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Pharmaceutical drugs

Pharmaceutical Waste Management: Flush, Take-Back Laws or Something Else?

Pharmaceutical drugsHow to best manage pharmaceutical waste has become a hot-button issue.

In September the EPA proposed new Management Standards for Hazardous Waste Pharmaceuticals, which sets regulations on how healthcare facilities, including retail stores and pharmacies, manage and dispose of pharmaceutical waste.

The EPA says its proposal would protect waterways, including drinking and surface water, by preventing the flushing of hazardous waste pharmaceuticals and simplifying the requirements for healthcare workers. Retailers have countered the new rule would limit retailers’ ability to recycle or reuse unsold consumer products and pharmaceuticals.

And now a group of more than 100 environmental and health organizations, agencies, and state lawmakers and officials is urging the Food and Drug Administration to end its “flush list” recommendation for medications, which says it’s OK to flush some pharmaceuticals down the toilet or throw them away in the trash. The coalition wants the agency to support a single disposal guidance system, such as a national medicine take-back program.

In a Jan. 26 letter to the FDA, organized by the National Stewardship Action Council, solid waste managers, environmental service manager and groups including Waterkeeper Alliance wrote: “the time has come for FDA to align its medicine disposal guidance with that of federal, state and local agencies who seek to protect both the public’s health and our water quality.”

The letter urges the FDA to tell the public that instead of flushing unused medications, they should take them to a community take-back program that will provide safe disposal and suggests checking with local waste or police departments for drop-off locations. But the pharmaceutical industry says this option is too expensive and doesn’t really improve the environment, either.

The FDA would not say if is considering ending its flush recommendation for some medicines. A spokesperson would only say “FDA will respond directly to those who signed the joint letter.”

Drug Take-Back Laws

The Product Stewardship Institute, which advocates for extended producer responsibility laws, isn’t a signatory on the letter. But, according to PSI’s Vivian Futran Fuhrman, associate for policy and programs, “We completely agree that medications should not be flushed. PSI’s stance is that pharmaceutical take-back programs are the ideal disposal strategy.”

Because collection programs are not always available and convenient, PSI says extended producer responsibility (EPR) laws, which require manufacturers to fund and manage recycling and disposal programs for their products, would provide the best waste management solution for household pharmaceuticals.

In 2012, Alameda County, California passed the first EPR law for pharmaceuticals in the US. Since then, the city of San Francisco and 5 other counties along the West Coast have passed similar drug take-back laws, according to PSI.

“We want to help provide the public with the safest disposal option for public and environmental health, which would be widespread and convenient pharmaceutical take-back programs, and we pursue EPR laws to that end,” Futran Fuhrman says. “We want to be a part of that solution.”

The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group, doesn’t have a position on the recommendation to end the flush list, says Priscilla VanderVeer, deputy vice president, communications. But mandating drug take-back programs is not a viable option, she says.

‘Greater Burden on the Environment’

“America’s biopharmaceutical research companies support efforts to educate consumers about the safe use, storage and disposal of our products, including voluntary take-back programs. However, there is no rationale for mandating new, costly and redundant take-back programs when in-home disposal in your household trash has repeatedly been shown to be effective, ecologically sustainable, secure, more convenient and less costly for patients.

“In fact, mandated take-back programs place a far greater burden on the environment because individuals have to travel to drop-off sites and somebody has to pick up and dispose of those drugs,” VanderVeer continues. “Instead, our companies will continue working with stakeholders to promote and enhance education about the safe disposal of our products.”

PhRMA doesn’t have estimates on how much a nationwide, mandatory take-back program would cost.

PhRMA and two other industry trade groups challenged the constitutionality of the Alameda County law to the US Supreme Court. In May 2015, the high court announced it would not hear the industry’s argument against the drug take-back law.

Still, Alameda County has encountered major challenges that have limited the program, VanderVeer says. She says the county has only had one take-back event that resulted in only 300 pounds of waste. Additionally, because of liability and security concerns, take-back kiosks must be placed in law-enforcement locations. To date, not a single kiosk has been placed.

“This is not due to hold-ups by the individual biopharmaceutical companies involved — it is due to the complexity, security and liability challenges inherent in managing take-back programs,” VanderVeer says.

Photo Credit: pills via Shutterstock

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6 thoughts on “Pharmaceutical Waste Management: Flush, Take-Back Laws or Something Else?

  1. Pharmaceutical disposal into trash is easy and guarantees at least a degree of waste isolation in landfills. Take-back programs, public or private, are costly and typically only partially successful (e.g., batteries). Lined landfill control trash disposal sounds best at this point.

    This doesn’t dispute the fact that endocrine disruptive pharmaceutical residuals in human waste and their subsequent re-appearance in downstream drinking supplies is emerging as a significant risk for the early- and mid-stage fetus in utero and ways to purge these chemicals from our drinking water systems, presumably as part of our waste-water treatment plants processes, need to be developed.

  2. Practically all pharmacists in Spain have a disposal and collection systems where unused medicines can be left. This system has been in operation for decades.

  3. In response to the PhRMA comment that they don’t have any estimates to the national cost of the program we respond by highlighting that PhRMA stipulated to the fact in the Alameda Case that the Alameda program would cost 1 cent for every $10 of meds sold, and since they sold almost a billion dollars of drugs into Alameda in 2010, the cost was going to be $1 million a year for the program in Alameda County. Here is how it breaks down in 2010 numbers for the US to get $245 million per year cost for a national program run by producers:

    $878.9 Billion in Global Sales (Reuters, April 20, 2010)
    $308.6 Billion in US Sales (Supreme Court Filings)
    $37.31 Billion in California Sales (Population proportion)
    $950.0 Million in Alameda County Sales (Supreme Court Filings)

    11.76% Average Net Profit in 2010 for nearly all Pharma companies (14.74% in 2014)

    $36.28 Billion in Net Profit for US
    $4.386 Billion in Net Profit for California
    $111.7 Million in Net Profit for Alameda County

    $0.126/$100 of Prescription Cost for EPR ($950M divided by $1.2M) x $100

    $244.8 Million in Cost for US EPR Program

  4. There’s no need to guess at the cost. In Santa Cruz County, California, we have had a retail takeback program for drugs and sharps for years. Almost all pharmacies host bins for drugs and sharps, and it’s easy for consumers to drop off their waste products. Total disposal costs are only about $50k per year, while keeping these materials out of our waterways, out of the landfill and off the black market. It’s a simple and easy solution that works.

  5. “But the pharmaceutical industry says this option is too expensive and doesn’t really improve the environment, either.”
    Wait, these same companies operate under EPR rules and regulations in many international countries, some for decades now. Overall costs decrease with program availability, consumers have sound options, and the environment is far better off rather than landfilling. Landfill liners will leak in due time, WWTP cannot treat the pharmaceuticals, and collection kiosks and events work very well, even here in Texas. Given the options easily afforded through companies such as Sharps Inc., the PhRMA claims of hardship from these program are unfounded.

  6. Besides Spain (thanks Pedro) Sweden and Australia have excellent national drug take back programs. In Canada, several provinces do as well. Extended Producer Responsibility programs are not only possible, they are the right thing to do! Shame on big pharma for resisting this so vehemently; one marketing campaign would likely cover most of the annual costs.

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