HCI 2 All Jurisprudence Combined

the right of the individual to make his or her own decisions

autonomy

acting with the best interest of the patient in mind

beneficence

above all, do no harm as stated in the Hippocratic Oath

non-maleficence

emphasis on fairness and equality among individuals

justice

four principles of medical ethics

autonomy, beneficence, non-maleficence, justice

expanded standards of practice for pharmacists to detection and resolution of drug therapy problems, drug utilization reviews, and counseling before medication dispensing

Omnibus Reconciliation Act of 1990 (OBRA 90)

basic framework of the OBRA '90 to achieve its goal of decreasing Medicaid expenditure by improving outcomes

rebates, demonstration projects, and drug utilization reviews

identifies and prevents medication related issues - used in OBRA '90

drug utilization review

T/F: in addition to retrospective and prospective reviews, educational programs are also used in drug utilization reviews

true

analyzes prescribing and dispensing patterns and includes audits for duplications, contraindications, and inappropriate drug use with Medicaid managed care plans

retrospective review

mandates continuing education (CEs) for pharmacists with the goal of improving collaboration of pharmacists and prescribers

educational programs

reviews every prescription for duplications, contraindications, interactions, DDIs, drug-allergy interactions, and clinical abuse/misuse

prospective review

T/F: a retrospective review includes interaction checkers and drug-disease contraindications before a drug is dispensed unlike prospective reviews

false

created national standards for protecting health information in 1996

Health Insurance Portability and Accountability Act (HIPAA)

covered entities includes these three groups that must comply with HIPAA

healthcare facilities, insurance companies, and professionals

T/F: HIPAA training must be documented and violations can result in fines and imprisonment

true

refers to individually identifiable health information that is transmitted or maintained in any form such as electronic, oral, or written

protected health information (PHI)

examples of PHI

medical records, labs, surgeries, medications, and payments

T/F: it is never okay to share PHI

false

T/F: a pharmacist can dispense PHI to law enforcement to identify a missing person or in response to criminal activity

true

required details for a written authorization if PHI is used or disclosed for situations not related to treatment, payment, or healthcare operations

who, purpose, expiration, revocation rights, and patient signature

standard used when sharing PHI to accomplish the intended purpose by limiting the amount of info given

"minimum necessary"

which of the following would "minimum necessary" standard be most applicable?

- treatment

- patient authorization

- payment and healthcare operations

payment and healthcare operations

document informing a patient of when and how their PHI can be used by the pharmacy; typically given in a pamphlet

Notice of Privacy Practices

the Notice of Privacy Practices is given to the patient by the pharmacy at the ____ delivery of service to the patient

first

PHI disclosures that are NOT part of HIPAA violation if proper safeguards were in place

incidental disclosures

T/F: as a pharmacist, you can look at any patient's profile even if you are not directly involved with the care of the patient

false

a pharmacy has ______ to comply with a patient's request to access and obtain a copy of their PHI

30 days

T/F: patients can amend their PHI

true

a pharmacy has _______ to comply with a patient's request for an accounting of PHI disclosures

60 days

scope of practice for a pharmacist includes

reduce verbal scripts to writing, ensure initials are on all prescription labels dispensed, have a list of drugs able to be prescribed by PAs and APRNs (prescriptive privileges) prior to dispensing, and deliver/distribute prescriptions accurately

when receiving verbal prescriptions, Florida pharmacists should

reduce to writing, document caller, time/date, and include handwritten initials

when dispensing medications, Florida pharmacists should

ensure initials are on labels, maintain accuracy of prescription, and dispense only as prescribed

regarding counseling, a Florida pharmacist should ______

offer counseling for all new prescriptions and document patient counseling refusals

counseling includes ________

drug name, dosage, route, duration, precautions, ADRs, interactions, storage, and missed dose instructions

regarding record keeping, a Florida pharmacist should maintain records of _______ and keep them secure and accessible

patient name, address, DOB, gender, medical history, drug reactions, and devices

a Florida pharmacist should keep a _____ ratio of technician-to-pharmacist

6:1

the rules of ______ must be posted in the Florida pharmacy

professional conduct

T/F: a pharmacist can be a PIC at two pharmacies like CVS simultaneously

false (only in charitable clinics/volunteering)

a PIC must work _______ for a pharmacy that is open 40+ hrs/week

30 hrs/week and 3 days/week

a PIC must work ______ of hours if the pharmacy is open less than 40 hrs/week

majority

who is notified for changes in PIC within 10 days, ownership, or address, permanent pharmacy closures, or installation/removal of automated pharmacy systems?

Board of Pharmacy (BOP)

responsible for pharmacy operations and compliance of drugs, patient records, staff licensing, and tech training

pharmacist-in-charge (PIC)

in addition to notifying the BOP when a PIC changes, these two things must also be updated and completed

controlled substance inventory and pharmacy permit (updated)

T/F: the updated pharmacy permit copy must be posted in the pharmacy after PIC change and the original permit is submitted to the BOP for records

true

the maximum duration that an interim PIC can serve for a pharmacy

60 days

T/F: interns can perform all pharmacist duties with the supervising pharmacist's permission

false (most duties except where restricted by law)

list the four exceptions for scope of practice for interns that ONLY A PHARMACIST can perform

transfer prescriptions for controlled substances, dispense schedule V meds without a prescription, possess key/codes to the pharmacy, and complete final check

pharmacist technicians are NOT ALLOWED to perform these duties in the pharmacy

receive verbal prescriptions and reduce to writing, interpret prescription drug orders, select drug products (substitutions/alternatives), interpret patient med records, perform drug regimen reviews, and deliver prescription to patient before final check

a prospective drug utilization review in which the pharmacist verifies prescription accuracy and clinical appropriateness before dispensing the medication to the patient

final check

a _____ (technician/technicians-in-training) must wear a name tag with legible lettering and designation

technician

a ____ (technician/technicians-in-training) must wear a name tag on a lanyard or clipped to a lab coat that can hold a board-issued wallet-sized credential and identify the individual by name and registration number

technician-in-training

T/F: all techs and trainees shall maintain professional appearance and sanitary attire

true

T/F: "should" means it is not an option - it is a requirement

false (shall)

T/F: "should" means it is highly recommended - it is not a requirement

true

a _______ (prescription/order) is an order for a medication which is dispensed to or for an ultimate user (patient)

prescription

a _____ (prescription/order) is dispensed for immediate administration to the ultimate user

order

an order is used to dispense a drug in the ____ (in-patient/out-patient) setting to the patient

in-patient

one hour CE = _______

0.1 CEU

one hour of participation in an accredited CE activity

CPE hour

a pharmacist must complete _____ of CE every 2 years to maintain licensure

30 hours

_____ does not occur until the product has been delivered to the patient or patient's agent (ultimate user)

dispensing

for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals that is recognized by the FDA

medicinal drugs

medicinal drugs ______ (does/does not) include devices

does not

T/F: marijuana includes all parts of the plants whether or growing or not except the mature stalks of the plant

true

T/F: the resin extracted from the mature stalks of the marijuana plant is not included in the definition of marijuana

false

means any of the following, produced directly or indirectly by extraction from substances of vegetable origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) opium and opiates, and a salt, compound, derivative, or preparation of opium or opiates;

(B) a salt, compound, isomer, derivative, or preparation of a salt, compound, isomer, or derivative that is chemically equivalent or identical to a substance listed in Paragraph (A) other than the isoquinoline alkaloids of opium;

(C) opium poppy and poppy straw; or

(D) cocaine, including:

(i) its salts, its optical, position, or geometric isomers, and the salts of those isomers;

(ii) coca leaves and a salt, compound, derivative, or preparation of coca leaves; and

(iii) a salt, compound, derivative, or preparation of a salt, compound, or derivative that is chemically equivalent or identical to a substance described by Subparagraph (i) or (ii), other than decocainized coca leaves or extractions of coca leaves that do not contain cocaine or ecgonine.

narcotic drug

any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability

opiate

law passed for purity and safety of serums, vaccines, and similar products for disease prevention

Biologics Control Act (1902)

outlaws states from buying and selling food, drinks, and drugs that have been mislabeled or tainted

Pure Food and Drug Act (1906)

prohibits labeling medications with false therapeutic claims intended to defraud the purchaser

Sherley Amendment (1911)

T/F: the Sherley Amendment (1911) was made void by the FDCA

true

requires that drugs must show safety before being sold in order to protect the public; drugs cannot be misbranded or adultered

Food, Drug, and Cosmetic Act (1938) (FDCA)

brought about the passing of the FDCA

sulfanilamide elixir tragedy of 1937

establishes criteria for distinguishing prescription drugs from OTCs, oral prescriptions and refills, prescription label information, and expiration/BUD

Durham-Humphrey Amendment (1951)

prohibits food additives in drugs that might cause cancer and any additive must be safe

Food Additives Amendment (1958)

prohibits color additives that might cause cancer

Color Additive Amendments (1960)

gave FDA jurisdiction over prescription drug advertising, established GMP requirements, and added more control for clinical investigations

Kefauver-Harris Amendment (1962)

the Kefauver-Harris Amendment (1962) is also known as the _____

Drug Efficacy Amendment

catalyst for the passing of the Kefauver-Harris Amendment (1962)

thalidomide

requires child-resistant containers for all prescription medications, certain OTC drugs, drug classes, preparations, or dietary supplements

Poison Prevention Packaging Act of 1970

only the ______ (patient/prescriber) can provide a blanket request for all future prescriptions

patient

the ______ (patient/prescriber) can request non-child resistant caps on individual scripts they write

prescriber

T/F: requests for non-child resistant caps must be in writing per federal law

false

allowed the FDA to review medical devices for safety and efficacy and classify based on risk, invasiveness, and impact on patient health

Medical Device Amendments (1976)

medical devices like electric toothbrushes, bandages, and hospital beds

category 1

medical devices like catheters, BP cuffs, contact lenses, contact lens cases, syringes, and insulin pumps

category 2 (most devices)

medical devices like breast implants, defibrillators, pacemakers, and extended wear contacts

category 3 (support/sustain life)

made it a crime to tamper with packaged consumer products after cyanide was placed into Tylenol capsules

Federal Anti-Tampering Act (1983)

provided incentives for manufacturers to develop and market drugs or biologics for the treatment of "rare diseases or conditions"

Orphan Drug Act (1983)

the Orphan Drug Act (1983) was created to help develop and market drugs that impact fewer than ______ people or which the costs of development will never be recouped

200,000

allows FDA to approve generic versions of brand-name drugs without repeating research and give brand-name companies up to 5 years of additional patient protection for new medicines

Drug Price Competition and Patent Term Restoration Act (1984)

the Drug Price Competition and Patent Term Restoration Act (1984) is also known as the _____

Hatch-Waxman Act

established sale restrictions and record keeping requirements for drug samples and prohibited hospitals from reselling their pharmaceutical purchases

Prescription Drug Marketing Act (1987)

bans individual or firms from participating in the drug approval process if convicted of related felonies

Generic Drug Enforcement Act (1992)

required manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review the studies

Prescription Drug User Fee Act (1992)

collects reports from HCP on problems with drugs and other medical products, voluntary reporting from HCP, and mandatory reporting for manufacturers

MedWatch System Launched (1993)

T/F: unlike the voluntary reporting from HCP, MedWatch requires mandatory reporting for manufacturers on MedWatch

true

defines what a dietary supplement is and made herms dietary supplement

Dietary Supplement Health and Education Act (1994)

streamlined regulatory procedures to expedite drug/device availability for serious or life-threatening conditions

Food and Drug Administration Modernization Act (1997)