PPP Law Lectures Flashcards
(175 cards)
1
Q
define law
A
the regulation of human affairs and human relationships
2
Q
What does the equality act 2010 do?
A
eliminates unlawful discrimination
3
Q
What are the 9 protected characteristics?
A
- age
- gender
- transgender
- religion
- marriage
- pregnancy
- race
- disability
- sexual orientation
4
Q
What are the 4 types of law in the UK?
A
- criminal law
- civil law
- administrative law
- common law
5
Q
define criminal law
A
the process for the investigation of crime and for dealing with suspects
6
Q
define civil law
A
law that regulates rights between citizens
7
Q
define administrative law
A
law that aims to ensure that government agencies operate within their legal authority
8
Q
define common law
A
the process in which judges interpret and apply the law in individual cases
9
Q
What are the 2 types of government papers?
A
green paper and white paper
10
Q
define green paper
A
a policy document which contains proposals that the government is planning to implement and they ask for feedback to draft a white paper
11
Q
define white paper
A
a paper presenting clear and more developed proposals which will become law if parliament agrees
12
Q
define primary legislation
A
legislation created and passed by the main legislative bodies such as UK Parliament
13
Q
define secondary legislation
A
legislation created by ministers or other bodies under powers given to them by an Act of Parliament -> often used to update existing laws without having to complete the gull parliamentary process
14
Q
Give examples of primary, secondary and tertiary healthcare services
A
primary -> GPs, dentist, community pharmacists
secondary -> hospitals
tertiary -> specialties such as transplants and neurosurgery
15
Q
When was the NHS introduced? Why?
A
in 1948 - with the aim to provide healthcare based on need, not the ability to pay
16
Q
Why was the Medicines Act introduced in 1948?
A
to start regulating our medicines as there was no control over marketing of new medicines
17
Q
Who was the Medicines Act 1968 enforced by?
A
MHRA -> Medicines and Healthcare products Regulatory Agency
18
Q
Since 1968, what has happened to the Medicines Act?
A
many more rules have been made by Statutory Instruments, a type of secondary legislation and much of the act has been revoked
19
Q
What is the current law of medicines regulation?
A
The Human Medicines Regulation 2012 (HMR)
20
Q
What does the HMR do?
A
regulates the manufacture, distribution, importation, sale, supply, labelling and advertisement, pharmacovigilance of drugs
21
Q
Who enforces the HMR 2012?
A
the Secretery of State, the GPhC and the Drug Authority (local council)
22
Q
How is the HMR 2012 enforced?
A
ensuring everyone has licenses to do things with medicines such as manufacture, sell, import etc
23
Q
What is the main aim of the HMR 2012? How many parts does it have?
A
to maintain the safety, quality and efficacy of medicinal products -> 17 parts to it
24
Q
define licensing authority
A
an official body that grants licences
25
define MHRA
The Medicines and Healthcare Products Regulatory Agency, the main licensing body in the UK
26
define advertisements
anything designed to promote the prescribing, supply, sale or use of a medicinal product
27
define GSL
medicinal product available on general sale to the public
28
define POM
medicinal product only available with a prescription
29
define P
medicinal product that is not a POM or GSL and is only available from a pharmacy
30
define the Special provision for pharmacies
exempts the need for manufacturing license when spontaneously dispensing
31
define medicinal product
any substance or combination with properties to prevent, diagnose or treat disease in HUMANS, correct a physiological function or have a pharmacological effect
32
Who are the main appropriate practitioners for POMs?
1. doctor
2. dentist
3. supplementary prescriber
4. nurse independent prescriber
5. pharmacist independent prescriber
33
Who are the three main advisory bodies in the UK?
1. Commission on Human Medicines (CHM)
2. British Pharmacopoeia Commission (BPC)
3. Expert Advisory Groups (EAG)
34
What do the CHM do?
give information to Ministers and advise them -> they are advised by the Expert Advisory Groups (EAGs)
35
What do the British Pharmacopoeia Commission do?
prepare the British Pharmacopoeia, which is a book containing all substances which are used in the practice of medicine, surgery, dentistry or midwifery
36
Who is the main body responsible for enforcing pharmacy law?
the GPhC
37
What is a yellow card in the BNF?
yellow pages that can be filled out and sent off to the MHRA to report new side effect of drugs
38
What does a black triangle next to a drug in the BNF indicate?
the drug is new
39
define medical device
all products except medicines used in healthcare for diagnosis, prevention, treatment of illness or disability
40
When did the UK introduce its own mark for medical devices?
in 2023
41
What is a Marketing Authorisation?
an approval every medicinal product needs before being prescribed or sold
42
Which licensing body approve a marketing authorisation?
the MHRA
43
What is a Manufacturer's license?
an approval to allow a company to produce a medicinal product
44
What is a Wholesale Dealer's license?
a permit that allows a company or person to wholesale deal
45
define wholesale dealing
selling or supplying to anyone other than the end-user
46
How often do the MHRA inspect facilities to check they are appropriate for Manufacturer's license?
every 2 years
47
How often do wholesalers get inspected during the 5-year period of having license?
just before and once during 5-year period
48
What are the 5 steps on the product development timeline?
1. finding new chemical product
2. clinical trials
3. marketing authorisation
4. production (need ML)
5. distribution to patients (need WDL)
49
When was the Clinical Trials Application introduced?
2004
50
What is a Clinical Trials Application?
approval by the MHRA to carry out clinical trials which are regulated
51
Who are the 3 phases of clinical trials tested on?
I -> healthy people
II -> particular condition or illness
III -> general population
52
Which 3 characteristics are assessed in the evaluation of a drug?
safety, quality, efficacy
53
What are the 3 steps of a drug being granted a marketing authorisation?
1. submission
2. validation
3. assessment
54
What are the 3 systems used to register medicines in the EU?
1. centralised
2. decentralised
3. mutual recognition
55
What is the centralised system used to register medicines?
one application is made to the EMA and one European Authorisation is granted by them -> ensures medicine is available to every EU state
56
What is the decentralised system used to register medicines?
one application is submitted at the same time by many member states and one state takes the lead -> identical national licenses are issued in each involved
57
What is the mutual recognition system used to register medicines?
the first application is made to one or more EU member state authorities and either a centralised or decentralised authorisation will be granted -> mutual recognition of this authorisation occurs by other member states involved
58
Which 3 things must every medicinal product have?
1. summary of product characteristics (SPC) or 'data sheet'
2. label
3. patient information leaflet (PIL)
59
What factors must the summary of product characteristics involve?
1. name, strength, dose
2. composition
3. name of UK Marketing Authorisation holder
4. number of UK Marketing Authorisations etc
60
What does a parallel import license involve?
allows medicinal products with a Marketing Authorisation to be bought in one European Member State and sold in another
61
What must the importer applying for a parallel important license already have?
1. manufacturer's license (to repackage and relabel)
2. wholesale dealer's license (to import)
62
define manufacturer's specials license
a license to allow products which have been specially made or imported for the treatment of an individual patients after being ordered by a prescriber
63
What must homeopathic medicines have?
A Homeopathic Certificate of Registration
64
Which 3 classes are medicinal products divided into by the HMR?
1. general sales list (GSL)
2. Pharmacy medicines (P)
3. Prescription only medicines (POM)
65
define GSL medicinal product
a medicinal product that can, with reasonable safety, be sold or supplied not under the supervision of a pharmacist
66
Are the any restrictions on GSLs?
some medicinal products are not usually GSL, but may be allowed sometimes, for example eye preparations and vitamin A under 7500 iu, paracetamol
67
What is the rule about retail pack size for GSLs?
if a pack size of a certain GSL product sold from a non-pharmacy businesses goes above limits, they are now classified as P or POM, for example paracetamol (16 tablets)
68
define PO medicinal product
a medicinal product which is licensed as a GSL, but the manufacturer only wants it available in pharmacies -> not an official class by HMR 2012
69
define pharmacy medicine (P)
a medicinal product that is not a POM or GSL but is covered by an authorisation that states it should be available only from a pharmacy
70
What conditions are needed to dispense pharmacy medicines?
from a registered pharmacy and a pharmacist must be signed in and able to supervise
71
define supervision in pharmacy
when the pharmacist must be aware of what is going on and be able to intervene in the transaction
72
define POM medicinal product
a medicinal production that requires a prescription from a licensed prescriber and must be dispensed from a registered pharmacy
73
What class of MP will new medicinal products be?
POMs for 5 years after first licensing unless there is existing evidence for safety
74
When may legal classification change from POM to P?
when the medicinal product is safe to be supplied without a prescription and will not be dangerous without supervision of prescriber -> still requires pharmacist supervision
75
When may legal classification change from P to GSL?
when the medicinal product is safe to be supplied without the supervision of a pharmacist
76
When may legal classification change from GSL to P?
when the medicinal product is no longer safe to be supplied without pharmacist supervision
77
When may legal classification change from P to POM?
when the medicinal product has new risks and needs supervision of a prescriber
78
define Patient Group Direction (PGD)
a written direction to be able to supply a POM to a generalised group of people and is signed by a doctor/dentist AND pharmacist e.g. morning after pill
79
Which details are required before a medicinal product is granted a PGD?
1. clinical condition
2. description of treatment
3. characteristics of pharmacist or other HCP
4. management of the PDG
80
Under which circumstances are PGDs allowed?
when NHS authorises a PGD for supply for a named person lawfully conducting a retail pharmacy business (PLCRPB)
81
For signed orders, which records must be kept in a pharmacy and for how long?
POMs -> must record in the POM book and keep for 2 years
82
For NHS prescriptions, which records of prescriptions must be kept and for how long?
GSL, P and POM -> no records legally required
CDs -> a register entry is legally required
83
For private prescriptions, which records must be kept and for how long?
GSL, P -> recommended to be recorded in POM book for good practice
POM -> POM book record legally required
CD -> CD register legally required
84
What happens to all FP10 (NHS) prescriptions?
- the pharmacy must keep the prescription until the end of the month, sort it and send it to the NHS Business Services Authority (NHSBSA)
- send prescriptions daily via the electronic prescription service (EPS)
85
What happens to private GSL or P prescriptions?
they must be approved by a pharmacist and returned to the patient
86
What happens to private POM prescriptions?
they must be retained in the pharmacy for 2 years unless they are 'repeatable'
87
What happens to private 'repeatable' POM prescriptions?
they are returned to the patient until final supply is given, then retained for 2 years after this date
88
What happens to private FP10CD prescriptions?
a photocopy must be retained in the pharmacy for 2 years and repeats are NOT allowed
89
What are the 4 main roles of the patient medication record?
1. pharmacy records of medicines supplied to patients
2. stock keeping/ordering
3. electronic prescription service
4. reimbursement submissions
90
What are the 7 details to be stored on a PMR?
1. patient identity
2. patient's GP/prescriber
3. prescription details
4. patients clinical conditions, allergies
5. New Medicines Service
6. records of pharmacy first consultations
7. records of NHS/private services e.g. PGDs
91
What is the the New Medicines Service (NMS)?
a service that gives support to people with long-term conditions who have been newly prescribed a medicine
92
What are the 5 main reasons pharmacy patient medication records are used?
1. monitoring prescriptions for errors
2. allows pharmacist to monitor the patients' medicines
3. responding to symptoms
4. checking compliance
5. to facilitate emergency supplies
93
How is it ensured that patients aren't given drugs that interact?
using only a few data providers -> standardisation
94
What may error in drug interaction checking be caused by?
1. using out-of-date referencing sources
2. using pharmacological groups instead of specific drugs
3. inadequate consideration of the route of administration
95
When did the Data Protection Act come into practice?
2018
96
Which force did the Data Protection Act 2018 bring?
the General Data Protection Regulation (GDPR)
97
If a pharmacist is under the GDPR, what are they deemed?
a 'data controller'
98
What must the 'data controller' be able to show?
to show that consent for processing patient data was given explicitly, either verbally or in writing
99
Who do the 'data controllers' report to?
a data protection officer (DPO)
100
What are the roles of the data protection officer?
1. monitoring the pharmacy's compliance with the GDPR
2. being a contact point for all patients with data protection issues
3. advising pharmacy staff of their data protection obligations
4. monitoring assignment of responsibilities and awareness training
101
define data processor
those who do exactly what you ask them to do with the personal data you send them, NOT data controllers
102
Who will the main processors for community pharmacies be?
the PMR supplier and the aggegator which together transfer prescription data from the pharmacy to NHS, OR any organisation that provides data capture systems
103
define Caldicott Guardian
a senior person responsible for protecting the confidentiality of people's health and care information and making sure it is used properly
104
How many Caldicott principles are there?
8
105
When was the Electronic Prescription Service (EPS) first introduced?
in 2006
106
define EPS prescribing token
a paper copy of an electronic prescriptions (EPS) that contains the same details as the prescription
107
define EPS dispensing token
a paper copy of the details of an electronic prescription (EPS) that a patient can take to another pharmacy to collect their medication
108
Is an EPS dispensing token a legal prescription?
NO -> as it is generated by the dispenser, the legal prescription is in the EPS system and the barcode on it is just used to access the prescription
109
define summary care record (SCR)
a national database that holds records of important patient information such as current medication, allergies etc
110
What are the benefits of the SCRs?
makes care safer, reduces risk of prescribing errors, helps avoid delays to urgent care
111
What is patient opt out?
when patients are able to opt out and prevent their data from being uploaded to the central system
112
How can a SCR be accessed?
the viewer must be able to strongly authenticate to access the system through a smartcard
113
What is clinical coding?
codes that allow clinical systems to communicate with each other and ensure the correct drug is prescribed
114
What has been developed to allow clinical coding?
the SNOWMED (systemised nomenclature of medicine)
115
What is the SNOWMED?
structured clinical vocabulary that codes for every illness, event, procedure, test, organism, substance and medicine -> it is always being updated
116
What is the NHS Dictionary of Medicine and Devices? (DM+D)
a dictionary that gives a unique code for every medication and deviceH
117
How often is the DM+D updated?
weekly
118
Labelling and presentation of medicines
119
What are the 5 basic principles of labelling?
what, where, when , who, how much?
120
What?
1. product name
2. active substances (API)
121
Where?
1. route of administration
2. storage
3. pharmacy name and address
122
When?
1. date of dispensing
2. frequency of dosing
3. expiry date
123
Who?
patient details
124
How much?
1. quantity
2. strength
3. dose
125
What are the rules of labelling on ALL medicinal products?
1. must be legible, comprehensible and indelible
2. in English language only, or in English AND in one or more other languages
126
What are the standard labelling particulars for medicinal products (19!)?
1. name of MP
2. strength and form
3. babies, adults or children
4. common name of each API if up to 3
5. dosage of API
6. pharmaceutical form and contents by weight or volume
7. sometimes its excipients
8. method of administration
9. prescribed dose if appropriate
10. keep out of sight and reach of children
11. any special warnings
12. product's expiry date
13. any special storage precautions
14. any special disposal precautions
15. name and address of MA
16. manufacturer's batch number
17. number of the MA for placing MP on the market
18. anti tampering device
19. product name in braille
127
What is the change to labelling from January 2025?
all medicinal products to be sold in the UK should display a 'UK only' label due to Brexit
128
What are the 2 paracetamol warnings?
1. must say medicinal product contains paracetamol unless already on packaging
2. 'do not take more medicine than the label tells you to'
129
What must P and POM medicines also have on the box?
'P' or 'POM' label
130
What are the 3 exceptions to 'P' and 'POM' labels?
1. blister packs for medicinal products
2. small containers for MPs e.g. eye drops
3. radiopharmaceuticals
131
Which labels MUST be on the packaging of medicines dispensed on prescription LEGALLY?
1. name of patient
2. name + address of person who sells or supplies
3. date of supply
4. name of product
5. directions for use e.g. take one daily
6. precautions relating to use of the product
132
133
What are labels that are on containers for dispensed medications?
1. 'keep out of sight and reach of children' -> LEGAL
2. 'use medicine only on your skin' -> where appplicable
3. 'shake well before use' -> suspensions
134
What does the National Patient Safety Agency (NPSA) advise?
to label to ACTUAL container e.g. inhaler or cream tube
135
Which label is legally required for topical dermatological products?
for external use only
136
When is the expiry date on a dispensing label needed?
only for veterinary prescriptions
137
What is the expiry date of sterile preserve eye drops?
4 weeks after opening
138
What is the expiry date of a recently prepared (BP) product?
4 weeks from quote date
139
What is the expiry date of freshly prepared (BP) products?
1 or 2 weeks from quote date
140
What is stated in the BNF?
certain medications that have been designated specific cautionary labels
141
What are the 3 main tips for wording use on labels?
1. use active verbs e.g. take, NOT to be taken
2. use words and not numbers in dosing
3. separate two numbers with dosage form e.g. take one tablet three times a day NOT take one three times a day
142
Where should you place the label on original packs?
1. in the space often provided
2. take care not to cover key information
3. label the innermost container whenever possible
143
What must all medicines include?
an officially approved package leaflet (PIL)
144
What was a variation to the HMR 2012 made in July 2014?
allows supply of salbutamol inhalers to schools for holding stock
145
Define advertisement from the HMR 2012
anything designed to promote the prescription, supply, sale or use of that product
146
What is classed as an advert?
digital, magazines, visits by sales reps, supplying samples, meeting sponsorship etc
147
What is NOT an advert?
1. reference material (factual statements)
2. information relating to human health or disease
3. answering a question about a medicinal product
4. journal articles
5. labelling and package leaflets of an MP
148
Who regulates advertisement of medicines?
a combination of
1. statutory measure enforced by the MHRA
2. self-regulation through codes of Practice for the Pharmaceutical industry e.g. PMCPA
149
Who is responsible for an advert?
the license holder, also the advertiser and publisher a bit
150
How long does the MHRA keep copies of complaints for?
7 years
151
What are the 4 main methods used by the MHRA to regulate advertising?
1. checking before publication (called vetting)
2. monitoring published adverts
3. handling complaints
4. enforces regulations when advert does not comply
152
If legislation is breached and a letter is sent to the advertiser, what may be requested?
amend advert, withdraw advert, issue corrective statement, submit future adverts prior to issue
153
What are the 4 pieces of information needed on an advert?
1. clear message that it is an advert and also a medicine
2. name of medicine
3. correct use of medicine
4. read the PIL/label if not leaflet
154
What are cautions for advertising?
1. don't aim at vulnerable groups
2. no comparative claims
3. don't suggest no side effect
4. can't be celebrity linked
155
When is sponsorship allowed?
ONLY for over-the-counter products, but NOT from individual celebrities -> could be by manufacturer
156
What are the rules around samples?
ALL medicines are prohibited to the public, but small pack sizes may be sold if have marketing authorisation
157
What are the rules on offers?
MHRA discourages volume-based promotion (e.g. 2-for-1) --> for best practice, no more than 2 packs should be sold in one transaction
158
What are the rules of advertising to prescribers?
1. essential info compatible with SPC
2. comprehensive information
3. 1 or more licensed indications
4. dosage and method of use from SPC
5. side effects, cautions
6. product name, API, license number, name and address of license holder
7. cost required
159
What must medical sales reps have?
exam and training
160
What additional information must advertisement for registered homeopathic medicines have?
the words 'homeopathic medicinal product without approved therapeutic indication' and warning to consult a doctor if symptoms persist
161
What is the British National Formulary (BNF)?
a document available in digital and print that summarises all information from different sources on medicinal products
162
How often is the BNF for Children (BNFc) PRINTED?
annually
163
How often is the BNF PRINTED?
every 6 months, March and September
164
What are the 3 main (broad) areas of the BNF?
1. guidance
2. treatment summaries
3. drug monographs
165
What information does 'guidance' give?
1. practical information on prescribing
2. prescribing for special patient groups
3. legal issue
4. ethical issues
5. adverse reactions etc
166
What is the 'treatment summaries' section?
it is an overview of a wider subject area
167
What are the 3 main types of 'treatment summaries'?
1. an overview of the use of drugs in a PARTICULAR DISEASE AREA e.g. malaria
2. a comparison between drugs in the same class e.g. beta-adrenoceptor blockers
3. an overview of drug delivery to a particular body system e.g. eye
168
What is the 'treatment summaries' section useful for?
when trying to choose a treatment for a patient as the individual drug monographs only consider one drug at a time, so don't compare treatments
169
How many subheadings can appear in the drug monograph section for each drug?
over 20, if relevant
170
What are the 6 main categories in the drug monographs section?
1. indication and dose
2. minimising harm and drug safety
3. use of drugs in specific patient populations e.g. pregnancy
4. administration and monitoring
5. choice and supply
6. medicinal forms
171
What can be included in the 'administration and monitoring' section?
pre-treatment screening, monitoring requirements, directions for administration, treatment cessation advice
172
How is the Electronic Medicines Compendium different to the BNF?
includes summaries of product characteristics (SPCs), patient information leaflets (PILs) etc
173
Which is the best source for information on drug interactions?
Stockley's Drug Interactions
174
What is included in the Clinical Knowledge Summaries (CKS)?
summaries of current best practice and practical advice for treating primary care conditions
175
