Prescriptive Authority and Prescription Writing Flashcards
Nurse practitioner prescriptive authority is regulated by
The State Board of Nursing for each state
Criteria for choosing an effective drug for a disorder include?
Consulting nationally recognized guidelines for disease management
Predictors of non-adherence to medications does not include what?
Age
It is important to include at least __________(how many) patient identifiers when completing a prescription.
two
The internet system for tracking over-prescribing prescription monitoring program (PMP) provides what?
- A direct secure access to view dispensed controlled substance prescription histories
- A list of all controlled substances dispensed across New York State
- info to providers to determine if there may be abuse or not.
What is the NP Modernization Act and why is it important?
It removes the requirement of a written agreement between an experienced NP and a provider (must have 3600 hours of practice or written agreement and practice protocols are needed)
who orders you a certificate to practice?
NYS EDUCATION DEPARTMENT
Who issues the National Provider Identifier (NPI)?
US Center for Medicaid and Medicare Services (CMS)
What do you need in order to obtain federal drug enforcement administration number and NYS official prescription form?
A National Provider Identifier (NPI)
What do you need in order to prescribe or dispense controlled substances?
A Federal Drug Enforcement Administration (DEA) number and NYS official prescription Forms
A Federal Drug Enforcement Administration (DEA) number
needed to prescribe or dispense controlled substances
New York State Official Prescription Form
needed to prescribe controlled substances
How often do you have to renew your prescription registration?
every 2 years
Before you can order prescriptions, you must register with who?
Bureau of Narcotic Enforcement
what 3 major things need to be on prescription?
Patient info, Prescriber info and Drug info
what patient information needs to be on prescription
name, DOB, address
what prescriber information needs to be on prescription?
Name, address, phone, signature, license number
what drug information needs to be on prescription?
name of drug, dose, dosage regimen, route, allowable substitutions
Food and drug act
helped to stop misbrand of food and drugs from interstate trade, drugs must meet standards of strength, labeling in effect
Harrison Narcotic act
the regulation and tax of imported opiates
Food drug and cosmetic act
gave FDA power to oversee safety of food, drugs and cosmetics
Durham-Humphrey Amendment
required addictive meds to be labeled “Federal law prohibited dispensing without prescription”
Kefauver-Harris Amendments
required drug manufacturers to prove scientifically that a medication was not only safe, but effective.
Comprehensive Drug Abuse Prevention and Control Act
requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs.
Orphan Drug Act
requires government to facilitate development of drugs for rare diseases (ALS, huntingtons etc)
Waxman-Hatch Amendments
patents on drugs established
How many phases in drug testing?
3, Pre-clinical, clinical trials and Registration,(Launch and sales)
Pre-Clinical testing takes how long and what are the phases? What are they testing?
2-3 years screening Phase 1 Phase 2 They test two different animal species, looks at side effects, duration and during phase 2 looks at elimination and reproduction effects
Clinical Trials takes how long and what are the phases? what are they testing on during these trials?
3-4 years Phase 1 Phase 2 Phase 3 Phase 4 Human trials, looking for toxicity, carcinogen indications
Center for Drugs Evaluation and Research (CDER)
assures safe and effective drugs are available
The FDA responsibility
safety and efficacy of all regulated marketed medical products
which kinds of products does the FDA regulate?
drugs, biologics, medical and radiation devices, nutritional products
The orange book
identifies drug products approved on the basis of safety and effectiveness by the FDA
Schedule 1 drugs and examples
high potential for abuse, not accepted in US ex. heroin, LSD
Schedule 2 drugs and examples
high potential for abuse, can be severe physical dependance ex: methadone, fentanyl, morphine, oxycodone
Schedule 3 drugs and examples
potential abuse (less than 1&2), mod or low physical dependence, ex: tylenol with codeine, norco
Schedule 4 drugs and examples
lower potential abuse than 3, limited physical dependence ex: alprazolam, lorazepam, diazepam, midazolam
Schedule 5 drugs and examples
low potential abuse, limited physical dependence ex: Robitussin AC, Phenergan
