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CHAPTER 3: THE PHARMACY PROCEDURES
3.1 Section 30 of the Health Act inserts a new section 72A into the Medicines Act, placing a statutory duty on the responsible pharmacist to secure the safe and effective running of the pharmacy business ((including registered pharmacies in hospitals) in relation to the supply and sale of medicines.
3.2 As added safeguards supporting the pharmacy's operation, in carrying out the duty the pharmacist responsible for a registered pharmacy must establish (if these are not already established), maintain and review pharmacy procedures to support the safe and effective running of the pharmacy and maintain the pharmacy record. The Government's view is that these requirements now make clear that the safe running of the pharmacy is not dependent on the pharmacist in charge being physically present in the pharmacy at all times.
3.3 In setting down effective pharmacy procedures, the responsible pharmacist can ensure that pharmacy staff continue to work under his/her direction and authority when he or she is present or away from the registered pharmacy premises. For example, this may be where the responsible pharmacist is working in an adjacent area of the same building which is not part of the registered pharmacy premises (eg in a consulting room) or is absent during a lunch break or during some other period of absence.
3.4 The Royal Pharmaceutical Society of Great Britain ( RPSGB) has made the use of Standard Operating Procedures ( SOPs) a professional commitment on pharmacists in the revised Code of Ethics and the supporting professional standards and guidance documents that came into effect on 1 August 2007. Since 2003, the Pharmaceutical Society of Northern Ireland has made SOPs a professional requirement. 2 Thus, pharmacists will already be aware of the professional regulatory bodies' guidance supporting the development of Standard Operating Procedures ( SOPs). In addition, the superintendent pharmacist or the pharmacy owner may also provide guidance and other information on establishing pharmacy procedures. The Government's view is that, generally, the regulations on pharmacy procedures should reflect and underpin these professional standards and other guidance.
3.5 The responsible pharmacist regulations may specify the matters covered in pharmacy procedures and the form in which the procedures are to be set out.
Pharmacy Procedures: Consistency and Flexibility
3.6 The Government's view is that there is a balance to be struck in providing some degree of consistency in the content of pharmacy procedures whilst allowing the responsible pharmacist sufficient flexibility to ensure that the procedures support the operational needs of the individual pharmacy.
3.7 Some consistency in the content of the procedures will support an incoming responsible pharmacist when assessing the comprehensiveness of the procedures, or those with responsibilities for ensuring standards of pharmacy practice wishing to consult the procedures. However, the responsible pharmacist must also be able to use his/her professional knowledge and judgement of the pharmacy and its staff, as appropriate, to satisfy himself/herself that the procedures support safe working in that pharmacy. Where not satisfied, the responsible pharmacist will need to consider any need to review or amend the procedures. For example, this might be required where there are changes in the availability of trained staff in the pharmacy.
Q. Do you agree with this approach? If not, what are your reasons for this and what do you propose instead?
Establishing Procedures: Matters to be included in Pharmacy Procedures
3.8 To achieve some consistency in the content of pharmacy procedures, the Government proposes that the regulations set out the minimum areas that the Government would expect to see covered in procedures, including
- arrangements for the safe, secure and effective ordering, storage, preparation, dispensing, sale or supply, delivery (delivery will include the handing over of a medicine to a patient or carer either in the pharmacy or as part of a pharmacy's arrangements for delivery of medicines to, for example, a patient's home) and disposal of medicines
- arrangements that demonstrate adherence to the legislative framework relating to the supply of controlled drugs 3
- activities that may be undertaken by specified pharmacy staff and the level of training/qualification/competence required to undertake these tasks
- record keeping
- arrangements for the provision of advice to patients and the public on the use of medicines by the pharmacist and by pharmacy staff, including general sales list ( GSL) medicines, and when pharmacy staff should seek the advice or the involvement of the pharmacist
- arrangements when the responsible pharmacist is absent from the pharmacy
- arrangements for recording amendments to the procedures
- arrangements for responding to complaints and adverse incidents relating to the sale and supply of medicines from the pharmacy
- arrangements for the transfer of responsibility for the pharmacy from the responsible pharmacist to an incoming responsible pharmacist
Q. Do you think these are the right, minimum , areas to be included in the regulations on pharmacy procedures?
Q. Are there any other areas that you feel should be specified in the regulations? If so, what are these and why should these be included?
Procedures: The sale of General Sales List ( GSL) medicines
3.9 In responding to consultation in 2005, about 60% of respondents considered there was a need for change in relation to the sale of GSL medicines to bring pharmacies more in line with other retail outlets. The replacement of the personal control requirement with the responsible pharmacist requirement, with greater clarity on the exercise of this requirement, makes clear that the safe operation of the pharmacy is not dependent on the responsible pharmacist's presence in the pharmacy at all times. It also makes clear that the sale of GSL medicines may take place other than under the supervision of a pharmacist (ie where these are not part of an NHS prescription) and when the responsible pharmacist is not in the pharmacy. This brings pharmacies more into line with other retail outlets selling these medicines. People will not have to await the responsible pharmacist's return or need to visit another pharmacy where a pharmacist is available to permit the sale of GSL medicines.
3.10 The Government recognises that people may choose to buy a GSL medicine from a pharmacy so they can seek the pharmacist's professional advice on using the medicine, which is not available in other outlets. (A point made by 7% of respondents to the 2005 consultation). Therefore, the Government proposes that the regulations require pharmacy procedures to include arrangements for the sale of GSL medicines from the pharmacy, including when pharmacy staff need to seek the pharmacist's advice or involvement prior to sale. As such, pharmacy staff will continue to work under his/her authority to support the safe sale of GSL medicines when the responsible pharmacist is away from the registered pharmacy premises.
Q. Do you agree that pharmacy procedures should include arrangements for the sale of GSL medicines from the pharmacy?
Other Matters that may be included in the Pharmacy Procedures
3.11 There may be other matters that a responsible pharmacist or the superintendent pharmacist or pharmacy owner may feel should be included in the procedures supporting the operation of individual pharmacies. Subject to the response to consultation on the minimum areas to be included, the Government's view is that it is open to the responsible pharmacist, in discussion with the superintendent pharmacist or the pharmacy owner, as appropriate, to consider other areas, over and above the minimum requirements, for inclusion in the pharmacy procedures.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for this?
3.12 The duty on the responsible pharmacist relates to the Medicines Act requirement in relation to the safe sale and supply of medicines not the provision of other aspects of NHS pharmaceutical services. During informal consultation, there were suggestions that the regulations should require matters such as clinical governance arrangements to be included in the pharmacy procedures. However, the Government's view is that clinical governance and other matters relating to the provision of NHS pharmaceutical services are more appropriate for consideration within wider NHS legislation and the pharmaceutical services contractual frameworks in the four countries of the United Kingdom.
Form of the Pharmacy Procedures
3.13 The Government proposes that regulations allow the responsible pharmacist to set out the written pharmacy procedures on paper or electronically - provided the procedures are readily available and accessible to those who need to consult them - for example, pharmacy staff, an incoming responsible pharmacist, the superintendent pharmacist and the pharmacy owner.
3.14 One view put forward during informal consultation was that the regulations should require the written procedures (particularly if set out in electronic form) to be kept securely. It was felt, for example, that such a requirement would help prevent unauthorised changes to the procedures. Another view was that regulations should specify that pharmacy procedures should not be in handwritten form to ensure these are legible to those needing to consult them. The Government agrees that pharmacy procedures must be kept secure and be legible to those who need to consult them. The new section 72A, inserted into the Medicines Act, makes clear the requirement for pharmacy procedures "designed to secure the safe and effective running of the pharmacy. To meet this statutory requirement, the procedures must be secure and legible and, therefore, the Government does not believe there is a need to include further requirements as to security and legibility in the regulations.
Q. Do you agree that the written procedures may be set down on paper or electronically?
Q. Other than being readily available and accessible to those that need to consult the procedures, do you think the regulations should include other requirements? If so, what are these requirements and what are your reasons for putting these forward?
3.15 Whilst a degree of consistency will help those wishing to consult pharmacy procedures, the Government's view is that the regulations do not need to set out a prescribed format for the procedures. This will allow the responsible pharmacist some flexibility in establishing procedures that support the differing operational needs of individual pharmacies.
Q. Do you agree that the regulations do not need to specify a prescribed format for the pharmacy procedures? If not, what do you propose and what are your reasons for this?
"Signing off" Pharmacy Procedures
3.16 One view put forward, during informal consultation, was the format used for the pharmacy procedures should enable an incoming responsible pharmacist to "sign off" that s/he is satisfied that the pharmacy procedures support safe and effective working at the time s/he took on responsibility for the pharmacy. The Government recognises that such a requirement may be helpful in supporting greater transparency that the incoming responsible pharmacist is content with the procedures but would welcome further views on this.
Q. Do you think the regulations should specify that the format used should allow the responsible pharmacist to "sign off" the pharmacy procedures in a way that confirms s/he has checked procedures on becoming the responsible pharmacist and is content that these support safe working in the pharmacy? If so, what are your reasons for supporting that view?
Q. Are there other matters that you think the regulations should include in relation to the format of pharmacy procedures? What are your reasons for putting these forward?
Review of Pharmacy Procedures
3.17 The responsible pharmacist is required to keep the pharmacy procedures under review. The Government believes this requirement will underpin up-to-date pharmacy procedures that reflect changes in professional and other guidance on modern pharmacy practice as well as changes within an individual pharmacy. The Government's view is that, where there is a change that could affect the safe running of the pharmacy (such as the absence of a key member of pharmacy staff), the expectation should be that the responsible pharmacist will review and amend procedures so that these continue to support the safe running of the pharmacy and inform pharmacy staff accordingly.
3.18 Further, the Government believes the responsible pharmacist's knowledge and professional judgement, as appropriate, will play an important part in assessing the need to review and amend the procedures. For example, the responsible pharmacist will wish to consider whether a review is timely and necessary to support continued safe working in the pharmacy. Following any review, there will also be a need to ensure pharmacy staff understand new or amended procedures and how these relate to their individual responsibilities. Any practice resulting in numerous, frequent, changes to procedures could result in unsafe working in a pharmacy where pharmacy staff have had insufficient time and training to gain an understanding of changes in the ways in which they are required to work.
3.19 The Government's view is that the responsible pharmacist should check the pharmacy procedures when s/he becomes responsible for the pharmacy to assess the need for any changes. In doing so, the responsible pharmacist will use his/her knowledge of the pharmacy business and the skills and experience of staff working in the pharmacy to satisfy him/herself that the procedures in place support safe working in the pharmacy and that staff are working to these procedures.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for this?
Possible Circumstances Supporting Review of Pharmacy Procedures
3.20 When taking on responsibility for a pharmacy and checking the pharmacy procedures, there may be few, if any, changes required. However, circumstances may prompt the responsible pharmacist to review and/or amend the pharmacy procedures. Some possible scenarios are set out below:
Scenario 1
A pharmacy is open for extended hours. During the day, the responsible pharmacist changes, as there is a shift pattern of working in operation to support the pharmacy's longer opening hours.
At 8.30am, the pharmacist responsible for the pharmacy during the first shift checks the pharmacy procedures and the pharmacy staff available in the pharmacy. There are no absences. The pharmacist considers that the procedures will continue to support safe working given the volume of business expected and the staff present in the pharmacy.
At 5.30pm, there is a handover to the responsible pharmacist in charge of the pharmacy until the pharmacy closes at midnight. However, whereas a pharmacy technician has been available in the pharmacy for the first shift, when he leaves at 5.30pm, there is a gap. His replacement is ill. The incoming responsible pharmacist checks the pharmacy procedures to assess the need for review in the light of the estimated volume of business in the pharmacy up until midnight and the absence of a trained member of staff who is unavailable to take on specified activities in the pharmacy. The responsible pharmacist decides that the procedures do not need to be changed. In his judgement, given the volume of business expected, he will be able to devote sufficient time to ensure that he is able to cover the pharmacy technician's absence for that shift. However, the pharmacy is likely to see a peak in the volume of business later in the week. Therefore, if the pharmacy technician remains sick, there may be a need to amend the procedures to reflect her absence or to use a locum during evening opening to ensure there is adherence to pharmacy procedures for continued safe working in the pharmacy.
Scenario 2
A locum pharmacist takes on responsibility for a pharmacy for the whole of a working day. When she arrives at the pharmacy, she checks the pharmacy procedures to satisfy herself that these will support safe working in the pharmacy on that day. One member of staff has only worked in the pharmacy for a few days and a key member of the pharmacy's trained staff has taken a day's holiday. The pharmacist does not feel she has sufficient knowledge of the individual pharmacy business and the extent of pharmacy staff experience and competence to be sure that the procedures will support safe working. Some changes may be needed and she contacts the superintendent pharmacist to discuss these. They agree, for that day, changes to the procedures are not necessary.
Scenario 3
A pharmacist takes on responsibility for a busy, independent, pharmacy. On arrival, he checks the pharmacy procedures and is satisfied that these support safe working in the pharmacy given the number of trained staff working in the pharmacy. However, over the coming weeks, a checking technician leaves for a new job in the local hospital and the responsible pharmacist has been unable to find a replacement in time to fill the gap. Two new staff in the pharmacy also need further training and support before he is satisfied that they have reached the required level of competency to take on the full range of their responsibilities. He decides that it is necessary to review the pharmacy procedures and to consider amending these to reflect the staff changes in the pharmacy and discusses these changes with the pharmacy owner.
Scenario 4
The pharmacy has a new consulting room, where the responsible pharmacist is offering services such as medicines use review ( MURs) and advice on stopping smoking. To support these new services, the pharmacy owner is using a locum pharmacist to supervise individual transactions in the pharmacy for the dedicated day each week that the responsible pharmacist is working in the consulting room. The responsible pharmacist has reviewed and amended the pharmacy procedures to ensure that all pharmacy staff understand and work to new working arrangements in the pharmacy.
A Minimum Period for Review of Pharmacy Procedures
3.21 The above scenarios help to illustrate the varying circumstances in which the responsible pharmacist may need to consider the review or amendment of the pharmacy procedures. Different circumstances will affect the timing of review or amendment of procedures in individual pharmacies. Given these different circumstances, the Government's view is that it will be difficult to set down a specific period in the regulations within which all responsible pharmacists must review pharmacy procedures but sought views on this during informal consultation. One view suggested a requirement on the responsible pharmacist to review procedures twice a year (eg at six-month intervals). Another view put forward was that the responsible pharmacist would only need to review procedures every two years. Others felt that it would be more appropriate if guidance, rather than regulations, set out a minimum period for the review of pharmacy procedures. This would also support a responsible pharmacist in looking at the need for review of procedures in the context of differing circumstances.
3.22 The Government recognises the value of guidance and that it may be more practical to look to guidance to set out the range of circumstances that might prompt review of the pharmacy procedures. For example, there are opportunities to build on existing guidelines on developing standard operating procedures ( SOPs), such as those available from the professional regulatory bodies, superintendent pharmacists and pharmacy owners. There is also the argument that guidance can offer a more flexible way of providing detailed advice on the review of procedures, including up to date information on good practice. The Government welcomes further views on the use of guidance to offer advice on any minimum requirements for review of pharmacy procedures. For example, following any serious incident involving the sale or supply of medicines from the pharmacy or where, for some time, there have been no changes in pharmacy staff and thus no changes to the procedures - including a suggested maximum period between reviews.
Q. Do you agree that it may be more helpful and appropriate to provide advice on the review of procedures in guidance rather than in the regulations? If so, what are your reasons for your view?
Q. Are there other proposal(s) that you wish to put forward in relation to the review of pharmacy procedures? What are your reasons for putting these forward?
Pharmacy Procedures: The Role of the Superintendent Pharmacist
3.23 The Health Act does not change the responsibilities of the superintendent pharmacist. Section 71 of the Medicines Act requires a body corporate to have a superintendent pharmacist managing the keeping, preparing, dispensing and sale of medicines (other than GSL medicines). Where the superintendent pharmacist is not the pharmacist in charge of a pharmacy operated by the business, another pharmacist must be the responsible pharmacist for the pharmacy and s/he remains subject to the directions of the superintendent pharmacist.
3.24 The Government's view is that the superintendent pharmacist's statutory role and responsibilities are distinct from, but complementary to, those of the responsible pharmacist. The superintendent pharmacist has company wide responsibilities which overarch and support the requirements on the responsible pharmacist, who is in day-to-day charge of an individual pharmacy owned by the body corporate. In setting out the company wide policies and governance framework for safe operation of the pharmacies to meet legal, ethical and professional standards, the superintendent pharmacist will enable the responsible pharmacist to exercise the statutory requirement relating to pharmacy procedures.
3.25 In early 2007, the Government informally sought views on the different roles of the superintendent pharmacist and the responsible pharmacist in setting out pharmacy procedures for safe and effective working. There was general agreement that the greater clarity on the responsibilities of the pharmacist in charge of each individual pharmacy also helped to define more clearly the superintendent pharmacist's responsibility to set out and oversee professional standards across the company and to provide an overarching operational framework for the company's pharmacies. The availability of company wide policies and guidance to pharmacies within the company will help support the responsible pharmacist in ensuring that procedures developed for his/her pharmacy maintain safe and effective day-to-day working.
3.26 The superintendent pharmacist, as part of his/her overall management responsibility, will have a duty to ensure each pharmacy has procedures in place, with arrangements for review and amendment as required. In exercising that responsibility, the superintendent pharmacist may choose to develop company guidance on procedures, including model procedures. However, the Government's view is that, in doing so, the superintendent will need to allow the responsible pharmacist sufficient flexibility, as necessary, to tailor procedures to the operational needs of the pharmacy for which he/she is responsible. There is scope for the superintendent pharmacist and individual responsible pharmacists to work together in developing the overall framework for pharmacy procedures within the company and in discussing and agreeing the need for local variations.
Q. Do you agree with this approach? If not, what are the reasons for putting forward your view?
Pharmacy Procedures: The Hospital Chief Pharmacist
3.27 Where an NHS Trust or Foundation Trust registers the pharmacy or pharmacies within the hospital, each set of registered pharmacy premises must have a responsible pharmacist. Within the hospital setting, the Trust Chief Pharmacist is regarded as having the role and responsibilities of the superintendent pharmacist.
Q. Do you agree with this approach? If not, what are the reasons for putting forward your view?
Pharmacy Procedures: The Role of the Pharmacy Owner
3.28 Chapter 2 looks at the role of the pharmacy owner, including a body corporate and those pharmacy businesses carried on by an individual, a partnership or a representative of a pharmacist (in cases, for example of death or disability). In some cases, the pharmacy owner will also be the responsible pharmacist for that pharmacy (for example, an individual pharmacist who owns an independent pharmacy). Others, such as a body corporate, are required to have a superintendent pharmacist with overall management responsibility for the sale and supply of medicines. There will also be pharmacy businesses run by partners or those representing a pharmacist, including where the partners or representative are not pharmacists. However, in all cases, the pharmacy owner must be clear as to his/her role in enabling the pharmacist responsible for a pharmacy to carry out his/her statutory duty, including the requirement on the responsible pharmacist in relation to pharmacy procedures. The pharmacy owner will need to allow the responsible pharmacist to use his/her professional knowledge and judgement, as appropriate, in deciding the procedures that best meet the operational needs of the individual pharmacy.
Pharmacy Procedures: The Role of the Professional Regulatory Bodies
3.29 The professional regulatory bodies - the Royal Pharmaceutical Society of Great Britain ( RPSGB) and the Pharmaceutical Society of Northern Ireland ( PSNI) - have set out requirements in relation to legal, ethical and professional standards for pharmacists. In August 2007, the RPSGB issued a revised Code of Ethics, with supporting professional standards and guidance documents, which include the standards for pharmacists in positions of authority such as a superintendent pharmacist and the pharmacist responsible for an individual pharmacy. The PSNI reviewed the Code of Ethics and Practice in 2006 and this includes guidance on the role of the superintendent pharmacist.
3.30 The professional regulatory bodies also have an important role in promoting and supporting best practice and in the provision of advice and support to pharmacists. For example, the RPSGB has already made the development of standard operating procedures ( SOPs) a professional requirement on pharmacists. Therefore, the professional regulatory bodies might be involved in the provision of guidance on the development of pharmacy procedures ( see Chapter 9).
Q. What is your view, in relation to pharmacy procedures, on the role of the
- responsible pharmacist
- superintendent pharmacist
- pharmacy owner
- professional regulatory bodies
Q. What are your reasons for taking that view?
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