Reducing the Human and Environmental Impact of Improper Drug Disposal

By Angelica Gums

MPP Candidate, expected 2016

Gums photo

Everyday people lack the necessary information and access to properly dispose of their unwanted or expired medications, leaving many to resort to harmful practices.  The lack of proper drug disposal practices in the United States has caused both environmental and human harm. While local government disposal programs and annual Drug Enforcement Administration (DEA) “take-back” programs divert many of the unwanted or expired medications from the waste stream, these programs are not enough to reduce improper disposal of pharmaceuticals. Given the implementation of the Affordable Care Act (ACA) in January 2014 and the expected increase in the amount of medications dispensed to patients, it is recommended that the United States adopt a federally mandated disposal policy to reduce the harmful environmental and human harm that improper drug disposal wreaks on society.

Drugs in the Water

Improper medication disposal is a significant environmental and public health problem in the United States.  Traces of pharmaceuticals in drinking water and unsafe stockpiling of medications in the home have contributed to the argument for alternative methods of disposal that divert consumers from disposing of medication down the toilet or in the trash. Although previously considered acceptable methods of disposal, these practices are now understood to be detrimental not only to the health and safety of consumers but to aquatic life.  Pharmaceuticals thrown in the trash eventually end up at municipal landfills and accumulate in leachate, liquid that forms and passes through solid wastes, eventually suspending into our water system.  Contaminated leachate has adversely impacted our environment as millions of gallons discharge annually into our waterways without adequate waste treatment systems in place to filter all compounds.[1]

The Department of Environmental Protection in Maine conducted a 2009 study on leachate samples at three municipal solid waste landfills and found traces of forty different prescription and over-the-counter medications.  Some argue that the majority of pharmaceutical traces enter our waterways via human excretion.  However, a recent report revealed that many of these products show up in filtered water as well.[2]  Because there are no criteria currently in place to evaluate the toxicity levels associated with concentrations of some of these medications, even at low levels, little is known about the effects they can have on our bodies.

Additionally, improper disposal harms aquatic life.  In 2006, two chemists discovered anti-depressant remnants in the brains of fish.[3]  Further observation showed delayed reactions in fish towards predators (generated stimuli in the study).  One chemist attributed this slow response to anti-depressant remnants found in the water.  As a result, fish were slower in protecting themselves against predators.  If this continues, the United States could see a potential decrease in the population of fish as a natural resource for human consumption.

Given imperfect access or information on proper disposal methods (what is considered safe or unsafe and the associated costs), some consumers have chosen to stockpile their leftover medications within their homes.  Unfortunately this practice has shown to encourage abuse of prescription drugs among teenagers, as one in four teens (24 percent) now admit to abusing prescription drugs at least once in their lifetime—up 33% from 2008.[4]  More than half of these teenagers retrieved those medications from their parent’s medicine cabinets.  Not only are teens abusing medications, some are sharing them with their peers at gatherings called “pharm parties,” where a variety of pills are consumed by teens in one setting.[5]  Over the last few years this has led to a 14% increase in the number of emergency room visits attributed to the misuse and abuse of these drugs.[6]  According to the DEA, if proper drug disposal methods were in place, access and availability of these drugs to teens would be reduced.[7]

The United States government should adopt a mandated disposal policy that addresses the challenges faced by current prescription drug abuse and disposal trends.  In January 2014, 32 million previously uninsured citizens became eligible to acquire health coverage under the new Affordable Care Act signed by Congress.  This includes an increase of roughly 19.5 million people in Medicaid alone.  As a result, the pharmaceutical industry can expect greater demand by consumers for prescription medications and will supply more to the market.  If a disposal program is not in place and consumers are misinformed about how to properly dispose of their medications and where to take them, the public health and environmental conditions of the United States will become worse.

A federally mandated policy is therefore necessary to implement long-terms solutions that address current practices.  The goals of this policy should include a significant reduction in prescription drug abuse trends among teenagers, and an increase in incinerated medications.  In this report, two policy alternatives are evaluated against the status quo: “Single Provider” policy, which allocates full administrative and financial responsibility in operating a national disposal program to the pharmaceutical industry, and the “Shared Cost” policy, which allows the industry to split costs with state governments.

Alternatives

Policy Option #1: The Status Quo

Current policies on medication disposal come from a variety of sources.  On the federal level, The Controlled Substances Act of 1970 (Title II of The Comprehensive Drug Abuse Prevention and Control Act of 1970) regulates the manufacture and distribution of controlled substances in the United States.  These include “narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances.” [8] In order to produce, distribute, or prescribe any of these drugs, one must register with the Drug Enforcement Administration (DEA).  If a “non-registrant” person wants to dispose of their medications, they must follow guidelines set forth in Title 21 of the Act.  In most cases, an authorized registrant or agent of the DEA is present to collect the drugs.[9]  However, many consumers are unaware of this process, making personal disposal of drugs difficult.

In 2010, the Obama Administration signed into law the Secure and Responsible Drug Disposal Act — an amendment to the Controlled Substances Act of 1970.  The law states that the Attorney General can disseminate regulations that allow consumers to:

“… deliver the controlled substance to another person for the purpose of disposal of the controlled substance if the person receiving the controlled substance is authorized under this title to engage in such activity; and the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.”[10]

This law resulted in the creation of “take-back” programs outside of registered state and local law enforcement agencies. Before this amendment, only registered state and local law enforcement agencies had “take-back” programs.  Now, pharmacies and other participating health facilities can register with the DEA to host collection bins and consumers can dispose of their medications in at those locations.

Local governments have responded to the 2010 law by partnering with independent pharmacies within their counties. For instance, in April 2012 the City and County of San Francisco launched their Safe Medication Disposal Program with an $110,000 grant from the pharmaceutical industry.[11]  Regulated by the County’s Environmental Health Department, tax revenue helps fund the program through partnerships with independent pharmacies.  Consumers may place their leftover medications in a clear bag and place the medications in a collection bin at one of the sites.  Across the bay and similar to the San Francisco program, minus the partnership with the pharmaceutical industry, Alameda County has its own disposal program.  In July 2012, the county became the first local government in the country to pass an ordinance mandating pharmaceutical companies to operate and fund collection programs.[12] In 2013, Pharmaceutical and Manufacturers of American (PHARMA) sued Alameda County, stating that its ordinance violated the Interstate Commerce Clause of the Constitution, which allows for the free exchange of goods.  A federal court in San Francisco and the 9th Circuit Court of Appeals disagreed, leading PHARMA to appeal its case to the Supreme Court.  On May 26, 2015, the Supreme Court declined to hear the case letting Alameda County’s ordinance stand.[13]

Policy Option #2: Single Provider

A “Single Provider” policy would require the Pharmaceutical Industry to solely finance and operate a disposal program that collects, transports, and disposes of unwanted prescription and over-the-counter medications without shifting cost to consumers in the form of higher medication prices, as outlined in the Alameda County Safe Medication Disposal Ordinance.[14]  The Pharmaceutical Industry is defined as all producers who sell, offer for sale, or distribute prescription and non-prescription medications in the United States.  Medications can include orphan products, which are medications that are no longer in production, or products acquired outside of the United States.  This “Product Stewardship Program” (PSP) can be operated by one producer or many producers in a Product Stewardship Organization (PSO).  The PSO would be responsible for the safe collection and disposal of medications.

These guidelines are an expansion of Alameda County’s Safe Medication Disposal Ordinance, which was adopted by the Alameda County Board of Supervisors in 2012 and is currently being administered through the County’s Environmental Health Department.  It states that the PSO will design a plan that outlines the implementation and administration of their program and submit it to the designated regulatory state agency (DRSA) by a set date.[15]  The plan must include:

  • Contact information of all producers in the PSP
  • Individuals on the governing body of the PSO, if applicable
  • An agreement to collect all prescription and over-the-counter medications, including those that are not produced by producers of the PSO
  • Methods about how medications will be safely collected, tracked, and incinerated
  • List of authorized personnel involved in transporting the unwanted medications and the hazardous waste facilities authorized to incinerate the medications
  • List of partnering collection sites, including retail facilities (if applicable)
  • A description on how producers will educate and outreach to the public on safe disposal practices
  • Detailed priorities for the plan over the next five years
  • Administration of a Mail-Back order, if applicable
  • Compliance with federal regulations on collection and disposal of unwanted medications
  • If a PSO includes more than one producer, the cost of administering the program should be distributed equally and outlined in the plan

The PSO must submit a plan to the DRSA for approval.  In addition, they must pay a fee to the DRSA for administrative cost to regulate the program.  If the PSO, at any time, does not comply with any of the requirements set forth in the plan, the DRSA can administer a penalty.  Regulatory structure over the PSP(s) and penalties are designed by the DRSA.

Policy Option #3: Shared Cost

A “Shared Cost” policy would require the Pharmaceutical industry to work in partnership with state governments to establish a Product Stewardship Program. In this case, the pharmaceutical industry and the state government would work together to determine an appropriate and effective cost toward implementing a PSP, given the demand by consumers and the regulatory agency.  For instance, in San Francisco County the Department of Environmental Health (DEH) administers the County’s Medication Disposal Pilot with a grant from the pharmaceutical industry.  However, the DEH is responsible for designing the program and complying with state and federal regulations on safe disposal methods.

Under this type of policy, a DRSA is responsible for designing a plan that meets some, but not all, of the requirements outlined in the Single Provider policy.  They include:

  • Methods about how medications will be safely collected, tracked, and incinerated
  • List of authorized personnel involved in transporting the unwanted medications and the hazardous waste facilities to incinerate the medications
  • List of partnering collection sites, including retail facilities (if applicable)
  • A description on how the department will educate and outreach to the public on safe disposal practices
  • Detailed priorities for the plan over the next five years
  • Administration of a Mail-Back order, if applicable
  • Compliance with federal regulations on collection and disposal of unwanted medications

Cost to fund the program can be administered through a tax on every prescription medication supplied to the state or through an annual funding grant provided by the Pharmaceutical Industry.  It is the responsibility of the DRSA to report the effectiveness of the program to the state legislature and for the legislature to determine the frequency of the reporting (i.e. quarterly, mid-year, annually, etc.).

In both options 2 and 3, the U.S. Environmental Protection Agency (EPA) would monitor the activities of state disposal programs.  If a PSO incurs more than three penalties in one year by the DRSA, the EPA would enforce sanctions against the organization.

Criteria and Evaluation

Effectiveness and Administrative Feasibility

Current policies are not enough to reduce the harmful side effects caused by improper drug disposal, as evidenced by the rise of prescription drug-related emergency room visits among teens and the emerging traces of pharmaceuticals found in our water system.  With the new health care law and the potential increase of pharmaceuticals available to consumers, local government programs and annual DEA take-backs cannot alone successfully reduce the effects of improper drug disposal.  Furthermore, implementation and regulatory oversight of such programs cost money and local governments are financially unable to meet the demands of consumers for more disposal sites.  Without more support from the pharmaceutical industry, future drug disposal trends are expected to get worse.

In administering an effective drug disposal program, both the government and members of the pharmaceutical industry have been shown to be equally capable.  In 1997, British Columbia instituted a product stewardship program requiring pharmaceutical companies to develop collection programs that take back and dispose of expired and unused mediations.[16]  The cost of the program is fully paid by the pharmaceutical industry while British Columbia acts as the regulatory agent.  This concept of “Extended Producer Responsibility” assigns no fee to consumers to dispose of their medications or pharmacies who decide to host bins (though some increased cost may be passed along in the form of higher prices for medication).  With its implementation, British Columbia has successfully increased the amount of returned products to pharmacies by 26% from 2011 to 2012.  If a Single Provider policy is adopted, the pharmaceutical industry should be able to administer a national drug disposal program.

Locally, San Francisco County administers its own program through the Department of Environmental Health.  Partnerships between 13 independent pharmacies and 10 police stations, in a year, has allowed San Francisco to collect 17,142 pounds of expired and unwanted medications to be incinerated.  .[17]  Yet, annual donations by the pharmaceutical industry help finance the program and it is unclear if the same effectiveness would be accomplished without their support.  If a Shared Cost policy is adopted, the state could use San Francisco’s program as an administrative model for running a state-wide program.

 Efficiency and Equity

It is important to evaluate efficiency and equity when analyzing the alternatives.  It is clear that local government disposal programs are not enough to promote the above goals. Sabatini (2013) states that San Francisco city officials are presently unsatisfied with current take-back operations and are seeking long-term financial solutions for their program.[18]  However, a key question is should responsibility of funding a state disposal program fall exclusively on tax payers or should the pharmaceutical industry fund or at least share the cost of its administration.  To analyze this argument, the financial impact to the pharmaceutical industry and to individual states in administering a drug disposal program must be evaluated.

According to World Health Organization (2013) the global pharmaceuticals market is currently worth $300 billion a year[19] and, in response to the ACA’s implementation in January, its revenue is expected to increase by $35 billion over the next decade.[20] Therefore, could the pharmaceutical industry fully fund and operate a national disposal program as described in the Single Provider Policy and is it fair given potential economic risks?

PHARMA’s 2013 Biopharmaceutical Research Industry Profile outlines the industry’s spending on Research and Development and total sales.  In 2012, they brought in approximately $295 billion dollars in revenue.[21]  Sixteen percent was spent on Research and Development (R&D), both in the U.S. and abroad, including cost of salaries, materials, supplies, manufacturing of drugs, and contracted or granted funds to laboratories or educational institutions for research purposes.  This calculation did not include “cost of routine quality control activities, capital expenditures, or any costs incurred for drug or medical R&D conducted under a grant or contract from other companies or organizations” or the costs of promoting drugs.  This leaves about $247 billion in profit, less the unincluded costs.  Based on this analysis, the pharmaceutical industry can financially support a nation-wide drug disposal program and remain profitable.  In British Columbia there are 8.2 million people who dispose of their medications under a program .[22]It costs the industry $430,340 thousand a year to operate the program and there has been no reported increased medication costs to the consumer.[23] If a similar program is adopted in the United States, annual costs are expected to be around 16.5 to 26.5 million dollars, considering the population size and standard of living of the United States compared to Canada.[24] [25] This makes up 0.005 to 0.01 percent of the industry’s current total sales.

In terms of the Shared Cost Policy, individual states must generate revenue to support a state-wide disposal program, which means increased taxes.  However, a tax on consumers can lead to less spending on goods and services, ultimately driving down economic activity and generating less revenue for state programs.  Additionally, some state governments are currently trying to recover from debt, and lack the revenue to fund and administer a new program.  When predicting potential costs, a new drug disposal program can be financially compared to an existing recycling program.  For instance, in California the collection of household hazardous waste (batteries, sharps, and paint, etc.) costs taxpayers $16 million ($0.42/per person) a year.[26]  With additional support from the pharmaceutical industry, costs could be leveraged for a drug disposal program without placing a significant burden on taxpayers.  For states smaller than California, costs for running such a program would be less.

Recommendation

Based on the above analysis, it is recommended that the federal government adopt the Single Provider Policy. Although both policies are effective in administering a drug disposal program, the Single Provider Policy is predicted to be more efficient at meeting the above goals.  There is less of a financial risk to the industry compared to the economic impact a Shared Cost would have on state resources.  Current annual revenue by the pharmaceutical industry plus projected revenue from the ACA will generate more than enough money to exclusively fund and administer a nation-wide drug disposal program. Society will benefit extensively and outcomes from the program will .  They may however oppose the recommended policy and challenge its legality in court.

 

About the Author

Angelica Gums

Angelica Gums is completing her final year in the Mills Public Policy Program. Her policy interests are in economic and education policy. After graduating, she seeks a career in government or consulting.

 

Footnotes

 

[1] Behr, R., Stahler, D., & Pistell, A. (2010). Preliminary Characterization of the Pharmaceutical Content of Municipal Solid Waste Landfill Leachate from three landfills in Maine. Retrieved October 27, 2013 from http://calpsc.org/products/pharmaceuticals

[2] Kolpin, D., Furlong, E., Meyer, M. Thurman, E., Zaugg, S., Barber, L., & Buxton, H. (2002). Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 19990-2000: A national Reconnaissance. Retrieved from University of Nebraska-Lincoln web site: http://digitalcommons.unl.edu/usgsstaffpub/68

[3] Raloff, J. (2008, December). Antidepressants Make for Sad Fish: Drugs May Affect Feeding, Swimming and Mate-Attracting. Science News, 174 (13), 15. Retrieved from http://www.jstor.org/stable/20465780.

[4] Metlife Foundation. (2013). 2012 Partnership Attitude Tracking Survey. Retrieved October 27, 2013, from http://www.drugfree.org/wp-content/uploads/2013/04/PATS-2012-FULL-REPORT2.pdf

[5] Sanborn, H. (2012). Safe Drug Disposal Powerpoint. Sacramento, CA: California Product Stewardship Council. Retrieved via email.

[6] U.S. Department of Health and Human Services. (2009-2011). Drug Abuse Warning Network, 2009-2011: National Estimates of Drug-Related Emergency Department Visits. Retrieved from http://www.samhsa.gov/data/DAWN.aspx

[7] Drug Enforcement Agency. (2012, August). Prescription for Disaster, How Teens Abuse Medicine. Retrieved from http://www.justice.gov/dea/pr/multimedia-library/publications/prescription_for_disaster_english.pdf

[8] The Catholic University of America. (2009). Controlled Substances Act of 1970. Retrieved from http://counsel.cua.edu/fedlaw/csa1970.cfm

[9] Electronic Code of Federal Regulations (2013). Disposal of Controlled Substances. Washington DC: U.S. Government Printing Office.

[10] Secure and Responsible Drug Disposal Act of 2010, S. 3397, 111th Cong. (2010).

[11] Sabatini, J. (2013, August 9). San Francisco finds funding to extend drug-disposal program. Retrieved October 27, 2913, from http://www.sfexaminer.com/sanfrancisco/san-francisco-finds-funding-to-extend-drug-disposal-program/Content?oid=2540240

[12] Sanborn, H. (2012). Safe Drug Disposal Powerpoint. Sacramento, CA: California Product Stewardship Council. Retrieved via email.

[13] Oakley, D. (2015, May 26). Supreme Court: Big Pharma must pay for prescription drug disposal in Alameda County. Retrieved June 7, 2015, from http://www.contracostatimes.com/breaking-news/ci_28191245/supreme-court-big-pharma-must-pay-prescription-drug.

[14] Alameda County Safe Drug Disposal Ordinance (2012). Retrieved from http://www.acgov.org/aceh/safedisposal/index.htm.

[15] Alameda County Safe Drug Disposal Ordinance (2012). Retrieved from http://www.acgov.org/aceh/safedisposal/index.htm.

 

[16] California Product Stewardship Council. (2012, April 23). British Columbia Product Stewardship Program: Pharmaceuticals. Sacramento, CA: California Product Stewardship Council. Retrieved October 27, 2013, from http://calpsc.org/products/pharmaceuticals

[17] Kreisberg, J. (2013, August 2).San Francisco Waste Characterization Study. Berkeley, CA: Teleosis Institute. Retrieved October 27, 2013, from http://calpsc.org/products/pharmaceuticals

[18] Sabatini, J. (2013, August 9). San Francisco finds funding to extend drug-disposal program. Retrieved October 27, 2913, from http://www.sfexaminer.com/sanfrancisco/san-francisco-finds-funding-to-extend-drug-disposal-program/Content?oid=2540240

[19] World Health Organization. (2013). Trade, foreign policy, diplomacy and health: Pharmaceutical Industry. Retrieved from http://www.who.int/trade/glossary/story073/en/

[20]Japsen, B. (2013). “Obamacare Will Bring Drug Industry $35 Billion in Profits.” Forbes Magazine 5 May 2013. Retrieved from http://www.forbes.com/sites/brucejapsen/2013/05/25/obamacare-will-bring-drug-industry-35-billion-in-profits/

[21] PHRMA. (2013). 2013 Profile Biopharmaceutical Research Industry. Pg. 60. Washington, DC: PHRMA. Retrieved from http://phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf

[22] California Product Stewardship Council. (2012, April 23). British Columbia Product Stewardship Program: Pharmaceuticals. Sacramento, CA: California Product Stewardship Council. Retrieved October 27, 2013, from http://calpsc.org/products/pharmaceuticals

[23] Laur, G. (2014, March 2). Drug Take-Back Bill Faces Opposition. Retrieved May 11, 2014, from http://www.californiahealthline.org/insight/2014/drug-takeback-bill-faces-opposition?view=print

[24] Standard of living was determined by the Levy Institute of Economic Well-being (LIMEW) measurement tool which computes “gross money income…noncash government transfers, public consumption, income from wealth, and household production, and nets out all personal taxes.”  It estimates Canada’s LIMEW as 7 percent lower than the United States.

[25] Wolff, E., Zacharia, A., Thomas, M., Selcuk, E., Andrew, S. & Hazell, E. (2012). A Comparison of Inequality and    Standards in Canada and the United States Using an Expanded Measure of Economic Well-Being. Retrieved April 1, 2014 from http://www.levyinstitute.org/pubs/wp_703.pdf

[26] California Product Stewardship Council. (2013). Pharmaceuticals. Retrieved October 27, 2013, from      http://calpsc.org/products/pharmaceuticals

 

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