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
interstate sharing of CS data?
problematic. cannot share across states yet, some states don’t even have systems. but that is the goal.
no Rx or any opiod or benzos may be dispensed in quantities greater than _______
a 30 day supply
side effects
additional effects of drug that are not the primary purpose of giving the drug (desirable and undesirable)
average number of side effects listed on meds
avg = 70 per medication
adverse reactions
unintended and undesirable responses to meds. Directly related to the drug.
package insert
list of side effects and potential adverse effects of drugs
Dear Healthcare Professional Letter
if enough instances of adverse event happen, manufacturers send this letter to warn prescribers in hopes of reducing instances of that particular adverse event or side effect
Black box or boxed warning
next step?
if letter does’t reduce instances of new side/adverse effect, must include a black box warning on the medication that lists the unwanted side/adverse effect. strongest warning the FDA can require. next step: pull drug from market
warning fatigue
too many warnings for things, pay attention to them less/don’t take as seriously. e.g. peanut warning on peanuts
two ways side effect/adverse events reach the FDA
voluntary reports by prescribers/consumers and reports by manufacturers (must report serious events within 15 days of hearing about it)
US deaths caused by drug use more common than_______
automobile accidents and either alcohol-induced or firearm-related deaths
Adverse Events Reporting System
FDA mechanism for reporting adverse events
CDC estimate for # ED visits due to medication errors
700K
examples of medication errors that lead to ED visits
taking multiple OTC drugs that contain similar/same products, mixing eye drops with ear drops, chewing non-chewable, splitting pills you shouldn’t split, using household spoon to measure dosage, missing or doubling doses
drugs in hospitals administered wrongly?
4 in 10.
most common medication errors in hospitals/with nurses
giving patients meds earlier or later than meant to, failing to flush tubes between administrations, using wrong syringes to inject meds into feeding tubes
medical errors are the ______ leading COD in the US
third
initiation of drug therapy must consider…?
the fish curve (aka the dose-response curve of beneficial vs. harmful effects). At some point, drugs do more harm than good
IOM recommendations for reducing medication errors
electronic prescribing, hospitals have std. bar code system for checking/admin drugs, patients seek info about drug risks, DO NOT USE ABBREV.
fetotoxic
toxic to the fetus
teratogenic
causes birth defects
women take and average of ______ prescriptions during pregnancy
3-5
old FDA system for categorizing risk during pregnancy
A (safe for use during) B (not unsafe), C (can’t determine risk), D (evidence of risk), and X (contraindication–never use)
new FDA system for relaying pregnancy risk info
labels must include categories for risk to: pregnancy, lactation, and female/male reproductive potential. pregnancy and lactation sections include 3 subsection: risk summary, clinical considerations, and data
SALAD drugs
sound-alike-look-alike drugs. drugs with names that are easy to mix up.
FDA guidelines for naming drugs
can’t name drugs things that imply efficacy/make medical claims, or suggest use that it’s not approved for, or promise more than drug delivers
drugs ending in -oxetine belong to what class?
antidepressants
drugs ending in -sartan belong to what class?
blood-pressure lowering drugs
drugs ending in -afil belong to what class?
erectile dysfunction drugs
drugs ending in -lukast belong to what class?
anti-asthma drugs
drugs ending in -azepam belong to what class?
anti-anxiety drugs
drugs ending in -coxib belong to what class?
anti-inflammatory pain relievers
drugs ending in -dronate belong to what class?
drugs that prevent calcium loss
drugs ending in -formin or -glitazone belong to what class?
diabetes drugs
drugs ending in -prazole belong to what class?
stomach acid reducers
drugs ending in -conazole belong to what class?
anti-fungals
drugs ending in -vir belong to what class?
antivirals
antiviral subclasses:
- amivir for…
- ciclovir for…
- navir for…
- amivir for anti flu drugs
- ciclovir for herpes drugs
- navir for HIV treatment drugs
drugs ending in -stat belong to what class?
enzyme inhibitors. have a bunch of subclasses.
-mab suffix refers to…?
monoclonal antibody drugs
-imod suffix refers to…?
immunomodulators
-sertib suffix refers to…?
serine/threonine kinase inhibitors
-mer suffix refers to…?
polymers
drug names in other countries
are often entirely different (brand and generic) than in the US
10 second interventions for SALAD drugs
tell patient what drug is supposed to treat or ask patient why they were prescribed that drug
how to reduce medication errors?
prescriber should take great care when writing/dispensing Rx. Ask prescribers to write indication/reason for taking drug in directions. patients should be encouraged to talk to pharmacist
three phases in how body handles drug:
pharmaceutical phase (how drug gets into body i.e. dosage form), pharmacokinetic phase (ADME), and pharmacodynamic phase (cellular mechanism by which it works)
drug receptor interaction theory
assumes drug has high affinity for a specific chemical group or particular constituent of a cell
receptor
particular reactive cellular site which which the drug may interact to produce desired effect/response
drug enzyme reaction
drug may increase or inhibit enzymes which control all biochemical reactions in cells
nonspecific drug interaction
drug that exerts more general effects on cell membrane and processes (no specific action can be elicited)
pharmocokinetic bell curve
drug administration > absorption on uphill > peak level at top > elimination on downhill.
duration of action
time when drug is at minimally effective concentration or more (time when drug is working to produce effect)
drugs are best absorbed in….
non-ionized, lipid-soluble form
only way to bypass absorption:
IV or spinal tap
pKa =
pH where 1/2 of the drug is ionized
absorption of drug depends on the….
absorbing surface
drugs with less ionization, more lipid solubility…
cross membranes quicker, work faster/better
drugs exist as ______ or _____ and may be ______ or ______.
weak acids or weak bases and may be water-soluble (cannot pass through membranes) or lipid-soluble (pass through membranes)
factors to consider when administering meds via enteral tubes:
type of tube, location of tube, liquid meds, bulk-forming or things that clog tubes, crushing tablets!!, enteral feedings may alter absorption
how are drugs distributed through body?
either free or bound to plasma proteins like albumin
drugs that are highly bound to plasma proteins may be displaced by…
other concurrently administered drugs with higher affinity for binding sites. displacement increases distribution of free particles, which increases the pharm activity of the displaced drug.
metabolism
aka biotransformation, prepared drug for excretion. not all drugs undergo biotransformation (e.g. penicillin and WWII soldiers urine)
what kind of drugs must be biotransformed before they can be excreted?
water-soluble drugs
metabolism usually takes place @ ______ and excretion @ ________.
liver; kidneys
CYP450 enzymes
partially responsible for drug metabolism. most commonly found in liver. each enzyme = isoform (derived from different genes). can either be induced or inhibited by chemicals in drugs, food (aka grapefruit as inhibitor).
how does pharmacogenomics play role in metabolism?
some people metabolize drugs faster, slower than others. pharmacogenomics can be used to personalize drug therapy based on genes. e.g. 1-7% of population rapid codeine metabolizers (29% in Ethiopians)
enzyme induction
drug that induces enzyme to increase metabolism or excretion of drug, lowering its blood level/pharm effect
enzyme inhibitor
drug that inhibits enzymes metabolism/excretion of drug, increasing its blood level and pharm effect
hepatic first pass effect
some drugs are immediately transported to liver and metabolized extensively on “first pass.” can bypass this effect by administering any way other than orally.
examples of drugs that undergo hepatic first pass effect
morphine, nitroglycerin (given higher doses orally or by other routes of administration)
prodrug or progenitor drug
a drug that is metabolized to another active drug/active metabolite e.g. clopidrogel/Plavix
metabolite
end product of metabolism. may be active or inactive.
zero-order
drugs that are metabolized at a constant amount per time / “flat rate” / e.g. alcohol. On graph: straight diagonal line
first-order
drugs that are metabolized at a constant proportion per time (@ each half life, 50% eliminated). On graph: curved line
half-life
T1/2 = the time it takes for the plasma concentration of a drug to be reduced by 50%
it generally takes _______ half lives to achieve steady state concentrations or to reduce the drug to an insignificant level
3-5 half-lives
loading dose
amount of a drug it takes to reach therapeutic range/minimally effective dose in circulation
maintenance dose
amount of drug it takes to maintain steady state concentration in circulation
drug interactions
many drugs interact as a result of enzyme induction or inhibition of enzymes. can result in larger or smaller response.
primary excretion
renal system/urine
urinary pH affects…
excretion (esp. amphetamines)
best way to measure renal function
creatinine clearance–cockroft-galt equation (common way). takes into account serum creatinine levels, age, weight, and gender.
other ways to measure renal function
serum creatinine levels (misleading, low doesn’t alway indicate good kidney function) or glomerular filtration rate (GFR–recommended for evaluating renal function for patients with chronic kidney disease)
normal serum creatinine level?
0.5 or 0.6-1.1 to 1.2
recommended way to test renal function in patients with chronic kidney disease?
GFR
factors that modify a drug’s effect…
variable (food), fixed (genetic)
drug-related problems
carcinogenicity, dependence and addiction, resistance, drug interactions, teratogenicity and fetotoxicity, extraversion and infiltration, adverse response/reactions
tolerance
state of adaptation in which exposure to drug induces changes that result in reduced effect of drug over time
tachyphylaxis
rapidly developing tolerance
physical dependence
involves symptoms of withdrawal related to abruptly stopping or rapidly reducing dose
addiction
impaired control over drug use/compulsive use despite harm/ craving
extravasion/infiltration
injury to tissue caused by leakage of solution from vein into surrounding tissue during IV administration. can cause extensive damage that may/may not be repairable.
adverse reactions include…
hypersensitivity reactions, idiosyncratic responses, hematologic effects, hepatotoxicity, nephrotoxicity, ototoxicity, ocular tonicity, emotional disorders, sexual dysfunction, taste disturbances/dysguesia
weird adverse effect of amiodarone
“smurf effect” where skin appeared bluish
idiosyncratic effect
a totally unexpected or unrelated reaction. unusual response “we have no idea why”
blood dyscrasias
abnormal or disordered state
ototoxicity…which cranial nerve?
8
dysguesia
foul, salty, rancid, metallic sensation persists
type I/ immediate hypersensitivity reaction
IgE mediated. Mast cells and basophils release histamine etc. in response to antigen. relatively rare. reaction develops rapidly, stronger with repeated exposure
type II/ delayed hypersensitivity
CARPA. pseudoallergy. from mild flushing to severe rxns with bronchospasm, hypotension. reaction on first exposure, can improve/resolve with subsequent exposures
most cutaneous drug rxns are related to…
drug hypersensitivity (drug specific activation of immune response). drug acts as antigen/hapten.
estimated ___% of population are allergic to one or more meds, but ____% think they are allergic due to adverse effects
5%; 15%
how can you determine if pt really has allergy or not?
ask CLARIFYING questions when patients say they have allergies to meds: age, time of reaction, characteristics of reaction, low long after med admin did run begin, what other meds/exposures around same time? what happened when discontinued?
5 classes of meds that comprise majority of all allergic/pseudoallergic reaction reports?
antibiotics and sulfaonamides, NSAIDs/analgesics, contrast media, anticonvulsants, anticoagulants
anaphylaxis
occurs within 30 minutes. Breathing/bronchospasm, rash, swelling, cardiac issues, BP drop, shock. Req. rapid tx for survival. tx = epinephrine (an dyphenylhydramine if have it)
angioedema/urticaria
occurs minutes to days after therapy. symptoms may include mucosal lesion involvement, hives, facial swelling, resp. distress, cardiovascular collapse.
serum sickness
occurs 1-2 weeks after initiation of therapy. delayed onset b/c immune complexes have to form. symptoms: fever, arthralgia (joint pain), and morbilliform lesions
steven-johnson syndrom (SJS)
usually related to sulfa drugs and viral infections, occurs 1-3 weeks after initiation of therapy, symptoms: eruptions, blisters, detachment of
toxic epidermal necrolysis (TEN)
occurs 1-3 weeks after therapy. erosions at 2+ mucosal sites, outer layer of epidermis separating from basal layer, large sheets of necrosis, totally detachment of >30% body surface area, sepsis most common COD.
acute generalized exanthematous pustulosis (AGEP)
“Pustular drug eruption” and “toxic pustuloderma”. sudden eruptions appearing avg 5 days after therapy. many drugs carry this warning.
fixed drug eruption
occurs 30 min- 8 hours after preexposure to drug. swollen lesions, reddening of skin/patches (erythema), darkens to deep purplish color. usually resolve 2-3 weeks after stop tx.
management of anaphylaxis
0.01 ml/kg IM epinephrine 1:1,000. Followed by adjust of diphenhydramine (Benadryl), arrange for rapid transport. Hospitalization or at least 12 hour monitoring.
pharmacokinetic changes associated with geriatrics
- changes in body composition alter distribution of drugs
- hepatic drug metabolism less efficient (increased serum concentrations)
- some degree of renal impairment (excretion probs)
pharmacodynamic changes associated with geriatrics
physical changes in old age may affect responses to drugs. fall risks increased with sedating drugs.
americans over the age of 65 account for ____% of the population, but consume ____% of Rx drugs and ____% of OTC drugs
13%; 30%; 40%
barriers to adherence in elderly population
forgetfulness, side effects, feel meds not needed, difficulty paying for meds, chronic conditions, med-related problems, difficulty with vision/reading instructions, hearing loss (hearing instructions, etc.)
____% medicare beneficiaries not adherent to meds
30%
elderly to age 70 are _____x more likely to experience adverse rxns than young adults and after 70 it increases to ______x more likely.
2-3x; 4-6x
____ of people who die in hospital from adverse reactions are elderly.
1/2
PIMS in elderly
potentially inappropriate medications; includes common meds like ibuprofen or digoxin. Listed in publications like “beers list”, “zhan’s list”, public citizens lists. Screening tools include STOPP and START.
Beer’s list
guide for drugs to avoid in nursing home patients to reduce drug problems. Many drugs have anticholinergic or sedative effects that cause drowsiness, cognitive impairment, increase falls risk.
Zhan’s list
categorizes beers list into “always avoid”, “rarely appropriate”, and “some indications” groups.
STOPP
Screening Tool of Older Persons potentially inappropriate Prescriptions. helps define PIMS and reduce adverse events in elderly.
START
Screening Tool to Alert doctors to Right Treatment. quality of care indicators. situations where meds are indicated.
Public Citizen’s list of PIMS for elderly
lists 136 meds that cause confusion in elderly. includes diphenhydramine (Benadryl), benzos, Detrol for overactive bladder, etc.
drugs and confusion in elderly
a number of drugs cause confusion in elderly pts. If elderly pt confused, sedated, ataxic…check meds. Reduce meds to see if signs/symptoms improve
5 things to question with geriatric patients
feeding tubes, antipsychotics, hemoglobin A1c >7.5% (moderate control better), benzodiazepines, antimicrobials for bacteriuria
team approach to care for elderly
functionality (PT/OT), social environment (social workers), medications (pharmacists/MD)…review all meds for interactions!
“backing off”
less is more approach to drugs in the elderly now favored over aggressive medicating. Reduce med burden to help improve quality of life.
Number of elderly at risk for major drug-drug event _____
doubles. more elderly pts using 5+ drugs, many with the potential for major interactions. Carefully consider meds, interactions, potential for adverse effects
therapeutic orphans
children. b/c little incentive to manufacture kids drugs, FDA doesn’t approve many kids drugs (issues with clinical trials and kids)
only ____% drugs approved have FDA approval to use in kids
25%
FDA regulations for packaging OTC liquid drugs
measuring device must be included, devices and directions should have consistent abbrevs/units, dose devices can’t hold more than max dose, abbreviations should be std and defined.
reasons kids not included in many drugs studies
1) vulnerable populations
2) informed consent issues
children’s medications are dosed by…
weight and age (weight most important)
administration of OTC products to kids…
significant number of caregivers giving improper doses to kids (probe with calculating, measuring, delivering)
Rxs for these kids conditions have increased
diabetes, asthma, ADHA, antihyperlipidemics, hypertension, antidepressants (childhood obesity culprit for most of these)
Rx categories that have declined in kids
allergy meds, cough/cold meds, pain, abx
formularies
list of what drugs are/are not covered for insurance/MCO. Often have PDL (preferred drug lists)…subject to change often! Some drugs require prior approval.
Drug info sources
Pharmacological Basis of Therapeutics (Goodman/Gilman); Physicians Desk Reference; US Pharmacopeia; epocrates.com; medscape.com; MICROMEDEX (free for UT students)
CAM
complementary and alternative medicine (herbal, supplements)
3 compounds intended for human consumption
drugs, food, supplements
difference between supplements and approved drugs?
regulatory status. drugs require safety and efficacy testing; supplements just have to make no health claims and are not proven unsafe.
DSHEA
- amended food, drug, cosmetic act to define supplements, set regulations (no health claims, not unsafe), requires statement that supplements are not FDA regulated/approved. Are allowed to make statements about structure/function of body.
dietary supplement is defined as…
product (other than tobacco) used orally and intended to supplement the diet that bears/contains one or more of the following: a vitamin, mineral, herb/botanical, amino acid, dietary substance to increase total dietary intake, concentrate/metabolite/constituent/extract/combinations.
FDA and supplements
cannot regulate, but can take enforcement actions after drug is on the market. Has new Office of Dietary Supplement Programs.
USP verified mark…
assures that labeling is correct, product doesn’t contain harmful levels of contaminants, product will break down and release in body, and that they used good manufacturing practices (GMP) to make it.
________ should not be considered inactive or benign.
Natural or Herbal supplements
St. John’s wart
MAOI/SSRI properties (antidepressants)…increased risk of serotonin syndrome (mild to severe symptoms, fatal if not treated)
Kava
hepatotoxic (7% of cases required liver transplant)
Ginkgo biloba
inhibits platelet activating factor (don’t use with aspirin/blood thinners)
Commission E
German Regulatory Authority’s herbal watchdog agency. probably best source for info on herbal/supplements.
poison control phone #
1-800-222-1222
drug toxicity in toddlers
1-2 tablets of a drug can kill a toddlers. some more deadly than others.
beta-blockers, Ca2+ channel blockers, clonidine and toddlers
1-2 tablets can be fatal
fatal dose of aspirin in toddlers
at least 6 extra strength tablets (methyl salicylate much more concentrate…1 tsp = 14 XS aspirins)
most common cause of fatal overdose in children
iron. make specific antidote for it. 10 tablets lethal to toddlers. esp important with prenatal vitamins and other iron containing supplements
methods of drug removal from GI tract
syrup of ipecac (not recommended anymore), activated charcoal, gastric lavage (stomach pump), whole bowel irrigation (laxatives)
recommended dose of activated charcoal
25-100grams (depends on body weight) strive for 10:1 charcoal to toxin ratio
what can be used to lower the systemic level of some drugs?
multi-dose activated charcoal (MdAC)
two types of drug tests?
preliminary (highly sensitive) and confirmatory (more specific)
immunoassays for drug testing
RIA, EMIT, FPIA, ELISA
confirmatory testing for drugs
GC/MS (gas chromatography/mass spec)
most used test for drugs
urine. easily obtained and drug concentrations usually relatively high
specimen for drug test that useful for quantitative determinations
blood
specimen for drug test that can be used to roughly gauge time of drug use/regular use
hair (but cannot detect if use occurred within just a couple days of testing).
drug testing often used in detox programs
hair testing
some drugs cause false positives on _______, but its ruled out using _____
screening tests; confirmatory tests
pseudoephedrine shows up on drug tests as…
amphetamines
rifampin or levofloxacin (like cipro) show up on drug tests as…
opiates
poppy seeds contain _____ and _____ and therefore show up on drug tests as _____ when eaten in mass quantities
morphine and codeine; opioids
PPI pantoprazole (Protonix) shows up on drug tests as…
cannabis
Sertaline (Zoloft) shows up on drug tests as…
benzodiazepines
how long after use can you detect amphetamines, heroin, cannabis, or PCP?
amphetamines and heroin: 1-3 days
cannabis or PCP: about a week unless chronic user
niacin (vitamin B3) and drug testing
urban legend that it helps you pass drug tests (increases metabolism of drugs). No evidence of this. Excessive doses can be toxic (c/c “I’m on fire”)
