How Should Drug Take-Back Work?
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Think Tank

How Should Drug Take-Back Work?

More Americans are being prescribed drugs than ever before and the trend is expected to grow.

Almost three out of every five American adults take at least one prescription drug regularly, according to a study published this month in the Journal of the American Medical Association. In 2012, the most recent data examined, 59 percent of U.S. residents ages 20 and older were prescribed at least one drug. That was a marked rise from 51 percent in 2000. In the same dozen-year span, the number of people taking five or more prescription drugs almost doubled — 15 percent in 2012 compared to 8 percent in 2000.

As this mountain of pills for aging baby boomers grows at one end of the equation, so does a smaller heap at the other end. What to do with old and unwanted prescription drugs is beginning to be a headache for governments large and small. Environmental and abuse problems abound with improper disposal of many drugs. Part of the headache involves who pays for it.

Because there is no state or federal system in place, cities and counties are creating their own.

Alameda County’s determination that the pharmaceutical industry should create, maintain and pay for a drug-take back program was challenged in the courts as far as possible. The U.S. Supreme Court this summer declined to consider pharmaceutical industry objections, potentially opening the door for similar laws across California and the U.S.

Last year, state Sen. Hannah-Beth Jackson (D-Santa Barbara) introduced a bill (SB 1014) in the California Legislature seeking to create a statewide version of Alameda’s program. SB 1014, faced strong industry opposition and died in committee.

The California Board of Pharmacy this fall is considering statewide regulations for getting rid of old and unwanted drugs. So far, the board is leaning toward making it a voluntary program for pharmacies, which is in conflict with at least one local government program that requires pharmacies to participate.

We asked stakeholders, experts and consumer advocates:

  • How should prescription drugs be discarded?
  • Should it be a statewide program or should counties and cities create their own systems?
  • Who should pay for it?
  • Should pharmacies be required to participate?

We got responses from:

Growing Problem Needs Attention

Safely disposing of medications has become a growing problem for the U.S. Sadly, in California, counties and cities have had to create their own ordinances to deal with the issue. While it’s great that communities are taking charge due to a lack of action by the health care community and state and federal government, we would like to see a statewide or national program put into place. After all, stopping the prescription drug misuse epidemic and protecting water quality are national issues.

The California Product Stewardship Council co-sponsored SB 727 and SB 1014 by Senator Hannah-Beth Jackson in 2013 and 2014.  These bills would have required producers of pharmaceuticals to create, finance and manage an unwanted medication collection system for the public. The proposals mirrored an existing program in Canada, which the industry has efficiently operated for 15 years. Unfortunately, while the bills had support from more than 100 organizations, cities and counties across the state, the opposition (a small group of pharmaceutical companies) killed them.

The pharmaceutical industry understands the importance of sharing responsibility and proper disposal and has successfully designed and implemented medicine take-back programs in many countries around the world. However, in California and the rest of the U.S. it’s a completely different story. As a result, cities and counties have had to develop their own ordinances to ensure sustainably funded and convenient medication take back programs.

Alameda County adopted the first ordinance in the nation to hold pharmaceutical companies responsible for the safe collection and disposal of unused medications from the public. The county’s motives were simple: provide a sustainably funded and convenient medication collection system that is effectively publicized. Groups that supported the effort included drug misuse prevention groups, environmental protection organizations, senior advocacy groups, hospice care workers, nurses union, veterinarians, local governments and many more.

The pharmaceutical industry fought Alameda and went so far as to sue Alameda and took the case all the way to the U.S. Supreme Court, which denied to hear it in May 2015.  Following Alameda’s lead, cities and counties throughout California and beyond began considering, and passing, medication take-back ordinances. Now, the most populated county in California (Los Angeles) is considering its own ordinance.

It’s unfortunate that these take-back programs are piecemeal because the pharmaceutical industry would rather fight the issue at every turn. Drug companies have many arguments as to why they shouldn’t share any responsibility in the U.S. They cite everything from that it will cause a rise in the price of drugs to it being an unfair financial burden on pharmaceutical commerce to the government can do it better. However, they have funded, managed and successfully designed and implemented similar take back programs in many countries around the world including Canada, Mexico, PortugalBrazil and Colombia.

Instead of spending billions on advertising or millions of dollars fighting take-back programs, the pharmaceutical industry should become good stewards by backing statewide legislation that provides an economically sustainable system to manage medications at end of life. The cost for a medication take-back program was determined in the Alameda court case to be at the most one cent for every $10 in prescription drugs sold.  That’s a very small amount of money when you consider that the industry spent $4.5 billion advertising medications last year in the U.S. Doctors are now calling for a ban on drug ads in part because of significantly increasing drug prices.  

We are asking the health care industry to help protect public health and work together with local governments to provide the same convenient and well publicized medication take-back system they provide in other countries. It’s not only the right thing to do and we know it works, but it can be a great public relations move to help an industry that has recently had its share of bad press.

Everyone Has a Role To Play

With more Americans being prescribed drugs than ever before, the quantity of medications that go unused will only continue to pile up in our medicine cabinets. If not properly disposed of, those drugs pose an environmental concern if they are thrown in the garbage or down drains, because either way, the active ingredients can end up in our waterways and harm fish and wildlife. And as we all know they also pose a public safety concern with potential accidental poisonings, drug addiction and overdoses. But this is also a practical issue — no state or federal agency gives a crystal clear solution about what to do with leftover drugs.

With all these issues in mind, in 2011, San Francisco launched a grant-funded medicine disposal pilot to provide residents an alternative to trashing or sewering unused medication. While no one knew how much we might collect, the quantity has far exceeded our expectations. Since inception, our program has collected and properly disposed of more than 62,000 pounds of medication, or about 20,000 pounds per year. That’s a lot of pills! Clearly, the program needed long-term funding to continue to provide San Franciscans this disposal option, and it made sense to us that the costs should be borne by those profiting from the increasing sales of drugs — the manufacturers.

It also made sense that such a program should be offered statewide, as many California jurisdictions are grappling with the same water quality and public health concerns. However, in 2014, when the pharmaceutical industry blocked statewide legislation to establish manufacturer-funded and operated collection programs, the San Francisco Board of Supervisors decided to take local action.  With overwhelming support from local law enforcement, public health advocates, environmental advocates, pet owners, seniors and the California Retailers Association, the San Francisco Board of Supervisors unanimously passed legislation requiring manufacturers to develop and fund safe drug disposal in San Francisco. 

Under the San Francisco Safe Drug Disposal Ordinance, everyone has a role to play — residents make the effort to bring leftover drugs to collection sites, retail pharmacies offer floor space for collection bins, drug manufacturers develop and pay for the program, and government provides oversight. In an ideal world, all parties would participate willingly, but because the government’s job is to protect public and environmental health, there may come a time when we have to require participation. Many of San Francisco’s independent pharmacies and residents are already doing their part, and we look forward to working with manufacturers and chain pharmacies to provide safe drug disposal throughout San Francisco.

Convenient Disposal Opportunities Needed for Patients

Pharmacists play an important role in ensuring patient safety and access to treatment.  Prior to dispensing a medication to any patient, pharmacists review the appropriateness of the medication therapy including contraindications or interactions with other drugs. As licensed health care professionals, pharmacists are also responsible for the security and integrity of all prescription drugs in a pharmacy.

Due to pharmacists’ role in medication treatment and concerns among patients about what to do with unused drugs, the California Pharmacists Association (CPhA) has long called for a comprehensive statewide program to provide patients with convenient disposal options. In the absence of a statewide program, some of our members have voluntarily overseen take-back bins in pharmacies or participated in community take-back events.

Prescription drug disposal is a very complex issue. Prescription drugs and their distribution fall under the control of multiple regulatory agencies.  The federal Drug Enforcement Administration the federal Food and Drug Administration and the California Board of Pharmacy each control different aspects of the flow of drugs within the supply chain, including the controlled scheduling, licensing, and distribution of medications as well as the licensing of entities and individuals involved in that distribution (e.g. pharmacies, wholesalers, manufacturers, pharmacists, distributors, reverse distributors, etc.). This makes prescription drug disposal entirely different and far more complicated than take-back programs for batteries, paint, light bulbs, or other common household hazardous waste.

The complexities specific to prescription drug disposal have unfortunately presented significant problems for those pharmacies that have voluntarily housed take-back bins on their premises. Beyond the federal and state regulatory mandates for managing and monitoring drug disposal, pharmacies report an array of challenging issues ranging from:

  • Questions from patients and non-patients about take-back bins;
  • Theft and vandalism of the bins;
  • Prohibited items placed in the bins, such as used sharps, illegal drugs, and hazardous drugs like chemotherapy.; and
  • Consumers accidentally dropping keys or other personal items in the bins, which are not retrievable without the pharmacy staff taking the time to contact the licensed waste hauler to come onsite to unlock the bin and retrieve the items.

All of these challenges take attention away from the pharmacists’ primary responsibility to provide quality patient-centered care and uphold their legal responsibilities for overseeing the safe and compliant operation of the pharmacy. For these reasons, CPhA encourages pharmacies to closely evaluate their infrastructure and capabilities before voluntarily participating in take-back programs, and only doing so where it is practical for that specific pharmacy and staff. CPhA strongly opposes mandates for all pharmacies to participate in take-back programs.

A viable statewide solution needs to provide convenient drug disposal opportunities. Patients will not properly dispose of prescription drugs when their disposal options are perceived as inconvenient. We believe that supplying free, postage-paid drug mail-back envelopes to consumers at their home provides the most convenient and affordable solution.

In California, local governments are responsible for managing waste — from garbage and recycling to household hazardous waste. Those agencies should do their part to manage prescription drug waste by providing free mail-back envelopes to their customers on trash collection day. These envelopes are already in use by some agencies and are certified to be used in returning all types of drugs, including controlled substances. Consumers simply place their unused medications in the envelope and drop it in the mail from the comfort of their home. This solution will provide the greatest impact for getting unused medications out of the medicine cabinets of homes in California.

In-home Disposal Safe, Sustainable

The biopharmaceutical industry, along with our many community-focused partners, is committed to educating consumers to take their medicines as prescribed, as well as safely and securely store and dispose of them in an environmentally-friendly way. To do so, we must realize that consumers rely on voluntary disposal methods that are both convenient and free.

We also must realize that mandating a costly and unnecessary take-back program is not the answer to questions about consumer disposal of unused prescription medicines.

A mandated take-back program will not help the environment. Up to 90% of the trace amounts of prescription medicines in the environment result from medicines passing through the human body without being metabolized, a fact with which FDA also agrees.

In fact, mandated take-back programs will increase the burden on the environment, because individuals will have to travel to drop-off sites and a completely new waste disposal infrastructure will have to be created. Collecting medicines in identifiable drop-off sites will also increase the risk for diversion of medicines for drug use disorders.

In Alameda, there have been major challenges in implementing the mandatory, industry-funded take back ordinance, not to mention significant costs. That program, which has to be in compliance with Federal Drug Enforcement Administration regulations, will likely only have kiosks at law enforcement locations. This complexity is highlighted by the fact that, to date, after more than two years of implementation negotiations, the program is just now beginning.

On the other hand, consumer education about in-home disposal has repeatedly been shown to be effective, ecologically sustainable, secure, more convenient, and less costly. The in-home disposal process, as described by the FDA, is simple: place medicines in a sealable container, such as a plastic bag, mix with water and an undesirable substance such as kitty litter or coffee grounds and place it in your household trash.

If local communities do decide to implement take-back programs, there must be safeguards in place to ensure funding and operations are the responsibility of the participating communities, theft or diversion of medicines is avoided and people are educated about the full range of safe disposal options available to them.