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Flashcards in L2 Law Deck (45):
1

Primary care includes

GPs, dentists, community practitioners, optometrists

2

Secondary care

Hospitals

3

Medicines Act 1968 regulates

Manufacture, distribution and importation

4

MHRA

Medicines and Healthcare products Regulatory Agency (licensed the MA)

5

MHRA are advised by

Medicines Comission

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Statutory Instruments

Orders and regulations (secondary legislation)

7

Much of the medicines act is now revoked by the

Human Medicines Regulation 2012

8

Human Medicines Regulations 2012 regulates

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

9

Licensing Authority is

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

10

MHRA is part of the

Department of health

11

Mission of the MHRA

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

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MHRA are responsible for....

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

13

Activities of the MHRA

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

14

GPRD

Geneal practice research database

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What do we mean by devices?

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

16

Eg. of devices

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

17

Enforcement of the HMR lies with

Secretary of state
General Pharmaceutical Council
"Drugs Authority" - local council

18

HMR also deals with

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

19

Registration of retail pharmacies lies with which act

Medicines Act of 1968

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3 main aims of the HMR

Quality, safety and efficacy of a medicinal product

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Marketing authorisation... "drug must..."

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

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Part 1

General terminology and definitions

23

Who is the licencing authority for Europe

European medicines agency (EMA)

24

Advertisements are defined as

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

25

Special provisions for pharmacies

excepts the need for manufacturing licence when extemporaneous dispensing

26

Medicinal Product is

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

Medicinal purpose means any one or more of the following

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

Who is an appropriate practitioner in relation to a POM

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

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Exceptions: community nurse prescriber

certain laxatives, mebendazole, nystatin, etc

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Exceptions: Optometrist independent prescriber

All POM except CDs and parenterals

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Exceptions: EEA health professional

All POM except CDs

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Part 2

Administration

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2 Advisory bodies

Commission on human medicines (CHM)
British Pharmacopoeia Commission

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Commission on human medicines function:

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

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Who advises the CHM?

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

36

BP Commission funcitons

Prepare the BP, other compendia, EP etc.

37

BP

comprises descriptions and standards

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EAG are appointed by

BPC or CHM

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EAG also

undertake detailed examinations of issues before referral to CHM or BPC

40

Current established EAGs

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

Ministers are solely responsible for

Licencing
Hospitals
Practitioners premises

42

GPhC is responsible for

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)

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Registrar & chief executie of the GPhC keeps a register of

premises, pharmacists and pharmacy technicians

44

Who is responsible for the sale of GSL medicines

Local council

45

What do the GPhC regulate with regards to MPs?

Quality
Purity
Labelling
Packaging
Advertising