Pharmacy Law Flashcards
(96 cards)
1
Q
What is Pharmacy Act 1852
A
Established framework of the pharmaceutical society
2
Q
In 2010, what 2 bodies replaced the pharmaceutical society
A
GPhc (General pharmaceutical council) and RPS (royal pharmacy society)
3
Q
What power did pharmaceutical society have
A
Hold examinations, issue certificates
4
Q
What became a restricted title
A
Pharmaceutical chemist
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
6
Q
Who established legal classification of medicines
A
Medicines Act 1968
7
Q
Why did Medicines Act 1968 establish legal classification of medicines
A
Control safe supply of medicines
8
Q
What’s MHRA
A
Medicines healthcare regulatory agency
9
Q
What should marketing authorisation include
A
Legal classification of product
10
Q
How many products have to have a marketing authorisation
A
All products
11
Q
3 legal classes
A
POM
P
GSL
12
Q
What does POM stand for
A
Prescription only medication
13
Q
What does P stand for
A
Pharmacy only medication
14
Q
What does P stand for
A
Pharmacy only medication
15
Q
What does GSL stand for
A
General sales list
16
Q
What determines legal classification
A
Relates to product and not to the active substance
17
Q
GSL pack size for paracetamol and aspirin
A
16
18
Q
P pack size for paracetamol and aspirin
A
32
19
Q
POM pack size for paracetamol and aspirin
A
100
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
21
Q
Is codeine and dihydrocodeine used for short-term or long-term treatment
A
Short-term treatment of acute, moderate pain
22
Q
When should you use codeine and dihydrocodeine
A
When pain is not relieved by paracetamol, aspirin, or ibuprofen alone only
23
Q
POM for codeine and dihydrocodeine
A
Product over 32 does units
24
Q
Addition warnings
A
Can cause addiction - 3 day use only
PIL
25
Humans medicines regulations 2012
- regulations 237
Legal restrictions on quantities that may be sold
26
Pseudoephedrine supply without prescription
720mg
27
Ephedrine supply without prescription
180mg
28
Can you supply pseudoephedrine and ephedrine together
Unlawful to supply at same time unless with prescription
29
Emergency hormonal contraception is also known as
EHC
30
What is levonorgestrel 1500mg tabs licenced as
P medicines
31
What is uliprista acetate 30mg tabs licenced as
P medicines
32
What must pharmacists be involved in
Assessing clinical suitability and approving sales
33
Marketing authorisation for levonorgestral
16 and over
34
Marketing authorisation for ulipristal
Women of child bearing age
35
What determines legal class
Product as per marketing authorisation not drug
36
Ibuprofen max strength as GSL
200mg
37
Bisacody tabs, 40 tabs licenced as
GSL larger packs are P
38
Daktacort 15g and 30g licenced as
15g is P
30g is POM
39
Is PO separate legal classification
No
40
PO used for
Classify some GSL ingredients but only licenced for sale through pharmacies
41
How are P medicines sold
Under supervision of pharmacist
42
How to find legal classification of product (4)
Marked on packaging of medication
Annotations on BNF
Manufacturer SPC - summary of product characteristics
MHRA authorisation
43
Why was the Health Act 1999 introduced
Modernise and strengthen the regulation of healthcare professionals
44
What did the Health Act 1999 replace
Pharmacy Act 1954
45
When was the pharmacist and technicians order introduced
2007
46
What is the medicines regulations 2008
Registration of pharmacy technicians
Same system of regulation of pharmacists and technicians
Continuing professional development (CPD) became a statutory requirement
47
What does RP stand for
Responsible pharmacist
48
When was RP introduced
October 2009
49
Statutory duty for RP
Ensure safe and effective running of pharmacy
50
RP has to
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
What is the statutory duty of the pharmacy owner regarding RP
Ensure RP maintains pharmacy records
52
How long can RP be absent from pharmacy
2 hours in a 24-hour period
53
Does the RP need to remain contactable during absence
Yes
54
What can be sold during RP absence
GSL
55
What is Humans medicines regulations 2012
First major consolidation and review of UK medicines since 1968
56
Major change to practice introduced by human medicines regulations 2012
Enable use of professional judgement when labelling medicines
57
What is professional judgement
Change directions
Change name or common name of medicines
Change precautions on label
58
Why was humans' medicines regulations 2012 introduced
Ensure medicines labels are optimised to ensure patient safety
59
What does changing direction mean
Abitary dose not supporting patient
Dose interval error
Overdose
Direction differs from the advice of prescriber
60
Limitations of humans medicines regulations 2012
Only allow change to label, generic substitution not allowed
61
Other Limitations of Human Medicines regulations 2012
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
When did pharmacy regulations 2013 come into effect
April 1st 2013
63
What did the pharmacy regulations 2013 do
Set legal framework for the commissioning of pharmaceutical services in England by ICBs.
64
What was the legal framework of pharmacy regulations 2013
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
What was the main change from pharmacy regulations 2023
Pharmacy contractors to apply to reduce the core opening hours of their 100 hour Pharmacy where certain requirements are met
66
When was Humans medicines regulations 2016 introduced
1st April 2016
67
Changes from HMR 2012, from human medicines regulations 2016
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
What were the POMs
Diamorphone
Morphine
Pethidine
69
HMR exemptions
Midwives
Orthoptists
Optometrist
Paramedic
Podiatrists
Chiropodists
70
Who is the largest group of prescribers
Doctors, along with dentists and vetinary surgeons, are able to prescribe on registration
71
What should prescribers recognise
All prescribers should recognise the limits of their own knowledge and skill and prescribe within their own competence and clinical expertise
72
When will all newly qualified pharmacists be independent prescribers
From September 2026
73
Prescribing restrictions for independent prescribers
There are none
74
Prescribing restrictions for supplementary prescribers
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
Types of prescription
NHS
Private
76
Who are restricted under NHS on what they can prescribe
Dental practitioners formulary
Nurse prescribers formulary
77
Types of prescription
5 main types
78
FP10
GP/Hospitals Drs/IP/SP
Green
79
FP10D
Dentist primary care
Yellow
80
FP10MDA
Installment prescriptions
IP treating addiction
Blue
81
FP10P
Prescribing nurse
IP
SP
Purple
82
FP10PCD
Private prescription for schedule 2 and 3 CD
Pink
83
How will Majority prescriptions in practice be
Electronic tokens sent via EPS
84
Legal requirements (10)
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
Label requirements (6)
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
What are 2 examples of good practice label requirements
Keep out of sight of children
Use this medicine only on your skin
87
What are the changes to poisons act 1972
Change how poisons and some chemicals are classified and regulated
88
What does the Poison Act 1972 require
Requires pharmacists to report suspicious transactions, significant stock loss, and theft to the police
89
What do public have to present before purchasing dangerous poisons and chemicals
Present a valid licence issued by home office
90
Who checks licences
Pharmacy teams need to check licence is valid
91
What must be on the licence for poisons
Transaction details
92
What must be on the licence for poisons
Transaction details
93
What are CDs
Controlled drugs
94
What are CDs controlled by
Misuse of drugs act 1971 and misuse of drugs regulations 2001
95
Are schedule same as classes
No, they are used to classify substances in law
96
What do schedule determine
Degree of control
Storage requirements
Record keeping requirements
