responsibilities of pharmacists

Question 1

what does the responsible pharmacist regulation 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
• The responsible pharmacist has a statutory duty to ensure the safe and effective running of the pharmacy
• This law applies to all retail (community) pharmacies

Question 2

what was the law before the responsible pharamacist regulation 2008?

Answer 2

a pharmacist must be in ‘personal control’ of a retail pharmacy business in relation to the sale of all medicinal products- must be anywhere on the premises- if not cannot be sold- vs in retail shop can be
no medicines, even GSL could be sold

Question 3

why was personal control abolished?

Answer 3

restricted the pharmacist/ improve range of services available- work more flexibly/ allow trained staff to use knowledge of GSL

Question 4

why do we not confused personal control with supervision?

Answer 4

Do not confuse ‘personal control’ with ‘supervision’ which requires a pharmacist to be present for the sale of P medicines and is still the law

Question 5

what is the legal definition of a pharmacist?

Answer 5

A pharmacist who is responsible for securing the safe and effective running of the pharmacy
- also responsible when absent

Question 6

can there be two responsible pharamcists?

Answer 6

no- there only can be one responsible pharmacist at a time

Question 7

what does the job of a responsible pharmacist involve?

Answer 7

1) Secure the safe and effective running of the pharmacy, including during periods of absence
2) Display a notice with details of who the responsible pharmacist on duty is
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 8

what is the max time the responsible pharamacist may be absent for?

Answer 8

2 hours- between midnight and midnight

the 2 hour absence starts when the RP leaves the pharmacy and ends when they get back to the pharmacy

Question 9

when can a responsible pharmacist be absent?

Answer 9

• 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 10

if the responsible pharmacist is not contactable what can they do?

Answer 10

appoint another pharamcaist to provide advise but the absent pharmacist still remains the RP

Question 11

what can still happen in the pharmacy when the RP is gone?- within 2 hours

Answer 11

• GSL medicines may still be sold
• P medicines must not be sold
• Prescriptions may be taken in
• Dispensed and bagged prescriptions waiting for collection must not be given out

Question 12

when displaying a notice what must it legally show?

Answer 12

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

Question 13

where must the notice be displayed?

Answer 13

Must be displayed in a place where members of the public can see it- must remain up even when the RP is there

Question 14

what should the pharmacy record 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 they left the pharmacy and the time they returned

Question 15

NB MCQ- how long after should the pharmacy record be kept?

Answer 15

This record must be kept for 5 years by the pharmacy owner or Superintendent Pharmacist- can be electronic/ paper

Question 16

is the pharmacy record a legally required document?

Answer 16

This is a legally required document –failure to complete the record or retain it is a criminal offence and may result in prosecution

Question 17

what is the Gphc’S advice for the pharmacy record?

Answer 17

• 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 assured). 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 18

why are pharmacy procedures/SOP kept?

Answer 18

Establish, maintain and keep under review, various procedures for safe working (i.e. SOPs)

Question 19

what should the SOPs relate to?

Answer 19

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
- handeling complaints
-arrangemnets during leave of RP
-procedure showing how staff are notified to changes in the SOP

Question 20

how often should the SOPs be reviewed?

Answer 20

at least every 2 years

Question 21

what happens if a SOP is amended or reviewed by a responsible pharmacist?

Answer 21

there must be an audit trail in place to show who amended it and the date this took place

Question 22

what happens if there is no responsible pharmacist in the pharmacy?

Answer 22

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
-safer to close and contact NHS about it