PHRM 231 Lecture Notes - Lecture 11: Health Canada, Enoxaparin Sodium, Major Trauma
Document Summary
Risk-benefit consideration in clinical decision making (part 1) Learn about the two gateways where risk-benefit considerations matters. Be familiar with the overall concept of risk-benefit analysis. It is unlikely that a given treatment provides only benefit. From a theoretical perspective, a cea is more comprehensive. Typically includes multiple different outcomes in terms of qaly. Sometimes costs are deliberately left out of the equation. In certain jurisdictions, regulatory/funding approvals do not include costs. In the us, fda is banned from cost considerations. Benefit-risk analysis is a formal component of medication approval if costs are not being considered. Health canada : hpfb is in charge of approval of drugs. Hpfb evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug. If the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a notice of compliance (noc)
