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Law > L2 Law > Flashcards

L2 Law Flashcards

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1
Q

Primary care includes

A

GPs, dentists, community practitioners, optometrists

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2
Q

Secondary care

A

Hospitals

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3
Q

Medicines Act 1968 regulates

A

Manufacture, distribution and importation

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4
Q

MHRA

A

Medicines and Healthcare products Regulatory Agency (licensed the MA)

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5
Q

MHRA are advised by

A

Medicines Comission

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6
Q

Statutory Instruments

A

Orders and regulations (secondary legislation)

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7
Q

Much of the medicines act is now revoked by the

A

Human Medicines Regulation 2012

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8
Q

Human Medicines Regulations 2012 regulates

A

Manufacture, distribution, importation, sale and supply, labelling and advertising, pharmacovigilience

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9
Q

Licensing Authority is

A

Secretary of state and the minister of health social services and public safety

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10
Q

MHRA is part of the

A

Department of health

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11
Q

Mission of the MHRA

A

to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptable

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12
Q

MHRA are responsible for….

A

regulation of medicines, medical devices and equipment used in healthcare, the investigation of harmful incidents, looking after blood and blood products

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13
Q

Activities of the MHRA

A

Assessing safety, quality and efficacy of medicines for human use and authorising their sale or supply.
Overseeing that UK notified audit medical device manufacturers
Yellow card scheme
Operating a proactive compliance programme for medical devices
Sampling and testing of medicines
Regulation of clinical trials
Ensuring compliance with statutory obligations
Promoting good practice in the safe use of medicines and medical deivices
Managing the GPRD and BP
Information provision to public and professionals

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14
Q

GPRD

A

Geneal practice research database

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15
Q

What do we mean by devices?

A

All products except medicines used in healthcare for diagnosis, prevention, monitoring or treatment of illness or disability

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16
Q

Eg. of devices

A

Dressings, orthodontics, catheters, condoms, urine test strips, contact lenses

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17
Q

Enforcement of the HMR lies with

A

Secretary of state
General Pharmaceutical Council
“Drugs Authority” - local council

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18
Q

HMR also deals with

A 
Supply of medicines to the public
Labelling and containers
Sales promotion
Preparation of BP & other books of standards
Pharmacovigilance
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19
Q

Registration of retail pharmacies lies with which act

A

Medicines Act of 1968

20
Q

3 main aims of the HMR

A

Quality, safety and efficacy of a medicinal product

21
Q

Marketing authorisation… “drug must…”

A

positive therapeutic effects must outweigh the risks to health of patients or of the public associated with the product

22
Q

Part 1

A

General terminology and definitions

23
Q

Who is the licencing authority for Europe

A

European medicines agency (EMA)

24
Q

Advertisements are defined as

A

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

25
Q

Special provisions for pharmacies

A

excepts the need for manufacturing licence when extemporaneous dispensing

26
Q

Medicinal Product is

A

any substance or combination of substances presented as having properties or treating or preventing disease in human beings, or that may be administered to human beings with a view to restoring, correcting or modifying physiological function by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis

27
Q

Medicinal purpose means any one or more of the following

A

treating or preventing disease
diagnosing disease or ascertaining the existence, degree or extent of a physiological action
contraception
inducing anesthesia
otherwise preventing or interfering with normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any other way

28
Q

Who is an appropriate practitioner in relation to a POM

A

doctor, dentist, supplementary prescriber, nurse independent prescriber and pharmacist independent prescriber

29
Q

Exceptions: community nurse prescriber

A

certain laxatives, mebendazole, nystatin, etc

30
Q

Exceptions: Optometrist independent prescriber

A

All POM except CDs and parenterals

31
Q

Exceptions: EEA health professional

A

All POM except CDs

32
Q

Part 2

A

Administration

33
Q

2 Advisory bodies

A

Commission on human medicines (CHM)

British Pharmacopoeia Commission

34
Q

Commission on human medicines function:

A

Advise appropriate ministers about: clinical trial regulations
Advise on: MPs, safety, quality and efficacy of MPs.
Promote yellow card scheme
INDEPENDENT EXPERT ADVICE TO MHRA

35
Q

Who advises the CHM?

A

EAG (8 minister appointed members, meet once a month)

36
Q

BP Commission funcitons

A

Prepare the BP, other compendia, EP etc.

37
Q

BP

A

comprises descriptions and standards

38
Q

EAG are appointed by

A

BPC or CHM

39
Q

EAG also

A

undertake detailed examinations of issues before referral to CHM or BPC

40
Q

Current established EAGs

A 
HIV/Anti-infectives/Hepatology
Biologicals/Vaccines
Cardio/Diabetes/Renal/Resp/Allergy
Chemistry, Pharmacy and Standards
Clinical Trials
Dermatology/Rheumatology/Gastrointestinal/Immunology
Medicines for Women's Health
Neurology/Pain Management/phychiarty
Oncology and Haematology
Peadiatrics
Patient and Public Engagement
Pharmacovigilance
41
Q

Ministers are solely responsible for

A

Licencing
Hospitals
Practitioners premises

42
Q

GPhC is responsible for

A

Register of Pharmacist, pharmacy technicians and pharmacy premises
Disciplinary control of the pharmacy profession
Restriction of titles
Sale and supply of MPs (POM and P - not GSL)

43
Q

Registrar & chief executie of the GPhC keeps a register of

A

premises, pharmacists and pharmacy technicians

44
Q

Who is responsible for the sale of GSL medicines

A

Local council

45
Q

What do the GPhC regulate with regards to MPs?

A 
Quality
Purity
Labelling
Packaging 
Advertising

Law (15 decks)

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