This response is written on behalf of the bodies that represent owners of community
pharmacies, in response to the consultation on proposals for the content of the
Responsible Pharmacist Regulations.
We welcome the opportunity of responding to the consultation and set out below our
responses in the form requested in the consultation document. In most of those areas,
the answers given are self explanatory, but in some cases further explanation may be
needed. Therefore this document is in three sections –
• Executive Summary
• Answers to Questions in form requested
• Further comments.
Signed by:
Sue Sharpe on behalf of:
PSNC
Robert Darracott on behalf of:
CCA
Colette McCreedy on behalf of:
NPA
Roy Carrington on behalf of:
AIMp
1 See End of document for remit of each body
1: Introduction and Summary
Executive Summary
1. The Medicines Act 1968 seeks to protect the public, by imposing controls on the
persons who may sell or supply medicines, and the circumstances under which
medicines can be sold or supplied. The amendments introduced through the
Health Act 2006 should establish appropriate levels of control, which will be
supplemented where necessary by NHS Regulations, the Code of Ethics and
arrangements made by owners of pharmacy businesses.
2. The consultation seeks views only on the proposed Responsible Pharmacist
Regulations, and defers consideration of the supervision of the sale or supply of
medicines. The consultation also does not address the measures that may be
required in the NHS Regulations. To make the most of the changes introduced by
the Health Act 2006, consultation on supervision and NHS measures should be
carried out without delay.
3. Our organisations discussed at length the framework permitting absence of the
Responsible Pharmacist from the pharmacy. We did not feel it was possible to
reach a final conclusion about this without consideration of the framework for
supervising supplies of medicines. The Medicines Act permits medicines that can
be sold with reasonable safety without the supervision of a pharmacist to be GSL
medicines. We concluded that it is essential to consider the provisions that will
ensure appropriate professional involvement in each supply of a non-GSL medicine
together with proposals for responsibility for the pharmacy systems that will
support safe supply. We recognise that absence of the responsible pharmacist will
not necessarily equate to there being no pharmacist in the pharmacy, but it will be
able to consider the safety of the medicines supply only with an understanding of
the combined effect of the government’s proposals.
4. Standard Operating Procedures should be developed using a risk based approach
under the management of the superintendent pharmacist2 to ensure they meet the
needs of the business and provide appropriate levels of public protection. The
periodic review of SOPs should also be carried out under the management of the
superintendent pharmacist.
5. The day to day assessment of the safe operation of the pharmacy within the
Standard Operating Procedures should be an obligation on the Responsible
Pharmacist, and any review of the SOPs needed on a day to day basis should be
carried out by the Responsible Pharmacist under the management of the
superintendent pharmacist.
6. The maintenance of a record of the name of the Responsible Pharmacist and the
times at which he takes on and relinquishes responsibility, accessible in the
pharmacy (but which could be held on suitable central IT systems) should be
undertaken by the Responsible Pharmacist.
7. The superintendent pharmacist should be responsible for preserving the records for
the requisite period and producing these for audit purposes if required.
8. The Responsible Pharmacist must be present in the pharmacy for sufficient time to
ensure that the SOPs continue to support safe working practices in the pharmacy.
9. In the absence of any evidence from the Department of Health, that there is
justification in requiring a responsible pharmacist to have a higher degree of skill
than any other pharmacist engaged in community pharmacy, there should be no
2 For the purpose of this consultation response, the use of the term ‘superintendent pharmacist’ should be taken
as meaning the pharmacy owner, where this is a sole proprietor or a partnership, as well as referring to the
superintendent pharmacist whose duty is to provide professional input into pharmacy businesses owned by
bodies corporate
qualification needed other than registration as a pharmacist. The length of
experience in community pharmacy in order to satisfy the above would therefore
be nil.
10. The superintendent pharmacist has a duty to ensure adequate staffing to provide a
safe pharmaceutical service. The employment policies of the pharmacy business
established under the management of the superintendent pharmacist will ensure
that only pharmacists who are competent to perform the role of Responsible
Pharmacist will be employed or engaged in that role. The Code of Ethics provides
additional safeguards for the public, in that every pharmacist has a professional
obligation only to work within his level of competency. Legislation requiring
additional qualifications or minimum length of experience is not required.
11. The NHS and the patients who receive pharmaceutical services from the NHS
should benefit from the Responsible Pharmacist provisions as soon as practicable.
12. At this stage, the regulations should not permit a pharmacist to be responsible for
more than one pharmacy at one time. We envisage that this could only happen in
exceptional, and unforeseen, circumstances. In these circumstances, which we
would not consider to be “sickness absence” we would envisage another
Responsible Pharmacist being able to be temporarily in charge of the afflicted
pharmacy in order to facilitate safe and continuous service to the public in the
immediate aftermath of the emergency. The Responsible Pharmacist undertaking
such a role would look to his superintendent pharmacist for guidance. When the
proposed Responsible Pharmacist regulations and the associated regulations on
supervision have been in place for some time, it may be possible to assess whether
(a) there is a need for such a relaxation of these provisions, and (b) the regulations
can be amended to maintain a safe environment in which to deliver NHS
pharmaceutical services.
13. The supervision of other staff carrying out preparation, assembly, sale or supply of
medicines by a Responsible Pharmacist who is not at the pharmacy where those
activities are carried out, must only be considered during the consultation on
supervision. If, however, a Responsible Pharmacist is present on pharmacy
premises of which he is not the Responsible Pharmacist (another pharmacist
fulfilling that role), then he should, as a pharmacist, be entitled to supervise staff
at that pharmacy notwithstanding that he is not the Responsible Pharmacist.
14. As the supervision of staff undertaking the activities mentioned above is a
fundamental cornerstone of the safeguards provided by the Medicines Act 1968, it
is wholly inappropriate to attempt to differentiate between the circumstances in
which the requirements of section 52 of the Act apply, and attempt to deal with
these at different times. Remote supervision cannot be discussed prior to the
consultation on supervision.
15. The lack of clarity relating to the sale of general sale list medicines, which means
that these cannot be sold unless a pharmacist is on the pharmacy premises can,
and must be dealt with immediately. There is no public risk arising from the sale
of GSL medicines by trained pharmacy staff in the absence of a pharmacist, and in
fact there is much greater safety in allowing that, than the current position of
having to refer members of the public to non pharmacy retail outlets for GSL
medicines.
Answers to Questions posed in the consultation
CHAPTER 3: PHARMACY PROCEDURES
Consistency of procedures
Q. Do you agree with this approach? If not, what are your reasons for this and what do
you propose instead?
A. Yes.
Standard Operating Procedures (SOPs) are designed with considerable thought
and attention to detail. There should be no need for the Responsible Pharmacist
to amend SOPs without good reason.
We would wish to see a situation where:-
• The superintendent pharmacist sets the framework for SOPs, which are not
intended to change on either a regular or frequent basis. The SOPs will
incorporate guidance to cover a range of predictable eventualities, such as
different staffing situations (e.g. when the dispensing technician is absent),
or when there is a technological failure. The SOP template will be kept under
regular review by the superintendent pharmacist.
• These SOPs may then be tailored to the specific circumstances of the
individual pharmacy by the Responsible Pharmacist at the time they are
issued, in consultation with the superintendent pharmacist.
• On a day to day basis, if the Responsible Pharmacist believes that an
amendment is necessary he should discuss the matter with the
superintendent pharmacist (or nominated representative) before making any
change; the superintendent pharmacist will then agree with the Responsible
Pharmacist what course of action to take.
• Where the Responsible Pharmacist cannot obtain access to the
superintendent pharmacist he must make his own decision on a course of
action and must take full accountability for that action.
• The Responsible Pharmacist must record any action taken, inform all staff
affected by any change and note any change to the SOP in the SOP log/diary.
Establishing Procedures: Matters to be included in Pharmacy Procedures
Q. Do you think these are the right, minimum, areas to be included in the regulations on
pharmacy procedures?
A. Yes. All the proposed matters, if limited to the sale and supply of medicines,
are appropriate for SOPs.
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?
A. No.
Procedures and the sale of General Sales List (GSL) medicines
Q. Do you agree that pharmacy procedures should include arrangements for the sale of
GSL medicines from the pharmacy?
A. Yes.
Other Matters that may be included in the Pharmacy Procedures
Q. Do you agree with this approach? If not, what do you propose and what are your
reasons for this?
A. Yes. Local operational decisions by the superintendent pharmacist and
Responsible Pharmacist must be permitted.
Form of the Pharmacy Procedures
Q. Do you agree that the written procedures may be set down or paper or electronically?
A. Yes.
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?
A. No. There is no benefit in legislation specifying any of the additional points
proposed. The superintendent pharmacist and Responsible Pharmacist would
introduce their own safeguards to ensure the accessibility and security of their
procedures.
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?
A. Yes. There is no benefit in legislation specifying the format. The
superintendent pharmacist and Responsible Pharmacist would introduce their
own format which would have sufficient flexibility to meet local operational
needs.
“Signing off” Pharmacy Procedures
Q. Do you think the regulations should specify that the format used for the pharmacy
procedures 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?
A. Yes. Signing (which could include IT solutions) to confirm that he has taken
on the responsibility for the pharmacy provides safeguards for the Responsible
Pharmacist, in that he does not carry any responsibility prior to formally
accepting the role at the time he takes over. Signing to confirm that he is
satisfied that the pharmacy business is capable of operating safely within the
SOPs provides a safeguard for the superintendent pharmacist, in delegating day
to day responsibility to the Responsible Pharmacist.
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?
A. No. There should be minimal legislative interference. The proposed
Responsible Pharmacist regulations should be restricted to those areas where
public safety requires legislation. The format of pharmacy procedures is for the
superintendent pharmacist and Responsible Pharmacist to establish.
Review of 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 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?
A. No. The Review of procedures should be the responsibility of the
superintendent pharmacist and the Responsible Pharmacist, acting jointly.
When the Responsible Pharmacist assumes responsibility for the safe working of
a pharmacy, he will consider whether the SOPs support safe working before he is
able to ‘sign off’ the SOPs and instruct staff. There is no need to legislate a
requirement, since in assuming responsibility for the pharmacy, he will be bound
by the Code of Ethics to ensure safe systems, and he would be acting
unprofessionally if he had not considered the safety of the SOPs.
Periodic Review of the SOPs will be required under the management of the
superintendent pharmacist, in order to maintain the safe and efficient conduct of
the pharmacy. It is therefore unnecessary to require through legislation, a
particular period for review. Professional and or good practice guidelines would
be sufficient, which will allow sufficient flexibility.
If government believes there is a need to direct the way in which review takes
place, then it must do so in legislation, but we suggest that whilst guidance on
the review of procedures may be helpful this should not be developed by
government.
Pharmacy Procedures: The Role of the Superintendent Pharmacist
Q. Do you agree with this approach? If not, what are the reasons for putting forward your
view?
As a general proposition the superintendent pharmacist and the owner should be
taken as having identical responsibilities. For the purpose of this consultation
response, the use of the term ‘superintendent pharmacist’ should be taken as
meaning the pharmacy owner, where this is a sole proprietor or a partnership, as
well as referring to the specific job role in a body corporate.
The ultimate accountability for the way a pharmacy operates lies with the
superintendent pharmacist who must retain the authority to direct the
Responsible Pharmacist in how the pharmacy business will be conducted, but
should be able to rely on the Responsible Pharmacist on a day to day basis to
ensure that the SOPs support safe working practice.
If any permanent change to SOPs is required, this will be carried out under the
management of the superintendent pharmacist, and may involve the Responsible
Pharmacist.
If temporary amendments are needed due to exceptional circumstances arising
on the day, the Responsible Pharmacist should attempt to discuss this with the
superintendent pharmacist or others involved in the management of the
business before implementing temporary changes. Where the Responsible
pharmacist takes unilateral action to amend procedures temporarily, then he
should carry the responsibility for his actions.
Pharmacy Procedures: The Hospital Chief Pharmacist
Q. Do you agree with this approach? If not, what are the reasons for putting forward your
view?
A. Yes. In a registered retail pharmacy in a hospital, exactly the same provisions
in the Medicines Act 1968 must apply.
Pharmacy Procedures: The Role of the Pharmacy Owner
A. See above.
Pharmacy Procedures: The Role of the Professional Regulatory Bodies
Q. What is your view, in relation to pharmacy procedures, on the role of the professional
regulatory bodies?
A. Every pharmacist is required to provide professional services in a way that
protects patients and members of the public. In so doing, every pharmacist
must operate within his own level of competence.
The Code of Ethics provides the necessary safeguards for the public, and no
amendment is necessary. The Royal Pharmaceutical Society currently provides a
professional support as well as the regulatory function. When the General
Pharmaceutical Council is formed, the different roles will be performed by the
two bodies, and at that time there should be steps taken to ensure no duplication
or inconsistency.
CHAPTER 4: THE PHARMACY RECORD
Q. Do you agree with this approach and the proposals for the minimum information to be
included in the pharmacy record?
A. Yes.
Other records
Q. What are your views on the proposals put forward above?
A. Records should be proportionate. The inclusion of the additional information
would be excessive.
Pharmacy Procedures and the Pharmacy Record
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?
A. No. Superintendent pharmacists may require additional information to ensure
he can satisfy his obligations to operate the pharmacy safely, but it is not
necessary to introduce further requirements in legislation.
Form in which the written pharmacy record is to be kept
Q. Do you agree with this approach? If not, what do you propose and what are your
reasons for putting these proposals forward?
A. Yes. Electronic records should be permitted. The format of records should be
determined under the management of the superintendent pharmacist so that this
can best meet local operational requirements. The format of the record should
not be specified in legislation.
The Pharmacy Owner and the Pharmacy Record
Q. Do you agree with this approach? If not, what do you think should be the minimum
period and why?
A. Yes. It is appropriate to place upon the superintendent pharmacist an
obligation to ensure records are maintained and preserved. Provided that the
records may be kept electronically, there is no objection to a five year period
being specified.
CHAPTER 5: CONDITIONS RELATING TO THE RESPONSIBLE PHARMACIST: ABSENCE
FROM THE PHARMACY
Q. Do you agree the regulations should specify the minimum proportion of time the
responsible pharmacist should spend in the pharmacy? Should this be the majority of the
time s/he is responsible for the pharmacy? What are your reasons for supporting your
view?
A. The Responsible Pharmacist is the pharmacist responsible for ensuring that
the SOPs support safe working on a day to day basis. To discharge his duties he
will need to be satisfied that the SOPs work as intended, the appropriate mix of
staff are present, and that no exceptional circumstances have arisen. This will
require presence in the pharmacy for substantial periods.
In setting up a framework for the new role of Responsible Pharmacist, there
should be no unnecessary shackles, and he should be able, subject to the
directions of the superintendent pharmacist, to decide for himself, how to ensure
patient and public safety.
The proposed Responsible Pharmacist Regulations will exist within a legislative
regime which includes supervision of the sale and supply of medicines. The sale
or supply of medicines is also one of the pharmaceutical services which are
accessible without appointment in NHS pharmacies. Because our organisations
need to consider how NHS pharmacies will provide a safe and accessible
pharmaceutical service, it is extremely difficult to draw a conclusion about the
amount of absence of the Responsible Pharmacist that may be permitted, due to
the uncertainty about the provisions relating to supervision and NHS Regulations
which are not being considered at this time. Nevertheless, we wish to
emphasise the importance of the Responsible Pharmacist’s responsibility to
ensure safe and effective supply of medicines and services. Taken together,
changes to regulations covering Responsible Pharmacist and supervision must
recognise this fundamental responsibility.
We request that the consultation on supervision and discussions about the NHS
requirements be brought forward, so that all these matters can be properly
addressed before the proposed Responsible Pharmacist regulations are drafted.
The minimum proportion of time set out in regulations
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 during each period that s/he
is the responsible pharmacist? What are your reasons for this?
Q. If you do not agree, what do you propose and what are your reasons for this?
A. See above.
A maximum period of absence from the pharmacy
Q. Do you agree that regulations should specify the maximum time that the responsible
pharmacist may be absent from the pharmacy during any one period of absence? If so,
should this be set at three hours?
Q. Do you think the specified maximum time could vary - subject to specified conditions
set out in the regulations? For example, where another pharmacist or certain other
pharmacy staff (e.g. a suitably trained and registered pharmacy technician) are present in
the pharmacy? If so, how might this vary and what are your reasons for supporting that
view?
Q. If you do not agree with these proposals, what do you propose and what are your
reasons for supporting your proposal?
A. See above.
Other Conditions relating to the Responsible Pharmacist’s Absence from the Pharmacy
Q. Do you agree that the responsible pharmacist be required to return to the pharmacy
with “reasonable promptness” and the approach taken? If not, what do you propose and
what are your reasons for this?
Q. Do you agree the regulations should require the responsible pharmacist to remain
contactable by pharmacy staff?
Q. What is your view on the proposal that it may be more practical and appropriate to
offer advice on this in guidance?
Q. If you do not agree with these proposals, what do you propose and what are your
reasons for putting your proposals forward?
Q. Do you agree 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 during his/her absence?
Q. Further, do you agree that it is unnecessary for the regulations to specify that the other
pharmacist should also be a responsible pharmacist or a pharmacist eligible to take on this
role?
Q. If you do not agree with one or either of these proposals, what do you propose and
what are your reasons for putting this view forward?
A. See above.
CHAPTER 6: THE CONDITIONS APPLYING TO THE RESPONSIBLE PHARMACIST:
QUALIFICATIONS AND EXPERIENCE
An Annotation to the Register
Q. What is your view of an option to annotate the register indicating a pharmacist has
experience to be a responsible pharmacist? What are your reasons for your view?
A. No. This would create an unnecessary and unwelcome additional burden, and
from our comments below, our opinion is that an annotation would have no
meaning.
Pharmacist Experience
A minimum period of experience following registration as a pharmacist
Q. Do you think there should be a minimum period of experience, following registration,
before a pharmacist may become a responsible pharmacist? If so, what should that
minimum period be and what are your reasons for putting this forward?
A. No. There is no evidence that any pharmacist currently acting as pharmacist
in charge presents a risk to the public through lack of qualifications, experience
or competency.
Variations to the minimum period of experience
Q. What is your view on the proposal that any minimum period of experience requirement
could be an additional condition supporting, for example, the responsible pharmacist’s
ability to be absent from the pharmacy? What are your reasons for supporting your view?
A. It is our position that minimum periods of experience be left to local discretion
of the superintendent pharmacist.
Recent Experience in the Relevant Pharmacy Sector
Q. What is your view and are there other issues in relation to recent experience in the
relevant pharmacy sector? If so, what are these and your reasons for putting them
forward?
A. This is an employment matter which needs not be included in the Regulations.
Superintendent pharmacists will ensure that their businesses’ needs are met,
and that only pharmacists with the necessary degree of familiarity with the
pharmacy sector will be engaged or employed in these positions.
A minimum period of relevant experience, where a pharmacist has not practised as a
pharmacist for three years or more
Q. Do you agree that the minimum period of experience might differ where a pharmacist
is returning to practise after an absence of three years or more? If so, what should this
be?
A. Yes. But this need not be included in regulations as superintendent
pharmacists will ensure that their businesses’ needs are met, and that only
pharmacists with the necessary degree of familiarity with the pharmacy sector
will be engaged or employed in these positions.
The pharmacists’ Code of Ethics places on pharmacists a personal duty to only
practice within their field of competence. Any stipulation of post-registration
experience would be arbitrary and would take little account of the competence of
the individual or of the quality of the experience. We do not, therefore, feel this
should be specified in regulation.
Q. If you do not agree with this approach, what do you propose instead and what are the
reasons for supporting your proposals?
A. In all the above, superintendent pharmacists can provide the necessary
safeguards. There is no reason to doubt that this has generally worked well in
the current requirement to have a ‘pharmacist in personal control’. There is no
evidence to suggest patient safety is compromised by newly registered
pharmacists being placed in areas of responsibility.
Imposing statutory limits removes local discretion, and could result in unsafe
practice, since length of experience alone is not an appropriate indicator of
competence.
CHAPTER 7: ONE PHARMACY/ONE RESPONSIBLE PHARMACIST
Q. What is your view of the two examples in providing a possible case for an exception to
the one pharmacy/one responsible pharmacist “rule”?
A. The Responsible Pharmacist provisions are concerned with patient safety
relating to the sale of medicines, and are major advances in the development of
the provision of pharmaceutical services.
It is paramount that patient safety is preserved. The two examples provided in
the consultation document are less concerned with the role of Responsible
Pharmacist and more concerned with how the sale and supply of medicines will
be supervised from those pharmacies.
As the Responsible Pharmacist provisions are new, and the concerns about the
exceptions to the one Responsible Pharmacist – One Pharmacy rule are mainly in
relation to the supervision of the sale and supply of medicines, the exceptions
should not be developed now, but after the regulations have been in operation
for some time. Once experience has been gained, the regulations can be
considered again, and a decision can be taken about whether exceptions are
needed and if they are, the safeguards that are needed, in the light of
experience, to maintain patient safety.
The remainder of the consultation questions on the exceptions to the one
Responsible Pharmacist – one pharmacy rule demonstrates why these provisions
cannot be commented on at this stage. In several comments, reference is made
to the presence of other staff and of the roles in supervising transactions. If the
government does wish to consider the exceptions at an early stage, then it
should be concurrently with the consultation on supervision.
Capacity to Exercise the Statutory Duty
Q. Do you agree the regulations should include, as a condition, the responsible
pharmacist’s capacity to be in charge of more than one pharmacy at the same time?
A. See above. It is not appropriate to consider the conditions for the Responsible
Pharmacist to be in charge of more than one pharmacy at the same time without
consideration of the framework for supervising supplies of medicines.
Staff employed in the pharmacies
Q. Do you agree with the proposal to include in the regulations, as a condition, that
certain staff should be available in the pharmacy? What are your reasons for your views?
A. No. The decision about appropriate staffing arrangements to ensure the safe
operation of the pharmacy is for the superintendent pharmacist and Responsible
Pharmacist.
The period for which a responsible pharmacist may be responsible for more than one
pharmacy at the same time
Q. Do you agree that the regulations should specify a limit to the period for which a
pharmacist may be responsible for more than one pharmacy at the same time? If so, what
are your reasons for supporting this?
A. See above. It is not appropriate to consider the time limits for the
Responsible Pharmacist to be in charge of more than one pharmacy at the same
time without consideration of the framework for supervising supplies of
medicines.
Notification that a pharmacist is responsible for more than one pharmacy at the same time
Q. What is your view on the proposal that the professional regulatory bodies are notified
of any arrangements where a responsible pharmacist takes on responsibility for more than
one pharmacy at the same time? If you agree, who should be required to notify the
arrangements – the responsible pharmacist or the pharmacy owner?
Q. If you do not agree, what do you propose and why?
A. There should be no requirement to notify in advance or to require the approval
of the RPSGB. It is for the superintendent pharmacist and Responsible
Pharmacist to decide, within the statutory requirements and within their own
procedures and competence whether two pharmacies will be operated safely. To
impose a regulatory body’s approval would deny the superintendent pharmacist
and Responsible Pharmacists the flexibility to make an appropriate judgement
about their own business.
Each pharmacy concerned should be owned and managed by the same company,
partnership or individual
Q. Do you think the regulations should include a condition that the same company,
partnership or individual should own each pharmacy where a pharmacist is responsible for
more than one pharmacy at the same time? What are your reasons for taking your view?
A. No. It is inappropriate to differentiate between businesses run by multiples
and those conducted by an independent pharmacist. Similarly, it is inappropriate
to differentiate between an employee pharmacist and a pharmacist engaged as a
locum.
The number of pharmacies for which a pharmacist may be responsible at the same time
Q. Do you agree that the regulations specify the maximum number of pharmacies for
which a pharmacist may be responsible at the same time? If so, what are your views on
the number of pharmacies (e.g. two)?
A. See above for our position relating to absence of the Responsible Pharmacist.
Q. Do you think the regulations need to include all or only some of the conditions outlined
above? What are your reasons for this?
Q. Are there any gaps – for example, do you propose that other or further conditions need
to be set out in the regulations? If so, what are your reasons for this?
A. See above.
CHAPTER 8: CONDITIONS RELATING TO THE RESPONSIBLE PHARMACIST: SUPERVISION
BY THE RESPONSIBLE PHARMACIST OF ACTIVITIES IN A PHARMACY WHERE HE OR SHE
IS NOT THE RESPONSIBLE PHARMACIST
Q. Do you think regulations should specify the need to meet certain other conditions (in
addition to those allowing absence from the pharmacy) before a pharmacist responsible
for one pharmacy is able to supervise transactions in a pharmacy where he is not the
responsible pharmacist? If so, what are your reasons for this?
Q. What are your views on the conditions identified? Are there others that you consider
might be included in the regulations and what are your reasons for suggesting these?
Q. If you do not agree with this approach, what do you propose and what are your
reasons for this?
A. The current consultation addresses only the provisions relating to the
Responsible Pharmacist and defers consideration of the provisions relating to
supervision under s52 of the Medicines Act 1968.
The consultation draws attention to the skills of pharmacists acting as
supervising pharmacist and the Responsible Pharmacist being different, and
therefore it is inappropriate to attempt to consider limited aspects of supervision
as part of the Responsible Pharmacist consultation.
CHAPTER 9: OTHER MATTERS RELATING TO THE RESPONSIBLE PHARMACIST
REGULATIONS
Enforcement of the Responsible Pharmacist Regulations
Comment. The medicines legislation includes criminal sanctions in the case of
contravention, the NHS legislation provides a contractual framework and the
Code of Ethics imposes professional obligations.
In all but a small minority of the items under discussion, criminal sanctions are
disproportionate. Care should be taken to ensure that the legislation is
introduced in a way that encourages and enables, and not in a way that creates
criminal offences with criminal sanctions for matters that can be dealt with
adequately in other ways.
Regulations introducing NHS Contractual obligations would not provide any
safeguards for patients receiving services outside the NHS, so only those matters
that are important to the provision of NHS services should be included in NHS
regulations, when they are considered.
The remaining matters could be dealt with adequately by the Code of Ethics.
However, it is important to emphasise that many of the provisions will be
introduced through contractual arrangements between the superintendent
pharmacist and Responsible Pharmacist – there will be no need for statutory or
professional interference, and leaving these matters for local determination will
provide a flexible and responsive system of control.
The RPSGB and in due course the General Pharmaceutical Council is expected by
the public, government and the pharmacy profession to maintain high
professional standards. Those standards should be enforced fairly and in a
proportionate manner. It may, in many cases, be more appropriate to provide
advice rather than taking enforcement action, and we express the hope that as
Regulator, it supports the pharmacy profession to deliver high quality and safe
services by encouragement and guidance as well as by enforcement.
The relevant provisions of the Medicines Act 1968 apply equally to a typical
registered pharmacy on the high street and a registered pharmacy in a hospital.
Adherence to statutory and professional obligations should be required from
both, and the enforcement of and guidance on legislation and the Code of Ethics
should be identical in the two sectors.
Introduction of the Responsible Pharmacist Regulations: Preparing for Change
Q. How long do you think pharmacy owners, pharmacists, and others need to prepare for
the introduction of the majority of the responsible pharmacist regulations? What are your
reasons for putting forward your view?
A. Sufficient time must be allowed after the regulations and any professional
standards have been published for superintendent pharmacists and Responsible
Pharmacists to comply.
The modification of pharmacy procedures will be dependent on business systems
and is likely that some areas, such as record keeping and signing to accept
responsibility when taking charge of a pharmacy will be coupled with many other
changes in systems, such as deployment of Release 2 of the Electronic
Prescription Service. The period for implementation should recognise the
timescales for development of these related business systems.
The clarification which will allow the sale of GSL medicines in the absence of a
pharmacist must be introduced immediately, so as to remove the anomaly and
improve patient safety and choice.
The supervision debate must take place before the proposed Responsible
Pharmacist regulations are drafted.
Q. Do you think there is a need for specific guidance to support introduction of the
responsible pharmacist regulations? If so, what should this cover and what are your
reasons for proposing this?
Q. Do you think, for example that the professional regulatory bodies should provide
guidance on certain matters? Or is there scope for a joint approach to developing guidance
by, for example, the Health Departments and the regulatory bodies? What are your
reasons for supporting your view?
A. Yes. It is impossible to identify at this stage what should be covered in
guidance, but once the regulations have been drafted, we would be very pleased
to work with others to ensure that appropriate guidance is produced.
Additional detailed comments
The consultation seeks comments on proposals relating to the Responsible Pharmacist.
The Responsible Pharmacist provisions will replace the current requirements to have a
pharmacist in personal control, as well as introducing additional requirements to assure
patient safety, build patient and public confidence, and allow pharmacy to make best use
of the workforce.
The Health Act 2006 introduces the changes by amending the Medicines Act 1968 and the
consultation focuses on the regulations which may be introduced to establish a suitable
framework for the Responsible Pharmacist. These regulations will not exist in isolation,
but will be augmented by regulations made under the National Health Service Act 2006,
which modify the conditions under which NHS services are provided. The pharmacy
profession’s Code of Ethics will also play a significant part of the overall regulatory
framework. There is, therefore:
• Medicines Act 1968, and associated regulations – Criminal legislation: the principal
purpose of which is protection of the public;
• NHS Act 2006, and associated regulations – Contractual obligations when providing
NHS services; and
• Code of Ethics – professional obligations.
Protection of the public is vital. It is also important to maximise the opportunities for
pharmacy to make best use of the workforce in providing a broad range of services to the
public, for the regulations and professional obligations to be drafted in a way that enables
progress. The introduction of regulations which create criminal offences if breached must
be proportionate and should be reserved for those areas where there is substantial risk to
the public. There are, unfortunately, several sections of the Medicines Act 1968 which
create criminal sanctions in the event of contravention, where the breach may be caused
by a simple error in the provision of pharmaceutical services. That must not be replicated
in regulations relating to the Responsible Pharmacist.
It is proposed that the current obligations of the superintendent pharmacist remain as at
present. There is an inconsistency between the responsibility and accountability of
superintendent pharmacists of bodies corporate and of sole proprietor and partnership
pharmacy owners. In principle, the ‘owner’ is responsible for the way the pharmacy
operates, and so in this response, the term superintendent pharmacist means the
pharmacy owner, and where the owner is a body corporate, the superintendent
pharmacist responsible for the professional aspects of the business. The respective
responsibilities of the owner are slightly higher than the superintendent pharmacist, and
this is not adequately recognised. But for the purpose of this consultation, both the
pharmacy contractor and superintendent pharmacist will have very similar objectives.
Finally, the opportunity must be taken again to state that the consultation on and
implementation of Responsible Pharmacist regulations prior to consultation on supervision
may make the workload more manageable, and improve clarity in the long term, but at
this stage in the process there is strength of feeling that the Responsible Pharmacist
provisions must not be implemented before supervision has been debated. To
accommodate those wishes, we suggest that the supervision debate takes place without
further delay, along with discussions on NHS matters.
