Drug delivery: How MGH is minimizing risks and enhancing regulatory compliance

Patient safety is every healthcare organization's top priority. News stories like New England Compounding Center's 2012 fungal meningitis outbreak serve as a stark reminder that drug delivery must be a strategic priority for administrators, pharmacy directors and chief pharmacy officers.

                           This content is sponsored by Fresenius Kabi

At Becker's Hospital Review's 10th Annual Meeting in Chicago, Fresenius Kabi hosted a workshop to explore how healthcare systems can minimize the risks associated with drug delivery and enhance regulatory compliance. Michael Sanborn, president and CEO of Baylor Scott & White All Saints Medical Center in Fort Worth, TX, and Christopher Fortier, PharmD, chief pharmacy officer of Massachusetts General Hospital, shared their experiences in this area.

The drug delivery landscape

Regulatory compliance for drug delivery is necessary and is critical to ensuring patient safety. Healthcare providers, administrators, and institutions  can easily jeopardized their reputation with a single patient safety sentinel event. In addition, the cost implications are significant.

While regulatory compliance is complicated, it is imperative that healthcare organizations develop expertise in this area. USP 797 and USP 800 are the standards relevant to sterile compounding. The Joint Commission, CMS and state boards of pharmacy all perfom routine scheduled as well as unscheduled hospital inspections.

"The Joint Commission is taking a closer look at sterile medication compounding during surveys, " noted Dr. Fortier. "Auditors are gowning up, going into IV rooms and examining them. They are also requesting considerable documentation. You have to have your ducks in a row."

Healthcare organizations have four primary options for acquiring compounded medications:

  1. In-house compounded IV solutions. This is a relatively low-risk option, since most in-house compounds are used immediately.
  1. Centralized (owned) compounding. Organizations may compound in a central location and then ship to facilities. This is a more complex and higher risk approach.
  1. Buying products originally packaged, without adulteration, from the manufacturer. This is one of the best and safest options. Many manufacturers are willing to work with organizations that use unique compounds.
  1. Outsourced compounding. This is highly risky because outside compounding pharmacies may not have safeguards in place. "This area has significant regulatory holes," Mr. Sanborn explained. "While the FDA regularly inspects national manufacturers' plants, this is not the case with standalone pharmacies."

MGH's hybrid drug delivery approach

Massachusetts General Hospital is a 1,000-bed academic medical center in Boston and one of the two flagship hospitals within the Partners HealthCare system. MGH has taken a hybrid approach to IV drug delivery, which includes:

  • In-house ambulatory oncology infusion pharmacy. This includes one positive-pressure room and two negative-pressure rooms, along with two separate anterooms for redundancy.
  • Centralized compounding. Rather than using a traditional, standalone compounding pharmacy, Partners works with a major generic drug manufacturer to build a facility that compounds drugs exclusively for the system's hospitals. The facility includes in-house labs and extra storage.

Recommendations for developing a drug delivery strategy

Mr. Sanborn and Dr. Fortier offered five tips for healthcare leaders who are responsible for creating drug delivery strategies:

  1. Develop a rigorous Request for Information when evaluating compounding pharmacies. Detailed guidelines published by the American Society of Health-System Pharmacists can be a helpful resource.
  1. Implement stringent screening procedures when selecting compounding pharmacies. A best practice is to tour facilities in person to ensure you are familiar and understand their compounding processes and quality processes. When creating contracts, include performance requirements.
  1. Encourage physicians to use manufacturer prepared ready-to-administer drugs whenever possible. Although manufacturer-prepared products may be slightly more expensive, the safety, quality, labeling, and potential decreased risk in patient harm and lawsuits far outweigh that cost.
  1. Consider technologies like IV automation. Hospitals must view IV automation as an investment in safety and efficiency. This expenditure is unlikely, however, to reduce pharmacy headcount.
  1. Make sure the pharmacy team is engaged. Remember that pharmacy technicians play an important role in regulatory compliance for IV compounds. Leading hospitals invest in and pay technicians competitively, train them and help them elevate their practice.

Mr. Sanborn emphasized that any substance brought into a healthcare organization must be subjected to tremendous scrutiny from a safety perspective. Dr. Fortier added, "You must constantly strive to do the right thing, push the limits and exceed the regulatory requirements. Compliance is complicated, but it has to be a strategic priority."

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