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Proposed Rule Changes from the Ohio Board of Pharmacy: Comments due 9/8 & 9/12

Client Alert

Over the past several months, the Ohio Board of Pharmacy has been busy drafting important amendments to its rules for outpatient and institutional pharmacies. Last month it proposed two packages of rules that are currently in review and open to public comment. These rules cover topics like staffing shortages, quality assurance programs, required reporting, and medication error reporting. BMD can help you comment on the rules (even after the deadline)! Read on for details.

Proposed New Rule: O.A.C. Rule 4729:5-3-21

Comments Due 9/8

The Ohio Board of Pharmacy’s first proposed new rule would require every outpatient and institutional pharmacy licensed as a terminal distributor of dangerous drugs to establish or participate in an established quality assurance program to document and assess medication errors. Following implementation, all medication errors discovered by a pharmacy will be subject to an investigation within three business days of the identification of the error and a quality assurance review within thirty days of identification of the error.

The Board will require that each individual quality assurance program be managed in accordance with written policies and procedures. Further, a record of any quality assurance review must be immediately retrievable in the pharmacy. The record should contain the following: (1) the date, location, and participants in the quality assurance review; (2) the pertinent data and other information relating to the medication error(s) reviewed and documentation of any patient contact required; (3) the findings and determinations generated by the quality assurance review; and (4) any recommended changes to pharmacy policies or procedures.

The new rule also dictates that when a pharmacist determines that a medication error has occurred and the drug was administered to or by the patient or the medication error resulted in a clinically significant delay to therapy, the pharmacist must 1) “communicate to the patient or the patient's caregiver the fact that a medication error has occurred, and the steps required to avoid injury or mitigate the error” and 2) “communicate to the prescriber the fact that a medication error has occurred” as soon as possible.

Amendments to Duty to Report Rules: O.A.C. Rule 4729:1-4-02

Comments Due 9/8

The Ohio Board of Pharmacy made minor amendments to its “duty to report” rules for pharmacists, pharmacy interns, and pharmacy technicians. The Board placed a time expectation on its general reporting requirement, requiring a pharmacist who has knowledge from direct observation or objective evidence to report bad behavior to the Board within ten days of discovery. Additionally, an error in dispensing—which is an act or omission of clinical significance relating to the dispensing of a drug—is required to be reported to the Board only in accordance with the Board’s proposed new rule: Rule 4729:5-4-02 of the Administrative Code. The “duty to report” rules for pharmacists are identical for pharmacy interns, see O.A.C. Rule 4729:2-4-02, and technicians, see O.A.C. Rule 4729:3-4-02.

Proposed New Rule: O.A.C. Rule 4729:5-4-02

Comments Due 9/8

Another proposed new rule creates a new duty to report for pharmacies. The rule would require every pharmacy licensed as a terminal distributor of dangerous drugs to report to the Board, from direct observation or objective evidence, any error in dispensing when the error is the result of reckless behavior. The Board defines reckless behavior as a person acting with “heedless indifference” to consequences and disregarding a “substantial and unjustifiable risk that the person's conduct is likely to cause a certain result or is likely to be of a certain nature.” O.A.C. Rule 4729:5-4-02. Pharmacies are also required to report any error in dispensing where the error (1) contributes to or results in temporary harm to the patient that requires hospitalization; (2) contributes to or results in permanent patient harm; (3) requires intervention necessary to sustain life; or (4) contributes to or results in the patient's death.

Moreover, pharmacies will also be mandated to report the termination or resignation of any individual licensed or registered by the Board that was based, in whole or in part, on an error or errors in dispensing; on engaging in unprofessional conduct or dishonesty; or on the individual being addicted to or abusing alcohol, drugs or other chemical substances or impaired physically or mentally so that they are unfit to carry out their professional duties.

Reports required by the proposed new rule must be made in writing, either by mail, using the Board's online complaint form, or by telephone, and must include the following information: (1) the name of the employer and the employer's terminal distributor license number; (2) the full name and license or registration number of the licensee or registrant for which a report is being made; (3) an explanation of the error in dispensing that occurred; (4) an explanation of the circumstances that resulted in the individual's termination or resignation, if applicable; and (5) the date(s) of and place(s) of occurrence(s), if known. Reports for dispensing errors and employee termination/resignation must be furnished to the Board within ten days from the date the error or termination/resignation occurred.

Proposed Rule Changes: Minimum Standards and Working Conditions

Comments Due 9/12

On August 11, 2023, the Ohio Board of Pharmacy released new draft rules aimed at remediating current problems with pharmacy understaffing. In drafting the rules, the Board relied on reports that workers in large, understaffed chain pharmacies—including CVS, Walgreens, and Kroger—are unable to safely do their jobs because of staffing problems. For example, inspection reports of a chain of CVS pharmacies in Ohio found severe understaffing, unsanitary conditions, expired drugs on pharmacy shelves, and little to no safety controls on dangerous drugs.

The proposed rule changes eliminate and prohibit quotas in the provision of ancillary services in an outpatient pharmacy. O.A.C. Rule 4729:5-5-02.1. Ohio’s biggest chain outpatient pharmacies reported that pharmacy must meet quotas for ancillary tasks not related to filling prescriptions, including calling patients to refill their prescriptions and to obtain vaccinations. These ancillary tasks, in the aggregate, prevented pharmacy workers from timely and efficiently filling their queue of thousands of prescriptions.

Additionally, the proposed rules require pharmacies to increase their staff and set a maximum time to fill prescriptions to avoid a “significant delay” in filling a prescription. See O.A.C. Rule 4729:5-5-02.4. A “significant delay” is defined as 72-hours (3 days) between a patient, provider, or caregiver submitting a script and the pharmacy dispensing the prescription. See O.A.C. Rule 4729:5-5-02.4. Every “significant delay” by the pharmacy would result in a violation of the pharmacy’s license.

Another proposed a rule requires pharmacies to “ensure sufficient personnel to prevent fatigue, distraction, or other conditions which interfere with a pharmacist’s ability to practice with reasonable competence and safety” (O.A.C. Rule 4729:5-5-02). The rule dictates that staffing levels should not be determined solely by prescription volume but also by the requirements of pharmacy personnel during working hours. This specific rule change would cost CVS $25 million a year; Walgreens $17 million a year; Kroger $14 million a year; and Walmart $10 million a year, per the Board’s estimate.

Moreover, to ensure safe staffing levels, outpatient pharmacies are now required to create and implement a process to address staffing concerns. See O.A.C. Rule 4729:5-5-02.3. Pharmacies must also develop and implement policies that allow pharmacists to 1) limit their provision of ancillary services if they will negatively impact patient access to medications and 2) limit pharmacy access points which interfere with a pharmacist's ability to practice with reasonable competence and safety. See O.A.C. Rule 4729:5-5-02.5.

Lastly, the proposed rules allow pharmacists to stop performing non-pharmacy functions if necessary for employees to receive proper breaks and to perform their jobs safely. See O.A.C. Rule 4729:5-5-02.2. Except in a documented emergency that would endanger the health and safety of patients, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs cannot require pharmacy workers to work more than twelve continuous hours in any workday and must allow workers to have at least eight hours off between consecutive shifts. See O.A.C. Rule 4729:5-5-02.2.

Submitting Comments

The full packages of proposed rules and comment submission instructions can be found on the Board of Pharmacy’s website. For more information on the rules and help with drafting comments, please feel free to reach out to BMD Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Partner Ashley Watson at abwatson@bmdllc.com.

 


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