struggle toward compliance

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P HARMACY&Purchasing Products

As Seen InDecember 2009 Vol. 6 No. 12

Stericycle28161 N Keith Dr, Lake Forest, IL 60045

847-367-5910 www.stericycle.com


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From the Editorial Director

Just as we are becoming more aware of the growing dangers fromimproperly disposed medications leaching into our drinking watersupply, so are the many regulatory bodies that oversee pharmacy. The resulting regulatory pressure is driving many changes in

approaches to pharmaceutical waste management. In a bid to betterunderstand where pharmacy practice stands today, Pharmacy Purchasing& Products conducted the second annual Going Green survey of health-system pharmacy waste processes.

Survey DesignIn the fourth quarter of 2009, PP&P polled a random, nationwide sam-pling of health system directors of pharmacy. We asked about their phar-maceutical waste management practices, expenditures, regulatory com-pliance, and staff training methods. Responses were solicited via e-mail,and we received a total of 260, yielding a confidence interval of 5.94 (95%+/-5.94) based on the total population of DoPs nationwide.

We intentionally surveyed a random sampling of DoPs, not just read-ers of PP&P to ensure our data reflects trends across the whole of hospi-tal pharmacy practice. We were pleased to learn that 61% of DoPs nationwide use PP&P as a resource for information on pharmaceutical wastemanagement.

Investing in ComplianceDespite an overall tightening of hospital budgets, the commitment toenvironmental protection in general and to compliant pharmaceutical waste management in particular increased this year. This was backed up

by significant growth in spending in 2009 and an expectation that spending and the commitment to compliant waste management will continueto increase over the next few years. In fact, 66% of DoPs would considepurchasing off-contract or even higher priced products to meet their insti-tutions environmental objectives.

Investing in developing compliant practices became more imperativethis year as EPA and state inspectors have demonstrated increased com-fort with the regulations and issued significantly more recommendationsand citations to hospitals. Forty-five percent of inspected facilities havreceived a recommendation or been cited. Given that RCRA violationscan result in fines of up to $37,500 per violation, per day, developing thexpertise necessary to manage pharmaceutical waste is crucial not only toensuring a facilitys environmental responsibility but also its financihealth. Nonetheless, 43% of hospitals have no plan to establish a budgetfor managing pharmaceutical waste. Without a solid financial commitment from pharmacy and administration, attaining compliant practices will be a daunting assignment.

Challenges for PharmacyPharmacy is well aware of the challenges they face in achieving compance given the complexity of the regulations and a lack of in-house experise. Most facilities report that their RCRA-regulated and non-hazardous waste practices are not in compliance, although hazardous chemotherapyand controlled substance waste management compliance rates faredsomewhat better.

DoPs demonstrated increased awareness of proper waste stream dis-

posal for many hazardous drugs this year. Fewer facilities are disposing o warfarin >0.3 mg in the regular trash and red sharps bins, for exampleHowever, those properly using RCRA-hazardous containers for disposalof this P-listed product and other hazardous drugs are still in the minority

A major impediment to establishing compliant practices is the dearthof expertise among pharmacy staff. Most DoPs report that their staff isnot sufficiently knowledgeable about hazardous pharmaceutical wastepractices. This is not surprising given that only 27% of facilities providformal education on pharmaceutical waste management. Those pharma-cy leaders who do provide training have recognized the value of comprehensive education and provided this training to staff much more regularlythis year. Of note, the small number of facilities that require risk managerand administrators to receive waste training along with the clinical stafreport much higher rates of compliance for RCRA-regulated waste.

ConclusionIn addition to the potential cost of fines, the potential cost to employeeshealth and our environment from improper waste stream disposal shouldbe deemed completely unacceptable by pharmacy and the hospital admin-istration. Just as pharmacy is responsible for ensuring patients receive safand effective medication, pharmacy must also lead the drive for ensuringsafe and proper drug disposal.

The Struggle toward Compliance

Deanne Halvorsen

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The challenges that led Thomas Jefferson University Hospitals(TJUH) to seek external assistance for pharmaceutical wastedisposal compliance were common enough. Most hospitalsare concerned with EPA and The Joint Commission (TJC)compliance, as well as the liability of potential harm to

patients, staff, visitors, and the environment. At TJUHwhich includes themain campus with 750 beds, Methodist Hospital with 250 beds, and Jefferson Hospital for Neuroscience with 120 bedsthe pharmacy operationis decentralized to meet the needs of each facility. We wanted our pharma-ceutical waste program to effectively do the same.

While the initiation of a pharmaceutical waste program was led by ourenvironmental services (EVS) and pharmacy departments, the processinvolved a multi-departmental pharmaceutical work group. This groupconsisting of representatives from nursing, nurse education, accreditation,facilities, risk management, safety and health, infection control, informa-tion systems, and sustainabilitywas collectively excited about the variousbenefits of such a program. Their cooperation was integral to the success-ful implementation.

In-house vs. Outsource We wanted to get ahead of the compliance curve by initiating a program thatlinked our organizations goals with TJC standards and regulatory require-ments. Given the complexity and sensitivity of TJCs 21 hospital standards, weknew a comprehensive turnkey solution was necessary.

The first step in this process was to determine which pharmaceuticals werehazardous and if proper disposal could be managed in-house. We also consid-

ered non-hazardous drugs that are damaging to the environment. We decidedthat the potential cost and risk to staff was such that an outsourced provider would be our best option. We wanted a service that could provide a wastecharacterization that segregated the formulary by EPA and DOT wastestreams and identified the compatibility of hazardous and non-hazardouspharmaceuticals based on chemical content.

Finding the Right VendorSome vendors we reviewed had program plans and characterization capabili-ties, others focused on hazardous waste disposal only. We wanted a vendor with national experience that could share best practices and coordinate costcontainment strategies with us. We chose Stericycles pharmaceutical wastecompliance program in part because it uses a system of checks and balancesto assess where we are and where we need to be. Implementing the programinvolved a four-phase approach:

I Identification of formulary characterization and waste coding :Stericycle provided the characterization within one week of submit-ting our formulary, and continues to provide updates as we add new

products. Additionally, Stericycle provides us with a comprehensivannual report. TJUH identifies drugs on patient labels and in ADCsusing simple codes on each container, thereby ensuring proper dis-posal.

I On-site education of pharmacy, nursing, and EVS staff : Staff weeducated on how to properly interpret the simple waste codes witha particular focus on proper disposal of partial IVs with instilledmedication. Continued drain disposal of plain IVs (electrolytessaline, and dextrose) and proper disposal of controlled substancesalso was reinforced.

I Implementation of color-coded, reusable containers : Having a vaety of container sizes and mounting options (wall brackets, floor dollies, etc) allowed us to address challenges related to space.

I Transportation and destruction : Stericycle technicians collect anbring full containers to a central accumulation area a few times each week where they pack the waste. The fully packed containers arpicked up from this location on a weekly basis. The pharmaceutical work group identified an adequate waste storage area and enlistedadministrative support in raising awareness and acceptance of theprogram.

TJUHs main campus began this process in November 2008 with manda-tory training for anyone handling hazardous waste. The training process tookjust two days. Later, new employee orientation and employee yearly competency reviews were added.

ResultsOur six-month pilot phase at TJUH included 150 beds and all inpatientpharmacies. With effective training, waste coding of all pharmaceuticals, and the use of color- coded containers, in its first year, the fullimplemented program dramatically minimized disposal costs, as only3,000 pounds of the roughly 75,000 pounds of pharmaceutical wastecollected was RCRA hazardous. The response from staff also has beenquite positive, with high visibility to the CEO and executive suite. Thufar, we have had success in meeting our goals, which included exceeding the standards for regulatory compliance, mitigating costs, keepingharmful pharmaceuticals out of the public water supply, and focusingon the safety and health of our staff, patients, visitors, and the communities we serve.

Michael Roshko, PharmD, is the operations manager for Thoma Jefferson University Hospital in Philadelphia, Pennsylvania. Heresponsible for all inpatient pharmacy services.

Stericycles PharmaceuticalWaste Compliance Program

By Michael Roshko, PharmD

Reprinted with permission from Pharmacy Purchasing & Products , Vol. 6 #12. 2009 Ridgewood Medical Media, LLC, Ho-Ho-Kus, NJ. All rights reserved.


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The Stericycle integrated approach includes

Formulary characterization and coding;

On-site education of healthcare facility s

Implementation and accumulation of colcoded containers; and

Transportation and destruction.

Uncertain of how to appropriately

dispose of pharmaceuticals?

Aware of The Joint Commission 2010 Standards?

Concerned about pharmaceuticals in the water?

Sustainable Solutions SM Environmental Best Practice

For more information, contact us at (866) 338-5120 or visit www.stericycle.com

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struggle toward compliance

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