Joint Subcommittee to Investigate Illegal Use of Ritalin and OxyContin and to Study ADD and ADHD
October 30, 2001, Richmond
Ritalin Diversion and Abuse
Topics addressed, in response to a variety of committee inquiries from the previous meeting, included plans for additional guidance to schools regarding required reporting of irregularities or thefts in the management and administration of student medications; diagnostic and evaluation processes; demographic data regarding students with ADHD in the public schools; data regarding the ages of students most likely to be threatened for their Ritalin; and the number of private school students with ADHD who transfer to public schools.
In response to a Department of Education survey conducted in September 2001 regarding numbers of students receiving medication at school for ADHD, 129 school divisions, representing 94.5 percent of Virginia's public school population and a 95.5 percent survey response rate, indicated that 16,521 studentsor 1.52 percent of the student populationreceived ADHD medication at school in 2000-2001 (see Table 1). Of these students, 55 percent receive Ritalin and 45 percent receive other ADHD medication. These numbers are not indicative of the numbers of public school children with ADHD, as some children may not be receiving medication or may be taking medication at home.
Department of Education Survey, September 2001.
While the survey indicated that children throughout grades K-12 receive ADHD medication at school, grades four and five had the highest rates. The lowest rates were in kindergarten and in grade 12. Boys comprised 76 percent of students receiving ADHD medication at school, and students with disabilities accounted for 59 percent of pupils receiving ADHD medication at school. The survey found no significant statistical differences among racial/ethnic groups receiving ADHD medication at school.
There is little additional demographic data regarding the numbers of children with ADHD in public schools. Students with ADHD may be eligible for special education services as "Other Health Impaired," a category that encompasses an array of conditions. In addition, there is no data regarding students with ADHD transferring from private to public schools.
Ritalin Use and ADHD
In responding to previous joint subcommittee inquiries, representatives of Novartis Pharmaceuticals Corporation, manufacturer of Ritalin, addressed the use of Ritalin in other countries, pilot Ritalin studies providing compensation for participation, Ritalin patent information, and primary sources for Ritalin abuse and diversion.
A neurobiologic disorder, ADHD is the most studied childhood psychiatric disorder. It interferes with the individual's ability to "regulate activity level and behavior, and sustain focus in developmentally appropriate ways." Affecting three to five percent of school-age children, ADHD is related to disturbances in certain neurotransmitters in the brain. The condition is best treated through a combination of educational, psychosocial, and pharmacotherapeutic interventions.
That the condition may affect academic and other achievement has been documented in recent years. According to a 1993 study, boys with ADHD achieved "significantly lower social class rankings, completed 2.5 years less schooling and had lower occupational rankings." One-third of the boys studied were diagnosed with a mental disorder at adult follow-upmost commonly antisocial personality or substance abuse. Treatment of the disorder is critical: a 1999 study indicated that children with ADHD who received treatment were at an 85 percent lower risk of substance abuse than those untreated children.
New guidelines have been issued by the American Academy of Pediatrics (AAP) to assist primary care physicians in diagnosing ADHD in children aged six to 12. The primary care clinician should initiate the ADHD evaluation for children exhibiting signs of academic underachievement, difficult family and school relationships, and other behavioral problems. In addition, the AAP recommends using the diagnostic guidelines set forth in the DSM-IV, requiring that ADHD symptoms be manifested in two settings and that these symptoms negatively affect "academic or social functioning for at least six months." An assessment of ADHD should also "include information obtained directly from parents or caregivers, as well as a classroom teacher or other school professional, regarding the core symptoms of ADHD in various settings, the age of onset, duration of symptoms and degree of functional impairment." Positive reinforcement, time-out, response cost (withdrawing rewards or privileges for undesirable behavior), and token economy (earning "tokens" for rewards for good behaviors) were cited as effective behavioral techniques for students with ADHD.
The subcommittee was urged to support:
A brand name for methylphenidate hydrochloride, Ritalin is one of many medications used to treat ADHD. The drug is a "mild central nervous system stimulant for the treatment of ADHD as well as narcolepsy." Methylphenidate is also produced as Concerta, Metadate, Methylin, and several generics. Amphetamines such as Adderall, Dexedrine, and other generics may treat the disorder, as well as Cylert and certain antidepressants.
Ritalin blocks the re-uptake of dopamine and norepinephrine, the neurotransmitters believed linked to ADHD. The medication has been used for 45 years and has been shown to be effective in 70 to 90 percent of children. Off-patent since 1964, Ritalin is the most extensively researched treatment for ADHD, with more than 200 studies of the drug having been completed, addressing more than 6,000 children. The medication is no longer the leading prescription for the treatment of ADHD, but rather comprises 10 percent of the analeptic market and 20 percent of the methylphenidate market.
Novartis has not participated in a direct-to-consumer advertising campaign for Ritalin. In addition, Novartis does not support payment to individuals participating in clinical trials. Patient benefits for participation may, however, include a comprehensive medical evaluation and free treatment as well as a high level of personal attention and monitoring. Nominal reimbursement may sometimes be provided for travel and time.
Increased treatment of ADHD in the last decade has been attributed to increased awareness of the condition, better diagnostic criteria and treatment guidelines, more diagnoses among adults and girls, and increased compliance with one-a-day treatments. A 1996 study indicated that students typically remain on methylphenidate into mid- and later secondary school grades. A 1998 study released by the Journal of the American Medical Association indicated "little evidence" of over-diagnosis or prescribing for ADHD; corroborating this finding was a 1999 report of the New England Journal of Medicine, indicating that ADHD may be "under-treated." The U.S. Surgeon General's National Action Agenda, released in early 2001, estimated that fewer than one in five children receive the treatment needed for mental illness (including ADHD).
To reduce Ritalin diversion and abuse, Novartis reconciles batch yields and conducts annual inventories. Cameras, sealed trucks, and full-time controlled substance officers are also used. The development of new one-a-day treatments will reduce the need for mid-day dosing at school, and educational programs targeting youths, such as Be SMART (Safe Medication And Responsible Treatment) and the 3 R's of RitalinRead, Respect, Responsibilitywere designed to reduce abuse and diversion.
The Drug Enforcement Administration (DEA) reports that youths abusing stimulant medications typically purchase, receive freely, or steal the drugs from youths for whom it has been appropriately prescribed. In October 2001, the Canadian Medical Association Journal reported that a small percentage of students gave away or sold their medication or were robbed or experienced coercion for it. The General Accounting Office reported in September 2001 that only eight percent of public middle and high school principals indicated knowledge of ADHD medication diversion or abuse at school.
The year 2000 witnessed the filing of five class action lawsuits against Novartis in California, Texas, Florida, Puerto Rico, and New Jersey. Four have been dismissed, and another motion to dismiss is pending in New Jersey.
ADHD Diagnoses in Southeast Virginia
Virginia ranks in the highest quartile in the nation for Ritalin prescription; within the Commonwealth, higher concentrations are seen in Tidewater, Richmond, and Northern Virginia. The Center for Pediatric Research has examined Portsmouth and Virginia Beach students receiving Ritalin in public school. The center's study indicates that eight to 10 percent of elementary school students in these divisions are getting Ritalin at schoola rate two to three times higher than national estimates. Black girls are least likely to be diagnosed and treated, and white boys are most likely to be diagnosed and treated.
Evidencing possible premature diagnoses is the fact that more than half of students were diagnosed by the first grade, and 28 percent of the Portsmouth and Virginia Beach elementary school students receive two or more psychotropic drugs. Also cited were the efforts of the School Health Initiative for Education (SHINE) in facilitating understanding of ADHD issues in Southeastern Virginia. A statewide epidemiological study was recommended, to be conducted by researchers with public health expertise to examine Ritalin use and ADHD diagnosis in the Commonwealth.
A professor of psychology at Longwood College noted that there are no diagnostic or laboratory tests for ADHD. Questioning whether ADHD is "a disease of the body or modern society," he cited concerns regarding addiction and possible as well as unknown short- and long-term side effects of psychotropic medications addressing ADHD. Studies have indicated that Cylert, used to manage ADHD, may suppress growth hormones and adversely affect the liver. He noted the Lovaas behavioral intervention method, and also described the success of the Caregivers Skills Program, which also uses behavior modification in handling noncompliance, oppositionalism, and temper tantrums. He concluded by stating that he is "not convinced" that there is a physical component to ADHD.
Statutory prescriptive authority is required to write a prescription. Professions licensed by the Board of Medicine and having prescriptive authority include doctors of medicine and surgery, doctors of osteopathy and surgery, doctors of podiatry, and physician assistants. Nurse practitioners, regulated by the Boards of Nursing and Medicine, also possess prescriptive authority. Dentists, veterinarians, and some optometrists also have this authority. Prescriptive authority is not unfettered among these professionals: nurse practitioners and physician assistants, for example, cannot prescribe Schedule II drugs, such as Ritalin and OxyContin. Only doctors of medicine, osteopathy, and podiatry, dentists, and veterinarians may prescribe Schedule II drugs.
Statutes govern prescribing procedures, requiring a bona fide practitioner-patient relationship and setting forth prescription formats. Statutes and regulations address unprofessional conduct. Prescriptions for Schedule II drugs cannot be refilled; rather, a new prescription must be obtained. These prescriptions cannot be filled more than six months beyond the date of issue. Partial filling is permissible only if a full supply is not available; further filling may occur upon the passage of 72 hours and the issuance of a new prescription. Pharmacists may dispense a small amount of a Schedule II in an emergency, upon the practitioner's oral authorization. A written prescription must be provided in seven days.
The Board of Medicine receives complaints about its licensees, some involving excessive or inappropriate prescribing practices. Ritalin and OxyContin have been named in such complaints, typically in combination with other medications. In addition to criminal penalties, professionals abusing prescriptive authority may also be subject to license revocation.
Abuse in Virginia Colleges and Universities
Discussing whether "the use of Ritalin or OxyContin for non-medical purposes is a problem among school-aged children and college students in the Commonwealth" (Study Directive xiii), the student affairs director of the State Council of Higher Education for Virginia (SCHEV) noted the experimentation and exploration that often marks adolescence. Citing increasing alcohol and drug arrests among college students and increased tobacco smoking on campuses, she also noted the mixing of prescription drugs with alcohol. Increased diagnoses of anxiety, depression, and ADHD among college students potentially bring more antidepressants and other medications to campuses.
While data regarding abuse is largely anecdotal, one study has indicated that 13 percent of students have used Ritalin without a prescription. While Ritalin and OxyContin abuse do not appear to be a problem at Virginia institutions of higher education, continued drug education and appropriate interventions are necessary to reduce high-risk behaviors. Two recent deaths on Virginia college campuses were attributed to a dangerous mix of drugs and alcohol. Briefly cited was the federal Campus Security Act, which will address issues concerning substance abuse and confidential treatment.
Investigations of pharmaceutical drug diversion may involve health professionals, "doctor shoppers," forgeries and altered prescriptions, and bogus "call-ins." The State Police Drug Diversion Unit makes one arrest every 2.1 days. Popularly diverted Schedule II drugs include methylphenidate (Ritalin), certain amphetamines, OxyCodone (OxyContin) and other analgesics. Southwest Virginia's serious OxyContin diversion and abuse concerns were cited, as was the need for funding for additional law-enforcement personnel. Identified as key components of abuse prevention were education of health professionals, patients, and communities; public awareness and support for accessible addiction treatment; and law enforcement.
OxyContin Diversion and Abuse
Oxycodone, contained in OxyContin, is an oral opioid painkiller that has better bioavailabilitya better absorption rate in the bodythan morphine. In treating pain, physicians strive to prescribe the minimum effective analgesic concentration (MEAC) for the patient, to ensure a sustained level of pain reliever in the bloodstream. The MEAC is influenced by the drug itself, the patient, and the pain intensity.
In addressing the potential diversion and abuse of OxyContin, Purdue Pharma, manufacturer of OxyContin, has developed non-promotional continuing medical education programs addressing pain assessment and treatment. Drug abuse and diversion information has been disseminated to 500,000 physicians and 60,000 pharmacists; drug education and prevention programs target youth. In addition, Purdue Pharma is involved in a study of prescription monitoring programs and is also coordinating with state Attorneys General. Tamper-resistant prescription pads have also been developed; an "Rx," printed on the reverse of each sheet, "disappears" when rubbed briskly. The word "VOID" will appear on photocopied or scanned sheets.
Abuse-resistant medications are also being explored, but the addition of any abuse antagonists to opioid medications should not interfere with drug efficacy and should be designed to block all routes of abuse. The antagonists should not prompt withdrawal symptoms in patients legitimately taking the medication, must be stable in preparation, and, ultimately, approvable by the Food and Drug Administration.
Committee discussion focused on "doctor shopping," the chilling effect of OxyContin abuse on legitimate prescribing of the medication, and the insufficient availability of methadone treatment centers for opioid abusers. The unique geographic distribution of OxyContin abuseMaine, Southwest Virginia, and Kentuckywas attributed to high rates of poverty, higher concentrations of persons on Medicaid, and use by persons with prior history of drug abuse.