Federal Requirements

Non-controlled RX handling

Receiving, ordering, refilling, labeling, dispensing returns, and take-back all follow similar but less strict rules than controlled substances.

OSHA

Requires eyewash stations and spill kits for hazardous substance exposure, and the hazard communication standard (“Employee Right to Know”) requires labeling and Safety Data Sheets (SDS) for chemicals. Ocuppational Safety and Health Administration.

HIPAA

the Health Insurance Portability and Accountability Act. Its a 1996 U.S. federal law that protects patient privacy — never discuss patient info where other can pver hear, and only share information on a need-to-know basis

OTC

Over The Counter, no RX needed

RX

Prescription Only

Behind The Counter

No RX needed, but must handled by pharmacy staff e.g. some pseudoephedrine products.

FDA

Its a U.S. federal agency (under health and human services) that regulates the safety of food, prescription and OTC drugs, medical devices, vaccines, cosmetics and tabacoo products, Food and Drug Administration.

OBRA-90

Federal law requiring pharmacist to offer patient counseling on a new prescriptions, specially for medicaid patients, Omnibus Budget Reconciliation Act of 1990.

Non-controlled RX transfers

Can be transfer an unlimited number of times, unless state law says otherwise.

DEA Number

Issued by the Drug Enforcement Administration to health care providers (Doctors, pharmachist, hospitals, etc..) who are autorized to prescribe, dispense or handle controlled substances.

Format: 2 Letters + 7 digits (e.g. AB1234563)

DEA record retention

Most controlled substance records must be kept a minimum of 2 years (Arizona state for at least 3 years)

NDC

National Drug Code

Vaccine requiring refrigerated storage, should be kept at what tempeture!?

36°F to 46°F (2°C to 8°C)

If a manufacturer’s label does not specify storage requirements for a drug, arizona pharmacies Must default to:

USP/NF compendium standars.

United States Pharmacopeia/National Formulary

BIN

Identifies the insurance processor/PBM (6 digits) Bank Identification Number

PCN

Routes the claim to the correct plan within that processor

Group Number

Identifies the specific employer/plan group

Member ID

Unique identifier for the patient on the insurance card

Copay

Fixed amount patient pays per prescription

Coinsurance

Percentage of cost patient pays (vs. fixed copay)

Deductible

Amount patient must pay out-of-pocket before insurance starts covering.

DAW

DAW (Dispense As Writing) codes- tells insurance whether generic substitution is allowed.

•DAW 0 = no products selection indicated (pharmacist can substitute)

•DAW 1= prescriber requires brand no substitution

•DAW 2= patient requested brand, generic available.

NDC not covered

Drug is not in the formulary

Refill Too Soon

Insurance won’t pay because not enough days have passed

Prior authorization (PA)

Prescriber must justify the drug before insurance approves

Plan limitations exceeded

Quantity/day supply exceeds plan limits

Patient not covered

Inactive plan or wrong ID/Group number entered

Primary insurance

Bill First

Secondary insurance

Covers remaining balance (copay etc)

Medicare Part D

Prescription drug covered for 65+/disabled

Medicaid

State/federal program for low-income patients

Tricare

Military health coverage