The Risks of Automated Compounding of IV Products

The last couple of years we have recorded a serious upswing and increase of use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of such technology we’ve seen an increase in the risks and sources of contamination of compounded products when prepared with an IV automation workflow machine. Currently there are many TPN compounder manufacturers on the market, such as Epic, Baxter, Baxa, MedKeeper, Omnicell, ICU medical and many other players in this segment. We’ve been carefully monitoring the responses regarding these types of machinery whenever there was an inspection by the FDA at a facility that houses and uses such technology. Pretty much all oversights noticed issues with the proper placement of the IV compounder in the working area; issues that either exposed the operator to risks or cases where the technician contaminated the product.

Reducing Risks of Exposure to HDs

Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving.

What is USP <800>?

 

Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed.  The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” This same organization also sets standards for general pharmacy practice.

Percentage of USP 797 & USP 800 Compliance

 

 

Updated Compounding Rules Could Affect Cleanroom Design

 

While all three chapters address cleanrooms, USP <795> is the first (of two) to have its revisions made public and, accordingly, provides facility owners with the first opportunity to provide public comment or seek clarification. Section four of the Proposed Revision to GC <795>, which covers Buildings and Facilities, states:

503B Audits and Services

 

 

 

 

Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements.

USP Compounding General Chapters Now Available for Public Comment

 

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.

Choosing Proper PPE for USP <800>

This article discusses appropriate hazardous drug (HD) personal protective equipment (PPE) for USP <800> compliance, including gloves, gowns, shoe covers, sleeve covers, donning and doffing, and PPE disposal. It also covers the appropriate respiratory protection, eye and face protection, and hair covers.

 

Time to Start your Compliance process

 

Complying with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating all of the regulations very challenging.

Choosing Engineering Controls Under USP 800

 

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these products.