Reading 4 & 5 - Federal Law Flashcards
Scope of Practice
what a practitioner can do based on their education and professional licensure
*** can ONLY prescribe under their scope of practice
What must ALWAYS be on a prescription label in order to not be misbranded?
Name and address of dispenser
Prescription #
Date of prescription or filling
Name of prescriber
What may be added to a label if included on the prescription?
Name of patient
Directions for use
Cautions for use
Expiration date for all OTC medication prescriptions
After 1 year of WRITTEN date
Agency and its limitations
a principal hiring an agent to deal with a third party on their behalf (a nurse calling in prescriptions)
**CANNOT be done for C-II medications
Drug Utilization Review
DUR
ongoing process to maintain appropriate and effective use of medications
OBRA ‘90
Omnibus Reconciliation Act
- ensures $$ is spent appropriately
-targets DUR
- Medicaid beneficiaries is a focus
The act that requires special packaging to protect from child poisoning:
Poison Prevention Packaging Act (PPPA)
The requirements of the PPPA
90% of adults can open without significant difficulty
85% of children under 5 who have never seen the package cannot open within 5 minutes
80% of children under 5 who have given instructions still cannot open within 5 minutese
CRC
Child Resistant Container
NOT CHILDPROOF!!!
What is required to have CRC according to the PPPA?
- CS for oral adminstration
- Rx for oral adminstration
- OTC for oral adminstration
What is NOT required to have CRC?
Nasal sprays
eye drops
ointments/creams
What are some drug exceptions for CRC?
NTG SL
Isosorbide dinitrate SL
Erythromycin grandules < 8 grams
Erythromycin tablets < 16 grams
Oral contraceptives
Anhydrous Cholestyramine (powder)
Potassium < 50 mEq
Betamethasone tab in manufacturers dispensed packages
Prednisone tab < 105 mg
Medroxyprednisolone < 84 mg
Colestipol poweder </= 5 g
Mebendazole tab </= 600 mg
What products MUST contain PPI?
estrogen products or oral contraceptives in both outpatient and inpatient!!!
** if not it is MISBRANDED
Package insert: label or labeling?
labeling
What is a FDA approved labeling written in patient friendly language that explains issues related to a specific drug or class?
MedGuide
What FDA approved labeling is required in both inpatient and outpatient setting?
PPI for estrogen and oral contraceptives
**MedGuides are only for outpatient settings
What medications are required to have MedGuides?
- drug is where patient labeling could help prevent serious ADR
- drug has serous risks for patient to be aware of and could affect decision to use
- drug adherence to directions of use is important for effectiveness
EX: NSAIDs, PPIs, SSRIs, opioids, amphetamines
Failure to dispense a required product with a MedGuide is assumed the drug is….
Misbranded
What must be included on a non-prescription label?
“Drug Facts” that include:
active ingredients
purpose
use
warnings
directions
inactive ingredients
EXPIRATION DATE
tamper-evident safety features
USP
United State Pharmacopeia is an official compendia to develop and piblish standards for drug products, excipients, and dietary supplements
— not technically law!
USP 795
Nonsterile compounding
USP 797
Sterile Compounding
USP 800
Hazardous substances:
- carcinogenicity
- teratogencity
- reproductive toxicity
- organ toxicity at low doses
- genotoxicity
- any new drugs that mimic existing hazardous drugs in structure or toxicity
If just a month/year appears as the expiration, we assume:
the product is good until the end of that month
EX: 3/24 —– march 31, 2024
Repackaging
taking a drug from the manufacturer’s bottle and putting it into a new package
BUD for non-aqueous formulations
no more than 6 months or products expiration date
BUD for Water-containing topical/dermal
no more than 30 days or product expiration
BUD for water-containing oral formulations
no more than 14 days or the products expiration date
T or F - filling a prescription by taking the stock bottle of tablets and despensing in a new prescription bottle is repackaging
NO - it is based on patient-specific prescription
FDA voluntary reporting system for ADR
MedWatch
