As Seen In

P
December 2009 Vol. 6 No. 12

HARMACY
Purchasing&Products

Stericycle
28161 N Keith Dr, Lake Forest, IL 60045
847-367-5910 • www.stericycle.com
 From the Editorial Director Deanne Halvorsen

The Struggle toward Compliance

J
ust as we are becoming more aware of the growing dangers from by significant growth in spending in 2009 and an expectation that spend-
improperly disposed medications leaching into our drinking water ing and the commitment to compliant waste management will continue
supply, so are the many regulatory bodies that oversee pharmacy. to increase over the next few years. In fact, 66% of DoPs would consider
The resulting regulatory pressure is driving many changes in purchasing off-contract or even higher priced products to meet their insti-
approaches to pharmaceutical waste management. In a bid to better tution’s environmental objectives.
understand where pharmacy practice stands today, Pharmacy Purchasing Investing in developing compliant practices became more imperative
& Products conducted the second annual Going Green survey of health- this year as EPA and state inspectors have demonstrated increased com-
system pharmacy waste processes. fort with the regulations and issued significantly more recommendations
and citations to hospitals. Forty-five percent of inspected facilities have
Survey Design received a recommendation or been cited. Given that RCRA violations
In the fourth quarter of 2009, PP&P polled a random, nationwide sam- can result in fines of up to $37,500 per violation, per day, developing the
pling of health system directors of pharmacy. We asked about their phar- expertise necessary to manage pharmaceutical waste is crucial not only to
maceutical waste management practices, expenditures, regulatory com- ensuring a facility’s environmental responsibility but also its financial
pliance, and staff training methods. Responses were solicited via e-mail, health. Nonetheless, 43% of hospitals have no plan to establish a budget
and we received a total of 260, yielding a confidence interval of 5.94 (95% for managing pharmaceutical waste. Without a solid financial commit-
+/-5.94) based on the total population of DoPs nationwide. ment from pharmacy and administration, attaining compliant practices
We intentionally surveyed a random sampling of DoPs, not just read- will be a daunting assignment.
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- Challenges for Pharmacy
wide use PP&P as a resource for information on pharmaceutical waste Pharmacy is well aware of the challenges they face in achieving compli-
management. ance given the complexity of the regulations and a lack of in-house expert-
ise. Most facilities report that their RCRA-regulated and non-hazardous
60 Consulting Services in Use waste practices are not in compliance, although hazardous chemotherapy
57% and controlled substance waste management compliance rates fared
somewhat better.
50 Facilities using a consulting DoPs demonstrated increased awareness of proper waste stream dis-
service to establish a RCRA-
characteristic pharmaceutical posal for many hazardous drugs this year. Fewer facilities are disposing of
waste management program warfarin >0.3 mg in the regular trash and red sharps bins, for example.
40 remain in the minority at 33%. However, those properly using RCRA-hazardous containers for disposal
of this P-listed product and other hazardous drugs are still in the minority.
Note: Totals A major impediment to establishing compliant practices is the dearth
30 exceed 100% as of expertise among pharmacy staff. Most DoPs report that their staff is
some facilities not sufficiently knowledgeable about hazardous pharmaceutical waste
21% use more than
20 one service. practices. This is not surprising given that only 27% of facilities provide
14% 15% formal education on pharmaceutical waste management. Those pharma-
12% cy leaders who do provide training have recognized the value of compre-
10 hensive education and provided this training to staff much more regularly
4% 3% 3% this year. Of note, the small number of facilities that require risk managers
and administrators to receive waste training along with the clinical staff
0 report much higher rates of compliance for RCRA-regulated waste.
cle ast
e
uto
r ors ource t ies al er
ricy /W ent istrib arb s n olog ment Oth
te gy H e e n n
S o m ed an l R em Tech nvi
ro
col age s Cle nta ag Conclusion
ar mE Man Rever n me Man aste ag eE
Ph iro W rit In addition to the potential cost of fines, the potential cost to employees’
Env rm He
Pha health and our environment from improper waste stream disposal should
Investing in Compliance be deemed completely unacceptable by pharmacy and the hospital admin-
Despite an overall tightening of hospital budgets, the commitment to istration. Just as pharmacy is responsible for ensuring patients receive safe
environmental protection in general and to compliant pharmaceutical and effective medication, pharmacy must also lead the drive for ensuring
waste management in particular increased this year. This was backed up safe and proper drug disposal.
 Stericycle’s Pharmaceutical
Waste Compliance Program
By Michael Roshko, PharmD
T
he challenges that led Thomas Jefferson University Hospitals
(TJUH) to seek external assistance for pharmaceutical waste
disposal compliance were common enough. Most hospitals
are 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 the
main campus with 750 beds, Methodist Hospital with 250 beds, and
Jefferson Hospital for Neuroscience with 120 beds—the pharmacy operation
is 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 our
environmental services (EVS) and pharmacy departments, the process
involved 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 various
benefits 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 that
linked our organization’s goals with TJC standards and regulatory require-
ments. Given the complexity and sensitivity of TJC’s 21 hospital standards, we
knew a comprehensive turnkey solution was necessary.
The first step in this process was to determine which pharmaceuticals were
hazardous and if proper disposal could be managed in-house. We also consid-
ered non-hazardous drugs that are damaging to the environment. We decided
that 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 waste
characterization that segregated the formulary by EPA and DOT waste
streams and identified the compatibility of hazardous and non-hazardous
pharmaceuticals based on chemical content.
Finding the Right Vendor
Some 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 cost
containment strategies with us. We chose Stericycle’s pharmaceutical waste
compliance program in part because it uses a system of checks and balances
to assess where we are and where we need to be. Implementing the program
involved 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
Reprinted with permission from Pharmacy Purchasing & Products, Vol. 6 #12. ©2009 Ridgewood Medical Media, LLC, Ho-Ho-Kus, NJ. All rights reserved.
products. Additionally, Stericycle provides us with a comprehensive
annual report. TJUH identifies drugs on patient labels and in ADCs
using simple codes on each container, thereby ensuring proper dis-
posal.
I On-site education of pharmacy, nursing, and EVS staff: Staff were
educated on how to properly interpret the simple waste codes with
a particular focus on proper disposal of partial IVs with instilled
medication. Continued drain disposal of “plain” IVs (electrolytes,
saline, and dextrose) and proper disposal of controlled substances
also was reinforced.
I 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.
I Transportation and destruction: Stericycle technicians collect and
bring full containers to a central accumulation area a few times each
week where they pack the waste. The fully packed containers are
picked up from this location on a weekly basis. The pharmaceutical
work group identified an adequate waste storage area and enlisted
administrative support in raising awareness and acceptance of the
program.
TJUH’s main campus began this process in November 2008 with manda-
tory training for anyone handling hazardous waste. The training process took
just two days. Later, new employee orientation and employee yearly compe-
tency reviews were added.
Results
Our six-month pilot phase at TJUH included 150 beds and all inpatient
pharmacies. With effective training, waste coding of all pharmaceuti-
cals, and the use of color- coded containers, in its first year, the fully
implemented program dramatically minimized disposal costs, as only
3,000 pounds of the roughly 75,000 pounds of pharmaceutical waste
collected was RCRA hazardous. The response from staff also has been
quite positive, with high visibility to the CEO and executive suite. Thus
far, we have had success in meeting our goals, which included exceed-
ing the standards for regulatory compliance, mitigating costs, keeping
harmful pharmaceuticals out of the public water supply, and focusing
on the safety and health of our staff, patients, visitors, and the commu-
nities we serve.
Michael Roshko, PharmD, is the operations manager for Thomas
Jefferson University Hospital in Philadelphia, Pennsylvania. He is
responsible for all inpatient pharmacy services.
 Sustainable Solutions
SM

Environmental Best Practice

Concerned
Con
ncerned
erned The Stericycle
Stericyycle integrated
integrated approach
app
proach includes:
about pharma
ppharmaceuticals
ph aceuticalss in the water?
w ?
s Formulary
Formullary characterization
characterization and
annd coding;

Uncertain
Unc
certain
rtain s On-sitee education of healthcare
healthcaare facility staff;
of how to appropriately
ppropria
s Implementation
Implem
mentation and accumulation
accumulation of color
dispose off pharmaceuticals?
armac
coded containers; and

s Transportation
Transportation and destruction.
destructioon.
Aware
A
Aw
Awar
re
of The
The Joint Commission
Com
mmission 2010
20 Standards?

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