The Catch-22 of controlled drug regulations

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John Kelsey
John Kelsey

[Editor's note: The U.S. Senate in August passed the Secure and Responsible Drug Disposal Act of 2010, S. 3397,  which makes it easier to dispose of controlled substances in long-term care facilities. The House has not yet voted on the bill.]

Disposing of unused controlled drugs is a modern day Catch-22. Caught among scores of regulatory policies from a number of government bodies that include the U.S. Food and Drug Administration (FDA), Office of National Drug Control Policy (ONDCP), U.S. Environmental Protection Agency (EPA), Drug Enforcement Agency (DEA), U.S. Fish and Wildlife Service (USFWS) and some state-level environmental regulatory agencies, there is no “right” answer. The fundamental problem is that original legislation assumed that any controlled drugs that were dispensed would be fully consumed for their intended purposes by the legal “Ultimate User.”

Existing rules do not coincide since the different agencies have different objectives and regulatory powers. Complicating the equation is that some states have authorizations that are more stringent than federal rules and, therefore, supersede federal law. All of the regulations fundamentally affect organizations, such as long-term care (LTC) facilities, which generate pharmaceutical waste, since they carry environmental, operational and financial implications.

Legislative background

A little background on the legislative initiatives that have been under consideration over the last few years: The EPA plans to reclassify hazardous pharmaceutical wastes to the Universal Waste Rule (UWR); the DEA wants to revamp rules on the disposal of controlled substances from non-registered Ultimate Users; and several states either already have or are considering authorizations that will affect pharmaceuticals and may govern how the federal regulations are implemented within their jurisdictions. All of these activities are happening essentially simultaneously.

The U.S. Senate Special Committee on Aging is also considering the issue, holding the most recent hearing on drug waste and disposal on June 30, 2010. Although it was ostensibly to consider “the health and safety risks associated with both improper disposal and lack of disposal options for consumers,” its findings will certainly apply to long-term care.

In stating the hearing's objective, Committee Chairman Senator Herb Kohl (D-Wis.) said, “We need to provide Americans with better information about what to do with their leftover medications. Contradicting guidelines put forth by the DEA, FDA, EPA, and U.S. Fish and Wildlife Service need to be reconciled. Americans deserve a safe and effective way to get drugs away from their homes and keep them out of our drinking water.” (Source: U.S. Senate press release, "Kohl Calls for Creation of One Federal Guideline on Drug Disposal")

CSA and ONDCP try to address disposal

Currently, disposal is governed by the Controlled Substances Act (CSA), which seeks to address the issue that controlled substances are often not fully consumed. The act establishes a closed system that is designed to keep controlled drugs from being improperly used by non-authorized people.

The distribution system consists of two broad participant classes: DEA registrants and those exempt from registration (Ultimate Users). The registrants must adhere to storage, distribution, record-keeping and other requirements.

Ultimate Users are exempt from the requirements but must lawfully obtain the drug for their own use or for the use of a member of their household. These same rules apply to controlled veterinary substances. The Catch-22 is that Ultimate Users cannot legally transfer a controlled substance to another person or organization, including DEA registrants, for any purpose, including disposal of the drug. The exception is that controlled substances may be returned to law enforcement authorities under strict guidelines.

Additional confusion results from the fact that these regulations apply to only controlled substances; other pharmaceuticals, including hazardous non-controlled substances, do not require the same handling and are subject to different disposal regulations. We're talking about a relatively small number of controlled substances, such as amphetamines, Valium, Ritalin, morphine, methadone and oxycodone. The complete list, available at http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf, includes a few hundred specific substances. Although a formidable list, controlled substances represent a small percentage of the overall number of drugs administered in long-term care facilities.

This means that administrators must deal with several dispensed pharmaceutical waste streams: non-hazardous waste that can be discarded with regular trash, hazardous waste that requires regulated handling, pharmaceuticals that can be submitted to reverse distribution, and controlled substances that cannot be legally returned except to law enforcement.

This forces other disposal options. ONDCP guidelines, developed in cooperation with the Department of Health and Human Services (HHS) and the EPA, outline sewering controlled drugs. This method contributes to a pernicious form of water pollution that has potentially devastating results. ONDCP also authorizes adulterating drugs by mixing them with undesirable substances (such as coffee grounds or kitty litter) and disposing in trash or participating in community pharmaceutical law enforcement take-back programs.

These remedies are clearly targeted to consumers and do not address the higher volumes of controlled substances that must be disposed of from LTC facilities.

Creative approaches/enforcement

Some states are already trying to address the issue. Maine is conducting an innovative pilot program with a grant from the EPA under which it collects both controlled and non-controlled medications from Ultimate Users through the U.S. Postal Service, using special sealed mailers.

Other states are taking a more regulatory approach. Illinois enforces a “Do Not Flush” law (S.B. 1919) that states, “No healthcare institution, nor any employee, staff person, contractor, or other person acting under the direction or supervision of a healthcare institution, may discharge, dispose of, flush, pour, or empty any unused medication into a public wastewater collection system or septic system.” This goes well beyond just unused controlled substances. (Source: http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId=76&GA=96&DocTypeId=SB&DocNum=1919&GAID=10&LegID=&SpecSess=&Session=)

Even more relevant to LTC facilities, the State of New York recently reached settlements with two hospitals and three nursing homes that allegedly dumped pharmaceuticals into a watershed that supplies nine million residents. The institutions were assessed civil penalties and had to reimburse the state for the investigation and they must stop introducing pharmaceutical waste into waterways and send the material to certified waste management disposal sites.

Bridging the gap

The challenge over the short-term is to stay in compliance by keeping current on both state and federal legislation and formalizing procedures. Keeping informed requires management resources to monitor federal and state legislation and rulemaking.

In the meantime, one sure-fire way to position your institution for the future is through what we refer to as “waste avoidance.” If a drug, controlled or otherwise, is not dispensed, it is not subject to the labyrinth of regulations governing its retrieval and disposal. By more effectively managing drug dispensing, you can reduce your drug costs and disposal headaches. It's the most direct and logical way to deal with the drug disposal issue.

For many institutions, working with a qualified medical waste disposal contactor is the solution. They make it their business to track legislative and technological developments in order to advise on and implement comprehensive pharmaceutical management programs. They also help with pharmaceutical waste characterization and avoidance, and are especially helpful to LTC facility networks by helping to standardize policies across facilities.

A relationship with the right pharmaceutical waste management partner is a key step to finding options, reducing expenses and ensuring compliance within your institution. They can't solve the regulatory Catch-22 but they can help you write the sequel.

John Kelsey is vice president of healthcare at Clean Harbors. During his 17 years at Clean Harbors he has held several operational positions, including packaging waste for healthcare customers as a lab pack chemist, general manager, and companywide development manager. Kelsey holds a Bachelor's degree in Aerospace Engineering from Syracuse University, and a Masters in Environmental Management and Policy from Rensselaer Polytechnic Institute.

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