Improving pediatric medications

Question 1

What is compounding?

Answer 1

manipulating a medication to achieve a desired dose or to ease administration

• Quality controls are weaker than for commercially prepared products
• Some formulations are commercially available in US or EU but not marketed in Canada

Question 2

How can pediatric medications be improved in Canada?

Answer 2

1. Establish & fund permanent Expert Pediatric Advisory Board (EPAB).
2. Direct Health Canada to:
   
   1. proactively solicit and review pediatric-specific drug data when pediatric use is anticipated
   2. Develop policy pathways to increase submissions for pediatric medications, indications, and formulations
   3. work with Health Technology Assessment agencies to develop and evaluate pediatric-specific standrads
3. Direct Health Canada to:
   
   1. promotes use of reviews and decisions to support efficient commercialization of priority pediatric medications and child-friendly formulations
   2. Review the Special Access Program to support timely access to essential medications
4. Fund the development of a national, comprehensive, continuously updated online resource to support consistent, evidence-informed prescribing in all centres and jursidictiosn across Canada
5. Invest in pediatric drug research and clinical trial infrastructure ensuring alignment between priority regulatory, reimbursement, and research activities

Question 3

What are the 4 steps to establish public reimbursement?

Answer 3

1. Health Technology Assessment (HTA) is conducted by Canadian Agency for Drugs and Technologies in Canada (CADTH)
2. Pricing review done by Patented Medicines Pricing Review Board (PMPRB) that ensures prices for patented meds aren’t excessive
3. Pricing negotiation done by pan-Canadian Pharmaceutical Alliance (pCPA)
4. Independent provincial/territorial/federal program reviews to determine appropriateness for listing on the public formulary