Early Drug Laws
What was the first federal law passed to establish minimal public safety standards?
1906 Pure Food and Drug Act
What led to the creation of the 1962 Kafauver-Harris Amendment?
Thalidomine Syndrome, babies being born w/ malformations
What does the CSA 1970 require for package labeling?
Every stock bottle or medication package from the manufacturer must have a label with a symbol designating the schedule to which it belongs (CII, CIII, CIV, CV).
Question: The Orphan Drug Act gave manufacturers what to motivate them to make drugs for what kind of diseases?
50% tax incentives for making drugs for less common diseases. ex: cancer
Why is it important for a technician to know if the patient takes supplements?
The supplements could interfere with the medication and may cause negative effects. (or just supplement interference)
The Food, Drug and Cosmetic Act of 1938 required new drugs to be shown ___ before marketing.
Safe
What regulation was created to decrease the amount of accidental child poisonings?
The Poison Prevention Packaging Act (PPPA) 1970
Name the factors that make Pharmaceutical Waste Hazardous:
Ignitability.
Corrosivity.
Reactivity.
Toxicity.
1984 Waxman-Hatch Amendment
The first company to submit their generic version of the brand name to the FDA receives what?
180 days exclusivity/ 6 months
How must pharmacy staff dispose of PHI?
De-identify and dispose of in the DPI bin, usually a locked trash bin.
The _____ was created to regulate and tax the production, importation, and distribution of opiates.
Harrison Tax Act of 1914
How was the 1982 Tamper-Resistant Packaging Regulations enforced?
By adding barriers: inner seal of container, wrapper, breakable caps, or blister packs
Which drugs require pharmacy staff training?
Pseudoephedrine and Ephedrine.
The Affordable Care Act
True or False: This act encouraged insurance companies to deny people coverage because they already had health problems like cancer.
False
What was changed with NDA?
fast-tracking of NDAs for serious or life-threatening illnesses and reduced timeframe from 30 months to 15 months or (reduced time frame for drug applications)
The Durham-Humphrey Amendment differentiated drugs into two categories.
Which of the following is not one of these categories?
● Controlled drugs
● Over the Counter drugs
● Legend (prescription) drugs
Controlled drugs
Which act was a result of the fungal meningitis outbreak?
Drug Quality and Security Act.
True/False: The PREP Act was designed specifically to encourage rapid production of vaccines to protect American citizens in case of a pandemic.
True
1990 Omnibus Budget Reconciliation Act
What is DUR, and what does it require? List one.
DUR is the Drug Utilization Review
It requires:
-set standards for a pharmacist's patients' education and counseling
-established a state Medicaid preferred drug list
-identifies potential drug therapy problems such as interactions, incorrect dosing
What was added to Medicaid as a result of the MPDIM Act and why?
Updated the Medicare system and established Medicare Part D prescription drug coverage as an elected benefit for Medicare-eligible patients. Helped elderly and disabled patients afford their medications. or (added part D to help old people and disabled people)