lecture 13: Pharmacy regulations 4

Question 1

what can GPhC standards relate to?

Answer 1

safe and effective provision of pharmacy services at or from registered pharmacies
working conditions
patient experience
staff training

Question 2

staff in retail pharmacy are…..

Answer 2

properly held accountable for the health, safety and well being of patients and other persons

Question 3

which pharmacies do these standards apply to?

Answer 3

all GPhC registered pharmacies

Question 4

define pharmacy services?

Answer 4

provided at or from a registered pharmacy including the management of medicines, provision of advice and referral, clinical services such as vaccination and care homes

Question 5

are agencies and contract workers of a pharmacy regarded as ‘staff’?

Answer 5

yes

Question 6

who is responsible for ensuring safe and effective provision of pharmacy services? AKA the standards being met

Answer 6

pharmacy OWNERS

Question 7

what if its owned by a body corporate?

Answer 7

the directors must assure themselves that the standards for registered pharmacies are being met

Question 8

can PTs raise concerns if they believe standards aren’t being met

Answer 8

yes a professional responsibility to raise concerns

Question 9

how many stardards are there for registered pharmacies? what are they?

Answer 9

5

1: governance arrangements
2: staff are empowered and competent
3: environment of the premises
4: way in which pharmacy services are delivered
5: equipment and facilities

Question 10

principle 1? what does it include?

Answer 10

governance arrangements, includes:
having clear roles and accountabilities of people involved in providing and managing p services
arrangements for managing risks
way registered pharmacy is managed and operated

Question 11

principle 2?

Answer 11

staff are empowered and competent to safeguard the health, safety and well being of patients and the public

Question 12

principle 3? what must the premises be?

Answer 12

environmental conditions, must be:

suitable for services being provided and protect and maintain patients health, safety and wellbeing

Question 13

principle 4?

Answer 13

ways pharmacy services are provided to the public

Question 14

what does ‘pharmacy services’ cover?

Answer 14

all pharmacy related services
meds managements
advice and referral
clinical services

Question 15

what does meds management include?

Answer 15

obtaining, keeping,handling, using and supplying meds

Question 16

does security and waste management come under medicines management?

Answer 16

YES

Question 17

Principle 5?

Answer 17

equipment and facilities

must be safe

Question 18

what is ‘traditional pharmacy service’

Answer 18

all parts of the pharmacy service, including the sale and supply of medicines, takes place in the same registered pharmacy

Question 19

what is ‘distance pharmacy service’

Answer 19

when certain activities are carried out at different registered pharmacies or places
also applies in all cases when the member of staff (or third party) providing any part of the pharmacy service, and the patient who uses the pharmacy are not in the same registered pharmacy together

Question 20

what are these certain activities?

Answer 20

EPS- Rx not given in by patient
delivery services to care/nursing home
mail order service
internet pharmacy service 
hub and spoke pharmacy service

Question 21

what is a hub and smoke pharmacy service?

Answer 21

where medicines are prepared, assembled, dispensed and labelled for individual patients against prescriptions at a central ‘hub’ registered pharmacy

Question 22

examples of proactive assessments to standards?

Answer 22

revalidation of registrants

inspection of premises

Question 23

what is active assessment to standards

Answer 23

concern identified and investigated

Question 24

what are the functions of a GPhC appointed inspector?

Answer 24

enforce standards
secure compliance of the pharmacies with the meds act 1968
secure compliance by pharmacists/ persons carrying out retail pharmacy with the poisons act 1972

Question 25

can inspectors assist council in investigation of FtP matters?

Answer 25

yes

Question 26

is practicing without being on the GPhC register an offence?

Answer 26

yes

Question 27

when can proceedings for this offence take place?

Answer 27

within 6 months of sufficient evidence avaliable

Question 28

how many inspectors in Great Britain?

Answer 28

38

Question 29

what is each inspector responsible for?

Answer 29

registered pharmacy premises in 5-7 organisations

Question 30

how many pharmacies do they inspect?

Answer 30

500-600 premises

Question 31

how many visits per year?

Answer 31

200 on average

Question 32

2 main roles of inspectorate?

Answer 32

inspection visits | investigations on complaints ect

Question 33

can inspectors give advice?

Answer 33

yes

Question 34

can inspectors lease with other regulatory and enforcement agencies?

Answer 34

yes and local primary care organisations

Question 35

how often do pharmacy premises get inspected?

Answer 35

every 5 years at least

Question 36

why would an inspector decide to do more than a visit every 5 years?

Answer 36

pharmacy provides high risk services | previous inspections indicates more frequent inspections are required

Question 37

what law was changed by the new powers law change in 2016&2018?

Answer 37

the inspectors must do reports of routine inspections, special inspections and other visits to registered pharmacies

Question 38

what do they record?

Answer 38

outcomes of the inspection and visit

Question 39

the inspector can do into the pharmacy at any time?

Answer 39

false, at any reasonable hour

Question 40

the inspector doesn't need to provide evidence of their identity?

Answer 40

false, they must

Question 41

are the inspectors obliged to notify the premises that they want to carry out an inspection?

Answer 41

no

Question 42

however what do they do most of the time?

Answer 42

send a notification of their visit, allows the team to prepare

Question 43

can inspectors inspect plants?

Answer 43

yes

Question 44

can inspectors remove any substances articles or products?

Answer 44

yes

Question 45

can they observe the FtP of the registrant at the premises

Answer 45

yes

Question 46

can they take copies of things?

Answer 46

yes

Question 47

inspectors aren't allowed to ask for access and check operation of computers/ electronic devices. TF

Answer 47

false, they can

Question 48

are they allowed to take things and retain them?

Answer 48

yes

Question 49

what is the result if you try to obstruct an inspector?

Answer 49

offence- get a fine

Question 50

what can the inspector do if they find that the pharmacy is not compliant with legal requirements or standards?

Answer 50

issue a improvement notice to the pharm, SI or owner

Question 51

what does the improvement notice do?

Answer 51

state grounds for believing there is a failure of compliance specify measures hat must be taken to rectify failure require that measures must be met within a specific period

Question 52

what must the improvement notice also state?

Answer 52

right of appeal and period to bring appeal

Question 53

the specified period to make changes can be no more than?

Answer 53

28 days

Question 54

if you don't comply with the improvement notice?

Answer 54

its an offence and can get a fine

Question 55

if you don't comply with the improvement notice what must the inspector do?

Answer 55

notify the registrar in writing

Question 56

what can the registrar do following receipt of this?

Answer 56

remove the pharmacy from the register | suspend registration

Question 57

can this be appealed?

Answer 57

yes

Question 58

3 core regulatory functions to the GPhC?

Answer 58

maintain register ensure FtP set and enforce standards

Question 59

what do the standards reflect the GPhCs commitment to?

Answer 59

improving | aspiring to excellence

Question 60

what will the inspectors seek on their inspections regarding the standards?

Answer 60

seek evidence from the owners, SIs and pharmacy team to demonstrate how the standards are being met

Question 61

how will the inspector gather and record evidence?

Answer 61

looking at written or documentary evidence observing interactions with patients questioning staff testing systems, processes and procedures

Question 62

when do we have a action plan?

Answer 62

when the pharmacy report is 'poor' and some 'satisfactory'

Question 63

prior to an inspection visit the GPhC inspectorate has to give a minimum of 5 days notice?

Answer 63

false

Question 64

what law allows the GPhC to publish inspection reports?

Answer 64

the pharmacy (premises standards, information and obligations) order 2016

Question 65

what does this law provide to patients?

Answer 65

better assurance that pharmacies are meeting standards

Question 66

3 types of inspections?

Answer 66

routine intelligence led themed

Question 67

4 possible findings?

Answer 67

standards not all met standards met good practice excellent practice