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pharmacy semester 2 > lecture 13: Pharmacy regulations 4 > Flashcards

lecture 13: Pharmacy regulations 4 Flashcards

1
Q

what can GPhC standards relate to?

A

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

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2
Q

staff in retail pharmacy are…..

A

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

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3
Q

which pharmacies do these standards apply to?

A

all GPhC registered pharmacies

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4
Q

define pharmacy services?

A

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

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5
Q

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

A

yes

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6
Q

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

A

pharmacy OWNERS

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7
Q

what if its owned by a body corporate?

A

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

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8
Q

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

A

yes a professional responsibility to raise concerns

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9
Q

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

A

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

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10
Q

principle 1? what does it include?

A

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

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11
Q

principle 2?

A

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

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12
Q

principle 3? what must the premises be?

A

environmental conditions, must be:

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

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13
Q

principle 4?

A

ways pharmacy services are provided to the public

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14
Q

what does ‘pharmacy services’ cover?

A

all pharmacy related services
meds managements
advice and referral
clinical services

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15
Q

what does meds management include?

A

obtaining, keeping,handling, using and supplying meds

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16
Q

does security and waste management come under medicines management?

A

YES

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17
Q

Principle 5?

A

equipment and facilities

must be safe

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18
Q

what is ‘traditional pharmacy service’

A

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

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19
Q

what is ‘distance pharmacy service’

A

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

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20
Q

what are these certain activities?

A 
EPS- Rx not given in by patient
delivery services to care/nursing home
mail order service
internet pharmacy service 
hub and spoke pharmacy service
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21
Q

what is a hub and smoke pharmacy service?

A

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

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22
Q

examples of proactive assessments to standards?

A

revalidation of registrants

inspection of premises

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23
Q

what is active assessment to standards

A

concern identified and investigated

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24
Q

what are the functions of a GPhC appointed inspector?

A

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

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25
Q

can inspectors assist council in investigation of FtP matters?

A

yes

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26
Q

is practicing without being on the GPhC register an offence?

A

yes

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27
Q

when can proceedings for this offence take place?

A

within 6 months of sufficient evidence avaliable

28
Q

how many inspectors in Great Britain?

A

38

29
Q

what is each inspector responsible for?

A

registered pharmacy premises in 5-7 organisations

30
Q

how many pharmacies do they inspect?

A

500-600 premises

31
Q

how many visits per year?

A

200 on average

32
Q

2 main roles of inspectorate?

A

inspection visits

investigations on complaints ect

33
Q

can inspectors give advice?

A

yes

34
Q

can inspectors lease with other regulatory and enforcement agencies?

A

yes and local primary care organisations

35
Q

how often do pharmacy premises get inspected?

A

every 5 years at least

36
Q

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

A

pharmacy provides high risk services

previous inspections indicates more frequent inspections are required

37
Q

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

A

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

38
Q

what do they record?

A

outcomes of the inspection and visit

39
Q

the inspector can do into the pharmacy at any time?

A

false, at any reasonable hour

40
Q

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

A

false, they must

41
Q

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

A

no

42
Q

however what do they do most of the time?

A

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

43
Q

can inspectors inspect plants?

A

yes

44
Q

can inspectors remove any substances articles or products?

A

yes

45
Q

can they observe the FtP of the registrant at the premises

A

yes

46
Q

can they take copies of things?

A

yes

47
Q

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

A

false, they can

48
Q

are they allowed to take things and retain them?

A

yes

49
Q

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

A

offence- get a fine

50
Q

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

A

issue a improvement notice to the pharm, SI or owner

51
Q

what does the improvement notice do?

A

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

52
Q

what must the improvement notice also state?

A

right of appeal and period to bring appeal

53
Q

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

A

28 days

54
Q

if you don’t comply with the improvement notice?

A

its an offence and can get a fine

55
Q

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

A

notify the registrar in writing

56
Q

what can the registrar do following receipt of this?

A

remove the pharmacy from the register

suspend registration

57
Q

can this be appealed?

A

yes

58
Q

3 core regulatory functions to the GPhC?

A

maintain register
ensure FtP
set and enforce standards

59
Q

what do the standards reflect the GPhCs commitment to?

A

improving

aspiring to excellence

60
Q

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

A

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

61
Q

how will the inspector gather and record evidence?

A

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

62
Q

when do we have a action plan?

A

when the pharmacy report is ‘poor’ and some ‘satisfactory’

63
Q

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

A

false

64
Q

what law allows the GPhC to publish inspection reports?

A

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

65
Q

what does this law provide to patients?

A

better assurance that pharmacies are meeting standards

66
Q

3 types of inspections?

A

routine
intelligence led
themed

67
Q

4 possible findings?

A

standards not all met
standards met
good practice
excellent practice

pharmacy semester 2 (15 decks)

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