Volume 155, No. 34 covering the 1st Session of the 111th Congress (2009 - 2010) was published by the Congressional Record.
The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
“SAFE DRUG DISPOSAL ACT OF 2009” mentioning the Environmental Protection Agency was published in the Extensions of Remarks section on pages E489-E492 on Feb. 26, 2009.
The publication is reproduced in full below:
SAFE DRUG DISPOSAL ACT OF 2009
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HON. JAMES P. MORAN
of virginia
in the house of representatives
Thursday, February 26, 2009
Mr. MORAN of Virginia. Madam Speaker, I rise today to join my colleague, Congressman Inslee, to support the ``Safe Drug Disposal Act of 2009,'' legislation that will address the risks to our families, our communities, and the environment from unwanted or unused drugs that are left in the home or that are disposed of improperly.
Drug waste is a problem at every juncture of the health care system. Medications can accumulate in numerous settings--in nursing homes, hospitals, and hospice care facilities, and in home-based care settings and private residences. To encourage safe disposal of these drugs, many communities have developed take-back programs or sponsored collection events that allow consumers to properly dispose of unwanted or unused drugs. These programs reduce the quantity of unused pharmaceuticals entering the environment and reduce the amount of drugs available for diversion, theft, abuse, or accidental poisoning.
While these programs are clearly of benefit to the consumer, they can be difficult to administer because, under current law, a representative of law enforcement must be present to take custody of medications that are classified as controlled substances. This bill will amend the Controlled Substances Act to allow end users, or caretakers of an end user, to safely dispose of unused prescription drugs and over-the-
counter drugs through Drug Enforcement Administration (DEA) approved state-run drug take-back programs. This bill also prohibits pharmaceutical companies from recommending flushing as a safe means of disposal on prescription drug labels.
Pharmaceuticals in surface waters and in drinking water supplies
For many years, consumers were advised to dispose of their unwanted medications down the toilet. However, we now know that chemicals from over-the-counter and prescription medications are not always screened in water treatment systems, and can be discharged into rivers and lakes and enter our drinking water supplies. In 2002, the U.S. Geological Survey reported that some traces of common medicines such as acetaminophen, hormones, blood pressure medications, codeine, and antibiotics were detected in very low concentrations in 80 percent of samples taken from 139 streams across 30 states.
Little was known about people's exposure to such compounds from drinking water, so scientists at the Southern Nevada Water Authority in Las Vegas screened tap water from 19 U.S. water utilities for 51 different compounds. The surveys were carried out between 2006 and 2007. Of the eleven most frequently detected compounds, nine were pharmaceuticals:
Atenolol, a beta-blocker used to treat cardiovascular disease.
Carbamazepine, a mood-stabilizing drug used to treat bipolar disorder.
Estrone, an estrogen.
Gemfibrozil, an anti-cholesterol drug.
Meprobamate, a tranquilizer widely used in psychiatric treatment.
Naproxen, a painkiller and anti-inflammatory.
Phenytoin, an anticonvulsant that has been used to treat epilepsy.
Sulfamethoxazole, an antibiotic used against the Streptococcus bacteria, which is responsible for tonsillitis and other diseases.
Trimethoprim, another antibiotic.
Further testing of drinking water supplies has shown that at least 46 million people are exposed to trace amounts of pharmaceuticals through this route, while the overwhelming majority of U.S. communities have yet to test.
The Environmental Protection Agency and other federal agencies are working to evaluate exposure and potential effects on humans and aquatic life. While we know that pharmaceuticals have health effects at the therapeutic dose, EPA is working to better understand and evaluate the potential risk to humans associated with long-term exposure to low concentrations of the same chemicals.
Aquatic organisms may experience more pronounced effects than humans because they are continually exposed. Researchers are finding evidence that even extremely diluted concentrations of pharmaceutical residues harm fish, frogs, and other aquatic species in the wild. Pharmaceuticals are seen as a source of the endocrine disrupting compounds in wastewater effluent that are suspected of causing the high rate of intersex characteristics detected in certain species of smallmouth bass found in the Potomac River. In addition, even small amounts of antibiotics that are not captured by wastewater treatment systems can kill off natural bacteria in waterways, encourage microbes to become drug-resistant, and poison fish. EPA is monitoring fish tissue and water samples in developed and urban areas across the country to produce a statistically representative estimate of the occurrence of pharmaceuticals in fish tissue and waterways.
EPA is also researching whether higher-level water treatment strategies can remove pharmaceuticals from wastewater and drinking water. EPA advises that while most pharmaceuticals from human sources are entering water through natural biological functions, it is important for the public to understand that they can help prevent pollution of our waterways by not using the toilet as a trash can for unused medications.
Abuse of prescription drugs
This legislation will address not only the risks to our water supply, but will have public health benefits. Several studies of drug abuse patterns indicate that nonmedical use of prescription drugs is increasing. Last fall, the Substance Abuse and Mental Health Services Administration of the Department of Health and Human Services released the results of the nation's largest substance use assessment, the National Survey on Drug Use and Health. For 2007, the study showed that cocaine and methamphetamine use among young adults dropped significantly, but that abuse of prescription drugs increased. Among young adults ages 18 to 25, the level of current nonmedical use of prescription pain relievers has risen 12 percent.
Results of a separate study of seventh through twelfth grade students were released in 2005 by the Partnership for a Drug-Free America. The Partnership Attitude Tracking Study tracks consumers' exposure to and attitudes about drugs. The study focuses on perceived risk and social attitudes. For the first time in its seventeen-year history, the study found that teenagers are more likely to have abused a prescription pain medication to get high than they are to have experimented with a variety of illicit drugs including Ecstasy, cocaine, crack, and LSD. The study reported that nearly one in five teenagers, or 4.3 million teenagers nationally, reported using the controlled substance Vicodin without a prescription; approximately ten percent, or 2.3 million teens nationally, reported using the controlled substance OxyContin without a prescription; and ten percent, or 2.3 million teenagers nationally, reported having used prescription stimulants, Ritalin and/or Adderall, without a prescription. Fifty percent of the teenagers surveyed indicated that prescription drugs are widely available; a third indicated that they were easy to purchase over the Internet; and 63 percent said they could easily obtain prescription opiates and painkillers from their own home.
The 2006 National Institute of Drug Abuse survey of drug use by teens in the eighth, tenth, and twelfth grades, ``Monitoring the Future: National Results on Adolescent Drug Use'', found that past-year nonmedical use of Vicodin remained high among all three grades, with nearly one in ten high school seniors using it in the past year. Despite a drop from 2005 to 2006 in past-year abuse of OxyContin among twelfth graders (from 5.5 percent to 4.3 percent), there had been no such decline among the eighth and tenth grade students, and the rate of use among the youngest students had increased significantly since it was included in the survey in 2002.
The consequences of prescription drug abuse are seen in the data collected by the Substance Abuse and Mental Health Services Administration on emergency room visits. In the latest data, ``Drug Abuse Warning Network (DAWN), 2005: National Estimates of Drug-Related Emergency Department Visits,'' SAMHSA estimates that about 599,000 emergency department visits involved nonmedical use of prescription or over-the-counter drugs or dietary supplements, a 21 percent increase over 2004. Of the 599,000 visits, 172,000 involved benzodiazepines and 196,000 involved opiates. Overall, controlled substances represented 66 percent of the estimated emergency department visits. Between 2004 and 2005, the number of visits involving opiates increased 24 percent and the number involving benzodiazepines increased 19 percent. About a third (200,000) of all visits involving nonmedical use of pharmaceuticals resulted in admission to the hospital; about 66,000 of those individuals were admitted to critical care units; 1,365 of the visits ended with the death of the patient.
The most recent data available in the National Poison Data Base compiled by the American Association of Poison Control Centers show that in 2006 there were 21 pharmaceutical-associated fatalities in children under age 6, and 47 such fatalities in children 13 to 19 years. We may never know how many of these incidents affecting our children and youth are due to access to unused medications found in the home. Even so, it is important to look for opportunities to reduce the frequency of these incidents.
Local and state programs operated under existing law
The Drug Enforcement Administration administers the Controlled Substances Act and its implementing regulations to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, and to deter the diversion of controlled substances to illegal purposes. Controlled substances are drugs that have a potential for abuse and psychological and physical dependence; these include opiates, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances. The substances are divided into five schedules. Schedule I substances have a high potential for abuse and have no accepted medical use in treatment in the United States. These substances may only be used for research, chemical analysis, or manufacture of other drugs. Schedule II-V substances have accepted medical uses and also have potential for abuse and psychological and physical dependence. Virtually all Schedule II-V controlled substances are available only under a prescription written by a practitioner licensed by the State and registered with DEA to dispense the substances. Overall, controlled substances constitute about 10 percent of all prescriptions written in the United States.
In enacting the Controlled Substances Act, Congress sought to control the diversion of pharmaceutical controlled substances into illicit markets by establishing a ``closed system'' of drug distribution governing the legitimate handlers of controlled substances. Under this closed system, all legitimate manufacturers, distributors, and dispensers of controlled substances must register with DEA and maintain strict accounting for all controlled substance transactions. DEA advises that current law does not allow a DEA registrant, such as a retail pharmacy, to acquire a controlled substance from a non-
registrant, such as an individual patient, even for purposes of disposal. The individual determines whether or when to dispose of unneeded medications, although DEA recommends that controlled substances be disposed of in a way that does not allow them to be easily retrieved.
Communities have responded to the public health and environmental problems posed by unused pharmaceuticals by developing several different models of take-back and collection programs at the State or local level, including:
Collecting unwanted pharmaceuticals at pharmacies, grocery stores, or other retail settings.
Having citizens turn over unwanted medications to law enforcement officers.
Accepting unwanted pharmaceuticals at periodic household hazardous waste collection events, often with law enforcement personnel present to take custody of controlled substances.
Collecting unwanted pharmaceuticals through caregivers in residential care settings (i.e. hospices, nursing homes, assisted living facilities, boarding homes, adult family homes, child care programs, schools, correctional facilities, and animal boarding facilities).
Using the U.S. Postal Service for mailing unwanted pharmaceuticals to a secure consolidation location for disposal.
Collecting pharmaceuticals lost or abandoned by residents or visitors from hotels, campgrounds, cruise ships, homeless shelters, and other temporary housing or recreational sites.
The volume of medications these programs have collected is stunning. In 2006, a one-day drug return program at 25 locations in Chicago netted 1,600 pounds of medications. Separate one-day take-back programs in Michigan and Milwaukee the same year each yielded more than a ton of medicine. In one day in November 2008, a community-based effort at the Detroit Medical Center Surgery Center in Madison Heights collected 300 pounds of prescription and over-the-counter medicines and sent them to an incinerator. In one week in April 2008, EPA's Great Lakes Earth Day Challenge collected nearly 4.5 million pills from throughout the Great Lakes region. Macomb County, Michigan's hazardous waste recycling program collects more than 1,000 pounds of drugs a year.
National guidelines
At the national level, both the public and private sectors have taken steps to address the problem of disposal of unused pharmaceuticals. In 2007, The White House Office of National Drug Control Policy, the Department of Health and Human Services, and EPA jointly released new guidelines for the proper disposal of unused, unneeded, or expired prescription drugs. The guidelines are designed to reduce the diversion of prescription drugs, while also protecting the environment. The new guidelines urge Americans to:
Take unused, unneeded, or expired prescription drugs out of their original containers.
Mix the prescription drugs with an undesirable substance, like used coffee grounds or kitty litter, and put them in impermeable, non-
descript containers, such as empty cans or sealable bags, further ensuring that the drugs are not diverted or accidentally ingested by children or pets.
Throw these containers in the trash.
Flush prescription drugs down the toilet only if the accompanying patient information specifically instructs it is safe to do so.
Return unused, unneeded, or expired prescription drugs to pharmaceutical take-back locations that allow the public to bring unused drugs to a central location for safe disposal.
In addition, the pharmacy profession through the American Pharmacists Association has partnered with the Pharmaceutical Research and Manufacturers of America and the U.S. Fish and Wildlife Service in establishing the SMARxT DISPOSAL program to help protect the country's fish and aquatic resources. SMARxT DISPOSAL is a consumer awareness-
heightening program that highlights the environmental threat posed by medications that are disposed of improperly, with the key message being
``crush, don't flush.'' It encourages consumers to dispose of most unused medications in household trash rather than through the wastewater system, to take advantage of state and local medication collection programs, and to consult with a pharmacist should any questions arise.
International programs
Under British Columbia's Medications Return Program, the public can return expired or unused medications at participating community pharmacies across British Columbia. The pharmaceutical industry voluntarily established the program in November 1996. In 1997, provincial legislation made all brand-owners of pharmaceutical products responsible for the collection and management of their left-over products. This program allows consumers to return unused or expired medications at no charge to over 90 percent of participating pharmacies in the province.
Spain's Integrated Waste Management System (SIGRE) allows citizens to return packaging and leftover medicines to pharmacies across the country free of charge. The program has been in place since 2002 and is funded by the pharmaceutical industry. Collected wastes are taken to a central processing facility for recycling or destruction.
France's medicine take-back program, established in 1995, is an industry-funded system that is run collaboratively among manufacturers, wholesalers, and community pharmacies. Households are invited to return all unused medicines and packaging. Bags and leaflets are handed out at the time of dispensing; window stickers and posters reinforce the message of safe disposal.
Hazardous pharmaceutical waste
EPA has offered its support of pharmaceutical take-back programs by proposing to revise its rules for managing hazardous pharmaceutical waste. A small proportion of pharmaceutical waste meets EPA's definition of hazardous waste. The proposed amendment to EPA's universal waste rule would improve the management of hazardous pharmaceutical waste by providing a more streamlined waste management system, while ensuring that the waste is sent to hazardous waste management facilities, rather than municipal landfills, for final disposal. The streamlined standards include modified requirements for storage, labeling and marking, preparing the waste for shipment offsite, employee training, response to releases, and notification. In addition, no manifest would be required to transport the waste. This management system could also be used for safely collecting, transporting, and disposing of unwanted non-hazardous pharmaceuticals as part of a take-back program. Should these proposed rules be finalized, states operating EPA-authorized hazardous waste programs could adopt them to support their take-back programs.
What this bill would do
The Safe Drug Disposal Act of 2009 amends the Controlled Substances Act to allow end users, or caretakers of an end user, to safely dispose of unused prescription drugs and over-the-counter drugs through DEA-
approved, state-run, drug take-back programs.
Accumulation of dispensed controlled substances in the hands of individual or institutional care takers, including those caring for animals, can be a serious concern. Long-term care facilities, nursing homes, hospitals, jails, schools, and veterinary clinics may act in a custodial capacity, holding controlled substances that are prescribed for an individual and belong to that individual. The care taker dispenses these medications as directed by a medical practitioner. As a result of these dispensing practices, when a patient dies, leaves the facility or their medication is discontinued or changed, the care taker may be left with excess controlled substances that must be disposed. Under present law, these care takers may dispose of controlled substances directly, but, unless they are registered with DEA, they may not transfer controlled substances that have been dispensed to an individual to a DEA-registered entity for disposal.
Specifically, this bill directs DEA, within one year, to create five approved drug take-back program models from which states may choose. Should a state seek to implement a model not listed among those five DEA approved models, a state must seek approval from DEA for the modified version. In creating the five specific drug take back program models, DEA must comply with a specific set of criteria:
Protecting the public safety.
Allowing the ultimate user to dispose of their unused drugs though persons other than law enforcement.
Respecting environmentally sound practices for disposal (take-back programs may not include the disposal of drugs through public waterways or municipal solid waste landfills).
Being cost-effective for the state.
Including take-back program options for both rural and urban locations.
Successful take-back programs are likely to receive substantial volumes of medications, most of which will not be controlled substances. Under the Controlled Substances Act, Congress established a
``closed system'' of distribution designed to prevent the diversion of controlled substances. As part of this closed system, all persons who lawfully handle controlled substances must be either registered with DEA or exempt from registration by the Act or by DEA regulations. Another central element of this closed system is that DEA registrants must maintain strict records of all transactions in controlled substances. Consistent with the Controlled Substances Act, current DEA regulations employ a system to account for all controlled substances received, stored, distributed, dispensed, or otherwise disposed of.
Take-back programs are unlikely to have the resources to separate controlled substances from other medications or to provide a detailed accounting of the kind contemplated in the Controlled Substances Act. Take-back programs currently in operation have demonstrated that it is possible nonetheless to protect against diversion. It will be particularly important for DEA model programs to provide methods for tracking collected medications that are cost-effective for the state to implement and operate.
Finally, the Safe Drug Disposal Act prohibits pharmaceutical companies from recommending flushing as a means of disposal on prescription drug labels. Guidelines issued by the White House Office of National Drug Control Policy recommend that the general public dispose of their waste pharmaceuticals in household trash, except for thirteen substances which should be flushed down the toilet. The federal guidelines recommend the flushing of these thirteen substances because their drug labels (required of all pharmaceutical products and resulting from the Food and Drug Administration's approval process) recommend flushing.
This bill provides that, in approving an application for a medication, FDA shall ensure that the labeling not include any recommendation or direction to dispose of the medication by means of a public or private wastewater treatment system, such as by flushing down the toilet. The bill also directs FDA to conduct a review of the labeling of medications already on the market, and to order any labeling that includes a recommendation or direction to dispose of the medication by means of a public or private wastewater treatment system, such as by flushing down the toilet, to be revised to exclude that recommendation or direction. This order would be required to be issued within one year of enactment of the bill.
Conclusion
Madam Speaker, it is clear that the lack of an effective disposal mechanism for excess controlled substances and other pharmaceuticals, including over-the-counter medications, is contributing to contamination of our drinking water supply and putting aquatic wildlife at risk. It is also associated with a dangerous increase in nonmedical use of pharmaceuticals, especially among our young people. While it is easy to identify the problem, it is more difficult to devise a solution that consumers and law enforcement professionals will both accept. This bill will allow States to adopt take-back programs suited to the needs of their communities, and as such will help our nation to move toward a comprehensive solution.
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