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USP <800>By Stephanie C. Bennett, PharmD, BCPS;

Katelyn C. Felt, PharmD; and Robert P. Granko, PharmD, MBA

Prepare Pharmacy and Nursing for USP <800>

Each year, approximately 8 million health care professionals through-out the United States are exposed to hazardous drugs (HDs) in the workplace.1 Depending on the type, quantity, and duration of expo-sure, consequences can range from transient skin rashes to lifelong complications, including the development of reproductive issues

and malignancies. These risks can be minimized through the implementation of safety processes, including engineering controls and closed system drug-transfer devices (CSTDs), policies and procedures defining safe work practices, and the use of proper personal protective equipment (PPE).1 Several organizations have established guidelines pertaining to antineoplastic and other HD handling (see TEXT BOX).

Cone Health is a not-for-profit network of health care providers serving patients in multiple counties in North Carolina. The institution’s tag line—The Network for Exceptional Care—highlights its commitment to excellence. Cone Health has more than 100 locations, including six hospitals, three ambulatory care centers, three outpatient surgery centers, four urgent care centers, a retirement commu-nity, more than 75 physician practice sites, and multiple centers of excellence.

Recognizing the critical importance of ensuring the safety of those staff handling HDs throughout the medication-use process, Cone Health has made education on HD handling a priority. With the advent of proposed USP Chapter <800>, health systems throughout the US must establish programs, or strengthen existing ones, to address appropriate HD handling policies and procedures (P&Ps) and staff education, including training for pharmacy and nursing that focuses on supplemental engineering control education and the use of CSTDs.

NIOSH and ONS Recommendations Understanding the NIOSH and ONS recommendations for HD handling, and putting these recommendations into practice, are central to ensuring a safe work

environment for staff. NIOSH’s 2004 alert, Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, provides strategies for safe HD use by health care workers, which include4:

Assess the Hazards in the Workplace■ Evaluate the workplace to identify and assess hazards before staff begins

working with HDs. As part of this evaluation, guidelines recommend a re-view of:� Total work environment� Physical layout of work areas� Equipment� Equipment maintenance� Types of drugs handled� Volume, frequency, and form of drugs handled� Waste segregation, containment, and disposal� Waste handling� Spill response� Decontamination and cleaning procedures� All potential exposure risks, including HDs, blood-borne pathogens, and

chemicals used to deactivate HDs or clean drug-contaminated surfaces■ Regularly review the inventory of HDs and the corresponding protective

equipment and practices, seeking input from affected workers■ Conduct regular training reviews with all workers in areas where HDs are

used

Safe Handling■ Implement a safe handling program that is reviewed annually based on

workplace evaluation■ Develop procedures and provide training that encompasses safe handling,

spill management, proper equipment use, and PPE requirements ■ Incorporate specific drug manipulation techniques into P&Ps■ Establish general hygiene practices, such as not permitting eating or drink-

ing in all areas where drugs are handled

Use and Maintain Equipment Properly■ Develop workplace procedures for using and maintaining all equipment de-

signed to reduce exposure, such as ventilated cabinets, CSTDs, needleless systems, and PPE

Last updated in 2014, NIOSH maintains a list of antineoplastics and HDs found in the health care setting.6 The list is separated into three categories: anti-neoplastic drugs, non-antineoplastic drugs that meet one or more of the NIOSH criteria for an HD, and non-antineoplastic drugs that primarily have adverse re-productive effects.

USP <797> Pharmaceutical Compounding—Sterile Preparations2

http://www.doh.wa.gov/Portals/1/Documents/2300/USP797GC.pdf

USP <800> Hazardous Drugs—Handling in Health Care Settings3

http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf

NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Pub. No. 2004-1654

http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

Polovich M, ed. Safe Handling of Hazardous Drugs. 2nd ed. Oncology Nursing Society; Pittsburgh, PA: 20115

https://www.ons.org/store/books/safe-handling-hazardous-drugs-second-edition

TEXT BOXHazardous Drug GuidelinesThese guidelines reinforce the need for broad communication of best practices and the establishment of quality standards about which health care professionals must become educated.

By Stephanie C. Bennett, PharmD, BCPS; Katelyn C. Felt, PharmD; and Robert P. Granko, PharmD, MBAUSP <800>

Pharmacopeial Forum for public review, comments, and suggestions prior to final publication.

The Chapter emphasizes education and training for all staff members who may have involvement with HDs, with a strong focus on nursing and pharmacy personnel. For example, to protect against HD exposure, proposed USP <800> frequently notes the importance of CSTDs. First introduced in 1999, CSTDs are designed to contain HD drips, sprays, and vapors.9 Given their ability to protect both the health care worker and the environment, proposed USP <800> recom-mends the adoption of CSTDs during HD compounding and requires their use during HD administration for protection of the health care worker, patient, and environment.3 A few of the most important recommendations from proposed USP <800> that impact both nursing and pharmacy personnel include3:

1. Each entity must designate a qualified and trained individual to be respon-sible for developing and implementing HD procedures; overseeing entity compliance with this chapter and other applicable laws, regulation, and standards; ensuring competency of personnel; and ensuring environmental control of the storage and compounding areas.

2. All personnel who handle HDs are charged with understanding the funda-mental practices and related precautions and also are responsible for con-tinually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contami-nation of the work and care environment.

3. CSTDs should be used when administering HDs when the dosage form allows.

4. Personnel who may be exposed to hazardous chemicals must be provided information and training before the initial assignment to handle a hazard-ous chemical, and also whenever the hazard changes.

5. All personnel who handle HDs must be fully trained based on their job func-tions (eg, in the receipt, storage, handling, compounding, dispensing, and disposal of HDs). Training must occur before the employee indepen-dently handles HDs.

6. Personnel who transport, compound, or administer HDs must document their training according to OSHA standards and other applicable laws and regulations.

Keep in mind that while HD training often focuses on IV medications, proposed USP <800> applies to oral preparations as well. Precautions are necessary with any HD manipulation, including crushing tablets or opening capsules; these activities

ONS also has guidelines for the safe handling of hazardous waste. The second edition of Safe Handling of Hazardous Drugs was published in 2011 and includes information on drug administration, management of spills, safety measures, and details on the adverse effects of HDs.5

Introduction of USP <800>Proposed USP <800> builds upon Chapters <795> and <797>, with a strong focus on the requirements for receiving, storing, compounding, dispensing, administering, and disposing of HDs.7 Its purpose is to describe standards to promote patient safety, worker safety, and environmental protection.3,8 The development of proposed USP Chapter <800> has been ongoing for several years. Last year, the original draft of USP <800> was revised and reposted in

Device Manufacturer FDA Cleared

PhaSeal Becton, Dickinson & Co Carmel Pharma (original)

1998

Spiros ICU Medical 2005

Texium with Smart Site Carefusion (has joined BD) 2006

OnGuard with Tevadaptor B.Braun (US distributor) Teva Medical (manufacturer)

2006

ChemoClave ICU Medical 2008

Equashield Plastmed, Ltd (original) 2009

SureConnecta Baxter CorpBaxa (original) 2010

ChemoLock ICU Medical 2013

Vialshield Carefusion (has joined BD) 2013

Equashield II Equashield 2014aNot commercially availableTable courtesy of Fred Massoomi, PharmD, FASHP.

TABLE 1Evolutionary Timeline of Key CSTD Developments in the United States

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July 2015 ■ 17

must be performed within a contain-ment primary engineering control (C-PEC), using appropriate PPE. The PPE requirements in proposed USP <800> include two pairs of ASTM-tested chemotherapy gloves, which should be changed every 30 minutes or when the integrity of the gloves has been compromised; disposable gowns and head/hair/shoe covers; and eye and face protection. Addi-tionally, compounding equipment, including mortars, pestles, spatulas, etc, must be designated for use only with hazardous materials.3

Developing a USP <800> Management TeamMeeting the requirements of pro-posed USP <800> requires the development of a collaborative, cross-functional health-system team comprising representatives from both pharmacy and nursing, as well as any other departments that will be impacted, such as risk management and custodial care. This team should meet monthly until a USP <800> management plan is established, and quarterly thereafter.

CSTD TrainingAmong the team’s tasks is determin-ing which elements of CSTD use to include in the training programs for pharmacy and nursing. It is key that training for both professions focuses on pharmacy-nursing collaboration, the value of CSTDs, and how and when to use these devices properly. Emphasize each department’s respon-sibility to ensure safe HD compound-ing, handling, and administration.

Education and training also must address the limitations within current CSTD use. Gaps in contain-ment currently exist given issues such as the presence of contami-nation on drug vials received from the manufacturer; ampule-based drugs that require an open system for filtering; the lack of secured bag spikes, which carry the risk of the IV bag becoming unspiked from the closed system; and routes of administration, such as intraocular, intrathecal, intravesical, or topical, that may require open systems for administration.9 WAITING

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PHARMACY&Purchasing Products18 ■ July 2015 ■ www.pppmag.com

By Stephanie C. Bennett, PharmD, BCPS; Katelyn C. Felt, PharmD; and Robert P. Granko, PharmD, MBAUSP <800>

All quality improvement and training efforts should be institution-specific, with consideration given to the type and volume of hazardous material used.

ConclusionThe public comment period for proposed USP <800> ended on May 31, 2015. Release of the finalized regulation is anticipated for 2016, although the official date has not been set. The development and evolution of USP <800> reflects a strong focus on safety. Ultimately, the safe handling of HDs will rely on the pair-ing on proper equipment, such as CSTDs, with the proper training for all person-nel involved with HDs. Although the changes that are likely to be required under this new regulation may appear daunting initially, planning and training can ease the transition and help ensure safety for all. ■

References

1. Hazardous Drug Exposures in Health Care. Centers for Disease Control and Prevention Web site. www.cdc.gov/niosh/topics/hazdrug/. Accessed May 29, 2015.

2. USP <797> Pharmaceutical Compounding—Sterile Preparations. http://www.doh.wa.gov/Portals/1/Documents/2300/USP797GC.pdf. Accessed May 29, 2015.

3. USP <800> Hazardous Drugs—Handling in Healthcare Settings. http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf. Accessed May 29, 2015.

4. National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed May 29, 2015.

5. Polovich M, ed. Safe Handling of Hazardous Drugs. 2nd ed. Oncology Nursing Society; Pittsburgh, PA: 2011.

6. National Institute for Occupational Safety and Health. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf. Accessed May 29, 2015.

7. Page MR. USP <800>: New Regulations to Protect Health Care Workers from Hazardous Drugs. Specialty Pharmacy Times. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/april-2015/USP-800-New-Regulations-to-Protect-Health-Care-Workers-from-Hazardous-Drugs. Accessed May 29, 2015.

8. US Pharmacopeial Convention. Frequently Asked Questions <800> Hazardous Drugs—Handling in Healthcare Settings. http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. Accessed May 29, 2015.

9. Massoomi F. The evolution of the CSTD. Pharm Purch Prod. 2015;12(suppl 2):1.

10. Massoomi F, Neff W. Implementing a personnel surveillance program for hazardous drug safety. Pharm Purch Prod. 2008;5(4):2-5.

11. Occupational Safety and Health Administration. Controlling Occupational Exposure to Haz-ardous Drugs. OSH technical manual, TED 1-0.15A. Section VI. Chapter 2. https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html#surveillance. Accessed May 29, 2015.

12. National Institute for Occupational Safety and Health. Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs. http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf. Accessed May 29, 2015.

Stephanie C. Bennett, PharmD, BCPS, received her doctor-ate of pharmacy from Campbell University College of Pharmacy and Health Sciences. She completed her first year of postgradu-ate pharmacy residency at the Moses H. Cone Memorial Hospital

and is currently completing a hematology/oncology specialty residency at the Cone Health Cancer Center in Greensboro, North Carolina.

Katelyn C. Felt, PharmD, received her doctorate of pharmacy from Butler University and is currently completing her first year postgraduate pharmacy residency at the Moses H. Cone Memo-rial Hospital.

Robert P. Granko, PharmD, MBA, is the director of pharmacy at the Moses H. Cone Memorial Hospital. Previously, he was the as-sociate director of pharmacy at the University of North Carolina Medical Center. Bob received his BS in pharmacy from Long Island

University, his PharmD from the University of North Carolina at Chapel Hill, and his MBA from Pfeiffer University.

Five CSTDs have received FDA clearance, including PhaSeal, OnGuard, Spiros with ChemoClave/ChemoLock, Texium with SmartSite VialShield, and Equashield (see TABLE 1).7,9 Choosing the right CSTD for your organization requires collaboration between pharmacists and nurses. The decision should be evidence-based and should consider available literature demonstrating per-formance (ie, containment), ease of use, and cost effectiveness.

Institutions that are new adopters of CSTDs may pursue training programs available from each CSTD’s manufacturer. Several manufacturers have training modules or educational videos available on their Web sites, in addition to offering hands-on, onsite training. At institutions where CSTDs are already in use, phar-macy and nursing should develop training programs for new employees. Such pro-grams should incorporate both written and hands-on components to ensure new employee competency. Pharmacists or lead pharmacy technicians with experience in compounding with CSTDs and nurses with experience administering medica-tions using CSTDs should handle the hands-on training of new employees.

Outside Educational Opportunities Because familiarity with proposed USP <800> and data on CSTD use remain limited, exploring education opportunities that exist outside the institution can help address this deficit. Consider investigating:

1. Local presentations for nurses, pharmacists, and boards of pharmacy 2. Universal and broad health-system education for other personnel3. Continuing education presentations or other programs available through

local area health education centers 4. Case-based learning modules for ongoing education5. Auditing measures to ensure ongoing safety and compliance

Investing in CSTD TrainingTwo of the central investments required to develop CSTD training are the costs to implement a program and the time requirements of training. However, the costs and time associated with such an endeavor are insignificant when com-pared with the potential risks of HD exposure and when viewed in terms of the overall reduction that can be achieved in long-term health-care personnel mor-bidity and mortality.7,9 To ensure the overall success of an HD program, be cer-tain to procure the appropriate resources and allot sufficient time for employee training; in addition, assign experienced individuals to lead training activities.

Continual Quality ImprovementAfter initiating a training program, continual quality improvement should be-come the focus. Proposed USP <800> recommends that a qualified and trained individual be designated to create and implement procedures, oversee policy compliance, and develop competency reassessments, which should be per-formed at least annually, when new equipment is introduced, or when significant procedural changes occur.3 Additionally, NIOSH and OSHA suggest instituting a medical surveillance program for at-risk employees.10-12 Similarly, the proposed USP <800> regulation mandates that hospitals have P&Ps for medical surveil-lance and recommends testing and monitoring of staff for HD exposure through medical history, physical examination, laboratory studies, and biological moni-toring.2,3,7 One example of a surveillance program is outlined by Massoomi and colleagues as a four-tier program10:

■ Tier 1: self-surveillance (education efforts, notification of health changes)■ Tier 2: employer/supervisor surveillance (tier one activities plus trending

sick call types for high-risk employees, etc)■ Tier 3: comprehensive medical surveillance (tier one and two activities plus

medical and laboratory tests)■ Tier 4: post-exposure surveillance (medical tests, documentation of known

exposure, continual monitoring)