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APPENDIX B: THE RESPONSIBLE PHARMACIST: FREQUENTLY ASKED QUESTIONS

WHY CHANGE?

A. The current legislation in the Medicines Act 1968 (the Medicines Act) is unclear. There is a requirement that each registered pharmacy must be under the "personal control" of a pharmacist. However, the Medicines Act does not define "personal control" nor does it specify how the pharmacist is to exercise "personal control".

The Medicines Act requires the sale and supply of medicines, other than general sales list ( GSL) medicines, to be under the supervision of a pharmacist. Further, NHS legislation requires the supply of all prescribed medicines to be under the direct supervision of a pharmacist.

The uncertainty about the personal control requirement and the different provisions in the Medicines Act and NHS legislation on pharmacist supervision have resulted in a common interpretation of the law as

• the pharmacist is only exercising personal control if he/she is physically present in the pharmacy at all times just as pharmacist supervision requires the physical presence of the pharmacist
• GSL medicines (where not supplied as part of an NHS prescription) may only be sold from a pharmacy when the pharmacist is present - although there is no requirement for a pharmacist to be present when these medicines are sold from other retail outlets such as a garage shop or newsagents
• If a pharmacy does not have a pharmacist in personal control, (i,e. because the pharmacist is not present in the pharmacy) nothing requiring the presence of the pharmacist (ie the sale or supply of POM and P) may take place.

The uncertainties arising from current legislation

• constrain pharmacists from using their extensive clinical training and expertise to provide a range of other services to patients, other than the dispensing of medicines, both in and away from the pharmacy

• prevent the pharmacist from working with other healthcare professionals away from the pharmacy or providing services to patients in clinics or their own homes

• make it difficult for the pharmacist to engage in continuous professional development or to participate in local health services planning
• hamper better use of the skills and training of other staff working in pharmacies (eg pharmacy technicians)
• prevent the pharmacist from leaving the pharmacy when it is open to the public
• restrict people's access to medicines - if the pharmacist is not present, they must await his/her return before they may collect prescriptions or purchase GSL medicines or travel to another pharmacy where the pharmacist is present
• highlight the need for change to keep pace with modern pharmacy practice and to enhance the ability of pharmacists to contribute to health strategies that increasingly focus on patient choice, improving public health and the provision of patient care and treatment in the community

There was strong and clear support for legislative change in response to the 2005 consultation on improving pharmacy skill mix. Around 75% of respondents wanted to see clarification of the "personal control" requirement and 80% wanted to see changes to the pharmacist supervision requirements to allow pharmacists to make better use of their skills and training and those of pharmacy staff.

THE PHARMACY

Q. What is the definition of "pharmacy" in relation to the responsible pharmacist?

A. In relation to the responsible pharmacist, "pharmacy" relates to registered pharmacy premises in hospitals and in the community.

The Medicines Act states a pharmacy business is one that concerns the retail sale of medicinal products or the supply of such products in circumstances corresponding to retail sale, excluding those businesses that sell only GSL medicines.

Pharmacy businesses can be carried on by individual pharmacists, partnerships of pharmacists (in Scotland where one or more of the partners is a pharmacist), bodies corporate or a representative of a pharmacist. In all circumstances, lawful conduct of the pharmacy insofar as it concerns the retail sale of medicines at the premises must be under the personal control of someone who is a pharmacist.

The Health Act 2006 (the Health Act) amends the Medicines Act to replace the "personal control" requirement with a requirement that each pharmacy is to have a responsible pharmacist.

THE RESPONSIBLE PHARMACIST

Q. Who will be the responsible pharmacist?

A. Under current legislation, sections 70, 71 and 72 of the Medicines Act require each pharmacy to be under the "personal control" of a pharmacist insofar as this concerns the retail sale of medicines from the pharmacy. The pharmacist "in personal control" is the pharmacist in day-to-day charge of an individual pharmacy.

The Health Act amends sections 70, 71 and 72 to replace the "personal control" requirement with a requirement that each pharmacy is to have a responsible pharmacist. The Health Act also 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 sets out a framework of how the responsible pharmacist - the pharmacist in charge of the pharmacy - is to exercise that duty.

The pharmacist in charge of a pharmacy on any day and at any time is the responsible pharmacist.

If a locum pharmacist is the only pharmacist working in the pharmacy, he or she will be the responsible pharmacist - as under current legislation the locum pharmacist is the pharmacist in personal control of the pharmacy if he/she is the only pharmacist in the pharmacy. As now with the "personal control" requirement, if a pharmacy does not have a responsible pharmacist it may not remain open for business involving the sale or supply of medicines. However, changes to the Medicines Act now make clear that the exercise of the statutory duty is not dependent on the responsible pharmacist's physical presence in the pharmacy at all times. Regulations may provide for the responsible pharmacist's absence from the pharmacy, whilst s/he remains responsible for the safe running of the pharmacy.

Currently, the Medicines Act makes separate provisions in relation to the pharmacist in "personal control" of the pharmacy insofar as this concerns the retail sale of medicines from the pharmacy (sections 70 to 72) and in relation to the requirement for a pharmacist to supervise the preparation, assembly, sale and supply of medicines (section 10 and section 52).

The Health Act 2006 amends the Medicines Act to replace the "personal control" requirement with a requirement that each pharmacy is to have a responsible pharmacist. There continue to be separate provisions in the Medicines Act in relation to the responsible pharmacist (sections 70, 71, 72 and 72A) and the supervision requirements (sections 10 and 52).

In many cases, where there is only one pharmacist working in the pharmacy, he or she will be the pharmacist responsible for the safe operation of the pharmacy and the pharmacist meeting the statutory requirement to supervise individual transactions involving the preparation, assembly, sale and supply of medicines. However, where there are two pharmacists working in the pharmacy, only one of them may be the responsible pharmacist at any one time.

It is for the owner of a pharmacy business, or where the pharmacy business is part of a body corporate the superintendent pharmacist, to ensure that each pharmacy has a responsible pharmacist and to appoint the responsible pharmacist. Where there is more than one pharmacist working in the pharmacy at the same time, one will be the responsible pharmacist although all may be fulfilling the supervision requirements.

Q. When does the responsible pharmacist take on responsibility for the pharmacy?

A. It is a statutory requirement that each pharmacy must have a responsible pharmacist when the pharmacy is operational - ie carrying out activities relating to the retail sale of medicines and their supply in circumstances corresponding to retail sale - ie dispensing.

This will include carrying out some of these activities on the premises when the pharmacy is not open to the public - for example, out of hours and on-call arrangements. If the on-call or out of hours pharmacist is the pharmacist recorded as the pharmacist in charge of the pharmacy on that date and at that time, he or she is the responsible pharmacist. S/he may also be supervising transactions. Only one pharmacist may be responsible for a pharmacy at any one time. Therefore, if another pharmacist is also supervising transactions as part of on-call or out of hours arrangements in the pharmacy, s/he will not be the responsible pharmacist.

The expectation is that such arrangements will be included in pharmacy procedures set down by the responsible pharmacist, who is responsible for ensuring that pharmacy staff (including a supervising pharmacist) work within those procedures.

The pharmacy record will also provide details of the pharmacist responsible for the pharmacy on any date and at any time.

Q. Do these responsibilities include pharmacy staff training?

A. The responsible pharmacist has a statutory duty to secure the safe and effective running of the pharmacy. We would expect the responsible pharmacist to set out in the procedures the required skills, training and experience to undertake specified activities in the pharmacy and the pharmacy staff able to take on these responsibilities.

Thus, the responsible pharmacist will need to ensure the availability of suitably trained pharmacy staff to support the safe and effective preparation, assembly, sale and supply of medicines.

Where a pharmacy has a series of locums as the responsible pharmacist, the Government believes that the pharmacy owner (or in the case of a business carried on by a corporate body, the superintendent pharmacist) will have a significant part to play. For example, they can support pharmacy staff in developing their skills and competencies to ensure the delivery of a safe and effective dispensing service and other pharmacy services.

THE SUPERINTENDENT PHARMACIST

Q. What is the difference between the responsible pharmacist and the superintendent pharmacist?

A. Currently, section 71 of the Medicines Act requires that, where a body corporate carries on a pharmacy business, the business must be under the management of a superintendent pharmacist. Where the superintendent pharmacist is not the pharmacist in personal control of pharmacy, it must be under the personal control of a manager or assistant who is a pharmacist and who is subject to the directions of the superintendent pharmacist .

The Health Act amends the Medicines Act to replace the "personal control" requirement with a requirement that each pharmacy is to have a responsible pharmacist. However, there is no change in the responsibilities of the superintendent pharmacist. As now, the responsible pharmacist remains subject to the directions of the superintendent pharmacist.

It may be that in some circumstances, someone is both the superintendent pharmacist and the pharmacist responsible for the pharmacy. However, it is unlikely that a pharmacist taking on the superintendent pharmacist's role in relation to a large number of pharmacies owned by a company would be in a position to secure the safe and effective running of each pharmacy. Neither is it likely that the superintendent pharmacist would be able to meet any requirements relating to absence from the pharmacy which may be set out in regulations under the new section 72A of the Act. Therefore, the Government's view is that the superintendent pharmacist has a wider, corporate, management responsibility to ensure that each pharmacy has a pharmacist in charge and the company carrying on the pharmacy business meets statutory, professional and ethical requirements and standards for the retail sale and supply of medicines. The responsible pharmacist is in charge of the day-to-day running of an individual pharmacy.

Some bodies corporate have appointed area managers to support the superintendent pharmacist in carrying out his/her responsibilities. An "area manager" is not the responsible pharmacist. However, it is for bodies corporate to decide on internal arrangements supporting the superintendent pharmacist in carrying out his/her responsibilities.

Q. When will the role of the superintendent pharmacist be reviewed?

A. The 2005 public consultation paper, Making the Best Use of the Pharmacy Workforce, sought views on the role of the superintendent pharmacist. The majority of respondents did not put forward a view. However, those who did so felt that this issue should be the subject of a separate consultation following detailed discussion with interested parties. Therefore, at this time, there is no change to the Medicines Act in relation to the responsibilities of the superintendent pharmacist.

PROFESSIONAL ACCOUNTABILITY

Q. Where does the professional accountability lie between the responsible pharmacist and other pharmacists working in the pharmacy?

A. Both the responsible pharmacist and other pharmacists working in a pharmacy are professionally accountable when exercising their professional judgement and in adhering to the professional code of ethics.

In addition, the new section 72A inserted into the Medicines Act requires the responsible pharmacist to secure the safe and effective running of the pharmacy. In exercising that duty, he or she is required to set out procedures for safe working in the pharmacy and is professionally accountable for those procedures. The new section 72B in the Medicines Act sets out that failure to comply with the provisions in section 72A, and any regulations made under section 72A, may constitute professional misconduct. A responsible pharmacist would only be accountable for any failure to comply with these statutory requirements during the period for which s/he is in charge of the pharmacy. The pharmacy record will set out who is the pharmacist responsible for the pharmacy on any date and at any time.

Pharmacy staff, including other pharmacists working in the pharmacy, will be working within the written pharmacy procedures set down by the responsible pharmacist - ie under his/her authority. For example if, in addition to employing a responsible pharmacist for the pharmacy, a pharmacy owner (or the superintendent pharmacist acting on behalf of a pharmacy owner) employs a locum pharmacist to supervise the preparation, assembly, sale and supply of medicines from the pharmacy, the locum pharmacist is required to adhere to procedures for safe working set down by the responsible pharmacist.

If a pharmacist working in the pharmacy, who is not the responsible pharmacist, exercises his/her professional judgement as to divergence from the procedures, he or she is professionally accountable for that decision and for working in that way.

For a pharmacy owned by a body corporate, the superintendent pharmacist has a wider, corporate, responsibility to ensure that each pharmacy has a responsible pharmacist and that the company carrying on the pharmacy business meets statutory, professional and ethical requirements and standards for the retail sale and supply of medicines. Where a body corporate employs a pharmacist as the pharmacist responsible for a pharmacy, the pharmacist is under a statutory duty to secure the safe and effective running of the pharmacy. He or she is also subject to the directions of the superintendent pharmacist.

ONE PHARMACY/ONE RESPONSIBLE PHARMACIST

Q. Can a pharmacist be responsible for more than one pharmacy at the same time?

A. The general "rule" continues to be that each registered pharmacy is to have a responsible pharmacist and that a pharmacist may not be responsible for more than one pharmacy at the same time. Where a number of pharmacists are working in the same pharmacy, only one may be the responsible pharmacist at any one time.

However, the Government's view is there should be sufficient flexibility to support consideration of exceptions to this general "rule" that may arise in the future. For example, there is already technology available that enables a pharmacist located in one pharmacy to operate a dispensing machine located in another set of registered pharmacy premises in a way that allows him/her to interact with the patient, see and assess the prescription and dispense the medicine(s) required. In such circumstances, it would not be sensible or practical to require a qualified pharmacist to stand by a machine located in one set of premises when another pharmacist controls and operates the machine from elsewhere. Therefore, the Government's view is that the pharmacist operating the machine could be responsible for two registered pharmacies, the main pharmacy and those premises housing the dispensing machine.

Thus, changes to the Medicines Act include a new provision to allow Health Ministers to specify in regulations the exceptional circumstances in which a pharmacist might be responsible for more than one pharmacy at the same time - and then only subject to compliance with certain conditions set out in the regulations.

Q. What happens if a pharmacy is open for 24 hours?

A. It is unlikely that a single responsible pharmacist will be able to exercise fully and effectively the statutory duty to secure safe and effective working in the pharmacy over a continuous 24-hour period in which a pharmacy is open to the public. Therefore, a pharmacy open for long periods might operate a pattern of shift working involving, for example, three responsible pharmacists. In these circumstances, each pharmacist would assume and hand over responsibility for the pharmacy at given times over the 24-hour period, with this information recorded in the pharmacy record.

Q. Will there be safeguards to ensure that each pharmacy has a responsible pharmacist?

A. There are a number of safeguards - for example

• Sections 70, 71 and 72 of the Medicines Act require each pharmacy to have a responsible pharmacist
• Section 72A(2) states that a pharmacist may not be responsible for more than one pharmacy at the same time, except in circumstances specified by Health Ministers in regulations and then only where there is compliance with certain conditions set out in regulations.
• The statutory duty on the responsible pharmacist includes a requirement to keep a record, in the pharmacy, which provides details of the responsible pharmacist for that pharmacy on any date and at any time. If the record shows that a responsible pharmacist has not handed over to another responsible pharmacist, then the pharmacy will be operating without a responsible pharmacist. This is illegal and the pharmacy must close to the public until another pharmacist takes on responsibility for that pharmacy. It is an offence for the responsible pharmacist to fail to maintain the pharmacy record as required
• The pharmacy owner is under a statutory duty to ensure the pharmacy record is kept properly and to preserve the record for as long as set out in the regulations. Failure to comply with these requirements is an offence
• The responsible pharmacist is required to display a notice, conspicuously in the pharmacy, stating that he or she is pharmacist in charge on that date and at that time, together with his/her registration number

PHARMACY PROCEDURES

Q. Who has responsibility for pharmacy procedures?

A. In exercising his/her statutory duty, the responsible pharmacist is required to establish (if these are not already established), maintain and review procedures that support safe and effective working in the pharmacy. It is important that the responsible pharmacist is able to exercise his/her professional judgement in assessing whether or not comprehensive systems are in place to support safe and effective working in that pharmacy.

Where a body corporate owns the pharmacy, the pharmacy owner is required to have a pharmacist in charge of each pharmacy - a responsible pharmacist. Within a body corporate, the superintendent pharmacist will have an important role in ensuring that the company meets statutory requirements and professional and other standards. Where the superintendent pharmacist is not also the responsible pharmacist for a pharmacy, the responsible pharmacist remains subject to the directions of the superintendent pharmacist. In exercising his/her responsibility, the superintendent pharmacist, for example, may wish to develop model procedures to support the responsible pharmacist in putting in place procedures tailored to the needs of the individual pharmacy.

Q. Will pharmacy procedures need review each time the responsible pharmacist changes - including where the responsible pharmacist is a locum pharmacist?

A. There is no intention to require a major review of procedures each time the pharmacy has a new responsible pharmacist. This is unlikely to be necessary unless there are also other significant staff changes. Frequent changes may also be unsafe if these constantly require staff to work differently .

However, the Government's view is that an incoming responsible pharmacist (including a locum taking on responsibility for the pharmacy) will need to be satisfied there are comprehensive procedures supporting safe working in that pharmacy. If there is a need to make changes, an incoming responsible pharmacist can discuss and agree these with the superintendent pharmacist or the pharmacy owner. The Government is seeking views on the review of pharmacy procedures, including the role of guidance.

Q. Will the requirement on the responsible pharmacist to establish, maintain and review pharmacy procedures supersede SOPs?

A. The pharmacy procedures may include a wide range of matters supporting safe operation of the pharmacy - in addition to those relating to the sale and supply of medicines. However, it is important to be clear that these regulations relate to the Medicines Act and the sale and supply of medicines - the provision of NHS pharmaceutical services is a matter for NHS legislation .

Therefore, for the purposes of these regulations, the Government is proposing that the procedures should include the minimum areas that it would expect to see pharmacy procedures cover in relation to the sale and supply of medicines. The Government is also seeking views on any additional areas that might need to be included - again in relation to the sale and supply of medicines.

Subject to including in the procedures those areas specified in the regulations, in developing pharmacy procedures the Government would expect pharmacists to build on experience and good practice provided by existing SOPs and to take into account guidance available from the professional regulatory bodies and the superintendent pharmacist.

The key difference is that there is now a statutory requirement for each pharmacy to have comprehensive procedures that support safe working in the pharmacy. The Government is proposing that regulations set out that the procedures should be readily accessible to staff and others who need to consult them.

THE PHARMACY RECORD

Q. Who has responsibility for the pharmacy record?

A. The new section 72A inserted into the Medicines Act requires the responsible pharmacist to keep a record, in the pharmacy, of the pharmacist responsible for that pharmacy on any day and at any time. The Government proposes that regulations allow the responsible pharmacist to keep the record in paper or electronic form, provided it is readily accessible to those who need to consult the record.

There is also a statutory duty on the pharmacy owner to ensure the responsible pharmacist keeps the record properly and to preserve the record for the period set out in regulations. It is for the pharmacy owner to fund any arrangements for keeping the record.

Failure to comply with the statutory requirements relating to the pharmacy record is an offence, subject to payment of a fine on conviction.

Those wishing to consult the pharmacy record will include an incoming responsible pharmacist, the pharmacy owner or the superintendent pharmacist in order to exercise the statutory duty to ensure it is properly maintained by the responsible pharmacist, and others such as pharmacy inspectors.

Q. What information must be included in the pharmacy record?

A. The Government proposes that regulations require the responsible pharmacist to record the following information, as a minimum, in the record

• Name and registration number of the responsible pharmacist
• Date and time at which the responsible pharmacist assumes responsibility for the pharmacy
• Date and time(s) the responsible pharmacist is absent from the pharmacy
• Date and time at which the responsible pharmacist ceases to have responsibility for the pharmacy

Thus, the responsible pharmacist will "sign in" and "sign off" the record to indicate when s/he became the responsible pharmacist and when s/he ceased to have responsibility or handed over responsibility to another responsible pharmacist.

As part of consultation on the content of the responsible pharmacist regulations, the Government is also seeking views on what other information might be included.

QUALIFICATIONS AND EXPERIENCE

Q. Will all registered pharmacists be able to be a responsible pharmacist on introduction of these regulations?

A. The Government is consulting on the content of the regulations relating to the qualifications and experience needed to become a responsible pharmacist.

The Government does not propose to introduce any formal, academic, qualification over and above the required training to become a qualified, registered, pharmacist.

Given the primary aim of the Medicines Act is to safeguard the public, the responsible pharmacist's ability to exercise his/her duty effectively is essential if public safety in relation to the preparation, assembly, sale and supply of medicines is to be maintained. The Government's view is that a pharmacist wishing to take on this important role will need some preparation and experience of the relevant pharmacy sector where he/she wishes to be a responsible pharmacist in order to exercise his/her statutory duty.

The responsible pharmacist is required to fulfil a number of requirements. These include responsibility for procedures for safe working, keeping a record of the responsible pharmacist, and compliance with any regulations relating to absence from the pharmacy and the pharmacist's ability to supervise activities from another location (ie remote supervision).

In addition, the Health Act 2006, together with existing provisions in the Medicines Act, provides for changes in the pharmacist supervision requirements. The Government proposes to consult on the content of these regulations later.

Subject to the outcome of consultation on the pharmacist supervision regulations, the responsible pharmacist - in certain circumstances and subject to conditions - will be allowed to permit another suitably trained registered healthcare professional working in the pharmacy (eg a pharmacy technician) to supervise certain aspects of the preparation, assembly, sale and supply of medicines. The responsible pharmacist will also determine whether another suitably trained, registered healthcare professional, and other pharmacy staff, are competent to undertake allocated tasks when the responsible pharmacist is absent from the pharmacy.

The Government recognises that pharmacists, pharmacy owners and others need time to prepare and develop training programmes (pre and post registration). Therefore, it may be that introduction of the regulations relating to qualifications and experience should follow later - for example, following the introduction of the majority of regulations relating to the responsible pharmacist. The Government is consulting on the time needed by pharmacists, pharmacy owners and others to prepare for changes relating to the responsible pharmacist.

Q. Where a responsible pharmacist takes a career break, on return will s/he need to practise for a minimum period before s/he is able to be a responsible pharmacist again?

A. During consultation on these regulations, the Government is seeking views on the minimum period of experience required by a pharmacist before taking on the role of the responsible pharmacist. For example, experience of the relevant sector (eg community or hospital) in which he or she wishes to become a responsible pharmacist, including how recent that experience should be. The Government is also seeking views on a requirement that a pharmacist returning to practise should have a minimum period of experience before taking on the role of the responsible pharmacist.

Q. What about pharmacists who have trained in Europe?

A. The Health Act inserts a new section 72A into the Medicines Act, which makes provision for Ministers to set out in more detail in regulations the qualifications and experience that a pharmacist must have if s/he is to be a responsible pharmacist. During passage of the Health Act, the Government made clear there was no intention to introduce any requirement for significant, additional, qualification over and above registration of a pharmacist. As a matter of European law, the United Kingdom recognises the qualifications of a pharmacist who has qualified in another member state. The Government does not intend that anything in the responsible pharmacist regulations should be inconsistent with that legal requirement. To qualify to practise as a responsible pharmacist in the UK, it will be sufficient to have undertaken a period of registration as a pharmacist in another member state - in the same way as in the UK. For example, working in a community pharmacy in another member state for a required period would satisfy the proposed "experience" requirement in these regulations.

Q. But what about pharmacists trained in Europe being unable to be in personal control of a pharmacy registered for less than 3 years?

A. The provisions of the Medicines Act are based on article 2(2) of EC Directive 85/433 - the Council Directive on the Mutual Recognition of Qualifications in the Field of Pharmacy. This states "…..member states need not give effect to [European] diplomas with respect to the establishment of new pharmacies open to the public. For the purposes of applying this Directive, pharmacies which have been in operation for less than three years shall also be regarded as new." From October 2007, Directive 2005/36/EC repeals and replaces EC Directive 85/433 but, in article 21(4), it contains an almost identical provision to article 2(2).

This article provides a derogation from the general rule that, as a matter of European law, the qualifications of a pharmacist who has qualified in another member state must be recognised. The Government's view is that member states may choose or may not choose to take up this discretionary derogation. However, having implemented it in the Medicines Act 1968, further legislation would be required to change the current position.

The derogation for which the Directives provide was originally sought by a UK Member of the European Parliament because pharmacy owners in the UK felt they were not in a comparable position to those in other parts of Europe. In a number of EU countries, the owners of pharmacy businesses are required to be pharmacists. In the UK, this is not the case although each registered pharmacy must have a pharmacist in charge. Therefore, UK pharmacy owners would be unable to develop their businesses within Europe unless they were qualified pharmacists, whereas European trained pharmacists would have the freedom to establish pharmacy businesses in the UK.

In recent years, the number of new pharmacies that have opened has increased. Therefore, there may need to be a fresh look at the provision in the Medicines Act relating to pharmacists who may be in charge of a pharmacy open for less than three years. In doing so, the Government will need to assess support for any change from all pharmacy interests in the UK and is prepared to listen and receive views from all concerned on this issue.

Meanwhile, a pharmacist qualified in an EU member state may be in charge of a pharmacy registered for three years or more. Where the pharmacy has operated for less than three years, a pharmacist qualified in the EU may be employed as a pharmacist supervising the sale and supply of medicines from the pharmacy.

ABSENCE FROM THE PHARMACY

Q. What is the definition of absence?

A. Absence refers to periods when the responsible pharmacist is away from the registered pharmacy premises for which he/she is responsible. This may be for a number of reasons. For example

• a session working with other healthcare professionals in a local clinic
• visiting patients at home, or in a residential care home, to monitor and provide advice on the effective use of prescribed medicines
• where a pharmacist is a member of the clinical team working with the PCT on the commissioning and development of local health services
• training as part of continuing professional development
• seeing patients in a consulting room in the non-registered area of the pharmacy

The consultation on the content of the responsible pharmacist regulations seeks views on the responsible pharmacist's absence from the pharmacy in relation to sale and supply of medicines from the pharmacy. It is important to look at these requirements in the context of the Medicines Act, which concerns the safe sale and supply of medicines. Any requirements on a pharmacist to be present in the pharmacy to provide pharmacy services other than the dispensing and sale of medicines do not come within the Medicines Act. This is a matter for NHS legislation on the provision of NHS pharmaceutical services.

Q. How can the responsible pharmacist be absent?

A. In relation to regulations on the ability of the responsible pharmacist to be absent from the pharmacy, the Government proposes that these set out the minimum proportion of time that a responsible pharmacist should spend in the pharmacy. During passage of the Health Act, the Government gave a commitment to Parliament that this should be the majority of the responsible pharmacist's time (ie greater than 50%).

The Government also proposes that regulations set out the maximum time that the responsible pharmacist may be away from the pharmacy during any one period of absence. Thus, where the responsible pharmacist is absent for more prolonged periods (such as sickness or holidays), the pharmacy owner is required (as now) to ensure another pharmacist is available to act as responsible pharmacist or to close the pharmacy.

Other proposals include specifying conditions such as the need to remain contactable so that pharmacy staff can seek advice or request return to the pharmacy and for the responsible pharmacist to be able to return to the pharmacy with reasonable promptness.

Where another pharmacist (who is not the responsible pharmacist) is in the pharmacy supervising dispensing activities, the Government is seeking views on whether this might vary the conditions supporting the responsible pharmacist's absence.

The responsible pharmacist must ensure there is safe and effective working in the pharmacy insofar as this relates to the retail sale of medicinal products and the supply of medicinal products (including GSL medicines) in circumstances corresponding to retail sale - ie dispensing. In exercising that responsibility, he/she must ensure suitably trained, experienced and competent pharmacy staff are available to undertake activities involving the preparation, assembly, sale and supply of medicines to the public. It will be for the responsible pharmacist to specify which pharmacy staff can take on specified activities in the pharmacy and we would expect him/her to make this clear in the pharmacy procedures.

Thus, pharmacy staff will continue to work under the authority of the responsible pharmacist when he/she is absent from the pharmacy, adhering to pharmacy procedures set down by the responsible pharmacist.

Until the pharmacist supervision regulations are introduced, the responsible pharmacist will be limited in his/her ability to be absent from the pharmacy, unless another pharmacist is working in the pharmacy to meet the supervision requirements.

In the future, the expectation is that where there is compliance with the pharmacist supervision regulations, the responsible pharmacist may permit another registered and suitably trained healthcare professional (eg a pharmacy technician) to supervise certain aspects of the sale and supply of medicines, including where the responsible pharmacist is absent from the pharmacy. The Government is not consulting on the pharmacist supervision regulations until later.

Q. Will services be able to continue where the responsible pharmacist is absent?

A. If the responsible pharmacist is absent and there is no other pharmacist in the pharmacy to comply with the current supervision requirements no transactions involving the sale or supply of P or POM medicines (or GSL medicines where part of an NHS prescription) can be made.

On introduction of the pharmacist supervision regulations, the responsible pharmacist, subject to compliance with the regulations, may be absent from the pharmacy where there is no other pharmacist in the pharmacy to supervise individual transactions. These regulations are expected to permit the responsible pharmacist to allow another suitably trained registered healthcare professional (eg a pharmacy technician) to supervise aspects of the sale and supply of medicines provided that the responsible pharmacist is satisfied that he/she is competent to take on this role.

The Government is not consulting on the content of the pharmacist supervision regulations until later.

Q. Will there always be a supervising pharmacist in the pharmacy?

A. In many pharmacies, the pharmacist will be the responsible pharmacist and the pharmacist supervising individual transactions involving the preparation, assembly, sale and supply of medicine .

Therefore, unless the pharmacy has another pharmacist to supervise transactions in his/her absence, the responsible pharmacist must be available to meet the supervision requirement. Otherwise, individual transactions involving the sale and supply of P and POM medicines may not continue. This also applies to GSL medicines where these are part of an NHS prescription.

On introduction of the pharmacist supervision regulations, subject to compliance with these regulations, the responsible pharmacist will have the ability to permit another suitably trained, registered healthcare professional (eg a pharmacy technician) to supervise aspects of the sale and supply of medicines. This includes where the responsible pharmacist is absent from the pharmacy. However, it is expected that certain activities - such as clinical checking of a new prescription - will always need to be undertaken by a pharmacist.

REMOTE SUPERVISION

Q. How is remote supervision different from absence?

A. "Remote supervision" describes circumstances where the responsible pharmacist is away from the pharmacy but is using appropriate technologies to supervise the sale and supply of medicines in the pharmacy from another location. For example, the responsible pharmacist may be located in Pharmacy A and supervising activity in this pharmacy. He/she may also be supervising activities in Pharmacy B by means of appropriate technologies (such as a video link).

During passage of the Health Act through Parliament, the Government made clear its view that telephone links alone would probably be insufficient to support remote supervision. The Government proposes to consult on conditions and circumstances supporting remote supervision as part of wider later consultation on the pharmacist supervision regulations. This will be in the next consultation stage, following that on the responsible pharmacist regulations.

SUPERVISION BY THE RESPONSIBLE PHARMACIST OF TRANSACTIONS INVOLVING THE SALE AND SUPPLY OF MEDICINES IN A PHARMACY WHERE HE/SHE IS NOT THE RESPONSIBLE PHARMACIST

Q. Will a responsible pharmacist be able to supervise individual transactions involving the sale and supply of medicines in another pharmacy, where s/he is not the responsible pharmacist?

A. There may be circumstances where the pharmacist responsible for pharmacy A asks the pharmacist responsible for pharmacy B to supervise transactions in pharmacy A. For example, where the pharmacist responsible for pharmacy A needs to be absent from the pharmacy and expects to be away for the proposed maximum time allowed under the absence regulations and there is no other pharmacist working in pharmacy A.

Subject to meeting the requirements for absence from the pharmacy, if there is another pharmacist working in pharmacy B to meet the current pharmacist supervision requirements, the pharmacist responsible for pharmacy B will be able to meet this request to supervise in pharmacy A. In doing so, the pharmacist responsible for pharmacy B will meet the supervision requirements in pharmacy A but will not take on responsibility for pharmacy A.

Following introduction of the pharmacist supervision regulations (on which the Government is consulting later), it is expected that responsible pharmacist B will be able to meet this request where s/he meets the proposed conditions for absence from pharmacy B and complies with certain conditions set out in these regulations. That is, if s/he is able to permit another suitably trained registered healthcare professional (eg a pharmacy technician) to supervise certain aspects of the sale and supply of medicines in pharmacy B whilst s/he is absent in pharmacy A.

In the meantime, the Government is consulting on possible specified conditions in the responsible pharmacist regulations, in relation to the ability of a pharmacist responsible for one pharmacy to supervise activities in a pharmacy where he/she is not the responsible pharmacist. For example, that the pharmacies concerned have adequate staffing and the same pharmacy owner.

PHARMACY TECHNICIANS

Q. Will a registered pharmacy technician be able to take on a supervisory role?

A. This will be subject to the introduction of the pharmacist supervision regulations. The Government's intention is that these regulations will specify compliance with certain conditions with the responsible pharmacist being satisfied that the registered pharmacy technician is suitably trained and competent to take on this role.

The Government has taken powers in the Health Act, which together with existing powers in the Medicines Act, will allow the responsible pharmacist to permit another suitably trained and registered healthcare professionals (eg pharmacy technicians and, possibly others) working in the pharmacy to supervise certain aspects of the sale and supply of medicines.

However, this will be subject to certain conditions. For example, it is expected the pharmacist will retain the responsibility for clinical assessment of new prescriptions and any changes in a repeat prescription. Other pharmacy staff taking on a supervisory role must be a registered healthcare professional (other than a pharmacist) with the training to do this competently and safely.

The availability of a suitably trained and registered pharmacy technician who is competent to take on a supervisory role will allow the responsible pharmacist to develop and offer a wider range of services in the pharmacy. For example, the responsible pharmacist will be able to maintain a safe and efficient dispensing service whilst he/she is engaged in providing services that make use of the pharmacist's clinical training and expertise in the use of medicines. This will allow the pharmacist to deliver these services elsewhere in the pharmacy (eg in a consulting room that is not part of the registered pharmacy premises) or to be absent from the pharmacy where providing these services in clinics or patients' homes

The Government is not consulting on the pharmacist supervision regulations until later.

DISPENSING DOCTORS

Q. Does this affect dispensing doctors?

A. No, this legislation relates to pharmacists and pharmacies.

HOSPITAL PHARMACIES

Q. How do these changes affect hospital pharmacies?

A. The responsible pharmacist regulations apply to all pharmacies registered with the registrar of the Royal Pharmaceutical Society of Great Britain (in Northern Ireland, the Pharmaceutical Society of Northern Ireland). Therefore, this will include registered pharmacies in hospitals.

Section 52 of the Medicines Act 1968 provides for POM and P medicines to be sold or supplied by a person lawfully conducting a retail pharmacy business, on registered pharmacy premises, under the supervision of a pharmacist. However, section 55 provides a specific exemption for hospitals, such that POM and P medicines can sold or supplied in the course of the business of a hospital, where that medicine is to be administered (whether in the hospital or elsewhere) in accordance with the directions (or written directions for a POM medicine) of a doctor. This exemption would include the dispensing of a private prescription for a patient receiving treatment privately in the course of the business of that hospital.

Hospitals may choose to have registered pharmacy premises to:

i) operate a retail pharmacy dispensing prescriptions generated out with the hospital and selling P or GSL medicines to visitors or staff;
ii) utilise the provision where a registered pharmacy can undertake a de minis level of wholesale dealing, without a wholesale dealers licence.

ENFORCEMENT

Q. Who is responsible for monitoring compliance?

A. The Health Act inserts a new section 72B into the Medicines Act, in relation to compliance with requirements in the responsible pharmacist regulations. The Health Act also amends sections of the Medicines Act relating to enforcement of the Medicines Act.

In relation to England and Wales, section 108 of the Medicines Act places a duty on the Royal Pharmaceutical Society of Great Britain ( RPSGB) to enforce provisions made under section 72A, with corresponding provision for Scotland in section 109 of the Act. The duty on the RPSGB includes matters relating to professional misconduct or an offence (eg the keeping of the pharmacy record). For Northern Ireland, provision is made in section 110 of the Medicines Act.

These amendments also give the appropriate Minister a right of entry to inspect and investigate in relation to provisions in section 72A. This reflects current arrangements in Northern Ireland, where the DHSSPSNI Inspectorate inspects and investigates matters in pharmacies rather than the Pharmaceutical Society of Northern Ireland ( PSNI).

The duty on the RPSGB and the PSNI extends to registered pharmacies located in hospitals and the community.

These amendments ensure full and proper enforcement of the responsible pharmacist provisions.

INTRODUCTION OF THE RESPONSIBLE PHARMACIST REGULATIONS

Q. Will pharmacists and pharmacy owners be given time to ensure they are meeting these requirements?

A. Yes. The aim is to introduce the regulations at a pace that will ensure continuing patient safety and public access to medicines and other pharmacy services and allow pharmacists and pharmacy owners enough time to prepare for change.

The Government is consulting on the time needed to introduce these changes and on the need to introduce some regulations before others. For example, further time to support introduction of regulations relating to the qualifications and experience needed to be a responsible pharmacist.

NHS PHARMACY SERVICES

Q. How do these changes fit with the pharmacy contract?

A. The Health Act amends the Medicines Act in relation to the safe and effective running of the pharmacy and both the Medicines Act and NHS legislation relating to pharmacist supervision of the preparation, assembly, sale and supply of medicines. The Medicines Act provisions relate to the sale and supply of medicines. NHS legislation, through the new contractual frameworks for community pharmacy services in England, Wales and Scotland, goes beyond the sale and supply of medicines. For example, these services include health promotion campaigns, sign-posting to other NHS services and stop smoking advice. The new contract for community pharmacy services in Northern Ireland is still being negotiated.

COMMUNICATIONS

Q. What plans are there to communicate these changes to the public and others?

A. The responsible pharmacist requirement clarifies how the pharmacist in charge of a pharmacy is to secure the safe and effective running of the pharmacy insofar as this relates to the safe sale and supply of medicines to the public. These changes to the Medicines Act do not affect the Act's primary aim to safeguard the public but remove uncertainties for pharmacists and pharmacy owners on meeting requirements relating to safe operation of the pharmacy.

Pharmacists and pharmacy owners will wish to ensure that those using their pharmacies understand these changes. For example, that they

• May identify the pharmacist in charge of the pharmacy on that day and at that time - through display of a notice in the pharmacy
• May buy GSL medicines from the pharmacy (where not part of an NHS prescription) when the pharmacist is not present in the pharmacy and that advice on the use of these medicines is available. The Government recognises the public will continue to choose to purchase these medicines from a pharmacy in order to be able to access professional advice unavailable in other retail outlets. Therefore, the expectation is that pharmacy procedures will include arrangements for the sale of GSL medicines, which staff are competent to provide advice on the use of these medicines when the pharmacist is away from the pharmacy, and when staff must seek the further advice or involvement of a pharmacist prior to sale.

• Know the times when the pharmacist is available for consultation and advice

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