The principal goals of the Resource Conservation and Recovery Act (RCRA) are to safeguard human health and the environment from the potential dangers of waste disposal, conserve energy and natural resources, decrease the amount of waste generated, and ensure that wastes are managed using an environmentally sound approach. Although RCRA has been a directive for more than 30 years, many facilities continue to experience challenges with compliance. In 2009, prompted by our corporate compliance officer, Evangelical Community Hospital, a 127-bed community hospital in central Pennsylvania, embarked on an initiative to improve compliance with the RCRA requirement for disposal of hazardous pharmaceutical waste. Our impetus was two-sided: not only did we seek to align our policies and procedures with RCRA to avoid costly fines, but as a green facility, we also sought to implement more environmentally conscious methods for disposing of hazardous pharmaceutical waste.  

The Results of Noncompliance
RCRA violations can incur fines of up to $37,500 per violation, per day, but these high penalties are obscured by the serious health and environmental impact of noncompliance. A 2002 study revealed that 80% of streams sampled from across the United States contained one or more organic wastewater contaminants, including various pharmaceutical medications and antibiotics.1 These contaminants can potentially affect human physical, mental, and sexual development, as well as contribute to antibiotic resistance. Because we do not want to contribute to environmental contamination, we launched a pharmacy-driven waste management initiative to avert the placement of hazardous drugs in the wrong waste streams.



Formulary Evaluation
Despite our facility’s desire to manage pharmaceutical waste responsibly, prior to our waste management initiative, we did not have complete control of this waste stream and some medications were being disposed of via the drain on a regular basis. The anesthesia department generates the majority of our narcotic waste and this has always been managed separately by pharmacy; however, on the floors narcotic waste commonly was flushed down the drain. Pharmacy leadership did not see this method as ideal, but like many other facilities, we struggled to find a suitable alternative. Many of the steps necessary to ensure compliance with RCRA seemed unclear and daunting, so we hired a consultant to help evaluate our formulary and identify all medications that are classified as hazardous under RCRA and require specific waste handling practices. While the long length of the resultant list added to our concern, it soon became clear that with a methodical evaluation of every listed medication, we could create a manageable list. For example, we removed epinephrine syringes from this list because epinephrine salts are excluded from RCRA. In addition, some of the listed agents are used during compounding only, so managing the resultant waste generated within the pharmacy is pretty straightforward: RCRA waste is placed in the black bins. This review process allowed us to assess whether infrequently used items that are RCRA-listed need to be on formulary or if purchasing different concentrations of a listed product would minimize waste. We also added additional drugs to the list, including insulin analogs, which contain the preservative m-cresol, a d-listed product (D024), indicated as hazardous under the toxicity characteristics. 

Key to our evaluation process was pharmacy’s communications with the state department of environmental protection (DEP). As part of our due diligence process, we worked with the DEP to gain assistance in defining hazardous medications; their help was critical in clarifying which medications required special handling. For example, we requested an interpretation of the requirement to handle all warfarin packaging as hazardous. Our state DEP clarified that if the packaging contained a product that was used for its intended purpose (ie, dispensed directly to the patient without incident), it never contained waste and therefore did not require special handling. However, if a coumadin tablet falls on the floor, both the tablet and the packaging are now hazardous waste and need to be managed as such. The DEP based their interpretation on the fact that the rules were originally designed for bulk producers and while it is clearly good practice to treat an empty barrel that originally contained warfarin as hazardous waste, transferring this requirement to a unit-dose package did not follow the intent of the rule. Keep in mind that different state agencies may offer different interpretations. It is a good idea to conduct any communication with these agencies in writing and retain all correspondence for your records. 

Going through the list carefully at the outset will reduce the burden of achieving RCRA compliance. The list our consultant initially provided included 108 medications, but after our evaluation process, we reduced the list to 71. Of these, just 46 medications were dispensed regularly from pharmacy to the units (the other 25 are chemotherapy drugs on formulary, but rarely used at our facility). The end result of the upfront efforts to thoroughly evaluate our formulary was a manageable number of medications that require special handling during the waste process.

Program Implementation
Once the list of hazardous drugs was determined, the hospital needed to identify an appropriate waste management strategy (Click here to view a sample pharmacy policy for hazardous pharmaceutical waste). During this process, one of our top priorities was to spare nursing from the tedious and time-consuming process of sorting waste. A common solution is to provide color-coded waste receptacles on the nursing units and then train the nursing staff on the proper disposal location for each drug. However, our goal was to implement a program that delivered control without adding significant time to nurses’ already busy days. It is important that nurses are able to focus on patient-centered tasks, rather than extraneous activities such as waste sorting. When a nurse must stop and look up the correct disposal method of an infrequently used item, that time could be better spent on patient care. Furthermore, we were concerned about the amount of time pharmacy would have to invest in training nursing staff to ensure continuously compliant sorting. To address these concerns, we felt pharmacy should take on the bulk of the responsibility for properly managing medication waste. 

After considering various options, our team created a sticker specifying “Requires Special Disposal.” This sticker is affixed by pharmacy to all items deemed hazardous under RCRA; when nursing encounters an item with the sticker, they simply place the item in the pharmacy return bin in the nursing unit or the patient’s medication drawer to be returned to and handled by pharmacy. The nurse does not have to consult a list or leave the unit and walk the item to the medication room to put it into a special medication container. 

When these RCRA items are returned, pharmacy stores them in receptacles in the pharmacy and once the containers are full, hospital environmental personnel remove the bins to the hazardous waste locker for storage until they are picked up by our waste hauler to be disposed of properly. Prior to shipment day, the waste hauler sorts the waste into the proper DOT shipping categories, waste codes, and DOT-approved shipping containers and then completes the manifest. The shipment is verified by a RCRA-trained staff member, who checks each item to ensure the manifest and products match. The manifest is then returned to the safety department for proper filing. 

All current pharmacy, nursing, and environmental services staff members were trained on the new hazardous waste procedure using an online presentation, which is also mandatory education for new hires. The definition of RCRA waste is discussed, and employees are taught to recognize the RCRA sticker and dispose of these items in the black receptacles. To prevent the continued disposal of controlled substances into the sewer, nursing staff is directed to dispose of that waste into containers that are then sent for incineration.

Perform Trash Audits for Continuous Compliance
Every new program implemented in a facility should be audited to ensure success and adherence to standards. Our compliance officer assesses waste management compliance through periodic, random trash audits, during which receptacles from the units are inspected to make sure no hazardous drugs have been improperly disposed of. Since implementing the new hazardous drug program, no instances of inappropriate disposal of hazardous medications have been identified. 

Future Directions
Our endeavor to better manage hazardous waste has been extremely successful. Nursing’s burden has decreased as a result of the initiative, and satisfaction levels with the program are high. Certain adjustments were made after the first months of using the waste hauler, as Evangelical is a fairly small hospital and therefore an equally small waste generator. Initially, pickups for RCRA waste were scheduled regularly, but when the first invoice arrived, pharmacy noted a minimum charge for each type of waste, as well as standard charges for transportation. These charges, coupled with our low levels of RCRA-listed waste, prompted us to lengthen our pickup interval, thus saving considerable funds. To ensure your program is in compliance, check with your state’s department of transportation to find out how long RCRA waste can be stored before pickup.

Although Evangelical’s hazardous waste management program has seen enormous improvements, there are still areas in which more progress is required. Policies and procedures guide the disposal of RCRA-listed waste generated in the pharmacy, and these same systems now need to incorporate waste from other hospital departments. Incorporating other departments’ practices into the RCRA waste program is our next goal. 

Conclusion
As medication experts, pharmacists must play a leadership role in implementing effective waste management strategies. Taking steps to identify medications deemed hazardous under RCRA and creating a strategic plan to ensure these products are disposed of appropriately will protect facilities from hefty fines and from damaging the environment and all its inhabitants.

Reference

1. Kolpin DW, Furlong ET, Meyer MT, et al. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000: a national reconnaissance. Environ Sci Technol. 2002;36(6):1202-1211.

Randall Strausser, RPh, received his pharmacy degree from the University of Pittsburgh. He has been the director of pharmacy at Evangelical Community Hospital for 25 years.