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
no refills, no telphone orders
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?
Immediate 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
When an APRN is working in a state that gives the NP full scope of practice, what roles/responsibilities does the NP have?
Evaluate patients, diagnose, order, and interpret diagnostic tests
Permit initiating and managing treatments incluidng prescribing meds and controlled substances under the exclusive licensure authority of the state board of nursing
What happens during the 3rd step in the drug approval process/Phase 2?
Drug is tested on 200-300 patients with the target disease to determine drug efficacy and dosing - Does it work?
Idiosyncratic Adverse Drug Reactions
- unpredictable
- not dose-related
- either mediated by the immune system, receptor abnormalities, drug-to-drug interactions, abnormalities in drug metabolism, pharmaceutical variations, or unmasking of an abnormal biological system
Type IV Immune-mediated adverse drug reactions
- Cell-mediated or delayed hypersensitivity
- Example: drug rash, eosinophilia, and systemic syndrome (DRESS)
- not antibody mediated, but cell-mediated responses that results in activation and proliferation of T cells
What type of time-related ADR occur at variable points in time after drug exposure and can occur after discontinuation of the drug?
Delayed reactions: example: tardive dyskinesia from metoclopramide
Who gives NPs prescriptive authority?
Board of Nursing in the state where the NP is licensed
What happens during the 1st step in the drug approval process/pre-clinical research?
studying the drug affect on animals for toxicology and safety
Controls required for a Schedule III drug
Prescription must be rewritten after 6 months or 5 refills
Telephone or fax prescription allowed
What are the 6 steps in the process of rational drug selection?
1) Define the patient’s problem
2) Specify the therapeutic objective/goal of therapy
3) Choose the treatment
4) Start the treatment
5) Educate the patient
6) Monitor the effectiveness of the drug
Definition and Examples of schedule V drugs
Has a medical use and has a very low risk of abuse
Examples: Loperamide, diphenoxylate Cough medications with less than 200mg/100mL Pregabalin
What happens during the 2nd step in the drug approval process/Phase 1?
Drug is tested on <100 healthy people to determine the drugs pharmacokinetics/how the drug works in the body
- safety and safe dosage but does NOT determine efficacy
Possible reasons for non-adherence to drug therapy
- Financial
- Adverse drug rx.
- Knowledge deficit
- Cognitive impairment
- Sensory or mobility challenges
What type of time-related ADR occur after repeated exposure to a medication?
Intermediate reactions - example: gout after prolonged treatment with furosemide
Pharmacokinetic factors
How the body affects the drug
Absorption - Distribution - Metabolism - Excretion
At what point in the drug approval process is an investigational new drug (IND) application filed with the FDA?
After the preclinical research phase
I Can PresCribE A Drug
- Indication
- Contraindications
- Precautions
- Cost/Compliance
- Efficacy
- Adverse effects
- Dose/Duration/Directions
Definition and Examples of schedule III drugs
Has a medical use and has a moderate risk of abuse and addiction
Narcotics (codeine in combination with nonnarcotirc ingredients; hydrocodone)
Stimulants (benzphetamine, chlorpheniramine, diethylpropion)
Depressants (butabarbital) Anabolic steroids, testosterone
What causes a Type I Immune-mediated adverse drug reaction?
The release of mediators such as histamine, leukotrienes, and prostaglandins from mast cells, basophils, and recruited inflammatory cells after antigen exposure, which then activate IgE.
Risk factors for developing ADRs
Genetics
Age (children and older adults)
Gender (women > men)
Drug interactions (can affect the rate of drug metabolism)
Medical conditions (such as CKD - can lead to increased serum concentrations and prolonged duration of drug activity)
What type of time-related ADR occur early in treatment and generally resolve with continued treatment as tolerance is developed?
Early reactions - example: metformin can initially cause stomach upset that should resolve w/ time
Two ways to monitor drug effectiveness after prescribing
1) Passive - patient is educated on drug outcome and is instructed to notify the provider
2) Active - follow-up lab tests or monitoring to measure therapeutic effectiveness
When considering whether or not to prescribe a drug to a patient, what should you consider?
- Is there a clear indication for drug therapy?
- What drugs are effective for this?
- Under what conditions do you decide that the drug is not meeting the goal and a different therapy or drug should be used?
- Are there unnecessary duplications with other drugs?
- Would an OTC drug be just as useful?
- What about cost?
- Where is the information to answer these questions?
What type of time-related ADR occurs during or immediately following administration?
Rapid reactions - example: red man syndrome from too rapid of dose administration
Management of a Type I Immune-mediated adverse drug reaction?
Usually involves epinephrine, antihistamines, and corticosteroids
What type of time-related ADR occur after prolonged exposure to an offending agent?
Late reactions - example: bone loss with prolonged treatment with corticosteroids
Pharmacological Adverse Drug Reactions
- most common
- predictable (based on the drugs mechanism of action)
- dose related
- managed by decreased the dose of the drug or stopping the drug
Definition and Examples of schedule IV drugs
Has a medical use and has a low risk of abuse and addiction
Pentazocine, phentermine, benzodiazepines, meprobamate
Pharmacodynamic factors
How the drug affects the body -
ligand (drug) - receptor - cellular response
2 types of Adverse Drug Reactions
Pharmacological
Idiosyncratic
6 Step Model of Rational Drug Prescribing
1) Define the pt’s problem.
2) Specify the therapeutic objective.
3) Choose the treatment.
4) Start the tx.
5) Educate the pt.
6) Monitor the effectiveness.
What is considered a severe ADR?
reaction that may be life-threatening and result in hospitalization, birth defects, or even death; require intensive medical intervention
When an APRN is working in a state that gives the NP “reduced” scope of practice, what roles/responsibilities does the NP have?
State practice and licensure laws reduce the ability of employees to engage in at least one element of NP practice
State laws require a career-long collaborative agreement with another health provider in order for the NP to provide patient care or it limits the setting of one or more elements of NP practice
Controls for a Schedule IV Drug
Same as Schedule III (prescription must be rewritten after 6 months or 5 refills; telephone or fax prescription allowed) **Penalties for illegal possession are different
What happens during the 5th step in the drug approval process/Phase 4/Post market research?
The drug is on the market - reporting of adverse reactions occurs - off label prescribing and black box warnings are formed at this point
Requirements for schedule III, IV, and V controlled substances
- new prescription must be written every 6 months - max of 30 day supply per refill - prescription can be written, called in, electronically prescribed
