Go Off, King Flashcards
What information would you find in the Drug Abuse and Dependence section of the package insert?
-med’s schedule classification, abuse and tolerance potential, if it’s a controlled substance
What information would you find in the Overdosage section of the package insert?
-signs, symptoms, and treatment options for an overdose
What information would you find in the product description section of the package insert?
-chemical name, structure, inactive ingredients
What information would you find in the clinical pharmacology section of the package insert?
-how it works, absorbed, and metabolized (explanations of various studies)
What information would you find in the nonclinical toxicology section of the package insert?
-cancer risks and effects on fertility
What information would you find in the clinical studies section of the package insert?
-information about how the drug works
What information would you find in the How Supplied section of the package insert?
-all the dosage forms, colors, shapes, markings, special storage rules
What information would you find in the Patient Counseling section of the package insert?
-the most important patient counseling points
What information would you find in the Contraindications section of the package insert?
-when a drug shouldn’t be used
What information would you find in the Drug Interactions section of the package insert?
-if a drug shouldn’t be used with another med
What information would you find in the Adverse reactions section of the package insert?
-what side effects it causes (constipation)
What information can you find in the Indications and Usage section of the package insert?
-what diseases/conditions the drug has been approved to treat
What information can you find in the Dosage and Administration section of the package insert?
- what drug dose to use for certain patients
- provides special dosing schedules and administration requirements
What information can you find in the Use in Specific Populations section of the package insert?
-safety concerns when using during pregnancy
What does the OrangeBook list?
-which generics are equivalent to which drugs
What do therapeutic equivalents have?
-identical active ingredients, strength, dosage forms, absorption, and release
A rating code is made of how many letters?
2
In a rating code, what are the options for the first letter and what do they mean?
- A= therapeutic equivalent
- B= not a therapeutic equivalent
In a rating code, what does the second letter demonstrate?
dosage form
What is the most common rating code?
AB
What is a benefit of Facts and Comparisons eAnswers?
you can do side by side comparisons of drugs
What is the downfall of Facts and Comparisons eAnswers?
it’s outdated
True or False: Prescriber’s Digital Preference log is no longer published
true
The USP-NF contains what information?
defines the standards of meds, dosage forms, drug substances, inactive ingredients
The handbook on injectable drugs is also called what?
Trissel’s
Trissel’s provides info on what?
If two parenteral drugs can be administered together
In rating codes, what do the letters A, N, P, and T mean when they are the second letter?
A= oral N= aerolization P= injectable T= topical
The FDA is a subset of which government department?
Health and Human Services
What is the FDA responsible for?
approval of Rx and OTC meds, labeling, and drug manufacturing standards
What is the CDC responsible for?
providing regulation for infection control, publishing the requirements for vaccines and national health issues
What is the DEA responsible for?
enforcing laws and regulations for controlled substances and illegal drugs, and requirements for dispensing and refilling controlled substances
What was the result of the Food and Drug Cosmetic Act of 1938?
before selling, manufacturers have to prove a drug’s purity, strength, and safety
What was the result of the Pure Food and Drug Act of 1906?
prohibited manufacturers from misbranding (false labeling) and adultering meds (contaminated)
What act created 2 classes of medications?
Duraham-Humphrey Act of 1951
What act led to us using child-resistant packaging on most meds?
Poison Prevention Packaging Act of 1970
True or False: sublingual nitroglycerin requires childproof packaging
false
True or False: oral contraceptives and hormonal treatments don’t require childproof packaging because of their memory aid packaging
True
Do inhalers require childproof packaging?
No
PPPA Act of 1970 says what about childproof packaging?
it can be opened by 90% of adults but not by 80% of kids younger than 5
When did the FDA start requiring package inserts?
1970
In an outpatient pharmacy, info has to be dispensed how frequently?
before every refill
In an inpatient pharmacy, info has to be dispensed how frequently?
before the first dose and once every 30 days
What does NDC stand for?
National Drug Code
NDCs are how many digits?
10
The first three digits of the NDC are what?
The Labeler Code: Manufacturer or Distributor
The middle three digits of the NDC are what?
The Product code: name, strength, and dosage form
The last three digits of the NDC are what?
Package code: size and type of packaging
How do the amount of digits in an NDC section vary?
Labeler= 4/5 product= 3/4 package= 1/2
The Drug Price Competition and Patent Term Act of 1984 is also called what?
the Hatch-Waxman Act
What was the result of the Hatch-Waxman Act?
- abbreviated new drug applications (ANDA) for generic meds
- still must prove generic is safe, effective, and performs like name brand
The Omnibus Budget Reconciliation Act of 1990 (OBRA 90) resulted in what?
-requires pharmacists to discuss info about meds with patients
Most dietary supplements are not considered drugs, but are considered what?
vitamins, minerals, and herbs
When did the FDA begin requiring solid oral dosage forms to have marking/imprints on the product?
1995
What governs the sharing of private information?
HIPPA
What are the three main rules of HIPPA?
- protect patient info
- use and disclose only the necessary amount of protected info
- patients have rights to approve who can access or use their medical info
Name, DOB, address, phone number, medical record, insurance info, etc. are all part of what?
Protected Health Info (PHI)
A handout with information on a medication’s significant risks is called what?
Medguide
Medguides are for what kinds of drugs?
Ones that pose the most serious public health risks
Who protects health, safety, and welfare of patients by setting laws specific to practice of pharmacy?
Board of Pharmacy
Who’s pharmacy laws are normally stricter: federal or state?
state
How many steps are in the drug approval process?
4
What is the first step in the drug approval process?
creation and study: drugs are identified as drugs or biologics
What is the second step in the drug approval process?
preclinical testing: animal trials to determine if safe and effective
What is the third step in the drug approval process?
clinical testing: investigational new drug (IND) application filed with the FDA
-once approved, INDs go through 3 phases
What is the fourth step in the drug approval process?
FDA approval: if a drug proves safe and effective in all three phases the drug manufacturer can apply for a new drug application (NDA)
-can take months or even years
What does the Institutional Review Board (IRB) do?
reviews and approves research within human subjects
What is the role of the drug sponsor in research?
providing funding to support the research
What is the role of the principal investigator in research?
who wants to conduct the study and who is responsible and accountable for the study implementation
Why would a drug be recalled?
it causes or could potentially cause adverse events
What is a class 1 recall?
likely to cause serious adverse events or death
What is a class 2 recall?
likely to cause temporary, but reversible side effects
What is a class 3 recall?
unlikely to cause adverse effects
ex: mislabeled count on bottles
Recalls are not equal to what?
Market Withdrawals
Market Withdrawals can’t return without what?
FDA approval
When a new drug is created, is has a patented brand name with exclusive rights for how long?
20 years
When a generic comes out after a 20 year patent, it has to be what?
pharmaceutically equivalent
What does it mean to be pharmaceutically equivalent?
same active ingredients, strength, dosage form, rout of administration
Therapeutic equivalents are what two things?
Pharmaceutically equivalent and bioequivalent
What does it mean to be bioequivalent?
it is absorbed and released in the body the same way
An authorized generic is identical to what?
the brand name
What does it mean when there is a number after the TE rating code?
meds with the same active ingredient are therapeutically equivalent to different brand name drugs
A pharmacological alternative has what?
The same active ingredients, but different strength and dosage forms
A therapeutic alternative has what?
similar product, but different active ingredients
Is a therapeutic equivalent the same as a therapeutic alternative?
Nah
What would be a therapeutic alternative of Motrin 800 mg tablets?
naproxen 500 mg tablets
What would be a pharmacologic alternative of Motrin 800 mg tablets?
Motrin 400 mg tablets
What is another name for automatic substitution in hospitals?
Formulary
Outpatient pharmacies have to call the prescriber for what?
Substitution authorization
What does DAW stand for?
Dispense As Written
Define DAW 0
No product selection preferred
-okay to substitute
Define DAW 1
Substitution is NOT allowed
Define DAW 2
Substitution is allowed
-patient requests brand
Define DAW 7
Substitution is NOT allowed
-mandated by state law
Define DAW 3
pharmacist decides that brand name product is to be dispensed
Define DAW 4
substitution is allowed, but generic is not in stock
Define DAW 5
Substitution is allowed, but the brand is dispensed as the generic
Define DAW 6
override is required (rare)
Define DAW 8
substitution is allowed, but the generic is not available in the marketplace
Define DAW 9
OTHER
DAW codes tell the insurance provider what?
if a special circumstance exists that affects product selection for the prescription
The Controlled Substances Act was created to do what?
define and regulate controlled substances
Who governs the Controlled Substances Act?
DEA
How many schedules are there?
5
Cardio means what?
Heart
Vas, Vado means what?
Blood vessel
What schedule is the most dangerous? Least dangerous?
1 = most, 5 = least
Schedule 2 substances are mostly what?
opioids and stimulants
True or False: Physician Assistants, Nurse Practitioners, and optometrists can write controlled substance prescriptions
false (SOME states)
What is required for a prescriber to write a controlled substance prescription?
DEA number
A DEA number has how many characters?
9
What does UIN stand for?
Unique Identification Number
What is the first letter of a pharmacy’s DEA number?
B
What are the things prescriptions must include?
- date of issue
- patient’s full name
- patient’s address
- prescriber’s name
- prescriber’s address
- prescriber DEA number
- drug name
- dosage form
- quantity
- directions
- number of refills
True or False: schedule 2 substances cannot be called or faxed in
true
the feds require pharmacies to complete a controlled substance inventory how often?
every 2 years from date of first inventory
How long does federal law require pharmacies to keep inventory records?
2 years
Partial fills for c2 substances is allowed, but the rest must be filled within how much time?
72 hours
How many forms come with DEA form 222?
3
What are the three forms of the 222?
1st- supplier’s copy
2nd- DEA’s copy
3rd- pharmacy copy
How long does a 222 form need to be saved?
2 years
When drugs expire, where are they sent?
DEA registered collector
Wasting requires how many signatures?
2
Who are the 2 signees of wasting?
- one destroying the med
- the witness
The pharmacy must submit what form to document destruction?
DEA form 41
What from is sent in when reporting theft?
DEA Form 106
How much pseudoephedrine can be sold?
3.6 grams a day, 9 grams over 30 days
Isotretinoin treats what?
Severe acne
Isotretinoin is what?
teratogenic
Isotretinoin is very dangerous to who?
pregnant women
What program gives a “do not dispense to patient after” date regarding isotretinoin?
IPLEDGE
Lotronex (alosetron) is used for what?
IBS
What are some side effects of Lotronex?
Ischemic colitis, complications from constipation
Clozapine is used to treat what?
mental disorders
Clozapine can cause what?
agranulocytosis (don’t make enough white blood cells)
REMS program is required for what?
transmucosal fentanyl
Cardio means what?
Heart
Vas/Vado means what?
Blood vessel
Vasodilators are what?
Drugs that cause the blood vessels to dilate or open to increase blood flow
The suffix -emia means what?
Substances in the blood
What does hem, hema mean?
Blood
What does thromb mean?
Blood clot
What does nephr mean?
Kidney
What does hepat mean?
Liver
What does gastro mean?
Stomach
What does thry mean?
Thyroid
What does derm?
Skin
What does osteo mean?
Bone
What does psych mean?
Mind
What does pulmo mean?
Lungs
What does bronch mean?
Bronchus
Oculo
Eye
Opthalm
Eyes
Oti
Ear
Gyne
Woman
Andro
Male
Chemo
Chemical
Ferro
Iron
Pyro
Heat
Hypno
Sleep
-mimetic
Mimicking
A (an)
Without
Hyper
Excessive
Hypo
Beneath
Auto
Self
Carcin
Cancer
Photo
Light
-itis
Inflammation
-rrhagia, rrhage, rrhea
Discharge, flowing
The sig is what?
The directions
The “disp” is what?
Quantity dispensed
What does “p” mean on a prescription?
After
What dues “c” mean in a prescription?
With
CM
With meals
AC
Before meals
PC
After meals
AM
Morning
PM
Afternoon
HS
At bedtime
Stat
At once
What does “d” mean on a prescription?
Day
What does “h” mean on a prescription?
Hour
aa
Affected area
PO
By mouth
en
Each nostril
SL
Sublingual
pr
Per rectum
IV
Intravenous
IVPB
Iv piggyback
IM
Intramuscular
SC, SubQ
Subcutaneous
AU
Both ears
ad
Right ear
as
Left ear
OU
Both eyes
OD
Right eye
OS
Left eye
IN
Intranasal
What does “Q” mean on a prescription?
Every
QD
Every day
QAM
Every morning
QPM
Every evening
QHS
Every bedtime
Q4h
Every 4 hours
QOD
Every other day
bid
2 times daily
tid
3 times daily
qid
Four times daily
nr
No refills
prn
As needed
uad, ud, ut dict
As directed
w,wk
Weekly
dtd
Dispense such doses
qs
Quantity sufficient
ss
One half
U
Unit
IU
International unit
APAP
Acetaminophen
ASA
Aspirin
FE
Iron
K
Potassium
Na
Sodium
HCL
Hydrochloride
MSO4
Morphine sulfate
MgSO4
Magnesium sulfate
ZnSO4
Zinc sulfate
PEN/PCN
Penicillin
TCN
Tetracycline
TMP/SMX
Trimethoprim sulfamethoxazole
IV vanc
Vancomycin
HCTZ
Hydrochlorithiazide
NTG
Nitroglycerin
D5W
Dextrose 5% in water
LR
Lactated ringers
NS
Normal saline
What is a near miss?
An error that happened but didn’t reach the patient
What are the five rights?
right: drug, dose, patient, time, instructions
A safety data sheet communicates what?
storing and manipulating hazardous materials
What gives employees the right to know and understand safety data sheets?
OSHA’s Hazard Communication Standard
Exposure documentation must be kept on file for how long?
30 years
Solid drugs are measured by what?
Weight
Liquid drugs are measured by what?
volume
How many grains are in a dram?
60
About how many mg in a grain?
60/65
Infants are dosed how frequently?
12-24 hours
Dosing for children is always done in what?
mg/kg
Subcutaneous injections are done where?
fat tissue
Milliequivalents (mEq) express what?
the concentration of electrolytes in a solution
“Units” are used for what?
Insulin, heparin, some vitamins
True or false: capsules contain preservatives
true
What does MCT stand for?
Multiple compressed tablets
What part of the package insert will say if the tablet can be divided?
Dosage and Administration
What does ODT stand for?
orally disintegrating tablets
What is a benefit of sublingual tablets and strips?
it avoids the stomach acids
A solute is what?
something completely dissolved in a solvent
adding water or another diluent to a powder at the time of dispensing is known as what?
Reconstituting
After reconstituting, antibiotic solutions are good for how long?
14 days
Do solutions or suspensions require a shake well label?
suspensions
A clear, sweetened, flavor combination of water and alcohol are known as what?
elixirs
Concentrated solutions of sugar in water are known as what?
syrup
Alcoholic or hydro alcoholic solutions or volatile substances are known as what?
spirits
Spirits are stored in what?
tight, light-resistant containers
What are tinctures?
alcoholic/hydroalcholic solutions prepared from vegetable extracts
Substances in which medication particles are not completely dissolved in a liquid are called what?
suspension
What is a solution?
preparations in which the solid ingredients of medications are dissolved in a liquid
Oil-based, greasy preparations that are good for dry and scaly areas are what?
ointments
Semi-solid emulsions that contain a combo of water, oil, active drug ingredients, as well as other substances are called what?
creams
Creams are better for what?
Weeping or oozing
Lotions are similar to creams, but they contain more what?
water
lotions are better for what?
hairy parts
semisolid preparations that contain small, solid particles suspended in a liquid are what?
gels
What is a highly flammable mixture where the active ingredient is dissolved in alcohol and ether?
collodion
What is a liquid mixture of various substances in an oil, emulsion, or alcoholic solution of soap?
liniments
What provides a protective layer over the area of the skin?
paste
What is the fingertip unit?
- 5g (enough to cover bother sides of an adult hand)
- 3= 1 adult arm
- 2= 1 adult foot
- 6= one adult leg
With a transdermal patch, the drug is delivered where?
through the skin
True or false: ophthalmics need to be sterile, but otics don’t
true
How many types of inhalers are there?
3
What is an MDI?
meter-dosed inhaler
What is an SMI?
soft-mist inhaler
What is a DPI?
dry powdered inhalers
An HFA is what?
A propellant used in most MDIs
What does an SMI use to aerosolize the drug?
a spring
What does a DPI use to aerosolize the drug?
the patient’s breath
Which inhalers need to be primed before use?
MDI and SMI