RokStories War on Drugs Includes Battle Over Disposal Options
By P.J. Heller

Heidi Sanborn and her colleagues can’t fathom why there is such a hodgepodge of city/county/state/federal guidelines and rules concerning how people should dispose of prescription and nonprescription/over-the-counter drugs.

Especially troubling, she says, is the Food and Drug Administration’s recommendation to flush some unused, expired and unwanted medications down the sink or toilet.

Sanborn, executive director of both the National Stewardship Action Council and its affiliated organization, the California Product Stewardship Council, is not alone in her concern about the effect of pharmaceuticals entering waterways. More than 100 environmental and health organizations, agencies, activists and state legislators signed on to a letter to the FDA urging it to end its “flush list” recommendations.

“We call on the FDA to end its recommendation that certain medications be disposed by flushing, and to clarify that secure medicine take-back programs provide the best disposal method for leftover household medications,” said the letter to FDA Acting Commissioner Dr. Stephen Ostroff. “. . . 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.”

In place of the assortment of rules and regulations being considered or crafted by governmental agencies at all levels, Sanborn and others recommend a single national disposal system for pharmaceuticals, to be funded by the industry similar to take-back programs such as those for electronics manufacturers.

A mandatory, industry-funded take-back program is vehemently opposed by the pharmaceutical industry.

Drug take-back programs run and funded by pharmaceutical and related companies already exist in other countries, including Canada, Mexico, Spain, Brazil, Belgium and Portugal. In Canada, for example, people can return their unused and expired medications to any pharmacy any day of the year.

“They do it in these other countries and they're fighting like hell here,” she says.

Sanborn pooh-poohs the argument by drug manufacturers that the cost of such take-back programs would be expensive and result in higher prices for drugs, noting that where such programs are in effect drug costs are actually lower than in the U.S.

“In Canada they do it very efficiently and do a great job,” she says. “But that’s where we get our cheaper drugs. So they can’t make the claim that the cost of the program is killing the budget.

“What it’s going to cut into is CEO pay . . . ” and commercial advertising, she says.

In the U.S., Sanborn estimates a take-back program would cost the industry only 1 cent extra for every $10 prescribed; to run the program in California would cost $42 million a year, she estimates.

That’s a drop in the bucket compared to the average 30 percent profit margin realized by drug companies. Sanborn points to people like Martin Shkreli, who as chief executive officer at Turing Pharmaceuticals generated outrage and prompted a congressional hearing into his plans to raise the price of a life-saving drug by more than 5,000 percent. Shkreli expected to make $1 billion on the drug price hike.

As You Sow, an activist organization that promotes environmental and social corporate responsibility through shareholder advocacy, has filed shareholder resolutions at major pharmaceutical companies asking them to take responsibility for the safe collection and disposal of unused and expired drugs.

“We believe the companies that put medications on the market and profit from them should be primarily responsible for financing take-back systems,” Conrad MacKerron, senior vice president at As You Sow, said in a news release. “We are concerned that the pharmaceutical industry has opposed such responsibility.”

While the Pharmaceutical Research and Manufacturers of America (PhRMA) is against a mandated industry-funded take-back program, at least one national retailer in the U.S. has launched such an effort.

Walgreens, one of the nation's largest drugstore chains, announced in February that it plans to install safe medication disposal kiosks in more than 500 drugstores in 39 states and Washington, D.C., primarily at locations open 24 hours. The bins will allow the public to dispose of unwanted, unused or expired prescriptions, including controlled substances and over-the-counter medications, at no cost.

In announcing the program, Richard Ashworth, Walgreens president of pharmacy and retail operations, noted that the company was “leading the way in retail pharmacy’s fight against prescription drug abuse. We understand the challenges our communities face, and we stand ready to help our patients and customers lead healthier lives. When the stakes are this high, the solutions must be comprehensive.”

Those stakes include prescription drug abuse; a national survey two years ago reported that 6.5 million Americans misused a prescription drug in 2014. And the Centers for Disease Control and Prevention reported a total of 47,055 drug overdose deaths, which include prescription and illicit drugs, during the same year.

Marcia Lee Taylor, president and chief executive officer of Partnership for Drug-Free Kids, calls prescription drug abuse an epidemic among American teens.

The FDA’s suggestion that some unused, unwanted and expired medications be flushed down the toilet or sink runs counter to suggestions by other agencies, environmental groups and others. The U.S. Environmental Protection Agency points to studies that have documented the presence of various pharmaceutical active ingredients and metabolic by-products in surface waters and groundwater in the United States.

“The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations,” it says.

An Associated Press investigation published in 2008 reported that “tests have detected minute concentrations of pharmaceuticals in the drinking water supplies of at least 46 million people in two dozen major American metropolitan areas . . . The federal government does not regulate prescription drugs in water.”

Sanborn points to the current drinking water contamination crisis in Flint, Mich. — caused by lead in the water and not drugs — as an example of why the public needs to demand action to protect its waterways from harmful substances.

“I think the public trust of government to protect their water is pretty much at an all time low,” she says.

“If we cannot get these meds out of the water, why on earth would we put it in there intentionally,” Sanborn asks. “So let’s stop it and let’s use the precautionary principal and say, ‘If we can’t get it all out, it shouldn’t go in. If we can cost-effectively keep it out, let’s do that.”

The way to accomplish that goal, she says, is to create a national drug take-back program designed and paid for by the industry in collaboration with local governments. Such an effort, she says, will be a paradigm shift on how waste is handled.

"Are we going to subsidize it and let companies put whatever they want on the market and walk away and leave the government holding the bag and then claim the government doesn’t do anything right, it’s too big, it’s inefficient,” she asks. “Or are we going to go the way the rest of the world is going, towards a producer-responsibility model where they [manufacturers] have a fair sharing of the responsibility and they even get to design it.

“It‘s not a command-and-control program,” Sanborn says. “For me, coming from government seeing the flaws in having government decide how a program runs . . . it makes a lot more sense to me to leave it in the private sector to design and run it and fund it, and then have the government do oversight and make sure it’s transparent and make sure it works. It’s the best of both worlds.”

The Pharmaceutical Research and Manufacturers of America, however, opposes any mandated take-back programs. An ordinance adopted three years ago by Alameda County, Calif. — the first in the nation to hold pharmaceutical companies responsible for the safe collection and disposal of unused medications from the public — went all the way to the U.S. Supreme Court, which in 2015 denied the industry’s request to review a lawsuit filed against the measure. Three industry trade groups had filed the lawsuit arguing the local law was unconstitutional.

“We will continue to actively work with all relevant stakeholders to educate consumers on the appropriate use of medicines, including providing information about safeguarding medicines in the home and promoting safe, secure and effective methods for disposal,” PhRMA said after the Supreme Court refused to review the case.

“Ensuring the safe and secure disposal of unused medications is a top priority for our industry,” a PhRMA spokesperson said. “The biopharmaceutical industry supports proper in-home disposal as the first-line option for the safe and effective removal of medicines from the household.”

The organization, which represents the nation’s leading biopharmaceutical researchers and biotechnology companies, points to the FDA website for suggestions on how to dispose of medicines.

The FDA says community-based drug take-back programs offer the best option, and failing that, “almost all medicines can be thrown in the household trash.” It also has a “flush list” of drugs that it says can go down the sink or toilet.

“There is a small number of medicines that may be especially harmful and, in some cases, fatal with just one dose if they are used by someone other than the person for whom the medicine was prescribed,” the FDA says on its website. “To prevent accidental ingestion of these potentially dangerous medicines by children, or pets, it is recommended that these medicines be disposed of quickly through a medicine take-back program or by transferring them to a DEA-authorized collector. If these disposal options are not readily available, it is recommended that these medicines be flushed down the sink or toilet as soon as they are no longer needed.”

PhRMA notes that many biopharmaceutical companies have participated in voluntary take-back events and activities nationwide, but insists mandating such programs is not the answer.

“There is no need to mandate 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,” it says.

It also contends that 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.

“While our industry does not oppose voluntary take-back programs, the fact remains that mandatory local, state or national take-back programs are not a solution,” it adds. “Studies have shown that only a relatively small percentage of consumers use take-back programs, which means most unused medicines never reach collection sites. Proper in-home disposal, particularly in conjunction with public education programs, promises much higher compliance rates and widespread participation.”

Despite that, Sanborn remains optimistic that the industry will come around. She describes the battle over drug disposal as the “perfect storm issue,” encompassing areas including drug abuse, law enforcement, water and the environment.

“No matter which angle you come from, you care about this issue,” she says.

Sanborn says the pharmaceutical industry needs to develop and fund its own take-back drug plan or face more and varied ordinances from governmental agencies at all levels, which she describes for the industry as “death by a thousand cuts.”

“Get ahead of it. That’s all you have to do,” she advises. "If you come up with a plan, I don't know of a legislature in the country that would force a law down on you when you’ve got a program that’s working. Nobody wants to go there. But you haven’t done anything. You can’t sit around and then complain [about a patchwork of laws] now that you’re getting death by a thousand cuts. We warned you that it was coming but you just don't want to pay for it, so here we are.”

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