14.2 Generic and Biosimilar Substitution

Why product selection is Competency 4.4

Quick Answer: CGS § 20-619 lets a pharmacist MAY substitute a generic of the same strength, quantity, dose, and dosage form that is, in the pharmacist’s professional opinion, therapeutically equivalent, unless the purchaser instructs otherwise or the prescriber specifies “brand medically necessary” or “no substitution.” Notify the patient. For an interchangeable biological product, inform the patient and document the substitution within 72 hours; inform the prescriber within 72 hours of dispensing. A technician shall not choose the substitute (RCSA § 20-576-39(a)(8)). Post the statutory counter sign in one-inch block letters.

NABP Area 4.4 grades product selection. Connecticut’s statute is permissive substitution for ordinary community fills, not “always generic” and not “never generic.” Medicaid medical-assistance claims pick up an extra CGS § 17b-274 brand-medically-necessary and prior-authorization overlay. Do not import that overlay onto a cash-pay Lipitor without reading the stem.

Generic substitution — same drug, Orange Book TE

§ 20-619(b) is the small-molecule engine. Except as limited by subsections (f), (h), and (l), unless the purchaser instructs otherwise, the pharmacist may substitute a generic drug product with the same strength, quantity, dose, and dosage form as the prescribed product which is, in the pharmacist’s professional opinion, therapeutically equivalent. Then tell the patient or representative, and the practitioner, at the earliest reasonable time.

Therapeutically equivalent is not a vibe. FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) rates products A when they are TE to the reference listed drug. AB is the workhorse tablet/capsule code: actual or presumed bioequivalence problems have been resolved. Other A-codes (AA, AN, AO, AP, AT) are also TE in their dosage-form lanes. B codes are not TE — do not auto-substitute a BX or BN product because the salt looks familiar.

If the prescriber is not reasonably available for consultation and the prescribed drug does not use a unique delivery-system technology, the pharmacist may substitute an oral tablet, capsule, or liquid of the prescribed drug so long as the form dispensed has the same strength, dose, and dose schedule and is therapeutically equivalent. That is a dosage-form flexibility when the office is closed, not a license to switch a long-acting osmotic tablet to an immediate-release liquid because the liquid is cheaper.

§ 20-619(h) adds money: the pharmacist may substitute only when there will be a savings in cost passed on to the purchaser. Disclose the amount of savings at the patient’s request. Substituting a “generic” that costs the patient more is not § 20-619 substitution.

How a prescriber (or patient) stops the switch — exact DAW language

§ 20-619(f) is the DAW statute. A prescribing practitioner may specify in writing, or by telephonic or other electronic communication, that there shall be no substitution for the specified brand-name drug or prescribed biological product, provided:

1. For written prescriptions, the practitioner specifies on the form that the product is “brand medically necessary” or “no substitution.”
2. For telephonic prescriptions, the pharmacist specifies “brand medically necessary” or “no substitution” on the prescription or in the electronic record.

Those two phrases are the open statutory language. Do not invent a requirement that the prescriber handwrite a federal DAW code “1,” and do not treat a pre-printed checkbox farm as automatically valid where the statute still cares about how the prohibition is communicated. Electronic prescriptions may default to “brand medically necessary” or “no substitution” when the prescriber selects the certified no-substitution code. The purchaser can also instruct otherwise at the counter — the statute’s first gate is the patient, not only the prescriber.

Medicaid / medical assistance is stricter on the prescriber side: CGS § 17b-274 requires the practitioner to specify the basis on which the brand is medically necessary compared with a chemically equivalent generic, and a pharmacist generally dispenses the generic unless that showing plus DSS approval is in place. That is a payer overlay, not the default cash-pay rule.

Interchangeable biologics — not “any biosimilar”

A biosimilar is highly similar to a reference biologic with no clinically meaningful differences. An interchangeable biologic has also met 42 U.S.C. § 262(k)(4) interchangeability (or is listed as TE in the Orange Book). § 20-619(a) uses that definition. § 20-619(c) lets the pharmacist substitute only an interchangeable biological product, and only if the practitioner has not blocked substitution under (f) and the purchaser has not instructed otherwise.

Two 72-hour clocks, and they are not the same event:

• Patient: Upon dispensing, the pharmacist or a duly authorized agent informs the patient or representative of the interchangeable substitution. Not later than 72 hours after that notice, the pharmacist documents the substitution in a manner authorized by § 20-619(m) — an interoperable electronic medical records system, electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record.
• Prescriber: Upon dispensing, but not later than 72 hours following the dispensing, the pharmacist informs the prescribing practitioner by facsimile, telephone, or electronic transmission.

CGS § 20-619a is a prescriber duty: before prescribing a biologic, discuss treatment methods, alternatives, and risks, and document that discussion within 24 hours. Do not confuse the prescriber’s 24-hour note with the pharmacist’s 72-hour substitution documentation.

The sign, the technician, and the decision tree

§ 20-619(g) requires a sign easily seen by patrons at the dispensing counter:

“THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT OR INTERCHANGEABLE BIOLOGICAL PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE.”

Printing is block letters not less than one inch in height. DCP’s sample sign tracks that sentence. A handwritten sticky note is not the statute.

RCSA § 20-576-39(a)(8) is the personnel wall: pharmacy technicians shall not determine generically and therapeutically equivalent drug products to be substituted for brand name products in accordance with § 20-619. A technician may pull the Orange Book stock the pharmacist already selected. The technician may not decide “we’ll send atorvastatin instead of Lipitor” or “Semglee-yfgn is close enough to Lantus.” That determination is pharmacist professional opinion.

Walk the fill in this order:

• Did the purchaser instruct “no generic”? Stop.
• Did the prescriber specify “brand medically necessary” or “no substitution”? Stop.
• For a small molecule: same strength, quantity, dose, dosage form, and Orange Book A/AB TE in the pharmacist’s opinion? If yes, and a savings will be passed through, the pharmacist may substitute and notify.
• For a biologic: is the proposed product interchangeable, not merely biosimilar? If yes, substitute, inform the patient, document within 72 hours, notify the prescriber within 72 hours.
• Who chose the substitute? If the answer is “the technician,” § 20-576-39(a)(8) already failed.

Realistic Connecticut scenario

A West Hartford prescription reads “Lipitor 40 mg, one daily, #90.” No DAW language. The patient does not object. The pharmacist selects AB-rated atorvastatin 40 mg that will cost the patient less, counsels on the switch, and bills the generic. That is § 20-619(b).

The next prescription is “Humira 40 mg/0.4 mL, brand medically necessary.” A biosimilar is in the refrigerator. Do not substitute. The statutory phrases are on the form. Even without those words, a product that is biosimilar but not interchangeable is outside § 20-619(c).

The third prescription is an interchangeable insulin analog. The pharmacist tells the patient at pick-up, enters the substitution in the pharmacy record that same afternoon (well inside 72 hours), and sends the prescriber an electronic notice before the weekend. A technician who “just picked the cheaper insulin” without the pharmacist’s TE/interchangeability determination has practiced outside § 20-576-39.

Official anchors

• CGS § 20-619 — generic and interchangeable-biologic substitution, DAW phrases, 72-hour clocks, counter sign, savings pass-through.
• CGS § 20-619a — prescriber biologic discussion, 24-hour documentation.
• FDA Orange Book — A/AB therapeutic equivalence.
• FDA Purple Book — licensed biologics, biosimilarity, interchangeability (42 U.S.C. § 262(k)(4)).
• RCSA § 20-576-39 — technician may not determine the substitute.