Pharmaceutical Policy Flashcards
why should Phc care about pharmaceutical policy?
- medication experts
- Understanding decisions & coverage to help patients understand as well
- Can get involved in drug reviews to help make decisions
who is responsible for international trade agreements with medications?
federal government
who provides the notice of complicance (NOC) for new drugs?
federal government (Health Canada)
when the federal government approves a new med for the market, what are the 3 key things it is looking for in the medication?
- safe
- effective
- quality
who negotiates the prices of patented medications?
PMPRB (patented medicines prices review board) through the federal government
what is the PMPRB (Patented Medicines Prices Review Board)?
a quasi-judicial branch of the federal government that protects Canadians against “excessive pricing”
what are patented medications?
those which are still protected by law from generic duplication
the federal government has been involved in what aspects of COVID-related initiatives?
- vaccine procurement
- recommendations (NACI)
- pharmaceuticals
what is an example of a Pan-Canadian Initiative?
Health technology Assessments (HTA)
what are Health Technology Assessments?
independent reviews to help guide what products become funded
what are 2 examples of health technology assessments?
- common drug review
2. Pan-Canadian Oncology Review
what agency runs both the common drug review and Pan-Canadian Oncology Review?
CADTH (Canadian Agency for Drugs and Technology in Health)
what is the Pan-Canadian Pharmaceutical Alliance (pCPA)?
a public drug program working to get Canadians better value for drugs
t/f the Atlantic Common Drug Review is an example of a Pan-Canadian Initiative
t
what level of government is responsible for how pharmacies are reimbursed?
provincial/juridicial
what is assessed by the health technology assessment of a new drug?
clinical effectiveness & cost-effectiveness
what is the name of the HTA agency in Quebec?
INESSS
what regulatory body is able to withdraw authorization for a drug to be sold in Canada?
Health Canada (federal government)
what are some challenges of expert review (HTA)?
- limited evidence, shot trials, lack of comparison to current practice
- uncertainty about cost-effectiveness, benefit and utility
- drugs keep getting more specialized and more expensive
what are the 3 types of recommendations an HTA might make WRT funding the cost of new medications?
- Cover
- cover with conditions/criteria
- do not reimburse
the price negotiations made by the Pan-Canadian Pharmaceutical Alliance are directed through the _____
Council of the Federation (Canada’s Premiers)
what are the objectives of the Pan-Canadian Pharmaceutical Alliance?
- more access to drugs
- consistent drug access & cost across provinces
- combined “buying power”
t/f when it comes to how new drugs are covered, each province makes their own final call
t
according to the PMPRB, less than __% of Canadian population accounts for 42% of patented medicine sales
1%
