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Kansas News: Continuous Quality Improvement
Published in the September 2009 Kansas State Board of Pharmacy Newsletter
In July 2008, the Board of Pharmacy began requiring each retail pharmacy to establish a continuous quality improvement (CQI) program. Hospital pharmacies are exempt from establishing a CQI because they are already required to do so under risk management procedures. CQI works because it brings pharmacy errors into the open without fear of reprisal, and it is important because it places the patient first and stresses patient safety as the highest priority.
The Board’s first step with this legislation was to amend the incident report regulation. Previously, a retail pharmacist was required to report all errors whenever they became aware of an alleged or real error in filling or dispensing a prescription. The amended regulation now defines a reportable incident as a preventable medication error involving a prescription drug in any of the following:
♦ the patient receiving the wrong drug;
♦ the patient receiving an incorrect drug strength;
♦ the patient receiving an incorrect dosage form;
♦ the drug being received by the wrong patient;
♦ inadequate or incorrect packaging, labeling, or directions;
or
♦ the dispensing of a drug to a patient in a situation that
results in, or has the potential to result in, serious harm
to the patient.
An incident report must be filed as soon as possible after
the discovery of the incident. The pharmacist shall prepare
a report that contains the following information:
1. the name, address, age, and phone number of any complainant,
if available;
2. the name of each pharmacy employee and the license
or registration number of each employee involved;
3. the date of the incident and the date of the report;
4. the pharmacist’s description of the incident;
5. the prescriber’s name and whether or not the prescriber
was contacted; and
6. the signatures of all pharmacy employees involved in
the incident.
The incident report should no longer provide a description of the actions taken as a result of the incident and it should not state any steps taken to prevent a recurrence. The incident report must be maintained for a period of five years and be made available to the Board or its representative within three business days upon request. The preparation of the report fulfills the requirement related to incident reports and it is the responsibility of the pharmacist involved in the incident and the PIC to see that the report is completed in a timely manner. The second portion of the pharmacy’s responsibility is to develop a CQI program. The Board drafted the minimum requirements of a CQI program. It requires the retail pharmacy to have a meeting every quarter to review all incident reports generated during the last quarter. The Board has required that each pharmacy conduct a meeting by September 30, 2009. As the Board could not anticipate the size of each pharmacy and the number of employees at each pharmacy, the minimum requirement is that the meeting be attended by the PIC. The Board envisioned that the meeting would be attended by not only the PIC, but the pharmacy manager, the quality supervisor, staff pharmacists, and pharmacy technicians. Each incident should be reviewed and discussion should ensue to determine what steps should be taken to avoid such a recurrence in the future. A report of the meeting should be documented with at least a minimum of who attended the meeting, the list of incident reports reviewed, and a description of the steps taken or to be taken to prevent a recurrence of each error.
Obviously, the regulation can only provide guidance for minimum requirements in order to provide best practices to the pharmacy community. The products that are being dispensed have the ability to cause serious harm and many patients cannot fully appreciate the risks associated with taking medication. Some negligence in the course of human endeavors is predictable and expected. Each pharmacy has a responsibility to develop and maintain a comprehensive CQI program even though the Board is legally requiring the minimum. There are tools available, such as continuing education, that will assist pharmacies in developing a CQI program that will contribute significantly to patient safety. Training materials will not only address staffing issues, workflow issues, communication issues, formulating solutions, process improvements, etc, but will also assist the pharmacy in providing assistance with their documentation. The records that a pharmacy maintains can make a difference in avoiding misunderstandings and ultimately medication errors. Therefore, the Board encourages every retail pharmacy to use risk management techniques and tools when forming their CQI program. A team approach gives everyone an opportunity to express ways to improve their system. This will provide
for the health, welfare, and safety of the patient as well as protection to the pharmacy from avoidable litigation.
In conclusion, it will help the pharmacy if everyone understands their role in the process, how errors are made, and what improvements can be made to prevent medication errors. CQI requires commitment in order for it to be successful.
