*Module 4: Laws Flashcards
What authority do Federal and State Administrative agencies have?
They are given authority to create rules & regulations.
What is the role of the court?
To apply applicable law.
What are the roles of the President?
Executive Orders and vetoes.
What is the U.S. Congress made up of?
House of Representatives and Senate.
Who must sponsor a bill?
A member of Congress.
What does U.S. Congress do?
Makes federal laws.
What is the state legislature made up of?
WV House of Delegates and Senate.
Who makes state laws?
State legislatures.
What are political subdivisions?
Cities and counties, ordinances.
Who has the authority to create regulations/rules regarding pharmacy in WV?
WVBOP.
What are the objectives of criminal handlings?
Deter, punish, rehabilitate.
What is the objective of civil handlings?
Compensation to injured party.
What do Administrative Actions include?
Disciplinary determination which may include warning, fines, licensure revocation, or suspension.
What is a summons?
Issued by court notifying defendant of suit and commanding defendant to file an answer.
What is a complaint?
Contains material facts of case, allegations against defendant.
What is an answer?
Admitting to or denying allegations.
What is discovery?
Pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely.
What is a deposition?
Out-of-court testimony by a party or witness under oath.
How is negligence generally defined?
As a failure to act as a reasonable prudent person under the same or similar circumstances.
What are the 4 elements of negligence?
Duty, breach of duty, damages, causation.
What must be proven regarding duty in negligence?
It must be proven that the pharmacist had a duty to provide the service/action.
What constitutes a breach of duty?
The pharmacist did not do the service or action appropriately or act as a reasonably prudent pharmacist under the same or similar circumstance.
What is considered damage in negligence?
The person was harmed.
What is causation in negligence?
The damage was caused by a breach of duty.
Who has a dual role of gatekeeper and enforcer regarding regulating pharmacy?
FDA.
What is the Joint Commission?
An independent regulatory body that focuses on patient care and safety and accredits/certifies health care organizations.
What is the goal of the National Association of the Boards of Pharmacy?
To ensure consistent standards among the state boards.
How do state medical boards regulate pharmacy?
Regulate scopes of practice, place prescribing limitations on some mid-level practitioners, and Pharmacist Collaborative Practice Agreements.
What department is OSHA part of?
Department of Labor.
Who enforces HIPAA?
Office of Civil Rights (OCR).
Why was the 1848 Drug Importation Act enacted?
Because products were coming into ports (primarily in New York) that were adulterated.
What did the 1848 Drug Importation Act do?
Mandated inspection of drugs prior to entry into the US.
What did the United States Pharmacopoeia (USP) focus on?
Drugs that were of first choice therapeutically.
What did the National Formulary include?
Drugs whose extent of use justified development of a monograph.
What is the official compendium for drug standards in the US?
USP-NF.
How does the FDA define a drug?
As a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or a substance (other than food) intended to affect the structure or function of the body.
What is a drug product?
The finished dosage form that contains a drug substance, generally in association with other active or inactive ingredients.
What did the Pure Food and Drug Act do?
Prohibited foods and drugs that were misbranded (mislabeled) and/or adulterated (tainted/not pure/not the correct strength) and defined drugs as all medicines and preparations recognized in the USP or NF.
What brought about the Food, Drug, and Cosmetic Act?
The sulfanilamide elixir tragedy.
What did the Food, Drug, and Cosmetic Act require?
Drugs must show safety before being sold.
What established criteria for distinguishing prescription drugs from OTC drugs?
Durham-Humphrey Amendment.
What legally established oral prescriptions and refills?
Durham-Humphrey Amendment.
What specified the minimum info that a dispensed Rx label must contain?
Durham-Humphrey Amendment.
What did the Food Additives Amendment do?
Prohibited food additives that might cause cancer.
What did the Color Additive Amendments do?
Prohibited additives that might cause cancer just like the Food Additives Amendment.
What was the catalyst of the Kefauver-Harris Amendment?
Thalidomide teratogenic effects causing phocomelia in thousands of infants in Europe.
What did the Kefauver-Harris Amendment do?
Required manufacturers to prove efficacy before the FDA will approve them for sale.
What is the Kefauver-Harris Amendment also called?
Drug Efficacy Amendment.
What established good manufacturing practices?
Kefauver-Harris Amendment.
What did the Medical Device Amendments do?
Allowed FDA to review medical devices for safety and efficacy and classify devices according to function.
What was the catalyst of the Federal Anti-Tampering Act?
Cyanide placed into Tylenol capsules.
What did the Federal Anti-Tampering Act do?
Made it a crime to tamper with packaged consumer products.
What did the Orphan Drug Act do?
Provided incentives for manufacturers to develop and market drugs or biologics for the treatment of ‘rare diseases or conditions.’
What is a device?
Instrument, apparatus, implement, machine, implant intended to cure, mitigate, treat or prevent disease in man or animal.
How do devices differ from drugs?
Unlike drugs, devices do not accomplish their purpose through chemical action and they do not hinge on being metabolized.
What class of devices are not intended to support or sustain life?
Class 1.
What class of devices are most devices with increased risk?
Class 2.
What class of devices are complex, high-tech instruments?
Class 3.
Give examples of Class 1 devices.
Dental floss, orthodontic bands, tongue depressor, scissors, examination gloves, toothbrushes, ear irrigation kits, non-electric wheelchair.
Give examples of Class 2 devices.
Powered wheelchairs, some pregnancy kits, syringes, insulin pump, surgical sutures, BP cuffs, intravascular catheters.
Give examples of Class 3 devices.
Breast implants, pacemakers, defibrillators, stents, cochlear implants, high-frequency ventilators, extended wear soft contact lenses.
What did the Drug Price Competition Act do?
Increased the availability of less costly generic drugs by allowing FDA to approve applications for generic versions of brand-name drugs without repeating the research.
What did the Prescription Drug Marketing Act do?
Established sales restrictions and record keeping requirements for drug samples and prohibited hospitals from reselling their pharmaceutical purchases.
What did the Omnibus Reconciliation Act of 1990 (OBRA 90) recognize?
The expectation that pharmacists don’t just deal with drug distribution, but also are fundamental in detection and resolution of drug therapy problems.
What was the aim of OBRA 90?
To decrease Medicaid expenditures by improving outcomes.
What established a requirement for drug utilization reviews?
OBRA 90.
What did OBRA 90 rebates require?
Manufacturers to provide drugs to Medicaid at their ‘best price.’
What did OBRA 90 use demonstration projects for?
To determine whether outcomes improve, and costs decrease when pharmacists are paid to provide DUR services.
What does Drug Use Review (DUR) include?
Retrospective review, educational programs, prospective review.
What does OBRA 90 Prospective review include?
Therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage, incorrect duration of treatment, drug-allergy interactions, clinical abuse/misuse of medications.
What is the function of the prospective review?
To detect ‘potential’ problems.
What was the catalyst of the Generic Drug Enforcement Act?
FDA staff accepting bribes to facilitate faster approval of drug products.
What does the Generic Drug Enforcement Act ban?
Individuals or firms from participating in the drug approval process if convicted of related felonies.
What did the Prescription Drug User Fee Act require?
Manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review the studies.
What does the MedWatch system do?
Collects reports from HCP and patients on problems with drugs and other medical products.
What does the Dietary Supplement Health and Education Act do?
Defines what a dietary supplement is and allows manufacturers to make certain claims that would have been illegal previously.
What did the Food and Drug Administration Modernization Act do?
Streamlined regulatory procedures to expedite drug/device availability and created a fast-track approval process for drugs intended for serious or life-threatening conditions.
What did the Patient Protection and Affordable Care Act do?
Extensively expanded health care law.
What is the Patient Protection and Affordable Care Act also known as?
ACA; Affordable Care Act; commonly called ‘ObamaCare’ by patients.
What is the Drug Quality and Security Act also known as?
‘Compounding Quality Act.’
What impact does the Drug Quality and Security Act have?
Clarifies and strengthens FDA oversight of pharmacies engaged in large-scale compounding/shipping of sterile products.
What was the catalyst of the Drug Quality and Security Act?
Meningitis outbreak caused by contaminated drugs manufactured at a New England pharmacy.
What did Part 2 of the Drug Quality and Security Act focus on?
Drug Supply Chain Security, including track and trace requirements.
What did the 21st Century Cures Act do?
Created new clinical trial design options and accelerated paths to market for drugs intended to treat certain serious or life-threatening diseases.
