Medicine Distribution & Supply 1 + 2

Question 1

Define a medicinal product. (first part)

Answer 1

1. Any substance or combination of substances presented as having
   properties for treating or preventing disease in human beings

Question 2

Define a medicinal product (second part)

Answer 2

2. Any substance that restores, corrects or modifies physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis

Question 3

Define a disease.

Answer 3

Any injury, ailment or adverse condition, whether of body or mind

Question 4

If it is a medicinal product what must it have?

Answer 4

• A marketing authorisation
• PL are issued for a period of time e.g. 5 years

Question 5

How do you get a MA?

Answer 5

• Product has to be submitted to the MHRA
• A new product means full info about manufacturing and testing including clinical trial results has to be made available to the MHRA

Question 6

What is key criteria in licensing a new medicine?

Answer 6

• Safety
• Quality
• Efficacy
• Cost

Question 7

What does it mean by supplying a MP ‘off-license’?

Answer 7

• Some medicinal products have efficacy in diseases that they are not licensed
• Precasts should only be used ‘off-license’ if there is no other suitable product available

Question 8

What is pharmacovigilance?

Answer 8

• Post-marketing surveillance of the safety of medicines
• Focused on ‘black triangle’

Question 9

What is one way to report suspected adverse reactions?

Answer 9

• Completing a ‘yellow card’

Question 10

What does thalidomide cause?

Answer 10

Phocomelia - malformations of human arms and legs

Question 11

What are GSL medicines?

Answer 11

• Medicinal products which can be sold with ‘reasonable safety’ by any shopkeeper

Question 12

What are pharmacy medicines?

Answer 12

• Only sold in the pharmacy
• No definitive list
• Products that aren’t on the POM or GSL

Question 13

Describe the retail sale of pharmacy (P) medicines.

Answer 13

May not be sold by any person unless:
- The premises is a registered pharmacy
- They are acting under the supervision of a pharmacist

Question 14

What happens if their is failure to comply with sales of p medicines?

Answer 14

Leads to prosecution and removal of pharmacists from the register

Question 15

What are prescription only medicines?

Answer 15

• A medicine listed in the POM order
• Can be only be sold by retail in accordance with a prescription by an appropriate practitioner

Question 16

When can POM be supplied without a Rx?

Answer 16

• Patient Group Directions
• Emergency supplies
• Written directions to supply in hospitals

Question 17

What is wholesale dealing?

Answer 17

1. Supplying medicine to someone else
2. Administers it to someone else in the course of their business

Question 18

Give three examples of wholesale dealing from a retail pharmacy.

Answer 18

1. To a GP
2. To a dentist
3. To another retail pharmacy