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CHAPTER 4: THE PHARMACY RECORD
4.1 Each registered pharmacy (including registered pharmacies in hospitals) is to have a responsible pharmacist. Where more than one pharmacist is working in the pharmacy, only one of them may be the pharmacist responsible for that pharmacy at any one time.
4.2 The pharmacist responsible for a pharmacy will be the pharmacist appointed by the pharmacy owner (and, in the case of a body corporate, the superintendent pharmacist) to take on this important role. Where an individual pharmacist owns and operates an independent pharmacy, he or she is both the owner and the responsible pharmacist.
The Registration Certificate
4.3 Currently, sections 70, 71 and 72 of the Medicines Act require the pharmacist in personal control of the pharmacy to display his/her registration certificate conspicuously in the pharmacy. As most pharmacists working in a pharmacy will display their certificates, it can be difficult to identify the pharmacist in charge if more than one pharmacist is working in a pharmacy at the same time. The Health Act amends these sections of the Medicines Act, requiring the responsible pharmacist to display a notice conspicuously in the pharmacy stating that he/she is the pharmacist in charge of the pharmacy on that date and at that time, together with details of his/her registration number. This will make it easier for those visiting the pharmacy to identify the responsible pharmacist.
The Annual Return to the Registrar and the Pharmacy Record
4.4 In addition, there is a change to the requirement on the pharmacy owner to make an annual return to the registrar with details of the pharmacist in personal control of the pharmacy (section 77 of the Medicines Act). Instead, the new section 72A requires the responsible pharmacist to keep a record, in the pharmacy, of the pharmacist responsible for that pharmacy on any date and at any time. Section 72A also places a statutory duty on the pharmacy owner to make sure the responsible pharmacist keeps the record properly and to preserve the pharmacy record for the period set out in the regulations. The regulations may specify the form in which the record is kept and the matters to be included in the record.
Information to be included in the Pharmacy Record
4.5 The Government believes the pharmacy record will be an important document that makes clear to pharmacy staff, the public and others:
- who is the pharmacist in charge of the pharmacy at any time and on any day
- that the pharmacy is operating legally (ie meeting the requirement that each registered pharmacy is to have a responsible pharmacist)
4.6 The Government is committed to avoiding unnecessary regulatory requirements that impose disproportionate burdens on businesses. Therefore, the Government proposes that regulations require the responsible pharmacist to include minimum specified information in the pharmacy record. That is
- The name and registration number of the responsible pharmacist
- The date and time at which the responsible pharmacist assumes responsibility for the pharmacy
- The date and time(s) at which the responsible pharmacist is absent from the pharmacy
- The date and time at which the responsible pharmacy ceases to have responsibility for the pharmacy.
Provided the record includes these minimum information requirements, the Government's view is that the inclusion of other information in the pharmacy record is a matter for the pharmacy owner, the superintendent pharmacist and the responsible pharmacist.
Q. Do you agree with this approach and the proposals for the minimum information to be included in the pharmacy record?
4.7 However, the Government has also sought views, informally, on what other information the regulations should require the responsible pharmacist to include in the pharmacy record - that is, in addition to the information requirements listed above. The views put forward are set out below.
- Details of the responsible pharmacist's registration date.
A number of people considered that, on becoming the pharmacist responsible for a pharmacy, the responsible pharmacist should include in the pharmacy record the date on which s/he became a registered pharmacist. (A view put forward in discussions on the pharmacy record, not the qualifications and experience needed to be a responsible pharmacist.) The Government does not support this proposal. It is for the professional regulatory bodies to hold this information on the register. A requirement on the responsible pharmacist to include this information in the individual pharmacy record would duplicate information already held more appropriately elsewhere. Further, the Government believes such a requirement is out of step with its commitment to reduce unnecessary regulatory burdens on businesses.
- The reason(s) for the responsible pharmacist's absence during the period in question
The Government does not believe there should be a requirement to include the reason(s) for absence in the pharmacy record. Primary legislation places a duty on the responsible pharmacist to secure the safe and effective running of the pharmacy at all times when s/he is responsible for the pharmacy. Whilst responsible for the pharmacy, the responsible pharmacist must ensure the pharmacy is operating safely when s/he is on the registered pharmacy premises, in another (non-registered) part of the same building or away from the pharmacy. This is not dependent on giving a specific reason for absence from the pharmacy (eg lunch break, attendance at a local health services planning meeting etc). Further, in this consultation paper, the Government puts forward separate proposals for regulations relating to the responsible pharmacist's absence from the pharmacy - see chapter 5.
- The record should include any amendment to the pharmacy record (eg to correct an error) and the reason for this.
One view put forward is this requirement will support the pharmacy owner in exercising his/her duty to ensure the responsible pharmacists keeps the pharmacy record properly. However, the Government's view is that it is unnecessary to specify this requirement in these regulations, as it is existing, accepted, practice to correct, date and sign any identified error in such a record.
- The record should include information on pharmacists, other than the responsible pharmacist, and other staff working in the pharmacy (including the date and hours of working).
The Government does not support this view as information on pharmacists and other staff working in a pharmacy will be part of the pharmacy business's staff employment records. Therefore, such a requirement will involve the responsible pharmacist duplicating this information in the pharmacy record. The Government's view is that this will place an unnecessary regulatory burden on the pharmacy business and the responsible pharmacist.
Q. What are your views on the proposals put forward above?
Pharmacy Procedures and the Pharmacy Record
4.8 During informal consultation, a number of people proposed the inclusion of similar information in both the pharmacy procedures and the pharmacy record. For example:
- Information relating to any significant or serious event occurring in the pharmacy on any day and at any time
- Confirmation that the responsible pharmacist has read and is content with pharmacy procedures
4.9 The Government's view is that the pharmacy procedures should include all information that allows those consulting them to identify the need for review, for any amendments and the reasons for changes. Further, the Government is aware that supporting professional standards, issued with the revised RPSGB Code of Ethics in August 2007, makes clear the requirement on a pharmacist in a position of authority to ensure "procedures are in place to record errors or near miss incidents….and review procedures as appropriate". The Government believes that it is unnecessary to provide the same information on a serious or significant event in both the pharmacy procedures and the pharmacy record. There should be no additional requirement on the responsible pharmacist to duplicate this information in the pharmacy record and, thus, be required to consult two separate documents on changes to the pharmacy procedures
4.10 As set out in Chapter 3, the Government's view is that the responsible pharmacist should be able to confirm that s/he has read and is content with the pharmacy procedures within the pharmacy procedures themselves, not the record.
4.11. During informal consultation, the majority view was that regulations should not require the responsible pharmacist to record the same information in the pharmacy record as that included in pharmacy procedures. However, the Government welcomes further views.
Q. Do you think there are other matters that the regulations should require to be included in the pharmacy record? If so, what are these and what are your reasons for putting these forward?
Form in which the written pharmacy record is to be kept
4.12 As with pharmacy procedures, the Government proposes that regulations allow the responsible pharmacist to keep the written pharmacy record in paper form or electronically, provided the record is readily accessible to those wishing to examine or consult it. Further, the Government proposes that, rather than requiring the responsible pharmacist to use a format prescribed in the regulations, the regulations set out that the responsible pharmacist include specified fields of information in the record. For example, those set out in paragraph 4.6 above and possibly others, subject to the outcome of consultation on the pharmacy record regulations.
Q. Do you agree with this approach? If not, what do you propose and what are your reasons for putting these proposals forward?
The Pharmacy Owner and the Pharmacy Record
4.13 The new section 72A of the Medicines Act places a statutory requirement on the pharmacy owner to ensure the responsible pharmacist properly maintains the pharmacy record. In addition, the pharmacy owner must preserve the record for as least as long as the period specified in the regulations.
4.14 The Government proposes that the regulations should set out a minimum period for preserving the record. During informal consultation, a wide range of views emerged on a minimum period for retention of the pharmacy record - from two years to more than twenty years. However, the majority view was that any period specified in the regulations should have some consistency with other legislation relating to records and record keeping (eg public records or professional and other liability). There was also a view that the period specified for preservation of the pharmacy record should take into account guidance on records and record keeping issued by the professional regulatory bodies and that issued to NHS organisations.
4.15 As no clear view has emerged on a period for preserving the pharmacy record, the Government proposes that, as a minimum, the regulations should specify that the pharmacy owner must preserve the pharmacy record for five years from the date of the last entry to the record. Further, that it should remain open to the pharmacy owner to decide if he or she wishes to preserve the pharmacy record for a longer period than that specified in the regulations.
Q. Do you agree with this approach? If not, what do you think should be the minimum period and why?
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