Compliant Handling & Adverse Event Reporting

Implementation Date: 10/2021

Date of Last Revision: 3/6/2023

Next Review Due: 5/2023

 

Reviewed by VTH Administrative Team: 10/2021

Reviewed by VTH Board: N/A

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Policy

This document outlines the process for handling complaints and ensuring the safety of drugs and products. This applies to all items that are dispensed (including compounds) that cover complaints reported by clients. When an adverse event or complaint is reported, necessary steps will be taken to ensure it has been followed through and corrective action may be applied.

Guidelines

The Medication Dispensary director will take necessary steps to ensure the safety and quality of drugs and products. In the case of a compliant or product recall, staff will follow up with the applicable protocol. 

Procedure (if applicable)

1. When compounding medications, precautions and steps are taken to ensure the quality of the product. Compounding sheets are documented with the Date, Lot # of the day, initials of person compounding and the witness doing a second verification. The bulk compounding ingredients are also documented with the Manufacturer, Expiration and bottle Lot #. Expiration dates of the finished compound are calculated out to best suit the drug stability with appropriate storing conditions. When a compound is dispensed, an extra label is printed and attached to that particular Compound Lot Sheet to document all clients who have received that bottle if corrective action ever needs to be taken.
2. When a client reports a complaint about a drug, the receiver will consider the situation factors (such as shipment times, packing and weather conditions) when the drug was dispensed/compounded and when the client picked up the medication. The receiver will then make the best judgement on answering and transfer the questions and concerns to the pharmacist. If the animal is having strong reactions to the medication, the pharmacist will advise them to discontinue taking the medication and transfer them to speak with their doctor.
3. If a product is recalled, staff will follow the Medications Recalled protocol and replace free of charge, if a replacement is available. If a product needs to be returned/replaced for incorrect dosing or other reasons, the Dispensary will investigate to see which department should be fittingly charged. 

Definitions (if applicable)

Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic.