Health care industry faces new environmental challenges
As if complying with the new and often complicated mandates of Obamacare isn’t enough, the health care industry is now facing even more complexity — and expense — as the U.S. Environmental Protection Agency establishes new regulations for the disposal of unused medications.
Getting rid of old prescriptions used to be a snap: Doctors and the EPA recommended we flush them to ensure the meds didn’t fall into the wrong hands. But some unintended consequences began surfacing in the 1970s, calling this approach into question. That’s when the EPA began finding low levels of anti-depressants, sleeping pills and other medications in the nation’s surface and ground water.
Most of this likely results from drugs that are consumed but are not fully metabolized, although disposal also plays a role. Unfortunately, wastewater treatment facilities were designed to capture industrial pollutants, not birth control pills or aspirin. While the potential health risk to people may not be particularly high — after all, the drugs have been approved by the FDA for human consumption — the potential impact to aquatic life is less certain.
In an effort to address the problem, the EPA plans to propose in 2014 new waste rules regulating the handling and safe disposal of pharmaceutical waste. And at least one county in California has decided to take matters into its own hands by establishing new rules applicable to drug manufacturers. Both of these have the potential to spell major changes and increased costs.
The EPA already regulates the disposal of hazardous and industrial waste, which includes many types of commonly used pharmaceuticals. The EPA regulations, however, were written largely with industry in mind, meaning the regulations are not always a good fit for hospitals, pharmacies and other non-industrial businesses.
While most manufacturers typically only have a handful of wastes to keep track of, health care facilities may have hundreds of different medicines that must be properly disposed. Making matters worse, some of the regulatory thresholds that apply to waste pharmaceuticals are very low — sometimes as low as one kilogram of waste generated in a month — putting health care facilities in the almost impossible position of trying to calculate how much pharmaceutical residue is left in empty containers that are thrown away.
Recognizing the problem, the EPA attempted to simplify and streamline regulation of pharmaceutical waste in 2008 by proposing a universal waste rule for pharmaceuticals. This rule would have allowed anyone that handles pharmaceutical waste to do so under a simplified set of regulatory standards that the agency currently applies to other common wastes, including fluorescent light bulbs.
After receiving negative comments from environmental advocates who wanted more stringent requirements, the agency backed off. It now plans to propose new rules next year that should provide regulations tailored to the health care industry — although likely with more requirements and a bigger price tag.
Next up: Alameda County in California passed an ordinance mandating that any pharmaceutical manufacturer that sells its products in the county must develop and fund a drug take-back program for that county.
Drug take-back programs are generally a good idea. The U.S. Drug Enforcement Agency recently sponsored its seventh National Prescription Drug Take Back Day. Since the voluntary program started in 2010, the DEA has recovered more than 2.8 million pounds of prescription and over-the-counter meds from nearly 6,300 locations nationwide, including West Michigan.
Mandating the creation of drug take-back programs on a county-by-county basis, though, would create a compliance nightmare. California is seen as a bellwether for consumer and environmental protection issues, so it’s possible other counties could adopt a similar approach. With more than 3,100 counties in the country, such a patchwork of regulations would be difficult, if not impossible, to meet.
The Association of Pharmaceutical Manufacturers of America has already sued Alameda County, alleging its ordinance would improperly burden manufacturers under the commerce clause. The ordinance withstood the first legal challenge but now faces an appeal.
Proper management and disposal of unused medications needs to be addressed thoughtfully and consistently, in a way that is protective but without adding unnecessary expenses for those involved. Many complain about the cost of prescription drugs — let’s not burden health care facilities and pharmaceutical makers with unnecessary regulations that drive up the pricing even more.
Dan DeWitt is a partner at Warner Norcross & Judd LLP who concentrates his practice in a wide range of environmental matters, with a special emphasis on hazardous waste. He can be reached at firstname.lastname@example.org.