According to the DEA (Drug Enforcement Agency), there is an epidemic of prescription drug abuse in the US. A primary source for the prescription drugs that are misused and abused is unused medications that sit in medicine cabinets due to very limited options for proper disposal. Improper disposal by flushing or discarded leftover medications into the trash poses serious environmental risks by contaminating waterways and harming aquatic life.
Mandatory local drug take-back programs are an effective solution for providing consumers with a safe, responsible, and convenient way to dispose of unused medicines.
Alameda County, California adopted the nation’s first extended producer responsibility law for pharmaceuticals in 2012, requiring pharmaceutical manufacturers to fund and manage a drug take-back program. Since then, the city of San Francisco and 5 other counties along the West Coast have passed similar laws.
The pharmaceutical industry challenged the constitutionality of the Alameda County law all the way up to the U.S. Supreme Court. In May 2015, the US Supreme Court announced that it would not hear the pharmaceutical industry's argument. This decision paves the way for state and local governments to move forward with passing pharmaceutical EPR legislation.
Here are resources to help you pass pharmaceutical EPR in your community:
Voluntary local take-back programs are another approach. Refer to PSI’s Best Practices Fact Sheet to get started on a voluntary effort.
In September 2014, the U.S. Drug Enforcement Administration (DEA) updated a rule governing collection of drugs to authorize retail pharmacies, law enforcement, manufacturers, drug distributors, reverse distributors, narcotic treatment programs, and hospitals/clinics with an on-site pharmacy to voluntarily collect controlled substances. Previously, only law enforcement could collect these types of medicines.
Funding voluntary efforts is difficult, however, especially for the long-term. Pharmaceutical EPR laws provide a sustainable funding mechanism for proper drug disposal by holding pharmaceutical companies accountable for managing their products throughout the entire product life cycle, instead of relying on taxpayers to fund management of these drugs at of the product end-of-life.
PSI's Role in Delivering Solutions
Administers Implementation Support
PSI assisted the King County, Washington Board of Health to implement the Secure Medicine Return regulations by conducting outreach and education to drug producers on requirements to ensure compliance.
Provides Technical Assistance
PSI has hosted, and will continue to host, webinars on pharmaceutical EPR, other timely issues such as the DEA rule change in 2014, and important court cases. On an on-going basis, PSI provides technical support for stakeholders to launch a new drug take-back initiative or modify an existing program.
Advocates for EPR Legislation
PSI monitors, informs and advocates for product stewardship legislation for pharmaceuticals. We offer expert testimony supporting EPR legislation for hearings. PSI tracked the pharmaceutical industry’s challenge of the Alameda County Safe Drug Disposal Ordinance to keep our members up to date on this legal battle and its implications.
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Brings Stakeholders Together
PSI works to bring various stakeholders together so that state and local governments, and even federal agencies, can create programs and develop solutions that address the need for convenient, safe disposal of unused drugs.
To allow for an exchange of perspectives, we organize and lead pharmaceutical waste stewardship summits and conference calls. After these meetings, we engage multi-stakeholder workgroups to discuss data needs; options for reducing pharmaceutical waste; best management practices for collection and disposal; and regulatory issues related to the collection, transport, and disposal of pharmaceutical waste from households.
PSI offers research and analysis services to inform and shape product stewardship policy. In 2010, for instance, we conducted qualitative research in Florida, to better understand which factors determine how much medicine patients receive to address over-prescribing of prescription drugs. Our findings, along with presentations provided by other experts, informed a multi-stakeholder National Summit on Preventing Pharmaceutical Waste. You can read the report in its entirety here.
Creates Toolkits and Online Resources
PSI provides tools for governments, NGOs and other stakeholders that wish to start or promote drug take-back programs. PSI launched the Go-To Guide for Safe Drug Take-Back, as part of the Great Lakes Pharmaceutical Stewardship project.
For more information, please contact Vivian Futran Fuhrman at (617) 236-4771.