medicines regulation

Question 1

what are they key 3 pieces of legislation relating to drugs and medicines in the UK?

Answer 1

1- the medicines act 1968
2- the misuse of drugs act 1971
3- the poisons act 1972

Question 2

what was the poisons act 1972 replaced with?

Answer 2

it was repealed in 2015 and replaced with other legislation to control poisons

Question 3

what was the medicines act 1968 replaced by?

Answer 3

Humans medicines regulations 2012

Question 4

what kind of law is the HMR 2012?

Answer 4

criminal law

Question 5

what is the HMR 2012 made up of?

Answer 5

17 parts and 35 schedules

Question 6

when did the HMR 2012 come into force?

Answer 6

14th of August 2012

Question 7

who is the HMR 2012 applicable to?

Answer 7

ALL medicinal products for human use at EVERY stage of development, production, licensing and supply to the public

Question 8

what kind of legislation is the HMR considered as?

Answer 8

consumer (patient) protection legislation

Question 9

what does the HMR apply to?

Answer 9

only substances when they are used as medicines or as ingredients in medicines

Question 10

who enforces the operations of the act of HMR 2012?

Answer 10

MHRA

Question 11

what aspects of the HMR is enforced by the GPHc?

Answer 11

some aspects relating to pharmacy

Question 12

are vetinary medicines included in the HMR 2012?

Answer 12

vet medicines are the subject to a different leglislation

Question 13

who controls the administration of the HMR 2012?

Answer 13

1- government health ministers
2- commission on human medicines (CHM)
3.1- MHRA
3.2- Other committees eg BP commission

Question 14

what did the CHM replace?

Answer 14

replaces the committee on safety of medicines (CSM)in 2005

Question 15

who are the members of the CHM?

Answer 15

comprises members with wide range of clinical, scientific and professional expertise

Question 16

how are the members appointed for the CHM?

Answer 16

chairman and members appointed by appoiptments commissions (independent of government ministers)

Question 17

what is the purpose of the CHM?

Answer 17

advises ministers on policy matters relating to medicines regulation
provides independent advise to the MHRA about the safety, quality or efficacy of medicinal products
promotes the collection and investigation of info relating to adverse drugs reactions
advising on the impact of new safety of the balance of risks and benefits of licensed medicines eg adding warnings, restricting or suspending use of a medicine

Question 18

what is the role of the MHRA?

Answer 18

ensuring that medicines, medicinal devices and blood components for transfusion meet applicable standards of safety, quality and efficacy

Question 19

what do the MHRA promote?

Answer 19

promote international standardization and harmonization to assure the effectiveness and safety of biological medicines

Question 20

who do the MHRA help to educate?

Answer 20

the public and HCP about the risks and benefits of medicines, medicinal devices and blood components, leading to safer and more effective use

Question 21

give an example of how the MHRA collects adverse reaction info

Answer 21

yellow card scheme

Question 22

who investigates the sale of medicines on the internet and counterfit medicines?

Answer 22

MHRA

Question 23

what is in the MHRA’s monthly drug safety update?

Answer 23

covers all aspects of drug safety- new warnings and reminders of current hot topics
info on yellow card scheme
info on other topics- Herbal medicnes, medicnial devices

Question 24

define medicinal product

Answer 24

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

Question 25

define administer

Answer 25

Administer 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 26

what are some examples that are excluded from legislation?

Answer 26

food and cosmetics
contriversial- vitamins and minerals
where doubt exists- the product should be regulated as a medicine

Question 27

what are boarderline substances?

Answer 27

Foods which can be prescribed under the NHS are listed in the BNF as ‘Borderline ubstances’). These are approved by Advisory Council on Borderline Substances (ACBS) for reimbursement on NHS prescription even though they are not medicinal products

Question 28

are cosmetics licensed as a medicinal product?

Answer 28

some cosmetics can be used as a medicinal purpose

Question 29

is glucosamine a medicinal product?

Answer 29

it is a natural product available as a food supplement- widely used for OA
some are licensed

Question 30

what is the limit for glucosamine to be licensed?

Answer 30

The MHRA has ruled that all glucosamine products containing > 1178mg/day of
glucosamine base must be licensed as a medicine

Question 31

what are the 3 main types of medical devices?

Answer 31

Active implantable medical device (e.g., cardiac pacemaker, catheter)
* General medical devices (e.g., bandages, contact lenses)
* In vitro diagnostic medical devices (IVDs) e.g., pregnancy testing kits, BP machines,
blood glucose monitors

Question 32

what logo will there be on medicinal devices to show it meets safety and performance?

Answer 32

‘CE’
The CE mark is an EU symbol, and the UK is no longer a member of the EU
* The CE mark can be used until 30/6/23. The UKCA (UK Conformity Assessed) logo can be used voluntarily now but will become mandatory from 1/7/23

Question 33

what is the UKCA mark?

Answer 33

UK Equivilant of CE

Question 34

what is important to remember when buying HIV home-testing kits?

Answer 34

• Approved HIV self-testing kits that carry a CE/UKCA mark have gone
  through the proper regulatory processes and, when used in
  accordance with their instructions, can be used safely
• Unregulated kits can be purchased over the internet but their
  quality is not guaranteed
• All packaging for any near patient testing kits should be checked for
  a CE/UKCA logo

Question 35

what is the medicines and medical devices act 2021?

Answer 35

• This legislation was introduced because when the UK left the EU some legislation
  relating to the EU which provided the Government with a legal authority to amend
  medicines legislation was repealed
• This Act allows the Government to amend medicines legislation

Question 36

what are the statuatory core duties of the patient safety commissioner for medicines and medcial devices act 2021?

Answer 36

(a) promote the safety of patients with regard to the use of medicines and
medical devices, and
(b) promote the importance of the views of patients and other members of
the public in relation to the safety of medicines and medical devices.

Question 37

what does the medciines and medical devices act 2021 also allow?

Answer 37

The Act also allows the prescribing of ‘low risk’ medicines (as yet, undefined) by a range
of other healthcare professionals (as yet, unspecified