[Congressional Record Volume 155, Number 34 (Thursday, February 26, 2009)]
[Extensions of Remarks]
[Pages E489-E492]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     SAFE DRUG DISPOSAL ACT OF 2009

                                 ______
                                 

                          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

[[Page E490]]

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

[[Page E491]]

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

[[Page E492]]

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.

                          ____________________