The Prescription Drug Abuse Epidemic
And The PillSafe Solution[1]
Prescription
drug abuse has become an epidemic across the United States, destroying and
affecting many lives. In fact, America is in a perfect storm of abuse of mind
altering prescription drugs. Even those who begin their use for legitimate
purposes can become unlawful users because the powerful nature of prescription
drugs greatly increases the potential for abuse. Millions of individuals
nationwide buy, sell, steal, and abuse controlled medication for recreational
(non-medical) purposes. America must come to terms with the troubling problems
these same drugs cost society. It is clear, however, that we cannot simply
arrest our way out of the problem of chronic drug abuse and drug-driven crime.[2]
The most well funded and staffed law
enforcement efforts cannot eliminate diversion and abuse of controlled
prescription medication on their own. Thus, programs aimed at preventing drug abuse and reducing demand are just as important,
if not more critical, as busting drug dealers.[3]
Therefore,
a look at the PillSafe, a preventive
innovation, is in order. It is anticipated that use of the PillSafe to package
dangerous prescription drugs can provide a 5% to 15% reduction in the problems
and costs associated with prescription drug abuse in the United States. This
reduction will save our society billions of dollars annually. How the PillSafe
will help society and the available savings estimates are discussed further
below. Before that, however, a few relevant comments and statistics are in
order to illustrate the gravity of this growing problem
The
Rise of Prescription Drug Abuse
The diversion and abuse of
controlled prescription drugs in the U.S. dates back to morphine abuse
during the Civil War and
continues through OxyContin¨ and Ritalin¨ abuse today. The problem can be seen
in every phase of life: rich and poor, young and old, teens partying or
cramming for exams, stressed executives, women juggling the challenges of work
and family, seniors coping with illness and loss, the mentally ill searching
for relief, movie stars, rock musicians and athletes. For far too many, abuse
becomes addiction ending in ruined lives, tragedy and death.
People
must understand the grave danger of using powerful medicines without the
meaningful oversight of a doctor who is treating them. They must also take
steps to protect their children and adolescents. That children have such
unregulated access to dangerous narcotics and other drugs is unacceptable. Its
potential for tragic outcomes is simply too great.[4]
Today,
the rise in youth abuse of powerful prescription drugs is particularly
disturbing. Abuse of prescription medications is highest and rising fastest
among young people who have easy access to pills in the medicine cabinets of
parents or friends. They wrongly think ÒprescriptionÓ drugs are safe, and stage
Òpharming partiesÓ to share and experiment with peers.
The
Substance Abuse and Mental health Services Administration (SAMHSA), an agency
within the Department of Health and Human Services, annually conducts the
National Survey on Drug Use and Health (NSDUH) on a random sample of U.S.
households to determine the prevalence of non-medical use of illicit and prescription
drugs. The 2004 Survey[5]
revealed some alarming statistics. An estimated 19.1 million Americans or 7.9 percent of the population aged 12 and
older used illicit drugs in 2004. 2.1
million persons used pain relievers non-medically for the first time within the
past 12 months. Almost half of all Americans have tried an illicit drug at least once in their lifetime. The rate of illicit
drug use among youth was 10.6 percent. Approximately one in every six youths is approached
by someone selling drugs.
The
2004 NSDUH reported that 6.0 million persons, or 2.5 percent of Americans age
12 and older, were current users of psychotherapeutic drugs taken
non-medically; 14.6 million persons, or 6.1 percent, had used such drugs
non-medically in the past year; and 48 million persons had used such drugs
non-medically at least once in their lifetimes.
Also,
according to the 2004 NSDUH, the number of people who had used pain relievers
non-medically at least once during their lifetime increased 7 percent from 2002
to 2004, for a total of 31.8 million Americans. The prevalence of lifetime
non-medical use of oxycodone-containing analgesics increased from an estimated
11.8 million users in 2002 to 13.7 million users in 2003.
The
reported rise of prescription drug abuse is corroborated by data on the
consequences of the non-medical use of prescription drugs. SAMHSAÕs Drug Abuse
Warning Network (DAWN) surveys a national sample of hospital emergency
departments. DAWN captures emergency room visits associated with substance
misuse and abuse, both intentional and accidental, as well as visits related to
the use of drugs for legitimate therapeutic purposes.
Emergency departments are
seeing alarming increases in visits secondary to prescription drug abuse. The
2004 DAWN Report[6] examined
the involvement of opiates and deaths related to drug misuse and found that
nearly 1.3 million emergency department visits in 2004 were associated with
drug misuse and abuse. Non-medical use of pharmaceuticals was involved in
nearly a half million of
these emergency room visits. In addition, opioid analgesics (pain relievers),
such as hydrocodone, oxycodone, and methadone were present in 158,281 emergency
department visits, and benzodiazepines such as alprazolam and clonazepam were
present in 144,385 visits associated with non-medical use of pharmaceuticals in
2004. Muscle relaxants, particularly carisoprodol and cyclobenzaprine, were
involved in an estimated 28,338 emergency room visits related to non-medical
use. Finally, over two-thirds of emergency department visits associated with
opioids, benzodiazepines, and muscle relaxants involved multiple drugs.
The Treatment Episode Data
Set (TEDS), also administered by SAMHSA, collects data on admissions to
federally funded drug and alcohol addiction treatment programs. Between 1999
and 2003, treatment admissions for primary abuse
of opiods other than heroin increased from 1 percent of all admissions (22,637
admissions) in 1999 to 3 percent in 2004 (63,243 admissions).[7]
More people are admitting
they abuse prescription drugs. In one study, there was a 90% increase (from 7.8
million to 14.8 million) in the number of people who admitted abusing controlled prescription drugs between 1992 and
2002.[8]
In another study, the number of people who admit abusing controlled prescription drugs increased from
7.8 million in 1992 to 15.1 million in 2003 - by 94 percent - seven times
faster than the increase in the U.S. population.[9] According to a third study, in 2003,
15.1 million people in the U.S. admitted abusing prescription drugs - more than the combined number who admits
abusing cocaine (5.9 million), hallucinogens (4.0 million), inhalants (2.1
million) and heroin (.3 million) combined. Between 1992 and 2002, the
population of the United States increased by 13%. During that same period, the
number of prescriptions written for non-controlled drugs increased by 57% while
the number of prescriptions filled for controlled drugs increased by 154%.[10]
In 2002, more than three
billion prescriptions were filled for over 500,000 different drugs; 234 million
(or about 7.8% of all prescriptions) were for controlled prescription drugs.[11]
Of controlled drugs, opioids were the most widely prescribed (152.8 million
prescriptions), followed CNS depressants (58.2 million) and CNS stimulants
(23.4 million).[12]
From 1997 to 2003, spending
on prescription drugs nearly tripled from $78.9 billion to $216.4 billion.[13]
Recent advances in gene therapy suggest that the greatest surge in
pharmacological therapeutics remains to be seen.
The U.S. Department of
Justice calls the diversion and abuse of pharmaceuticals among the Òleading drug threats to the country.Ó[14]
The DEA has stated that the
diversion and abuse of legitimately produced controlled pharmaceuticals
constitute a multi-billion dollar illicit market nationwide.[15]
In 2001, ÒThe National Community Pharmacists Association estimated the impact
of prescription drug abuse and misuse on U.S. healthcare costs alone to be more
than $100 billion.Ó[16]
Controlled prescription
drugs are now the fourth most abused substances in America behind only
marijuana, alcohol and tobacco. The most commonly abused drugs include
oxycodone (Percodan¨, Percocet¨, Roxicet¨, Tylox¨, OxyContin¨), hydrocodone
(Vicodin¨, Vicoprofen¨, Lorcet¨, Lortab¨), hydromorphone, morphine
(Astramorph¨, Duramorph¨, MS Contin¨, Roxanol¨), codeine, clonazepam
(Klonopin¨), alprazolam (Xanax¨), lorazepam (Ativan¨), diazepam (Valium¨) and
carisoprodol (Soma¨).[17]
Non-medical use of the
currently popular OxyContin¨ has been skyrocketing (see table).[18]
Because the abuse of OxyContin¨ is particularly acute in Appalachia it has
earned the nickname Òhillbilly heroin.Ó
|
1997 |
2000 |
2001 |
2002 |
2003 |
2004 |
|
221,000 |
399,000 |
957,000 |
1,924,000 |
2,832,000 |
3,176,800 |
Prescription
drug diversion is a lucrative business because many pills sell on the street
for as much as ten times their retail cost. An 80 mg OxyContin¨ pill, for
example, sells for about $6 at a pharmacy. It sells for $65 to $80 on the
street.[19]
The
National Center on Addiction and Substance Abuse (CASA) at Columbia
UniversityÕs three-year landmark report, Under the Counter: The Diversion
and Abuse of Controlled Prescription Drugs in the U.S., July 2005,
http://www.casacolumbia.org/absolutenm/articlefiles/380-underthecounter-diversion.pdf,
has documented the enormous increase in the manufacture and distribution of
controlled prescription drugs. With increased availability has come increased
abuse of these drugs.[20]
Between 1992 and 2003, the number of people abusing controlled
prescription drugs jumped 94 percent – twice the increase in the number
of people abusing marijuana, five times the number abusing cocaine, and 60 times
the increase in the number abusing heroin.[21]
Drugs can be diverted from
their lawful purpose to illicit use at any point in the pharmaceutical
manufacturing and distribution process. For instance, prescription forgery can
occur at any point from manufacturer to the patient. Thefts are on the rise,
largely due to drastic increases in prescription drug abuse and high street
prices,[22]
and use by teens is increasing dramatically due, in large part, to easy
access to powerful prescription medications on the Internet and in the medicine
cabinets of their parents and friends.
The major categories of diversion are:
|
Diversion and Abuse Categories of Controlled Prescription Drugs in the
USA |
|
|
|
Diversion secondary to: Traditional street-level drug
dealing; illegal trafficking |
|
Diversion secondary to: Drug trafficking in schools |
|
Diversion secondary to: Theft |
|
Diversion secondary to: Doctor shopping |
|
Diversion secondary to: Fraudulent prescriptions +Dishonest healthcare practitioners who knowingly
over prescribe +Unscrupulous doctors who carelessly over prescribe |
|
Diversion secondary to: Fraudulent pharmacies |
|
Diversion secondary to: Patient scams |
|
Diversion secondary to: Prescription sharing through criminal
operatives |
|
Diversion secondary to: Illegal purchases without a
prescription over the Internet |
|
Diversion secondary to: Receiving prescription drugs for no
cost from family and friends |
|
Diversion secondary to: Teen ÒPharming PartiesÓ |
As with abuse of illicit
drugs, prescription drug abuse causes substantial harm both to abusers
directly, and to everyone bearing the indirect burdens on our systems of
criminal justice and public health. The data by itself, however, sanitizes the
full story. It leaves out the anguish of parents who find out too late that
their teenager was abusing a fatal cocktail of narcotics obtained on the
Internet. It fails to capture the lost promise of the student who drops out of
college to feed his habit, or the despair of the father of three whose
addiction to painkillers costs him his livelihood. As with illicit drugs,
prescription drug abuse exacts a heavy price from those who become its victims.
The toll on our systems of criminal justice and public health is also profound.
While law enforcement data shows that illicit drug abuse still accounts for a
larger proportion of violent and property crime, the impact of prescription
drug abuse on criminal activity is on the rise. One state investigator
estimates that Òat least 70% of the enforcement cases involve pharmaceuticals.
The problem is as big as or bigger than street drugs.Ó[23]
More than 4% of all state and local law enforcement agencies in the
Northeast, in fact, reported in 2004 that pharmaceuticals were the drugs that
contributed most to violent and
property crime in their areas.[24]
Indeed,
prescription drug abuse has become an epidemic in our society adversely
affecting millions of individuals in America. Clearly, prescription drug abuse
in the United States costs our communities and government substantial sums of money - in the billions of dollars annually - across the board for law enforcement, overloaded
court dockets, jail incarcerations and overcrowded prisons, soaring healthcare
costs, lost productivity, and other devastating social costs.
America must come to terms
with the many troubling problems that prescription drug abuse imposes on our
society. It is time to find new and innovative methods to combat this growing
epidemic. For instance, U.S. Rep. Hal Rogers, R-Somerset, KY created ÒUnited
Narcotics Investigations, Treatment & EducationÓ (UNITE) in 2003, as one
measure to confront the problem. However, according to Dan Smoot, Director of
Law Enforcement for UNITE, the task of eliminating diversion and abuse cannot
be left to law enforcement alone.
ÒWeÕre not going to arrest our way out of this problemÓ, said Smoot. The
other elements of UNITE, education programs aimed at preventing drug abuse, and
coordination of treatment and outreach programs to help addicts, are just as
important, if not more critical, as busting drug dealers.[25]
Therefore, a look at a preventive innovation, the PillSafe, is in order.
The
PillSafe
Origin and Development
In 2003, Anthony
McEldowney, M.D., a practicing orthopedic surgeon, and Dr. Robert Muncy, Jr.,
D.M.D., a dentist, became concerned about the widespread abuse of controlled
prescription medications in areas of Kentucky. As doctors, they were concerned
that legitimately prescribed medications were being diverted and abused in many
ways. Hoping to help alleviate the complex problems and the human tragedy
associated with the widespread and growing abuse of dangerous prescription
drugs, they wanted to create a device that would both reduce current levels of
prescription drug abuse, and help prevent future abuse of prescription medications.
Moreover, they wanted to increase public health and safety in our communities.
They further realized that both our state and federal governments could benefit
from a reduction in the skyrocketing costs for law enforcement, criminal
justice, healthcare, and social services associated with prescription drug
abuse. They saw a need for a better-protected pill bottle designed to prevent
diversion of dangerous medications and approached the University of Kentucky
Center for Manufacturing (UKCM) with an idea for a new kind of pill dispenser.
The UKCM regularly
works with entrepreneurs and businesses to develop and improve products. Soon
after the doctors approached the UKCM, a team was formed to work with the two
doctors. The team included Richard Muse (UK Center for Manufacturing), John T.
Henninger (UK Center for Manufacturing), William Dieter (UK Department of
Electrical and Computer Engineering), Robert Lodder (UK College of Pharmacy),
and Larry Holloway (UK Center for Manufacturing).
Powerful prescription
medications can be life saving when taken under the supervision of a physician,
but when abused, they can be just as life threatening as illicit drugs. The
team concluded that the new kind of pill dispenser envisioned by the doctors
should be one that: (a) would allow dispensing of a prescribed medication only
in the prescribed amount no faster than the prescribed rate; (b) would detect
tampering if someone were to try to break open the container or to otherwise
forcibly remove the medication early; and (c) upon detection of tampering,
would destroy the medications in the dispenser and render them unusable,
harmless and of no value. Thereby, the chance of abuse or theft by the patient
or others would be reduced. The device would be relatively small and inexpensive,
allowing it to be widely used for potentially addictive drugs. The team used
two grants from the Innovative Group at the Kentucky Science and Technology
Corporation, and drew upon the expertise of its different members to design and
make the PillSafe prototype. The current prototype incorporates electronic
circuitry to timely release the medication and detect tampering, mechanical
design for the outer shell containing the medication and the destruct
mechanism, and the internal mechanisms needed to release the medication and
prevent tampering. Their pharmaceutical expertise regarding destruction of the
medications was also needed to comply with FDA regulations.
The University of Kentucky
team is working on more advanced prototypes to demonstrate the deviceÕs safe
and reliable operation. Funding is currently needed to allow additional
research aimed at advancing the tamper-destruct mechanism.
How Does the PillSafe Work?
The PillSafe was
designed to satisfy three main regulatory concerns: clinical, pharmaceutical
and packaging. From the clinical aspect, it was necessary that the burn residue
from the incinerated medicine be completely destroyed and inedible. From the
pharmaceutical aspect, drug tablets stacked next to fuel rods needed to be
stable over time and not subject to chemical degradation in the presence of a
destruct-oriented reactant. And lastly, the packaging needed to be safe and
inaccessible to those for whom the medicine is not intended. It was also
necessary for the PillSafe to be designed so that hot gases created upon
ignition are brief and contained in an insulating vessel, posing no danger of
igniting external fires.
The pills are
stored in columns adjacent to fuel. Hot exhaust gases from the burning fuel are
directed toward the pills. The entire assembly is essentially in a miniature
vented Thermos¨ bottle, enveloped in a protective shell with a loop printed on
the interior using conductive ink. Breaching the shell breaks the loop,
signaling the microcontroller to ignite the fuel. The entire system is powered
by two alkaline AA batteries and constructed from inexpensive parts costing
less than $10.00.
Destroying tablets
rapidly requires a very fast, reliable chemical reaction that proceeds in the
presence of interferences. Because the tablets are stored for an extended
period in close proximity to the components of this reaction, the destructive
reaction must not proceed even at a very low rate in the absence of a tampering
trigger. For these reasons, a stable metallic aluminum-based fuel was chosen as
the means of tablet destruction.
The magic
underlying the PillSafe innovation is a novel computer regulated dosing and
destruct mechanism that allows patients only to take dangerous medication
exactly as prescribed by their attending physician and programmed by their
pharmacists. The PillSafe simply presents the patient with a small button. When
pressed, it dispenses the appropriate medication through a small aperture if,
and only if, the prescribed dosing period has passed since the previous pill
was dispensed. Meanwhile, the dispenser monitors its outer shell for tampering
and rapidly destroys all of the pills contained in the dispenser if tampering
is detected.
Ideally, the
PillSafe would be adopted and introduced to the market by the drug
manufacturers out of their commitment to public health and safety. If not, the
PillSafeÕs developers believe that the drug companies can be shown enough
commercial advantages to using the PillSafe that any resistance can be
overcome. It is contemplated, then, that the PillSafe would be shipped to the
individual drug companies where they would be filled with appropriate
medications and shipped to local pharmacies and dispensaries. A pharmacist
would then program the PillSafe according to a prescribing doctorÕs
instructions and deliverer the filled prescription to the patient in the
programmed PillSafe.
How Will the PillSafe Improve Public Health
and Safety in the United States?
By
no means is the PillSafe offered as a Òbe all – end allÓ solution to
prescription drug abuse in the United States. Rather, its developers believe
solving the complex problems associated with prescription drug abuse requires a
comprehensive approach that employs a collection of tools including the
criminal justice system, educational programs, outreach programs and treatment
for addicts, and innovative
technology aimed at preventing
drug abuse. While each of these tools is an important part of the solution, the
PillSafe offers an additional line of defense that is both innovative and preventive.
The
PillSafe will provide safety for the patient and community. It will prevent
life-threatening overdose, even death, of vulnerable children, teens and the
elderly. Our schools and streets will benefit from the deterrence of theft, and
the illegal sale and distribution of prescription medication, which is so
easily available with the standard prescription bottles in use today.
Use
of the PillSafe will reduce the availability of controlled prescription medication, which, in
turn, will diminish criminal opportunity secondary to illegal drug trafficking. Fewer abuse-related arrests
will reduce costs of law enforcement, lighten heavy court dockets, and decrease
overcrowded prison populations. Additionally, reduction of prescription drug
abuse will ease the burden of soaring healthcare costs, lost productivity, and
other devastating social costs discussed below.
The PillSafe will
address serious public health problems secondary to abuse of powerful
prescription medication. Concurrently, it will ease the tremendous financial
burdens presently on the shoulders of the taxpayer and our national, state and
local governments.
Substance
Abuse and Child Welfare: The overwhelming majority of parents
who encounter the child welfare system have problems with substance abuse.
Problems with addiction can significantly affect a parentÕs ability to raise a
child and can threaten a childÕs safety. Specifically, addiction can have the
following effects on a parentÕs abilities: [26]
These
problems dramatically affect state budgets. Approximately $7.6 billion is spent
at the state level for the child welfare system. Of this money, $5.3 billion
– 70 percent – is spent on problems caused or exacerbated by
substance abuse and addiction.[28]
For a very modest cost the
PillSafe will reduce substance abuse by parents. Parental aggression and
threats of physical violence towards their children will be reduced. Parental
neglect of their children will become less prevalent. Parents will do a better
job attending to the basic needs of their children and the potential for
bonding will grow. The entire family unit will benefit, children will have a
better chance to succeed and fewer will end up in foster care and society as a
whole will benefit from a less burdened welfare system.
Substance
Abuse and Criminal Justice: ÒThey
(mandatory sentences) have not stemmed the drug trade. The only thing they've
done is to fill the prisons.Ó[29] One can argue that as a result, the criminal justice
system is often the largest and the fastest growing element of a stateÕs budget.
Thus, ÒÉwe cannot simply arrest
our way out of the problem of chronic drug abuse and drug-driven crime.Ó[30]
Currently,
more than 2 million people are behind bars in this country, and the number has
increased by an average of 3.4 percent per year during the past 10 years.
Roughly 20 percent of these inmates are incarcerated on a drug-related offense,
such as selling or possession.[31]
This fact does not tell the full story of addictionÕs true effect on the
criminal justice system, however. For the vast majority of inmates – as
well as former inmates and parolees – substance abuse and addiction
play a significant role in their lives and in the crimes they committed. In
addition to buying and selling illegal substances, many offenders have
committed crimes while under the influence, stolen money or goods to buy drugs,
driven drunk or under the influence, or have acted violently because of their
addiction. Overall, drugs and alcohol are implicated in the crimes of 81
percent of state inmates. [32]
As the prison
population has increased during the past 25 years, so has spending on the
criminal justice system. In 2001, state spending on corrections totaled $38
billion. In 1986, the total was just $15 billion, adjusted for inflation.[33] This represents the fastest
growing parts of most state budgets, vastly eclipsing Medicaid. Approximately
80 percent of that money ($30.4 billion) was spent specifically on inmates who
committed a crime either while under the influence, to raise money to support
their habit, or some other drug or alcohol related offense.[34]
á
Incarceration of a
drug-using offender costs between $20,000 and $50,000 per year, and the cost of
building a prison cell can be as much as $80,000.[35]
á
From 1990 to 2000, the
number of drug offenders in State prison increased from approximately 149,700
to 251,100. During this time, drug offenders
accounted for 20% of total growth in the State prison population.
á
In 1999, drug offenders
in State prison served approximately 43% of their sentences, an average of 27
months, before being released. This is up from an average of 20 months served
before release in 1990.
á
The Federal prison
population increased by 9,042 admissions from October 1, 1999, to September 30,
2000. Of the 9,042 admissions, 4,389 were for drug offenses. On September 30,
2000, there were 73,389 drug offenders in Federal prisons.
á
As of October 2001,
55.5% of sentenced prisoners in Federal Bureau of Prisons (BOP) facilities were
drug offenders. In comparison, in 1970 approximately 16% of BOP sentenced
prisoners were drug offenders.[36]
While
incarceration is certainly a vital tool in combating prescription drug abuse,
new tools like the PillSafe are badly needed that can effectively control the
diversion of dangerous prescription medication. Such tools will significantly
decrease chronic prescription drug abuse and related drug-driven crime thereby
reducing our prison population and its soaring costs.
Substance Abuse and
AmericaÕs Youth: Today, the rise
in youth abuse of powerful prescription medications is particularly disturbing.
According to a report from CASA, in 2003, 2.3 million teens ages 12 to 17 (9.3
percent) reported using a controlled prescription drug in the past year; 83
percent of them reported abusing opiods.[37]
While
the overall substance abuse among teens is steadily declining, prescription
drug use among teens is increasing. The
212 percent increase from 1992 to 2003 in the number of 12-to-17 year olds
abusing controlled prescription drugs, and the increasing number of teens
trying these drugs for the first time is particularly alarming. New abuse of
prescription opioids among teens was up an astounding 542 percent.[38]
ÒThe explosion in the prescription of addictive opioids, depressants and
stimulants has, for many children, made the medicine cabinet a greater
temptation and threat than the illegal street drug dealer, as some parents have
become unwitting and passive pushersÓ says Joseph A. Califano, Jr., Chairman
and President, The National Center on Addiction and Substance Abuse at Columbia
University.[39]
ÒTeens
who abuse controlled prescription drugs are twice as likely to use alcohol,
five times likelier to use marijuana, 12 times likelier to use heroin, 15 times
likelier to use Ecstasy, and 21 times likelier to use cocaine, compared to
teens who do not abuse such drugs,Ó[40]
says Califano.
ÒAbout five million school-age children take a
prescription drug daily for some sort of a behavior disorderÓ according to
Carol Falkowski, director of research communications at the Hazelden
Foundation. Consequently, Òkids learn at an early age that if you take a pill,
you get a mood change.Ó
Abuse of prescription drugs is highest and rising
fastest among young people who have easy access to pills in the medicine
cabinets of parents or friends. They wrongly think ÒprescriptionÓ drugs are
safe, and stage Òpharming partiesÓ to share and experiment with their peers.
This new practice, which can often lead to early drug abuse, is becoming
rampant among middle and high school students. Pharming parties are of the
bring-you-own-pills variety. Teenagers will bring whatever pills they can get
their hands on, toss their pharmaceutical offerings into a communal bowl, grab
an assortment as if they were Skittles, and down their hand full of assorted
pills, usually with alcohol. Thus, a dangerous game of drug roulette occurs
– sometimes with fatal consequences. At other parties, teens barter with
one another for their drug of choice or to mix drugs to get a specific kind of
high. Mixing powerful prescription drugs, however, can be extremely dangerous.
A Vicodin¨-Ambien¨-Xanax¨-booze combination, for example, can do a lot more
than just put you to sleep; it can put you to sleep permanently.
Alarmingly,
many teens view pharming parties as safe, since the drugs are of pharmaceutical
quality. This is a dangerous myth that can have fatal results. Prescription
drugs can be more potent than
street drugs. ÒOne in ten 12th graders admits to using Vicodin¨ at
least once in the last year,Ó says A. Thomas McLellan, PhD, director of the
Treatment Research Institute in Philadelphia and a professor of psychiatry at
the University of Pennsylvania. ÒIf one in ten kids is using heroin, people
would go through the roof.Ó However, Òwhile heroin sold on the street might be
10 to 40 percent opiate, pharmaceutical grade Vicodin¨ could be ten times more
powerful an opiateÓ says McLellan.[41]
For
young people, the PillSafe will restrict easy access to dangerous prescription
medications, curtail their ability to stage dangerous pill-frenzy pharming
parties, and limit their ability to introduce their friends and peers to these
dangerous substances. The PillSafe will reduce the number of visits to
emergency departments of hospitals, incarceration of our youth, school drop
outs and lost futures. Most importantly, the PillSafe will save lives of our
young people.
Substance Abuse and
Older Adults and the Elderly: Our
elderly population is particularly at risk. Many have difficulty in managing
complex medication regimes. They often become confused and are accidentally
overdosed, or fail to take their medications as prescribed by their physician
and suffer unnecessary complications to their medical condition resulting in
emergency room visits or hospitalization. They sometimes intentionally fail to
follow their doctorÕs instructions and over medicate seeking relief, for
example, from chronic pain. They believe if one pill helps reduce most of the
pain, two is better because it should get rid of all the pain. This can lead to
dependency and addiction, resulting in death secondary to their prescription
drug abuse.
Substance abuse among older
adults (age 60 and older) also poses unique problems. Typically, prescription
drug abuse in older adults begins with misuse due to inappropriate prescribing
or a lack of patient compliance with medication regimens. Generally, older
adults are not trying to get high but, like the elderly, they intentionally
over medicate trying to stop the pain. Again, misuse can progress to abuse,
dependence and addiction.
Older adults and the elderly
are also more vulnerable to prescription drug abuse because of age-related
physiological changes that influence the metabolism and response to
prescription drugs. This situation indicates a greater likelihood of
undiagnosed psychiatric and medical co-morbidities. Another challenge facing
these populations and proper prescription drug usage comes from difficulties
complying with complex multiple drug regimens that may increase the likelihood
of drug interactions.
As our nationÕs baby boom
generation ages, the need to understand and reduce prescription drug abuse
becomes more urgent. The PillSafe will increase safety for the older adults and
the elderly in the management of their medication regimes, and will decrease
complications from the failure to follow their physicianÕs instructions, and
the tragic consequences of addiction or accidental overdose.
Substance
Abuse and the Homelessness:
Substance abuse and addiction are major causes of homelessness, and chemically
dependent homeless people are likely to end up institutionalized or
incarcerated adding to the burden of our prison and welfare systems. By use of
the PillSafe, the availability and street market for pills will shrink. A
reduction in availability of prescription drugs on the street will necessarily
cause a reduction in abuse and addiction by the homeless. This, in turn, will
ease the burden on our criminal justice, healthcare and social services
systems.
Substance
Abuse and Other Vulnerable Populations: Mature Women (age 59 and over) constitute another segment of the
population that struggles with prescription drug abuse. Mature women take more
prescription drugs than any sex or age group. Women are much more likely than
men to be prescribed potentially addictive drugs, and prescription drug abuse
among older women is a serious problem that often goes unrecognized by health
professionals.[42] They
are the biggest users of tranquilizers, sedatives and anti-depressants, and
they are frequent users of narcotic painkillers.[43]
In
a sample of mature adults who were abusing prescription drugs - 90 percent of
them women - more than half (56 percent) had arthritis and almost a third (30
percent) suffered chronic pain. Chronic pain also contributes to depression, a
connection that appears more often among women than men.[44]
Because other research
suggests that most adults who suffer from chronic pain are under medicated, these findings underline the importance of
careful prescribing practices by physicians to treat pain adequately without
contributing to abuse or dependence.[45]
Given a new tool like the PillSafe, physicians who may currently fear
they will incur regulatory scrutiny if they prescribe narcotic or other often
abused prescription drugs, would no longer feel compelled to deprive deserving
patients of the appropriate pain management medication they really need.
Another
vulnerable population is healthcare professionals including doctors, nurses,
dentists, pharmacists, veterinarians, all of whom are at risk because of their
ready access to prescription drugs and high levels of stress associated with
their work.[46] While
easy access to prescription drugs is the best predictor of abuse, other factors
such as frequency of administering these drugs are important indicators.[47]
The
PillSafe will benefit both of these groups by restricting access to medications
subject to abuse, dispensing only the proper dosage at correct intervals,
thereby reducing inappropriate use, dependency and potential addiction.
Substance
Abuse and Lost Productivity:
Whenever someone is unable to work or contribute positively to our economy, it
becomes Òlost productivityÓ, which is measured in a variety of ways such as
time lost, dollars lost, opportunity lost, reduction of output, and so on. In
any case, whenever an individual is away from work due to addiction,
hospitalization, institutional, or the like, our economy suffers, and the rest
of society must pay the price. Loss of productivity secondary to prescription
drug abuse is enormous (See ÒManchikanti TableÓ, infra). The PillSafe, when in use throughout the country, will stem
these losses by reducing prescription drug abuse and addiction, making our
nation more productive overall and saving our economy millions of dollars.
Substance
Abuse and Social Costs: Use of
the PillSafe for packaging dangerous prescription drugs will limit access to
these drugs and help alleviate virtually all of the other social ills
associated with prescription drug abuse, including juvenile delinquency,
domestic violence, broken homes, mental health problems, drug-driven crime and
homicide. Manpower and monetary costs required to deal with these devastating
problems will thereby be reduced.
The Effectiveness of Prevention
Recent
estimates show that states spend $81.3 billion to deal with substance abuse and
addiction. Of this amount, only 4 percent was spent on prevention and
treatment; the remainder was spent on the consequences of addiction.[48]
Shifting focus
toward effective substance abuse prevention and treatment would help to reduce
many of the problems associated with addiction and would lead to significant
reductions in the amount of state expenditures on substance abuse issues.
Addiction affects all Americans and much of the public sector, and many of the
public sector issues intersect. For example, parents held in U.S. prisons had
an estimated 1,498,800 minor children in 1999, an increase of over 500,000 from
1991.[49]
This burdens both the stateÕs correctional system and the child welfare system.
Chemically dependent inmates are in need of publicly financed health care.
Chemically dependent homeless people are likely to end up institutionalized or
incarcerated
Effective
state-level prevention and treatment programs significantly reduce the problems
associated with substance abuse. The first step is prevention, which seeks to
stop individuals from using in the first place. From a cost-benefit standpoint,
studies have shown that effective prevention programs have net benefits to
society ranging from $2.64 to nearly $20 for every $1 spent.[50]
Research from Washington shows savings from effective prevention programs
ranging from $54 up to $9,316 per individual.[51]
The RAND CorporationÕs Drug Policy Research Center estimates savings from
school-based prevention programs at $840 per student.[52]
Research also has shown that, if children avoid using illicit substances
or abusing alcohol before age 21, then they are virtually certain never to do
so.[53]
The waste and abuse of prescription drugs hurts all Americans. By simply
controlling the dosage of dangerous prescription drugs, getting the right drug
to the right person at the right time, states can cut through the complex set
of issues that involves every aspect of healthcare delivery.
The 2006 anti-drug
program of the White House Office of National Drug Control Policy focused on
expanding or improving existing campaigns for prevention, treatment and reducing supplies, a strategy that it has been showing dramatic
results. Drug abuse is down for almost all categories except prescription
drugs..[54]
How
Much Does Prescription Drug Abuse Cost Society in the United States?
The
primary cost burdens resulting from prescription drug abuse in the United
States are linked to law enforcement and court costs, incarceration, healthcare
and mental health, social services (e.g., child abuse, teen pregnancy), lost
productivity and human suffering.[55]
To date, it appears that no
comprehensive study has been undertaken to determine the actual costs of prescription
drug abuse to our society. Therefore,
setting forth the true of cost prescription drug abuse with precise accuracy is
almost impossible and it is a very difficult figure to calculate with any
degree of certainty. Moreover, disagreement exists among the experts due to
different study methods and investigator bias. However, by looking at available
information relating to separate parts of the puzzle, a reasonable basis emerges
upon which rational minds can agree. In other words, understanding many of the
smaller pieces of the puzzle allows us to see the big picture more clearly.
While no one knows for sure
the exact and direct annual costs
of controlled prescription drug diversion and abuse, numerous academic reports
and research papers shed light on key parts of the puzzle. These individual
puzzle-parts illustrate the stunning economic consequences of prescription drug
abuse and its cost to society each year.
To answer the question,
Òhow much money does prescription
drug abuse cost our society each year?Ó one must recognize there is a huge
difference between cost of Òdrug abuseÓ and that of Òprescription drug abuse.Ó It is first necessary to isolate and
identify the costs of prescription drug abuse whenever possible. For instance, one cannot rely on
statistics regarding the costs of Òdrug abuseÓ in our criminal justice system
for purposes of evaluating the potential benefits of the PillSafe. The PillSafe
will not affect the abuse of alcohol or the use cocaine, heroin, marijuana or
other illegal substances.
However, there is little
disagreement that diversion of prescription drugs into the illegal market is
increasing each year. It costs states billions of dollars annually for law
enforcement, court costs, healthcare, and social services. In fact, the DEA has
stated diversion and abuse of legitimately produced controlled pharmaceuticals
constitute a multi-billion dollar illicit market nationwide.[56]
This is a significant number and an important piece of the puzzle.
In 2001, The National
Community Pharmacists Association estimated the impact of prescription drug
abuse and misuse on U.S. healthcare costs alone to be more than $100 billion.[57]
The health problems of addiction significantly affect state healthcare budgets,
primarily the stateÕs Medicaid budget. In fiscal year 2004, states spent nearly
$86 billion of their own funds on Medicaid[58] Roughly 25 percent of state
Medicaid funding goes directly to substance abuse.[59]
The dollars spent by states and at the federal level on Medicaid as a result of
prescription substance abuse remains unclear. However, it has been estimated
that fraud, alone, contributes to a $1 billion loss annually in Medicaid
spending on prescription drugs.[60]These
costs are huge and are another significant part of the puzzle.
A third piece of the puzzle
is identified by merging the following two clues: (a) ÒWhile the true extent of
prescription drug abuse and diversion is unknown, estimates from a 2004
national survey indicate that the principle drugs of abuse for nearly 10% of
U.S. patients in treatment are a prescription drugÓ[61];
and (b) controlled prescription medications are highly
available, and the availability of these drugs is increasing each year. The
potential for abuse grows with increased availability. For instance, in 2002,
more than three billion prescriptions were filled for over 500,000 different
drugs; 234 million for controlled prescription drugs.[62]
This is also a significant number. The 234 million estimate represents
7.8% of the three billion prescriptions filled in 2002, which correlates
reasonably well with Ònearly 10%Ó number, above.
In addition, when the Drug
Abuse Warning Network (DAWN)[63]
examined the involvement of opiates and deaths related to drug misuse it found
that nearly 1.3 million emergency department visits in 2004 were associated
with drug misuse and abuse. Non-medical use of pharmaceuticals was involved in
nearly a half million of these emergency room visits. At the average cost of
outpatient treatment (in the emergency department) set at $1,300, and nearly
500,000 emergency room visits involving non-medical use of pharmaceuticals,
this category of costs amounts to $650 million annually. But, this number
assumes none of those seen in the emergency room required a hospital stay.
Assuming then, that only 10% of those seen in the emergency room required
hospitalization, at the average charge for a hospital stay set at $15,700[64],
another category of expense costing $785 million annually becomes evident.
A review of the literature
on prescription drug abuse revealed three important findings. First, illegal
diversion and abuse of prescription drugs are associated with incalculable
costs to society in terms of addiction, overdose, death, and related criminal
activities.[65] Second, prescription drug abuse is
a complex issue and there is disagreement among the experts regarding the issue
of costs. Many studies align costs directly with the abuse of prescription
drugs. Others, however, insist that a portion of direct costs is more
accurately attributed to ÒprohibitionÓ considerations.[66]
Third, despite these disagreements, both sides agree that the annual
costs of prescription drug abuse to society are Ònot an insignificant figure.Ó[67]
In any case, by
conservatively discounting the available estimates regarding the annual costs
of prescription drug abuse and accommodating the prohibition views advanced by
some experts, a process emerges by Òconnecting the dotsÓ that supports the
reality that prescription drug abuse in the United States is substantial,
costing billions of dollars every year, and that the costs, however measured,
have been skyrocketing.[68]
|
Year |
Healthcare Costs |
Productivity Losses |
Other |
Total |
|
1992 |
10,820 |
69,421 |
21,912 |
102,153 |
|
1994 |
11,279 |
82,685 |
24,440 |
118,404 |
|
1996 |
11,428 |
92,423 |
27,444 |
131,295 |
|
1998 |
12,862 |
98,467 |
32,083 |
143,412 |
|
2000 |
14,899 |
110,491 |
35,274 |
160,664 * |
The following
table (the ÒManchikanti TableÓ) shows costs from 1992 to 2000 (expressed in
millions of dollars).[69]
Perhaps the true extent and
cost of prescription drug diversion and abuse may remain unknown. But,
conservative estimates of objectively reported Ôpuzzle-partsÕ sheds credible
light upon the actual nature of the growing tragedy of prescription drug abuse,
and the staggering costs it exacts upon society every year in the United
States.
How Much Will the PillSafe Save Society Annually?
*Three main cost categories (healthcare costs, productivity losses, other costs)
are reported for year 2000, totaling $160,664,000,000. ($1,000,000 X 160,644 =
$160,664,000,000, more than $160 billion dollars for year 2000.)
Once the costs to society
were reasonably determined, three percentage estimates of how much the PillSafe will save society
each year were selected for purposes of illustration.
á
5% (Very conservative);
á
10% (Perhaps most
reasonable and accurate);
á
25% (PresidentÕs
Strategy for National Drug Control)70