RUNNING HEAD: Disposal of Unused Pharmaceuticals !
Disposal of Unused Pharmaceuticals: Obstacles and Opportunities for Reform
Rachel Cox University of San Francisco
Disposal of Unused Pharmaceuticals 2 Disposal of Unused Pharmaceuticals: Obstacles and Opportunities for Reform
I. INTRODUCTION Environmental pollution via pharmaceutical products has recently received increased attention from the public and scientists alike. Across the United States, trace levels of pharmaceutical components have been found throughout the environment, including waterways, soil, and treated drinking water. While the research is limited, there is evidence that pharmaceutical compounds may negatively impact human health through exposure to antibiotics 1 and endocrine-disrupting substances 2 , among others (Fent et al., 2006). Although some pollution via pharmaceuticals is inevitable as a result of human excretion, public health risks arising from unsafe disposal, including flushing and trashing, are becoming more apparent. Furthermore, the presence of unused controlled substances 3 in homes is likely contributing to increased rates of prescription drug abuse (Department of Health and Human Services, 2005). Despite the evidence demonstrating increased pollution and potential human health effects, the federal government and most state and local governments have failed to take action, largely because there are a number of laws and regulations that limit the scope and reliability of unused drug take-back programs. The Controlled Substances Act (CSA) and Drug Enforcement Agency (DEA) are the most significant barriers in the movement to promote proper disposal. The CSA and DEA prohibit
1 Medications that destroy or slow the growth of bacteria 2 Chemicals that may interfere with the bodys endocrine system and produce developmental, reproductive, neurological, and immune effects in both humans and wildlife. 3 Drugs that are regulated by state and federal law that aim to control the danger of addiction, abuse, physical and mental harm, and trafficking by illegal means. Disposal of Unused Pharmaceuticals 3 pharmacies, providers, and hospitals from collecting controlled substances (Controlled Substances Act, 1970). While law enforcement officers are exempt from this restriction, most take-back programs and events do not ensure the presence of law enforcement and therefore cannot accept controlled substances at their sites. Additionally, the U.S. Postal Service does not allow individuals to mail prescription drugs; only DEA-registered entities are allowed to do so (USPS, 2011). With these regulations in place, take-back programs are unable to offer simple, comprehensive collection, often resulting in unsafe pharmaceutical disposal by consumers. In order to improve the efficacy of take-back programs, reduce the level of pharmaceutical pollution and health risks, and control the potential for controlled substances abuse, reforms at all levels of government are necessary. The federal government has the potential to remove the most significant barriers facing consumers today. Reform that allows pharmacies, providers, and hospitals to collect all substances will significantly increase the scope of take-back programs and allow ease for consumers. Allowing consumers to mail all prescription drugs to a designated take-back program will facilitate return and ensure substances are disposed of in an approved, environmentally friendly manner. Once these obstacles are addressed, state and local governments will be able to adopt more efficient and practical solutions for take-back programs that speak to the needs of all stakeholder groups. The DEA is currently drafting regulations to be implemented under the Secure and Responsible Drug Disposal Act (2010). New regulations will allow expansion of take-back and mail-in programs and give states the ability implement comprehensive collection of all pharmaceutical substances with the potential to harm human health. Disposal of Unused Pharmaceuticals 4 Once regulations are passed, states should implement programs funded by all relevant stakeholders, including pharmaceutical manufacturers, retailers, and consumers, to ensure equal representation, convenience, and economic feasibility of program continuation.
II. SOURCES & DISPOSAL OF UNUSED MEDICATION Recent collection efforts suggest that consumers do not use nearly 45 percent of the prescriptions drugs they are prescribed. This may be for a number of reasons, including allergic reactions, symptom or dosage change, reluctance to finish a regimen due to improved condition, and death. Of those prescriptions returned, opioids and other controlled substances account for only 2.15 percent (Teleosis Institute, 2010). While the number of unused medications is high, the frequency of return remains low, with many consumers keeping drugs, because they do not know how to properly dispose of them, or disposing of them in an unsafe manner. Research has found that consumers primarily use three disposal methods: flushing them down a toilet or sink, throwing them into the trash, and returning them to a pharmacy. A 2006 survey of outpatient pharmacy customers found that fewer than 20 percent had received information about proper disposal from their providers and more than half had flushed unused medication down the toilet (Seehusen and Edwards, 2006). An earlier study found that 35.4 percent of consumers flushed unused medication down a sink or toilet, 54 percent disposed of unused medication in the garbage, and only 1.4 percent returned unused medication to the pharmacy (Glassmeyer et al., 2009).
Disposal of Unused Pharmaceuticals 5 Figure 1: How US consumers dispose of medications
Flushing is the most convenient method for pharmaceutical disposal, but raises the potential for environmental concerns. In 2002, the U.S. Geological survey found human and veterinary drugs in 80 percent of wastewater streams tested. Among those found, antibiotics and prescription drugs were detected most frequently. Throwing prescription drugs in the trash is also convenient but not without risks. Research indicates that pharmaceuticals present in landfills may leach into groundwater and waterways, eventually reaching humans through drinking water (Bain, 2010).
Figure 2: How pharmaceuticals enter the water supply (Source: Bound and Vouvoulis, 2005) Disposal of Unused Pharmaceuticals 6 III. HEALTH RISKS FROM IMPROPER DISPOSAL Pharmaceuticals are intended to cause biological reactions in the patients for whom they are prescribed. However, once free in the environment, these reactions have the potential to affect unintended persons and induce cumulative effects such as increased antibiotic resistance. In some cases, the pharmaceutical concentrations found in water are equal to or higher than the biologically effective dose (Fent et al. 2006). Studies have shown that environmentally persistent pharmaceutical pollutants (EPPP) 4 have resulted in compromised reproductive function and endocrine disruption in aquatic organisms and their presence is suspected to contribute to a lowered average age for puberty initiation (Kime, 1999; Christen et al., 2010). Additionally, Zhang et al. (2009) found that wastewater effluent 5 actually had a higher prevalence of antibiotic- resistant 6 strains than influent, suggesting that treated wastewater bound for human consumption may pose a significant risk to human health. While the full impact of pharmaceutical pollution in our environment is not yet understood, these studies and others similar to them indicate the potential for widespread and serious health effects.
# Compounds that are resistant to environmental degradation through biological and chemical processes $ Wastewater treated or untreated that flows out of a treatment plant, sewer, or industrial outfall. Generally refers to wastes discharged into surface waters. % Bacteria that have evolved with the ability to resist treatment by certain classes of antibiotics. Disposal of Unused Pharmaceuticals 7 Table 1: Risk indicators of various pharmaceutical groups
(Source: Bound and Voulvoulis, 2005)
IV. COLLECTION MODELS Current environmental indicators demonstrate the need for immediate improvement of disposal practices. While risks are currently significant, they are also changeable through improved practices. With the increased attention devoted to pharmaceutical pollution, consumers are concerned and insisting on the expansion of collection programs. Daughton et al. (2003) found that questions about proper disposal are among the top inquiries practitioners receive about pharmaceuticals in the environment. Two collection models, in addition to pharmacy return, are becoming more Disposal of Unused Pharmaceuticals 8 popular, but are currently limited by laws and regulations, ultimately resulting in incomplete collection practices. Drop-off programs operate as both permanent collection sites and one-day events. Permanent collection programs are often run by nonprofits, counties, and state boards of pharmacy and provide drop-off services at predefined locations. The locations generally include pharmacies, household hazardous waste facilities, and police stations, which are the only locations that can accept controlled substances under the Controlled Substances Act. One-day take-back events are typically community- or city-wide and bring together pharmacies, health agencies, and law enforcement to allow the collection of controlled substances. In a mail-back program, consumers send unused prescriptions to a disposal location via the U.S. Postal Service (USPS). Because the USPS only allows DEA- registered entities to mail prescription drugs, mail-back programs are pilot studies and few currently operate. In order to comply with USPS standards, the destination must be registered with the DEA and prescriptions must be mailed in a specified mailer. In order to return controlled substances in compliance with the Controlled Substances Act, consumers must mail prescriptions directly to the Drug Enforcement Agency.
V. AGENCIES THAT REGULATE PHARMACEUTICALS While the idea of expanding these programs in gaining traction, the frequency of their implementation is incredibly low, in large part because of the various government agencies and regulations relating to pharmaceutical disposal. The Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Drug Enforcement Disposal of Unused Pharmaceuticals 9 Agency (DEA) all have conflicting, environmentally unsound, and limiting recommendations and regulations regarding consumer disposal. In addition, the U.S. Postal Service (USPS) regulates the mailing of unused pharmaceutical products. Historically, the FDA suggested flushing all unused pharmaceuticals in order to avoid poisonings. While they no longer advise flushing all pharmaceuticals, they do still provide a list of drugs that consumers are advised the flush. The Medications Recommended for Disposal by Flushing list currently includes many narcotics and pain relievers that consumers are advised to mix with undesirable substances such as coffee grounds. The FDA has been reluctant to set drug disposal standards and prefers that states address this issue. However, their lack of action has delayed effective implementation of adequate disposal practices (Daughton, 2003). The EPA is responsible for implementing the Resource Conservation and Recovery Act (RCRA), which regulates the disposal of hazardous wastes, including 4- 10 percent of pharmaceutical products (Lauer, 2010). Because the percentage of pharmaceuticals considered hazardous waste is so small, most hazardous waste facilities do not accept medications at all, with many citing the inability to effectively categorize and store medications (Glassmeyer, 2009). Additionally, because RCRA does not include household-generated hazardous waste, this key regulation often misses the majority of hazardous pharmaceutical waste pollution. The DEA regulates controlled substances through the Controlled Substances Act (CSA). The CSA mandates that any person who manufactures, distributes, or dispenses a scheduled pharmaceutical be registered with the DEA (Glassmeyer, 2009), which prohibits third parties from taking back controlled substances. The one exception Disposal of Unused Pharmaceuticals 10 allowed by the CSA is for law enforcement officials, who are allowed to receive and handle controlled substances. However, this process often requires time and resources that patients, care facilities, and take-back programs do not have. USPS regulations are among the most widely talked about and limiting restrictions pertaining to take-back programs. The USPS prohibits the mailing of any controlled substance unless both the mailer and recipient are registered with the DEA, are exempt from DEA registration, or are a practitioner mailing directly to the patient. Non-controlled substances are also subject to similar guidelines requiring direct practitioner-to-patient mailing (USPS, 2011).
VI. STAKEHOLDER PERSPECTIVES When it comes to possible solutions regarding unsafe pharmaceutical disposal and the regulatory changes necessary, stakeholders have differing opinions. In order to improve the efficacy of take-back programs, the stances of manufactures and pharmacies must be explored. Pharmaceutical manufacturers often maintain that drugs predominantly appear in drinking water as a result of human excretion and, despite research suggesting otherwise, not from flushing or trashing. For this reason, the industry does not see take- back programs as appropriate strategies for pollution reduction and even educates consumers that flushing and trashing are safe, effective methods of disposal. In addition, manufacturers argue that industry programs are not as convenient to consumers as community programs (SMARxT; Oregon, 2007). Pharmacists, on the other hand, encourage proper disposal of unused medications; however, their chief Disposal of Unused Pharmaceuticals 11 concern is cost and how it will likely be passed on to the consumers (Lis Houchen, 2008). In order to address the concerns of these two groups, certain factors are critical: convenience and economic feasibility. Both concerns can be addressed through changes to regulations that currently limit the scope of drop-off and mail-back models and funding that includes all stakeholder groups.
VII. A TWO-FOLD APPROACH TO REFORM 1. Federal Reform I. Controlled Substances Act The CSA creates a very restricted system that limits opportunities for collection of controlled substances. Once dispensed and outside the system, controlled substances are hard to track and even more difficult to collect. By prohibiting the transfer of medication from consumer to pharmacist, doctor, or hospital, the CSA is contributing to opportunities for pollution and prescription abuse. Currently, only two exceptions exist for this rule: 1) consumers may return controlled substances in case of recalls or dispensing errors ( 1307.21); 2) controlled substances may be collected by law enforcement officials ( 1301.24). Because law enforcement officers must be present, many take-back programs have opted not to collect controlled substances at their locations. If no programs with law enforcement presence exist near consumers, they are forced to either dispose of the medication in an unsafe manner or follow provision 21 CFR 1307.21, which requires consumers to transfer medication to a DEA registrant, deliver it to the nearest DEA office, or destroy it in the presence Disposal of Unused Pharmaceuticals 12 of a DEA agent. While this provision includes safe means for disposal, it is simply unrealistic for the majority of consumers. Amending the CSA to allow for more disposal options and locations will facilitate expansion of take-back programs and reduce the amount of pharmaceuticals disposed of improperly. By no means should the DEA allow any location to collect pharmaceuticals, however expansion of collection allowances to trusted DEA-registered reverse distributors, pharmacies, hospitals, and practitioners will ensure that all drugs, not just non-controlled substances, are sent directly to disposal.
II. USPS Regulation of Prescription Mailings The USPS does not currently allow for the mailing of prescription drugs, except by manufacturers, pharmacies, and authorized dispensers; consumers are prohibited from mailing unused pharmaceuticals back to their source. Allowing consumers to freely send pharmaceuticals in designated envelopes to DEA-approved entities would greatly improve the ease of collection.
Although neither of these avenues has been fully explored at the federal level, both the DEA and USPS have begun to explore the possibility of these reforms through state-run pilot programs. State-run programs are essentially a Band-Aid for a lack of national reform, but are providing valuable evidence that reform is the most feasible route to expanded, uncomplicated pharmaceutical collection.
Disposal of Unused Pharmaceuticals 13 2. State Reform Facilitating Take-back Programs The state of Maine had an operational test agreement with the DEA and USPS and began a mail-back program that accepted all pharmaceuticals, including controlled substances. Pharmaceuticals were mailed from consumers to the Maine DEA through the Safe Medicine Disposal for ME (SMDME) program. SMDME was created in 2004 through a state bill, LD 411 An Act to Establish a Pilot Program for the Return of Unused Prescription Drugs by Mail. All received medications were sorted by the Maine DEA and sent to the appropriate disposal site (University of Maine, 2010). Although the program has since ended due to a lack of funding, as of December 2012, SMDME had properly disposed of over 8,00 pounds of unused medications (University of Maine, 2012).
VIII. REFORM FEASIBILITY THROUGH FUNDING As witnessed in the state of Maine, prescription collection reform is a safe, effective means of reducing improper medication disposal, yet funding such programs remains a challenge. Historically, the pharmaceutical industry has been vehemently opposed to funding clean-up or take-back systems. However, manufacturer product- Disposal of Unused Pharmaceuticals 14 stewardship programs that fund disposal programs have gained support in New York and Washington 7 . Extended producer responsibility (EPR) is both fair and feasible. Producers of toxic substances that pollute the environment have been responsible for clean-up in other industries, including mercury thermostats and electronic waste, for years and it is time for pharmaceutical manufacturers to take the same responsibility (Product Policy Institute, 2011). It should not be the responsibility of the public, especially in a struggling economy, to pay for the totality of disposal programs. However, if pharmaceutical companies were to be responsible for all disposal funding, the cost would likely be redistributed to the consumer anyway. For this reason, collaboration between the pharmaceutical industry, retailers, and consumers is likely the best approach. By involving all stakeholder groups, programs will be able to induce the best possible levels of compliance and participation.
IX. MERGING STATE AND FEDERAL REFORM Complete reform, particularly for large industries, is never an easy task and often calls for the involvement of many agency levels. For successful pharmaceutical disposal reform, this remains true. While the federal government retains control of the most limiting regulations regarding pharmaceutical disposal, states are better equipped to implement individual programs. For this reason, a reform system involving federal leadership and state execution is likely the most effective approach. Maine successfully implemented this practice for 8 years with impressive results and imitation of their
& New York State Assembly Bill A840; Washington House Bill 2600 Disposal of Unused Pharmaceuticals 15 program at the national level is promising. In 2010, the federal government began the process of loosening restrictions pertaining to controlled substance collection and consumer mail-back programs. The Secure and Responsible Drug Disposal Act was enacted in 2010 and the DEA is currently drafting the regulations to be implemented under the act (EPA, 2012). Regulations will allow the public to more easily dispose of unused pharmaceuticals in a secure, environmentally friendly manner. In December 2012, the DEA issued proposed regulations under the Secure and Responsible Drug Disposal Act. The proposal would expand collection options to include take-back events, mail-back programs, and collection receptacle locations; certain registrants will be designated as collectors for mail-back programs. Passage of these regulations will give states the ability to implement more comprehensive and appropriate pharmaceutical collection programs. As such, states should be sure to implement programs that take into account stakeholder concerns of convenience and economic feasibility.
X. AN INCOMPLETE APPROACH While the nation waits for DEA reforms under the Secure and Responsible Drug Disposal Act, some states and counties are taking action. The state of Washington has introduced a program advocated for by Take Back Your Meds, a focus group comprised of all stakeholder groups including environmental and health organizations, pharmacies, and law enforcement agencies. The group is working to pass legislation that would introduce a permanent, rather than pilot, program to the state. However, the program, which would be funded solely by pharmaceutical manufacturers, has been met with Disposal of Unused Pharmaceuticals 16 harsh criticism by the industry (How Medicine Take-Back Works, 2010). The same is true for a program introduced in Alameda County, California, which was recently found constitutional by the U.S. District Court for the Northern District of California. California also introduced S.B. 727, which was canceled at the request of the author, Senator Jackson (Karst, 2013). While all of these programs address legitimate concerns, they all have one thing in common: they are funded solely by manufactures, rather than sharing the burden among all stakeholder groups.
XI. NEXT STEPS: STATE POLICY RECOMMENDATIONS Focus Group Formation Successful, statewide environmental programs have historically been developed under the guidance of an established, diverse group of stakeholders. For example, the Rhode Island Climate Change Commission was formed to study projected impacts of climate change, identify strengths and weaknesses of current systems, and review amendments to existing regulations (State of Rhode Island, 2010). States interested in expanding pharmaceutical collection programs, following DEA approval, should form a focus group to take on similar responsibilities and inform program establishment.
Program Establishment Successful programs such as Maines Safe Medicine Disposal for ME are composed of clear guidelines, designate legally-responsible collectors, and maintain supplies to deliver all necessary sufficient services. In addition, programs comply with all state regulations, which vary widely across the nation. Disposal of Unused Pharmaceuticals 17 Program Funding States should introduce legislation mandating EPR programs for pharmaceutical manufacturers providing products within the state. In addition to EPR funding, states should implement a fee system for retailers and consumers alike to fund a balanced collection program for all stakeholders. Pharmaceutical manufacturers are not the only party responsible for improper disposal, and should not be asked to fund programs as if they were.
XII. CONCLUSION State and local communities have begun to implement programs for collecting and disposing of unused pharmaceuticals, however these programs are currently very limited in scope. Take-back and mail-in programs have become accepted strategies to prevent pharmaceutical pollution due to flushing and controlled substance abuse. However, the barriers currently in place by federal regulations restrict programs from offering comprehensive collection of all medications. The DEA has already started the process of reforming the most limiting factors the Controlled Substances Act and mail-in requirements. Following reform, states will need to lead the way and produce programs that include widespread, easily accessible collection strategies and engage all stakeholder parties in funding and participation to ensure convenience and economic feasibility. Without these two critical components, consumers will likely fail to reduce the amount of pharmaceutical pollution taking place and continue to increase human health risks.
Disposal of Unused Pharmaceuticals 18 References Bain, K. (2010). Understanding the public health implications of household pharmaceutical waste in the US- part one. Medical Waste Management, July- September 2010, 4-14. Bound, J. & Voulvoulis, N. (2005). Household disposal of pharmaceuticals as a pathway for aquatic contamination in the United Kingdom. Environmental Health Perspectives 113 (12), 1705-1711. Christen, V., Hickmann, S., Rechenberg, B., & Fent, K. (2010). Highly active human pharmaceuticals in aquatic systems: a concept for their identification based on their mode of action. Aquatic Toxicology, 96, 167-181. Daughton, C. (2003). Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. II. Drug disposal, waste reduction, and future direction. Environmental Health Perspectives, 111 (5), 775-783. Results from the 2005 National Survey on Drug Use and Health: National Findings. Department of Health and Human Services. SAMHSA. Office of Applied Studies. Fent, K., Weston, A., & Caminada, D. (2006). Ecotoxicology of human pharmaceuticals. Aquatic Toxicology, 76: 122-159. How Medicine Take-Back Works. Take Back Your Meds. Retrieved November 12, 2013. http://www.takebackyourmeds.org/why/how-medicine-take-back-works. Glassmeyer, S., Hinchey, E. Boehme, S., Daughton, C., Ruhoy, I., Conerly, O., Daniels, R., Lauer, L., McCarthy, M., Nettesheim, T., Sykes, K., & Thompson, V. (2009). Disposal practices for unwanted residential medicines in the United States. Environment International, 35, 566-572. Kime, D. (1999). Environmentally induced endocrine abnormalities in fish. The Royal Society of Chemistry: Issues in Environmental Science and Technology, 12, 27-48. Lauer, L. (2010). RCRA and pharmaceutical waste management: a brief federal overview. (PowerPoint Presentation by the EPA). Retrieved November 10, 2013, http://www.epa.gov/aging/resources/presentations/2010_0112_rcra_psi_call.pdf Letter from Lis Houchen, National Association of Chain Drug Stores to Janet Gillaspe, Oregon Association of Clean Water Agencies, April 21, 2008. Oregon Pharmaceutical Take Back Stakeholder Group. Final Report. July 1, 2007. p. 78. Product Policy Institute. (2011). What is extended producer responsibility? Economic benefits. Retrieved on November 11, 2013, http://www.productpolicy.org/content/define- epr. Disposal of Unused Pharmaceuticals 19 Safe Medicine Disposal for ME. Research. Retrieved on November 11, 2013. http://www.safemeddisposal.com/Research.php Seehusen, DA and J. Edwards. Patient practices and beliefs concerning disposal of medications. Journal of the American Board of Family Medicine 19 (2006):542-547. SMARxT Disposal: A Prescription for a Healthy Planet. www.smarxtdisposal.net/. State of Rhode Island. (2010). The Rhode Island climate risk reduction act of 2010. RI State Legislation, Title 23, Chapter 84, section 3. Retrieved on November 11, 2013, http://www.rilin.state.ri.us/statutes/title23/23-84/23-84-3.htm. Teleosis Institute. (2010). Bay Area medication disposal study 2009: an inventory of household pharmaceutical waste. Final report, version 2.1. Retrieved November 10, 2013, http://www.teleosis.org/ University of Maine, Center on Aging. (2010). Safe medicine disposal for ME: a handbook and summary report. Retrieved on November 10, 2013, http://www.safemeddisposal.com/documents/MailbackProgramReportFINAL.pdf. US Environment Protection Agency (2012). Notice of proposed rulemaking. Federal Register, 77(246). US Postal Service. (2011). Publication 52- hazardous, restricted, and perishable, mail. Retrieved October 28, 2013, http://pe.usps.com/cpim/ftp/pubs/pub52/pub52.pdf Zhang, Y., Marrs, C., Simon, C., Xi, C. (2009). Wastewater treatment contributes to selective increase of antibiotic resistance among Acinetobacter spp. Science of The Total Environment, 407(12), 3702-3706.