INTRODUCTION TO PHARMACY LAW

Question 1

What is pharmacy law?

Answer 1

The application of legal rules and principles to the practice of pharmacy in all its branches

Question 2

Where can pharmacy law be found in (2)?

Answer 2

UK and EU legislation

Question 3

What’s the prime objective of pharmacy law?

Answer 3

Protection of the public

Question 4

Give two ways in which public protection is achieved through pharmacy law?

Answer 4

1. Restrict public access to poisons, potent drugs and medicines = prevents use for criminal purposes, self medication and gratification of addiction
2. Ensures purity, potency and efficacy of medicines by controlling all stages of manufacture, distribution and sale

Question 5

Which pharmacy laws affect medicines? (3)

• Name any secondary legislation too

Answer 5

1. Medicine Act 1968 (controls medicinal products at all stages)

• Veterinary medicines regulations 2013
• Human medicines regulations 2012

1. Misuse of drugs act 1971 (controls drugs and medicines that are addictive or misused)
   * Misuse of drug regulations 2001
2. Poisons act 1972 (controls poisons)
   * Amended by deregulation act 2015

Question 6

Which pharmacy laws affect pharmacists and the pharmacy? (2)

Answer 6

1. Health Act 2006 (supervision and management of CDs)
   * Supervision = responsible pharmacist
2. Health Act 1999

• Amended by Health and Social Care Act 2008
• Pharmacy Order 2010
  
  • Directs GPhC
  • Controls the pharmacy profession (pharmacists & pharmacy technicians)

Question 7

How many parts does Human Medicines Regulations 2012?

Answer 7

17 parts

Question 8

Who is Human Medicines Regulations 2012 (HMR 2012)?

Answer 8

1. Secretary of State for Health
2. Minister for Health, Social Services & Public Safety

Question 9

Who did the Medicines Act 1968 establish the licensing authority to be?

Answer 9

• The Medicine Healthcare products Regulatory Agency (MHRA)
• MHRA is a government agency that ensures that medicines and medical devices work and are acceptably safe

Question 10

Who are the Commission on Human Medicines and what do they do (2)?

Answer 10

• The committee of the MHRA (membership includes clinicians, pharmacists, lay members and expert advisory groups)
• CHM advises ministers on the safety, efficacy and quality of medicinal products.

Question 11

What is definition of a medicinal product (2)?

Answer 11

Any substance that:

1. Prevents or treats disease
2. Makes a medical diagnosis/ changes a physiological function by exerting a pharmacological/immunological or metabolic action
   
   • restores physiological function - hormone replacement therapy
   • correct physiological function - insulin for diabetes

Question 12

What is the definition of a authorised medicinal product (3)?

Answer 12

If product has:

1. marketing authorisation (medicines)
2. certificate of registration (homeopathics)
3. traditional herbal registration (herbal remedies)

Question 13

What is the definition of a relevant medicinal product (2)?

Answer 13

1. A medicinal product with marketing authorisation
2. Not a registrable homeopathic MP or traditional herbal product

Question 14

What’s the definition of medicinal purpose? (5)

Answer 14

1. Treats/prevents disease
2. Diagnoses disease
3. Contraception
4. Induces anaesthesia
5. Prevents or interferes with the normal operation of a physiological function

Question 15

What are the different ways of administering drugs? (2)

Answer 15

1. Internally (oral, injection, other introduction into body)
2. External application

Question 16

What can be administered (2)?

Answer 16

A substance or article either:

• In its existing state
• After it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle