Legislation Dec 2019

1 A

What are the drug classifications of the following: (1 mark each)

a) A syrup containing 3.6 mg/5ml promethazine hydrochloride, 9 mg/5ml codeine phosphate and 7.2 mg/5ml ephedrine hydrochloride

b) A tablet containing 15 mg ertugliflozin and 100 mg sitagliptin

c) An ear drop containing 3 mg/ml ofloxacin

d) A solution for irrigation containing 0.9% sodium chloride

e) A tablet containing 5 mg of desloratadine

f) A syrup containing 15mg/5ml phenobarbital sodium

g) A shampoo containing 5 % minoxidil

h) A capsule for inhalation containing 110 microgram of glycopyrronium and 50 microgram of indacaterol

i) A solution for injection containing 20 mg/2ml deoxycholic acid

j) An oromucosal spray containing 0.45% of povidone-iodine

k) A vial of powder for solution for injection containing 1 g ceftazidime

l) A tablet containing 1 mg flunitrazepam

Note: Structure of flunitrazepam is

m) A tablet containing 100mg erlotinib

1B

Describe the specific conditions under which the following poisons would be exempted from the provisions of the Pharmacy and Poisons Ordinance as stipulated under the regulation 8 of the Pharmacy and Poisons Regulations:

a) Antihistamine 1 mark

b) Lignocaine 1 mark

c) Norethisterone 1 mark

e) Sodium fluoride 4 mark

2

a) What are the substances to which the Antibiotics Ordinance applies?

b) Describe the control of sale and supply of antibiotics as stipulated under the Antibiotics Ordinance.

c) Describe the record-keeping requirements for an authorised seller of poisons in relation to the receipt and supply of antibiotics as stipulated under the Antibiotics Ordinance. 

(20 marks)

3

a) Define ‘advertisement’, medicine’ and orally consumed product’ under the Undesirable Medical Advertisements Ordinance. 

b) Describe the prohibition and exceptions of advertisements relating to promotion of ‘orally consumed product’ and ‘medicines’ as stipulated by the Undesirable Medical Advertisements Ordinance.

(20 marks)

4

a) Define ‘Pharmaceutical Product’ under the Pharmacy and Poisons Ordinance.

b) Describe the requirements, exemptions and factors relevant to determination of application for registration of pharmaceutical product as stipulated under the Pharmacy and Poisons Regulations.

c) Describe the requirements for conducting clinical trial on human beings and the relevant power of the Committee as stipulated under the Pharmacy and Poisons Regulations. 

(20 marks)

5

a) Describe the statutory requirements stipulated under the Pharmacy and Poisons Regulations on the supply and storage of medicines by an institution as defined under the Pharmacy and Poisons Ordinance.

b) Describe the authority conferred by the Dangerous Drugs Ordinance on a registered pharmacist employed at a prescribed hospital in relation to the possession supply or manufacture of dangerous drugs. What restrictions apply to this authority?

(20 marks)