Logical Approach Enhances Safety, Protects Patients

Pharmacy Practice in Focus: Health SystemsJanuary 2021
Volume 10
Issue 1

Maintain vigilance to decrease chance of adverse effects, problems with storage and compliance of hazardous drugs.

Requirements for handling of hazardous drugs (HDs) have been part of US Pharmacopeia (USP) chapter <797> since 2004.

They appear separately in general chapter USP <800>, which was officially released in 2016 and became official on December 1, 2019. USP <800> was implemented to oversee the handling of HDs and promote environmental protection and patient and worker safety. Now that USP <800> is surveyable, officials can see how organizations are doing with complying with the receipt, storage, compounding, dispensing, and administration of HDs.1

For pharmacies to address USP <800> issues, an internal review would need to be conducted of engineering controls, environmental quality, personal protective equipment (PPE), and more. This list of considerations may appear overwhelming, but it is critical to address them, keeping in mind the hierarchy of controls. To identify a manageable starting point for a facility, pharmacists can use a checklist in the American Society of Health-System Pharmacist’s (ASHP) Pharmacy Quick Reference Guide.2

Assign responsibility. Identifying a key employee who will ensure compliance with this initiative is essential. This individual should have obtained the proper training in HD preparation and handling. Additional training may be required related to internal assessments of compliance. HDs have regulations from several different entities, including the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health (NIOSH), and USP <800>, so having a single contact point is paramount.1 It is often the state board of pharmacy inspector ensuring compliance, so having a single person establishing a dialogue with the pharmacy board is also a best practice.1,2

This individual’s responsibility will include editing the facility’s policies and procedures according to feedback and guidelines; ensuring ongoing compliance; and training the person who will help manage the changes with employees. In some cases, this may be a full-time job, whereas in others, depending on the organization’s scope and size, these responsibilities may be tacked on to an existing role.1,3

Determine what HDs are stocked. Create a comprehensive list of HDs available in the facility. Per USP <800>, an HD is any identified as such by NIOSH based on carcinogenicity, developmental toxicity or teratogenicity, genotoxicity, organ toxicity at low doses in animals or humans, and new drugs that mimic existing HDs in structure or toxicity.1

Once this list is written, additions and deletions should be made as medications are added and removed from inventory. Also, there must be a mechanism to allow staff members to understand when they are working with an HD.

Using pharmacy informatics, staff members may be extremely helpful in flagging potential HDs and generating future reports.

Develop and implement a plan. Review the requirements for the safe handling of hazardous medications, create a gap analysis, or use one already written by others such as the ASHP or Critical Point. Perform the gap analysis not through a paper trail but through direct observation of the work being done.4,5

After creating a list of HDs, determine the potential for employee exposure to each via a risk assessment, as shown in the Table.This assessment should include an overview of how each drug is used and by whom, potential exposure, the consequence of such exposure, containment strategies to minimize this risk, and contingency plans for how to address potential exposure. Through this process, organizations can understand the scope of HD use and how it applies to them and prioritize compliance actions based upon the risk identified.

The gap analysis and risk assessment create an organized action plan to address facility-specific areas with the highest risk to patients and the workforce. Practices identified as high risk should be corrected or stopped. PPE should be available in areas where it is needed.

Maintain the program. Once a facility has conducted its gap analysis and rewritten policies and procedures ensuring compliance, employees must be trained on the new procedures and document to ensure ongoing adherence to policies. It is vital to maintain momentum to engage employees’ knowledge and understanding and enforce policy and procedures changes. There should be ongoing direct observations of the work being done to review and correct any procedure breaks.


Although the safe handling of HDs is undoubtedly complex, a logical approach can help facilities enhance workplace safety and protect patients. Remember, safe handling is not a 1-time event. Maintain vigilance to mitigate the chances of adverse effects associated with HD exposure. For additional information, facilities may review free resources on the USP’s website, including its overview and FAQ sections.1

KENNETH MAXIK, MBA, MBB, is vice president of operations support CompleteRx in Houston, Texas.CRAIG KIMBLE, PHARMD, MBA, MS, BCACP, is director of experiential learning, manager of clinical support services, and associate professor of pharmacy practice, administration, and research at Marshall University School of Pharmacy in Huntington, West Virginia.ALBERTO COUSTASSE, DRPH, MD, MBA, MPH, is a professor of health care administration at the Management and Healthcare Administration Division at Lewis College of Business at Marshall University.


  • USP general chapter <800> hazardous drugs—handling in healthcare settings. Accessed December 15, 2020. https://www.usp.org/compounding/ general-chapter-hazardous-drugs-handling-healthcare
  • American Society of Health-System Pharmacists. Chapter 800. Accessed December 15, 2020. https://www.ashp.org/search?q=Chapter%20800
  • CDC. Hierarchy of controls. National Institute for Occupational Safety and Health (NIOSH). Updated January 13, 2015. Accessed December 15, 2020. https://www.cdc.gov/niosh/topics/hierarchy/
  • Critical Point. Tools & rresources. Accessed December 15, 2020. https:// www.criticalpoint.info/tools-resources/
  • Petroff B. USP 800 resource. American Society of Health System Pharmacists. April 3, 2017. Accessed December 15, 2020. https://connect. ashp.org/blogs/barbara-petroff/2017/04/03/usp-800-resource?ssopc=1

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