Pharmacotherapeutics Exam 1 Flashcards
Pharmacology
the study of substances that interact with living systems through chemical processes
Toxicology
branch of pharmacology that deals with the undesirable effects of chemicals on living systems
Drug vs Medicine
Drug:
Substances which act on the body and are used for prevention, diagnosis and treatment
Medicine:
Substances that have definite form and therapeutic use for treatment
all drugs are not medicine
All medicines are drugs
Pharmacogenetics
using a persons genetic makeup to help guide drugs and their doses for a particular person
Pharmacodynamics vs Pharmacokinetics
Pharmacodynamics (PD)
Drug action and mechanism
Pharmacokinetics (PK)
Absorption, distribution, metabolism, excretion
Pharmacodynamics
What the drug does to the body
Drug action and mechanism
the biochemical and physiological effects of drugs on the body
the mechanisms of drug action in the body
the relationship between drug concentration and drug effect.
Pharmacokinetics
What the body does to the drug
Absorption, distribution, metabolism, excretion
the rate and extent to which drugs are absorbed into the body and distributed to the body tissues
the rate and pathways by which drugs are eliminated from the body by metabolism and excretion
the relationship between time and plasma drug concentration.
Targets for drug binding
Receptors
Ion channels
enzymes
transporters
factors that can affect responses to drugs
Drug interactions
Adherence to a drug regimen
Tolerance and resistance
Vomiting
DEA
The agency which controls the distribution of drugs that may be easily abused.
FDA
The leading enforcement agency at the federal level for regulations concerning drug products.
Controlled Substances Act of 1970
(CSA) established by US Congress, identifies 5 groups or schedules of drugs as controlled substances and put strict guidelines on their distribution.
Drug schedules
I-V
Schedule I being worst, no acceptable medical uses, high potential for abuse
Schedule V being best , low potential for abuse
Schedule I
Schedule I – High potential for abuse and no accepted medical use in the US.
Heroin, some opium derivatives, and hallucinogenic substances, Marijuana?
Schedule II
Schedule II – High potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US.
Amphetamines, cocaine, methadone, and various opiates
Schedule III
Schedule III – Potential for abuse is less than those in Schedules I and II and there is a currently accepted medical use in the US, but abuse may lead to moderate or low physical dependence or high psychological dependence.
Anabolic steroids , compounds that contain codeine
Schedule IV
Schedule IV – Low potential for abuse relative to Schedule III and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence.
Phenobarbital, sedative chloral hydrate, and some anesthetics
Schedule V
Schedule V – Low potential for abuse relative to Schedule IV and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence.
Limited amounts of codeine included in this group
Exempt narcotics are in this group
Florida prescription monitoring program
Eforce
When must you have a written prescrition
Schedule II drugs require a written prescription
Schedule III - V may be oral or written (also fax)
How are medications assessed
Medications are assessed based on safety, efficacy, and cost-effectiveness
Efficacy
Efficacyis the capacity to produce an effect
maximum response that can be achieved by a drug
Effectiveness
Effectivenessdiffers from efficacy in that it takes into account how well a drug works in real-world use
maximum response achieves when the drug is taken exactly as prescribed
Drug Formulary
Drug formulary is a list of approved drugs that a health plan or a State/Territory, often has agreed to cover, and defines the prescription drug benefit
The purpose of using a drug formulary is to provide high-quality care using the most cost-effective medications. Typically, a drug formulary is developed by experts using clinical evidence.
Guideline vs protocol
A guideline is defined as “a statement or other indication of policy or procedure by which to determine a course of action.”
In contrast, a protocol is “a precise and detailed plan for the study of a biomedical problem or for a regimen or therapy.”
Therapeutic index=
the ratio that compares the blood concentration at which a drug becomes toxic and the blood concentration at which the drug is effective
Pharmacodynamic-
activity of the drug at the site of action is directly or indirectly altered
Antagonism-
opposes the drugs action
Addition/summation-
opposes the drugs action adds to the drugs action
Synergism/potentiation-
enhances the action of the drug
a change in behavior caused by biochemical
Addiction: changes in the brain after continuous substance abuse
Dependence:
stopping would cause withdrawal (physical/mental symptoms)
Tolerance:
a state in which an organism no longer responds to a drug & a higher dose is required to achieve the same effect
Number 1 abused prescription drug
Alprazolam (Xanax) Number #1
FDA MedWatch
Prescribers are encouraged to voluntarily report any adverse effects by approved drugs.
Monitoring system
Recalls Class 1
Class I – strong likelihood that the product will cause serious adverse effects or death
Recalls Class 2
Class II – product may cause temporary but reversible adverse effects, little likelihood of serious adverse effect
Recalls Class 3
Class III– the product is not likely to cause adverse effects
Recalls
Action to remove a drug from the market and are voluntary on the part of manufacturer
3 classes
Drug regulatory authorities often have other important functions including:
Pharmacovigilance.
Regulating clinical trials.
Regulating herbal and homeopathic medicines.
Inspecting and maintaining standards of drug development and manufacture
Other offices of FDA
Center for Drug Evaluation and Research (CDER)
Center for Biologic Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary medicine (CVM)
Exclusivity
Exclusivity refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition.
Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product.
Patent / exclusivity Times
The terms also vary because a patent runs 20 years from filing (subject to extension) while exclusivity is granted according to the type of drug, usually between 6 months and 7 years.
Must demonstrate equivalence with FDA approval
Over 50% of all meds are generic.
Who can prescribe
Under the CSA, only licensed medical practitioners are authorized to prescribe controlled substances listed in Schedules II-V to patients.
Open vs closed formularies
“Open” formularies list drugs favored by the organization and serve an educational role. Typically there are no incentives to prescribe from the list.
“Closed” formularies are lists of drugs that are available for coverage by the organization. Coverage for medications not on the list may be available only if the physician believes that the drug is clearly preferable and obtains a waiver.
What can’t A PA prescribe in FLorida
In State of Florida:
\
Prescribing physician assistants are able to prescribe any medication except those specifically prohibited by the Formulary Committee of the PA council and the Boards of Medicine.
Primary vs secondary caregiver
Primary (gatekeeper)
GP, faily physician, PCP, urgent care, ED
Secondary:
Specialists
Clinical testing phases
Phase 1-3 testing
Phase 4 marketing
How are drugs classified
Body system (cardiology) Therapeutic use (channel blocker) site action (cellular site) molecular structure (steroid, alkaloid( Legal (schedule 1-5)
Medication reconciliation (MR)
The process of comparing a patient’s medication orders to all of the medications that the patient has been taking.
This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions.
Medication reconciliation (MR) 5 Steps
(1) develop a list of current medications
(2) develop a list of medications to be prescribed
(3) compare the medications on the two lists
(4) make clinical decisions based on the comparison
(5) communicate the new list to appropriate caregivers and to the patient
High risk medications list
A PINCH
Anti infectives Potassium (electrolytes) Insulin Narcotics (sedatives) Chemotherapeutic drugs Heparin (anticoagulants)
JCO
Do not use abbreviation list
U (unit) IU (International Unit) QD / QOD (every day) Trailing zero (xxx.0mg) MS, MSO4, MsSO4 (Morphine/mag sulfate)
Write out words
Osteoarthritis medications
NSAIDS
Capsacin
Duloxetine
Intraarticular glucocorticoids
Osteoarthritis, when to use capsacin
Topicalcapsaicinis an option when one or a few joints are involved and other interventions are ineffective or contraindicated; however, its use may be limited by common local side effects.
Cox 2 selective NSAIDS Drugs
Celebrex
Semi-selective NSAIDS Drugs
Meloxicam diclofenac etodolac indomethacin prioxicam nabumetome sulindac
non-selective NSAIDS Drugs
Ibprophen
Naproxen
Irreversible non-selective NSAIDS Drugs
Asprin
What drug types should RA patients initially be started on
DMARDS
Shown better outcomes than NSAIDS & steroids
What test should you get if you are taking hydroxychloroquine
Eye exam
What test should you get if you are taking a biologic agent or Janus kinase (JAK) inhibitor
TB test
What tst should all patients get prior to intiating DMARD treatment
HEP B, HEP C screening
RA patients with flares
Patients with RA flares should be treated as patients with sustained disease activity and should have modifications of their baseline drug therapies
DMARD Types
TNF Inhibitors Newer TNF inhibitors B cell Agent T cell action IL 6 Inhibitor
Why DMARDS over other drugs
NSAIDS offer only symptomatic relief
They have no effect on bone or cartilage
Inflammation is maximal at an early age
If given early DMARDS can stabalize joint function near normal
Osteomyelitis antibiotic Unknown Pathogen:
Vanc
Ceph (3rd or 4th gen)
Osteomyelitis antibiotic for Staph (non MRSA)
Nafcillin Oxacillin Cefazolin Flucloxacillin Ceftriaxone
MRSA Drug
Osteomyelitis
Vanc
Alt - daptomycin
Gram negative pathogen drug
Osteomyelitis
cipro levaquin Ceph Ertapenem Meropenem
Enterococci drug
Osteomyelitis
Ampicillin
Aqueous Cyrstalline Penecillin G
Vanc
Combo: ampicillin plus Ceftriaxone
Streptococci Drug
Osteomyelitis
Ampicillin
Aqueous Cyrstalline Penecillin G
Ceftriaxone
Vanc
Cutibacterium Drug
Osteomyelitis
Aqueous Cyrstalline Penecillin G
Ceftriaxone