(a) For purposes of this regulation, "reportable incident" and "incident" shall mean a preventable medication error involving a prescription drug and resulting in any of the following:
- (1) The patient receiving the wrong drug;
- (2) the patient receiving an incorrect drug strength;
- (3) the patient receiving an incorrect dosage form;
- (4) the drug being received by the wrong patient;
- (5) inadequate or incorrect packaging, labeling, or directions; or
- (6) 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.
- (b) For each pharmacy other than a medical care pharmacy, the pharmacist-in-charge shall ensure that procedures exist requiring each pharmacist who becomes aware of a reportable incident to report the incident to the pharmacist-in-charge as soon as practical.
(c) As soon as possible after discovery of the incident, the pharmacist shall prepare a report containing 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 number of each licensee 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.
For each pharmacy, the pharmacist-in-charge shall ensure that procedures exist requiring that the incident report be maintained in the pharmacy for at least five years in a manner so that the report can be provided to the board or its representative within three business days, upon request.
- (d) The preparation of an incident report that meets the requirements of this regulation shall be the responsibility of each pharmacist involved in the incident and the pharmacist-in-charge. The maintenance of incident reports as required by this regulation shall be the responsibility of the pharmacist-in-charge.
(Authorized by K.S.A. 65-1630; implementing K.S.A. 2007 Supp. 65-1626 and K.S.A. 2007 Supp. 65-1626d; effective Feb. 7, 2003; amended Oct. 24, 2008.)