Week 1: Intro to Pharmacology & Drug regulations in Canada

Question 1

Three general categories of substances applied for therapeutic purposes

Answer 1

Drug / medications, biologics, Natural health product

Question 2

Define drug

Answer 2

chemical agent capable of producing biological responses within the body

Question 3

define medication

Answer 3

drug that is considered medically therapeutic

Question 4

Biologics and give examples

Answer 4

Agents naturally produced in animal cells, by microorganisms, or by the body itself

Example: hormones, monoclonal antibodies, natural blood products, vaccines

Question 5

Natural health products (NHPs)

Answer 5

includes natural plant extracts, herbals, vitamins, minerals, & dietary supplements

Question 6

Why are some drugs needed to be prescribed by a qualified healthcare provider?

Answer 6

Prescription drugs are considered potentially addictive or too harmful for self-administration

Question 7

3 Advantages to requiring an authorization for a prescription drug

Answer 7

1. HCP has an opportunity to examine client & deteremine specific diagnoses
2. HCP can maximize therapy by ordering the proper drug & control amount & frequency of drug
3. HCP can teach the client the proper use of drug & its side effects

Question 8

what is Therapeutic Products Directorate of the Health Products & Food Branch (HPFB) of Health Canada’s role is?

Answer 8

• regulatory agency responsible for ensuring that drugs are safe & effective
• authorizes marketing of a pharmaceutical drug / medical device when manufacturer presents sufficient scientific evidence

Question 9

What does a drug marketed in Canada needs to have which indicates official approval?

Answer 9

Notice of Compliance (NOC) & Drug Identification Number (DIN)

Question 10

What is the purpose of preclinical investigation?

Answer 10

It’s an extensive testing on cultured cells and in animals that allows scientists to predict whether the drug will cause harm to humans

Question 11

What is a patent protection?

Answer 11

Applied by manufacturer that gives them the right to sell the drug without competition for 20 years

Question 12

What is the longest part of the drug approval process?

Answer 12

Clinical trials

Question 13

What are the steps of approval drugs marketed in Canada?

Answer 13

1. Initial drug is conducted
2. Preclinical studies in cultured cells, living tissue & species of animals are performed
3. Clinical trial application is submitted to Health Canada
4. Pharmaceutical company completes a New Drug Submission (NDS) to Health Canada
5. Committee of drug experts review NDS
6. Health Canada reviews information about the drug & passes on important details to HCP & consumers
7. Health Canada issues Notice of Compliance (NOC) & Drug Identification Number (DIN)
8. Health Canada monitors the efficacy of the drug & safety concerns after is has been marketed

Question 14

Who are the few special populations with insurance coverage for approved drugs?

Answer 14

Veterans, Aboriginal peoples, members of the Royal Canadian Mounted Police, & Canadian Armed Forces

Question 15

What is the special access program (SAP)?

Answer 15

Program that allows access to drugs not currently approved in Canada by clients with serious or life-threatening conditions for whom conventional therapies are ineffective, unavailable or unstable

Question 16

What are the characteristics of an ideal drug?

Answer 16

• Effectively treats, prevents, or cures the client’s condition
• produces a rapid, predictable response at relatively low doses
• produces no adverse effects
• can be taken conveniently, usually by mouth
• can be taken infrequently, usually once a day, & for a short length of time
• inexpensive & easily accessible
• quickly eliminated by the body after it produces its beneficial effect
• does not interact with other medications or food

Question 17

How are home medications administered when drugs produce serious adverse effects or must be given by invasive routes?

Answer 17

• Drug is administered in a clinical setting by a nurse
• client receives careful instructions & regular monitoring on an outpatient basis