HIPPA
What does HIPPA stand for and what year was it established?
What is Health Insurance Portability and Accountability Act of 1996 ?
What is the Food, Drug, and Cosmetic Act?
What is a law that brought cosmetics and medical devices under control and required that drugs be labeled with adequate directions for safe use?
When was the Food, Drug, and Cosmetic Act established?
What is 1938?
This act regulates the use of substances with a potential for abuse.
What is the Controlled Substance Act?
Under the Controlled Substances Act, how long must records related to controlled substances be kept by a pharmacy?
What is 2 years?
What is the 10-digit number each pharmacy must use on all transactions addressed by HIPAA?
What is an NPI (National Provider Identifier)?
What is the Kefauver-Harris Act?
What is an amendment that requires manufacturers to prove the effectiveness of drug products before they go on the market?
When was the Kefauver-Harris Act established?
What is 1962?
Who enforces the Controlled Substances Act?
Who is the DEA (Drug Enforcement Agency)?
True or False: State boards of pharmacy can impose stricter regulations than federal law.
What is true?
How long must pharmacies keep HIPAA acknowledgments on file after providing a service?
What is 6 years?
What is the Durham-Humphrey Amendment?
What is an amendment that didn't allow regulation of unsafe medications to be taken without medical supervision, distinguishing between over-the-counter and prescription drugs?
When was the Durham-Humphrey Amendment established?
What is 1951?
True or False: Federal law requires distinct labeling to prevent medication mix-ups.
What is True?
Which program does the FDA use to collect reports on adverse effects and safety concerns for medications?
What is MedWatch?
What action must a pharmacy take with documents containing Protected Health Information (PHI) once they are no longer needed?
What is shredding any documents containing the patient's PHI?
What is the Sherley Amendment?
What prohibits labeling medication with false therapeutic?
When was the Sherley Amendment enacted?
What is 1912?
To prescribe or dispense controlled substances, practitioners must have this special registration issued by the DEA. What is it called?
What is a DEA registration number?
What law's primary goal was to ensure child safety by preventing accidental ingestion of harmful chemicals?
What is the Poison Prevention Packaging Act?
A pharmacy technician, Sarah, is working at the prescription counter when she receives a call from a patient’s spouse asking for information about the medications that were picked up earlier that day. The spouse claims they need the information to ensure the correct dosage is administered to the patient. Sarah looks up the patient’s prescription history and considers sharing the details over the phone. If Sarah provides the information to the spouse, would this be a violation of HIPAA?
What is YES?
(This would be a violation of HIPAA unless the patient has provided explicit authorization allowing their spouse access to their PHI)
A pharmacist named John receives a prescription for a new medication that doesn't have proper instructions for use or adequate safety warnings. He's unsure whether he can legally dispense it without clear labeling. Which amendment would clarify that certain drugs must be labeled as "prescription only" and provided with appropriate use instructions?
What is the Durham-Humphrey Amendment?
A pharmaceutical company releases a new sedative without conducting thorough clinical trials. Soon after, reports of severe birth defects linked to the drug started surfacing. Public outrage leads to stricter regulations requiring drug manufacturers to provide proof of safety and efficacy before their products can be marketed. Which law or amendment was responsible for these new regulations?
What is the 1962 Kefauver-Harris Act?
A patient named Mr. Thompson visits his local pharmacy with a prescription for a Schedule II pain medication. He asks the pharmacist if he can get a refill on the medication next month without needing a new prescription. Based on federal law, how many refills are the pharmacists allowed?
What is none?
A pharmaceutical company is facing criticism after releasing a medication that was found to have serious side effects, which were not disclosed before approval. New regulations now require proof of effectiveness and safety before drugs can be marketed. Which law was enacted to address this issue?
What is the 1962 Kefauver-Harris Act?