the Government's view is that the pharmacy owner(s) should be clear as to their statutory responsibilities and of those they appoint to be in charge of a pharmacy.
2.18 Thus, the pharmacy owner, where not also the responsible pharmacist and in the case of a body corporate the superintendent pharmacist, must
- Ensure that a pharmacist is appointed as the responsible pharmacist for each of the pharmacies within the pharmacy business
- Enable the responsible pharmacist to meet the statutory duty placed on him/her to ensure the pharmacy is operating safely and effectively - including allowing the responsible pharmacist to exercise his/her professional judgement, where appropriate, as to pharmacy procedures and staffing requirements for that pharmacy
- Ensure the responsible pharmacist properly keeps the pharmacy record
- Ensure the pharmacy record is preserved for each pharmacy for as long as specified in the regulations
2.19 The Royal Pharmaceutical Society of Great Britain has recently issued a revised Code of Ethics, together with professional standards for pharmacists and pharmacy technicians in positions of authority. These standards will apply where a pharmacist owns a pharmacy business, is a superintendent pharmacist or is a pharmacist responsible for an individual pharmacy. The Pharmaceutical Society of Northern Ireland Code of Ethics for pharmacists and superintendent pharmacists sets out principles and obligations, together with guidance on standards of good professional practice 1.
The Responsible Pharmacist Regulations
2.20 In the following chapters, this consultation paper considers a range of proposals relating to the content of the responsible pharmacist regulations. These take into account the views put forward during the informal consultation events hosted by the UK Health Departments in February and March 2007 and in further meetings with a number of pharmacy organisations.
- Chapter 3 sets out proposals relating to pharmacy procedures
- Chapter 4 sets out proposals relating to the pharmacy record of the pharmacist responsible for the pharmacy on any date and at any time
- Chapter 5 looks at the ability of the responsible pharmacist to be absent from the pharmacy
- Chapter 6 considers matters relating to the qualifications and experience needed to be a responsible pharmacist
- Chapter 7 looks at the statutory requirement that each pharmacy is to have a responsible pharmacist who may only be responsible for one pharmacy at the same time. Chapter 7 also considers possible exceptional circumstances, together with specified conditions, that will allow a pharmacist to be responsible for more than one pharmacy at the same time
- Chapter 8 puts forward possible conditions to be met if a responsible pharmacist is to supervise individual transactions involving the sale and supply of medicines in a pharmacy where s/he is not the responsible pharmacist
- Chapter 9 looks at other matters relating to the responsible pharmacist regulations, such as enforcement. It also seeks views on the timing of introduction of the responsible pharmacist regulations (such as the time needed to prepare for these changes) and the need for guidance to support introduction of the regulations
Remote Supervision by the Responsible Pharmacist: Later Consultation
2.21 At this stage, the Government is not seeking views on the content of regulations relating to the ability of the responsible pharmacist to supervise the preparation, assembly, sale and supply of medicines when he or she is away from the pharmacy. That is, to supervise activities from another location (or remotely) with the aid of new technologies. This is because the Government believes it will be more helpful and appropriate to seek views on these provisions within the context of wider consultation on proposals for the content of the regulations relating to pharmacist supervision. The Government will be consulting on the pharmacist supervision regulations later.