HealthJune 05, 2015

Sterile Compounding and the Evolving Regulatory Landscape

For decades, the healthcare industry has attempted to establish and advance the adoption of standardized best-practice guidelines around sterile compounding. A high-risk process within pharmacy operations, sterile compounding can present great opportunity for error and negative impacts to patient safety as evidenced by research from Pew Charitable Trusts, an organization that documented over 25 compounding errors with 1,049 adverse events and 89 deaths since 2001.1

While USP Chapter <797> went into effect in 2004 as the first official and enforceable compounded sterile preparations chapter in USP National Formulary, compliance until recently had been highly variable because state Board of Pharmacies were responsible for adopting and enforcing the standard. Renewed focus on compounding processes is changing the trajectory of USP 797 adoption as states increasingly look to these guidelines as the industry "gold standard of practice."

Over the past three years, there has been a lot of activity on the compounding regulatory front, and many experts agree that the volume will only increase going forward.  Consider that between 2012 and 2013, states proposed 25 new regulations and passed 10 into law, and since 2012, there have been 54 recalls by compounders, two-thirds of which involved sterile medications. Further blurring the lines and adding to the confusion, the federal government has recently staked a regulatory claim in the sterile compounding space through such efforts as the Compounding Quality Act in 2013 and the Drug Quality and Security Act.

While USP 797 is a far-reaching regulation that affects nearly every aspect of compounded sterile preparations in any setting, the proposed USP Chapter <800> (USP 800) is expected to significantly expand and up the ante on compliance and competency surrounding hazardous drugs compounding. Designed to more fully address the scope of hazardous drugs, the new standard is expected to be published and adopted within the next few years.

Simply put, healthcare organizations must be prepared for heightened compliance expectations. Clinical leaders must commit to deploying necessary resources to meet new these new USP standards for enhanced patient and staff safety. As the national and state regulatory landscape continues to evolve and the lines become increasingly blurred, healthcare organizations will also need to stay abreast of trends, expectations, and requirements relative to compounded preparations, whether out-sourced or done internally.

Faced with the complexities of compliance alongside limited resources, many clinical leaders are turning to automated compliance monitoring and education as the answer. Simplifi 797 offers more than 30 expert-based policies and procedures compliant with USP 797 and 25 well-tested forms as a compliance and quality management solution.

Staff can easily manage all tasks and schedules associated with USP 797 compliance through a dynamic dashboard design. APCE-approved sterile compounding training equating to 30 hours of CE credit is also available with direct links to USP 797 standards.

By reducing the burden associated with manual tracking and paper-based documentation, hospital pharmacies can significantly reduce time associated with USP 797 by deploying Simplifi 797. Plus, automatic noti?cation of overdue tasks, exceptions and out-of-range measurements ensures compliance and greater safety for staff and patients.

1 U.S. Illnesses and Deaths Associated With Compounded Medications. The Pew Charitable Trusts
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Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.