Most physicians probably give little thought to the estimated 10%-30% of medications that patients don’t end up consuming.1, 2 On the rare occasion when patients do ask their doctors where to dispose of unused medications, a physician could hardly be criticized for recommending disposal in the household garbage. Indeed, until recently, trash disposal was assumed by most clinicians and patients, as well as the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), to be a safe and environmentally friendly method of disposing of unused pills.
Recently, however, the identification of pharmaceuticals within environmental water at the nanograms-to-low-micrograms-per-liter range has raised concerns that medications disposed of in the trash may be leaking into the environment where they could harm marine life or humans.3
Moreover, unused medications often linger in medicine cabinets where unintended recipients may access them. Accidental ingestion of pharmaceuticals has been on the rise, including an epidemic of opioid overdoses, which may be due in part to the buying, stealing, or accidental ingestion of stockpiled medications. These trends underscore the need for a simple, expedient, and environmentally friendly mechanism for pharmaceutical disposal.
In response to these concerns, environmental advocates and public health leaders have begun promoting pharmaceutical “take-back” programs in which qualified entities such as fire departments, police stations, or pharmaceutical retailers provide collection kiosks for unwanted pills. Such an approach has been used to collect other potentially hazardous consumer products, including batteries, paint, packing, tires, and electronics. Products collected through take-back programs are transferred for incineration or processing, minimizing their release into the environment.
In advocating for take-back programs, proponents have invoked a principle known as “Extended Producer Responsibility.”4 The Extended Producer Responsibility principle suggests that manufacturers of environmentally harmful products must assume responsibility for their disposal. In the case of pharmaceuticals, the Extended Producer Responsibility principle places the onus on the pharmaceutical industry for ensuring appropriate disposal of their products.
Not surprisingly, manufacturers have questioned the Extended Producer Responsibility principle, arguing that it is not just producers, but also others along the supply chain, who profit from the sale of their products. However, holding producers rather than a complex network of suppliers and retailers responsible for product disposal has the benefits of simplicity, as well as directly incentivizing environmentally friendly product redesign. Thus far, the US legal system—including the US Supreme Court—has affirmed the constitutionality of mandatory industry-funded take-back programs for pharmaceuticals.
Nevertheless, take-back programs remain something of a novel concept in the US. Only this year did the FDA and DEA endorse take-back programs as the preferred approach for disposing of pharmaceuticals, and only in settings in which pharmaceutical collection sites are easily accessible; where such collection sites are not available, trash disposal remains appropriate. And although certified pharmaceutical drop-off sites have been widely available in Canada for over a decade, in the US they are available only sporadically and intermittently, often in the form of quarterly take-back events.
But this may be changing. This spring, Walgreens began offering pharmaceutical collection kiosks in certain stores, and other retail chains may follow suit. Additionally, a handful of US municipalities—mostly on the West Coast—have recently passed ordinances requiring pharmaceutical manufacturers to develop and fund take-back programs.
This year I had the privilege of participating as a scientific adviser in a debate about a proposed ordinance to mandate an industry-funded take-back program in Los Angeles County. After a long and thoughtful discussion, the Board of Supervisors voted to defer on a comprehensive industry-funded take-back ordinance in favor of a more limited motion calling for quarterly take-back events. However, the Board plans to reevaluate the issue in November after more data are available.
After witnessing the debate, I have come to feel—contrary to my initial reaction—that mandating a comprehensive industry-funded take-back approach for pharmaceutical disposal in the US would be premature.
First, from an environmental standpoint, the extent to which unused pharmaceuticals reach the environment via trash disposal remains unclear. According to one industry-funded study,5 just 0.1% of pharmaceuticals disposed of in the trash leak out of landfills and into the environment. Moreover, landfill leakage may be responsible for just a fraction of pharmaceuticals in the environment. Many medications are not fully metabolized after consumption, but rather are excreted in feces or urine. They then enter the sewage system, where they drain into the environment after incomplete processing. Large quantities of pharmaceuticals also reach the environment as a result of usage in livestock. Thus, even if all unused pharmaceuticals were effectively processed, the overall impact on environmental contamination could be modest.
Second, it is by no means clear that a take-back effort would reduce accidental ingestions. In fact, such an approach might have the unintended consequence of increasing the stockpiling of unused medications by encouraging patients to store unused pills for drop-off at collection facilities. This could increase consumption by unintended recipients.
For these reasons, I feel that more research is needed to better understand the impact of pharmaceutical take-back efforts. Nevertheless, there are important actions we can take at this time.
As an alternative to mandatory industry-funded take-back programs, I would instead favor legislation that broadly endorses the Extended Producer Responsibility concept but without specifying precisely how manufacturers should reduce environmental contamination from their products. Specifically, I believe governments should hold manufacturers directly accountable for the outcomes we care about, namely lowering the concentration of pharmaceuticals in the environment and reducing accidental ingestions. This accountability could be enforced through financial and other penalties if targets are not met. Such an approach would provide manufacturers the flexibility to prevent their products from reaching the environment in the most efficient manner possible. For example, rather than funding a take-back program with uncertain benefits, manufactures might invest in filtering technology to remove pharmaceuticals from the sewage system and landfills. Or they might redesign their products so that a higher proportion is metabolized.6 And to lower rates of accidental ingestions, companies might invest in educational resources for consumers.
In the meantime, we also should educate consumers about medication disposal. Based on the recent FDA and DEA guidelines, we should inform consumers that they may bring unused medications to certified collection sites or quarterly take-back events when feasible. However, when such options are not easily accessible, consumers should dispose of unused medications expediently in the household trash to reduce the risk of accidental ingestion. When disposing of medications in the trash, consumers should put them in a plastic bag and mix them with substances like kitty litter or coffee grounds to make them less palatable to scavengers. Disposal in sinks and toilets, which drain into the environment via the sewage system, should be discouraged except as a last resort for high-risk medications like opioids when the threat of diversion is high (eg, a family member with a substance abuse problem).
The problem of appropriate disposal of unused medicines, while not glamorous, has important environmental and public health implications. It is critical that policymakers take an evidence-based approach to determining the optimal disposal strategy, just as we would for any medical question.
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-Michael E. Hochman, MD, MPH
This article originally appeared in the February 2017 issue of The American Journal of Medicine.
