Thursday, December 23, 2010
What PPE should be worn when compounding in an isolator located outside of the cleanroom?
<797> states that the manufacturer has to provide supporting evidence that garbing is not required. However, the main concern herein is the potential exposure from the handling of hazardous drugs. We do not want our staff exposed to contamination on the outside of vials, so at a minimum, gloves should be worn along with shoe covers to limit the spread of contamination. So, while the chapter defaults to the manufacturers’ recommendation, consider the products that are being compounded and assign garb requirements accordingly. As well, include these requirements in your policies and procedures manual so employees have clear guidance on safe practices. Clear, consistent policies that are not subject to interpretation are key to a successful pharmacy operation. Furthermore, the pharmacy director should enforce these policies with vigorous management to ensure they are followed consistently. Keep in mind the adage: People respect what others inspect.