Recall/Discontinuation Notice Policy



Effective Date: 04/02/02

Review Date: 03/24/08___

POLICY: RECALL/DISCONTIUATION OF MEDICATION AND VACCINES

SUMMARY: In the event of a medication recall/discontinuation, SCHC has developed the following procedure to assure that patients are properly notified.

DESCRIPTION:

1. The Pharmacist or Provider will notify the Pharmacy & Therapeutic committee members of any recall or discontinuation. The P&T Committee will meet to determine what action will be taken by SCHC.

2. The P&T committee may determine from the following actions.

A. No action needs to be taken. If this action is taken, the pharmacist will document that the P&T committee met, the course of action decided upon and the rationale for that action, including members consulted, date, and time.

B. If SCHC determines to act on the medication recall, then a report will be generated from the pharmacy computer to track patients who may have received the recalled prescription and will also review the sample medication log book to determine if SCHC has carried the lot numbers affected.

C. SCHC may notify patients affected by phone or letter depending on the recommendations made from the manufacturer regarding the severity of the recall/discontinuation situation.

1. If phone calls are used, phone calls will be documented in the chart and on the Recalled Medication Notification Form (03-PHA-1023).

2. If letters are used, the letter will contain a self addressed letter that the patient will send back to the clinic documenting that the patient was notified of the recalled/discontinued medication problem.

3. If the patient is notified, the contact with the patient will be documented in the chart by the person making the contact.

D. If there is a vaccine recall/discontinuation, the IRIS system will be reviewed to determine if SCHC has ever carried the lot number affected. If the Health Center has been affected, a report will be generated from the IRIS System to determine what patients have received the specific vaccine.

1. For those patients that have received a lot number, the provider team will make all necessary attempts to reach the patient by phone or letter. The Health Center staff will follow the recommendations made by the manufacturer who is initiating the recall. The Recall/Discontinued Notification Form will be utilized to track patient notification.

3. All Notification Forms will be given to the Pharmacist who will report to the P&T Committee the method taken for the recall/discontinuation. This

information is to include how many patients are involved, as well as how many were contacted. This information is to be documented in the P & T Committee meeting notes.

COO Signature: Signature on File

CEO Signature: _ Signature on File

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