Midterm Study Guide Flashcards
what are the three branches of federal government?
Legislative, Executive, and Judicial
what comprises the federal legislative branch?
house and senate
what comprises the federal executive branch?
President
what comprises the federal judicial branch?
supreme court
what are the three federal agencies that regulate pharmacy laws?
US congress (house & senate)
DEA
FDA
what are the two main state agencies that regulate pharmacy laws? (for Oregon) where do they incorporate changes in laws?
State legislature: Oregon Revised Statutes (ORS)
Oregon BOP: Oregon Administrative Rules (OAR)
Who grants power to BOP?
State legislature
BOP board members are appointed by who? they are approved by?
governer
senate
BOP reports to?
governer
define liability
responsibility for actions of yourself & others
define Vicarious Liability
employers are responsible for actions of employees
define negligence
is negligence considered a tort?
specifically for a pharmacist, define what it means
failure to behave or perform in the correct way
yes
a legal standard for your behavior as a licensed professional
define malpractice
examples where malpractice can occur in the pharmacy include? (multiple options)
a. counseling someone who is not the patient
b. quality of drug dispensed
c. incorrect drug
d. different NDC of the same drug
e. incorrect quantity or dosage
f. technician counting a controlled substance
g. failure of duty to warn/inadequate counseling
negligence occurring in the practice of professionals
b,c,e,g
what four factors must be proven for legal liability of negligence?
duty owed
breach of duty
causation
damages
explain comparative negligence
plaintiff could’ve avoided the consequences of negligence such as a patient knowingly taking a medication they thought was incorrect
define statute of limitations
time limit when a malpractice claim must be filed
define tort
a civil wrong that unfairly causes someone harm resulting in legal liability
Differences between ORS and OAR:
ORS: signed by governor, changes require vote
OAR: laws passes by state agencies like BOP, written and passed by BOP
what type of lawsuit is criminal?
a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee
a
what type of lawsuit is civil?
a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee
b
what type of lawsuit is administrative?
a. government (the people) vs. person
b. person vs. person
c. agency vs. licensee
c
define burden of proof
requirements for criminal, civil, and administrative cases?
level of evidence required to prove charges
criminal: beyond a reasonable doubt
civil: preponderance of evidence (50% chance claim is true)
administrative: preponderance of evidence (50% chance claim is true)
what is the purpose of antitrust laws?
protect consumers from predatory business practices and ensure fair competition
what was the Sherman Antitrust Act?
what was the main goal?
Prohibits competitors from entering into agreements that inhibit competition
help markets remain competitive and keep prices low via competition
what was the Robinson-Patman Act?
prevent discriminatory pricing to similar competitors
what main impact did the Pure Food and Drug Act have on patient health & safety
what was its flaw?
Protect public from adulterated & misbranded food & drugs
had no regulation of drug safety
what main impact did the Food Drug and Cosmetic Act have on patient health & safety
FDA regulates safety of products
what was the main impact of the Durham-Humphrey Amendment to the Food Drug and Cosmetic Act?
establishment of OTC category of drugs (created two categories of drugs: prescription and OTC)
what was the main impact of the Kefauver-Harris Amendment to the Food Drug and Cosmetic Act?
required proof of safety and efficacy and established GMPs
what was the main impact of the Orphan Drug Act to the Food Drug and Cosmetic Act?
created incentives to manufacture drugs for diseases affecting a small population of Americans
what was the main impact of the Waxman-Hatch Amendment (aka Drug Price Competition and Patent-Term Restoration Act) to the Food Drug and Cosmetic Act?
accelerated the generic drug approval process
what was the main impact of the Prescription Drug User Fee Act (PDUFA) to the Food Drug and Cosmetic Act?
drug manufacturers pay fees for product applications to fund FDA reviewers and speed up review/approval
what was the main impact of the Dietary Supplement Health & Education Act (DSHEA) to the Food Drug and Cosmetic Act?
- establish specific labeling requirements
- authorize FDA to pass GMP regulations for dietary supps.
- manufacturer is responsible for dietary supp. safety before marketing (FDA approval not required)
what was the main impact of the Food and Drug Administration Modernization Act (FDAMA) to the Food Drug and Cosmetic Act?
fast-track drug approval for serious diseases and regulate advertising of approved drugs & devices
what was the main impact of the Food and Drug Administration Amendments Act (FDAAA) to the Food Drug and Cosmetic Act?
- Expanded PDUFA
- Expanded FDA authority to mandate label changes, req. clinical trial data reporting, and req. post market clinical studies
what was the main impact of the Drug Quality & Security Act to the Food Drug and Cosmetic Act?
-regulated compounding and drug supply chain
Class I recall:
could cause serious health problems or death
Class II recall:
might cause temporary health problems
Class III recall:
unlikely to cause adverse reactions, but violate FDA labeling/manufacturing laws
what is MedWatch?
FDA program to report drugs/products
Is reporting on MedWatch a responsibility of pharmacists & physicians?
Patients?
Yes
No, voluntary
What is VAERS?
Vaccine Adverse Event Reporting Systems
Which of the following is NOT considered adulteration of a drug?
a. If it consists in whole or in part of any filthy, putrid or decomposed substance
b. If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health
c. If it has been tampered with and intentionally altered by a third-party post-marketing
d. If the strength differs, or quality or purity fall below label standards
c
misbranding of a drug occurs when?
the label is false or misleading
Risk Evaluation & Management Strategies (REMS):
uses risk minimization strategies to ensure benefits outweigh risks of prescription drugs
for class III and IV prescriptions, what is the maximum number of refills allowed on one prescription? How long does the prescription last? how many times can they be transferred from pharmacy-pharmacy?
5 refills
6 months from issue date
once
what is the form 222 used for?
ordering controlled substances
what is CSOS?
DEA Controlled-Substance Ordering System
During July 1 - June 30 of each biennial licensing cycle, pharmacist must complete what for their continuing education?
3 continuing pharmacy education cred`its
During July 1 - June 30 of each biennial licensing cycle, COPhT must complete what for their continuing education?
20 continuing pharmacy education hours
Pharmacy technician:
how long does license last?
can it be renewed?
2 years
no
Certified Oregon Pharmacy Technician:
how long does license last?
can it be renewed?
what is required to become certified?
2 years
yes
passing nation certification exam
what is the mission statement of the BOP?
to promote, preserve, and protect public health, safety, and welfare by ensuring high standards in the practice of pharmacy and by regulating the quality, manufacture, sale, and distribution of drugs
once the board finds licensee guilty of violation, what are the different repercussions they can invoke?
Civil penalties/fines (limits in ORS) Probation (time-limited) Suspension (time-limited) Conditions (time-limited) Revocation (permanent, almost)
who/how many of whom comprise the BOP?
5 pharmacists, 2 licensed pharmacy technicians, and 2 public members (are not a spouse, partner, child, parent or sibling of a pharmacist)
what are the three licensing exams?
NAPLEX
MPJE
FPGEE
what manages the licensing exams?
National Association of Boards of Pharmacy (NABP)
what is Category 1 compounding?
risk level?
non-sterile, simple (not compounding)
ex. adding water to make a suspension
zero
what is Category 2 compounding?
risk level?
non-sterile, complex
ex. making a solution by mixing certain amounts of ingredients
zero
what is Category 3 compounding?
risk level?
low risk, sterile, up to 3 sterile ingredients combined
risk level I
what is Category 4 compounding?
risk level?
medium risk, sterile, more than 3 sterile ingredients combined
risk level II
what is Category 5 compounding?
risk level?
high risk, non-sterile ingredients combined then sterilized
risk level III
OAR 855-006 Definition of Interpretation and evaluation of prescription orders
review of the order for therapeutic and legal correctness
OAR 855-006 Definition of oral counseling
communication process b/w pharmacist and patient to gain info from patient to give them advice for safe and effective use of the prescription drug
OAR 855-006 Definition of drug utilization review
evaluating a prescription drug order based on information from patient and patient’s record to identify potential problems
what information is in USP Chapter 795?
pharmaceutical compounding of non-sterile preparations
what information is in USP Chapter 797?
pharmaceutical compounding of sterile preparations
what information is in USP Chapter 800?
provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment
what was the poison prevention packaging act?
requires child resistant packaging for OTC and prescription meds
what is the purple book?
FDA approved list of drugs determined to be biosimilar or interchangeable
what dose of methadone is for opioid use disorder?
any licensed pharmacy can dispense methadone, but only for what use?
can a pharmacy dispense 40mg?
40mg
analgesic purposes
no
what was the main impact of the Drug Supply Chain Security Act to the Food Drug and Cosmetic Act?
Requires records for all prescription drug sales
