PP&P: How do you identify best management practices for pharmaceutical waste management?

Charlotte Smith: Because the RCRA regulations are not up-to-date, establishing best management practices is a key step in the waste management process. The first step is to identify those drugs that are considered hazardous waste under the RCRA rules. The same must be done for those states with additional hazardous waste regulations. Once that is done, we recommend a second category be designated for particularly hazardous drugs —such as chemotherapy, endocrine disrupters and other highly toxic drugs — that are not listed under RCRA and then manage these drugs as hazardous waste. 

The disposal of drugs via the drain should be avoided wherever possible; rather, all chemical entities used as drugs should be segregated and disposed of through either regulated medical waste incineration or municipal incineration. Exceptions can be made only for innocuous products, such as bran flakes and Metamucil, which should be sent to a landfill to avoid the unnecessary cost of incineration. There are also some items that are officially categorized as drugs but are not synthetic chemical entities, such as saline or dextrose, which should be designated for potential sewer or landfill disposal.

The next step in this process is to approach your local wastewater treatment plant with a list of potentially sewerable items, such as saline or electrolytes, to determine if these products will be permitted in the sewer.

Finally, make sure that any trace chemotherapy is put into a segregated container, generally yellow, to ensure it is incinerated at a regulated medical waste incinerator. Trace chemotherapy should not be disposed of in regular red sharps bins, which will most likely be autoclaved or microwaved, but not incinerated.

PP&P: How common is this broad approach to waste management?

Charlotte Smith: Many of our clients are taking this approach. Once they have gone through the effort of establishing which drugs are hazardous waste, many decide that they may as well take the next step and keep everything possible out of the drain or landfill. We would encourage hospitals that are embarking on this process to make the full commitment and segregate both hazardous and non-hazardous drugs and discontinue using the drain and landfill, wherever possible.

PP&P: How do controlled substances fit into this picture?

Charlotte Smith: Controlled substances continue to be very problematic and there are some situations where they may still need to be disposed of via the drain. However, this process would also need to be approved by the wastewater treatment plant.

PP&P: What processes need to be developed beyond identifying which drugs are P-listed and U-listed?

Charlotte Smith: For starters, any D-list drugs in the facility must be identified and properly managed. These are the drugs that exhibit a hazardous waste characteristic, which can be difficult to identify because each formulation needs to be evaluated for ignitability, toxicity, reactivity, or corrosivity.

Processes must also be established for managing containers that are full or partially full versus those that are considered empty, and this requires a thorough understanding of the RCRA definitions of empty. In addition, you need to be informed about the federal exclusions for Pand U-listed waste as well as used syringes. Finally, contact your state to determine if your state has adopted the federal exclusions.

PP&P: How do you make practical choices as to which products are to be incinerated vs. landfilled vs. sewered?

Charlotte Smith: That’s a great question because after wrestling with this issue over the last 12 months, our solution was to literally go item by item through our database and designate any products that are considered innocuous as candidates for landfilling or sewering. For example, we have garlic tablets and Metamucil, which is psyllium seed husk, coded to go into the landfill. As mentioned earlier, saline and dextrose may be coded for drain disposal. 
We draw the line at any chemical entity that has been designed as a drug. We recommend that none of these be disposed of via the drain or landfill; rather, they should be incinerated.

PP&P: What elements define the most successful waste management
programs?

Charlotte Smith: One factor common to successful programs is the mission statement or overall vision of the hospital, many of which now include environmental responsibility or sustainability commitments.

Also at the top of the list is corporate buy-in; supportive administrators who are in sync with the goals of environmental responsibility will be more willing to allocate resources in support of these programs.

I cannot stress strongly enough the importance of having a designated champion, because somebody has to be in charge. This person should have a philosophical commitment to environmental management as well as the ability to work within the organization to get things done and the authority to make decisions. Generally this position is filled from one of three departments: pharmacy, environmental services, or safety/facilities. Another option is to split this position between two people who work really well together.

A designated team or task force is also key. This team should be multi-disciplinary and include a much broader range of departments, beyond the aforementioned three. Nursing, administration, purchasing, infection control, nursing education, and eventually the medical staff should be part of this team.

Successful waste management programs should also have a defined timeline with specific mileposts and goals. 

Finally, the ability to rely on outside resources as needed. From container suppliers and waste haulers to expert guidance from consultants, a good working relationship with your vendors is key to a successful program. Outside vendors can bring a special expertise as they have the benefit of broad experience with a variety of clients. As with any vendor, ask for multiple bids so you may choose the most appropriate vendor or combination of vendors.

PP&P: What is pharmacy’s role in the waste management program?

Charlotte Smith: Pharmacy’s role is very important from a couple perspectives. One is the identification of those drugs that become hazardous waste. Because pharmacists traditionally have not been trained in this, the help of an outside vendor may be warranted at this stage.
Secondly, pharmacy needs to be involved in determining what level of segregation can occur at the hospital. For example, is hazardous waste going to be segregated from non-hazardous, and if so, how will these products be identified in the pharmacy. We recommend taking a shelf-sticker approach.

Pharmacy must also determine the best method for communicating this information to the nursing staff. Simply sending a list of hazardous products to nursing is ineffective; rather, we recommend implementing a sticker system or embedding the information in the dispensing software. Pharmacy should create a label map where they record every different way that drugs are labeled, as many pharmacies often have four or five different labeling systems depending on what is being dispensed. Then they can look at each label and determine how to best embed the information, either electronically or manually.

PP&P: Is waste management a concern during a Joint Commission inspection?

Charlotte Smith: It is our understanding that environmental concerns and waste management are now much more of an issue with The Joint Commission than in the past. More hospitals are reporting being asked about their waste management practices and the Commission has hired health care engineers who bring expertise on these issues to their survey practices.

In addition, waste management can certainly come up within the tracer methodology. For example, if a drug was not used, the surveyor will want to know what happened to it, which can then lead to a more detailed examination of waste practices.

PP&P: What are the most common roadblocks to implementing a compliant program?

Charlotte Smith: Because a successful effort requires funding and leadership, the lack of corporate support or of a champion poses a significant challenge. A lack of awareness is certainly another issue. Oftentimes, if there has not been a perceived immediate threat, it can be difficult for one or two people to build enough support to launch a program.
Sustaining effort over the long-term can also be challenging as a successful program requires a concentrated effort for 12 to 18 months. Other potential roadblocks include the lack of a multi-disciplinary team effort, and a lack of knowledge or expertise in waste management processes.

PP&P: Should certain regions expect increased inspection pressure from the EPA?

Charlotte Smith: While it is difficult to predict, we are certainly seeing sustained pressure in Region 7 right now, and Regions 1, 4, and 5 have also seen increased inspections. Of course the regions do communicate with each other, so we are beginning to see more consistency across the regions.

PP&P: When will the new RCRA Universal Waste Rules draft be available for comments?

Charlotte Smith: The pre-publication version was made available on the EPA website on Nov. 20th and can be accessed at http://www.epa.gov/epawaste/hazard/wastetypes/uni versal/pharm.htm.  EPA expects to have the draft regulations out in December. A 60-day comment period will follow the release and the process will continue.

PP&P: What changes can we expect to see in that document?

Charlotte Smith: There is a lot of confusion around this issue. First of all, it is important to understand that universal waste, in terms of EPA parlance, is a subset
of hazardous waste. Thus, only drugs that are already considered to be hazardous waste will be impacted by the universal waste regulations, which is only about four to five percent of pharmaceuticals stocked in the hospital.

Currently universal waste includes items such as fluorescent lamps, batteries, pesticides and mercury-containing devices. Assuming drugs are added to this designation, hospitals will no longer need to document their waste generation status based on the pharmaceutical waste they generate.

One misconception is that under the new rule you will not have to manage these as hazardous waste anymore.  That is not the case; the drugs still must go to a permitted hazardous waste incinerator, although there will likely be some alleviation of the manifesting requirements.

PP&P: Many pharmaceutical waste management programs focus on achieving RCRA compliance. What are the important issues beyond RCRA?

Charlotte Smith: There are two main issues here. The toxic drugs that are not included under RCRA need to be identified and managed as we discussed earlier. In addition, we have drugs causing problems in our water and ecosystems. For example, research shows that frogs do not mature when exposed to low levels of antidepressants. As we are beginning to understand the impact individual drugs and mixtures of drugs are having on different aquatic species, it is becoming clear that we need to get drug waste out of the water and ecosystem, regardless of whether or not they are RCRA classified, by discontinuing sewering and landfilling practices wherever possible. 

PP&P: How would you recommend pharmacists approach their administration to get appropriate budget support for waste initiatives?

Charlotte Smith: As professionals we have an obligation to try to stay on top of public health issues. Proper pharmaceutical waste management is very much a public health issue in addition to a regulatory issue and because pharmacy has to be so intimately involved in this effort, pharmacists should certainly work with their administration to help them understand the broader commitment of the hospital to the community. From a more immediate perspective, moving forward with a pharmaceutical waste management program mitigates the risk of a potential fine from state or federal regulators. With the increasing focus on drugs in the water, it is also likely the hospital may be approached by the local media and queried on their pharmaceutical waste disposal practices. We have seen this happen with a number of our clients.

I would recommend pharmacy first meet with the environmental services and safety departments to develop a consensus plan. Too often, one department develops a plan and begins working with their supervisor, while a second department, operating independently, develops a separate plan and goes through a parallel administrator. It is much more effective for the departments to approach the C-suite together and bring a concerted team effort to their administrators. 

PP&P: Is there a cycle in the costs associated with waste management?

Charlotte Smith: We are all still trying to get a handle on costs. The initial data suggest that the start-up costs continue for approximately 12 to 18 months. As more units within the hospital come on board with the program, container and actual waste disposal costs will rise. We expect to see decreasing costs in the following operational phase.

The more mature programs report that they are focusing on reducing their waste management costs by improving segregation, reviewing contracting options, and reducing the amount of pharmaceuticals being wasted. There are many opportunities to reduce pharmaceutical waste generation by examining purchasing, preparation, and dispensing practices. Good inventory management will also result in fewer outdated products. Obviously, as you reduce the amount of drugs wasted, you will see a savings in your initial purchasing.

PP&P: The EPA is developing a detailed questionnaire on pharmacy waste practices that will be sent to a significant number of US hospitals, who in turn will be required to complete, certify, and return the questionnaire to the EPA. What should hospitals expect to see in that questionnaire?

Charlotte Smith: I think we can presume that the basic questions are going to be: what drugs are you disposing of, in what quantities, and by what methods. The EPA is particularly concerned with those drugs being disposed of down the drain.

It is very important to note that not only is the completion and certification of this questionnaire mandatory, but not returning it to the EPA will constitute a criminal offense.

PP&P: What criteria should be used in choosing a pharmaceutical waste vendor?

Charlotte Smith: Due diligence is important in selecting a waste management vendor. You want a vendor licensed and insured to handle the types of waste you are generating. Because the hospital is liable for the waste through its final disposal, it is key that you review the indemnification in the vendor’s contracting to ensure the hospital will be protected should anything go wrong in the vendor’s disposal process. Further­more, ascertain whether the vendor has the financial strength to support their indemnification policy in the event of a problem. Determine if the vendor will take title to the waste at the dock, which will transfer more liability to them. If any services will be subcontracted by your vendor, you must perform due diligence on each of the subcontractors as well.

You also want to determine the vendor’s level of knowledge regarding pharmaceutical waste. A more sophisticated vendor can save you money due to a greater understanding of the nature of the waste. For example, if your hauler reviews your waste codes and determines your waste profile allows you to combine compatible hazard classes, such as toxic and ignitable items, your manifest process will be simpler and you will use fewer containers.

PP&P: How would you recommend pharmacists prioritize their approach to waste management?

Charlotte Smith: After establishing processes to segregate hazardous and non-hazardous waste, pharmacy should concentrate on keeping drug waste out of our water supplies by discontinuing sewering and landfilling practices. A committed effort by pharmacists nationwide is necessary to ensure the long-term safety of our water supplies.

Charlotte A. Smith, RPh, MS, HEM is president of PharmEcology Associates, LLC, an information management and consulting company specializing in the cost-effective and compliant management of hazardous pharmaceutical waste. She can be reached at csmith@pharmecology.com or 414-292-3959.