The objective of this tutorial is to take you through the Ordinances relevant to pharmacy legislation.

References

The main reference is the e-legislation website. Other references include Codes of Practices issued by the Poisons and Pharmacy Board, and the Department of Health guidelines. I have no affiliations with PPB, PSHK, or DOH.

All references are linked. I recommend you click on the links and have a look at them.

Objectives and how to use these notes

The main problem with the Ordinances for studying purposes is that they are in old legal English, and there's a lot of back and forth cross-referencing which makes them not reader-friendly.

So the aim here is to translate them in to plain English and also in to study note form.

The best way for you to use these notes is to go through the Ordinance and use these notes as a supplement to interpret the Ordinance. Things like the Poisons Lists I won't reproduce in these notes, and you should read these from the Ordinance itself.

Abbreviations etc.

In order to make the notes more reader friendly, I have used various abbreviations:

PPB: Pharmacy and Poisons Board

PPO: Pharmacy and Poisons Ordinance

PPR: Pharmacy and Poisons Regulations. Regulations are supplementary to the Ordinance.

S.1: Section 1. Sections are the sub-parts in Ordinances.

R.1: (Or 'Reg.1' sometimes) Regulation 1. Regulations are the sub-parts in the Regulations.

P.1: Paragraph 1

DD: Dangerous Drug

ASP: Authorised seller of poisons

LSP: Listed seller of poisons

Also because it is a legal document the Ordinance will be very wordy, for example:

"registered medical practitioner" - I will only write doctor

"registered dentist" - I will only write dentist

"registered veterinary surgeon" - I will only write vet

"The medicine shall not be supplied except by, or on and in accordance with a prescription of, a duly registered medical practitioner for the purposes of medical treatment, or a registered dentist for the purposes of dental treatment, or a registered veterinary surgeon for the purposes of animal treatment."

For example in the case of supply by a doctor, if 'doctor' is all I write you should assume that I mean a registered doctor supplying medication to a patient he/she is looking after.

The same applies to hospitals, clinics, etc. The ordinance only applies to registered hospitals, clinics, etc.

I will simplify text right down by leaving out what I think should be obvious (eg. a doctor can't supply to someone who isn't their patient, or a doctor can only supply in the hospital they are employed in to a patient in their care) for study purposes. But what I think is 'obvious' may not be to everybody else, or there may be misunderstandings. So (disclaimer!) this is why you should also cross reference with the original text from the ordinance.

Parts

In order to try and break up the Ordinance to make it a little more digestible it is divided into chapters called 'Parts'. You will see what I mean when you look at the Index/Contents at the front of the Ordinances and Regulations. I wanted to point this out because the Poisons Lists and the Dangerous Drugs lists are also divided into 'Parts', which may be of more significance because these are used in the legal classifications of drugs. For example P1S1S3 poisons, or P2 poisons, or P1DD, etc. I want you to be aware of this to avoid confusion.

Sections of the course

The Sections of these notes are:

• Going through PPO Parts 1-8 and Schedule 1 and the Poisons List
• Labelling
• Storage
• Wholesale
• Manufacture
• Registration of pharmaceutical products and substances
• Dangerous Drugs Ordinance (DDO) and Regulations
• Antibiotics Ordinance (AO)
• Undesirable Medical Advertisements Ordinance (UMAO)

From the above list up, until the section on Dangerous Drugs I am basically going through the PPO and PPR. Only the main areas are covered, parts which I don't think will come up in the exam I won't cover (eg. fines and penalties), but as said before you should still have a quick read through of the original Ordinance and wording.

The DDO, AO and UMAO are the three other main relevant Ordinances to pharmacists, questions on which often come up in the exams.

Section 1 of each Ordinance is just the citation/short title: Eg. "This Ordinance may be cited as the Antibiotics Ordinance."

Section 2 is usually 'Interpretation' which is like a mini-glossary.

Definitions

Basic definitions have come up a few times in past exams, eg what is the definition of a pharmaceutical product, medicine, ASP, advertisement. Definitions are in Section 2 'Interpretation' of the Ordinances. You don't need to remember the definitions exactly word for word, but try aim to recall 80-100% of the definition.

Language

The exam is in English. Although some Chinese is in the Ordinance eg for some labelling requirements, Chinese is not a requirement to be able to pass the exam.

Drug classification

If you have not done so already you need to read through the and understand the tutorial on looking up drug classification.

Past papers

You need to do past papers to see what kind of questions are being asked and practise doing them. You can also go through the past paper tutorials and compare your answers with the model answers provided.

Finally...

If there are any parts you don't understand, or think I've missed out, or if you just want to give me any feedback please message me via the Facebook group

Happy Studying

Sharon

March 2019