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Pharmacy Law Flashcards

1
Q

What is Pharmacy Act 1852

A

Established framework of the pharmaceutical society

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2
Q

In 2010, what 2 bodies replaced the pharmaceutical society

A

GPhc (General pharmaceutical council) and RPS (royal pharmacy society)

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3
Q

What power did pharmaceutical society have

A

Hold examinations, issue certificates

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4
Q

What became a restricted title

A

Pharmaceutical chemist

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5
Q

Medicines Act 1968 covers (8)

A

Licensing of medicines
Sales promotions
Regulation of retail pharmacy business
Legal classification of medicines
Wholesale dealing
Herbal, homoeopathic veterinary medicines
Containers
Pharmacopeias

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6
Q

Who established legal classification of medicines

A

Medicines Act 1968

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7
Q

Why did Medicines Act 1968 establish legal classification of medicines

A

Control safe supply of medicines

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8
Q

What’s MHRA

A

Medicines healthcare regulatory agency

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9
Q

What should marketing authorisation include

A

Legal classification of product

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10
Q

How many products have to have a marketing authorisation

A

All products

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11
Q

3 legal classes

A

POM
P
GSL

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12
Q

What does POM stand for

A

Prescription only medication

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13
Q

What does P stand for

A

Pharmacy only medication

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14
Q

What does P stand for

A

Pharmacy only medication

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15
Q

What does GSL stand for

A

General sales list

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16
Q

What determines legal classification

A

Relates to product and not to the active substance

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17
Q

GSL pack size for paracetamol and aspirin

A

16

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18
Q

P pack size for paracetamol and aspirin

A

32

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19
Q

POM pack size for paracetamol and aspirin

A

100

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20
Q

Why were tighter controls introduced for codeine and dihydrocodeine
Who introduced them
When was they introduced

A

Minimise risk of addiction
MHRA
September 2009

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21
Q

Is codeine and dihydrocodeine used for short-term or long-term treatment

A

Short-term treatment of acute, moderate pain

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22
Q

When should you use codeine and dihydrocodeine

A

When pain is not relieved by paracetamol, aspirin, or ibuprofen alone only

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23
Q

POM for codeine and dihydrocodeine

A

Product over 32 does units

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24
Q

Addition warnings

A

Can cause addiction - 3 day use only
PIL

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25
Q

Humans medicines regulations 2012
- regulations 237

A

Legal restrictions on quantities that may be sold

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26
Q

Pseudoephedrine supply without prescription

A

720mg

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27
Q

Ephedrine supply without prescription

A

180mg

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28
Q

Can you supply pseudoephedrine and ephedrine together

A

Unlawful to supply at same time unless with prescription

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29
Q

Emergency hormonal contraception is also known as

A

EHC

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30
Q

What is levonorgestrel 1500mg tabs licenced as

A

P medicines

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31
Q

What is uliprista acetate 30mg tabs licenced as

A

P medicines

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32
Q

What must pharmacists be involved in

A

Assessing clinical suitability and approving sales

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33
Q

Marketing authorisation for levonorgestral

A

16 and over

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34
Q

Marketing authorisation for ulipristal

A

Women of child bearing age

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35
Q

What determines legal class

A

Product as per marketing authorisation not drug

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36
Q

Ibuprofen max strength as GSL

A

200mg

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37
Q

Bisacody tabs, 40 tabs licenced as

A

GSL larger packs are P

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38
Q

Daktacort 15g and 30g licenced as

A

15g is P
30g is POM

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39
Q

Is PO separate legal classification

40
Q

PO used for

A

Classify some GSL ingredients but only licenced for sale through pharmacies

41
Q

How are P medicines sold

A

Under supervision of pharmacist

42
Q

How to find legal classification of product (4)

A

Marked on packaging of medication
Annotations on BNF
Manufacturer SPC - summary of product characteristics
MHRA authorisation

43
Q

Why was the Health Act 1999 introduced

A

Modernise and strengthen the regulation of healthcare professionals

44
Q

What did the Health Act 1999 replace

A

Pharmacy Act 1954

45
Q

When was the pharmacist and technicians order introduced

46
Q

What is the medicines regulations 2008

A

Registration of pharmacy technicians
Same system of regulation of pharmacists and technicians
Continuing professional development (CPD) became a statutory requirement

47
Q

What does RP stand for

A

Responsible pharmacist

48
Q

When was RP introduced

A

October 2009

49
Q

Statutory duty for RP

A

Ensure safe and effective running of pharmacy

50
Q

RP has to

A

Establish, maintain, and keep under review procedures of safe working
Keep a record of pharmacists responsible at any one time
Display notice - name, registration number, and statement confirming they are in charge

51
Q

What is the statutory duty of the pharmacy owner regarding RP

A

Ensure RP maintains pharmacy records

52
Q

How long can RP be absent from pharmacy

A

2 hours in a 24-hour period

53
Q

Does the RP need to remain contactable during absence

54
Q

What can be sold during RP absence

55
Q

What is Humans medicines regulations 2012

A

First major consolidation and review of UK medicines since 1968

56
Q

Major change to practice introduced by human medicines regulations 2012

A

Enable use of professional judgement when labelling medicines

57
Q

What is professional judgement

A

Change directions
Change name or common name of medicines
Change precautions on label

58
Q

Why was humans’ medicines regulations 2012 introduced

A

Ensure medicines labels are optimised to ensure patient safety

59
Q

What does changing direction mean

A

Abitary dose not supporting patient
Dose interval error
Overdose
Direction differs from the advice of prescriber

60
Q

Limitations of humans medicines regulations 2012

A

Only allow change to label, generic substitution not allowed

61
Q

Other Limitations of Human Medicines regulations 2012

A

Cannot change strength or quantity
Not change conventions for incomplete prescription - legal requirements must still be met
Does not apply to schedule 2 and 3 controlled drugs

62
Q

When did pharmacy regulations 2013 come into effect

A

April 1st 2013

63
Q

What did the pharmacy regulations 2013 do

A

Set legal framework for the commissioning of pharmaceutical services in England by ICBs.

64
Q

What was the legal framework of pharmacy regulations 2013

A

Requirement for publication of a pharmaceutical needs assessment by health and wellbeing boards
Maintenance of lists of contractors who provide pharmaceutical services
Specific matters relating to the provision of services in rural areas
Terms of service for those contractors who provide pharmaceutical service

65
Q

What was the main change from pharmacy regulations 2023

A

Pharmacy contractors to apply to reduce the core opening hours of their 100 hour Pharmacy where certain requirements are met

66
Q

When was Humans medicines regulations 2016 introduced

A

1st April 2016

67
Q

Changes from HMR 2012, from human medicines regulations 2016

A

Permitting registered therapeutic radiographer independent prescribers
Adding registered dietitians to a list of health professionals
Enabling general sale and supply of certain POM to be supplied by registered orthoptists
Enabling POMs to be supplied by registered midwives

68
Q

What were the POMs

A

Diamorphone
Morphine
Pethidine

69
Q

HMR exemptions

A

Midwives
Orthoptists
Optometrist
Paramedic
Podiatrists
Chiropodists

70
Q

Who is the largest group of prescribers

A

Doctors, along with dentists and vetinary surgeons, are able to prescribe on registration

71
Q

What should prescribers recognise

A

All prescribers should recognise the limits of their own knowledge and skill and prescribe within their own competence and clinical expertise

72
Q

When will all newly qualified pharmacists be independent prescribers

A

From September 2026

73
Q

Prescribing restrictions for independent prescribers

A

There are none

74
Q

Prescribing restrictions for supplementary prescribers

A

Restricted to areas of clinical competence and included within an agreed clinical management plan
Often written and agree with a prescriber and the patient

75
Q

Types of prescription

A

NHS
Private

76
Q

Who are restricted under NHS on what they can prescribe

A

Dental practitioners formulary
Nurse prescribers formulary

77
Q

Types of prescription

A

5 main types

78
Q

FP10

A

GP/Hospitals Drs/IP/SP
Green

79
Q

FP10D

A

Dentist primary care
Yellow

80
Q

FP10MDA

A

Installment prescriptions
IP treating addiction
Blue

81
Q

FP10P

A

Prescribing nurse
IP
SP
Purple

82
Q

FP10PCD

A

Private prescription for schedule 2 and 3 CD
Pink

83
Q

How will Majority prescriptions in practice be

A

Electronic tokens sent via EPS

84
Q

Legal requirements (10)

A

POMs only, but we treat GSL and P the same in terms of requirements
Summarised In MEP.3.3.1
Signed in ink
Dated
Written/generated in indelible ink
Address of practitioner
Particulars to indicate type of prescriber
Name and address of patient
Age

85
Q

Label requirements (6)

A

Name of patient
Name and address of the supplying pharmacy
Date of dispensing
Name of medicines
Directions for use of the medicines
Precaution relating to the use of medicines

86
Q

What are 2 examples of good practice label requirements

A

Keep out of sight of children
Use this medicine only on your skin

87
Q

What are the changes to poisons act 1972

A

Change how poisons and some chemicals are classified and regulated

88
Q

What does the Poison Act 1972 require

A

Requires pharmacists to report suspicious transactions, significant stock loss, and theft to the police

89
Q

What do public have to present before purchasing dangerous poisons and chemicals

A

Present a valid licence issued by home office

90
Q

Who checks licences

A

Pharmacy teams need to check licence is valid

91
Q

What must be on the licence for poisons

A

Transaction details

92
Q

What must be on the licence for poisons

A

Transaction details

93
Q

What are CDs

A

Controlled drugs

94
Q

What are CDs controlled by

A

Misuse of drugs act 1971 and misuse of drugs regulations 2001

95
Q

Are schedule same as classes

A

No, they are used to classify substances in law

96
Q

What do schedule determine

A

Degree of control
Storage requirements
Record keeping requirements

PHARMACY (4 decks)

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