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Proposed USP Chapter <800> Update
December 2015 - Vol. 12 No. 12 - Page #8

Q&A with Patricia C. Kienle, RPh, MPA, FASHP, Director of Accreditation and Medication Safety for Cardinal Health

Pharmacy Purchasing & Products: What can you tell us about the nature of the comments received during the second round of review for proposed USP <800>?
Patricia C. Kienle: This round of review has produced a multitude of thoughtful, useful comments on every section of the chapter. Throughout the review process, USP has made it a priority to have multiple parties give full consideration to each comment. Numerous comments received during the second round of review were directed at clarifying the wording of proposed USP <800> to eliminate ambiguity and reduce confusion. In addition, USP received a number of comments related to facilities concerns. Some respondents indicated that compliance requirements should be stricter in certain areas; however, ideas that have not been published by USP for public comment cannot be added to the chapter.

PP&P: What are the most significant challenges to achieving compliance with hazardous drug (HD) management?
Kienle: One of the enduring challenges with ensuring the safe management of HDs in health care involves the culture of safety in health systems. Despite over 30 years of research illuminating the dangers to health care workers from improper handling of HDs, a culture of denial still permeates many organizations. There are those who fail to recognize that significant gaps may exist in their management of HDs, and that these gaps can contribute to health problems among staff members, including adverse reproductive outcomes (such as infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers. However, denial does not negate the reality of these risks. The purpose of proposed USP <800> is to provide standards to protect personnel and the environment when handling HDs. Ensuring that staff has a clear understanding of why proposed USP <800> is critical to safety is the first step. (For a thorough review of the available data discussing HD exposures in health care, see the Centers for Disease Control and Prevention Web site.1,2)

Another common challenge organizations encounter when endeavoring to improve HD management is identifying where to begin. The following three steps offer a practical starting point:

  1. Review the NIOSH list of HDs3 to identify which drugs and dosage forms are used at your hospital. This is the first hurdle to appropriate HD management. It is important to note that confusion remains between the HDs defined in proposed USP <800> that are hazardous to health care personnel and the hazardous materials defined by the Environmental Protection Agency (EPA) as hazardous to the environment. The confusion is due to the fact that the word hazardous is included on both lists, and some drugs are included on both lists. Proposed USP <800> addresses those medications that are hazardous to health care personnel.
  2. Each health system must address the facilities concerns in proposed USP <800>, which are not new; facilities requirements have been part of USP <797> since 2008. If a hospital meets current USP <797> standards, including the utilization of a negative pressure cleanroom and a positive pressure anteroom, they will be compliant with the facility requirements in proposed <800>. However, hospitals without a <797>-compliant cleanroom will require changes to comply with proposed USP <800>. For example, proposed USP <800> impacts facilities with either a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI) that is placed outside the negative pressure room. Although this has been allowed under <797> (provided a low volume of HDs is compounded), this is no longer permitted under proposed USP <800>; all HD compounding must take place in a separate negative pressure area designated for that purpose. That is probably the most challenging aspect of proposed USP <800> from a facilities perspective.

    In addition, hospitals that were noncompliant with <797> will require a complete overhaul to be compliant with proposed USP <800>. The responsibility is not pharmacy’s alone, as the administration likely will need to designate capital funds for facilities requirements to ensure compliance.

  3. Review other items in proposed USP <800>, including personal protective equipment (PPE) use, staff training, monitoring, policies for waste segregation and disposal, etc. It is important to consider all areas in the hospital and health system that handle HDs. For example, it is not uncommon for hospital pharmacies to be compliant, while the hospital’s freestanding oncology center, physician offices, and external clinics are not. Ambulatory oncology sites should be an area of particular concern for pharmacy. In fact, highlighting its commitment to protect health care workers from the harmful effects of exposure to HDs in ambulatory chemotherapy infusion areas, NIOSH is sponsoring a multisite study to examine oncology nurses’ use of PPE when handling chemotherapy (see SIDEBAR 1 for more information).

SIDEBAR 1
NIOSH Hazardous Drug Study

The DEFENS study (Drug Exposure, Feedback and Education for Nurses’ Safety: Study Protocol for a Randomized Controlled Trial) is a NIOSH-funded, cluster randomized trial that examines hazardous drug (HD) handling by nurses. The study will compare the efficacy of education (control) versus an audit and feedback intervention (treatment) on nurses’ self-reported use of personal protective equipment (PPE) when handling HDs. The treatment intervention will include tailored messages based on nurses’ reported barriers to PPE use. DEFENS will use blood samples and pharmacokinetic methods to detect the presence of HDs in plasma. The goal is for the study to result in improvements in health care worker safety.

The study began recruiting nurse participants from 11 major cancer centers in the US in April 2015. See http://www.defensstudy.org/ for more information.4


PP&P: How can pharmacy convey the importance of compliance with proposed USP <800> to administration?
Kienle: Employee safety is not a new concern; USP <797>, which was released in 2004 and revised in 2008, includes information about HD handling. Pharmacy should frame the discussion around the fact that the chapter is a federally enforceable standard. Moreover, proposed USP <800> affects employee safety, and, thus, is a risk issue. For this reason, the compliance discussion should include pharmacy as well as risk managers. Educate risk managers about the chapter’s content and purpose. Aligning with risk management is a highly effective means for ensuring pharmacy has the resources necessary to keep employees safe.

As state boards of pharmacy become more familiar with the requirements of sterile compounding practices, enforcement is likely to occur at the state level. CMS recently updated the pharmaceutical services requirements in the hospital Conditions of Participation (CoP) related to compounding,5 so there will be additional emphasis from CMS, state hospital survey teams, and accreditation organizations.

PP&P: What part do closed system drug-transfer devices (CSTDs) play in HD safety?
Kienle: Studies show that CSTDs reduce the frequency and amount of contamination on surfaces surrounding chemotherapy infusion.6,7 Proposed USP <800> recommends the use of CSTDs during compounding and requires use during administration (when the dosage form allows).8 Evaluating and choosing a CSTD can be challenging; be sure to involve pharmacy and nursing in the evaluation process.

In August of this year, NIOSH published a performance protocol for CSTDs for public comment (see SIDEBAR 2).9 The purpose of the protocol is to test a CSTD’s capability to perform as a closed system, and is intended to be used by manufacturers to evaluate CSTD prototypes, by hospitals to compare CSTD products, and by jurisdictions that want to adopt a protocol for a CSTD performance certification procedure. (A model CSTD certification statement is available in the appendix to reference 9.)

In addition, education must be provided to nursing that includes the rationale behind the use of CSTDs and the expectation that they will be used. The ideal CSTD is the one that both pharmacy and nursing use consistently.


SIDEBAR 2
A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Compounding and Administration of Hazardous Drugs

NIOSH Docket Number 288, CDC-2015-0075
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment, entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs.

The purpose of the protocol is to test a closed system transfer device’s (CSTD) capability to perform as a closed system. During an evaluation of the protocol, registered pharmacists, familiar with the use of CSTDs, tested the protocol’s prescribed compounding and administration tasks using five commercially available CSTDs. They also performed the assigned tasks using a negative control condition without a CSTD. Prescribed tasks were performed in a NIOSH-developed environmental test chamber with 70% isopropyl alcohol (IPA) as the challenge agent. A highly specific gas analyzer, with measurement capabilities specific to IPA and with a low limit of detection (LOD), was used to detect vapor concentrations of escaped IPA during the tasks. The protocol is not intended for CSTDs designed to operate using air-cleaning technologies. This protocol has multiple applications and can be used by manufacturers to evaluate prototype CSTDs, by consumers to compare CSTD products, or by jurisdictions wishing to adopt the protocol for a CSTD performance certification procedure.

A panel consisting of peer reviewers and stakeholders was asked to review and comment on the draft guidance document and protocol. NIOSH reviewed the recommendations of the peer reviewers, and stakeholders then made the final determination regarding document content, as well as the decision not to propose a specific pass/fail performance threshold. The protocol is being published for comment in CDC-2015-0075 and Docket Number NIOSH-288 and can be found at www.regulations.gov.

To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2015-0075 in the search field and click “Search.”

Public Comment Period
Comments will be accepted until 11:59 p.m. EST on March 8, 2016.

Written comments, identified by CDC-2015-0075 and docket number NIOSH-288, may be submitted by any of the following methods:

Federal rulemaking portal: Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov.

Mail: National Institute for Occupational Safety and Health
NIOSH Docket Office
1090 Tusculum Avenue
MS C-34
Cincinnati, OH 45226-1998

Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov.

Reference
Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs (August 2015). NIOSH Docket Number 288, CDC-2015-0075. http://www.cdc.gov/niosh/docket/review/docket288/default.html. Accessed November 13, 2015.


PP&P: What is the timeline for proposed USP <800> finalization and implementation?
Kienle: The Compounding Expert Committee announced on November 20, 2015, that USP has approved proposed USP <800>. The revised general chapter will be published on February 1, 2016, in the first supplement to USP 39-NF 34. USP standards usually become official 6 months after publication in the USP-NF. However, for high impact chapters and significant revisions, USP can extend the final implementation date for new standards. As such, the Expert Committee approved a delayed official implementation date of July 1, 2018, to allow entities more than 2 years to implement the chapter.10

PP&P: Will there be any conflicts between proposed USP <797> and proposed USP <800>?
Kienle: No. In fact, in the proposed changes to <797>, which are available for public comment now, the chapter states that proposed USP <800> should be consulted for guidance on handling HDs. USP has a process for harmonizing the two chapters; once both chapters are official, there will be no conflict.

The proposed revisions to General Chapter <797> were published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov-Dec 2015] on November 2, 2015, and are available at:  http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf.

References

  1. Centers for Disease Control and Prevention. Hazardous Drug Exposures in Health Care. http://www.cdc.gov/niosh/topics/hazdrug/. Accessed November 12, 2015.
  2. Centers for Disease Control and Prevention. Occupational Exposure to Antineoplastic Agents and Other Hazardous Drugs. http://www.cdc.gov/niosh/topics/antineoplastic/. Accessed November 12, 2015.
  3. Centers for Disease Control and Prevention. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138_v3.pdf. Accessed November 12, 2015.
  4. DEFENS (Drug Exposure Feedback and Education for Nurses’ Safety) Web site.
    http://www.defensstudy.org/. Accessed November 16, 2015.
  5. DHHS Centers for Medicare & Medicaid Services. Center for Clinical Standards and Quality/Survey & Certification Group. Ref: S&C: 16-01-Hospital. Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf. Accessed November 19, 2015.
  6. Vyas N, Turner A, Clark J, et al. Evaluation of a closed-system cytotoxic transfer device in a pharmaceutical isolator. J Oncol Pharm Pract. 2014;Jul 29. Epub ahead of print.  
  7. Clark BA, Sessink PJ. Use of closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J Oncol Pharm Pract. 2013;19(2):99-104.
  8. USP Website. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. http://www.usp.org/usp-nf/notices/compounding-notice. Accessed November 13, 2015.
  9. Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs (August 2015). NIOSH Docket Number 288, CDC-2015-0075. http://www.cdc.gov/niosh/docket/review/docket288/default.html. Accessed November 13, 2015.
  10. United States Pharmacopeia. General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings to be Published in USP 39-NF 34, First Supplement. http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings-published-usp-39-nf-34-first-supplement. Accessed November 20, 2015.

Patricia C. Kienle, RPh, MPA, FASHP, Director of Accreditation and Medication Safety for Cardinal Health, is a member of the USP Compounding Expert Committee and chair of the Hazardous Drug Subcommittee and Expert Panel, although her comments herein are her own and not official information from USP.

 

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