lecture 9: responsible pharmacist

Question 1

what is personal control?

Answer 1

physical presence of the pharmacist in the pharmacy

Question 2

when was supervision used? what is it?

Answer 2

before medicines act introduced RP legislation

up to October 2009

Question 3

why was this changed?

Answer 3

locked pharmacist on the premises, change was to give them a greater role

Question 4

how did they change? 1st step

Answer 4

RP regulations

Question 5

2nd step?

Answer 5

not happened yet, enabling legislation

freeing up pharmacists time

Question 6

what act changed personal control to RP?

Answer 6

health act 2006

Question 7

what act provides detailed requirements of the RP? came into force?

Answer 7

the medicines (pharmacies) (RP) regulations 2008

October 2009

Question 8

a pharmacy carried on by a body corporate-ie chains requires the management of a _____. who does what?

Answer 8

superintendent

that oversees pharmaceutical bits

Question 9

can the RP be the SI?

Answer 9

yes- more common in small chains but in big ones ie lloyds, the SI is a full time job so wouldn’t have time to be a RP

Question 10

individuals in positions of authority?

Answer 10

superintendents
chief pharmacists- hospitals
owners
RP

Question 11

if a pharmacy business is carried on by partnership, the RP must be ….

Answer 11

one of the partners

Question 12

one pharmacy _____ RP

Answer 12

one, even if several are working at once

Question 13

details of requirements of RP?

Answer 13

display a notice
pharmacy procedurers
pharmacy records
absence from the pharmacy

Question 14

what must the notice from the RP state?

Answer 14

RP name
RP GPhC reg number
that this person is in charge of the pharmacy at that time

Question 15

what is the pharmacy record? what needs to be on it?

Answer 15

RP must record:
name and reg no
date and time at which RP- became RP and ceased to be RP

Question 16

What needs to be recorded in relation to absence from the pharmacy?

Answer 16

date of absence

time at which absence commenced and when they returned

Question 17

do they need to give a reason for absence

Answer 17

not legally, but good practice

Question 18

do these records need to be in writing?

Answer 18

no can be electronic

Question 19

how long must the record be kept? and by who?

Answer 19

5 years

by SI or pharmacy owner

Question 20

when do these records need to be made?

Answer 20

contemporaneously- at the time or soon after.

Question 21

who establishes SOPs?

Answer 21

RP

Question 22

SOPS must be in writing. TF

Answer 22

false, can be electronic as well

Question 23

is there an exact time frame when SOPs must be reviewed

Answer 23

no, but at least once every 2 years is good practice

Question 24

what must be covered in the SOPs?

Answer 24

–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
–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 25

how long can a RP be absent from the pharmacy?

Answer 25

2 hours in 24 hours

Question 26

in absence the RP must:

Answer 26

remain contactable

be able to return promptly

Question 27

what if this isn’t possible?

Answer 27

another pharmacist must be available to provide advice

Question 28

does this pharmacist need to come to the premises?

Answer 28

no

Question 29

can you sign in retrospectively

Answer 29

no- looking back at the day and seeing things didnt go well so not signing in

Question 30

is supervision defined by medicines act 1968? what then can help us define?

Answer 30

no, so we need case law to help define

Question 31

case law definition of supervision

Answer 31

where supervision by a pharmacist is required, transaction cannot take place without the pharmacists physical supervision

Question 32

what activities can only be done by the RP/ Supervising pharmacist being in charge and physically present?

Answer 32

professional check of Rx
sale and supply of P medicines 
sale and supply of POMs
supply of medicines under a PGD
emergency supply

Question 33

activity that can take place with RP supervising but not needing physical presence?

Answer 33

assembly process 
generating labels 
taking meds of shelf 
labelling of containers 
accuracy checking

Question 34

activities that can take place with pharmacist being in charge of pharmacy but not physically present?

Answer 34

sale of GSL medicines
processing waste stock medicines or patient returned medicines
excluding CDs

Question 35

activities that can take place without RP being in control of premises?

Answer 35

as long as correctly trained staff
ordering stock 
recieving and putting away- excl CDs
date checking- excl CDs
accessing PMR 
receiving Rx-s 
delivery person conveying medicines to patient

Question 36

if unsupervised pharmacy and the pharmacist has been gone less than 2 hours can you hand out bagged, checked Rx?

Answer 36

no

Question 37

can you sell GSL medicines if the pharm has been gone >2 hours

Answer 37

no

Question 38

only community pharmacies require a RP?

Answer 38

FALSE