Session 5 - Substitution

The label must accurately describe the contents of the bottle

Anti-substitution law

Affixing an untrue label, stamp, or designation of contents, substituting or dispensing a different article than prescribed/demanded (unless mandated by law), putting up a greater or lesser quantity of an ingredient than specified, or otherwise deviating from the terms of the prescription is a ________ under Anti-Substitution Law

Misdemeanor

The primary goal of mandatory substitution is to _____ healthcare costs for the public

Reduce

A pharmacist shall substitute a _____ expensive drug product if it contains the same active ingredients, dosage form, and strength

Less

To be substituted, the drug must be FDA-approved and in the NYS _____ ____

Orange Book

When dispensing a generic substitution, the label must contain the drug name, strength, and __________

Manufacturer name

For ______ prescriptions, generic substitution is assumed allowed unless DAW is written in the box

Written

For _____ prescriptions, allowance for substitution must be explicitly stated by the provider

Oral

For written prescriptions, if the DAW box is empty, the pharmacist _________

Substitutes

For oral prescriptions, if there is not statement on substitution, ________

Do not fill

If generic is unavailable and the brand is dispensed, the pharmacist must charge the patient the contracted _____ price

Generic

In a medical emergency with generic unavailable, the pharmacist may charge the patient the contracted _____ price

Brand

Includes severe pain requiring immediate relief and situations where prompt treatment is necessary to avoid disability or threat to life

Medical emergency

In the prescription record for substitution, you can include the _____ _____ or the manufacturer name of the dispensed product

Brand name

In cases of emergency dispensing, the pharmacist must record these three things on the back of the prescription

Date, hour, and nature of emergency

To be ________ ________, a drug must be approved, pharmaceutically equivalent, and bioequivalent

Therapeutically equivalent

Same active ingredient, dosage form (including release mechanism), and strength

Pharmaceutical equivalence

No significant difference in rate/extent of absorption

Bioequivalence

The first letter of the Orange Book evaluation code indicates _________ status

Equivalency

Considered therapeutically equivalent; RPh may substitute without provider permission

A-rated

Not therapeutically equivalent; they are not automatically substitutable; RPh must call provider for approval

B-rated

The first approved version of the drug (the brand name)

Reference listed drug

The “Orange Book for biologics”; lists reference products, biosimilars, and interchangeables

Purple Book

Biologic that is highly similar with no clinical difference but cannot be substituted without provider consent

Biosimilar

Biologic expected to produce the same clinical effect; permitted to substitute without prior consent

Interchangeable

RPh must substitute a less expensive biologic if it is designated _______, provided DAW is not indicated

Interchangeable

Pharmacist must notify the provider within _____ business days of biologic substitution with the product name and manufacturer via shared EMR, fax, or electronic means

5

All _________ biologics are biosimilar, but not all biosimilars are _________

Interchangeable