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pharmacy act implementation

Guidance on the Roles and Responsibilities of


Superintendent and Supervising Pharmacists
Introduction Role of a Pharmacist Scope
A Pharmacist is an expert in the science of

A
ny registered pharmacist operating in a The role of the pharmacist is essentially that
pharmacy must act in accordance with of the expert in the science of medicines, medicines, inclusive of development, supply and
all legislative requirements, guidance of inclusive of development, supply and use. In the use. A number of basic criteria apply to every
the Regulator, and the Code of Conduct, and is exercise of this expertise, a patient has a right to pharmacist in their professional practice (see
personally accountable for all professional safe and effective pharmacy services operated Figure 1); however, the responsibilities
practices he or she carries out and oversees. by a competent, trained professional in a underpinning each of the criteria vary
regulated and appropriate environment. Each depending on the clinical governance position
The Pharmacy Act 2007 establishes the roles
pharmacist in practice should ensure that, in held. In addition to fulfilling the role of
of ‘superintendent’ and ‘supervising’
partnership with colleagues and the patients ‘pharmacist’, each and every action will be
pharmacists, and places the clinical and
attending, a measurable quality of pharmacy governed by demonstrated awareness,
professional management and accountability of
service is available that is safe, efficient, application of and adherence to the provisions
a retail pharmacy business within these two key
effective and respectful of the patient’s rights of the statutory Code of Conduct.
roles, in co-operation with the pharmacy
owner. and entitlements. Differing levels of
accountability will apply in respect of differing Criteria
During public consultations on the
roles fulfilled, but all practitioners are required
implementation of the Pharmacy Act 2007, it Each and every pharmacist in practice will:
to possess, maintain, update and display
became apparent that further guidance on the 1 Produce and distribute/supply medicinal
competence and accountability in respect of the
roles and responsibilities of these pharmacist preparations and products
management of the health of a patient and the
grades was required.
delivery of an acceptable standard of 2 Optimise professional performance and
Notwithstanding the fact that the two roles pharmaceutical care. contribute to the optimisation of the
may rest in the one individual, there is a performance of others
The Pharmacy Act 2007 has provided for an
reporting relationship between the supervising
appropriate structure of accountability and 3 Contribute to the effectiveness of the
pharmacist and his or her clinical manager, the
governance to ensure the safe delivery of a pharmacy systems and activities
superintendent pharmacist.
professional, clinical service. The following is 4 Contribute to the effective operation of the
initial guidance on the differing levels of practice environment
accountability and responsibility as provided for 5 Provide pharmaceutical care including
Legislative basis in the Act. information and services

Pharmacy Act 2007


• Requirement for pharmacist operation of a
pharmacy practice is contained in sections
Figure 1
27(d), 28(c) and 29(d), which state that at Criteria that apply to every pharmacist in their professional practice
“the sale and supply of medicinal products
in the premises in which the business is
carried on is conducted in those premises …
by or under the personal supervision of a
registered pharmacist”.
Optimise professional
• Requirement for a Supervising Pharmacist is
performance (of
contained in sections 27(c), 28(b) and 29(c) themselves and those
which state that at the premises where a
retail pharmacy business is carried on, there they supervise)
must be “a registered pharmacist who has a Contribute to the Produce and
3 year minimum post-registration
experience in whole time charge of the effectiveness of the distribute/supply
carrying on of the business there”.
pharmacy systems and medicinal preparations
• Requirement for a Superintendent
Pharmacist is contained in sections 27(b), activities and products
28(a) and 29(b) which state that in the
carrying on of a retail pharmacy business
Pharmacist
“the part of the business that consists of the expert in the science of
management and administration of the sale
and supply of medicinal products is under medicines, inclusive of
the personal control of a registered
pharmacist who has a 3 year minimum post-
development, supply
registration experience”. and use
The Regulation of Retail Pharmacy Business
Regulations 2008 (Section 18 regulations) and Contribute to the Provide
the Retail Pharmacy Business Registration Rules
2008 further set out requirements in respect of effective operation of pharmaceutical care,
the roles, and have implications in practice, as the practice including information
do the Code of Conduct, and guidance issued
by the PSI. environment and services

IRISH PHARMACY JOURNAL OCTOBER/NOVEMBER 2008 194


pharmacy act implementation

Role and Responsibilities of a • Ensure that all pharmacists, • Ensure that a practice-specific operations
pharmaceutical assistants and other staff in manual is maintained, regularly reviewed
Supervising Pharmacist the pharmacy are qualified, trained, and updated, and implemented by all staff,
competent and fit to perform the functions and that staff receive appropriate training
The Supervising Pharmacist of a practice is
assigned to them. on the manual’s procedures.
the professional who is in whole-time charge of
the operation of the pharmacy, and has three • Ensure that all personnel operating within
years’ post-registration experience. This a retail pharmacy business under his or her
individual is responsible for all operations charge are aware of the scope of their role 4 In respect of the contribution to the
of the pharmacy, even when absent, and and the limits applicable in respect of the effective operation of the practice
has a reporting relationship to the management of the professional services environment, a supervising pharmacist
superintendent pharmacist. The pharmacist provided. should:
fulfilling this role may operate in this capacity
for one pharmacy practice only at a given time. • Ensure that all personnel are aware of the • Be responsible for personally managing,
circumstances necessitating referral to a controlling and supervising the pharmacy
In fulfilling the role of a pharmacist, the pharmacist, and that appropriate controls
supervising pharmacist is impacted specifically • Ensure that all personnel employed are
are in place to govern the accessibility of
by the following additional considerations: adequately and appropriately identified,
medicines, including prescription
referencing name and role in a manner
medicines, medicines exempt from
1 In respect of the production, distribution which is clear to the patient.
prescription control and CD 5 classified
and supply of medicinal preparations
products, or products liable to misuse. • Ensure that the appropriate registration
and products a supervising pharmacist
should: certificates are conspicuously displayed,
• Be responsible for prohibiting any
including his or her own certificate.
individual or entity from unduly
• Attend for reasonable, regular and
influencing, directing, controlling or • Ensure that full co-operation be provided
ongoing periods of the operating time of
supervising in a way that is contrary to the to the Regulator and all requests for
the pharmacy at the professional services
law, Code of Conduct for Registered information from the PSI be answered
area of the practice, in order to properly
Pharmacists, or is unethical or within the appropriate timeframe.
carry out the role of supervising
inappropriate to the professional activity of
pharmacist. • Ensure on a day-to-day basis that the
the pharmacy for which he or she is
• Ensure that clear, structured procedures are responsible. pharmacy premises are maintained to a
in place and consistently operated within standard that is safe for patients and staff.
• Ensure that compliance with the Code of
the pharmacy, with regard to the
Conduct, in respect of his or her own
management of dispensing activity,
professional activity and of those he or she
including quality-assured safety checking 5 In respect of the provision of
supervises, is expected and facilitated.
systems and the maintenance of adequate pharmaceutical care, including
records. • Ensure that the duty log is properly and information and services, a supervising
accurately maintained in the pharmacy. pharmacist should:
• Ensure that procedures are in place and
consistently operated within the pharmacy • Ensure that the policies and procedures of • Ensure that any pharmacist operating
to facilitate the supervision of, and the organisation are implemented and while he is absent from the pharmacy is
intervention by, the pharmacist in the raise concerns about those policies and suitably qualified to do so.
supply of non-prescription controlled procedures with the superintendent
medicinal products. • Ensure that continuing professional
pharmacist or pharmacy owner, if in the
development is undertaken by him or her,
reasonable opinion of the supervising
• Ensure that all medicinal products, and by any other pharmacist operating in
pharmacist they are in breach of the law,
including animal remedies, are sourced the retail pharmacy business for which he
the Code of Conduct, or are unethical or
from an authorised supplier. or she is responsible.
inappropriate in a pharmacy context.
• Ensure that all medicinal products, for both • Ensure that a registered pharmacist reviews
human and animal use, are authorised for all prescriptions dispensed, to assess the
supply. 3 In respect of the contribution to the pharmaceutical and therapeutic
effectiveness of the pharmacy systems, a appropriateness of the product for the
• Ensure inter-practice transfers of medicinal patient, in accordance with appropriate
supervising pharmacist should:
products occur only with a view to parameters thereof.
facilitating immediate patient need. • Be accountable for all professional
activities occurring there, including the • Ensure that any patient receiving a
• Ensure any returned unwanted or out-of- dispensed medicinal product is provided
provision of medicines, products and
date product is appropriately segregated with sufficient information, advice and
services, and advice and counselling
and located in a designated secure area. counselling to facilitate the safe use and
regarding those medicines, products and
• Ensure any medicinal product held is services. handling of the product.
maintained in a manner that is in • Ensure that any supply of a non-
• Be responsible for the generation,
accordance with its authorisation and with prescription, controlled medicinal product
implementation and application of
provisions to maintain quality of the is conducted in a manner such that the
procedures and systems documents to
product. pharmacist is satisfied it may be safely and
cover all personnel operating in the
particular pharmacy in accordance with appropriately used and is not being sought
current law and best practice. to intentionally abuse or misuse.
2 In respect of the optimisation of
professional performance and • Ensure that standards and guidance issued • Ensure that there is proper clinical
contribution to the optimisation of the by the PSI and other bodies are adhered to. management of the delivery of the
performance of others, a supervising pharmaceutical care services provided by
• Ensure that appropriate records are the pharmacy.
pharmacist should:
maintained.

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pharmacy act implementation

Role and Responsibilities of a superintendent pharmacist should: and issues in practice can be identified and
auctioned.
Superintendent Pharmacist • Ensure the supervising pharmacist
responsible for the operational control and • Ensure that a robust complaints system is
The Superintendent Pharmacist of a implementation of the pharmacy policy in place and implemented in the pharmacy
practice is the individual responsible for the has three years’ post registration in order that complaints are properly
professional policy and clinical management of experience. addressed in the interests of patients, and
the pharmacy practice. This individual is in that learning from complaints made feed
personal control of the management and • Ensure a clearly-defined policy is into reviews of policies, systems and
administration of the sale and supply of understood by the individuals employed at procedures.
medicines, and has overall control of the the practice as to the necessity for
professional and clinical pharmacy policy. pharmacist supervision of any operation of • Ensure that the organisation’s policies and
The pharmacist fulfilling this role will have three the practice. decision-making processes take account of
years’ post-registration experience and may the ethos of a pharmacy as location for the
operate in this capacity for more than one • Ensure that all pharmacists and other staff provision of healthcare services.
pharmacy practice at a given time. employed are in possession of the
knowledge, skills and competence to
(The roles of superintendent and supervising perform, and are identified as being
pharmacist may rest in the one individual; appropriately registered, as applicable. 4 In respect of the contribution to the effective
however, such an individual can only act as operation of the practice environment, a
supervising pharmacist in respect of one retail • Ensure that policies are in place to support superintendent pharmacist should:
pharmacy business, but as superintendent in compliance with the Code of Conduct.
• Ensure policy is in place to assure that a
respect of more than one).
• Ensure a policy is in place to address the pharmacist is facilitated in exercising
In fulfilling their role as a pharmacist, the requirement for ongoing training and appropriate supervision, in respect of the
superintendent pharmacist has the following development of all pharmacy staff. delivery of professional services.
additional responsibilities:
• Ensure that robust and proper policies and • Ensure that the designated area for
1 In respect of the production, distribution and procedures are in place and implemented professional counselling is appropriate and
supply of medicinal preparations and for the recruitment and vetting of utilised for this purpose only.
products, a superintendent pharmacist pharmacists and all staff employed or
engaged at the pharmacy. • Ensure and facilitate the pharmacy owner
should:
in complying with obligations in respect of
• Ensure the pharmacy premises are of the practice premises.
appropriate standard to provide for safe
3 In respect of the contribution to the • Ensure there is a policy requiring the
storage, preparation, dispensing,
effectiveness of the pharmacy systems, a availability of systems for the appropriate
compounding, sale and supply of
superintendent pharmacist should: use, management and protection of IT
medicinal products, and address this with
resources and electronic data, and that
the pharmacy owner if this is not so. • Ensure that a duty log is available and these are utilised.
appropriate procedures in place to ensure
• Ensure that an ethical and appropriate
it is appropriately maintained. • Ensure that an ethical and appropriate
policy is in place that provides proper
policy is in place and implemented for the
controls to govern the accessibility of • Ensure the appropriate policy is in place to selection and evaluation of products and
medicines, including prescription comply with disposal of medicinal and services which are offered by the pharmacy
medicines, pharmacist-supervised other products supplied in the pharmacy. as a provider of healthcare services.
medicines, and other products, and that
CD 5 classified products and veterinary • Ensure that the policy in respect of the
medicines are not available to the public running of the pharmacy practice and the
for self-selection. organisation and governing thereof is in 5 In respect of the provision of pharmaceutical
compliance with the legal framework in care, including information and services, a
• Ensure that ethical and appropriate policies place. superintendent pharmacist should:
are in place and implemented within the
organisation and pharmacy to ensure the • Ensure that policy is in place in accordance • Ensure that policy reflects the requirement
rational and safe use of medicines in the with best practice in human resource that a registered pharmacist reviews any
interests of patients. management and this is applied in the prescription dispensed, to assess the
recruitment of individuals operating within pharmaceutical and therapeutic
• Ensure that co-operation is afforded to the the pharmacy practice. appropriateness of the product for the
IMB in respect of product recalls and/or patient, in accordance with appropriate
withdrawals and procedures are in place to • Ensure that the supervising pharmacist in parameters thereof.
manage this. each practice maintains a practice-specific
operations manual for which policies on • Ensure that policy is in place to encourage
• Ensure that policy is clear to guarantee that record-keeping, error management, ADR evaluation and improvement in respect of
all medicinal products, including animal reporting, complaints-handling, quality the delivery of care.
remedies, are sourced from an authorised assurance and governance matters are
supplier. clearly outlined. • Ensure that policy is in place to encourage
involvement with local and national health
• Ensure that policy is clear to guarantee that • Ensure there is a policy requirement to promotion or education initiatives.
all medicinal products, for both human ensure a system is in place for inducting all
and animal use, are authorised for supply. individuals associated with the delivery of • Ensure that the clinical management
pharmacy care and service. policies of the organisation are in place
• Ensure the maintenance of a system to and implemented within the pharmacy,
manage the return of unwanted medicines • Ensure that effective systems of and ensure there are robust systems of
and out-of-date medicines. communication exist with the supervising review and audit of the delivery of the
pharmacist and other pharmacists pharmaceutical care services provided by
2 In respect of the optimisation of professional
employed or engaged at the pharmacy so the pharmacy.
performance and contribution to the
that policies are properly communicated
optimisation of the performance of others, a

IRISH PHARMACY JOURNAL OCTOBER/NOVEMBER 2008 196

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