Exam 1 All Material (not done lol)

sigh

name the four elements of malpractice

duty of care

breach of duty

causation

damages

T or F:

if any of the four elements CANNOT be proven, the the malpractice claim will likely fail

T

what is contributory negligence

0% or 100% at fault

what type of negligence does this describe:

even if the doctor was negligent, the pt may lose their claim if they are even 1% partially at fault

contributory

what is comparative negligence

instead of losing everything, the damages are reduced by the patients percentage of blame

what is the statute of limitations

lawsuits must be filed within 1 year of the negligent act or its discovery

what is vicarious liability

basically suing the employer and the staff member for the harm

actual compensatory damages include

medical expenses

lost wages

pain and suffering

emotional distress

punitive damages descriiption

where the defendant was willingly negligent, malicious, or egregious

meant to punish the defendant and is limited by law

can be awarded on top of compensatory damages

what are nominal damages

small monetary award

a dollar

symbolic

Hooks Super X vs. McLaughlin:

Pt was given hella tablets and became suicidal, family sued.

what was the ruling?

court ruled that the pharmacist is not a pill counter, they must intervene when a customer is misusing a medication

Hooks Super X vs. McLaughlin:

Pt was given hella tablets and became suicidal, family sued.

court ruled that the pharmacist is not a pill counter, they must intervene when a customer is misusing a medication

what was the impact?

pharmacist has the duty to monitor pt medication use

pharmacist has the duty to refuse to fill or refill if they can prevent foreseeable harm

morgan v walmart:

child given med and developed super rare ADE, family used for negligence bc they were not warned

rulilng?

court said that the pharmacist duty was to fill the prescription, not warn of SE as that is the physicians duty

morgan v walmart:

child given med and developed super rare ADE, family used for negligence bc they were not warned

court said that the pharmacist duty was to fill the prescription, not warn of SE as that is the physicians duty

impact?

established the duty to warn pts of risks belongs to the physician not the pharmacist

pharmacists do not have the general duty to warn pts of potential ADE

Horner v Spalitto:

man prescribed 2 CNS depressants; pharmacist contacted prescriber that said it was chill; pharmacist filled meds; pt died

ruling?

in favor of pt

calling the physician and documenting that they said it was fine is not protection for the pharmacist

Horner v Spalitto:

man prescribed 2 CNS depressants; pharmacist contacted prescriber that said it was chill; pharmacist filled meds; pt died

ruled in favor of the pt bc in favor of pt bc calling the physician and documenting that they said it was fine is not protection for the pharmacist

impact?

pharmacist has the duty to refuse to fill, clarify, warn family, exercise judgment

pharmacist cannot solely rely on the prescriber

if harm is foreseeable, act reasonably

assumption of duty in LA

If a person undertakes a task that he otherwise has no duty to perform, he must perform the task in a reasonable or prudent manner

Baker Vs Arbor Drugs:

pt taking meds, prescribed drug that flagged potential fatal drug reaction, technician (likely, we dont know) ignored the warning; pt had stroke then committed suicide

ruling?

pharmacy was not legally required to monitor for drug interactions but they had a computer system that did it anyway so they had the assumption of duty to warn the pt

pharmacy found negligent

Whiting v Rite Aid

pharmacist gave bad advice to wife of pt over the phone, pt suffered; pt family sued for negligent advice on OTC med

ruling?

ruled in favor of the pt

the learned intermediary doctrine does not protect the pharmacist from making affirmative statements about OTC products

Whiting v Rite Aid

pharmacist gave bad advice to wife of pt over the phone, pt suffered; pt family sued for negligent advice on OTC med

ruled in favor of the pt

the learned intermediary doctrine does not protect the pharmacist from making affirmative statements about OTC products

impact?

pharmacist can be sued over bad advice on OTC drugs if they fail to give appropriate advice or if they volunteered to counsel

Riveria Case:
girl had epilepsy and had med covered by insurance for years; med now requires PA; pharmacy requested PA and while waiting on it pt died from seizure

ruling and impact?

pharmacist has the duty to contact for PA

pharmacist does not have the duty to follow up on a PA

Harco Drugs v Holloway:

pharmacy documents errors for quality control; pt suffered error and requested records; couldn’t get them bc they were for quality control

ruling?

allowed for punitive damages against the pharmacy

placing employees in position with high potential for error without proper supervision is bad

Harco Drugs v Holloway:

pharmacy documents errors for quality control; pt suffered error and requested records; couldn’t get them bc they were for quality control

allowed for punitive damages against the pharmacy

placing employees in position with high potential for error without proper supervision is bad

impact?

put higher responsibility on pharmacy mgmt to ensure safety

5 C’s of risk mgmt

correct

complete

concise

consistent

cautious

Terry paul Smith:

pt med was given with the wrong directions; pt spouse denied counseling offer; pt died bc they took too many pills (followed incorrect directions on the label)

ruling?

pharmacist liable due to duty of care, should have verified the incorrect sig

Terry paul Smith:

pt med was given with the wrong directions; pt spouse denied counseling offer; pt died bc they took too many pills (followed incorrect directions on the label)

pharmacist liable due to duty of care, should have verified the incorrect sig

impact?

pharmacists have final say, not techs

design defects

product is bad from the get go

even if manufactured and labeled right

manufacturing defect

drug design is good

manufacturing error (production, packaging, sterility, dosing)

warning defects

drug design is good

manufacturing is good

missing warning label

DioGiovanni V albertsons:

pt taking med and then prescribed one that can increase levels and lead to toxicity; pharmacist called physician and physician said it chill; pt died

ruling?

pharmacist was not liable for death and did not have the duty to warn the pt of the interaction due to learned intermediary doctrine

DioGiovanni V albertsons:

pt taking med and then prescribed one that can increase levels and lead to toxicity; pharmacist called physician and physician said it chill; pt died

pharmacist was not liable for death and did not have the duty to warn the pt of the interaction due to learned intermediary doctrine

impact?

pharmacist is not required to warn pt for every interaction

Smith V CVS:

pt on two meds and when combo they lead to reanl failure; pt developed renal failure, sued CVS

ruling?

pharmacy malpractice does not equal medical malpractice

pharmacists are not considered qualified health care providers

Smith V CVS:

pt on two meds and when combo they lead to reanl failure; pt developed renal failure, sued CVS

pharmacy malpractice does not equal medical malpractice

pharmacists are not considered qualified health care providers

impact?

pharmacists are treated differently than physicians for malpractice classification purposes

Even though pharmacists are healthcare providers, they are not protected under LMMA

Pharmaists have greater financial risks

Hollier v Brookshires:

pharmacist called doc over dosing error, doc said it chill, med was dispensed; pt was harmed and family sued the pharmacy

ruling?

calling the physician does not protect you

if there is an obvious error pharmacist has the duty to refuse to fill

Hollier v Brookshires:

pharmacist called doc over dosing error, doc said it chill, med was dispensed; pt was harmed and family sued the pharmacy

calling the physician does not protect you

if there is an obvious error pharmacist has the duty to refuse to fill

impact?

pharmacies has own duty of care

calling physician is not legal immunity

most malpractice claims are (cost)

under 50k

which type of retail pharmacy is sued more?

independent

which type of institution is sued more?

compounding

what is the most likely error to be sued over?

wrong drug

importation of drug law of 1848:

purpose

prevent low quality imported drugs from entering the US

importation of drug law of 1848:

requirements

inspection of imported drugs

enforced by customs

importation of drug law of 1848:

limitations

only applied to imported drugs

did not regulate domestic manufacturing

Butter v Margarine act of 1886:
purpose

attempt to protect consumers via labeling laws

Pure food and Drug Act of 1906

purpose

reduce the risk to the public

reduce misbranding of ingredients

reduce false claims

set purity standards

Pure Food and Drug Act of 1906:

what did it ban?

manufacture or sale of food, drinks or drugs containing poisonous ingredients

Pure Food and Drug Act of 1906:

requirements

must have accurate labeling

Pure Food and Drug Act of 1906:

government oversight

gave USDA power to inspect products and seize misbranded items

Pure Food and Drug Act of 1906:

accomplishments/ what is actually did

manufacturers stopped listing ingredients (lowekenuinley did not work lol)

Pure Food and Drug Act of 1906:

limitations

wording only allowed for regulation on misbranding not false claims

did not regulate cosmetics or medical devices

1912 amendment to the Pure Food and Drug Act of 1906:

why was it needed?

US v Johnson case

1912 amendment to the Pure Food and Drug Act of 1906:

was needed due to the US vs Johnson case. Johnson company selling a product claimed to cure dx. They argued that stopping the claims is a violation of freedom of speech.

what was the ruling?

the Pure Food and Drug Act of 1906 did not apply to false claims about drug effectivness

only regulates labeling not if the drug actually works

1912 amendment to the Pure Food and Drug Act of 1906:

was needed due to the US vs Johnson case, tell me about the case

1912 amendment to the Pure Food and Drug Act of 1906:

what did it do?

prohibited false or fraudulent efficacy claims

1912 amendment to the Pure Food and Drug Act of 1906:

limitations

burden of proof for efficacy was on the government

in 1930, what major event happened?

FDA was founded

In 1957 the sulfanilamide tragedy occurred:

this directly led to…

FDCA act of 1938

Food, Drug, Cosmetic Act of 1938:

why was it passed?

sulfanilamide tragedy of 1937

increasing drug abuse and misuse

Food, Drug, Cosmetic Act of 1938:

what did it define?

what a new drug is

how new drugs are approved for human use

Food, Drug, Cosmetic Act of 1938:

defined a new drug as…

any drug that has not been proven safe and effective

manufacturers must submit data to the FDA before marketing

Food, Drug, Cosmetic Act of 1938:

how was the process for new drug approval for human use defined?

must complete a NDA to the FDA before selling it

drug had to be proven safe before marketing

what is included in an NDA

safety data

manufacturing info

labeling info

which act eventually led to good manufacturing practices?

Food, Drug, and Cosmetic act of 1938

Food, Drug, Cosmetic Act of 1938:

covers…

drugs

medical devices

cosmetics

Food, Drug, Cosmetic Act of 1938:

limitations

loophole for current products

only had to document safety

created Rx only class of medication

application to intrastate commerce only

Durham -Humphrey Amendment of 1951:

what did it do?

clarified how rx work

formal separation bt rx and OTC

rx can only be dispensed when ordered by authorized person

written and oral prescriptions are allowed

refills must be authorized

physicians can dispense directly to pt

Durham -Humphrey Amendment of 1951:

what was the labeling requirement

“Caution: Federal law prohibits dispensing without a prescription”

Kefauver Harris Amendment of 1962:

why was it passed?

thalidomide tragedy

Kefauver Harris Amendment of 1962:

requirements

extensive testing before human use

IND

NDA after human clinical trials

efficacy must be proven

informed consent

side effects must be reported

good manufacturing processes

Kefauver Harris Amendment of 1962:

what testing is required before human testing?

animal testing

pharmacological studies

toxicology testing

Medical Device Act of 1976:

what did it do?

classified medical devices

Medical Device Act of 1976:

how did they classifiy medical devices?

§  Specific function

§  Performance standards

§  Pre market approval requirements

§  Conformance with GMP standards

§  Adherence to record and reporting requirements

in 1980, the FDA became part of…

department of health and human services (where it current still is)

how are FDA commissioners chosen?

Appointed by the president and confirmed by the senate

what do FDA commissioners do/ regulate?

Drug approval

Food safety

Biologics

Medical devices

Tobacco regulation

Orphan Drug Act 1983:

why was it passed?

companies were not making drugs for rare dx

Orphan Drug Act 1983:

what did it do?

Provided tax incentives for research and development

Licensure incentives

Extended market exclusivity

Drug Price Competition and Patent Term Restoration Act of 1984 / Hatch Waman Act:

why was it passed?

wanted to encourage generic competition

want to protect innovation for brand drugs

what is a ANDA

Abbreviated New Drug Application

used by generic manufacturers

ANDA requirements

proof of:

Bioequivalence

Same active ingredient

Same dosage form

Same strength

Drug Price Competition and Patent Term Restoration Act of 1984 / Hatch Waman Act:

what did it do?

Extend patent life for some drugs

made it easier for generics to be made

Prescription Drug Marketing act of 1987:

why was it passed?

black market

Prescription Drug Marketing act of 1987:

what did it require?

Tracking of samples for states and wholesalers

Prescription Drug Marketing act of 1987:

what did it prohibit?

hospitals from selling their stocks

reimportation of prescription drugs

Nutrition Labeling and Education act of 1990:

why was it passed?

Bc ppl were making food claims that were not regulated

Nutrition Labeling and Education act of 1990:

what did it do

Allowed regulation of food claims

Supported food claims

Gave FDA power to regulate them

Prescription Drug User Fee Act of 1992:

why was it passed?

Approval was getting slow from the FDA

Made drug companies pay fees to the FDA to support review process

Prescription Drug User Fee Act of 1992:

what did it do?

Decreased time to market new drugs

Benefits large companies

Fees can be waived

Dietary and Supplement Heath Education Act of 1994:

why was it passed?

Wanted to limit FDA control over dietary supplements

Dietary and Supplement Heath Education Act of 1994:

what did it do?

Defined dietary supplements

Made the FDA not regulate supplements as drugs

FDA can only take action if the supplement is shown to be unsafe

required labeling specifics of supplements

Dietary and Supplement Heath Education Act of 1994:

labeling requirements

supplement labeling cannot claim to diagnose, treat, cure, or prevent dx

they can make structure and function claims though

FDA Modernization act of 1997:

purpose

Intended to improve FDA approval process and support drug development

FDA Modernization act of 1997:

what did it do?

Encouraged pediatric trials

Created federal guidance for compounding

created specific rules for compounding PET drugs

national Institutes of Health (NIH) was required to create a system listing clinical trials for serious diseases

FDA Modernization act of 1997:

labeling changes

“Caution: Federal law prohibits dispensing without a prescription.” was changed to: “Rx only.”

Did away with “may be habit forming label”

Disseminated off label usage (what does that even mean)

Food and Drug Administration Amendment Act of 2007:

purpose

expanded the FDA’s authority to monitor drug safety after approval

Food and Drug Administration Amendment Act of 2007:

what did it do?

reinstated PDUFA

more authority

REMS programs

Family Smoking Prevention act of 2009:

purpose

FDA authority to regulate tobacco products.

(Manufacturing, distribution, and marketing)

Family Smoking Prevention act of 2009:

what did it do

tobacco products must include specific warning labels and images about health risks.

banned most flavorings in cigarettes (not menthol)

grandfathered in products before 2007

Patient Protection and Affordable care Act of 2010:

idk what this man wants from me, tell me two important cases that relate to this

o   Burwell v. Hobby Lobby: The Court ruled that closely held private companies could refuse to cover certain medications (such as some contraceptives) if doing so conflicted with the owners’ religious beliefs.

o   King v. Burwell: he Court ruled that federal health insurance exchanges count as state exchanges, allowing people using federal exchanges to receive insurance subsidies.

FDA Safety and innovation act of 2012:

purpose

strengthened the FDA’s ability to regulate drug manufacturing and supply chains

reauthorized PDUFA, allowing the FDA to continue collecting user fees from drug manufacturers

FDA Safety and innovation act of 2012:

what did it do?

introduced user fees for generic drug manufacturers, helping fund the review of generic drug applications.

FDA gained authority to inspect drug manufacturers, including those outside the United States.

prevent adulterated drugs from entering the U.S. drug supply.