Laws to Know
if you are unsure of what law to follow (between state and federal), choose the more strict law
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
created FDA
gave responsibility to approve all new drugs and ensure purity standards by creating rules against adulteration (contamination or failure to meet purity standards) and misbranding (false, improper, confusing labeling/if the product is harmful when used according to label directions
power to reinforce recalls (I is worst, III is least harmful)
I: for risk of serious adverse health consequences/death
II: for risk of temporary or medically irreversible adverse health consequences/low probability of serious consequences (MOST COMMON)
III: for products unlikely to cause harm
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
regulates the way health care personnel handle Protected Health Information (PHI)
PHI is defined as any identifying health information
under HIPAA pharmacies:
must ensure the confidentiality of PHI
includes all manners of communication
workers MAY NOT disclose medical information to anyone OTHER than the patient
must protect against possible breaches with security measures
any breaches must be reported to the Department of Health and Human Services Office for Civil Rights
Fewer than 500—> must be reported within 60 days of the end of the calendar year
More than 500—> must be reported within 60 days of the breach
must dispose of PHI correctly
must appoint a designated privacy officer
must inform patients on their privacy rights and how the pharmacy handles their info
must provide patients with their PHI records as requested
Occupational Safety and Health Act of 1970
created Occupational Safety and Health Administration (OSHA) to ensure the safety of worldwide workers
requires workers to be trained in safety measures
safety sheets are available for hazards
personal protective equipment
requires that the manufacturer provide safety data sheets to a pharmacy for products that are:
combustible
flammable
result in injury if contact is made
sets standards for keeping pharmacy employees safe while completing tasks associated with pharmacy practice
Controlled Substance Act of 1970
created formal scheduling of drugs with the potential for abuse and dependency (controlled substances)
lead to Drug Enforcement Administration (DEA) in 1973 for regular drug regulation
DEA Number Calculations
Ex. Dr. James Bryant sends in a prescription with a DEA of AB6390467
First letter of DEA number
A —> physicians
B —> physicians
F —> physicians
M —> mid-level practitioners
P —> pharmacy
R —> pharmacy
B —> second letter has to match the prescriber’s last name
1, 3, and 5 number are added together
6+9+4=19
2, 4, and 6 number are added together, then multiplied by two
3+0+6=9Ă—2=18
Then you add the two products (19 & 18) together
19+18=37
The last digit of this product needs to match the last digit of the DEA number
Schedules
I: no accepted medical use/high potential of abuse
Ex. heroin, LSD
no refills
II: high abuse potential, severe psychological or physical dependence
Ex. cocaine, ADHD drugs, opioids
no refills
III: moderate abuse and dependence potential
Ex. drugs containing codeine
five refills
IV: low abuse and dependence potential
Ex. benzodiazepines and sleep aids like Ambien
five refills
V: lowest abuse potential
Ex. codeine-containing cough syrups, Lyrica
5 refills
DEA form 222: distribution of class I or II; controlled substance; used to order said drug
DEA form 71: destroying medicines
DEA form 106: used to report the theft of controlled substances
Poison Prevention Act of 1972
requires child safety caps on all dispensed prescriptions
exceptions include nitroglycerin and inhalers
easy open caps can be requested
record must be kept if requested
Drug Listing Act of 1972
establishes rules for all drug manufacturers to supply a current drug list to the FDA
NDC code is assigned
unique to the manufacturer and package size
broken into different sections
first section
refers to the manufacturer/repackager
second section
refers to the specific drug
includes strength and form
third section
refers to packaging size
Prescription Drug Marketing Act of 1987
requires wholesale distributors to be licensed
samples of prescription medication may only be given to licensed prescribers
exported prescription drugs may not be reimported
Omnibus Budget Reconciliation Act of 1987
widespread federal deficit reduction budget bill
up to individual states to determine how to force OBRA
three major requirements
pharmacists must offer counseling to all patients and document if patient refusals for counseling
pharmacists must perform a prospective drug utilization review (DUR) prior to filling each prescription to evaluate potential problems (allergies, interactions)
pharmacies must keep patient profiles on site for two years
Combat Methamphetamine Act of 2005
requires pharmacies to limit sales of OTC meds that contain pseudoephedrine
3.6 g per purchaser per day and no more than 7.5 g in a month period
has to be in locked container
no one under 18 can purchase (needs a valid photo id)
pharmacy must contain a logbook (physical or electronic) for at least two years
contains: signature, address, product, quantity of product, date & time of sale
Durham-Humphrey Amendment of 1950
establishes the distinction between OTC and prescription drugs
allows prescriptions to be called to the pharmacy from the physician’s office
Kefauver Harris Amendment
proof-of-efficacy requirement is introduced by this amendment
guarantees safety, purity, and effectiveness of drugs
United States Pharmacopeia (USP)
USP 797: dictates the appropriate standards for sterile compounding
USP 795: non sterile compounding
USP 800: establishes standards for the handling of hazardous drugs concerning patients, healthcare workers, and the environment
Orphan Drug Act of 1983
facilitates the drug development for rare diseases