Tragic events can occur at any time, but avoidable ones somehow seem worse. In 2012, 64 people died and more than 700 people became ill due to a nationwide fungal meningitis outbreak. After an investigation, it was determined the cause of the outbreak was due to contaminated steroid injections prepared by a compounding pharmacy.

United States Pharmacopeia (USP) is a compendium of drug information which is published annually and establishes written and physical standards for medicines, food ingredients, dietary supplement products, and ingredients which are also used by regulatory agencies and manufacturers to help ensure that these products are of the appropriate identity, as well as strength, quality, purity and consistency.

One such standard, USP <797> Pharmaceutical Compounding – Sterile Preparations, implemented in 2004, was created to ensure quality and safety for compounded products. USP 797 details a number of factors, including HVAC systems, clean room requirements, humidity, temperature and pressure factors, additional equipment, personnel training and gowning requirements. It also includes equipment maintenance specifications, approved cleaning solutions, testing procedures and standard operating procedures that should be implemented. So if this standard was in place since 2004, how did such a disastrous event occur eight years later? The answer: non-compliance.

“Regarding USP 797, the number one reason for non-compliance is usually budgetary constraints,” said Katrina Harper, PharmD, MBA, BCPS, senior clinical manager, pharmacy sourcing operations at Vizient. “Hospitals may contend they can’t afford it, but that’s not an option.”

Regulatory agencies are now cracking down on hospitals regarding compliance with USP 797 and on October 30, 2015, CMS added it to their conditions of participation. This means any facility that receives Medicare/Medicaid funding must comply with USP 797, regardless if their state pharmacy board enforces it or not. Failure to do so can cost a facility accredited status and may place the facility in immediate jeopardy.

The path to USP 797 compliance

“The question I get asked most often is, ‘Does compliance fall under the good-to-have category or is it a must-have’ and the answer is, it’s definitely a must-have,” Harper said. “The next question is ‘Can this process be broken down into stages?’ And the answer is, yes it can.”

Harper advises the first step is to conduct a gap analysis.

“Once you know the scope of the regulation and identify what your gaps are, the next step is to address anything that requires a capital purchase or construction,” Harper said. “That typically requires six months to a year before it can be completely implemented.”

Additional tasks include adjusting standard operating procedures, which covers the need for correct gowns, gloves, bolsters and transport devices. In comparison to construction, these are smaller purchases but can add up quickly. A hospital must also plan on staff education, which is a substantial cost whether it’s funding online training or pulling hospital employees away from their normal duties. A hospital must also implement quality assurance elements. For example, sterile compounding rooms require certification every six months.

Hospitals can utilize online tools to guide them through this process and Vizient consultants can conduct the gap analysis, as well create an action plan and implementation strategies arranged by priority.

Coming to your hospital soon: USP 800

While USP 797 covers all facets of sterile compounding and is aimed at protecting the patient, USP 800 is aimed at protecting health care workers who come in contact with hazardous drugs.

The most hazardous drugs are chemotherapy-related, but other concerns include drugs that may pose a reproductive risk to women who are pregnant, trying to conceive or breastfeeding. There are 264 drugs that are considered hazardous."USP 800 is not just a pharmacy issue, it’s an “everyone” issue,” said Harper. “This includes nurses, transporters, etc. Anyone who potentially comes into contact with hazardous drugs has to follow all of the requirements of USP 800 to achieve compliance by July 1, 2018.”

Tools and resources to help achieve compliance

To assist members with ensuring they achieve and maintain compliance, Vizient offers information, education and expert resources. For information, members can request numerous resources regarding USP 797 and USP 800 compliance, such as documents and links to gap analysis procedures. These informational resources help pharmacy or facility leaders quickly assess where they stand in terms of compliance and where they need to focus efforts if needed.

Regarding education, members can request slide decks and webinar recordings from previous presentations and webinars where Harper has presented this subject matter.

Vizient also offers a consulting solution where professionals will visit the facility to conduct a gap analysis, prepare a customized action plan and assist with the implementation.

Harper advises that even before conducting a gap analysis, the first move must be to make senior leadership aware of the existence of USP 797 and USP 800, and that failure to comply with these standards could affect Medicare/Medicaid funding, cause immediate jeopardy or in a worst-case scenario, lead to patient deaths or workplace harm for care providers.

"Action needs to be taken now. It’s not something that can be put off any longer,” Harper said.

For more information on complying with the USP 797 and USP 800 standards or to request informational or educational resources, please contact Katrina Harper. To inquire about a Vizient consulting solution, please contact Gregory Gousse.

For additional insight and strategies to help your organization anticipate trends affecting pharmacy practice, click here to see the latest Vizient Drug Price Forecast.

Published: July 20, 2017