Medicinal Products 4 - Paracetamol

Question 1

What do regulations 12-16 refer to

Answer 1

Medicinal products consisting of or containing Paracetamol

Question 2

What is the maximum pack size for products where each single dosage unit contains more than 120mg of Paracetamol but not more than 500mg (pharmacy)

Answer 2

24 dosage units

Question 3

What is the maximum pack size for products where each single dosage unit contains more than 500mg but not more than 600mg (pharmacy)

Answer 3

20 dosage units

Question 4

What is the maximum pack size for products where each single dosage unit contains more than 600mg but not more than 1000mg (pharmacy)

Answer 4

12 dosage units

Question 5

What is the maximum pack size for products where each single dosage unit contains not more than 120mg and is intended for children under 6 years (pharmacy)

Answer 5

24 dosage units

Question 6

What is the maximum pack size for products made for children where the products are in liquid form and contain not more than 120mg/5ml (pharmacy)

Answer 6

140ml

Question 7

What is the maximum pack size for products are in liquid form and contain not more than 250mg/5ml (pharmacy)

Answer 7

70ml

Question 8

What is the exception for supply of Paracetamol

Answer 8

Pharmacist interviews patient and is satisfied that it is safe - supply maximum 50 dosage units or two packs (when the dosage unit is not a tablet or a capsule)

Question 9

What is the maximum pack size for products where each single dosage unit contains more than 120mg of Paracetamol but not more than 500mg (non-pharmacy)

Answer 9

12

Question 10

What is the maximum pack size for products where each single dosage unit contains more than 500mg but not more than 600mg (non pharmacy)

Answer 10

10

Question 11

What is the maximum pack size for products where each single dosage unit contains more than 600mg but not more than 1000mg (non pharmacy)

Answer 11

6

Question 12

What is the maximum pack size for products made for children where the products are in liquid form and contain not more than 120mg/5ml (non pharmacy)

Answer 12

maximum of 12 doses - e.g. 60ml

Question 13

What 3 labels should be on a product containing paracetamol

Answer 13

Contains paracetamol
Do not take any other paracetamol containing products
Do not exceed the stated dose

Question 14

What does regulation 17 refer to?

Answer 14

prohibition of supply of medicinal products from vending machines

Question 15

What does regulation 18 refer to?

Answer 15

Prohibition of supply of medicines after the supply date
- unless the expiry date may be extended (by authorised body)

Question 16

What 4 things do websites registered with ISS need?

Answer 16

• the contact details of the society
• a hyperlink to the website referred to in paragraph (13)
• the common logo (established by Commission Implementing Regulation) clearly displayed on every page
• a statement that a record of each transaction will be retained for 2 years from the date of transaction

Question 17

List 4 exemptions from supply regulations

Answer 17

• universities or other institutions
• a sampling officer
• a person who requires the product for the purpose of complying with any requirements relating to the medical treatment of persons employed or carried by that person in any trade or business carried out by him
• a person employed or engaged in connection with any arrangement made for testing the quality or amount of the drugs, medicines and appliances

Question 18

When can a registered optometrist obtain medicinal products?

Answer 18

When a signed order has been given by the optometrist to the supplier for the purpose of each supply.

Question 19

List examples of Optometrist medicinal products

Answer 19

• Cyclopentolate hydrochloride
• Fluorescein sodium
• Lidocaine
• Proxymetacaine hydrochloride
• Tetracaine hydrochloride
• Oxybuprocaine hydrochloride
• Tropicamide