Hazardous Drug Handling in Light of USP <800>

February 2015 - Vol.12 No. 2 - Page #18
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Q&A with Seth Eisenberg,
RN, OCN, BMTCN
 

Pharmacy Purchasing & Products: What is pharmacy’s responsibility for educating nurses on compliant hazardous drug (HD) handling practices?
Seth Eisenberg: First, it is important to understand that while pharmacy curricula include HD handling education, nursing curricula may not. Many nurses gain most of their HD training from mentors, colleagues, educational courses, and lectures, and are significantly influenced by the culture in which we practice. Each organization supports its own safety culture; depending on the hospital, HD safety practices may be emphasized, downplayed, or even ignored. With the support of pharmacy leadership, nursing managers can gain insight into acceptable practice at the bedside and ensure that nurses are practicing safely. 

Nurses need to understand the serious risks associated with handling HDs. Despite the wealth of information and clinical guidelines available, many nurses still are risking exposure. Only by acknowledging the existence of these risks can we develop the foundation for a comprehensive safety program. 

Pharmacy and nursing departments can collaborate in a number of ways. Pharmacy-sponsored, unit-based inservices can help clarify the dangers associated with HDs. This education is particularly vital when these agents are administered in non-oncology settings. Patients being cared for in general medical and surgical units, for example, receive HDs, but nurses working in these areas may be unaware of the dangers because they do not administer HDs as often as nurses working in other areas of the hospital. Similarly, some medications (eg, ganciclovir) are not considered chemotherapy, yet require the same level of safe handling precautions. 

In addition, collaboration between the nursing and pharmacy departments is critical when testing, selecting, and implementing a closed system drug-transfer device (CSTD). During the evaluation process, keep in mind that a device that is ideal for pharmacy use may be untenable for nursing. If a CSTD unnecessarily complicates the administration process or is too difficult to use, it even may be discarded. Prior to evaluating CSTDs and conducting a pilot study, nursing and pharmacy should meet to identify the concerns of both departments. While choosing a single device is clearly preferable, it is possible to implement a hybrid system whereby a different device is used in each department. 

PP&P: What should a comprehensive HD plan include?
Eisenberg: The National Institute for Occupational Safety and Health (NIOSH) and the Oncology Nursing Society (ONS) have been quite clear that a comprehensive HD plan must be implemented. The plan should be specific (ie, who is responsible for each element and what steps must be taken) and detailed (eg, what constitutes proper PPE for drug administration, the proper procedure for cleaning spills, etc). 

When developing a plan, involve managers and staff, all of whom must understand the problem and the policies and procedures (P&P) in place to protect health care workers. In addition, securing the support of management is paramount. Collaborative development of an HD medication list, which serves as a reference for how medications are to be handled throughout the organization, is especially important. Be sure to include P&Ps for handling oral HDs, as often nurses are responsible for crushing or manipulating an oral dosage form for patients who are unable to swallow. Finally, the plan should require regular audits; without regular auditing, practice drift is likely and hard won safety gains may be lost.

Effective HD management is contingent not only on developing a robust handling plan, but also on enforcing internal P&Ps designed to protect nurses and pharmacists. All staff should understand that adhering to safe handling P&Ps is mandatory and expected. Annual safety reviews can serve to reinforce the content of policies and the expectation that they are followed. Intentional failure to follow written policies should meet with implementation of the institution’s normal disciplinary process. This is particularly salient as staff members who see other staff violate policies without consequence may engage in similar practice violations, knowing there will be no repercussions. 

PP&P: How will proposed USP Chapter <800> affect HD handling and administration?
Eisenberg: The overwhelming majority of nurses are unaware of USP and its stance on HDs. This is not surprising, as USP historically has focused on drug compounding rather than administration. USP <797> was the first document to address HD management, but USP <800> describes a cradle-to-grave approach, that, when adopted, will require significant practice changes for nurses who administer HDs. Initially, nurses may have difficulty understanding why USP—arguably not a nursing organization—is dictating their practice. Open dialogue will help answer questions and alleviate concerns. 

  • CSTD Use During Drug Administration. One of the most significant changes detailed in <800> is the requirement to use CSTDs during drug administration. While CSTDs are recommended in the ONS1 and NIOSH2 guidelines, they have not been required. Interestingly, USP <800> does not require CSTDs for compounding; however, when a hospital adopts a CSTD for drug administration, it may be an opportune time to implement a CSTD for drug preparation as well. Whether used for compounding or for administration, to varying degrees, CSTD adoption will require practice changes. Hands-on education provided by the manufacturer, is the best way to ensure the devices are being used correctly. This cannot be overemphasized, as facilities have experienced increases in HD spills after initial CSTD implementation due to improper use. After implementing CSTDs, quality audits must be performed to ensure compliance and, if required, foster a change in workplace culture. Audits can be performed a number of ways, including via spot checks or peer audits during the nursing bedside verification steps.
  • Double-Gloving Requirement. USP <800> requires double gloving during drug administration. While the double-gloving requirement was published previously in the NIOSH Alert and ONS guidelines, neither of these organizations have enforcement power; thus, double gloving had been considered a best practice guideline, but will be required by USP<800>. This, too, will require additional education and likely changes in glove supply, as the outer glove may need to be a larger size than the inner one. 
  • Manipulation of Oral Agents. If USP <800> is adopted, manipulating oral agents at the point of administration will no longer be acceptable. This change will affect pharmacists’ workloads and perhaps drug delivery models. 

USP <800> will create a number of challenges for both pharmacy and nursing departments. However, it also creates an opportunity for interdepartmental collaboration and for ensuring that all staff members who handle HDs receive the education and protection they deserve.

References

  1. Polovich M, ed. Safe Handling of Hazardous Drugs. 2nd ed. Oncology Nursing Society; 2011.
  2. NIOSH Alert. Preventing Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH) Publication Number 2004-165, September 2004. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed January 13, 2015. 

 


Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 29 years in hematopoietic stem cell transplantation associated with the Fred Hutchinson Cancer Research Center. 

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