PHARMACY&Purchasing Products

As Seen InDecember 2009 Vol. 6 No. 12

Stericycle28161 N Keith Dr, Lake Forest, IL 60045

847-367-5910 • www.stericycle.com

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 nation-wide 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 pharmaceuticalwaste management in particular increased this year. This was backed up

by significant growth in spending in 2009 and an expectation that spend-ing and the commitment to compliant waste management will continueto increase over the next few years. In fact, 66% of DoPs would considerpurchasing off-contract or even higher priced products to meet their insti-tution’s 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 havereceived a recommendation or been cited. Given that RCRA violationscan result in fines of up to $37,500 per violation, per day, developing theexpertise necessary to manage pharmaceutical waste is crucial not only toensuring a facility’s environmental responsibility but also its financialhealth. Nonetheless, 43% of hospitals have no plan to establish a budgetfor managing pharmaceutical waste. Without a solid financial commit-ment from pharmacy and administration, attaining compliant practiceswill be a daunting assignment.

Challenges for PharmacyPharmacy is well aware of the challenges they face in achieving compli-ance given the complexity of the regulations and a lack of in-house expert-ise. Most facilities report that their RCRA-regulated and non-hazardouswaste 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 ofwarfarin >0.3 mg in the regular trash and red sharps bins, for example.However, 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 provideformal education on pharmaceutical waste management. Those pharma-cy leaders who do provide training have recognized the value of compre-hensive education and provided this training to staff much more regularlythis year. Of note, the small number of facilities that require risk managersand administrators to receive waste training along with the clinical staffreport much higher rates of compliance for RCRA-regulated waste.

ConclusionIn addition to the potential cost of fines, the potential cost to employees’health 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 safeand effective medication, pharmacy must also lead the drive for ensuringsafe and proper drug disposal.

The Struggle toward Compliance

Deanne Halvorsen

0

10

20

30

40

50

60 Consulting Services in Use

Note: Totalsexceed 100% assome facilitiesuse more thanone service.

Stericycle

PharmEcology/Waste

Management

Reverse distributor

Clean Harbors

Environmental Resource

Management

PharmWaste Technologies

Heritage Environmental

Other

57%

21%

15%

3%3%4%

12%14%

�Facilities using a consultingservice to establish a RCRA-characteristic pharmaceuticalwaste management programremain in the minority at 33%.

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 TJUH—which includes themain campus with 750 beds, Methodist Hospital with 250 beds, andJefferson Hospital for Neuroscience with 120 beds—the 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 group—consisting of representatives from nursing, nurse education, accreditation,facilities, risk management, safety and health, infection control, informa-tion systems, and sustainability—was collectively excited about the variousbenefits of such a program. Their cooperation was integral to the success-ful implementation.

In-house vs. OutsourceWe wanted to get ahead of the compliance curve by initiating a program thatlinked our organization’s goals with TJC standards and regulatory require-ments. Given the complexity and sensitivity of TJC’s 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 providerwould 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 vendorwith national experience that could share best practices and coordinate costcontainment strategies with us. We chose Stericycle’s 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:

� 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 comprehensiveannual report. TJUH identifies drugs on patient labels and in ADCsusing simple codes on each container, thereby ensuring proper dis-posal.

� On-site education of pharmacy, nursing, and EVS staff: Staff wereeducated 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 (electrolytes,saline, and dextrose) and proper disposal of controlled substancesalso was reinforced.

� Implementation of color-coded, reusable containers: Having a vari-ety of container sizes and mounting options (wall brackets, floor dol-lies, etc) allowed us to address challenges related to space.

� Transportation and destruction: Stericycle technicians collect andbring full containers to a central accumulation area a few times eachweek where they pack the waste. The fully packed containers arepicked up from this location on a weekly basis. The pharmaceuticalwork group identified an adequate waste storage area and enlistedadministrative support in raising awareness and acceptance of theprogram.

TJUH’s 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 compe-tency reviews were added.

ResultsOur six-month pilot phase at TJUH included 150 beds and all inpatientpharmacies. With effective training, waste coding of all pharmaceuti-cals, and the use of color- coded containers, in its first year, the fullyimplemented 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. Thusfar, we have had success in meeting our goals, which included exceed-ing 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 commu-nities we serve.

Michael Roshko, PharmD, is the operations manager for ThomasJefferson University Hospital in Philadelphia, Pennsylvania. He isresponsible for all inpatient pharmacy services.

Stericycle’s Pharmaceutical Waste 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.

The Stericycle integrated approach includes:

Formulary characterization and coding;

On-site education of healthcare facility staff;

Implementation and accumulation of color coded 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 SolutionsSM Environmental Best Practice

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

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