Ensure Compliance of Your Pharmacy’s Systems and Workflow Processes

January 27, 2023
Satish V. Poondi, Esq.

The New Jersey Board of Pharmacy regulation N.J.A.C. 13:39-1.9 (Continuous Quality Improvement Program) took effect in October, whereby a pharmacy permit holder and registered pharmacist-in-charge must implement a continuous quality improvement program (CQI) to detect, identify, and prevent prescription errors.

The primary purpose of the CQI is to advance error prevention by analyzing, individually and collectively, investigative and other pertinent data collected in response to a prescription error to assess the cause and any contributing factors, such as system or process failures.

Per the new regulation, a pharmacy permit holder must use the findings of its continuous quality improvement program to develop pharmacy systems and workflow processes designed to prevent prescription errors, as well as communicate those findings to all pharmacy personnel.

Pursuant to N.J.A.C. 13:39-1.9, the CQI Program developed by the pharmacy must include at minimum the following documentation as part of its policies:

  • Incident reports;
  • Resolutions;
  • Root cause analyses;
  • CQI program meeting minutes and attendance records; and
  • Corrective action plans.

Additionally, the pharmacy must also include policies and procedures relating to its

  • Internal incident reporting system;
  • Assessment of prescription errors to determine the cause of the error; and
  • The appropriate response to the error.

The new regulations also require the pharmacy to conduct a meeting at least once every three months, to discuss the results of, and any issues identified from, the continuous quality improvement program, and any corrective action plans. Meetings must be conducted in-person or through live, interactive webinars and must include, at a minimum, those personnel involved in an error under review and their supervisors.

The pharmacy permit holder must document that pharmacy personnel who did not attend the CQI meeting have received the CQI meeting minutes, and that the pharmacy permit holder has communicated any changes to policies and procedures resulting from a CQI meeting with those personnel affected by such changes.

Note that for a pharmacy that submits quality-related events to a patient safety organization (PSO) for primary quality improvement, the Board will deem the pharmacy as having a continuous quality improvement program if the PSO satisfies the minimum requirements of this regulation.

It is anticipated that future Board of Pharmacy inspections will include a review of the pharmacy’s adherence to the requirements set forth above. Accordingly, pharmacies are encouraged to implement policies and procedures in this regard.

If you have any questions about this alert or would like to speak to an attorney, please contact the author Satish Poondi, Esq. at spoondi@tisslaw.com or (973) 533-1000