U.S. Counties Requiring Drug Makers To Take Back Unwanted Medicines

PRESCRIPTION DRUG TAKE BACK 101

◾ Consumers may bring unwanted prescription medicines to participating pharmacies, hospitals, fire stations, and law enforcement offices. There, they can deposit the drugs into secured containers.
◾ The collected drugs are taken to a hazardous waste incinerator for safe disposal.
◾ County ordinances requiremakers of drugs sold within the jurisdiction to form a cooperative to finance and manage the local program.
◾ Ordinances allow some drugmakers to seek exemption from the programs if they only sell small amounts of pharmaceuticals in the county and establish their own mail-back programs. For example, in Alameda County, Calif., Exelixis, a small biotech firm that makes drugs to treat rare diseases, was granted an exemption.

The U.S. is swimming in medications. In 2014, physicians ordered or provided $275.9 billion in prescription drugs. Nearly 49% of U.S. residents have used at least one prescription drug in the past 30 days, according to the Centers for Disease Control & Prevention (CDC), and the majority of those over age 60 take two or more drugs each day.

The pharmaceutical industry estimates that only 70 to 90% of prescription drugs are consumed. Sometime patients stop taking them. Sometimes doctors change a patient to a different drug. Pharmaceuticals purchased by consumers can age beyond their expiration date before they are taken. Recent estimates suggest that as much as $5 billion worth of leftover drugs are consigned to medicine cabinets, thrown in the trash, or flushed down the toilet each year in the U.S. These actions can lead to accidental poisonings, cause harm to aquatic life and water quality, and even help drug abusers obtain fixes.

To address these issues, some U.S. counties are creating regulations requiring pharmaceutical companies to pay for programs that establish places for consumers to drop off unwanted medication and see to its safe incineration.

Drug disposal ordinances take a stab at a number of pressing issues in one fell swoop, says Heidi Sanborn, executive director of the California Product Stewardship Council, a network of nonprofits and local governments that works to push manufacturers to share responsibility for a product’s end of life. “It’s about the water issues but also the huge national epidemic of prescription drug use,” she says. “It also touches on the cost of health care and overprescribing by doctors.” She points out that while many paint, battery, and carpet manufacturers have adopted policies to minimize harm at the end of their products’ usefulness—for example, increasing the ease of recycling these items—the pharmaceutical industry has no similar efforts.

Other countries, such as Canada, Mexico, and France, have federal requirements for government and industry together to handle safe disposal of medicines. But the U.S. doesn’t, so local governments are stepping in to tackle the problem. They are crafting ordinances that put the onus on drugmakers to pay for a secure medicine-return-and-disposal program.

This trend started east of San Francisco Bay. There, Alameda County, Calif., in June 2012 passed its Safe Drug Disposal Ordinance. Now, three years later, the program is starting to actually collect medicines.

Shortly after the ordinance was enacted, the drug industry mounted a legal challenge, saying the new requirements interfered with interstate commerce. A federal appeals court, however, found the county’s action was lawful. The drug industry lodged an appeal, but earlier this year, the U.S. Supreme Court declined to hear it. This means the county prevailed and is implementing its ordinance.

Since 2012, three more neighboring California counties as well as King County, Wash., which includes Seattle and Tacoma, passed similar ordinances. Legislation elsewhere in the U.S. may be in the works, says Maria Wood, board of health administrator for King County, which was the second jurisdiction in the U.S. to adopt safe disposal requirements for medicine. “Counties concerned about this issue are considering it,” she says. Her agency continues to get calls from boards of health and water districts across the country that are thinking about enacting take-back programs.

The new ordinances require the setting up of take-back containers at drugstores, making it convenient for consumers to dispose of old medication at the same time they purchase new prescriptions. While the federal Drug Enforcement Administration sponsors one-day drug take backs, these events are often held at sheriffs’ offices or police stations. They don’t tend to have a large impact because people aren’t comfortable bringing drugs to the police, claims Scott Cassel, the chief exectuive officer and founder of the Product Stewardship Institute, a national nonprofit organization based in Boston.

Pharmaceutical makers staunchly oppose the take-back ordinances. They say that most drug compounds in the environment get there because people take their medications as prescribed—the chemicals pass through the body and get flushed away. They argue there is no reason to put money into collection of unwanted pharmaceuticals.

“It has always been the industry’s position that you shouldn’t put drugs down the toilet; you should put them in the trash,” says John Murphy, assistant general counsel for the Pharmaceutical Research & Manufacturers of America, a trade group representing brand-name drugmakers. Adding the pills to a plastic bag filled with coffee grounds or kitty litter, and putting it in the trash, eliminates the potential for abuse or accidental poisoning and is also convenient for the consumer, he says.

“The Alameda program hasn’t collected a drug and has cost the industry a fortune,” Murphy says without giving an exact number. Part of the problem is coaxing the 2,000-odd drugmakers to work together to pay for the program and figuring out how much each must ante up for the program. Each company’s contribution is based on the number of pills it sells in the county each year. “It’s incredibly burdensome to follow the regulations,” Murphy says.

However, most consumers will not bother with putting pills in plastic bags, and that’s why it’s so important to create simple and safe drug collection points, Cassel says. As for cost, France’s national take-back program, Cyclamed, considered one of the highest-performing programs in the world, operates for about $0.15 per person per year. King County estimates its program will cost about $1 million per year—roughly $0.49 per capita—in the early years of the program.

Safe medicine disposal also means that drugs get incinerated at high temperatures. Putting them in the trash could lead to drugs in landfills, where the compounds may leach into groundwater, Cassel says.

Inspiring the local medicine take-back efforts are concerns about public health and environmental safety. Pharmaceuticals flushed down the drain can have adverse effects on animals down the watershed, and some medications have particularly potent effects. Birth control medications are potent endocrine disruptor, which can cause male fish to grow female sex organs, according to a 2007 study in the Proceedings of the National Academy of Sciences USA (DOI: 10.1073/pnas.0609568104). Traces of antidepressants can cause fish to be slower to respond to predator threats, according to research published in Aquatic Toxicology (2014, DOI: 10.1016/j.aquatox.2013.12.033). Dana Kolpin, a U.S. Geological Survey researcher who studies contaminants of concern, points out that pharmaceutical traces are rarely found alone—there can be up to 50 different drugs in the water at one place and time. That makes teasing apart each drug’s impact on watersheds tricky.

Most of the pharmaceuticals in water get there not through the dumping of pills or liquids down the drain, Kolpin says, but through being processed in the body and excreted through feces or urine that is then flushed. Some sewage treatment plant operators are considering new technology that would break down pharmaceutical compounds, but those systems are expensive—and as the number of drugs increases, the technology would need work on a diversity of molecules.

Overprescription by doctors can play a role in creating unwanted drugs. “If you go in and have a tooth pulled, you may be getting 30 days of Vicodin instead of 10 days of Tylenol,” says Sanborn of the California Product Stewardship Council. In addition, prescription drug plans often encourage consumers to order a few months of a prescription through the mail by making the per-dose price cheaper than if they refilled it monthly at a drugstore. This practice, too, can add to the inventory of unused medicines.

Meanwhile, prescription drug abuse is the fastest-growing drug problem in the U.S., according to the CDC. Of those who misuse prescription drugs, over half report that they took pills that were prescribed to a friend or family member. Drug overdoses from both legal and illegal drugs have become the leading cause of injury and death in 37 states.

Cassel says that it’s too early to say what impact county-level take-back ordinances will have on the levels of accidental poisonings and overdoses. Baseline research is starting now, so any changes will be monitored after collection programs begin. “We need to do the research,” he says. “But that doesn’t mean we should stop until we do a 10-year study.”

The concept of governments requiring drugmakers to take back unwanted medicine may well continue to spread across the U.S. and the world too. In October at the United Nations’ Fourth International Conference on Chemicals Management, governments, the chemical industry, and health and safety activists backed the need for global cooperation to address prescription drugs as pollution.

Katharine Gammon is a freelance reporter in California.