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