Senate passes prescription drug disposal bill

In the first week of August, the Senate unanimously passed the Secure and Responsible Drug Disposal Act (S. 3397) to provide for take-back disposal of controlled substances by legitimate users-patients.

Under this act, patients with controlled substances can transfer these drugs for disposal to a non-DEA registered person who is authorized to dispose of them and the disposal occurs in accordance with regulations issued from the Attorney General to prevent drug diversion.

The legislation would also allow long-term-care (LTC) facilities to dispose of controlled substances, according to regulations that will be written by the Justice Department.

Congressional hearing

At a June Congressional hearing, Sen. Herb Kohl (D-Wis.) pledged to work toward a “comprehensive package” of legislation to reduce drug waste and ensure safe drug disposal.

The hearing offered various potential solutions, including medication therapy management (MTM), improved medication compliance, patient education, limits on initial prescriptions for some drugs, “reverse distributors” for taking-back drugs, rewriting laws to allow take-back of controlled substances, and harmonizing the recommendations of various federal agencies.

Sen. Kohl, who chairs the Senate Special Committee on Aging, had stressed both the detrimental impact of improper drug disposal into the environment and the hazard of illegal drug diversion.

At the hearing, Joseph T. Rannazzisi, deputy assistant administrator, Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice, acknowledged that current law had created a problem of drug disposal because patients are not DEA registrants and could not “distribute” a controlled substance by giving it to a take-back program.

Under the current Controlled Substances Act, “DEA must monitor pharmaceutical take-back programs, because in all likelihood any organized collection of unwanted or unused pharmaceuticals will also include collection of controlled substances,” he said.

He noted, however, that DEA had supported proposed legislation (H.R. 1359) to allow the agency to write regulations allowing communities and regulated entities to dispose of controlled substances. That legislation would have also allowed the creation of regulations that authorize LTC facilities to dispose of controlled substances on behalf of their patients, he said.

Concern about mail-back programs

At the June hearing, Sen. Susan Collins (R-Maine) cited the concerns from some groups that Maine’s mail-back programs could create opportunities for diversion, because the standard mailer used for mail-backs is addressed to the state’s DEA, making it obvious that drugs are inside.

R. Gil Kerlikowske, director of the Office of National Drug Control Policy (ONDCP), responded that although he’s only slightly familiar with the Maine program, he thought drugs found in the medicine cabinets would be by far a greater danger than the risks connected with take-back or mail-back programs.

In the Maine program, a number of pharmacies serve as distribution sites for the mail-back envelopes.

Asked about another Maine program, one that limits initial prescriptions of certain drugs to 15 days, Stevan Gressitt, MD, founding director of the Maine Institute for Safe Medicine, said that 3 classes of drugs were selected by MaineCare for the restriction: opiates, second-generation antipsychotics, and second-generation anti-depressants. After some initial trepidation, eventually many physicians said that the rule was good common sense, Gressitt told the committee.

“I would say that having a check at 15 days to look at adherence and side effects is important,” he said.

The NACDS stated, however, that giving patients only a limited supply of medications initially may be detrimental to adherence, because patients might not return for the rest of the medications, for reasons including being busy or confused about what they are supposed to do. “Patients often take a number of medications and are accustomed to receiving a 30-day supply or up to a 90-day supply of their chronic medications.” In addition, MTM is vital in helping to reduce drug waste because it ensures that patients take the correct medications and adhere to their drug regimen, according to the National Association of Chain Drug Stores.

A webcast of the June hearing and written testimony are on the committee’s website (http://aging.senate.gov/).