Responsible Pharmacists

Question 1

Before 1 October 2009 what did supervision by pharmacists relate to?

Answer 1

Supervision linked to personal control

Personal control = physical presence of the pharmacist in the pharmacy

Question 2

Why was there a change from physical presence at the pharmacy

Answer 2

To enable pharmacists to leave the premisis allowing pharmacists to pursue a greater clinical role

Question 3

What is the first phase of the new responsible pharmacist regulations

Answer 3

1st step – Responsible Pharmacist regulations
set the quality framework
largely mandatory

Question 4

What is the second phase of the new responsible pharmacist regulations

Answer 4

supervision changes (not yet!)
will be enabling legislation
freeing up pharmacists’ time for enhanced roles

Question 5

Which legal changes were required to allow for changes in the supervision regulations

Answer 5

The Health Act 2006:
-Made changes to personal control and supervision requirements
-Replaces ‘personal control’ with ‘responsible pharmacist’
-Sets out statutory duty of responsible pharmacist
to secure the safe and effective running of the pharmacy - in relation to the sale & supply of all medicines
-Enables ministers to make regulations covering the ability of the responsible pharmacist to be absent from the pharmacy
(the act was needed to change the legislation outlined in a previous act)

Question 6

Which regulations relate to responsible pharmacists

Answer 6

The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
Provides the detailed requirements of the Responsible Pharmacist
Came into force 1st October 2009

Question 7

When are superintendants required

Answer 7

A pharmacy carried on by a ‘body corporate’ requires to be under management of a SI

Responsible pharmacist (RP)
where s/he is not a SI
remains subject to direction of SI. There must be one in each branch

Question 8

When are responsible pharmacists required

Answer 8

Individuals in positions of authority must ensure that each pharmacy premises registered with the GPhC (if make supply to a patient or another legal entity) has a Responsible Pharmacist

Superintendent
Chief pharmacists of Health Boards and Trusts
Owner

They:
Appoint RP
Ensure procedures in place
Record kept, accessible, preserved

Question 9

Who can be a responsible pharmacist

Answer 9

The person carrying on the business, or
If business carried on by partnership, one of partners, or
Another pharmacist

For a body corporate:
Superintendent
Manager or assistant pharmacist subject to directions of superintendent

Question 10

What must the responsible pharmacist do

Answer 10

to secure the safe and effective running of the pharmacy:
Display a notice
Undertake pharmacy procedures
Make pharmacy records
Ensure there is protocol for their absence from the pharmacy

There can only be one responsible pharmacist

Question 11

What must be displayed in the phamacy

Answer 11

As RP you must display a notice (conspicuously) with:
RP name
RP GPhC registration number
That you (pharmacist) are in charge of the pharmacy at that time
(The notice layout and design is discretionary)

Question 12

What must the responsible pharmacist record when they turn up for work

Answer 12

Responsible Pharmacist must record:
Their name and registration number 
Date and time at which RP:
became RP
ceased to be RP

Question 13

What needs to be recorded if the pharmacist is absent from the pharmacist

Answer 13

In relation to their absence from the pharmacy
Date of absence
Time at which absence commenced
Time at which they returned
(Reason* – not legally required, but may be good practice)

Question 14

What are the regulations surrounding the keeping of pharmacy records

Answer 14

Can be electronic, in writing or both
Pharmacy owner/ SI must keep record
for 5 years
Contemporaneous record
Daily record
Continuous, e.g. sign in Mon am, sign off Fri / Sat pm
Identify who has made alterations to either paper or electronic record

Question 15

What is the RPs role in relation to SOPs

Answer 15

RP must establish (if not already established), maintain and review procedures
Can be electronic, in writing or both
Must be marked with date prepared & review date
Amendment – temporary change (like if certain trained staff are absent from the pharmacy on a given day)
Review (re-evaluate content)
Exact time not specified
Recommended good practice (GPhC):
at least once every two years (or following an incident)

Question 16

What must be covered in the SOPs

Answer 16

Need to cover:

• Arrangements to secure that medicines are ordered, stored, prepared, sold, supplied, delivered & disposed of in safe & effective manner
• Giving advice on medicines by non-pharmacist staff
• Identify pharmacy staff competent to undertake specific activities
• Record keeping (for bullet 1)
• 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

Question 17

When is the RP actually responsible

Answer 17

Only responsible when pharmacy is in operation

• Usual opening hours, i.e. when open to public
• Could be while pharmacy is shut,
  e. g. staff preparing/ assembling Rx’s

Cannot sign in retrospectively

• Sign in to state that taking responsibility
• Sign record personally
• Entry can be made remotely

Question 18

What are the rules surrounding the RPs absence from the pharmacy

Answer 18

Responsible Pharmacist may be absent from the pharmacy for a maximum of 2 hours
(in 24 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 (does not have to be on pharmacy premises)

Question 19

What are the 4 different ways a task can be carried out in relation to the presence of a RP

Answer 19

1. RP in charge of premises and the task
   Requires pharmacist supervision and
   supervising pharmacist needs to be physically present
2. RP to be in charge of premises and
   Requires pharmacist supervision and
   but pharmacist who may not need to be physically present
3. RP to be in charge of premises and
   but does not require pharmacist supervision
4. RP not required to be in charge of premises but
   Requires pharmacy support staff undertaking activity to be appropriately trained
   and for activity to be done under SOPs

Question 20

What is supervision legally?

Answer 20

Where supervision by pharmacist is required, transaction cannot take place without physical presence of pharmacist
who is able to advise and intervene, even though s/he will not need to carry out transaction themselves

Not defined in Medicines Act 1968
but is through case law

Question 21

Which tasks must be carried out with RP supervising and physically being present

Answer 21

Professional check (clinical & legal) of a Rx
Sale/supply of P medicines
Sale/supply of POM medicines
Incl. handing over to pt, pt rep, delivery person
Supply of medicines under PGD
Emergency supply at request of patient or healthcare professional

Question 22

What is professional supervision

Answer 22

A degree of supervision required by good practice within the profession, having regard to the qualifications and experience of the person being supervised, but actual physical presence may not be necessary. This applies to assembly

Question 23

Which tasks can be carried out with RP (professionally) supervising but the pharmacist doesn’t need to be physically present

Answer 23

Assembly process (incl. MDS)
Generating dispensing label
Taking medicines off shelves
Assembly of item (incl. counting tablets)
Labelling of containers with dispensing label
Accuracy checking

Question 24

Which tasks ca be carried out where an RP needs to be in charge of premises
but does not require the pharmacist being present

Answer 24

Sale of GSL meds

Processing waste stock medicines or patient returned meds (excl. CDs)

Question 25

What tasks can be carried out without a responsible pharmacist

Answer 25

Ordering stock form pharmaceutical wholesaler’s
Receiving stock (excl. CD)
Putting away onto shelves (excl. CD)
Date checking (excl. CDs)
Accessing the PMR
Receiving Rx’s directly from patient or collecting from surgery
Delivery person conveying meds to patient

Question 26

Recap:

What must be contained in the RP record

Answer 26

Must contain:
 Name, reg. number,
 Date & time you became RP
 Date & time you stopped
    being the RP
If absent:
 Date, time left & returned
 Must be kept for 5 years

Question 27

Recap:

What must be contained in the notice

Answer 27

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

Question 28

Recap:

What must be contained in the RP procedures

Answer 28

Must be established,
   maintained and reviewed
    regularly
Should be marked with date,
   and date to be reviewed 
   (every 2 years)

Question 29

Recap: What are the requirements for the RP

Answer 29

Secure safe & effective
   running of pharmacy
Display a notice 
Establish, maintain &
   review procedures
Complete the record

Question 30

What does the Rebalancing Medicines Legislation and Pharmacy Regulation
do

Answer 30

Reviews relevant pharmacy legislation and regulation to ensure it:

• provides safety for users of pharmacy services
• reduces any unnecessary legislation
• allows innovation and development of pharmacy practice

Question 31

Which areas does the RMLPR work in

Answer 31

Areas of work

Pharmacy legislation on dispensing errors and standards
The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 (SI 2016 No. 372)
The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 - PJ article
Pharmacy premises, RP, superintendent/ owner responsibilities – 2020
Dispensing errors in other settings: hospitals, secure environment etc. – 2020
Supervision…