New Wisconsin Patient Consultation Rule Affecting Resident and Non-Resident Pharmacies to Take Effect on January 1, 2021
Health & Life Sciences Alert 12/02/20 Susan Brichler Trujillo, Richard B. Davis, Christopher M. Guthrie
Written Counseling Still Permissible…With Exceptions
After a long year largely consumed by the COVID-19 crisis, the new Wisconsin pharmacy rules are set to take effect on January 1, 2021. These constitute an entire rewrite of the rules governing the practice of pharmacy. Due to the potential impact on mail order pharmacies, the Quarles & Brady Pharmacy Team has been closely tracking the evolution of the new patient consultation rule via a series of articles (10/25/19, 10/30/19, 11/05/19, 11/19/20, 11/25/19, and 01/14/20).
The Wisconsin Pharmacy Examining Board (the "Board") and the Wisconsin state legislature ultimately adopted the final draft version of the rule, imposing the following requirements on resident pharmacies and those holding a nonresident Wisconsin pharmacy permit:
- A prescription drug or device delivered by common carrier, mail, or delivery service, or picked up at a drive through window shall include a copy of information which is Board-approved stating a patient’s rights to pharmacist consultation and information on how to file a complaint to the Board. A copy of the relevant "delivery insert" is available here.
- A pharmacist must consult the patient or patient’s agent for every new prescription which has not been dispensed previously to the patient, any change in the patient’s therapy, upon request of a patient or patient’s agent, and whenever it is in the pharmacist’s professional judgement that a consultation should occur.
- The patient may refuse consultation.
- Consultation may occur via written materials which contain any of the following information that, in the pharmacist’s professional judgment, serves the best interest of the patient:
- Name and description of the drug
- Form, dose, route of administration, and duration for drug therapy
- Intended use of the drug and expected action
- Directions and precautions for preparation, administration, and use
- Common severe side or adverse effects or interactions, and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur
- Techniques for self-monitoring drug therapy
- Action to be taken in the event of a missed dose
- Proper storage and appropriate disposal method of unwanted or unused medication
- While an offer to counsel may accompany any such written materials (and it is likely a best practice to do so), an offer to counsel alone is not likely sufficient to meet the new Wisconsin consultation requirement
- The consultation required in this section shall be communicated verbally when in the pharmacist’s professional judgment it is in the best interest of the patient. The final version of this provision differs from the Board’s initial proposal, which would have required that patient counseling be communicated verbally unless, in the pharmacist’s professional judgement, it would not be in the best interest of the patient or if it would not practicable. The Board declined to provide specific examples of when verbal counseling may be in the patient's best interest, but it may be advisable to flag particularly complex or dangerous drugs for a telephone follow-up if the drug is dispensed via the mail or other delivery service.
- When a consultation is required, a pharmacist must provide a "written patient drug education monograph." The new Wisconsin rule does not define this term. Accordingly, the intent here is likely to follow the typical industry understanding of a drug monograph, which is generally characterized as a written supplement to the oral counseling patients receive from pharmacists when the medication is dispensed.
- The consultation required under the new rule may occur before or after delivery of the prescription to the patient or patient's agent
The full text of the Board’s pending rule with plain language summary is available here.
For more information on how the pending rule changes may affect your business, please contact your Quarles & Brady attorney or: