The Food and Drug Administration (FDA) launched a new website with information for consumers on how to dispose of certain medications, including prescription pain killers. The website counsels consumers that most drugs can be disposed of in the household trash. For certain drugs, however, the FDA instructs that they should be flushed to avoid accidental use by children, pets, or other consumers.
The FDA provides a list of these drugs that they recommend for flushing, most of which are high-potency opioids and other selected controlled substances.
With regard to potential environmental risks associated with flushing medications, the FDA "believes that any potential risk to people and the environment from flushing this small, select list of medicines is outweighed by the real possibility of life-threatening risks from accidental ingestion of these medicines".
On August 10, Illinois Gov. Pat Quinn signed into law a bill that prohibits healthcare facilitates from disposing of unused medication through flushing. The bill seeks to protect consumers from potential hazards of pharmaceuticals in wastewater.
The Pharmaceutical Disposal Act and was sponsored by Sen. Susan Garrett (D-Lake Forest) and Rep. Karen May (D-Highwood). Healthcare facilities that violate the law will be subject to fines.
"For years, disposing unused or expired medicines in wastewater was common, even recommended practice. Today, we’re making clear how serious we are at stopping this practice before Illinois faces an environmental or community health crisis", said Sen. Garrett.
This month, two bills were introduced in the Senate that would be companion bills to legislation already introduced in the House.
On June 18, Sens. Amy Klobuchar (D-MN) along with Chuck Grassley (R-IA), and Diane Feinstein (D-CA), introduced S. 1292, the Secure and Responsible Drug Disposal Act of 2009. This is a companion to H.R. 1359, sponsored by Reps. Bart Stupak (D-MI) and Lamar Smith (R-TX). The bill would amend the Controlled Substances Act to allow patients to return unused controlled substances to disposal programs.
And, on June 24, Sen. Patty Murray (D-WA) introduced S. 1336, which appears to be a companion to H.R. 1191, introduced by Rep. Jay Inslee (D-WA) and co-sponsored by 22 other House members.
Both bills were referred to the Senate Judiciary Committee.
This month,
Utah unveiled a new initiative to control prescription drug abuse in the state. Prescription drug overdoses in
Utah have increased 400 percent since 2000. Dubbed the Utah Pharmaceutical Drug Crime Project, the task force includes
a broad swath of stakeholders interested in the issue: the DEA, the Salt Lake City Police Department, the Utah Department
of Public Safety and other law enforcement groups, the Utah Department of Human Services, the FBI, the Utah Attorney
General's Office, and healthcare providers. The task force seeks to reduce the availability of prescription drugs for
abuse and increase public awareness of the potential risks associated with prescription drugs. The objective of the group
is to pass new legislation that would make disposal of unused prescription drugs easier for consumers.
Without fanfare or announcement, the federal government updated its consumer guidelines for proper disposal of prescription drugs. The guidelines, available online, now state up front that drugs should not be flushed unless recommended by the FDA. The guidelines, first published in 2007, originally included a list of the drugs for which flushing was the recommended method of disposal. This list has been removed; the guidelines direct consumers to the FDA website for more information on disposal instructions.
Additionally, the guidelines seem to de-emphasize placing unused drugs in the trash – instead suggesting that consumer seek out take-back programs first. If a take-back program is not available, the guidelines recommend mixing unused drugs with an undesirable substance, like kitty litter or coffee grounds, sealing the mixture in a container or plastic bag, removing any personal information from the prescription bottles, and then placing the sealed container and empty bottles in the trash.
In response from requests, the EPA extended the comment period on its Notice of Proposed Rulemaking to add pharmaceuticals to the Universal Waste Rule. The deadline for comments is now March 4, 2009.
Northeast Waste Management Officials’ Association, Waste Management, Pharmecology® Associates, LLC, the Healthcare Distribution Management Association, Clean Harbors Environmental Services, and the Environmental Technology Council all requested additional time to fully assess the regulation’s impact. The stakeholders also requested that EPA coordinate with the DEA on this issue. DEA is seeking comment on disposal options for controlled substances (see story below).
To inform development of safe disposal options for dispensed controlled substances, the Drug Enforcement Agency (DEA) issued an advanced notice of proposed rulemaking to get input from interested stakeholders. Specifically, DEA seeks input from patients and their families, state and local law enforcement, publicly owned treatment works, long-term care facilities, hospices, pharmacies, drug treatment programs, reverse distributors, state regulatory agencies, and any other interested parties.
State Rep. Dawn Morrell (D-Puyallup) plans to introduce a bill that would require pharmaceutical manufacturers to establish and provide sustainable funding for a statewide drug disposal program. "We feel it's their responsibility," said Morrell, who is a nurse. "We can't have them in the environment and in the drug cabinets for our little kids." Similar industry-sponsored disposal programs have been established for consumer electronics, like televisions and computers.
As reported by the Seattle Post Intelligencer, this industry-funded program is intended to be a permanent implementation of a pilot program that collected 15,000 pounds of prescription and over-the-counter pills at participating retail and clinical pharmacies in six counties since 2006.
In an effort to streamline the process for disposing of waste pharmaceuticals, the Environmental Protection Agency (EPA) issued a Notice of Proposed Rulemaking to add pharmaceuticals to the Universal Waste Rule. The proposed addition will make it easier to safely and properly dispose of these items as hazardous wastes. The rule would apply to:
Pharmacies
Hospitals
Physicians′ offices
Dentists′ offices
Outpatient care centers
Ambulatory health care services
Residential care facilities
Veterinary clinics
Other facilities that generate hazardous pharmaceutical wastes.
The EPA hopes that adding hazardous pharmaceutical waste to the Universal Waste Rule will facilitate the collection of personal medications from the public at various facilities so that they can be more properly managed.
Hospitals, nursing homes, and other long-term care facilities in the U.S. dispose of approximately 250 million pounds of unused medications by flushing them down the drain, according to an ongoing Associated Press investigation.As reported in the San Francisco Chronicle , some unused medications are incinerated or sent to landfills; however, the Environmental Protection Agency believes these facilities use sewer systems to dispose of most of their unused drugs.
The EPA is contemplating national standards for the amount of pharmaceutical waste that can be released into waterways, but Benjamin Grumbles, EPA's Assistant Administrator for Water, thought it would be at least 2009 until those standards are finalized.
Because of the strict rules DEA places on controlled substances, healthcare facilities are often forced to dispose of prescription drugs like codeine, morphine, oxycodone, diazepam (Valium) and methylphenidate (Ritalin) by flushing them down the toilet. DEA requires that anyone who handles controlled substances, other than the patient, be certified as a law enforcement officer or registered with the DEA - including pharmacists, doctors and waste handlers.
As reported in USA Today, many stakeholders are encouraging the DEA to revise its rules to allow for more flexible disposal options. DEA spokeswoman Rogene Waite said: "DEA is currently developing regulations to allow for the safe and effective destruction of controlled substances." Benjamin Grumbles, the Environmental Protection Agency's Assistant Administrator for Water, confirmed that EPA has participated in these discussions.
Consumers in the U.S. rarely receive instructions for safe disposal of unused medications, according to the Associated Press. As reported in the Denver Post , the AP surveyed pharmacists around the country about the disposal guidance they give customers and reviewed the materials that consumer receive with the 50 most-dispensed prescription drugs in the U.S. The AP found that none of this accompanying information includs the federal drug disposal guidelines released in 2007. The federal guidelines, crafted by the White House Office of National Drug Control Policy and the FDA, recommend mixing unwanted medications with coffee grounds or kitty litter and placing them in the trash or taking advantage of a community drug take-back program, if available. The guidelines do recommend flushing for 13 medications, most of which are narcotics.
Not all federal agencies present a consistent message to consumers regarding flushing, though. The U.S. Fish and Wildlife Service's SMARxT Disposal campaign says "DO NOT FLUSH unused medications" and the Drug Enforcement Agency states that there is no "safe, secure and reliable disposal system" for some controlled substances.
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