L2 Law

Question 1

Primary care includes

Answer 1

GPs, dentists, community practitioners, optometrists

Question 2

Secondary care

Answer 2

Hospitals

Question 3

Medicines Act 1968 regulates

Answer 3

Manufacture, distribution and importation

Question 4

MHRA

Answer 4

Medicines and Healthcare products Regulatory Agency (licensed the MA)

Question 5

MHRA are advised by

Answer 5

Medicines Comission

Question 6

Statutory Instruments

Answer 6

Orders and regulations (secondary legislation)

Question 7

Much of the medicines act is now revoked by the

Answer 7

Human Medicines Regulation 2012

Question 8

Human Medicines Regulations 2012 regulates

Answer 8

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

Question 9

Licensing Authority is

Answer 9

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

Question 10

MHRA is part of the

Answer 10

Department of health

Question 11

Mission of the MHRA

Answer 11

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

Question 12

MHRA are responsible for….

Answer 12

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

Question 13

Activities of the MHRA

Answer 13

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

Question 14

GPRD

Answer 14

Geneal practice research database

Question 15

What do we mean by devices?

Answer 15

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

Question 16

Eg. of devices

Answer 16

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

Question 17

Enforcement of the HMR lies with

Answer 17

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

Question 18

HMR also deals with

Answer 18

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

Question 19

Registration of retail pharmacies lies with which act

Answer 19

Medicines Act of 1968

Question 20

3 main aims of the HMR

Answer 20

Quality, safety and efficacy of a medicinal product

Question 21

Marketing authorisation… “drug must…”

Answer 21

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

Question 22

Part 1

Answer 22

General terminology and definitions

Question 23

Who is the licencing authority for Europe

Answer 23

European medicines agency (EMA)

Question 24

Advertisements are defined as

Answer 24

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

Question 25

Special provisions for pharmacies

Answer 25

excepts the need for manufacturing licence when extemporaneous dispensing

Question 26

Medicinal Product is

Answer 26

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

Question 27

Medicinal purpose means any one or more of the following

Answer 27

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

Question 28

Who is an appropriate practitioner in relation to a POM

Answer 28

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

Question 29

Exceptions: community nurse prescriber

Answer 29

certain laxatives, mebendazole, nystatin, etc

Question 30

Exceptions: Optometrist independent prescriber

Answer 30

All POM except CDs and parenterals

Question 31

Exceptions: EEA health professional

Answer 31

All POM except CDs

Question 32

Part 2

Answer 32

Administration

Question 33

2 Advisory bodies

Answer 33

Commission on human medicines (CHM) | British Pharmacopoeia Commission

Question 34

Commission on human medicines function:

Answer 34

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

Question 35

Who advises the CHM?

Answer 35

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

Question 36

BP Commission funcitons

Answer 36

Prepare the BP, other compendia, EP etc.

Question 37

BP

Answer 37

comprises descriptions and standards

Question 38

EAG are appointed by

Answer 38

BPC or CHM

Question 39

EAG also

Answer 39

undertake detailed examinations of issues before referral to CHM or BPC

Question 40

Current established EAGs

Answer 40

``` 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 ```

Question 41

Ministers are solely responsible for

Answer 41

Licencing Hospitals Practitioners premises

Question 42

GPhC is responsible for

Answer 42

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)

Question 43

Registrar & chief executie of the GPhC keeps a register of

Answer 43

premises, pharmacists and pharmacy technicians

Question 44

Who is responsible for the sale of GSL medicines

Answer 44

Local council

Question 45

What do the GPhC regulate with regards to MPs?

Answer 45

``` Quality Purity Labelling Packaging Advertising ```