Herbals and Drug Regulation Flashcards
Because herbals are FDA regulated as a food instead of a drug, what is not regulated (what do consumers lack info on)?
If there are active ingredients If ingredients are bioavailable If dosage is appropriate If each bottle has the same components If the pill has any contaminants or additives Safety studies aren't required
What are classes 1-4 of herbal safety and toxicity in the American Herbal Product Association?
Class 1: safe
Class 2: restrictions about pregnant/nursing
Class 3: only should be used under supervision of expert
Class 4: not enough data
____ # of americans taking herbs
____% of patients use herbs do not report use preoperatively
70 million
70 %
We tell patients to d/c herbals ___ days prior to surgery
14
Kava Kava anesthetic considerations
CNS depressant, sedative, anxiolytic
Potential for addiction, tolerance, withdrawal
SE: headache, dizzy, sluggish reflex, less coordinated, HEPATOTOXICITY with long term use
Valerian anesthetic considerations
Sedative, anxiolytic, sleep aid
Avoid with barbs, opioids, benzos
SE: headache, ataxia
Can develop withdrawal (cardiac abnormalities, delirium)
St Johns Wort anesthetic considerations
Treats depression, like Prozac
SE: allergy, headache, dizzy, restless, additive effects with anesthesia
Interacts with MAOIs
Inducer of CP450 (interacts with indinovir, cyclosporins, digitalis, CCB, B-blockers, barbs, benzos, birth control, lidocaine, steroids, NSAIDs)
Gingko anesthesia considerations
Inhibits platelet aggregation and platelet-activating factor, used to improve cognition
SE: BLEEDING, headache, dizzy, enhances other anticoagulants
Garlic anesthesia considerations
Inhibits platelet aggregation, increased fibrinolysis
SE: BLEEDING, especially with other anticoagulants, HYPOTENSION
Ginseng anesthesia considerations
Lowers blood glucose, inhibits platelet aggregation, mood/energy enhancer
SE: excitation, tachycardia, headache, HTN, BLEEDING esp with other anticoags, electrolyte disturbance, HYPOGLYCEMIA
Saw Palmetto anesthesia considerations
Inhibits COX and platelet dysfunction, BLEEDING
Used for BPH
Ephedra anesthesia considerations
Direct/indirect sympathomimetic effects, CNS stimulant, for weight loss and energy
SE: HTN, tachycardia, arrhythmias, MI, stroke, seizures, panic attack, psycosis, develop tachyphylaxis, lifethreating interaction with MAOIs
Echinacea anesthesia considerations
Short-term immune system stimulation, treats infections (URIs)
SE: allergic reaction, prolonged use can cause immunosuppression, HYPOGLYCEMIA, HEPATOTOXICITY
Melatonin anesthesia considerations
Sedative effects, controls sleep-wake cycle
Can interact with anticoagulants, immunosuppressants, diabetic meds, birth control pills
What Carrie said to focus on: 1. Know Barash Table 2. Know pregnancy categories 3. Know DEA classifications 4. EXACTLY what is on inpatient order writing 5. Who is responsible for what measures 6. Needle slide Don't worry about history stuff 7. Know role of IRB 8. Purpose of 3 phases, how many people in each
…
Position statement 2.13 of safe practices for needle and syringe use..
Can you reuse a needle to draw up a med on the same pt?
Can you refill a syringe of the same med for the same pt?
Reuse syringe/needle on multidose medication vial?
NO
Position statement 2.14 of securing propofol says what?
Propofol must me kept in a secure environment, draw up med for the case you’re on only
To lessen access leading to abuse, addiction, and death
List some ethical principles in clinical drug research process?
Trial must minimize risk for subjects
Provisions must be made for overall care of pt
Investigator must terminate trial when data shows the drug is way better/worse than current drug (HIV drug trial)
Adverse events reported immediately to ethics committee
This is all a balance of risk and benefit
What does the IRB do?
Make sure participants are fully informed
Oversee that rights and welfare of people participating in trials are protected
Located at hospitals/research institution, mandated/monitored by FDA
Approve, modify, or disapprove research proposals
Safeguards human subjects, vulnerable populations
IRB composition?
At least 5 people
3 that must be on the board: scientific person, nonscientific person (usually lawyer), and someone with no ties to the institution
This variety is to evaluate regulations, law, standards of conduct, and community attitudes
What is included in preclinical research?
FDA requires data compiled from animals/in-vitro or previous studies, then make a proposed protocol IND submitted (application) giving info on chemistry, pharmacology, toxicology
Compare phases 1-3 of clinical trials.
Phase 1: 20-100 subjects over months, non-blinded
Phase 2: 100s of subjects over a year, single/double-blind
Phase 3: 1000s of subjects of a few years, randomized, double-blind
Now that we know what it takes for a new drug to get through the process, what are anesthetic considerations of giving a new drug?
It may react differently in your patient, so be cautious and report any adverse effects, the drug may not be safe in certain populations
What is CDER’s mission regarding generic drugs?
Assure the generic drugs are safe and effective, as well as available to public
Generic drugs must gain FDA approval, strict standards
Note: other missions involve monitoring marketing/labeling
In the post drug approval phase (phase 4), which is sometimes required by the FDA, what did the MEDwatch Program do to help with this phase?
Make it easier to report events
Make it clear what should be reported
Disseminate information
Increase understanding of drug
Inpatient requirements on prescription writing?
Patient identification
Date and time the Rx written
Allergy status
Full name of med, dose, frequency, duration
Reason for administration on PRN meds
Parameters for titration/monitoring
If med is weight based, include pt weight and actual dose (round to nearest increment)
Sign with full name, title, and pager number
The order is invalid if any of this is missing
DEA classes of drugs 1-5
1: not accepted treatment d/t high potential for abuse (heroin, marijuana)
2: high potential for abuse (morphine)
3: less potential for abuse (lortab)
4: low potential for abuse (ambien)
5: least potential for abuse (cough syrup)
Pregnancy categories: A, B, C, D, X
A: studies show no risk in any trimester
B: no evidence of harm in animals but no human studies OR adverse effect in animals but no risk to human fetus in any trimester
C: animal has adverse effect but no human studies OR no animal/human studies
D: human studies show risk to fetus, but benefits may outweigh risk (withdrawal)
X: human/animal studies show risk to fetus, absolutely contraindicated
Pharmacogenomics vs pharmacogenetics?
Pharmacogenomics: study of genes that determine drug behavior
Pharmacogenetics: study of drug response based on genetics
What did the human genome project find?
> 99% of nucleotide bases are the same in all humans, we have 3 billion bases
Note: the differences are mostly SNP variations
Pharmacokinetic variability vs. pharmacodynamic variability leads to what drug differences?
Pharmacokinetic: Drug absorption, distribution, metabolism, and excretion
Pharmacodynamic: Drug target variability, drug target interactions, receptor signaling, indirect effects on drug response
What is the CYP2D6 polymorphism effect (pharmacokinetic variability) on beta blockers? Codeine? Dextropmethorphan?
B blockers: enhanced drug effect
Codeine, dextromethorphan: decreased drug effect
What is the CYP3A4 polymorphism effect (pharmacokinetic variability) on CCB? Alfentanil?
CCB: uncertain
Alfentanil: enhanced drug response
What is the CYP2C9 polymorphism effect (pharmacokinetic variability) on ARBs? Warfarin? Phenytoin?
ARBs: enhanced BP response
Warfarin: enhanced drug effect, bleeding!
Phenytoin: enhanced drug effect
What is the NAT2 polymorphism effect (pharmacokinetic variability) on procainamide?
Enhanced drug effect
What is the BCHE (butyrylcholinesterase) polymorphism effect (pharmacokinetic variability) on sux?
Enhanced drug effect
What is the ABCB1/MDR1/P-glycoprotein polymorphism effect (pharmacokinetic variability) on digoxin?
Increased bioavailability
What is the Na/K channel (SCN5A, KCNH2, KCNE2, KCNQ1) polymorphism effect (pharmacodynamic variability) on QT prolonging drugs (antiarrhythmics, cispride, erythromycin)?
Long QT syndrome
Risk of torsade de pointes
What is the glycoprotein IIIa (ITGB3) polymorphism effect (pharmacodynamic variability) on aspirin and glycoprotein IIb/IIIa inhibitors?
Variability in antiplatelet effects
What is the endothelial nitric oxide synthase (NOS3) polymorphism effect (pharmacodynamic variability) on phenylephrine?
BP response
