Medicolegal Issues

Sound Advice


 

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Physicians generally are not required to keep records of prescribed or administered medications unless prescribed or administered for maintenance detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

  • Name and address of the person;
  • Name and quantity of each controlled substance to be disposed of;
  • Explanation of how the applicant obtained the controlled substance, if known; and
  • Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

  • Taking the prescription drugs out of their original containers;
  • Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
  • Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
  • Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
  • Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

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