responsible pharmacist regulations

Question 1

what does the responsible pharmacist regulations of 2008 state?

Answer 1

*It is a legal requirement for every retail pharmacy to have a named responsible pharmacist on duty when the pharmacy
is open
*There is a statutory duty on the responsible pharmacist to ensure the safe and effective running of the pharmacy

Question 2

who does the RPR 2008 apply to?

Answer 2

*This law applies to all retail (community) pharmacies
*This law applies to hospital pharmacies but only if they are registered with GPhC (more on this later)

Question 3

what is the legal definition of RP?

Answer 3

A pharmacist who is responsible for securing
the safe and effective running of the pharmacy

Question 4

who is the RP in a pharmacy with two pharmacists?

Answer 4

if there are two or more pharmacists working in a pharmacy only one can be the responsible pharmacist

Question 5

can a pharmacist be responsible for more than one pharmacy at the same time?

Answer 5

A pharmacist cannot be the responsible pharmacist for more than one pharmacy at any one time (although the law does allow this in exceptional circumstances authorised by the
Secretary of State (i.e. in an emergency or in the case of a pandemic))

Question 6

what does being the RP involve?

Answer 6

1) Secure the safe and effective running of the
pharmacy, including during periods of absence
2) Display a notice with their name, registration
number and the fact that they are in charge of the pharmacy at that time
3) Complete the pharmacy record to identify who the responsible pharmacist is for the pharmacy at any one time
4) Establish (if not already established), maintain and keep under review, procedures for safe working

Question 7

how long can a RP be absent from a pharmacy?

Answer 7

The responsible pharmacist may be absent from the pharmacy for a maximum of 2 hours, during the operational hours of the pharmacy, between midnight and midnight
*The total period of absence allowed for (all) responsible pharmacist(s) during one 24 hour period for one pharmacy must not exceed 2 hours

Question 8

what is the duties of a RP who is absent?

Answer 8

*Only be absent if the pharmacy can continue to run safely and effectively
*Remain contactable
*Be able to return with ‘reasonable promptness’ and do so where they feel it is necessary to secure the safe and effective running of the pharmacy

Question 9

what happens if a RP is not contactable?

Answer 9

Where they are not able to be contactable they may arrange for another pharmacist to be contactable and to provide advice (but the absent pharmacist remains the RP)

Question 10

what can occur in the pharmacy when the RP is absent?

Answer 10

*GSL medicines may still be sold
*P medicines must not be sold
*Dispensed and bagged prescriptions waiting for collection must not be given out
*Supply of medicines on a PGD must not take place
*Wholesale dealing must not take place
*Emergency supply to a patient must not take place
*Prescriptions may be taken in - whether the medicines may be assembled depends on many factors (see the next
two slides)

Question 11

can a dispensed medicine be given out while RP is missing?

Answer 11

A definition of ‘supervision’ in this context has never been provided by the
Courts
*‘Supervision’ has only been defined (in a pharmacy context) in the Courts when a poison was sold to a member of the public in 1943 – this definition has been assumed to be the same when a P medicine is sold (see P medicines lecture) i.e. physical presence and be aware of the sale and in a position to intervene
so basically up to pharmacy themselves

Question 12

what must the note display about RP?

Answer 12

The notice must state
*Pharmacist’s name
*Pharmacist’s GPhC registration number
*The fact that s/he is in charge of the pharmacy at this time

Question 13

do you take the RP notice down when RP is absent from pharmacy?

Answer 13

Must remain on display – even when the RP is absent from the premises

Question 14

what must the pharmacy record legally include?

Answer 14

*Pharmacist’s name
*Pharmacist’s GPhC registration number
*The date and time at which s/he became the
responsible pharmacist
*The date and time at which s/he ceased to be the responsible pharmacist
*If s/he is absent from the premises the date of
absence, the time s/he left the pharmacy and the time s/he returned

Question 15

how long must the pharmay record that the RP signed be kept for?

Answer 15

The record must be kept for 5 years by the pharmacy owner or Superintendent Pharmacist
*The record must be available for inspection at the pharmacy to which it relates
can be electron/ paper

Question 16

what is the advice the GPhC give in relation to the pharmacy record?

Answer 16

*The record should be completed personally by the responsible pharmacist
*The reason for absence should be noted
*Any amendments or alterations should identify who made them and when
*The record should be completed in real time and not retrospectively
*The record must not be completed until the pharmacist assumes the role of the responsible pharmacist (i.e. the safe and effective
running of the pharmacy is secured). The pharmacy must not open until this is done.
*The record provides an important audit trail of responsibility
*Electronic records must be backed up regularly

Question 17

what are the pharmacy procedures the RP has to do?

Answer 17

*Establish (if not already established), maintain and keep under review procedures for safe working
*These should cover a wide range of aspects relating to medicines including ordering, storing, preparing, selling,
supplying, delivering and disposal of medicines
*Should also cover circumstances in which non-
pharmacist members of staff may give advice about medicines
*Should identify pharmacy staff competent to undertake specific activities
*SOPs may be kept on paper or electronically

Question 18

what is the advice the GPhC give in relation to the pharmacy procedures?

Answer 18

*SOPs should be reviewed at least every 2 years (i.e. they should be dated when they are first written and should also include the date when they should be reviewed)
*If a SOP is amended or reviewed by a responsible pharmacist there must be an audit trail in place to show who amended it and the date this took place
*The SOPs should be always be available for
inspection

Question 19

what if there is no RP for a pharmacy?

Answer 19

The pharmacy must close for the sale and supply of medicines
*BUT this is likely to be in breach of its NHS contract to dispense prescriptions if it closes
*Also, the display of restricted titles (such as ‘chemist’ or ‘pharmacy’) in connection with the sale of goods by retail is unlawful if there is no Responsible Pharmacist signed in

Question 20

define a retail pharmacy business

Answer 20

A business which consists of or includes the retail sale of medicinal products other than medicinal products on a GSL

Question 21

who may a retail pharmacy business be conducted by?

Answer 21

*A pharmacist
*A partnership where each partner is a pharmacist
*A body corporate
*A representative of a deceased, bankrupt or mentally
ill pharmacist

Question 22

who is the superintendent pharmacist?

Answer 22

This is the person who has the overall management of the ‘keeping, preparing and dispensing of medicinal products
other than medicinal products on a GSL’

Question 23

who can the superintendent pharmacist be?

Answer 23

*Must be a pharmacist (i.e. on the GPhC register)
*That person must not act in a similar capacity for any other
body corporate (this will be deleted from 1/12/22)
*The restricted title ‘chemist’ may only be used by the
business if the superintendent pharmacist is a member of
the board of the body corporate

Question 24

does the RP legislation apply to hospitals?

Answer 24

There is no need for a hospital pharmacy to be registered with the GPhC so long as the supply of medicines is within the same legal entity
*This would include the supply of medicines to patients who are patients of
that hospital

Question 25

what is the law change to a superintendent pharmacist?

Answer 25

The order transfers new powers to the GPhC to define how the
roles of the RP, SP and Chief Pharmacist are fulfilled
*The GPhC will write new rules after considering the views of
patients, public, health professionals and the NHS about the
requirements and expectations around the roles of the RP, SP and
Chief Pharmacist
*The new rules (standards) document will be drafted by the GPhC
and then there will be a public consultation before the final version
is produced
*This is a move to the roles and responsibilities being enforced via
professional standards (and the GPhC) rather than legislation (and
the Criminal Courts)