|
|
Statement by: Terrance
Woodworth Before the: Committee
on Education and the Workforce: Subcommittee on Early Childhood, Youth
and Families Date: May 16, 2000
Note: This document may not reflect changes made in actual delivery.
Mr. Chairman, distinguished members of the Subcommittee: I want to thank you for the opportunity to address you today on behalf of the Drug Enforcement Administration (DEA) Acting Administrator, Donnie Marshall. The DEA is the agency responsible for the regulation and control of substances with abuse potential that are subject to the Controlled Substances Act (CSA). In this regard, the DEA provides for the production of sufficient material to meet the legitimate need for controlled substances, but at the same time, minimizes the amount of these substances available for diversion. In striving to maintain this balance, the DEA has made every effort to keep the health and safety of our young people uppermost in our mind. Of the many psychoactive substances prescribed to young children in the United States, only two controlled substances are widely utilized by American physicians to treat children: methylphenidate (commonly known as Ritalin®) and amphetamine (primarily Adderall® and Dexedrine®). Both are approved and used in the treatment of attention deficit (hyperactivity) disorder referred to as ADHD or ADD. Both of these substances are powerful stimulants that have been in Schedule II of the CSA since 1971. Schedule II of the CSA contains those substances that have the highest abuse potential and dependence profile of all drugs that have medical utility. In 1995, in response to a petition by Children and Adults With Attention Deficit Disorder (CH.A.D.D.) and the American Academy of Neurology to lower the regulatory controls on methylphenidate, the DEA conducted an extensive review of the use, abuse liability, actual abuse, diversion, and trafficking of methylphenidate. The CH.A.D.D. petition characterized methylphenidate as a mild stimulant with little abuse potential - this is not what our review found and the petitioners subsequently withdrew their petition. In December 1996, the DEA held a conference on "Stimulant Use in the Treatment of ADHD". We gathered experts in the fields of ADHD research and treatment, psychiatry, social work, ethics and law enforcement who offered their expertise and unique perspectives to the many controversial topics related to ADHD and its treatment. In addition, the DEA participated in the 1998 National Institutes of Health (NIH) Consensus Conference. In 1998 and 1999, the DEA was invited to the Council of Europe to participate in joint meetings with the Pompidou Group and the International Narcotics Control Board (INCB) to discuss the control of stimulants in Europe and the diagnosis and treatment of ADHD with stimulants. Today, I will present a summary of the data we have gathered about the use of Ritalin and like drugs. These data show:
Production, Distribution and Prescription Data: The DEA has observed a dramatic increase in the production and use of both methylphenidate and amphetamine. Each year, the DEA establishes an aggregate production quota (APQ) for each Schedule I and II controlled substance. This quota is based on sales and inventory data supplied by the manufacturers as well as information supplied by the Food and Drug Administration (FDA) regarding legitimate medical and research needs. The methylphenidate quota has increased from 1,768 kilograms in 1990 at which time there were two bulk manufacturers and four dosage-form manufacturers. This year, the APQ is 14, 957 kilograms with six bulk manufacturers and 19 dosage form manufacturers. Prior to 1991, domestic sales reported by the manufacturers of methylphenidate remained stable at approximately 2,000 kilograms per year. By 1999, domestic sales increased by nearly 500 percent. The amphetamine APQ has increased from 417 kilograms in 1990 with two bulk manufacturers and seven dosage form manufacturers. This year's amphetamine APQ is 9,007 kilograms with six bulk manufacturers and 19 dosage form manufacturers. This is more than a 2,000 percent increase for amphetamine in nine years (See Figure 1). The increases in production and use of methylphenidate are even more striking when compared to worldwide data (Figure 2). According to the United Nations, the U.S. produces and consumes about 85 percent of the world's production of methylphenidate (INCB Report, 1999).
IMS Health (a national prescription auditing firm) has provided the DEA with prescription data for amphetamine and methylphenidate. The vast majority of all prescriptions for amphetamine and methylphenidate (about 80 percent) are written for children diagnosed with ADHD. After sharp increases in the use of methylphenidate in the early 1990s, methylphenidate prescriptions have leveled off at about 11 million per year for the past four years. However, amphetamine prescriptions (primarily Adderall®) have increased dramatically since 1996: from about 1.3 million to nearly six million (see Figure 3). Collectively, this data indicates that the number of prescriptions written for ADHD has increased by a factor of five since 1991. Figure
3. Amphetamine and Methylphenidate Prescriptions
More than 50 percent of all amphetamine and methylphenidate prescriptions are written by pediatricians. In addition, boys are four times more likely to receive a diagnosis of ADHD and be prescribed stimulant medication. In 1998, IMS estimated that about 40 percent of all prescriptions for ADHD were written for children three to nine years of age and 4,000 methylphenidate prescriptions were written for children two years of age or less. It should be noted that methylphenidate is not approved for use in children under six years of age because safety and efficacy have not been established. The DEA has a system known as ARCOS (Automation of Reports and Consolidated Orders System) that tracks Schedule II controlled substances from point of manufacture to a location where it will ultimately be distributed to the consumer. This system can be utilized to determine the amount of methylphenidate and amphetamine used in various localities. Analyzed on a per capita basis in entire states or by zip code areas within a state, ARCOS data indicates that there is wide variability in the use of methylphenidate and amphetamine from one state to another and from one community to another within the states. This variability are noted in a number of data sources and suggests both under and over-identification of ADHD. Most experts claim that the true prevalence of ADHD in the U.S. is about three to five percent. However, ARCOS data, prescription data and epidemiological studies have identified areas with almost no use of methylphenidate and communities with 10 to 20 percent or more of the student population receiving stimulants for ADHD treatment. The 1999 ranking for the states with the highest use of methylphenidate and amphetamine per 100,000 population are listed in Table 1. Table
1. 1999 Methylphenidate and Amphetamine Distribution: Top Ten Users
1999
Methylphenidate U.S. average = 3,082 grams per 100,000 population California and Hawaii have the lowest per capita use of methylphenidate (1,748 and 1,208 grams per 100K, respectively) and New York and Hawaii have the lowest use for amphetamine (509 and 305 grams per 100K, respectively). A graphic representation of this data is seen in the figures below.
Abuse Liability Extensive scientific literature spanning over 30 years of research unequivocally indicates that both methylphenidate and amphetamine have high abuse liabilities:
In more simplistic terms, this data means that neither animals nor humans can tell the difference between cocaine, amphetamine, or methylphenidate when they are administered the same way at comparable doses. In short, they produce effects that are nearly identical. Actual Abuse A significant body of literature is available that describes the actual abuse of methylphenidate and consequences associated with that abuse. Like amphetamine and cocaine, abuse of methylphenidate can lead to marked tolerance and psychic dependence. Methylphenidate can be abused orally or tablets can be crushed and snorted or dissolved in water and injected. The pattern of abuse is characterized by escalation in dose, frequent episodes of binge use followed by severe depression and an overpowering desire to continue the use of this drug despite serious adverse medical and social consequences. Typical of other central nervous system stimulants, high doses of methylphenidate often produce agitation, tremors, euphoria, tachycardia, palpitations, and hypertension. Psychotic episodes, paranoid delusions, hallucinations, and bizarre behavioral characteristics similar to amphetamine-like stimulant toxicity have been associated with methylphenidate abuse. Severe medical consequences, including death, have been reported. Although the majority of the cases cited in the literature pertain to adults, case studies have profiled adolescents who abused their prescribed methylphenidate medication. This body of literature indicates that the improper use of methylphenidate can pose a serious risk for the user. Unlike amphetamine, methamphetamine and cocaine where illicit manufacturing accounts for the vast availability of these drugs for abuse, pharmaceutical products diverted from legitimate channels are the only sources of methylphenidate available for abuse. Diversion of methylphenidate has been identified by drug thefts, illegal sales, prescription forgery, and various scams involving doctor shopping. From January 1990 to May 1995, methylphenidate ranked in the top ten most frequently reported controlled drugs stolen from registrants. From January 1996 to December 1997, about 700,000 dosage units of methylphenidate were reported to our drug theft database. In 1998 there were 376 reported thefts from pharmacies. Night break-in, armed robbery, and employee theft are the three major sources of this diverted methylphenidate. In addition, the DEA has received a significant number of reports of methylphenidate theft at unregistered locations, primarily at schools and homes where methylphenidate supplies are kept. It is important to note that many schools have more methylphenidate on hand for student daytime dosing than is available in some pharmacies. While State and Federal laws require accountability of controlled substances by licensed handlers, no such requirements are imposed at schools. The manner in which medication is handled at schools has provided an opportunity for some individuals to divert and abuse this medication. For example, a highly respected teacher was videotaped stealing methylphenidate from the nurse's office the evening of an awards ceremony that was honoring him as "teacher of the year." In another incident, a school nurse who was responsible for safeguarding student medications, stole the children's methylphenidate for her own use. In a school that required students to provide a doctor's prescription for proof of medication need, the principal was discovered taking the methylphenidate prescriptions, forging his name and filling them in pharmacies throughout the state for his own personal use. Students have been discovered taking medication from a teacher's desk where medication was being stored. A student who left home with a month's supply of medication, arrived at school with only six tablets having distributed the others to friends on the bus on the way to school. Schools have been broken into and medication supplies have been taken. In some of these reports, the school had no idea exactly how much or whose medication was taken. It is not at all surprising that these types of activities could occur. A 1996 DEA sampling of practices employed by schools for the handling of medication indicated that most schools did not have a nurse dispensing medication. Frequently supplies were kept in unlocked desks and a variety of people were tasked with giving medication to the students: school secretaries, parent aides, teachers and, in one school, the janitor was given that responsibility. Few schools kept records of drugs. At any given time, many schools may have no idea how much medication they should have. Although most schools had regulations prohibiting students from having drugs in their possession, many junior and senior high school students carried or administered their own medication. Methylphenidate is sought after by a wide range of individuals. Information from DEA case files and State investigative services indicate that methylphenidate has been involved in criminal drug trafficking activities including:
In addition, numerous states have reported "Attention Deficit Scams" (a parent or other adult who takes a child who purportedly has ADHD to a number of physicians to obtain methylphenidate prescriptions- the adult obtains the drug for their own use or to sell or trade for other drugs). The magnitude and significance of methylphenidate diversion and trafficking is comparable to pharmaceutical drugs of similar abuse potential and availability (like morphine sulfate). There is little doubt that Schedule II controls and the lack of clandestine production have limited the illegal use of this drug. However, reports of methylphenidate misuse/abuse among adolescents and young adults is particularly disturbing since this is the group that has the greatest access to this drug. Adolescents don't have to rob a pharmacy, forge a prescription or visit the local drug dealer to acquire methylphenidate - they have little difficulty obtaining it from a friend or classmate at school. Reports from numerous states and local municipalities indicate that:
The extent to which adolescents are abusing methylphenidate is unknown. The following data suggests that the number is small and has increased with the availability of this drug. In 1994, the national high school survey (Monitoring the Future) reported that about one percent of all seniors in the U.S. used Ritalin in the previous year without a doctor's order. In 1999, that percentage increased to about three. In 1990, there were 271 estimated emergency room mentions for methylphenidate in DAWN (Drug Abuse Warning Network). In 1998, there were 1,727 mentions for methylphenidate in DAWN of which about 56 percent were for ages 10-17. A 1996 DEA survey of three states (Wisconsin, South Carolina and Indiana) found that about 30 to 50 percent of adolescents in treatment centers were reporting "non-medical" use of methylphenidate although it was not identified as their primary drug of abuse. A 1998 Indiana University survey of 44,232 students found that nearly seven percent of high school students surveyed reported using Ritalin illicitly at least once and 2.5 percent reported using it monthly or more often. Anecdotal reports relating to the illicit use of methylphenidate among children continue to be reported to DEA on a daily basis. In conclusion, amphetamine and methylphenidate can significantly improve the symptoms of ADHD when these mediations are appropriately prescribed and used. However, the inappropriate use of these stimulants carries significant risks. The data show that methylphenidate has a high abuse potential. It is associated with diversion and trafficking and is abused for its psychic effects. The extent of these activities is similar to other pharmaceutical Schedule II substances. However, unlike other Schedule II drugs, methylphenidate is primarily prescribed to children. Information from physicians, parents, schools, poison control centers, adolescent treatment centers, surveys, and law enforcement data, suggest that adolescents who are using this drug illicitly obtain it from individuals that have been prescribed this drug for ADHD. Probably the single most disturbing trend is that adolescents do not view abuse of this drug as serious. The DEA continues to urge the proactive effort of many groups including physicians, parents, school officials, and law enforcement to evaluate the use of these drugs in their communities. Continued increases in the medical prescription of these drugs without the appropriate safeguards to ensure medication compliance and accountability can only lead to increased stimulant abuse among U.S. children. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
