CPTP4.1-4.5 Flashcards
CMA?
Cost minimalisation analysis; assume all else is equal and pick cheaper drug.
CEA?
Cost-effectiveness analysis. Create ICER:
cost of A - cost of B)/(effectiveness of A - effectiveness of B). = £/(live saved
CUA?
Cost utility analysis. Accounts for benefit/happiness to patient using QALYs. QALY = survival (years) * quality of those years (0-1). Then do cost per QALY gained of one treatment to another i.e. (difference in cost of A & B)/(difference in QALYs) = £/QALY gained.
Central approval of drugs in Europe?
Done by EMA; important for cancer/HIV/gene therapies etc. Other drugs have mutual recognition.
Licensing for drugs in the UK?
Done by the MHRA, advised by CHM. Not based on cost, only safety and efficacy.
Importance of patents?
Allows companies to ensure return on their product therefore incentivising new research.
Ways that drug sales can be protected when patents expire?
New formulations (e.g. MR), new indications, new routes, new combinations (e.g. APS, HAART), use of enantiomers (esomeprazole).
Basics of pharmaceutical marketing?
- To healthcare providers. Sales reps, drugs samples, sponsoring CME. Influential peers, journal articles.
- Direct-to-consumer. Only allowed in US and NZ.
In UK, regulated by ABPI code.
Role of NICE?
- Provide guidelines about management, technology appraisals, interventions.
- Develops quality standards and performance metrics.
- Provides range of evidence e.g. NICE Evidence, BNF.
Problems with clinical guidelines?
Can force people to prescribe against convictions for fear of litigation, can get bias in authors (financial conflicts), only as good as evidence used, inflexible re specific patients, can promote waste etc.
Legal impact of guidelines?
Can remove the need for expert testimony in court, as guidelines provide clear examples of expected standards. Deviation from guidelines becomes a case to answer
What happens if drug not approved by NICE?
Local/regional commissioners or exceptional case panels can be used to secure funding
Cost benefit analysis?
Values everything e.g cost to society of people missing work in analysis. Express as net monetary gain. Rarely used in healthcare.
Assessing concordance?
Directly e.g. drug concentrations in plasma and observation. Indirectly i.e. clinical response, history, no. of prescription refills, diaries.
Three ways of doing therapeutic drug monitoring?
- Measure clinical response (no. of seizures)
- Measure pharmacodynamic response (BP, INR)
- Measure plasma drug concentrations.
Considerations when measuring plasma drug concentrations?
Await steady state (~5 half lives), time appropriately e.g. trough for digoxin, establish therapeutic range, consider confounders e.g. low albumin. Treat the patient not the concentration!
Indications for measuring plasma drug concentration?
Start of therapy, change in renal function, drug interactions, suspected toxicity, treatment failure e.g. breakthrough seizures, concordance.
Causes of medical errors?
Intrinsic e.g. not enough experience/knowledge, hesitation, did not ask for advice, tired. Extrinsic e.g. complex/atypical cause, no supervision, lab report wrong.
Strategies to reduce medications errors?
Keep high risk drugs separate, lock-and-key design, charts for calculations, accurate handovers, scan wristbands, standardise infusion devices, drug monitoring, have antidotes available
Monitoring gentamicin?
Bactericidal efficacy closely related to peak concentration, and adverse effects (oto/nephrotoxicity) relates to total exposure i.e. more likely above peak of 12 and trough of >2.
