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APPENDIX A: SUMMARY OF CONSULTATION QUESTIONS
THE PHARMACY PROCEDURES: Chapter 3
The Government believes there is a need for a balance to achieve some consistency in the content of the pharmacy procedures whilst allowing the responsible pharmacist sufficient flexibility to ensure these meet the operational needs of the individual pharmacy
Q. Do you agree with this approach? If not, what are your reasons for this and what do you propose instead?
The proposal is the procedures cover, as a minimum requirement, the areas specified in the regulations. Chapter 3 sets out what these minimum areas might be.
Q. Do you think the proposed minimum areas are the right areas?
Q. Are there any other areas that you feel the regulations should specify be covered in the procedures? If so, what are these and why should these be covered?
Q. Do you agree the pharmacy procedures should include arrangements for the sale of GSL medicines?
Q. Do you agree that the inclusion of areas, over and above the specified minimum areas, should be a matter for the pharmacy owner/superintendent pharmacist and the responsible pharmacist? If not, what do you propose and what are your reasons for this?
The proposal is that pharmacy procedures may be set out on paper or electronically, provided these are readily available and accessible to those needing to consult them.
Q. Do you agree with this approach? Are there any other requirements (other than readily available and accessible) that you consider should be set out in the regulations? If so, what are these and your reasons for putting them forward?
The proposal is that regulations do not specify the format used for setting out the pharmacy procedures
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for this?
Q. Do you agree with the view, set out in the consultation paper, on requiring the format used to allow the responsible pharmacist to "sign off" that s/he has checked the procedures and is content these support safe working in the pharmacy? If so, what are your reasons for supporting that view?
Q. Are there other matters that you feel should be included in the regulations in relation to the format of the pharmacy procedures?
The Government's view is the responsible pharmacist should check the procedures on taking on responsibility for the pharmacy and assess the need for review and/or amendment as appropriate.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for this?
The Government is seeking views on the review and/or amendment of the pharmacy procedures
Q. Do you agree that guidance may be a more appropriate means of providing information and advice on the review of procedures? If so, what are your reasons for supporting that view?
Q. Are there proposal(s) that you wish to put forward in relation to the review of procedures? What are the reasons supporting your proposals?
The consultation paper looks at the role of the responsible pharmacist, the pharmacy owner, the superintendent pharmacist, and the professional regulatory bodies in relation to the pharmacy procedures.
Q. What is your view of their role and what are your reasons for taking that view?
THE PHARMACY RECORD: Chapter 4
The Government proposes the regulations require the responsible pharmacist to include minimum specified information in the pharmacy record. Other information for inclusion in the record would be a matter for the pharmacy owner/ the superintendent pharmacist
Q. Do you agree with this approach and the proposed minimum information requirements?
Q. What are your views on proposals set out in the consultation paper for other information requirements in relation to the pharmacy record?
Q. Do you think there is a need for other information requirements in relation to the record? If so, what are these and your reasons for putting these forward?
The proposal is the pharmacy record may be kept electronically or on paper, provided it is readily accessible and available to those who need to consult it. The Government does not propose that regulations specify the format for the record - instead the regulations will specify the fields of information to be included in the record.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for putting your proposals forward?
The Government proposes the regulations set out the minimum period that the pharmacy owner is required to preserve the pharmacy record and that the minimum period should be 5 years from the date of the last entry to the record.
Q. Do you agree? If not, what do you propose? What do you think should be the minimum period specified in the regulations and why?
ABSENCE FROM THE PHARMACY: Chapter 5
The Government has stated the regulations specify the minimum proportion of time that the responsible pharmacist should spend in the pharmacy and this should be the majority of his/her time (ie more than 50% of each period when s/he is the responsible pharmacist and the pharmacy is operational).
Q. Do you support this view? What are your reasons for this?
Q What do you think should be the minimum proportion of time that the responsible pharmacist should be required to be present in the pharmacy? What are your reasons for this?
Q. If you do not agree, what do you propose and why?
The Government proposes the maximum time during any one period of absence that the responsible pharmacist may be away from the pharmacy should be three hours. The Government seeks views on whether this period might vary in certain circumstances
Q. Do you agree the regulations should specify a maximum time? If so, should this be set at three hours?
Q. Do you think the maximum time might vary, subject to meeting conditions set out in the regulations? Eg where another pharmacist or a suitably trained and registered pharmacy technician remain present in the pharmacy? If so, how might this vary and what are your reasons for putting that view forward?
Q. If you do not agree, what do you propose and why?
The proposal is the regulations specify the responsible pharmacist must be able to return to the pharmacy with reasonable promptness.
Q. Do you agree? If not, what do you propose and what are your reasons for this?
The proposal is the regulations require the responsible pharmacist to be readily contactable by pharmacy staff during any period of absence but do not specify the arrangements to be made - however, it may be appropriate to provide advice on this in guidance.
Q. Do you agree with this approach, including that guidance may be a more appropriate way of providing advice on arrangements for being readily contactable by pharmacy staff?
Q. If you do not agree, what do you propose and what are your reasons for this?
The proposal is that the responsible pharmacist is required to arrange for another pharmacist to be available to provide advice when s/he is absent from the pharmacy and is unable to be contacted by pharmacy staff. The Government is also seeking views on whether the other pharmacist should also be a responsible pharmacist or eligible to take on that role
Q. Do you think that the regulations should require the responsible pharmacist to arrange for another pharmacist to provide advice where s/he is unable to maintain contact with the pharmacy? If so, should the other pharmacist also be a responsible pharmacist or eligible to take on this role?
Q. If you do not agree, you propose and why?
The regulations should not set out how the responsible pharmacist is to arrange for another pharmacist to provide advice during his/her absence. However, this might be a matter to be included in guidance.
Q. Do you agree with this approach? If not, what do you propose and why?
QUALIFICATIONS AND EXPERIENCE: Chapter 6
The Government is seeking views on an annotation to the registrar against those pharmacists with sufficient length of registration and experience to be a responsible pharmacist.
Q. What is your view and your reasons for this?
Q. Do you think there are other matters to consider in addition to those outlined in chapter 6? If so what are these and your reasons for putting them forward?
Should there be a requirement that a pharmacist have a minimum period of experience following registration before taking on the role of the responsible pharmacist? In addition, could the period vary in specified circumstances?
Q. What is your view on a requirement for a minimum period of experience following registration before becoming a responsible pharmacist?
Q. Do you think the period could vary in certain circumstances? If so, what might these circumstances be and what is your reason for putting these forward?
The proposal is that regulations could specify a minimum period of experience in the relevant pharmacy sector and this, eg, could be expressed as 'x' period of experience in the last 'y' years.
Q. Do you agree with this approach? If so, what are your reasons for doing so?
Q. What do you think should be the minimum period and how should this be defined?
Q. If you do not agree, what do you propose instead and what are your reasons for this alternative approach?
Views are also sought on a proposal for a required minimum period of experience before taking on the role of the responsible pharmacist where a pharmacist has not practised for three years or more.
Q. Do you agree that a minimum period of experience might differ where a pharmacist is returning to practise following an absence of three years or more? If so, what are your reasons for this? If you do not agree, what do you propose instead?
ONE PHARMACY/ONE RESPONSIBLE PHARMACIST: Chapter 7
The consultation paper sets out two examples of possible exceptional circumstances that might support allowing a pharmacist to be responsible for more than one pharmacy at the same time.
Q. What are your views on the examples given?
Q. Are there any other exceptional circumstances that you think should be considered?
To permit a pharmacist to be responsible for more than one pharmacy at the same time, there will need to be compliance with exceptional circumstances and certain specified conditions. The Government is seeking views on what these conditions might be
Q. What are your views on each of the proposed conditions set out in chapter 6 and what are your reasons for supporting these views?
Q. Do you think the regulations should specify all or only some of the proposed conditions? What are your reasons for putting these forward?
Q. Do you think there is a need to specify other conditions? If so, what are these and what are your reasons for putting these forward?
SUPERVISION BY THE RESPONSIBLE PHARMACIST IN A PHARMACY WHERE S/HE IS NOT THE RESPONSIBLE PHARMACIST: Chapter 8
The Government is seeking views on possible conditions supporting a responsible pharmacist's ability to supervising activities in another pharmacy where s/he is not the responsible pharmacist. Eg, such conditions (in addition to conditions set for the pharmacist's absence) might include that one or both pharmacies should employ certain staff (eg a registered pharmacy technician) and that both pharmacies have the same owner
Q. What are your views on conditions supporting supervision by a responsible pharmacist in a pharmacy where s/he is not the responsible pharmacist and the possible conditions set out in chapter 8?
Q. Are there other conditions that you feel need to be specified in the regulations?
Q. If you do not agree this approach, what do you propose instead?
INTRODUCING THE RESPONSIBLE PHARMACIST REGULATIONS: PREPARING FOR CHANGE: Chapter 9
The Government is seeking views on the time needed to prepare for the introduction of the responsible pharmacist regulations. Firstly, the Government proposes to introduce the regulations that provide a statutory framework supporting the safe and effective running of the pharmacy. That is, the regulations relating to
The pharmacy procedures
The pharmacy record
Absence from the pharmacy
Requirements relating to recent and relevant experience
Q. What are your views on this proposal and your reasons for putting these forward?
Q. How long do you think that pharmacy owners, pharmacists and others need to prepare for the introduction of these regulations? What are you reasons for this?
There is a view more time is needed to prepare for introduction of other responsible pharmacist regulations - in particular, those linked to the pharmacist supervision regulations. In chapter 9, the Government is seeking views on a phased approach to introducing these regulations.
Q. Do you think it would be helpful to take a phased approach to introducing further responsible pharmacist regulations? If so, what are your reasons for your view?
Q. What are your views on the option outlined in chapter 9 and your reasons for putting forward these views?
Q. If you not agree with the approach outlined, what do you propose instead?
The Government welcomes views on the need for guidance to support introduction of the responsible pharmacist regulations
Q. Do you think there is a need for guidance? If so, what matters should this cover?
Q. Who should provide this guidance? For example, is there scope for a joint approach to developing guidance by the Government and the regulatory bodies?
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