Pharmacology Nur 615
FNP Tutoring Session
Module 1
Google images:
https://as2.ftcdn.net/v2/jpg/01/44/05/57/1000_F_144055779_mb5HQZMxamX5wOGU89hGBYuvUPUiNPO0.jpg
, Drug Therapy
• CDC 2018
- ages 45-64 Entire process
* 73% of women 3 or more Rx may take years
* 64% of men 3 or more Rx
• Drug costs continue to rise
• FDA regulates, monitors, approves new drugs
- Clincial trials (preclinical, phase 1 -> phase 4)
* Phase 1 = 20-100 patients, determine effective routes
* Phase 2 = several 100 patients with disease
* Phase 3 = double blind research trials, several thousand patients
Evaluates data and accepts or rejects drug
* Phase 4 = After market surveillance, look at effects on quality of life
Compare with other drugs on market
Arcangelo et al. (2022). Pharmacotherapeutics for advanced practice. Wolters Kluwer.
,Fast tracking process
Prescription Drug Monitoring Program
* May be used to look at historical use
• Public health considerations
- remdesivir for Covid-19
** may be as little as 6-10 months for approval
• FDA Controlled Substances Act 1970
- identifies drugs with risk for abuse/misuse
Rx requires
DEA license
https://psychedelicreview.com/wp-content/uploads/2019/03/FDA-schedule-1-1.jpg
Arcangelo et al. (2022). Pharmacotherapeutics for advanced practice. Wolters Kluwer.
, NPI (National Provider Identifier)
Purpose: identify all provider transactions with unique ID
* required for insurance billing
https://www.streamlineverify.com/wp-content/uploads/2017/02/npi-number-lookup.png
FNP Tutoring Session
Module 1
Google images:
https://as2.ftcdn.net/v2/jpg/01/44/05/57/1000_F_144055779_mb5HQZMxamX5wOGU89hGBYuvUPUiNPO0.jpg
, Drug Therapy
• CDC 2018
- ages 45-64 Entire process
* 73% of women 3 or more Rx may take years
* 64% of men 3 or more Rx
• Drug costs continue to rise
• FDA regulates, monitors, approves new drugs
- Clincial trials (preclinical, phase 1 -> phase 4)
* Phase 1 = 20-100 patients, determine effective routes
* Phase 2 = several 100 patients with disease
* Phase 3 = double blind research trials, several thousand patients
Evaluates data and accepts or rejects drug
* Phase 4 = After market surveillance, look at effects on quality of life
Compare with other drugs on market
Arcangelo et al. (2022). Pharmacotherapeutics for advanced practice. Wolters Kluwer.
,Fast tracking process
Prescription Drug Monitoring Program
* May be used to look at historical use
• Public health considerations
- remdesivir for Covid-19
** may be as little as 6-10 months for approval
• FDA Controlled Substances Act 1970
- identifies drugs with risk for abuse/misuse
Rx requires
DEA license
https://psychedelicreview.com/wp-content/uploads/2019/03/FDA-schedule-1-1.jpg
Arcangelo et al. (2022). Pharmacotherapeutics for advanced practice. Wolters Kluwer.
, NPI (National Provider Identifier)
Purpose: identify all provider transactions with unique ID
* required for insurance billing
https://www.streamlineverify.com/wp-content/uploads/2017/02/npi-number-lookup.png
