1.

A)

Indicate by using the abbreviations respectively shown in square brackets, the legal classifications of the following drugs showing whether they are included in Part 1 of Schedule 10 to the Pharmacy and Poison Regulations [P1], Part 2 of Schedule 10 to the Pharmacy and Poisons Regulations [P2], Schedule 1 to the Pharmacy and Poisons Regulations [S1], Schedule 3 to the Pharmacy and Poisons Regulations [S3], Part I of Schedule 1 to the Dangerous Drugs Ordinance [P1DD], Part II or Part III of Schedule 1 to the Dangerous Drugs Ordinance [P2DD], Schedule 1 to the Antibiotics Regulations [A], or none of the above [NP]:

a) An injection containing 10 mg ibuprofen

b) A tablet containing 150 mg cobicistat, 800 mg darunavir, 200 mg emtricitabine and 10 mg tenofovir alafenamide

c) A tablet containing 300 mg allopurinol

d) A syrup containing 9 mg/5ml codeine phosphate, 4 mg/5ml ephedrine hydrochloride and 2 mg/5ml promethazine hydrochloride

e) A patch containing 10 mg/24 hours glyceryl trinitrate

f) A nasal ointment containing 2% mupirocin

g) A cream containing 1% sulfadiazine w/w

Note the structure of sulfadiazine is:

h) A tablet containing 800 mg of piracetam

i) An eye drop containing 2% homatropine hydrobromide

j) A surgical scrub containing 4% chlorhexidine gluconate

l) A tablet containing 100 mg nitrofurantoin

m) A nasal spray containing 0.05% beclomethasone dipropionate 

n) An injection containing 15 mg/ 3ml midazolam

B)

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) Ethinyloestradiol (1 mark)

e) Sodium fluoride (4 mark)

2

a) Describe the control and requirements when an institution defined under the Pharmacy and Poisons Ordinance supplies a medicine as provided under the Pharmacy and Poisons Regulations

b) under the Pharmacy and Poisons Regulations, what are the requirements on the storage of poisons in an institution?

c) What authority is conferred by the DDO on a registered pharmacist who is employed at a prescribed hospital in relation to the possession, supply or manufacture of dangerous drugs? What restrictions apply to this authority?

(20 marks)

3

a) What are the differences between "authorised seller of poisons" and "listed seller of poisons" under the Pharmacy and Poisons Ordinance?

b) Describe the conditions and limitations on sale of Part 1 and Part 2 poisons by an "authorised seller of poisons" and a "listed seller of poisons" respectively.

c) What are the additional restrictions when an authorised seller of poisons sells a poison included in Schedule 3 to the Pharmacy and Poisons Regulations?

(20 marks)

4

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

b) Describe the control of advertisements relating to ‘orally consumed products’ as stipulated under the Undesirable Medical Advertisements Ordinance.

(20 marks)

5

a) Define 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)