Module 1 - Regulations and Governance

Question 1

Pharmacology

Answer 1

“Study of Medicines”

• key intervention in relieving and preventing human suffering
• how drugs are administered
• where they travel in body
• actual response
• how drug is eliminated

Question 2

Factors of Complexity

Answer 2

1. Large volume of drugs
   - >10,000 agents currently
   - nomenclature can confuse communication
2. Each drug has own characteristics
   - therapeutic applications, interactions, side effects, mechanisms of action
3. Each drug has more than one indication
   - overlapping map of knowledge
   - cannot diagnose pt by medication list
4. Drugs elicit different responses depending on individual factors (ie. age, sex, body ass, health status, genetics)

Question 3

Evidence-based medicine

Answer 3

Making decision according to research.

eg. Pharmacotherapy practices EBM

Question 4

Drug

Answer 4

chemical agent capable of producing a biological response

• a medication is a medically therapeutic drug
• synthesized in lab

Question 5

Patent

Answer 5

Period of exclusivity, where that pharmaceutical company only determines the price of medication

• provides 20 years of protection, actual length of exclusivity is around 7-9 years in Canada due to regulatory hurdles
• Once period of exclusivity ends, generic companies can produce same drug w/ no consequence, market te generic equivalent of drug for less money and consumer savings are considerable

Question 6

Point and Justification of patent

Answer 6

Point - for company to recover costs and make money

Justification - they have to recover money spent on clinical trials

Question 7

bioequivalent

Answer 7

the rate and extent to which the active ingredient is:

• absorbed from a drug product and
• becomes available at site of drug action to produce effect
  - if they can prove product to be bioequivalent to one that is on market, they are granted approval (no need for replication of clinical trials)

Question 8

Biologics

Answer 8

Medications produced using biological process in living organisms such as yeast and bacteria
- complex, large molecules derived from living sources and produced through intricate steps

Question 9

Examples of Biologics

Answer 9

• hormones (eg. Insulin made my ecoli molc) or erythropoeitin
• monoclonal antibodies (Mab)
• natural products and components
• interferon
• VACCINES (where they use an organism to make the drug)

Question 10

Natural health products (NHP)

Answer 10

• vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics
• similar action to modern drugs, but regulated differently

Question 11

Advantages of Prescription drugs

Answer 11

1. HCP examines client and order specific drug (guaranteed expert advice)
2. Amount of frequency of drug is controlled
3. Instructions interactions and side effects of drug are identified and monitored (ideally)

Question 12

Disadvantages of Prescription drugs

Answer 12

1. require prescription

2. need for HCP appointment

Question 13

Advantages of OTC drugs

Answer 13

1. No HCP appt. required

2. Less expensive than prescription drugs

Question 14

Disadvantages of OTC drugs

Answer 14

1. client may choose wrong drug
2. Client may not know reactions or interactions
3. ineffective treatment may result in progression of disease

Question 15

Canadian Drug Regulations

Answer 15

• purpose is to protect the Canadian public

- some drugs contained hazardous levels of dangerous and/or addictive substances

Question 16

Health Products and Food Branch

Answer 16

• part of health canada
• responsible for ensuring health products and food are safe and of high quality
• regulates the use of therapeutic products through directorates

Question 17

Therapeutic products directorate

Answer 17

• authorizes marketing of pharmaceutical drug (both prescription and OTC) or medical device
• products must be scientifically proven (through clinical trials ) to the Food and Drugs Act and Regulations

Question 18

Biologics and Genetic Therapies Directorate

Answer 18

• regulates biologic drugs and radiopharmaceuticals
• examples of biologics: blood products, vaccines, tissues, organ and gene therapy products
• examples of radiopharmaceuticals : radioactive iodine for hyperthyroidism

Question 19

Natural and Non-prescription Health Products Directorate

Answer 19

• regulates use and sale of NHPs
• conducts a review of safe and appropriate uses of each product before it can be authorized for sale
• also set up regulations for manufacturing within Canada or importation of sale in Canada