Responsible Pharmacy

Professional Empowerment and
Responsible Pharmacist
A Review of Personal Control
Personal control = physical presence of the
pharmacist in the pharmacy
Why introduce a change ?
It was felt that there was a need to introduce
enabling legislation for pharmacists to pursue a
greater clinical role
• Within the pharmacy
• In the same location adjacent to the pharmacy
• Elsewhere
Phased Approach
1st step - responsible pharmacist regulations
• These set the quality framework
2nd step - supervision changes
• This will be enabling legislation
• Freeing up pharmacists time for enhanced roles
Legal changes
The Health Act 2006
• Made changes to the personal control and
supervision requirements
• Replaces ‘personal control’ with ‘responsible
• Sets out statutory duty of responsible
• Enables ministers to make regulations
covering the ability of the responsible
pharmacist to be absent from the pharmacy
Superintendent Role
• Superintendent pharmacist role continues
• Pharmacies carried on by bodies corporate
required to be under the management of a
superintendent pharmacist
• Responsible pharmacist, where he is not the
superintendent pharmacist, remains subject to
the directions of the superintendent pharmacist
Key areas covered by law
Provides detailed requirements for:
• Securing the safe and effective running of the
• Display a notice
• Pharmacy procedures
• Pharmacy records
• Absence from the pharmacy
Displaying the Notice
As the RP you must display a notice with:
• Your name
• Your registration number
• That you are in charge of the pharmacy at that
• The notice layout and design is discretionary
The Pharmacy Record
The Responsible Pharmacist must record:
• name and registration number
• date and time at which the responsible pharmacist:
became the responsible pharmacist;
ii. ceased to be the responsible pharmacist;
In relation to their absence from the pharmacy:
•The date of absence
•The time at which the absence commenced
•The time at which they returned
The Pharmacy Record
• Can be electronic, in writing or both
• The pharmacy owner/SI must keep the record
for 5 years
• Identify who has made alterations to either the
paper or electronic record
• If same RP from Mon –Fri, could make record
at end of week or every day, must be able to
justify that it is a contemporaneous record
Pharmacy Procedures
• RP must establish (if not already established) ,
maintain and review procedures
• Can be electronic, in writing or both
• Must be marked with date prepared and review
• Amendment – temporary change
• Review – at least once every two years;
re-evaluate the content
Pharmacy Procedures
• Cover arrangements to secure that medicines
are ordered, stored, prepared, sold, supplied,
delivered & disposed of in safe & effective
• The giving of advice on medicines
• Identify pharmacy staff competent to undertake
specific activities
• Record keeping (for bullet 1)
Pharmacy Procedures
• Arrangements when RP absent
• Steps to be taken when RP changes
• Procedure when there is a complaint
• Procedure when there is an adverse incident
• Notification of changes to procedures to
pharmacy staff
Absence from the Pharmacy
The Responsible Pharmacist may be absent from
the pharmacy for a maximum of 2 hours
In order to be absent RP must
• Remain contactable
• Be able to return with reasonable promptness
• If this is not possible another pharmacist must
be available to provide advice
GSL medicines can continue to be sold
The Record
The Notice
Must contain: name, reg number,
date & time you became RP.
Date and time you stopped
being the RP.
If absent – date, time
Must be kept for 5 years.
Must be displayed at all times where
members of the public can see it &
contain RP name, reg number, state
they are in charge of pharmacy.
The Procedures
Must be established,
maintained and reviewed
Must be marked with date, and
date to be reviewed (every 2
Responsible Pharmacy
Secure the safe and effective
running of the pharmacy.
Display a notice
Complete the record
Establish, maintain and review
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Activities involving supply of individually
dispensed medicines
• Supply of licensed or unlicensed medicines to patient
of the same legal entity –registration with GPhC/PSNI
not necessary
• Supply of licensed medicines to patient of a separate
legal entity - registration with GPhC/PSNI is required
• Supply of licensed medicines to patient of a separate
legal entity under a service level agreement or contract registration with GPhC/PSNI is necessary
• Supply of unlicensed medicines to patient of a
separate legal entity - registration with GPhC/PSNI not
required (cannot be handed direct to patient)
Wholesale of Medicines
Pharmacy premises registered with the GPhC/PSNI are
exempt from the need to hold a wholesale dealer licence
(WDL), provided that:
• Transaction is supervised by a registered pharmacist
• Transaction constitutes no more than an inconsiderable
part of the business carried on at that hospital (not
defined in legislation)
This is likely to change in the very near future following
the consultation on the consolidation of the medicines
Activities involving the wholesale of
Supply of licensed stock to separate legal entity – either
WDL or registered pharmacy premises.
Supply of assembled packs to another legal entity – need
a manufacturers licence from MHRA.
Supply of unlicensed stock to separate legal entity:
• If want to make the unlicensed medicine and wholesale
them: need a manufacturers ‘specials’ licence (MS)
• If want to only wholesale the unlicensed medicines:
need a WDL
Supply of stock within the same legal entity: is called
distribution – no need for licence or registered pharmacy
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What can I do?
• Join the Professional Empowerment Priority
Group go to: and click on
support the professional empowerment
• Ensure I feel happy with the way in which I work
as an RP – talk to my employer / pharmacy owner
/ SI if I don’t
• Sign up to the establishment of a ‘Just Culture’ in
pharmacy – more details about how to do this will
be published over the next few weeks

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