WEEK 1: Pharmacology in Advanced Practice Nursing Flashcards
What is considered a mild ADR?
reaction can typically be managed by dose reduction, discontinuation, or may subside as tolerance builds
Controls for a Schedule I drug
No accepted medical use No legal use permitted For registered research facilities only
Type I Immune-Mediated Adverse Drug reaction
IgE mediated - immediate type hypersensitivity
Example: angioedema and anaphylaxis
May be local or systemic and involved the skin, bronchopulmonary system, nasopharyngeal tract, eye and/or GI tract
Can be mild to severe
Can occur within minutes to hours post-exposure
Definition and Examples of schedule II drugs
Has a medical use and has a very high risk of abuse
Narcotics (morphine, codeine, meperidine, opium, dyromorphone, oxycodone, oxymorphone, methadone, fentanyl)
Stimulants (cocaine, amphetamine, methylphenidate)
Depressants (pentobarbital, secobarbital)
If serious or unexpected adverse drug reactions occur during the post market research phase, how long do you have to report these to the FDA?
15 days
What type of time-related ADR occurs 1 hour after exposure?
Delayed reactions
When an APRN is working ina states that gives the NP “restricted” scope of practice, what roles/responsibilities does the NP have?
State practice and licensure laws restrict the ability of NP to engage in at least one element of NP practice. State law requires career-long supervision, delegation or team management by another health provider in order for the NP to provide patient care.
Definition and Examples of schedule I drugs
Has no medical use and has a very high risk of abuse/addiction
Examples: Heroin, LSD, mescaline, peyote, marijuana** **(Marijuana may be classified under individual state law as a Schedule II drug and used for medical purposes. It may not be “prescribed” however. )
At what point in the drug approval process does the new drug application (NDA) need to be submitted to the FDA?
After phase 3 research - must be approved before the drug can be put on the market
What happens during the 4th step in the drug approval process/Phase 3?
Drug is tested in double blinded randomized clinical trials on thousands of patients to get more precise information on dosing and efficacy
Requirements for prescribing schedule II controlled substances
- must be hand written on a script pad or other security/watermarked paper - max of 30 day supply - no refills allowed
What type of time-related ADR occurs after the first dose of a medication?
First-dose reactions - example: lightheadedness or dizziness after the 1st dose of ACE inhibitors
What is considered a moderate ADR?
reaction that often requires discontinuation of the drug and minimal medical intervention and typically does not cause permanent harm to the patient
What is a time-related ADR that occurs within 1 hour of exposure?
Immediate reactions
Type III Immune-mediated adverse drug reaction
- Immune complex hypersensitivity
- Example: Arthus reaction to tetanus vaccine
- Occurs when aggregates of antigens and IgG and IgM antibodies create insoluble immune complexes in vessels or blood than may be deposited in tissues, such as kidneys or joints.
- May take up to a week to occur and can present as vasculitis to, perhaps, a vaccine.
Controls required for a Schedule II drug
No refills permitted
No telephone orders unless true emergency and followed up by written prescription within 7 days
Electronic prescribing permitted with specific software and secure identification processes
Type II Immune-mediated adverse drug reaction
Antibody-dependent cytotoxicity
Example: heparin-induced thrombocytopenia hemolytic anemia with the administration of Bactrim (breakdown of RBCs)
May affect a variety of organs and tissues in the bloodstream or on the cell’s surface, antibodies unite with antigens and induce destruction of cells (thrombocytopenia)
Management of Type III immune-mediated adverse drug reactions
Anti-inflammatory agents and antihistamines.
Management of Type IV immune-mediated adverse drug reactions
Corticosteroids and other immunosuppressive agents
What are the 5 steps in the drug approval process?
1) Preclinical research
2) Phase 1
3) Phase 2
4) Phase 3
5) Post-market research / Phase 4
What is the PDMP?
prescription drug monitoring program
Controls required for a Schedule V drug
Same as all prescription drugs May be dispensed without a prescription unless regulated by the state