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Pharmacy > PPP Law Lectures > Flashcards

PPP Law Lectures Flashcards

1
Q

define law

A

the regulation of human affairs and human relationships

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2
Q

What are the 4 types of law in the UK?

A
  1. criminal law
  2. civil law
  3. administrative law
  4. common law
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3
Q

define criminal law

A

the process for the investigation of crime and for dealing with suspects

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4
Q

define civil law

A

law that regulates rights between citizens

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5
Q

define administrative law

A

law that aims to ensure that government agencies operate within their legal authority

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6
Q

define common law

A

the process in which judges interpret and apply the law in individual cases

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7
Q

What are the 2 types of government papers?

A

green paper and white paper

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8
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

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9
Q

define white paper

A

a paper presenting clear and more developed proposals which will become law if parliament agrees

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10
Q

define primary legislation

A

legislation created and passed by the main legislative bodies such as UK Parliament

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11
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

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12
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

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13
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

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14
Q

Who was the Medicines Act 1968 enforced by?

A

MHRA -> Medicines and Healthcare products Regulatory Agency

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15
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

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16
Q

What is the current law of medicines regulation?

A

The Human Medicines Regulation 2012 (HMR)

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17
Q

Who enforces the HMR 2012?

A

the Secretery of State, the GPhC and the Drug Authority (local council)

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18
Q

How is the HMR 2012 enforced?

A

ensuring everyone has licenses to do things with medicines such as manufacture, sell, import etc

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19
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

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20
Q

define licensing authority

A

an official body that grants licences

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21
Q

define MHRA

A

The Medicines and Healthcare Products Regulatory Agency, the main licensing body in the UK

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22
Q

define advertisements

A

anything designed to promote the prescribing, supply, sale or use of a medicinal product

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23
Q

define GSL

A

medicinal product available on general sale to the public

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24
Q

define POM

A

medicinal product only available with a prescription

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25
Q

define P

A

medicinal product that is not a POM or GSL and is only available from a pharmacy

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26
Q

define the Special provision for pharmacies

A

exempts the need for manufacturing license when spontaneously dispensing

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27
Q

define medicinal product

A

any substance or combination with properties to prevent, diagnose or treat disease in HUMANS, correct a physiological function or have a pharmacological effect

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28
Q

Who are the main appropriate practitioners for POMs?

A
  1. doctor
  2. dentist
  3. supplementary prescriber
  4. nurse independent prescriber
  5. pharmacist independent prescriber
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29
Q

Who are the three main advisory bodies in the UK?

A
  1. Commission on Human Medicines (CHM)
  2. British Pharmacopoeia Commission (BPC)
  3. Expert Advisory Groups (EAG)
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30
Q

What do the CHM do?

A

give information to Ministers and advise them -> they are advised by the Expert Advisory Groups (EAGs)

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31
Q

What do the British Pharmacopoeia Commission do?

A

prepare the British Pharmacopoeia, which is a book containing all substances which are used in the practice of medicine, surgery, dentistry or midwifery

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32
Q

Who is the main body responsible for enforcing pharmacy law?

A

the GPhC

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33
Q

What is a yellow card in the BNF?

A

yellow pages that can be filled out and sent off to the MHRA to report new side effect of drugs

34
Q

What does a black triangle next to a drug in the BNF indicate?

A

the drug is new

35
Q

What is a Marketing Authorisation?

A

an approval every medicinal product needs before being prescribed or sold

36
Q

Which licensing body approve a marketing authorisation?

A

the MHRA

37
Q

What is a Manufacturer’s license?

A

an approval to allow a company to produce a medicinal product

38
Q

What is a Wholesale Dealer’s license?

A

a permit that allows a company or person to wholesale deal

39
Q

define wholesale dealing

A

selling or supplying to anyone other than the end-user

40
Q

How often do the MHRA inspect facilities to check they are appropriate for Manufacturer’s license?

A

every 2 years

41
Q

How often do wholesalers get inspected during the 5-year period of having license?

A

just before and once during 5-year period

42
Q

What are the 5 steps on the product development timeline?

A
  1. finding new chemical product
  2. clinical trials
  3. marketing authorisation
  4. production (need ML)
  5. distribution to patients (need WDL)
43
Q

Who are the 3 phases of clinical trials tested on?

A

I -> healthy people
II -> particular condition or illness
III -> general population

44
Q

Which 3 characteristics are assessed in the evaluation of a drug?

A

safety, quality, efficacy

45
Q

What are the 3 steps of a drug being granted a marketing authorisation?

A
  1. submission
  2. validation
  3. assessment
46
Q

What are the 3 systems used to register medicines in the EU?

A
  1. centralised
  2. decentralised
  3. mutual recognition
    4.
47
Q

What is the centralised system used to register medicines?

A

one application is made to the EMA and one European Authorisation is granted by them -> ensures medicine is available to every EU state

48
Q

What is the decentralised system used to register medicines?

A

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

49
Q

What is the mutual recognition system used to register medicines?

A

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

50
Q

Which 3 things must every medicinal product have?

A
  1. summary of product characteristics (SPC) or ‘data sheet’
  2. label
  3. patient information leaflet (PIL)
51
Q

What factors must the summary of product characteristics involve?

A
  1. name, strength, dose
  2. composition
  3. name of UK Marketing Authorisation holder
  4. number of UK Marketing Authorisations etc
52
Q

What does a parallel import license involve?

A

allows medicinal products with a Marketing Authorisation to be bought in one European Member State and sold in another

53
Q

What must the importer applying for a parallel important license already have?

A
  1. manufacturer’s license (to repackage and relabel)
  2. wholesale dealer’s license (to import)
54
Q

define manufacturer’s specials license

A

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

55
Q

What must homeopathic medicines have?

A

A Homeopathic Certificate of Registration

56
Q

Which 3 classes are medicinal products divided into by the HMR?

A
  1. general sales list (GSL)
  2. Pharmacy medicines (P)
  3. Prescription only medicines (POM)
57
Q

define GSL medicinal product

A

a medicinal product that can, with reasonable safety, be sold or supplied not under the supervision of a pharmacist

58
Q

Are the any restrictions on GSLs?

A

some medicinal products are not usually GSL, but may be allowed sometimes, for example eye preparations and vitamin A under 7500 iu, paracetamol

59
Q

What is the rule about retail pack size for GSLs?

A

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)

60
Q

define PO medicinal product

A

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

61
Q

define pharmacy medicine (P)

A

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

62
Q

What conditions are needed to dispense pharmacy medicines?

A

from a registered pharmacy and a pharmacist must be signed in and able to supervise

63
Q

define supervision in pharmacy

A

when the pharmacist must be aware of what is going on and be able to intervene in the transaction

64
Q

define POM medicinal product

A

a medicinal production that requires a prescription from a licensed prescriber and must be dispensed from a registered pharmacy

65
Q

What class of MP will new medicinal products be?

A

POMs for 5 years after first licensing unless there is existing evidence for safety

66
Q

When may legal classification change from POM to P?

A

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

67
Q

When may legal classification change from P to GSL?

A

when the medicinal product is safe to be supplied without the supervision of a pharmacist

68
Q

When may legal classification change from GSL to P?

A

when the medicinal product is no longer safe to be supplied without pharmacist supervision

69
Q

When may legal classification change from P to POM?

A

when the medicinal product has new risks and needs supervision of a prescriber

70
Q

define Patient Group Direction (PGD)

A

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

71
Q

Which details are required before a medicinal product is granted a PGD?

A
  1. clinical condition
  2. description of treatment
  3. characteristics of pharmacist or other HCP
  4. management of the PDG
72
Q

Under which circumstances are PGDs allowed?

A

when NHS authorises a PGD for supply for a named person lawfully conducting a retail pharmacy business (PLCRPB)

73
Q

For signed orders, which records must be kept in a pharmacy and for how long?

A

POMs -> must record in the POM book and keep for 2 years

74
Q

For NHS prescriptions, which records of prescriptions must be kept and for how long?

A

GSL, P and POM -> no records legally required
CDs -> a register entry is legally required

75
Q

For private prescriptions, which records must be kept and for how long?

A

GSL, P -> recommended to be recorded in POM book for good practice
POM -> POM book record legally required
CD -> CD register legally required

76
Q

What happens to all FP10 (NHS) prescriptions?

A
  • 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)
77
Q

What happens to private GSL or P prescriptions?

A

they must be approved by a pharmacist and returned to the patient

78
Q

What happens to private POM prescriptions?

A

they must be retained in the pharmacy for 2 years unless they are ‘repeatable’

79
Q

What happens to private ‘repeatable’ POM prescriptions?

A

they are returned to the patient until final supply is given, then retained for 2 years after this date

80
Q

What happens to private FP10CD prescriptions?

A

a photocopy must be retained in the pharmacy for 2 years and repeats are NOT allowed

Pharmacy (16 decks)

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