COVID-19: Therapeutic Interchange
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The chart below is NASPA’s compilation of state actions regarding therapeutic interchange.
Return to COVID-19: Information from the States
|Arizona||4/2/2020||The Board of Pharmacy shall allow pharmacists to utilize their professional judgment to interchange therapeutically equivalent medications of the same Food and Drug Administration (FDA) drug classification unless the prescriber has noted that the medication shall be dispensed as written. (Executive Order 2020-20)|
|Arkansas||Existing Authority||“Prescription” means an order for medicine or medicines usually written as a formula by a physician, optometrist, dentist, veterinarian, or other licensed medicinal practitioner. It contains the names and quantities of the desired substance, with instructions to the pharmacist for its preparation and to the patient for the use of the medicine at a particular time and may authorize the pharmacist to substitute a therapeutically equivalent drug that is at a lower cost to the patient and communicate that authorization by any generally accepted means of communication of a prescription from a prescriber to a pharmacist.
“Therapeutically equivalent” means drug products from the same therapeutic class that if administered in appropriate amounts will provide the same therapeutic effect, identical in duration and intensity.
(070-00 Ark. Code R. § 007)
|Arkansas||4/15/2020||Therapeutic substitution if a medication is not available and there is a therapeutically equivalent medication available during the emergency the pharmacist can discuss with the patient and substitute with a notice sent to the prescriber of the substitution due to emergency when the prescriber is unavailable.
**The first medication we have agreement with the medical community on would be any of the albuterol or levalbuterol inhalers as they are in short supply immediately. If you have a patient in need of an albuterol or levalbuterol inhaler that is not available currently you may automatically substitute and change the prescription to another available therapeutically equivalent product (a different albuterol or levalbuterol inhaler). The Board would suggest checking for continued insurance coverage and this should be discussed with the patient prior to substitution to ensure they know what is going on.
We will continue to monitor drug shortages as this moves forward for other medications for possible inclusion…
(Board of Pharmacy waiver: 17‐92‐101 (18) (B))
|District of Columbia|
|Idaho||Existing Authority||54-1768. PRESCRIBER-AUTHORIZED SUBSTITUTION.
(1) A licensed prescriber may authorize a pharmacist to substitute a drug with another drug in the same therapeutic class that would, in the opinion of the pharmacist, have a substantially equivalent therapeutic effect even though the substitute drug is not a therapeutic equivalent drug, provided the following conditions are met:
(a) The prescriber has clearly indicated that drug product substitution is permissible by indicating “therapeutic substitution allowed” or by making a similar designation;
(b) The drug product substitution is intended to ensure formulary compliance with the patient’s health insurance plan or, in the case of a patient without insurance, to lower the cost to the patient while maintaining safety;
(c) The patient opts in to the drug product substitution, and the pharmacist clearly informs the patient of the differences in the drug products and specifies that the patient may refuse the substitution; and
(d) If a drug product substitution is made:
(i) The prescriber’s directions are modified to allow for an equivalent amount of drug to be dispensed as prescribed; and
(ii) The pharmacist shall notify the patient’s original prescriber of the drug product substitution within five (5) business days of dispensing the prescription.
(2) Nothing in this section shall apply to biological products, as set forth in section 54-1769, Idaho Code, or to narrow therapeutic index drugs.
(3) For purposes of this section:
(a) “Drug product substitution” means dispensing a drug product other than the drug product originally prescribed.
(b) “Narrow therapeutic index drug” means a drug where a small difference in dose or blood concentration may lead to serious therapeutic failures or adverse drug reactions.
(c) “Therapeutic class” means a group of similar drug products that have the same or similar mechanisms of action and are used to treat a specific condition.
(d) “Therapeutic equivalent drug” means a product assigned an “A” code by the federal food and drug administration (FDA) in the “Approved Products with Therapeutic Equivalence Evaluations” (orange book) and animal drug products published in the FDA’s “Approved Animal Drug Products” (green book).
|Iowa||4/6/2020||In Section Thirty-Three, Governor Reynolds temporarily suspends the provision in Iowa Code § 155A.32 that otherwise limits drug product selection without prior approval from the prescriber to generically equivalent drug products. For the duration of this disaster emergency, a pharmacist should follow this guidance for drug product selection when presented with drug product shortages. The temporary suspension of this provision is limited to drug product selection in response to a drug product shortage or for formulary management and, where identified below, only when a substitute prescription or order cannot be obtained from the prescriber after reasonable effort. This guidance applies to therapeutic substitution of prescription drug products. A pharmacist who engages in therapeutic substitution pursuant to this guidance shall exercise professional judgment when making such substitutions and should consult with scientific literature and/or peer-reviewed drug information resources for dosing equivalencies.
The authority to therapeutically substitute prescription drugs in response to a drug shortage under this guidance shall NOT apply to:
– Controlled substances
– Biological products, with the exception of insulin products
– Drug products with a narrow therapeutic index
For inhaled beta-agonist prescription drug products, a pharmacist may engage in therapeutic substitution with respect to drug and dosage form without prior prescriber authorization when necessary due to a documented drug shortage.
Prior to the substitution, the pharmacist shall discuss the therapeutic substitution with the patient, including the reason for the substitution and any cost or third-party payor implications.
Following therapeutic substitution, the pharmacist shall provide notice to the prescriber in writing or by electronic means within 7 days of dispensing.
For other prescription drug products not previously identified which are subject to a drug shortage during this disaster emergency, a pharmacist shall follow this guidance.
– Consider limiting dispensing to no more than a 30 day supply to preserve drug supply.
– Consider assigning one pharmacy staff member with the task of daily review of drug shortage reports (through FDA and wholesaler, etc.).
– As a drug appears on a drug shortage list, identify all current patients with active prescriptions for the drug. For those patients whose supply will run out in the near term (within 15 days, for example), send a request as soon as possible to the patient’s prescriber for an alternate prescription in case the medication cannot be procured in time for the patient’s prescription to be filled.
– When a prescription must be filled, the drug is not available, and the prescriber has not responded to the pharmacy’s request(s) for substitution, the pharmacist may dispense an appropriate alternate drug within the same therapeutic drug class, ensuring a complete prospective drug utilization review is completed, and adjusting the dose and directions accordingly to result in the same therapeutic outcome for the patient.
– Within 7 days of dispensing a therapeutically-substituted prescription, the pharmacist shall notify the prescriber of the substitution in writing or by electronic communication.
– Prescriptions dispensed in this manner should be processed as a new prescription with the name of the prescribing physician on the original prescription for the unavailable drug product. The prescription record shall include the pharmacy’s attempts to contact the prescriber for a substitution.
– The pharmacist shall, prior to dispensing, counsel the patient about the alternate product selected to include notification to the patient that the selected drug product does not contain the identical active ingredient present in the originally prescribed drug.
|Kentucky||Existing Authority||Section 1. Dispensing.
(1) A pharmacist may dispense a therapeutic equivalent drug product under the following conditions:
(a) The ordering practitioner has indicated “formulary compliance approval” on the prescription, in one of the following ways:
1. In the practitioner’s own handwriting; or
2. By checking a “formulary compliance approval” box on a preprinted form;
(b) The pharmacist receives a formulary change as a consequence of the patient’s thirdparty plan; and
(c) The product designated as “preferred” by the third-party formulary is in the same therapeutic class as the prescribed drug.
(2) The pharmacist, within twenty-four (24) hours of the formulary compliance substitution, shall notify the ordering practitioner, in an original writing or by facsimile:
(a) That the pharmacist engaged in formulary compliance; and
(b) The therapeutic equivalent drug product that was dispensed.
Section 2. The pharmacist may make adjustments in the quantity and directions to provide for an equivalent dose of the preferred formulary therapeutic alternative.
|Michigan||3/26/2020||Pharmacists may substitute a therapeutically equivalent medication for a medication subject to critical shortages without the authorization of a prescriber. The pharmacist must inform the patient of any substitution. The pharmacist must inform the prescriber within a reasonable period of time of any prescriptions or refills dispensed under this section. A prescriber must not incur any criminal or civil liability or licensing disciplinary action as the result of a pharmacist filling or refilling a prescription under this section. (Executive Order 2020-25)|
|Minnesota||5/27/2020||Subd. 2. Therapeutic interchange. Notwithstanding Minnesota Statutes, section 151.21, subdivision 7a, paragraph (a), a pharmacist may dispense a therapeutically equivalent and interchangeable prescribed drug or biological product, without having a protocol in place, provided: (1) the drug prescribed is in short supply and the pharmacist is unable to obtain it from the manufacturer, drug wholesalers, or other local pharmacies; (2) the pharmacist is unable to contact the prescriber within a reasonable period of time to get authorization to dispense a drug that is available; (3) the pharmacist determines a therapeutically equivalent drug to the one prescribed is available and is in the same American Hospital Formulary Service pharmacologic therapeutic classification; (4) the pharmacist informs the patient as required in Minnesota Statutes, section 151.21, subdivision 7a, paragraph (b), and provides counseling to the patient, as required by the Board of Pharmacy rules, about the substituted drug; (5) the pharmacist informs the prescriber as soon as possible that the therapeutic interchange has been made; and (6) the therapeutic interchange pursuant to this section is allowed only until the expiration date under subdivision 3. Subd. 3. Expiration. This section expires 60 days after the peacetime emergency specified in subdivision 1 is terminated or rescinded by proper authority.|
|Nebraska||11/13/2020||(3)(a) A pharmacist who is exercising reasonable care and who has obtained patient consent may do the following:
(i) Change the quantity of a drug prescribed if:
(A) The prescribed quantity or package size is not commercially available; or
(B) The change in quantity is related to a change in dosage form;
(ii) Change the dosage form of the prescription if it is in the best interest of the patient and if the directions for use are also modified to equate to an equivalent amount of drug dispensed as prescribed;
(iii) Dispense multiple months’ supply of a drug if a prescription is written with sufficient refills; and
(iv) Substitute any chemically equivalent drug product for a prescribed drug to comply with a drug formulary which is covered by the patient’s health insurance plan unless the prescribing practitioner specifies “no substitution”, “dispense as written”, or “D.A.W.” to indicate that substitution is not permitted. If a pharmacist substitutes any chemically equivalent drug product as permitted under this subdivision, the pharmacist shall provide notice to the prescribing practitioner or the prescribing practitioner’s designee. If drug product selection occurs involving a generic substitution, the drug product selection shall comply with section 38-28,111.
(b) A pharmacist who adapts a prescription in accordance with this subsection shall document the adaptation in the patient’s pharmacy record.
|South Dakota||4/1/2020||If, during the COVID-19 emergency, a pharmacist is unable to fill a product with an AB rated product, the pharmacist may select a therapeutically equivalent drug product if unable to reach the prescriber. Notification should be made to the prescriber. (S.D. Admin. R. 20:51:14:04 – waiver)|
|U.S. Virgin Islands|
|Washington||Existing Authority||(1)(a) Except as provided in subsection (2) of this section, any pharmacist filling a prescription under a state purchased health care program as defined in *RCW 41.05.011(2) shall substitute, where identified, a preferred drug for any nonpreferred drug in a given therapeutic class, unless the endorsing practitioner has indicated on the prescription that the nonpreferred drug must be dispensed as written, or the prescription is for a refill of an antipsychotic, antidepressant, antiepileptic, chemotherapy, antiretroviral, or immunosuppressive drug, or for the refill of a immunomodulator/antiviral treatment for hepatitis C for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks but no more than forty-eight weeks, in which case the pharmacist shall dispense the prescribed nonpreferred drug.
(b) When a substitution is made under (a) of this subsection, the dispensing pharmacist shall notify the prescribing practitioner of the specific drug and dose dispensed.
(2)(a) A state purchased health care program may impose limited restrictions on an endorsing practitioner’s authority to write a prescription to dispense as written only under the following circumstances:
(i) There is statistical or clear data demonstrating the endorsing practitioner’s frequency of prescribing dispensed as written for nonpreferred drugs varies significantly from the prescribing patterns of his or her peers;
(ii) The medical director of a state purchased health program has: (A) Presented the endorsing practitioner with data that indicates the endorsing practitioner’s prescribing patterns vary significantly from his or her peers, (B) provided the endorsing practitioner an opportunity to explain the variation in his or her prescribing patterns to those of his or her peers, and (C) if the variation in prescribing patterns cannot be explained, provided the endorsing practitioner sufficient time to change his or her prescribing patterns to align with those of his or her peers; and
(iii) The restrictions imposed under (a) of this subsection (2) must be limited to the extent possible to reduce variation in prescribing patterns and shall remain in effect only until such time as the endorsing practitioner can demonstrate a reduction in variation in line with his or her peers.
(b) A state purchased health care program may immediately designate an available, less expensive, equally effective generic product in a previously reviewed drug class as a preferred drug, without first submitting the product to review by the pharmacy and therapeutics committee established pursuant to RCW 70.14.050.
(c) For a patient’s first course of treatment within a therapeutic class of drugs, a state purchased health care program may impose limited restrictions on endorsing practitioners’ authority to write a prescription to dispense as written, only under the following circumstances:
(i) There is a less expensive, equally effective therapeutic alternative generic product available to treat the condition;
(ii) The drug use review board established under WAC 388-530-4000 reviews and provides recommendations as to the appropriateness of the limitation;
(iii) Notwithstanding the limitation set forth in (c)(ii) of this subsection (2), the endorsing practitioner shall have an opportunity to request as medically necessary, that the brand name drug be prescribed as the first course of treatment;
(iv) The state purchased health care program may provide, where available, prescription, emergency room, diagnosis, and hospitalization history with the endorsing practitioner; and
(v) Specifically for antipsychotic restrictions, the state purchased health care program shall effectively guide good practice without interfering with the timeliness of clinical decision making. Health care authority prior authorization programs must provide for responses within twenty-four hours and at least a seventy-two hour emergency supply of the requested drug.
(d) If, within a therapeutic class, there is an equally effective therapeutic alternative over-the-counter drug available, a state purchased health care program may designate the over-the-counter drug as the preferred drug.
(e) A state purchased health care program may impose limited restrictions on endorsing practitioners’ authority to prescribe pharmaceuticals to be dispensed as written for a purpose outside the scope of their approved labels only under the following circumstances:
(i) There is a less expensive, equally effective on-label product available to treat the condition;
(ii) The drug use review board established under WAC 388-530-4000 reviews and provides recommendations as to the appropriateness of the limitation; and
(iii) Notwithstanding the limitation set forth in (e)(ii) of this subsection (2), the endorsing practitioner shall have an opportunity to request as medically necessary, that the drug be prescribed for a covered off-label purpose.
(f) The provisions of this subsection related to the definition of medically necessary, prior authorization procedures and patient appeal rights shall be implemented in a manner consistent with applicable federal and state law.
(3) Notwithstanding the limitations in subsection (2) of this section, for refills for an antipsychotic, antidepressant, antiepileptic, chemotherapy, antiretroviral, or immunosuppressive drug, or for the refill of an immunomodulator antiviral treatment for hepatitis C for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks by no more than forty-eight weeks, the pharmacist shall dispense the prescribed nonpreferred drug.