Responsible Pharmacist

Question 1

What are the four legal requirements of the responsible pharmacist?

Answer 1

secure the safe and effective running of the pharmacy
- including periods of absences

display a notice

complete the pharmacy record

procedures for safe working

Question 2

What does ‘securing the safe and effective running of the pharmacy’ include?

Answer 2

establish scope of role and responsibilities
- for themselves and others

clarify ambiguities with owner/superintendent

only assume the role if you are professionally competent

only be the RP of one pharmacy at any time
- can only be the contactable pharmacist for one pharmacy at a time

ensure that any operational activities can only occur once you are satisfied that you have secured the safe and effective running of the pharmacy

Question 3

What does ‘displaying a notice’ mean?

Answer 3

is required to display a notice that is clearly visible to patients and the public

information that must be included:

• the name of the responsible pharmacist
• the GPhC registration number
• the fact that the responsible pharmacist is in charge of the pharmacy at the time

Question 4

What does ‘completing the pharmacy record’ entail?

Answer 4

shows who is responsible for the pharmacy at any given time and date

should include:

• the RP’s name
• the date and time at which the pharmacist became the RP
• the date and time at which the responsible pharmacist stopped being the RP

if you are absent from the premises:
– the date of absence
– the time which the RP left the pharmacy premises
– the time at which the RP returned to the pharmacy premises

Question 5

What is the pharmacy record?

Answer 5

is an important legal document which shows who the responsible pharmacist is at any given date and at any time.

it can be:
- in writing 
- electronically 
- in both forms
= must be made by the RP themselves 

must be kept for five years by the pharmacy owner or superintendent
- must be available at the pharmacy it relates to

Question 6

What do ‘pharmacy procedures’ entail?

Answer 6

SOPs - must be kept in writing, electronically or both

must cover the following:
- the arrangements to secure that medicinal products are
= ordered, stored, prepared, sold by retail, disposed of in a safe and effective manner

• the circumstance in which a member of staff who is not a pharmacist can give advice about medicinal products
• steps to be taken when there is change of RP
• procedure to be followed if there is a complaint made
• procedure to be followed when an incident occurs that indicates the pharmacy may not be running in a safe and effective manner
• the keeping of records of arrangements

Question 7

What should the pharmacist do in regards to the pharmacy record?

Answer 7

they must
- make it available for inspection by the pharmacy owner, pharmacy superintendent, the RP, pharmacy staff and GPhC inspectorate

• keep it for five years
• review it regularly
  = once every two years or following an incident
• can make temporary amendments if circumstances in the pharmacy change
  = must identify when the alterations were made and by whom

Question 8

What are the regulations in regards to pharmacist absence?

Answer 8

legally the RP is only allowed to be absent for a maximum of 2 hours during the pharmacy’s business hours between midnight and midnight

if there is more than one RP then the total period of absence for all RPs must not exceed two hours

they must:

• only be absent if the pharmacy can continue to run safely and effectively
• remain in contact with pharmacy staff for the duration of their absence and be able to return in reasonable promptness
• if they cannot remain in contact, then they must arrange for another pharmacist to be contactable and provide advice

Question 9

What activities can only take place under the supervision of the RP and must have the RP physically present?

Answer 9

professional check of a prescription
- legal and clinical

sale/supply of P medicines

sale/supply of POMs
- handing dispensed medicines to patient, patient representative or a delivery person

supply of medicines under a PGD

wholesale of medicines

emergency supply of medicines at the request of a patient or healthcare professional

Question 10

What are the activities that can take place under the supervision of the RP but does not need the RP to be physically present?

Answer 10

generating a dispensing label

taking medicines off dispensary shelves

assembly of the item
- counting tablets

labelling of containers with the dispensing label

accuracy checking

Question 11

What are the activities that can take place without the supervision of the RP and their physical presence?
- they are still in charge and present in the pharmacy

Answer 11

sale of GSLs

processing waste stock medicines or patient returned medicines (excluding CDs)

Question 12

What are the activities that can place without an RP in charge of the pharmacy?

Answer 12

ordering stock from pharmaceutical wholesalers

receiving stock from pharmaceutical wholesalers into the building (excluding CDs)

putting medicinal stock received from the wholesaler away onto the pharmacy shelves (general sale medicines, P, and POMs, excluding CDs)

accessing the PMR

date checking (excluding CDs)

receiving prescriptions from the EPS systems (England only), patient or collecting from surgery

Question 13

How can RP’s and contactable pharmacists can there be?

Answer 13

there can only be one RP at a time
- pharmacist can only be in charge of one pharmacy at a time

you can only be the contactable pharmacist for one pharmacy