Good medicine

Now that managing pharmaceutical waste is becoming standard practice and a regulatory requirement, more hospital environmental services (ES) and facilities managers are being tasked with making it happen.

While there are a number of guidance documents available, such as "Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities In the United States" (Download PDF here) by the Practice Greenhealth organization, managers are still looking for a simple tool to help them get started.

With this in mind, this quick-start guide is designed to reduce a complex process down to the very basic elements and provide health care organizations with a path forward that is less daunting.

Getting started

The Environmental Protection Agency (EPA) and state environmental protection agencies are becoming more aggressive in their enforcement of the hazardous waste regulations at health care facilities. Fines can be as high as $37,500 per violation per day. In addition, the EPA Office of Water is developing guidelines to encourage health care facilities to reduce the volume of drugs disposed through the sewer system and may at some point develop effluent guidelines that will impact disposal of pharmaceutical waste.

Before tackling this situation, health facilities professionals will need a working knowledge of the EPA hazardous waste regulations, known as the Resource Conservation and Recovery Act (RCRA), as they apply to waste pharmaceuticals.

The 10-step blueprint mentioned above remains the most comprehensive, easy-to-use document to understand this complex regulation. A shorter summary, "Managing Pharmaceutical Waste: What Pharmacists Should Know" (Download PDF here) may be helpful, although some regulatory changes have occurred since the article was written in 2002. Whoever champions this process will need to spend time gaining a thorough understanding of the applicable regulations, especially the definitions of what waste is hazardous.

One of the more common pitfalls, for instance, is that the RCRA regulations were originally written in the late 1970s to prevent land disposal of hazardous chemicals and were designed for industrial wastes from chemical and manufacturing plants and processes. Thus, some of the definitions and applications do not fit health care well at all. While a great deal of relief has been obtained by working with the EPA over the years, there are still some areas that are problematic.

However, until these are changed or interpreted differently by the EPA and state regulatory agencies, the health care industry must live by them. An example is the need to triple-rinse a container that held a P-listed waste to render it "RCRA empty." Warfarin tablets meet the definition of a P-listed waste; therefore, following a strict interpretation of the rule, stock bottles and unit dose packaging that held warfarin tablets should be managed as hazardous waste when empty.

Ten-step process

A concise quick-start guide to managing pharmaceutical waste can be constructed around a 10-step process. It includes the following actions:

Step 1. The ES professional can designate himself or herself as the champion of the process or he or she can partner with another department manager, such as the manager of pharmacy, safety, facility or nursing, who is willing to commit time and energy to make it happen.

It all comes down to leadership and individuals who are willing to drive the process forward. For instance, Cheryl Chisholm, pharmacy technician at Northern Michigan Regional Hospital in Petos­key, Mich., is passionate about proper pharmaceutical waste disposal, helping to preserve the northern Michigan environment and the water quality of Lake Michigan. Her diligence during a three-year pharmaceutical waste implementation process enabled her facility to be the first in the nation to achieve PharmE Certification from PharmEcology Services at WM Healthcare Solutions (www.pharmecology.com), Houston. Chisholm is now an active participant and advisor on a committee formed by the Michigan Department of Natural Resources and Environment.

Step 2. Health facilities professionals must gain commitment from the C-suite that managing pharmaceutical waste is a priority for the health care organization.

There are two primary drivers for managing pharmaceutical waste in compliance with regulations and best management practices: liability and sustainability. If the health care organization's management is highly risk averse, ES professionals can utilize the well-publicized fines that have been levied recently against hospitals for violating RCRA. If the organization is highly committed to sustainability efforts and going "green," preventing drugs from contaminating the environment should be a very attractive proposal. Regardless of the motive, professionals also should emphasize that these efforts can be used as a Joint Commission Performance Improvement Initiative.

Step 3. Team members should form a new committee or task force or, better yet, revamp an existing committee, such as the facility's Environment of Care group, to take responsibility for this process. They should plan on meeting at least monthly to develop plans, set milestones, document progress and solve problems. The group should include ES, safety and facilities management, pharmacy, nursing, infection control, risk management, administration, purchasing and other interested parties based on the organization's management structure.

Step 4. Team members should make budget decisions around the purchase of intellectual property, containers, and transport and treatment. In some cases, it may make sense for the pharmacy department to purchase information regarding waste categorization and consulting, while ES budgets can be used for containers and transport and treatment. Depending on the structure of the organization, an integrated program may make sense, especially if other waste streams can be included in the total package.

During this step, team members should meet with prospective vendors to gain an understanding of costs, being sure to compare apples to apples with respect to services provided by each vendor.

Step 5. Health facilities professionals should determine the composition of their pharmaceutical inventory with respect to hazardous waste regulations. Several companies can provide waste categorization based on the product description. However, the depth of detail varies.

The following list highlights information that is currently available:

• RCRA hazardous waste designations with appropriate waste codes;
• Occupational Safety and Health Administration (OSHA) hazardous material designations with appropriate annotations;
• Items eligible for potential sewer or landfill disposal, with permission from the publicly owned treatment works (POTW) and municipal solid waste vendor;
• "Nonhazardous" pharmaceutical waste designations;
• Detailed container recommendations for full, partial and empty packaging, including syringes;
• Material Safety Data Sheet (MSDS) links for EPA hazardous wastes and OSHA hazardous drugs; and
• Department of Transportation shipping descriptions for all containers linked to container recommendations.

Step 6. Team members should then make initial decisions on how various waste designations will be managed. For example, many organizations have chosen to manage any bulk chemotherapy waste as hazardous waste, even if it is not technically defined as such by EPA. Likewise, a growing number of organizations have stopped putting any drugs into the sewer and have directed all nonhazardous drug waste into containers destined for incineration at either a medical waste or waste-to-energy facility.

Step 7. These decisions should then be piloted in the pharmacy department by utilizing the following practices:

• Place either a black dot or printed square labels with the appropriate hazardous waste letter on or near the shelf stickers to train staff about which drugs to segregate as hazardous waste.
• Determine which containers will be used to collect hazardous and nonhazardous waste. Covidien (www.covidien.com), Mansfield, Mass., and BD (www.bd.com), Franklin Lakes, N.J., make collection units for hazardous, nonhazardous and trace chemotherapy containment.
• Determine which vendors will provide hazardous and/or nonhazardous pharmaceutical waste disposal services. The selection will vary greatly by geography.
• Determine if any P-listed waste will be generated. If the organization is not a large quantity generator of hazardous waste, determine how to document P-listed waste generation quantities each month.
• Train pharmacy personnel on the segregation requirements and monitor the program for at least one month before moving on.

Step 8. Team members should then make a list of how all items in the pharmacy department are being labeled for delivery to the nursing units.

They should note how many notices can be automated to enable one-time data entry for an appropriate waste designation. For example, most health facilities use some type of automated dispensing cabinets. These can be programmed to pop up specialty messages and can be turned on by unit, enabling a systematic rollout. Other examples include electronic medication administration records (e-MARs), which also allow inserted messages. Depending on the flexibility of the IV administration labeling software, messages also can be inserted automatically into these systems.

In all, as many as six or more different software and labeling mechanisms may be used in the pharmacy department. All of these need to be considered. It's also likely that some single-patient multiuse items may require manual labeling. In these instances, team members should consider designing a special label or using a black dot or other definitive sticker.

Step 9. Health facilities professionals then can pilot the labeling and segregation program in one nursing unit.

If the facility has an oncology department, team members should choose both inpatient and outpatient units for the first rollout to nursing. Not only are these units relatively easy to manage, but they are likely to be audited by regulatory inspectors or accrediting teams.

For example, if the facility is currently collecting all chemotherapy in yellow containers labeled "chemotherapy waste," it risks being cited for a RCRA violation. Eight chemotherapy drugs are listed as hazardous waste and any nonempty containers must be managed as a hazardous waste under RCRA. In compliant programs, these are commonly collected in a black container and shipped on a uniform hazardous waste manifest to a RCRA-permitted treatment, storage and disposal facility.

By not having a black container in the pharmacy or in the oncology units, the facility is advertising that it is not handling these wastes correctly.

Step 10. The piloted system then can be evaluated to determine if it will work throughout the facility. If not, the primary concerns should be determined and reworked until the system is successful.

Once nursing and pharmacy are both satisfied, team members should work through the following action items:

• Develop a timetable for a whole house rollout by nursing unit.
• Revise policies and procedures for pharmaceutical waste disposal, including the chemotherapy handling policies and procedures in pharmacy and nursing.
• Work with vendors to develop and implement training programs, both for the initial rollout and on an ongoing basis. Train-the-trainer models and Web-based training are both effective, depending on the organization's training philosophy and capability.

It is essential that nursing be on board with the program. Nurses comprise the majority of the clinical labor force and dispose of more drugs than any other department.

Finally, the system should be continuously monitored to ensure compliance and improve effectiveness and efficiency.

An evolving discipline

Managing pharmaceutical waste is an evolving discipline. The goal is to analyze how and why pharmaceutical waste is being generated and reduce waste generation through appropriate changes so that a savings in drug purchasing can fund the new cost of compliant management.

Charlotte A. Smith, R.Ph., M.S., HEM, is director, PharmEcology Services, for WM Healthcare Solutions Inc., Houston. She can be reached at csmith@pharmecology.com. This tutorial provides a general description of regulatory requirements and does not constitute legal advice. For a complete description of the regulations, health facilities professionals should consult the relevant federal and state statutes.

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