2- Health Canada Databases, Bugs and Drugs and CPS and Lexicomp Flashcards
(25 cards)
What does DIN Approved mean?
Refers to an ACTIVE DIN that has been reviewed and authorized for sale in Canada but has not yet been marketed in Canada
What does DIN Dormant mean?
refers to an active DIN that was previously marketed in Canada but for which there have been no sales for a period of at least 12 months.
What does DIN Marketed mean?
Refers to an active DIN that is currently being sold in Canada.
What does DIN mean?
Drug identification Number
What does DIN Cancelled mean?
No further sales may be made by the manufacturer.
What is the exception with DIN Cancelled?
That wholesalers, retailers, pharmacists and medical practitioners may continue to market or distribute after the DIN is cancelled PROVIDED: the expiry date of the lot has not been passed and the cancellation of the DIN was not due to health or safety reasons.
What is referred to as Cancelled Post Market?
Cancelled further to the discontinuation of the sale by the manufacturer
What is referred to as Cancelled Pre Market?
Cancelled before it was ever marketed in Canada?
What is referred to as Cancelled: Unreturned?
Annual failure to provide the Annual notification
What are the safety issues associated to DIN Cancelled?
- Failure to provide evidence regarding the safety and effectiveness of a drug
- Suspension of an Notice of Compliance
- Failure to comply with the ordered issued to conduct an assessment and provide the results
- Following examination of the results of an assessment provided in response to an order.
Why would there be a change in sales in Atridox?
- Subgingival controlled-release product
- Two syringe mixing syste
- Drug is doxycyline Hyclate
What is the status of Amoxil?
- All cancelled post market.
- Except one marketed for veterinary use only
What is the Anatomical therapeutic chemical (ATC)
It is the classification system that was developed by the World Health Organization (WHO)
What is the purpose of the Anatomical therapeutic chemical (ATC)?
It is a tool for drug utilization research in order to improve the auality of drug use.
How are drugs divided in groups?
Based on the organ or system on which they act as well as their chemical pharmacological and therapeutical properties.
What is Active Ingredient Group (AIG)?
It is a 10 digit number that identifies products that have the same active ingredients and ingredient strengths.
What are the 3 portions of AIG?
1.) the first portion (2 digits) identifies the number of active ingredients.
2.) The second portion (5 digits) identifies the unique groups of active ingredients (s)
3.) The last portion (3 digits) identifies the active ingredients group strength. The strength group has a tolerance of -2% to +10%
What does Schedule I drugs require?
They require a prescription for sale and are provided to the public by the pharmacist following the diagnosis and professional intervention of a practitioner.
What do schedule II drugs require?
While they are less strictly regulated, they do require professional intervention from the pharmacist at the point of sale and possibly to a practitioner.
What do Schedule III drugs require?
They may present risks to certain populations in self-selection. Do not require a prescription, these drugs are to be sold from the self-selection area of the pharmacy which is operated under the direct supervision of the pharmacist.
What do unscheduled drugs inquire?
They can be sold without professional supervision. Adequate information is available for the patient to make a safe and effective choice and labeling is deemed sufficient to ensure the appropriate use of the drug
What are the 4 types of health products?
1.) Food
2.) Cosmetic
3.) Device
4.) Drug
What are 3 types of drugs?
1.) Natural health product
2.) Biologic
3.) Pharmaceutical
What are the 2 types of pharmaceutical drugs?
1.) Prescription drugs
2.) Non-prescription drugs
