Managing pharmaceutical waste throughout a multi-facility health system that services a wide geographic area can be quite challenging, especially considering the varying waste requirements in different states. Adhering to the multiple, complex regulations guiding compliant pharmaceutical waste management requires significant knowledge and expertise to ensure the safe containment and disposal of all waste streams. As the resident medication experts, it is the professional responsibility of pharmacists to help implement a compliant waste management program that protects the environment and keeps pharmaceutical waste out of the water system.

MedStar Health, a large health system in the Mid-Atlantic region, operates approximately 150 facilities, including ten hospitals in the Baltimore/Washington, DC area. The pharmacy footprint includes ten inpatient pharmacy operations, nine outpatient pharmacies, a home infusion company, a centralized IV admixture operation, and a centralized automated dispensing cabinet (ADC) replenishment facility. A large ambulatory presence exists throughout the health system, with physician offices, multi-specialty freestanding facilities, ambulatory oncology practices, a surgery center, and fifteen urgent care centers.

A multidisciplinary effort to implement a comprehensive program for managing pharmaceutical waste throughout the health system was rolled out over the past few years at MedStar. The program relies on collaboration between pharmacy, nursing, anesthesia, environmental services, administration, safety, and multiple vendors, in addition to ongoing training and monitoring, which are vital to meet regulatory requirements that continually evolve over time.

Changing Waste Requirements

In 2009, the Unused Pharmaceutical Safe Disposal Act (UPSDA) was enacted by the Washington, DC Department of Health (DOH),1 with the primary purpose of promoting environmentally friendly disposal of pharmaceuticals. A key caveat of the UPSDA establishes that it is “Unlawful for a health care facility to dispose any pharmaceutical product, used or unused, by flushing the product down the drain or by any other method that utilizes the public sewer system.” January 1, 2011 was initially given as the start date, at which time a civil fine of $1000 could be assessed if pharmaceuticals were disposed in a manner prohibited by the act.

This act created urgency for all DC-based health care facilities to develop compliant methods of pharmaceutical disposal, with the DC Hospital Association meetings serving as a forum for the exchange of ideas on achieving compliance. A major focus of the discussion was determining the proper disposal of controlled substances. The dilemma at hand was establishing a method that would comply with DC DOH regulations, while also maintaining compliance with DEA regulations.

Conversations evolved into consideration of a waste process or a device that would render pharmaceuticals, particularly controlled substances, non-recoverable. In late 2012, the DEA published in the Federal Register proposed rules for the disposal of controlled substances by registrants in a manner that rendered them non-retrievable, ie, to “Permanently alter any controlled substance’s physical or chemical state through irreversible means.”²

Developing a Waste Strategy

As our hand was forced to rapidly develop and roll out compliant processes for our three DC-based hospitals, we began to review our pharmaceutical waste streams, with the goal of developing a policy that addressed all types of waste. Pharmacy leadership agreed to adopt a standardized approach in our Maryland hospitals based on the DC implementations. The policy would be used for internal training and to illustrate to government agencies that our system had mechanisms in place to ensure compliance with regulations. A key component of the policy was the creation of a grid that serves as a reference to guide caregivers in the proper disposal of pharmaceuticals. The grid was reproduced as a poster for display on the walls of medication rooms on our nursing units (see FIGURE 1).

Click here to view FIGURE 1.

Waste streams were developed in conjunction with our vendors and reverse distributor, and encompassed: sharps, trace chemo, chemo/RCRA, controlled substances, exempted IV fluids, “other” pharmaceuticals, infectious waste, and ordinary trash. (It should be noted that the DC UPSDA allowed some exemptions for certain base IV fluids, which could still be wasted via the sink or toilet.) While an eight component waste stream is complex, it was seen as necessary to ensure compliance and to control costs. It also is important to note that only two new waste streams were actually introduced: one for controlled substances and the other a blue bin system for “other” pharmaceuticals.

Controlled Substance Waste Disposal

The UPSDA was disputed for over 2 years by DC health care facility constituents while awaiting clear compliance guidelines associated with the promulgation of the regulation. Enforcement authority would rest with the DC Board of Pharmacy as a division of the DC DOH. Consequently, the act did not become enforceable until July 1, 2013.

In the months preceding that deadline, MedStar Corporate Pharmacy, our corporate environmental and safety officer, and our DC pharmacy directors proposed to hospital administration the adoption of the aforementioned waste streams to support the regulatory change. Coincidental to the DEA’s proposed rule for controlled substance disposal, an evolving product on the market seemed to possess the capability to meet the need for rendering these products non-retrievable. The device features bi-compartmental containers that securely capture unused solid and liquid pharmaceuticals to render them unrecoverable and unusable. These dual-canister devices were designed to reduce drug diversion and improve patient safety while reducing the negative impact of waste on the environment.

MedStar Health determined that use of the dual-canister systems would address the DEA’s proposed requirement for controlled substance disposal. Manual options also were discussed, including use of a petroleum distillate in a large container to denature wasted pharmaceuticals, but were quickly discarded due to the inherently unwieldy nature of such a system. Moreover, a denaturation protocol would need to be submitted to the DEA for approval before we could consider wide-scale rollout. Therefore, implementing the commercially available, dual-canister system was deemed most viable.

We established the quantities of dual-canister systems to purchase by totaling the number of nursing units and pharmacy locations where they would be placed in our three Washington DC hospitals. Pharmacy directors engaged nursing and facilities staff in the site-by-site effort to determine the best locations to place or mount the systems—for example, within medication rooms or on the units.

Our reverse distributor vendor offered a program to utilize expired drug credit dollars to offset the price of the dual-canister devices. The other costs were unbudgeted, but were justified as budgetary variances for the purpose of regulatory compliance.

Non-Hazardous Waste

A major component of compliance is handling non-hazardous drug waste, or more specifically, those drugs that do not include DEA, medical waste, RCRA designation, chemo, or sharps status. Large 8– to 11-gallon blue bins were employed for this purpose, and were obtained in the same quantity and placed in the same locations as the dual-canister devices. Our RCRA pharmaceuticals waste vendor provides these bins and periodically comes onsite to sort the pharmaceuticals disposed in them. They also decontaminate the bins and re-deploy them, similar to the method for managing the black bins already in use at MedStar for RCRA waste. The vendor consolidates this non-regulated pharmaceutical waste into 200-gallon reusable totes that are removed from the campus for incineration. The vendor also periodically provides waste analyses reports to confirm compliance and ensure appropriate documentation.

Managing Waste in Offsite Areas

Other significant areas of concern for our health system were our ambulatory physician offices and urgent care centers. It was determined that these facilities would not need the blue bins, black bins (RCRA), and dual-canister devices. Following a review of their operations, it was clear that the use of sample medications provided by pharmaceutical companies would have to be discontinued, because expired samples are considered waste and transportation from the facility must be regulated. A minor list of samples is approved for continued use per the MedStar P&T Committee. These physician offices and urgent care centers typically order limited pharmaceuticals from their wholesaler, which includes only routine medications used in office-based practice.

A geographic dispersion of regional facilities was developed for our many smaller ambulatory sites to send their soon-to-expire medications. A recommendation was made to send medications with 60 days or less dating to the regional facilities for pickup. Medications that are in-date do not have the same requirements associated with transporting product considered as waste. Our pharmaceutical waste vendor performs pickups and sorting only from the regional facilities, which minimizes costs. A modified policy was developed and adopted for these ambulatory sites.

Vendor Assistance

Staff Training

Internal training was a major component in the development and rollout of a compliant method of pharmaceutical disposal. Due to the large size of our health system and the number of nurses who required training, we accepted assistance from our reverse vendor and from our RCRA waste vendor for training. Pharmacy and facilities department employees also received waste training.

Formulary Classification Service

Our pharmaceutical waste vendor provides a formulary classification service to us at no additional cost. Every 6 months, we send our acute care site formularies (from four disparate pharmacy information systems) to our vendor, who uses a third-party company to classify whether each drug listed is RCRA, hazardous, non-hazardous, or is recommended to be handled as hazardous. We then use these classifications to denote electronic medical record messages to nursing with handling and waste stream disposal guidances.

Conclusion

These waste processes were ultimately replicated in our Maryland hospitals after they had been fully implemented in the DC-based hospitals. Hospital and pharmacy leadership is proud to have developed a waste management program that sets MedStar Health apart as a steward of the environment, at a cost that is considered very reasonable. Regulatory standards continue to mature for pharmaceutical waste, and we will continue to work with our reverse distributor and waste vendors to streamline processes moving into the future.

More information about pharmaceutical waste management, including guidelines, policies, tools, and resources, is available at the ASHP Web site: www.ashp.org/menu/PracticePolicy/ResourceCenters/PharmaceuticalWastes.

References

1. Unused Pharmaceutical Safe Disposal Act of 2009. District of Columbia Municipal Regulations, Title 22-B. http://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Title_22B_Chap_5_Safe_Disposal_Regulations.pdf. Accessed September 15, 2016.
2. Disposal of Controlled Substances. Federal Register, Vol 77, No 246, Part V. December 21, 2012. www.gpo.gov/fdsys/pkg/FR-2012-12-21/pdf/FR-2012-12-21.pdf. Accessed September 15, 2016.

Raymond Lake, RPh, MS, is the corporate director of pharmacy operations at MedStar Health in the Baltimore/Washington, DC area, where he has practiced for 11 years. Raymond received his BS Pharmacy degree from the University of Connecticut and then completed an ASHP-accredited residency at the Veterans Affairs Medical Center in Washington, DC, while obtaining an MS in Institutional Pharmacy from the University of Maryland, Baltimore. His role involves supply chain activities, technology evaluation, and regulatory compliance.

Bonnie Levin, PharmD, MBA, is assistant vice president, pharmacy services, for MedStar Health, and leads the pharmacy enterprise’s strategy, technology, and supply chain for an integrated health system in Maryland and Washington, DC, that includes ten hospitals (academic and community), nine outpatient pharmacies, a centralized distribution/IV admixture service, ambulatory care, and home infusion. She received a PharmD from the University of Maryland and an MBA from Johns Hopkins.