Pharmaceutical Policy

Question 1

why should Phc care about pharmaceutical policy?

Answer 1

1. medication experts
2. Understanding decisions & coverage to help patients understand as well
3. Can get involved in drug reviews to help make decisions

Question 2

who is responsible for international trade agreements with medications?

Answer 2

federal government

Question 3

who provides the notice of complicance (NOC) for new drugs?

Answer 3

federal government (Health Canada)

Question 4

when the federal government approves a new med for the market, what are the 3 key things it is looking for in the medication?

Answer 4

1. safe
2. effective
3. quality

Question 5

who negotiates the prices of patented medications?

Answer 5

PMPRB (patented medicines prices review board) through the federal government

Question 6

what is the PMPRB (Patented Medicines Prices Review Board)?

Answer 6

a quasi-judicial branch of the federal government that protects Canadians against “excessive pricing”

Question 7

what are patented medications?

Answer 7

those which are still protected by law from generic duplication

Question 8

the federal government has been involved in what aspects of COVID-related initiatives?

Answer 8

1. vaccine procurement
2. recommendations (NACI)
3. pharmaceuticals

Question 9

what is an example of a Pan-Canadian Initiative?

Answer 9

Health technology Assessments (HTA)

Question 10

what are Health Technology Assessments?

Answer 10

independent reviews to help guide what products become funded

Question 11

what are 2 examples of health technology assessments?

Answer 11

1. common drug review

2. Pan-Canadian Oncology Review

Question 12

what agency runs both the common drug review and Pan-Canadian Oncology Review?

Answer 12

CADTH (Canadian Agency for Drugs and Technology in Health)

Question 13

what is the Pan-Canadian Pharmaceutical Alliance (pCPA)?

Answer 13

a public drug program working to get Canadians better value for drugs

Question 14

t/f the Atlantic Common Drug Review is an example of a Pan-Canadian Initiative

Answer 14

t

Question 15

what level of government is responsible for how pharmacies are reimbursed?

Answer 15

provincial/juridicial

Question 16

what is assessed by the health technology assessment of a new drug?

Answer 16

clinical effectiveness & cost-effectiveness

Question 17

what is the name of the HTA agency in Quebec?

Answer 17

INESSS

Question 18

what regulatory body is able to withdraw authorization for a drug to be sold in Canada?

Answer 18

Health Canada (federal government)

Question 19

what are some challenges of expert review (HTA)?

Answer 19

1. limited evidence, shot trials, lack of comparison to current practice
2. uncertainty about cost-effectiveness, benefit and utility
3. drugs keep getting more specialized and more expensive

Question 20

what are the 3 types of recommendations an HTA might make WRT funding the cost of new medications?

Answer 20

1. Cover
2. cover with conditions/criteria
3. do not reimburse

Question 21

the price negotiations made by the Pan-Canadian Pharmaceutical Alliance are directed through the _____

Answer 21

Council of the Federation (Canada’s Premiers)

Question 22

what are the objectives of the Pan-Canadian Pharmaceutical Alliance?

Answer 22

1. more access to drugs
2. consistent drug access & cost across provinces
3. combined “buying power”

Question 23

t/f when it comes to how new drugs are covered, each province makes their own final call

Answer 23

t

Question 24

according to the PMPRB, less than __% of Canadian population accounts for 42% of patented medicine sales

Answer 24

1%