This paper covers the following ordinances related to pharmacy practice in Hong Kong:
- Pharmacy and Poisons Ordinance Cap. 138A
- Pharmacy and Poisons Regulation Cap. 138A
- Poisons List Regulation Cap. 138B
- Pharmacy and Poisons (Pharmacy and Poisons Appeal Tribunal) Regulations Cap. 138D
- Pharmacists (Disciplinary Procedure) Regulations Cap. 138E
- Dangerous Drugs Ordinance Cap. 134
- Antibiotics Ordinance Cap. 137
- Undesirable Medical Advertisements Ordinance Cap. 231
- Import and Export (general) Regulations Cap. 60A
I strongly recommend you not to order the ordinance printouts as instructed by PPBHK. I had a bad experience of purchasing outdated ordinances printouts for my exam and lost 10% score in the exam paper. I remember I have purchased the ordinance printout 3 months prior to the exam, and I wasn’t aware that there was an update to the ordinance about 1 month after I made the purchase. It turned out that the newly added topic was appeared on the paper, and I failed to answer it. But still fortunately, I passed.
I suggest you to Google or search the most up-to-date ordinances at the Department of Justice website, download and print out the PDF files for revision. Also regularly check for any updates online to avoid the same story happens to you.
The exam paper normally consists of 5 long questions, each with a 20% score weighing. You roughly have 36 minutes to answer each question.
Question 1 (20%)
Question 1 normally consists of sub-question (a), with another sub-question (b) or (c). So the combination will be either (a) + (b) or (a) + (c).
(a) Legal Classifications of Drug (12%)
(b) Exemption conditions of poison in different schedules (8%)
(c) Name of derivatives of specific groups of chemical substances (8%)
Sub-question (a) – Legal Classifications of Drug:
You will have to determine the drug class for around 12-14 poisons as listed below, 1 mark will be awarded for each correct answer.
- Non-Poison [NP]
- Part II of the Poisons List [P2]
- Part I of the Poisons List
- only in Part I [P1]
- also in First Schedule of the Pharmacy and Poisons Regulations [P1S1]
- also in Third Schedule of the Pharmacy and Poisons Regulations [P1S1S3]
- Part I of the First Schedule to the Dangerous Drugs Ordinance [DD]
- Schedule 1 to the Antibiotics Regulations [A]
This is an easy part to score and require the least time to memorize, you should get at least around 8-10 answers correct. I strongly suggest you not to skip this part in your revision.
For the poison class of Part I, Third Schedule, I prefer to answer [P1S1S3] instead of [S3] as indicated in the exam question. You should also note that for some specific poisons such as cocaine and codeine, different range of concentrations are classified into different schedule categories.
E.g. Product with cocaine less than or equal to 0.01% is classified as P2, while cocaine greater than 0.1% is classified as DD.
Sub-question (b) – Exempted conditions of poison in different schedule
Questions about the exemption conditions of poison as Second Schedule (regulation 8), Third Schedule (regulation 9) under the Pharmacy and Poisons Ordinance were appeared in the last few years past papers, which are listed in A Consolidated List of Poisons, Antibiotics and Dangerous Drugs – HKPJ.
E.g. 3rd schedule applies to Aciclovir and its salt when contained in skin creams packed in a package size of not more than 3 grams and labeled for the treatment of cold sores only.
There are around 40+ conditions in 2nd Schedule and 50+ conditions in 3rd Schedule to be revised for all the poisons. Since my short-term memory is not so good, I did only memorize 10 – 20 of them and allocated more time on the other questions. You never know if the board is going to put question on the First Schedule in the next paper.
Sub-question (c) – Name of derivatives of specific groups of chemical substances
In this question, you have to list out a total of 6 – 8 names of derivatives for 2 – 4 specific groups of chemical substances, which are listed in Poison or Antibiotics? A Guide to “Class” Entries, at the “Drugs Covered by the Entry” column. Since there are 136 groups of chemical substances with over 600+ derivatives, I did only memorize 4 derivative names for around 30 of the most common groups of chemical substances. Look at the past paper trend and select the short and easy names to remember.
It is a step-by-step guidance published by the Department of Health to determine the poison class of any pharmaceutical products. I used it as a complete drug list for my revision.
This search engine allows you to find out the legal classification of poisons. Enter the active pharmaceutical ingredient name and search, pick the single API product with your desired strength and dosage form, then click “Click to view details”. The legal classification of that product will be displayed.
This is a structured full list of all poisons, antibiotics and dangerous drugs, with stating the specific conditions (i.e. strength and dosage form) of 1st, 2nd and 3rd schedule category for each poison.
Question 2 – 5 (4 x 20%, 80%)
Four standard long questions about the ordinances will be asked in the paper. I suggest you to review the standard questions appeared on past papers, draft an answer for each question for 1 – 2 pages and memorize them. Less questions were appeared on disciplinary actions, appeal tribunal, import and exports ordinances, I spent less time on these papers and only drafted 0.5 – 1 page key point answers for each of these questions.
Exam Tips and Study Kit:
A 120-page study kit for the legislation exam paper is available, please message me for more details.
Highlights of the tips and answers, including:
– Summarised key drug classifications (including different strength and conc.)
– Assigned drug classes to the key guide entries
– Drug classification explanations
– Table of key derivatives
– Key points of labelling of drugs
– Key points of supply of drugs
– Key points of antibiotics
– Key points of UMAO
– Key points of DD
– Key points of wholesaler
– Key points of ASP
– Key points of disciplinary committee
– Drafted key answers to past paper questions
– Supplementary key notes
– Import / export
– New amendments of ordinance from 2013, e.g. oral product question
In every year’s April, the Pharmaceutical Society of Hong Kong will co-organize a series of lectures on Pharmacy Legislation of Hong Kong with the Drug Office, Department of Health. This could be a learning opportunity for candidates who will be sitting the Hong Kong Pharmacist Registration Examination on Pharmacy Legislation. Please click here for more details.