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Kansas News: Drug Disposal
Originally Published in the March 2011 Kansas State Board of Pharmacy Newsletter
Drug Enforcement Administration (DEA) reports that increasing prevalence of prescription drug abuse, especially among teens, has become an issue of public concern in recent years. The 2009 Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health estimates that greater than seven million Americans currently abuse prescription drugs. Furthermore, the Partnership at Drugfree.org estimates that about 2,500 teens use prescription drugs each day to get high for the first time. Drug disposal programs (“take-back” programs) play an important role in reducing the availability of unused, unwanted, and expired medications, a potential source of abusable drugs.
Pharmacists are uniquely positioned as readily available medication experts, and the public often turns to them for advice on medication disposal. However, there continues to be confusion among Kansas pharmacists who wish to implement take-back programs, especially in regard to two issues: environmentally friendly disposal and disposal of controlled substances.
The Kansas Department of Health and Environment (KDHE) issued guidance relating to the disposal of non-controlled substance pharmaceuticals and the potential for surface and groundwater contamination. KDHE indicates the most desirable disposal method available to pharmacists is reverse distribution (returning medications to manufacturers for credit). Medical or hazardous waste incineration, as well as disposal in a permitted hazardous waste landfill, is also a viable option, though not readily available to most pharmacists. A less desirable method – combination with coffee grounds or kitty litter prior to disposal in the trash – is easier and often preferred by pharmacists. KDHE advises against disposal into sanitary sewer systems (“flushing”) due to water contamination concerns, except when specifically indicated by the package insert. Currently, KDHE has defined pharmaceuticals that have been dispensed as hazardous waste. Hazardous waste can only be collected in Kansas at a hazardous waste facility. Further guidance of benefit to pharmacists may be accessed at www.kdheks.gov/waste.
The second issue of particular concern to pharmacists is the disposal of controlled substances. The public often asks pharmacies to take back unwanted, unused, and expired controlled substances; however, doing so would violate the Controlled Substances Act (CSA) as it is currently written. DEA registrants (like pharmacies) are only allowed to obtain controlled substances from other registrants. Federal law has not allowed take-back programs to accept controlled substances from non-registrants (like the general public) without special permission from DEA and arrangements for law enforcement officers to receive them directly from the member of the public who wishes to dispose of them.
In an effort to increase disposal of controlled substances, Congress amended the CSA through the Secure and Responsible Drug Disposal Act of 2010. This law allows DEA to develop new regulations regarding the manner in which ultimate users can turn in unwanted pharmaceuticals for disposal. DEA is undergoing the rulemaking process and should publish a Notice of Proposed Rulemaking this year. In the meantime, DEA has scheduled a National Prescription Drug Take-Back Day to be held nationwide on Saturday, April 30, 2011. In order for a pharmacy to participate in the DEA Take-Back Day they must be signed up with DEA and have local law enforcement involved in the process. Details of the program, including local collection sites, will soon be posted at www .deadiversion.usdoj.gov.
If a pharmacy wishes to dispose of controlled substances from its own stock, it may transfer them to a DEA-registered reverse distributor. The DEA district office that serves the registrant’s area can provide a list of approved reverse distributors. The pharmacy must maintain a record of distribution that includes the drug name, dosage form, strength, quantity, and date transferred. DEA Form 41 provides instructions, and the reverse distributor that destroys the controlled substances is responsible for submitting DEA Form 41 to the special agent in charge at the DEA district office. Form 41 should not be used as the record of transfer of controlled substances between the pharmacy and the reverse distributor. Also, pharmacies should remember to satisfy the requirements of transfer of Schedule II drugs using DEA Form 222.
Kansas, Nebraska, and western Missouri are currently served by DEA’s Kansas City District Office, 7600 College Blvd, Ste 100, Overland Park, KS 66210-1853, phone: 913/825-4200, fax: 913/825-4182.
