Pharm Section 1 Flashcards
Ways to save on drug costs
lifestyle changes, older or generic drugs (newer isn’t always best), insurance plan & formularies (buy in bulk, etc.)
PAP
patient assistance programs by pharmaceutical manufacturers–help people who cannot afford their meds
anticipated increase in drug spending will be driven by…
expensive new drugs, aging populations, and increased generic drug use in developing countries
prescription drugs account for about ___% of over US health expenditures
11%
Tennessee Health Care Innovation Initiative
shift from fee-for-service payment to outcomes-driven reimbursement for physicians
____% of americans are on at least 1 prescription drug; _____% take two; and ____% are on five or more prescription meds
70%; 50%; 20%
non-adherence
people not taking meds as directed. nearly 3/4 consumers admit they don’t take as they should (forget to take, don’t fill Rx, take less than recommended, substitute OTC meds instead)
More than _____% of drug Rxs not filled within 9 months. Highest non adherence for ______ kinds of drugs
more than 30%; expensive or chronic preventive drugs.
only _____ drugs are sampled
branded, patent-protected
pros/cons of drug samples
pros: allows pt to test drug before committing to full rx worth (cost savings)
cons: pts start on more expensive samples, then can’t afford when they have to buy full Rx (adds to cost later, might have to change meds which can be difficult on body)
FDA def drug (and why they changed it)
“an article (other than food) intended to affect the structure or any function of the body.” Changed it in an effort to control nicotine.
clinical def drug
any substance used in the dx, tx, cure, or prevention of disease or health condition
pharmacology
study of actions and effects of drugs within a living system (legal, illegal, Rx, non-rx drugs)
pharmacokinetics
study of drug absorption, distribution, metabolism, and excretion (ADME) (“How they get in, move around, and leave the body”)
pharmacodynamics
study of drug interactions within body tissues and how drugs produce their specific effects (“how they work”)
pharmacogenetics
study of the variability in drug response and toxicity due to genetic factors
pharmacogenomics
information gained from pharmacogenetics applied to the development and use of medications. aka precision or individualized medicine
how is information from the US Human Genome Project being incorporated into pharmacology?
pharmacogenetic/genomic information included in warnings of over 100 drugs; genetic profiles may be used to choose medications with minimal side effects (CYP450 enzymes)
polymorphisms
tiny discrepancies in human genomes that can be important markers of disease risk
indication
an illness or disorder for which a specific drug has documented usefulness
contraindication
when there is evidence that a drug should not be used to treat a particular disease or disorder
action
the chemical changes or effects a drug has on body cells. may be reversible or irreversible.
agonist
drug that has an affinity and intrinsic activity for a receptor site–acts to illicit a specific effect
antagonist
drug that has an affinity for a receptor site, but does not illicit and effect (“blocks” the receptors)
toxicity
a measure of the difference between effective and lethal/toxic doses
therapeutic index
LD50/ED50 or TD50/ED50 (measure of the margin of safety for a drug…ratio of the effective dose and the toxic/lethal dose)
narrow therapeutic index (NTI) drugs
drugs that have a small margin of safety for therapeutic index…require measurement of serum plasma levels to avoid adverse effects
therapeutic drug monitoring
measuring serum plasma levels of drugs to assure
peak level
highest level of drug in serum plasma
trough level
lowest level of drug in serum plasma
how many half-lives does it generally take to achieve steady state serum concentrations?
usually after 5 half-lives for most drugs
OTC drugs
over the counter drugs. Rx not required
BTC drugs
behind the counter drugs. Restricted to pharmacies, but don’t require a prescription. E.g. pseudophed
Rx drugs (legend drugs)
require a prescription to be dispensed
orphan drugs
drug that has potential use in only a small number of people with particular conditions (not significant enough for FDA to provide incentives for drug development. controversial b/c “no reasonable expectation of profitability”).
drugs possess ______ actions and effects
multiple
__________ is a fact of life as evidenced by the normal curve of distribution
biological variation
all drugs are _______
toxic, only the toxicities and doses required differ.
placebo effect
beneficial effect produced by a drug or treatment that cannot be attributed to the properties of the placebo itself, but to the patients belief in the treatment instead (though to be the result of the body’s production of endorphins when pt believes in the drug)
cost may have a _____ effect
placebo. more expensive drugs thought to have greater effect
potency
how much of a drug is required to illicit a pharm effect (more potent drug just means to have to use more of it). potency does not equal efficacy.
efficacy
how well a drug actually accomplishes the effect it is supposed to produce (i.e. how well it actually works)
chronotherapeutics
delivery of medications in varying amounts during the day, taking temporal patterns in the risk of disease/change in symptoms/pt tolerance into account
EBP/EBM
evidence-based practices or medicine. interdisciplinary approach to clinical medicine. research best practices and put them into clinical practice
evidence
research findings derived from the systemic collection of data through observation and experiment and the formation of questions and testing of hypotheses.
dosage forms
how drugs are delivered. include: liquids, tablets, capsules, transdermals, buccal films, implants, pumps, topical, aerosols, and parenterals,
controlled release dosage forms
LA (long acting), SR (sustained release), XL, and CR (controlled release) drugs.
what kind of dosage forms should not be crushed?
enteric coated tablets and controlled release dosage forms
chemicals (drugs) break down in the presence of _____, ____, and ____
heat, light, and moisture
all states require that medications be packaged/dispensed in _________ containers
child-resistant
all original packages must include an ________
expiration date
shelf life
the timeframe in which the manufacturer state that the drug will maintain its full potency
what kind of drugs are labeled with “beyond use” dates? how long are these dates (usually)?
repackaged drugs. Generally 1 year or less from the repackaging date.
can drugs be used past their expiration dates?
drugs may be stable after their expiration dates (generally are), but that date is how long drug manufacturers can guarantee drugs will remain stable based on testing. When no substitute is available, outdated drugs may be effective. Potency and efficacy varies with the drug, batch, preservatives used, and storage.
expiration dates are generally set for _______ months after production
12-60 months.
destruction of drugs
used to flush down toilet, but started seeing in water systems. Now, “drug take-back programs” at pharmacies and other participating locations for proper disposal. If not possible, remove from vials, mix with coffee grounds or kitty litter, and put in sealed bag.
generic drugs
drugs modeled after a single, brand-name drug that performs approximately the same in the body as the brand name drug. Slight, but not medically important variations from original drug.
generic drugs now make up _____% of the pharmaceutical market volume
~84%
brand name drugs account for ____% of all dollars spent on prescription drugs
75%
average time brand name drugs stay in market without generic competition?
12.8 years
GPhA suggests that use of generics has reduced US healthcare spending by _____ over past decade
1 trillion
comparison of cost between Rx and generics
Rx ~$84, generic ~$25
drug nomenclature includes
chemical name, generic (nonproprietary) name, and trade name
guidelines for substituting generic for brand name drug?
can substitute generic for brand name if the generic is deemed “A” rated to be bioequivalent to brand name
bioequivalent
generic drugs that are synthesized to be chemically equal to brand name drugs
biosimilar
“generic” biological drugs. called biosimilar instead of generics because they’re made from living organisms, which can’t be copied exactly.
What is the name of the FDA publication that lists therapeutic equivalent (bioequivalent) drugs?
The “orange” book
What FDA publication lists biosimilar agents?
the “purple” book
what are the FDA guidelines for bioequivalence?
drug must exhibit bioavailability properties similar to the produce its being compared to. Requires that the 90% confidence interval of these properties fall with the 80-125% range of the brand product in three categories: max concentration, time to mac concentration, and area under the curve.
80-125% rule does NOT refer to:
amount of drug in the product or amount of drug absorbed/avg blood levels
DTCA pros/cons
direct-to-consumer advertising
pros: informing patient about options
cons: cost
STEPS for evaluating a new drug
S: safety T: tolerability E: effectiveness P: price S: simplicity
Primary function of the FDA
to write the label for every drug it approves
drugs must be proven _____ and _____ before FDA will approve them, companies can market them
safe and effective
FDA makes judgments about whether or not a drugs ______ outweigh ______
benefits outweigh risks
new FDA emphasis?
used to focus on safety, non inferiority, and effectiveness, now moving toward outcomes and superiority over existing drugs
off-label drug use
when drugs are used to treat illnesses/conditions/populations they are not FDA approved to treat. occurs when MDs depart from approved use, dosage, dosage form/administration, or patient population.
most common off-label drug use?
pediatrics
types of review for new drug applications
standard (drugs with therapeutic qualities similar to one or more already on market); priority (drugs appear to be significantly better than those on market); and “Animal Testing” (don’t require human clinical trials bc dangerous, only require human safety trials)
estimated average cost of developing new drugs?
$4 billion
animal studies are conducted to…
determine toxicity/therapeutic index/margin of safety (lethal dose only in animals) and pharmacokinetic information
human studies are conducted to…
aka clinical trials. determine safety, dosage range, side effects, effectiveness, compare to current drugs
IND
investigational new drug exemption
clinical trails
usually RCTs that are double blind, placebo-controlled, cross-overs, etc. Not all have placebo arm (standard of care vs. new drug)
NDA
new drug application
ANDA
abbreviated new drug application (basically for generics)
patent rights
15-20 years from IND (varies depending on a number of factors)
Phase I clinical trials
20-80 people; tests for safety, safe dose range, identify side effects
Phase II clinical trials
100-300 people; tests for effectiveness and safety in larger population
Phase III clinical trials
1000-3000 people; confirms effectiveness, monitors side effects, compares to commonly used drugs on market, collects info for how to use safely
Phase IV clinical trials
post-market studies. continues studies on adverse effects, risks, benefits, optimal use
REMS
risk evaluation and mitigation strategies. system to help manage medication risks/safety issues. 1/2 strategies provide info; 1/2 require additional training for prescribers.
legacy drugs
drugs that have “grandfathered in” approach by FDA until they can be tested. allowed to remain on the market despite lack of FDA approval.
drug pedigree
tracks drugs from original manufacturer through subsequent sales to attempt to control counterfeiting
“track and trace”
pedigree and tracking (RFID chip) requirements for drugs to try and mitigate counterfeiting
FAA regulations
“bottle to throttle” rules: can’t consume alcohol within 8 hours of flight, must wait 6 hours for viagra (b/c alters blue/green color perception)
pharmacognosy
study of plant-based drugs (aka phytopharmaceuticals)
chemical synthesis of drugs started in the…
1950s. (also discovery of DNA by wanton/crick)
biotechnology era….
1980s (1st biotech drug developed was human insulin in ‘83)
gene therapy
drugs tailored to people based on their human genome
1906 Food & Drug act
instituted labelling requirements for drug manufacturers
1914 Harrison Narcotic Act
set up taxation for opiates
1938 Federal Food, Drug & Cosmetic Act
1st safety testing requirements (following sulfanilamide disaster that killed 107 people mostly kids)
1952 drug legislations
further distinguished between Rx and OTC drugs
1962 Kefauver-Harris Amendment
1st requirements for efficacy testing (in response to thalidomide birth defects crisis)
1970 Controlled Substances Act
established schedules/ classes of drugs based on potential for abuse
animal testing for controlled substances
test to see if animal will self-administer drug and continue taking it rather than taking food/water
5 schedules for drugs
Schedule I-V
Schedule I drugs
no legitimate medical use in the US. examples: LSD, heroin, marijuana
Schedule II drugs
have high potential for abuse that may lead to severe dependence. Cannot get refills. E.g. morphine, oxycodone, hydrocodone
Schedule III drugs
potential for abuse, but less than CII. abuse may lead to moderate-low dependence. can refill 5x in 6mo. E.g. codeine with tylenol, steroids
Schedule IV drugs
lower potential for abuse than CIII. abuse may lead to limited dependence. Can refill 5x in 6 mo. e.g. benzos, tramadol
Schedule V drugs
Lowest potential for abuse, dependence. Can be Rx or OTC. e.g. codeine cough syrups, Lomotil (high doses have opiate like effect)
Top 10 prescribed controlled substances in TN (2015)
hydrocodone (Vicodin, Lortab), alprazolam (Xanax), oxycodone (OxyContin, Percocet), zolpidem (Ambien), tramadol (Ultram), clonazepam (Klonopin), lorazepam (Ativan), diazepam (Valium), morphine (MS Contin), buprenorphine (Suboxone, Subutex)
TCSMD
Tennessee Controlled Substance Monitoring Database–includes info on prescriber, date Rx, when filled, who filled, new rx or refill, basic patient info, name + form of med, source of payment
when do prescribers check TCSMD?
before prescribing opioids, benzos (and annually for patients on those meds)
exemptions for checking TCSMD
hospice, surgical procedures in licensed healthcare facility, quantity doesn’t exceed max for 7 day tx pd and doesn’t allow refills, vets