lecture 9: responsible pharmacist Flashcards
what is personal control?
physical presence of the pharmacist in the pharmacy
when was supervision used? what is it?
before medicines act introduced RP legislation
up to October 2009
why was this changed?
locked pharmacist on the premises, change was to give them a greater role
how did they change? 1st step
RP regulations
2nd step?
not happened yet, enabling legislation
freeing up pharmacists time
what act changed personal control to RP?
health act 2006
what act provides detailed requirements of the RP? came into force?
the medicines (pharmacies) (RP) regulations 2008
October 2009
a pharmacy carried on by a body corporate-ie chains requires the management of a _____. who does what?
superintendent
that oversees pharmaceutical bits
can the RP be the SI?
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
individuals in positions of authority?
superintendents
chief pharmacists- hospitals
owners
RP
if a pharmacy business is carried on by partnership, the RP must be ….
one of the partners
one pharmacy _____ RP
one, even if several are working at once
details of requirements of RP?
display a notice
pharmacy procedurers
pharmacy records
absence from the pharmacy
what must the notice from the RP state?
RP name
RP GPhC reg number
that this person is in charge of the pharmacy at that time
what is the pharmacy record? what needs to be on it?
RP must record:
name and reg no
date and time at which RP- became RP and ceased to be RP
What needs to be recorded in relation to absence from the pharmacy?
date of absence
time at which absence commenced and when they returned
do they need to give a reason for absence
not legally, but good practice
do these records need to be in writing?
no can be electronic
how long must the record be kept? and by who?
5 years
by SI or pharmacy owner
when do these records need to be made?
contemporaneously- at the time or soon after.
who establishes SOPs?
RP
SOPS must be in writing. TF
false, can be electronic as well
is there an exact time frame when SOPs must be reviewed
no, but at least once every 2 years is good practice
what must be covered in the SOPs?
–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
how long can a RP be absent from the pharmacy?
2 hours in 24 hours
in absence the RP must:
remain contactable
be able to return promptly
what if this isn’t possible?
another pharmacist must be available to provide advice
does this pharmacist need to come to the premises?
no
can you sign in retrospectively
no- looking back at the day and seeing things didnt go well so not signing in
is supervision defined by medicines act 1968? what then can help us define?
no, so we need case law to help define
case law definition of supervision
where supervision by a pharmacist is required, transaction cannot take place without the pharmacists physical supervision
what activities can only be done by the RP/ Supervising pharmacist being in charge and physically present?
professional check of Rx sale and supply of P medicines sale and supply of POMs supply of medicines under a PGD emergency supply
activity that can take place with RP supervising but not needing physical presence?
assembly process generating labels taking meds of shelf labelling of containers accuracy checking
activities that can take place with pharmacist being in charge of pharmacy but not physically present?
sale of GSL medicines
processing waste stock medicines or patient returned medicines
excluding CDs
activities that can take place without RP being in control of premises?
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
if unsupervised pharmacy and the pharmacist has been gone less than 2 hours can you hand out bagged, checked Rx?
no
can you sell GSL medicines if the pharm has been gone >2 hours
no
only community pharmacies require a RP?
FALSE
