ASCs strive to offer a quality of care and operate at a level of excellence that at least meets the standards set by hospitals, and ASCs are often successful are exceeding these standards. But one area of operations where hospitals should serve as models for surgery centers is in the proper disposal of pharmaceutical waste.
"Every major hospital handles their waste properly," says Gregory McKenna, R.Ph., JD, managing member of PharmASC-e Consultants, a pharmaceutical waste management consulting company. "Every major hospital has identified the pharmaceuticals they have, have active participation in minimizing the amount of pharmaceuticals they generate and waste and they properly dispose of it."
There are a number of reasons why pharmaceutical waste disposal has become a critical to hospitals, reasons that should make this issue just as important for ASCs, says Mr. McKenna.
▪ Hospitals are under the close watch of the Department of Environmental Protection and the Environmental Protection Agency (EPA) to follow the requirements set forth in the Resource Conservation and Recovery Act (RCRA), the primary U.S. law for governing the disposal of hazardous waste.
▪ Failure to follow RCRA can result in corporate fines of $32,500 for each violation per day. It can also result in personal fines and imprisonment for managers up through the C-suite.
"It’s one thing to pay money to get out of an issue, but you can never walk away from the fact that you did it and people know you did it," says Mr. McKenna. "That reputation you built up — when it’s lost, it’s gone forever."
▪ Improper disposal of pharmaceutical waste may be hazardous to health, with new studies demonstrating that pharmaceuticals are in drinking water, and dangerous ramifications potentially associated with levels of pharmaceuticals even as low as "parts per billion" says Mr. McKenna.. There are less than five public water treatment facilities in the country that are able to process pharmaceutical waste and take it out of the water.
▪ An organization may violate accreditation standards if it fails to properly dispose of hazardous materials and waste.
Growing issue for ASCs
"From ASCs' point of view, although RCRA currently has created responsibility towards surgery centers in regard to how they dispose of their pharmaceutical waste, the EPA has recently chosen to look for less onerous regulations coming in 2009, but has reiterated the ASCs’, along with other healthcare professionals', responsibility to dispose of their waste appropriately," says Justin Funk, vice president of PharmASC-e Consultants. "There's no regulation yet (for ASCs) but it's going to start soon."
In fact, in Nov. 2008 the EPA proposed to add hazardous pharmaceutical wastes to the Universal Waste Rule under RCRA in order to provide a more uniform system for disposing hazardous pharmaceutical wastes. This proposed rule would apply not only to hospitals but also ambulatory healthcare facilities (Find out more at www.epa.gov/epawaste/hazard/wastetypes/universal/pharm.htm#3).
"You get into healthcare to help people," says Mr. Funk. "You don’t get into healthcare and then find out I’ve been hurting maybe more people than I’ve been helping because I’ve not been responsible about the way I’m supposed to manage my waste."
Here are six best practices to help you start to develop a law-abiding, efficient pharmaceutical waste management program and also potentially reap some financial benefits for your surgery center.
1. Understand the EPA's three pharmaceutical waste management requirements.
Before you start changing how you handle waste, it is critical to research and understand about the EPA's requirements for proper waste management, says Mr. McKenna. These requirements are
- classification of all pharmaceuticals used by the facility;
- active programs which minimize the amount of pharmaceutical waste; and
- proper disposal and documentation.
It is important to learn your own state's requirements as well as federal rules. Not all states have followed the federal lead on all requirements, says Mr. McKenna, so you should learn your state guidelines and how they compare to federal requirements.
2. Analyze and characterize your waste.
With these requirements in mind, you should perform a comprehensive analysis of every pharmaceutical and cleaning supply that your facility uses. Once you have assembled this data, you can calculate how many kilograms of hazardous waste per month your facility generates. With this figure, you can determine what kind of waste generator you are according to the EPA, which breaks it down into three categories.
- Large Quantity Generators generate 1,000 kilograms per month or more of hazardous waste, more than 1 kilogram per month of acutely hazardous waste, or more than 100 kilograms per month of acute spill residue or soil.
- Small Quantity Generators generate more than 100 kilograms, but less than 1,000 kilograms, of hazardous waste per month.
- Conditionally Exempt Small Quantity Generators generate 100 kilograms or less per month of hazardous waste, or 1 kilogram or less per month of acutely hazardous waste, or less than 100 kilograms per month of acute spill residue or soil.
Each generator type must comply with its own set of requirements. You can learn more about these generator types and the requirements by visiting www.epa.gov/epawaste/hazard/generation/index.htm.
You should also determine what waste categories your wastes fall into.
Hazardous wastes are divided by RCRA into two categories — listed wastes and characteristic wastes. Listed hazardous wastes fall into one of four lists of hazardous waste (F, K, P and U), with pharmaceuticals are found on only the P and U lists which both contain commercial chemical products. These lists designate certain unused chemicals or manufacturing chemical intermediates as hazardous waste. "Characteristic wastes" possess at least one of four measurable properties or characteristics — ignitability, corrosivity, reactivity or toxicity.
Note: You can view a list of P and U wastes in EPA's regulations code 40 CFR 261.33 which details identification and list of hazardous waste (View this at http://edocket.access.gpo.gov/cfr_2006/julqtr/pdf/40cfr261.33.pdf).
Note: You can learn if any of your wastes as characteristic wastes and view a hazardous waste identification flowchart that may be helpful in identifying the type of waste you have by visiting www.fedcenter.gov/resources/facilitytour/hazardous/whatis/flowchart.
3. Identify opportunities for waste reduction.
The analysis you performed should provide you with a clear understanding of where your waste comes from and, if you did your research, the types of wastes you are creating and how you need to dispose of them properly. This analysis can also provide an opportunity identify ways you can reduce your waste. This may not only help you move to a lower type of generator, thus reducing the number of requirements you must meet, but can also help you find savings.
"Active minimization programs give people a cause to pause," says Mr. McKenna. "When you start looking at this (analysis), you may say, 'okay, I didn’t really realize this is a drug I need to be cautious of — why am I using it? Do I need to be using it all of the time?"
For example, ophthalmic and orthopedic surgeons often use epinephrine in a balanced salt solution for irrigation. Some physicians may have individual bags of this solution made for each case, but they should look and see if they always use a full bag or even half of a bag.
"You shouldn't make up much more than you need because anything extra is waste," says Mr. Funk. "It's not just the cost of the drug you can save on; you can save a staff member who is preparing the drug. You start looking at some of the cost savings. First identify that it’s a worry-drug; explore how it’s used and if it’s necessary. This process is good for the bottom-line."
4. Develop policies and procedures.
As with any component of your operations, you will want to develop policies and procedures for how you handle your pharmaceutical waste. These policies and procedures should cover practices including how:
- hazardous waste is identified;
- it is properly disposed of;
- you document the processes involving pharmaceutical waste;
- you comply with state and federal regulations
- you track your disposal;
- your facility is prepared for and responds to an emergency involving a waste spill or other possible compromise of patient and staff safety from pharmaceutical waste; and
- staff is trained — at least annually to handle and dispose of waste (with documentation of this training).
It is also worthwhile to develop benchmarking procedures that allow you to demonstrate the types and quantity of waste your facility generates, says Mr. McKenna.
For example, "If the facility is utilizing mitomycin ophthalmic drops — how many are purchased relative to caseload?" he says. "How many are destroyed because they are expired?" This may lead to opportunities to improve efficiency and cut costs
5. Educate current staff and future staff about pharmaceutical waste.
It's certainly important to train staff on how to handle pharmaceutical waste, but it is perhaps as important to just inform them that they will be doing so.
"When do you make your employees aware that they are dealing with hazardous pharmaceutical waste?" says Mr. McKenna. "I think you should include it in job description so they are not surprised or caught off guard. You should also include it in employee training procedures. RCRA will tell you that a Large Quantity Generator needs to have their employee trained within the first six months. You may want to even try to do it in the first week.
"You’re letting them know that you — as a facility care — about it; you care about it so much so that you’re taking the time to make sure they are trained," he says. "You might want to even mention in any ads that they are dealing with pharmaceuticals in preparation for surgery so you're cutting out all of the steps so they can't say they didn’t know" they would be handling this waste.
6. Proclaim your commitment to safety.
Many surgery centers include mention of the fact that they are accredited on their Web site, in brochures and in the ASC itself. Once you put together a comprehensive program to properly manage and reduce pharmaceutical waste, this is another badge of honor you may want to consider sharing with the public.
"ASCs want to get people to come to their center over a competing center or a hospital, and if they can proclaim that they have been handling their waste properly, with all of the things that have been in the news, then that’s to their advantage," says Mr. Funk. "Something that says 'our drugs are properly handled when we’re wasting them;' that’s just going to be to your benefit. It’s one more level of comfort when you’re going into surgery."
Note: For additional best practices, view "Managed Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States," published by Practice Greenhealth, a nonprofit membership organization offering tools and resources for environmental stewardship in healthcare, at www.practicegreenhealth.org/page_attachments/0000/0102/PharmWasteBlueprint.pdf.