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HDMA’s Position:
HDMA supports efforts to ensure the safe and secure disposal of unused, unwanted or expired
medications. HDMA advocates for ensuring patient privacy and safety, preventing diversion, streamlining
standards for disposal and destruction of controlled substances and preserving a safe and efficient system
for pharmaceutical distribution. Congress must consider the complexity of the regulatory environment and
the multiple agencies involved in establishing disposal standards and guidelines for controlled substances
— such as the Environmental Protection Agency (EPA), the Drug Enforcement Administration (DEA),
the Food and Drug Administration (FDA) and other regulatory entities — as well as the importance of
maintaining a secure system to prevent diversion.
Issue:
The DEA oversees the prescribing, delivery, and distribution of prescriptions covered by the Controlled Substances Act (CSA), but the CSA is largely silent on ways in which patients can properly dispose of medications. This has led to growing concern over the vulnerability of the supply chain towards illicit diversion and the potential environmental effects of disposing controlled substances by current prescribed methods.
Existing mechanisms by which to dispose drugs include:
- Flushing unused medication has been recommended in the past; however more recent analysis has shown that by depositing the drugs into the water supply, a potential environmental hazard may exist;
- Throwing away unused medication, a process by which consumers are encouraged to coat the leftover pills in cat litter or coffee grounds to make them less appealing for diversion;
- Returning them through DEA approved take-back programs limited by current law to law enforcement agencies that have obtained a waiver from DEA to take custody of unused controlled substances.
Congressional efforts to improve consumers’ knowledge of and adherence to proper disposal methods, particularly for controlled substances, have resulted in proposals to authorize additional entities to accept unused, expired, or unwanted medications for disposal. Additionally, proposed legislation expands the DEA’s authority to determine a proper disposal venue and tasks various other entities in studying current drug disposal mechanisms.
Additional Information:
HDMA remains committed to ensuring the safety and integrity of the healthcare supply chain by enhancing public safety through increased consumer education on proper drug disposal methods.
HDMA supported the Secure and Responsible Drug Disposal Act of 2010, which was signed by President Obama on October 12, 2010, to become Public Law 111-273.
The Healthcare Distribution Management Association (HDMA) is the national association representing primary healthcare distributors, the vital link between the nation’s pharmaceutical manufacturers and healthcare providers. Each business day, HDMA member companies ensure that nearly nine million prescription medicines and healthcare products are delivered safely and efficiently to nearly 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. HDMA and its members work daily to provide value and achieve cost savings, an estimated $42 billion each year to our nation’s healthcare system.
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