Pharmaceutical waste management is one of the most complex sustainability issues. People and ecosystems are increasingly subjected to medication exposure through the manufacture and disposal of medication. The emergence of drug-resistant "superbugs" in patients and the impact of endocrine disruptors on humans and wildlife are issues of deep concern.
What do regulations say, and how can healthcare sustainability leaders prevent waste from being generated while improving environmental impact through new practices, staff education and the pursuit of more healthful options?
In 2008, the Associated Press reported that 250 million pounds of medication waste were generated each year in the United States' healthcare sector. It is safe to assume this number has been growing ever since, as more Americans consume more prescription drugs every year (PDF), much of which goes down the drain.
The U.S. Geological Survey reported that sewage sludge used as fertilizer on farms can leave traces of prescription drugs and household chemicals deep in the soil. Furthermore, persistent pharmaceuticals in the environment are not removed in wastewater treatment plants, and can be found in drinking water. Numerous studies and reports detail the feminization of fish, where they have both testes and eggs. And this month, a study in Science Daily showed that many endocrine-disrupting chemicals interfere with human sperm function.
Confusing regulatory landscape
Despite existing Drug Enforcement Administration and Environmental Protection Agency regulations, proper management of pharmaceutical waste remains on the to-do list for many hospitals. Top compliance barriers are staff training challenges, complexity of regulations, lack of storage space, lack of in-house expertise and unclear regulations for “controlled” addictive substances, according to the latest annual survey by Pharmacy Purchasing and Products.
At the same time, growing commitment among healthcare entities reflect a positive trend. As recently as 2000, healthcare administrators were not aware of, or on board with, pharmaceutical waste collection. This year, 81 percent of hospitals have committed to the proper management of pharmaceuticals, up from 77 percent last year, according to Pharmacy Purchasing and Products.
Complying with DEA and EPA ill-adapted regulations is a challenge for healthcare entities, according to Charlotte A. Smith, a senior regulatory advisor with WM Healthcare Solutions, Inc. and an expert on pharmaceutical waste management. That's especially true when those regulations are not in sync.
The EPA’s 1976 Resource and Conservation Recovery Act was written primarily for industrial settings. Applying it to healthcare over the past 10 years has been a complex process. With increased awareness have come increased confusion and cost. Healthcare professionals are calling for more clarity from regulators, and for a set of regulations specific to healthcare. EPA is working on revisions that are expected to be published later this year.
Discarding controlled substances
Preventing diversion of addictive drugs while protecting the environment can lead to conflicting practices. As per the DEA, controlled substances have to be rendered "non-retrievable." The agency has stated that such substances mixed with coffee grounds, cat litter or sharps containers do not meet its “non-retrievable” requirement, although it has not provided clear protocols that do. As a result, complying with DEA regulations while avoiding disposing of waste controlled substances in the sewer has proved a huge challenge.
The long-anticipated revised DEA regulations regarding the capacity of a pharmacy or other entity to accept the unused portion of controlled substances that are used outside of a hospital or a nursing home setting are likely to be released in late spring.
Pharmacies will be permitted to host kiosks for collection. The new rules do not allow for a kiosk in a hospital unless it is located within a retail pharmacy on-site. Long-term care facilities may be required to use kiosks provided by their provider pharmacy. Mail-back programs to a reverse distributor with an on-site incinerator also will be permitted.
The revised regulations also will include provisions for controlled substance disposal protocol for hospitals, nursing homes and pharmacies. While the DEA accepts flushing as a “witnessed” disposal for discarding addictive drugs, some regions such as the District of Columbia, Florida and Connecticut oppose this view, developing “no flush rules” for controlled substances. In the new regulations, the DEA is leaving it to the marketplace to figure out ways to avoid flushing while ensuring controlled substances are rendered “non-retrievable.”
Private sector to the rescue
The most promising choice to date, according to Smith, is the Cactus Smart Sink. The Cactus Smart Sink looks like a sink with a drain, but rather than connecting to a sewer, the contained system has a chemical process that renders the drugs unrecoverable and neutralized.
With the technical expertise frequently insufficient in-house, most hospitals contract with companies that provide a turnkey approach including conducting a pharmacy formulary review which identifies the proper means of disposal for each of thousands of medications, a method for labeling pharmaceuticals and an educational strategy for nurses, clinicians and other key staff to segregate pharmaceutical waste streams. Training and an auditing protocol are critical for success.
Anja Leetz, the executive director of Health Care Without Harm in Europe, tracks European initiatives designed to address pharmaceutical waste management. For instance, the noPILLS project is an international cooperation project which recognizes that the vast majority of pharmaceuticals in water are not from hospitals or nursing homes but from the home-user. Its focus is on educating consumers on best management of pharmaceutical waste management and research on emerging areas to identify alternatives to current disposal practices.
Another initiative, Chem21, brings together pharmaceutical manufacturers and universities under the leadership of the University of Manchester and GlaxoSmithKline, working together to identify healthier biological and chemical materials to replace natural resources such as precious metals that are used in medication manufacture. Their goals include review of emerging research around green chemistry and educational tools to share with pharmaceutical manufacturers.
This is a lot to digest. Let’s help get hospitals on the right track. Here are 10 ways hospitals can add value to their pharmaceutical waste management initiatives:
1. Check pharmacy inventory to insure rapid turnover, and avoid high stock level to reduce incidents of medication expiration.
2. Consider stocking neostigmine instead of physostigmine for the operating room to remove one acutely toxic pharmaceutical from the formulary.
3. Educate, train-the-trainer and integrate segregation protocols in departmental training, regular updates and ongoing audit and compliance processes.
4. Analyze the pharmacy’s formulary annually and have the pharmacy buyer seek waste categorization information for all new drugs as they are purchased.
5. Make it easy for anesthesiologists and emergency room staff by having all drugs in those departments placed into the hazardous waste container.
6. Track data and watch for any spikes. Hazardous pharmaceutical waste should be only 5 to 8 percent of total hazardous waste stream, including non-RCRA chemotherapy waste.
7. Perform rotating pharmaceutical waste audits weekly or at least monthly to check on compliance by each department.
8. Educate patients on proper medication waste disposal. Support the community and consider hosting a community pharmaceutical waste collection day for Earth Day or National Pharmaceutical Take Back Day. The 2014 National Take Back Day resulted in over 4,000 events nationwide and collection of over 390 tons of medication. Search your state for regional resources such as Michigan’s Yellow Jug Program and learn how to host a pharmaceutical take-back program.
9. Develop a written policy as part of the Joint Commission Hazardous Material and Waste Management Plan. Document staff training and audits in meeting minutes to demonstrate compliance and quality protocol. Ensure that all hazardous waste manifests are in order and readily accessible.
10. Keep an eye on emerging research and engage clinicians and pharmacists to address prescribing practices — overprescribing, amount prescribed and medication choices.