Get ready for the new USP hazardous medications standards

In February 2016, the U.S. Pharmacopeial Convention published Chapter <800> Hazardous Drugs-Handling in Healthcare Settings, which sets standards for handling these drugs. Although those standards will not be implemented until July 1, 2018, the countdown is on- and health-system pharmacists and others who deal with hazardous drugs need to start getting ready now, if they have not started already.

The standards will be enforceable by the FDA, state pharmacy boards, and the Joint Commission. This makes understanding what they entail of vital importance to pharmacists and anyone who uses these drugs.

A symposium about ensuring readiness for USP Chapter <800> was held at the 51st Midyear Clinical Meeting and Exhibition of the American Society of Health-System Pharmacists in Las Vegas. A poll of those in attendance or listening to the symposium via webinar found that 12% said that their organization was already in full compliance with Chapter <800> standards. However, 20% clicked yes to “We are in trouble.” 

Chapter <800> applies to all health care personnel who handle hazardous drugs and all entities that store, prepare, transport, or administer these drugs, with no exceptions based on size or type of facility or on the amount of drugs used, said Martha Polovich, PhD, RN, Director of the PhD Program at Byrdine F. Lewis School of Nursing and Health Professions Georgia State University in Atlanta. There is a three-fold purpose to the standards: patient safety, worker safety, and environmental safety, she noted. Environmental safety refers to safety within the workplace. “There is plenty of time to be in compliance, but it is not too early to start,” she said.

The first step in compliance is to compile a list of hazardous drugs being used or stored, which will determine which parts of Chapter <800> apply, Polovich said. The second step is to create an interdisciplinary team because the effort must be organization-wide since it runs from pharmacy practice to nursing and every part of an organization where hazardous drugs might be handled or used, she added.

The National Institute of Occupational Safety and Health (NIOSH) created a list of hazardous drugs in 2014 and categorized them into three groups, (See box) said Ryan A. Forrey, PharmD, MS, FASHP, Director of Pharmaceutical Services at Emory University Hospital Midtown in Atlanta. The three groups are antineoplastic drugs, all of which have reproductive hazards; non-antineoplastic drugs, some of which have reproductive hazards; and drugs that have reproductive hazards only, he said. These groupings do not indicate a level of risk, he added.

Three Types of Hazardous Drugs

· Antineoplastic drugs*

· Non-antineoplastic drugs**

· Drugs that have reproductive hazards

*All of which have reproductive hazards

**Some of which have reproductive hazards

Each organization or entity needs to create an assessment of risk based on which hazardous drugs they handle, Forrey said. “Anyone who would come in contact with a hazardous drug has to be involved in the assessment of risk process.”  He noted that a hazardous drug in tablet form might not pose much risk, but if a nurse crushes the tablet to put in applesauce for a patient, there is a greater risk. If the patient then vomits after receiving the drug, there is a risk to the personnel who clean the mess up.

Engineering controls must meet the Chapter <800> standards, Forrey said. There are several types of primary and secondary engineering controls that may be required based on the hazardous drugs used in a facility. A primary control is a device such as a biological safety cabinet that minimizes worker exposure to a hazardous drug, he explained. A secondary control is the room in which the primary is placed, one that might need negative air pressure and several changes of air per hour.

These types of safety equipment, along with personal protective equipment, are intended to protect nurses and other employees, said Polovich. Training must be done across the organization. Forrey added that the nursing staff needs to understand what the risks are and why the protective equipment needs to be used consistently and correctly.

In each facility or entity, someone must be assigned to oversee compliance, training, and review certifications for Chapter <800>, said Jeannell Mansur, PharmD, FASHP, FSMSO, CJCP, a principal consultant with the Medication Management and Safety Joint Commission Resources Joint Commission International in Oak Brook, IL. This person must understand the chapter and the risks of hazardous drug exposures. There will be a lot of documents that will need to be developed and standard operating procedures that must be created. “It is a considerable assignment,” she said.

However, there are resources to help. “There are tools that have been created for you to see where you are in compliance with <800>,” Mansur said. The Joint Commission has created a self-assessment tool that is available online at http://www.hazmedsafety.com. There is also a book, Safe Handling Practices for Hazardous Drugs, that contains information, checklists, and training materials, and which is also available at the same website, she added. 

In addition, USP has a list of frequently asked questions about Chapter <800>.

The symposium was to have been led by Thomas H. Connor, PhD, Research Biologist with NIOSH and the CDC in Cincinnati. Connor could not attend.