We all know that pharmaceuticals are an essential component of our health care system. They save lives and improve quality of life for many of us. The number of prescriptions being written in the U.S. is rapidly increasing. Not surprisingly, some of downsides to prescription medications are also rapidly increasing, including prescription drug abuse and environmental impacts.
New rules for the disposal of unwanted medications goes into effect tomorrow – October 9, 2014 – to help address the problems caused by the growing abundance of unwanted medications. Before discussing this major change in regulation, I want to illustrate the extent of the problem and tell you a bit about what I, as a wastewater pretreatment coordinator, have done to address it in my community.
To start, this chart of accidental overdose deaths is a real eye opener:
Source: CDC NCHS data brief 166
The Center for Disease Control and Prevention (CDC) has a fact sheet on prescription drug overdose in the U.S. Some highlights from the fact sheet include the following:
- Drug overdose was the leading cause of injury death starting in 2011.
- Drug overdose death rates have been rising steadily since 1992, with a 118% increase from 1999 to 2011 alone.
- In 2011, drug misuse and abuse caused about 2.5 million emergency department visits. More than half of these were related to pharmaceuticals.
- In the United States, prescription opioid abuse costs were about $55.7 billion in 2007.
Teens now abuse prescription drugs more than any illicit drug except marijuana. Prescription drugs are abused more than cocaine, heroin, and methamphetamines combined. Surveys show that teens find them easy to obtain from family or friends. Violent crime and property crime associated with abuse and diversion of prescription medications (specifically controlled substances) has increased throughout the United States from 2005-2010, according to the Secure and Responsible Drug Disposal Act of 2010.
Trace amounts of many pharmaceuticals have been found in surface and drinking water throughout the country. Studies have shown that even these low concentrations are having negative impacts on the biology of fish and other wildlife. Most pharmaceuticals are likely to remain as unregulated “emerging contaminants” not because they are safe but because determining a safe level of exposure is extremely difficult.
As a wastewater operator, I have learned that treatment plants remove varying amounts of specific pharmaceuticals and their metabolites. For many of them, only a small percent is removed. As a pretreatment coordinator, I wanted to know what I could do to remove medications at the source, before they could enter the wastewater stream.
I found my answer in Monroe County, just an hour or so north of Ithaca. They were one of the first communities to hold take back events in partnership with local law enforcement. Using their program as a template, I searched for community partners to help put together our own program.
Take back events encourage residents to clean out unused and expired medications from their homes and deliver them for safe disposal. Removing medications means they can no longer cause an accidental overdose, won’t be stolen for illegal use, and won’t be put in the trash or flushed down a toilet, contaminating the environment.
The Tompkins County Coalition for Safe Medication Disposal (CSMD) initially included representatives from the Sheriff, county administration, solid waste and recycling, health department, county youth services, a seniors group, Cornell University, and TCAT, the county bus service.
Our first collection event was in 2010. During the six hour event, 509 vehicles come through, an average of 1.4 vehicles per minute! About 1.35% of the households in our county participated. We filled 22 barrels with collected medications along with 20 cases of medicated IV's. Quite a bit of the paper/cardboard packaging was recycled. The net weight collected was 1741 pounds. Subtracting the 632 pounds of IV bags (brought in by one household!), we collected 1109 pounds of pills, ointments, liquids, powders, etc. Not counting the IVs, the average weight dropped off per participant was roughly two pounds, in line with other events. Some medication bottles that were turned in were from 1915-1930!
More recently, the CSMD started a drop box program, installing nine permanent boxes in law enforcement buildings throughout Tompkins County. We wanted to increase opportunities for safe disposal by having a year-round disposal option.
Some argue that collection events are a waste of effort. They say that the bulk of the medication that is in wastewater comes from bodily excretions. Even if true, I say that this is no reason to avoid doing something that helps address the problem. The U.S. Drug Enforcement Administration (DEA) has organized twice a year take back events, with the first eight bringing in more than 41 million pounds of unwanted medications. As of this writing, they haven’t released numbers for the most recent event. With so much collected, it is hard to imagine how anyone could argue that take back events are a waste.
I agree that efforts should be made to reduce the amount of drugs that are excreted. There are a few ways to achieve this goal. Drug manufactures could develop medications that are more completely utilized by the body or that biodegrade to harmless substances. Doctors should strive to prescribe the lowest effective dose for each patient. In some cases, prescribing guidelines should be adjusted to help doctors find the correct dose.
Dispensing guidelines could be adjusted to help prevent so much medication from becoming waste. At a number of collection events, the CSMD was able to inventory what percent of the dispensed medications came back unused. The average was about 70%! That is a lot of preventable waste.
The number of sites participating in DEA collection events (6,072 for the April 26, 2014 event) and the number of communities that have permanent drop box programs have both steadily increased. But still, many communities do not have a convenient way to dispose of unwanted medications. The DEA’s new rule for the Secure and Responsible Drug Disposal Act of 2010 allows for the possibility of a whole new level of convenience for even more communities.
The new rule allows pharmacies (and other registered distributors) to take back unwanted controlled substances from final users. It goes into effect on October 9, 2014.
Having take back mailers or drop boxes in pharmacies, long term care facilities, hospitals and clinics (that have a pharmacy), narcotic treatment programs, etc. will make prompt, safe disposal very convenient. This new rule is an important step towards greater public participation in take back programs for safe disposal. However, the new DEA rule is voluntary and unfunded. Only time will tell which eligible entities will participate and how long it will take for them to get their programs up and running. To date, only one pharmacy chain has indicated they will participate with a pilot program.
There is the added problem that the DEA announced that the September 27, 2014 take back event was their last. This will leave a gap in disposal options, for those served by the DEA collections, until the newly allowed options are implemented.
There are two things I believe need to happen, one short term and one long term. As an interim measure, the DEA should continue its phenomenally successful take back program. This will only happen if all of us let the DEA know how important this is.
As successful as the DEA collections are, they would be unnecessary if most pharmacies had take back programs. The best way to insure that this happens is to provide secure, long term funding.
This leads to the question of who should fund it. To me, the answer is clear. The pharmaceutical manufactures, who are making huge profits in the U.S., should pay for the lifecycle costs of their products. In 2013, total U.S. prescription retail sales were $235,447,332,092, according to the Kaiser Family Foundation.
I venture to guess that one tenth of one percent of this amount ($23.5 million in 2013) would be enough to fund take back programs in every pharmacy, long term care facility, and narcotic treatment program in this country. Pharmaceutical manufacturers are already paying for programs in some other countries. Yet, in the U.S., they have fought in the courts against local product stewardship laws (the local ordinance of Alameda County, California, was recently upheld in the 9th Circuit Court of Appeals). The time is right for the product stewardship model to be applied to pharmaceuticals!
Ed Gottlieb is Chair of the Tompkins County Coalition for Safe Medication Disposal and is the Industrial Pretreatment Coordinator for the Ithaca Area Wastewater Treatment Facility. He has organized seven, mostly multiple location, one day collection events. These events have brought in 6910 pounds of unwanted medications, including an estimated 100,000+ doses of controlled substances. He coordinated inventories of collected medications and produced a series of how-to videos to help others wanting to start collection events. Mr. Gottlieb has also led the initiative to install 9 permanent drop-boxes at police stations throughout Tompkins County. He has an environmental studies and geology degree from SUNY-Binghamton.