Concerned by rising rates of prescription drug abuse, the Drug Enforcement Administration announced Monday that it will permit consumers to return unused prescription medications such as opioid painkillers to pharmacies.
The move is intended to help reduce stockpiles of unneeded medicines in homes, which are often pilfered by teenagers. Under the new regulation, patients and their relatives will also be allowed to mail unused prescription drugs to an authorized collector using packages to be made available at pharmacies and other locations such as libraries and senior centers.
The new regulation, which will be put into effect in a month, covers drugs designated as controlled substances, which include opioid painkillers like OxyContin, stimulants like Adderall and depressants like Ativan.
Until now, those drugs could not legally be returned to pharmacies. The Controlled Substances Act allowed patients only to dispose of the drugs themselves or to surrender them to law enforcement.
"This is big news and long overdue," said Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health. "It's baffling that it's so easy to get a prescription for opioids and yet so difficult to dispose of these drugs safely."
Injuries and deaths from prescription drug abuse, particularly opioids, have soared in recent years.
"The sooner we get those unused medications out of the home and medicine cabinets, the better and safer it is for everyone," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Until now, consumers have had limited options for the disposal of controlled substances. Twice annually, citizens could anonymously return them to police departments during thousands of national "take-back" events organized by the DEA.
In the past four years, those events have removed from circulation 4.1 million pounds of prescription medications. The next one is from 10 a.m. to 2 p.m. Sept. 27.
Still, about 3.9 billion prescriptions were filled at pharmacies in 2013 alone, according to the Kaiser Family Foundation.
"They only removed an infinitesimal fraction of the reservoir of unused drugs that are out there," said Dr. Nathaniel Katz, an assistant professor of anesthesia at Tufts University School of Medicine in Boston who studies opioid abuse. "It's like trying to eliminate malaria in Africa by killing a dozen mosquitoes."
Katz is optimistic that the DEA's decision could have a powerful effect. Putting drop-off receptacles for controlled substances in pharmacies will mean consumers have year-round access to disposal services.
It would be a "very positive" development if such access gets consumers in the habit of returning unused drugs to the pharmacies from which they were obtained, Katz said.
"It's more likely to accomplish the objective of minimizing the reservoir of potentially fatal medications in our medicine cabinets than can be accomplished by intermittent programs," he said.
Flushing controlled substances, especially prescriptions that might kill a child or pet with a single dose, remains an option for consumers, as is throwing out other prescriptions in zipped plastic bags mixed with kitty litter, but both are discouraged because of environmental concerns.
The Environmental Protection Agency favors disposal through drug take-back programs over flushing to keep medicines from entering streams and rivers. Yet the Food and Drug Administration recommends flushing unused medications when the potential for harm to someone in the household is great.
The new programs will be voluntary. Pharmacies may choose to register with the drug agency to take back controlled substances or to receive leftovers through the mail.
To minimize the risk that returned drugs might be stolen, the DEA will require authorized collectors running mail-back programs to have and use an "on-site method of destruction to destroy returned packages."
Organizations collecting unused drugs could be pharmacies, including those within a clinic or a hospital, narcotic treatment programs or so-called "reverse distributors" -- companies contracted by other collectors to destroy controlled substances. Retail pharmacies or hospitals and clinics with on-site pharmacies may manage collection receptacles at long-term care facilities.
But some experts warned that a number of issues must be resolved and that there is no guarantee pharmacies would establish take-back programs.
Police departments often use incinerators, for example, to destroy seized illicit drugs, but a local pharmacy might not be able to accommodate an incinerator, limiting the number that could accept packages of prescriptions by mail.
The new rules do not require a particular method of destruction, as long as the drugs are permanently and irreversibly altered. Reverse distributors must do so within 30 days.
Whether communities, pharmacies, insurance programs, patients or pharmaceutical companies must pay for disposal costs also is not addressed in the new rule.
Mitch Rothholz, the chief strategy officer of the American Pharmacists Association, which supports the idea of pharmacy take-back programs, suggested that the costs of the system should not be "a burden on the pharmacy."
Keeping returned medications secure also poses challenges.
To get prescribed drugs off the streets, police stations in 49 states have installed about 1,500 permanent steel boxes made by MedReturn, a Wisconsin company.
Anytime the boxes "are available to the public, they have to be under law enforcement eyes, because they are gold at the end of the rainbow for someone with an opioid addiction," said Gary Tennis, secretary of the Department of Drug and Alcohol Programs in Pennsylvania, which has 200 MedReturn boxes and plans to install 100 more.
In a letter to the DEA last year, the American Pharmacists Association expressed concern that pharmacies might be held legally liable should a secure drug drop-off receptacle be broken into and its contents stolen. Without more clarification, the association cautioned, "there may be limited participation by pharmacies."
But the biggest obstacle might be convincing the public that it is irresponsible to hold onto medications that are no longer needed.
"With our opioid crisis, the level of overdoses we have and the amount of kids who are stealing these drugs, to be a good citizen you must get rid of your prescription drugs as soon as you're finished with them," Tennis said.
A Section on 09/09/2014