Automated IV compounding: A path to cost containment, patient safety and regulatory compliance

Ensuring clinically sound, cost-effective medication therapy is a critical function of pharmacists.

Yet addressing the costly and potentially dangerous process of sterile IV compounding—one of the most complex and risky pharmacy operations— continues to challenge most health systems. Many turn to third party providers to support their sterile compounding needs, despite ongoing FDA documented issues of “high risk” compounding sterility and safety lapses similar to those that caused the 2012 New England Compounding Center (NECC) case - where unsanitary conditions resulted in over 800 people infected with meningitis and 64 deaths.

The evidence underscoring the inherent dangers and potential for error with common sterile IV compounding processes cannot be denied. Industry statistics point to wrong drug or diluent selection and subsequent mislabeling errors in one out of every 100 IVs. Additionally, compounding errors have been found in up to nine percent of prepared solutions. Many hospital leaders argue bar code medication verification can help reduce these errors, so the need for IV compounding automation is minimal – however, less than 20% of hospitals regularly use this type of verification in the initial compounding stage. And bar code medication administration at the bedside cannot detect, prevent or safeguard against upstream errors in the IV compounding process.

Implementing automated robotic technology, which leverages gravimetric controls to provide greater dose accuracy, mitigates the potential for human contact and error, supporting a safer and more sterile means of IV preparation. Leveraging automation also creates a complete audit trail with documentation for regulatory compliance – and most importantly, puts facilities on the path to safer, more cost effective operations.

While just 5% of hospitals in the United States have implemented robotic IV compounding, these early adopters are already seeing measurable benefits in terms of safety and reduced costs. At one 570-bed teaching hospital in the United States, compounding its most common drugs in-house saved them almost $470,000 compared to purchasing “prefills.” Additionally, many hospitals that decide to insource see cost savings within a time frame of two years, while some facilities see them in as soon as a few months. In addition to the savings, hospitals that insource have complete control of their IV quality assurance process.

Promoting Patient – and Employee – Safety

The Drug Quality and Security Act (DQSA) created laws for better visibility into how medications are transported, stored, and tracked. Additionally, the Institute for Safe Medication Practices updated their guidelines for medication compounding, deeming the once popular syringe “pull-back” IV dose verification method as an unsafe means of dosing medications. In ISMP’s updated best practices for hospitals in 2016-2017, the organization supports technology-enabled workflows that reduce the risk of harmful errors.

Hazardous drug compounding is another area where the use of automated IV robotics is extremely beneficial for compliance with safety and cleanroom standards while also reducing costs. When preparing or transporting these medications, healthcare workers often put themselves at risk of harmful exposure, particularly as most hospitals and clinics today are not compliant with the breadth of USP 800 protective requirements. This lack of compliance to best practice and OSHA regulatory requirements found in USP 800 will likely result in civil litigation and some industry turmoil as the new requirements become the standard for worker safety.

Adding to the urgency of this shift, the USP Chapter <800> becomes official on July 1, 2018, which creates handling requirements that help ensure the safety of employees. Some mandates include maintaining a designated hazardous negative pressure cleanroom with proper air ventilation and the use of approved protective equipment.

As industry trends point toward increased sterile compounding activity within hospitals and health systems, patient and staff safety considerations must be placed at the forefront. Rather than outsourcing the problem as a means of circumventing risk, hospital leaders should look toward embracing the insourcing process to better control cost and quality for the benefit of their patients.

About John P. Barickman, BS Pharm, MBA, FACHE

John Barickman is the Senior Executive Pharmacy Consultant of IV Automation at Aesynt, an Omnicell company. Previously, John spent 18 years with the Main Line Health System in suburban Philadelphia, PA where he was director of pharmacy at Bryn Mawr Hospital and VP of Operations at Lankenau Hospital.

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