Medicines Regulation

Question 1

T/F: The term ‘medicine’ is not defined in the Human Medicines Regulations 2012?

Answer 1

TRUE

no legal definition

Question 2

T/F: A condom is a medicinal product?

Answer 2

FALSE

a medicinal device

Question 3

T/F: All shampoos are cosmetics and are therefore exempt from the HMR 2012?

Answer 3

FALSE

not all, some for medical conditiions (sebhorrhic dermatitic, dermatitis)

Question 4

T/F: A salbutamol MDI is classified as a medical device?

Answer 4

FALSE

medicinal product, MDI contains the medicinal product and plastic

Question 5

T/F: Packaging for medical devices should be marked with the letters ‘EC’?

Answer 5

FALSE

should be CE

Question 6

T/F: Folic acid tablets 400mcg can be licensed as a medicinal product?

Answer 6

TRUE

can also be sold as a food supplement, not a med product

Question 7

T/F: Liquid nitrogen can be classified as a medicinal product?

Answer 7

TRUE

can also be a gas or not a medicinal product, med product more expensive/more licencing

Question 8

T/F: Emulsifying Ointment BP contains no active ingredient and is therefore not a medicinal product?

Answer 8

FALSE

is a med product, just because it doesn’t have active ingredients doesn’t mean can’t be licenced as med product

Question 9

T/F: A tinzaparin pre-filled syringe is classified as a medicinal product?

Answer 9

TRUE

has medicine in it
(an empty syringe diepensed to patient is med device)

Question 10

T/F: It is possible for eye drops and nasal drops to be classified as medical devices?

Answer 10

TRUE

unusual, some eye drops/nasal sprays can be medical devices, usually med products that don’t contain recognised active ingredients

Question 11

What was the reason for the Medicines Act 1968?

Answer 11

the thalidimide problem

Question 12

3 pieces of legislation relating to drugs/meds in UK

Answer 12

1. The Medicines Act 1968
2. The Misuse of Drugs Act 1971
3. The Poisons Act 1972

Question 13

What was the Medicines Act 1968 replaced by?

Answer 13

Human Medicines Regulations 2012

Question 14

What type of law is HMR 2012?

Answer 14

criminal law

Question 15

Who enforces HMR 2012?

Answer 15

MHRA

medicines and healthcare regulatory agency

• some aspects relating to pharmacy monitored by GPhC

Question 16

What is the HMR 2012?

Answer 16

• Single legal framework applicable to ALL medicinal products for human use at EVERY stage of development, production, licensing & supply to the public
• Patient protection legislation
• Only applies to substances when they’re used as medicines or as ingredients in medicines

Question 17

who does MHRA advise

Answer 17

CHM

commission on human medicines

Question 18

who does CHM advise

Answer 18

government health ministers

Question 19

What is the CHM (commission on human medicines)?

Answer 19

• composed of members with wide range of clinical/scientific/professional expertise
• advises ministers on matters relating to medicines regulation
• gives advice to the MHRA about the safety/quality/efficacy of med products
• promotes collection & investigation of info relating to ADRs
• advises on new safety issues, risks & benefits of licensed meds (adding warnings, restricting/suspending use of a med)

Question 20

What is the MHRA? - Medicines and Healthcare Products Regulatory Agency

Answer 20

• ensures meds, devices, blood components for transfusion meet applicable standards of safety/quality/efficacy
• safeguards the public’s health
• ensures supply chain for meds/devicesblood components is safe and secure
• assures effectiveness & safety of biological medicines
• educates the public & hc professionals about risks/benefits of meds/devices/blood components
• issues drug alerts
• recalls
• supports R&D
• collects & investigates ADRs via yellow card scheme
• investigates sale of meds on internet and counterfeit meds

Question 21

definition of a medicinal product

Answer 21

a) any substance/combination of substances presented as having properties of preventing/treating disease in human beings
OR
b) any substance/combination of substances that may be used by or administered to human beings with a view to
1. restoring, correcting or modifying a physiological fxn by exerting a pharmacological, immunological or metabolic action
2 making a medical diagnosis.

Question 22

definition of administer

Answer 22

means to administer to a human being:

a) orally, by injection, or by introduction into the body in any other way
OR
b) by external application (whether or not by direct application to the body) either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with a substance used as a vehicle

Question 23

products exempt from med legislation

Answer 23

food

cosmetics

Question 24

doubt if product comes under med legislation

Answer 24

should be regulated as a medicine - stricter regulation

Question 25

foods that can be prescribed under the NHS, what are the listed as?

Answer 25

Borderline Substances

Question 26

Who approves foods licenced as medicinal products?

Answer 26

ACBS - advisory council on borderline substances foods are reinbursed on NHS Rx even though not medicinal products

Question 27

glucosamine

Answer 27

routinely- natural substance found in mucopolysaccharides, mucoproteins and chitin - glucosamine products available as food supplements - used for joint health (OA) - limited evidence, should not be routinely prescribed - glucosamine products containing > 1,178mg/day of MUST licensed as a medicine - below this available as a food supplement

Question 28

legislation that regulates medical devices

Answer 28

Medical Devices Regulation 2002

Question 29

definition of medical device

Answer 29

does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means

Question 30

3 types of medical devices

Answer 30

1. Active implantable medical device (pacemaker, catheter) 2. General medical devices (bandages, contact lenses) 3. In vitro diagnostic medical devices IVDs (pregnancy test, BP machines, BM monitors, strips for BMs)

Question 31

logo/letters on packaging for medical device

Answer 31

'CE' - Conformité Européenne - EU symbol - used until 30/6/23 UKCA - UK Conformity Assessed - will now be this in UK - mandatory from 1/7/23

Question 32

What does CE/UKCA mean?

Answer 32

medical device meets safety and performance requirements (fit for its stated use)

Question 33

Who receives reports about medical devices and how?

Answer 33

MHRA via yellow card scheme

Question 34

what are medical apps classed as

Answer 34

medical devices

Question 35

What regulates home testing kits?

Answer 35

regulated under medical device legislation

Question 36

if device doesn't have CE/UKCA what does it mean?

Answer 36

quality is not guaranteed unregulated

Question 37

How to report issues with medical devices?

Answer 37

to MHRA via yellow card scheme

Question 38

new act when UK left EU

Answer 38

Medicines and Medical Devices Act 2021

Question 39

What did the Medicines and Medical Devices Act 2021 do/mean?

Answer 39

- allows the Government to amend medicines legislation - used to create a Patient Safety Commissioner

Question 40

duties of the Patient Safety Commissioner

Answer 40

1. promote safety of pts with regard to use of medicines & medical devices AND 2. promote importance of the views of patients/members of public in relation to the safety of medicines and medical devices