FDA (Food and Drugs Act)

What is a Type II Recall?

- A situation in which the use of or exposure to a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote

The FDA itself gives the Federal Minister of Health the authority to regulate, insect, seize, and impose penalties on all activities related to what 4 items?

- Drugs - Foods - Cosmetics - Medical Devices

The federal or Health Canada legislation has several lists or schedules of drugs which require a prescription. These include:

- Drugs listed in the Prescription Drug List (PDL) - Narcotics (N) - Controlled Drugs (G) - Benzodiazepines and targeted substances

The most important regulations to the FDA for pharmacy are:

- Food and Drug Regulations (Part C=drugs, Part G=controlled drugs) - Natural Health Products Regulations - Medical Devices Regulations

What is a Type III Recall?

- Least serious - A situation in which the use of or exposure to a product is not likely to cause any adverse health consequences

What is a Type I Recall?

- Most serious - Reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death

What 3 directorates fall under Health Canada's "Health Products and Foods Branch"

- Therapeutic Products Directorate - Health Products Directorate - Veterinary Drugs Directorate

Any adverse reaction reports received by the manufacturer must be reported within _____ days to Health Canada

15 days

Schedule B

A list of publications describing official or international standards - Any substance or product sold in Canada must meet the criteria in these standards

Schedule D

Allergenic substances, blood derivatives, and immunizing agents - Regulated to ensure that the premises used to manufacture or process these substances meet specific federal requirements of quality and safety

Schedule G

Controlled drugs

Schedule A

Disease states or conditions for which treatments may not be promoted to the public - E.g. asthma, cancer, depression - Any conditions found listed in this schedule must comply with specific requirements if advertising any product promoted as a treatment or cure for these listed conditions

What are the FDA active schedules regulated by Health Canada

FDA Schedules A, B, C, and D are lists of drugs and medical conditions that are regulated by Health Canada

All drugs - whether they are made here or imported for sale in Canada - must first be approved by _________ before being made available to the Canadian public

Health Canada

What are the responsibilities of Health Canada?

Health Canada is a federal regulator has a broad range of responsibilities to protect the health of Canadians: - From ensuring the safety of the food and drugs people consume - To encourage health lifestyles Health Canada is responsible for: - Consumer product safety - Reducing environmental risks Supporting the delivery of health care to First Nations and Inuit communities - Promoting innovation in health care - Keeping Canadians informed on health and safety matters - Working with others in ongoing research

Prescription Drug List (PDL)

List of prescription drugs - excluding drugs that already fall under the Controlled Drugs and Substances Act

Reporting by the public or health professionals is voluntary and reports of ADRs are sent to ___________ through the ___________ program

MedEffects Canada, Canada Vigilance

If a product requires a prescription, would it for sure have a Pr symbol on its packaging?

No. The Pr symbol only indicates that the drug is listed in the Prescription Drug List (PRL) which is one of the FDA Schedules under Health Canada (federal) NAPRA scheduling is more strict than the FDA scheduling

What is the purpose of post-market surveillance?

Post market surveillance enables Health Canada to monitor the safety profile of health products once they are marketed to ensure that the benefits of the products continue to outweigh the risks

Schedule C

Radio-pharmaceuticals - Regulated to ensure that the premises used to manufacture or process these substances meet specific federal requirements of quality and safety

When drugs have received approval for sale but are pending review as to which schedule they belong, they are automatically placed in _____________

Schedule I

True or False? Scheduling amendments made to the National Drug Scheduling System are immediately effective in Ontario

TRUE