Is Your Hospital Prepared for Chapter Guidelines? Here’s What You Should Be Doing Now.

Health-system pharmacists and others dealing with hazardous drugs have July 1, 2018 top of mind. This is the date when the US Pharmacopeial Conventions’ Chapter <800> Hazardous Drugs Handling guidelines go into effect. Announced in February, 2016, hospitals are beginning to prepare, with many health systems needing to overhaul their medication handling protocols to meet the new guidelines.

These standards, which are enforceable by the FDA, state pharmacy boards, and the Joint Commission, look to ensure safety and could have serious licensing and fiscal implications. At the American Society of Health-System Pharmacists’ Annual Midyear Meeting, a symposium was held to discuss these changes. Among attendees, only 12% said their organizations were in full compliance with Chapter <800> standards and 20% self-reported that they are in trouble.

Given the guidelines hope to improve patient safety, worker safety, and environmental safety, it’s not too late to get started, and certainly not the time to panic. Members of the symposium offered some guidance for organizations on where to start and what can be done now:

  • Compile a list of hazardous drugs being used or stored. This will determine which parts of the Chapter <800> guidance apply to your organization.
  • Create an interdisciplinary team to evaluate proposed changes. Any effort must be done organization-wide as medications are handled and used in multiple practice areas, running from pharmacy to nursing.
  • Develop a risk assessment based on which hazardous drugs are handled. The National Institute of Occupational Safety and Health (NIOSH) has already categorized hazardous drugs into three groups, which provides a framework for this assessment. Hospitals must also consider the mechanism of delivery when evaluating risk, and real-world situations, such as vomit cleanup, where additional workers would be exposed.
  • Understand what modifications may need to be made to engineering controls to meet the new standards. This is best to do early as training for how to use new safety or personal protective equipment often needs to be conducted across the organization.
  • Assign someone to oversee compliance, training, and review certifications. While some tools have been created to see where organizations are in compliance with <800>, many documents and standard operating procedures will need to be developed for each unique organization.

More information about the new standards, as well as a self-assessment tool from the Joint Commission, can be found online at

Related articles:

Pharmacy Today

U.S. Pharmacopeial Convention

Pharmacy Practice News

Leave a Comment

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s