Prescription Drug Abuse

1. Prescription Drug Abuse UCSF SBIRT Collaborative Education ProjectElinore McCance-Katz MD, PhD

2. Learning Objectives Describe the high prevalence of prescription drug misuse and associated etiologic and social factors. Illustrate the wide distribution of opioid receptors in the brain and link the use of opioids to increased vulnerability to addiction for some individuals. Explain the clinician’s obligation to treat chronic pain, while identifying and treating addiction should it occur. Apply best practices in the treatment of chronic pain with opioids. List warning signs of opioid misuse and discuss how a clinician might respond. Identify and apply therapeutic options should a substance use disorder be identified.

3. What Prescriptions Drugs Get Abused? Principally opioids (main focus of this module) Most common: hydrocodone (Vicodin), oxycodone (Oxycontin): relief of pain Anxiolytics: benzodiazepines (Xanax, Valium), barbiturates (butalbital, Fiorecet): reduce anxiety, insomnia Stimulants: amphetamine (Adderall), methylphenidate (Ritalin): attention deficit disorder, narcolepsy

4. Epidemiology of Prescription Drug Misuse and Abuse • In 2006, approximately 7.0 million persons were current users of psychotherapeutic drugs taken nonmedically (2.8 percent of the U.S. population). This class of drugs is broadly described as those targeting the central nervous system, including drugs used to treat psychiatric disorders (NSDUH, 2007). • Pain relievers - 5.2 million • Tranquilizers - 1.8 million • Stimulants - 1.2 million • Sedatives - 0.4 million.

5. Epidemiology of Prescription Drug Misuse and Abuse • It is generally believed that the broad availability of prescription drugs (e.g., via the medicine cabinet, the Internet, and physicians) and misperceptions about their safety make prescription medications particularly prone to abuse. • Among those who abuse prescription drugs, high rates of other risky behaviors, including abuse of other drugs and alcohol, have also been reported (another good reason to be doing urine tox screens in your clinic (see Mod 9). • Most commonly abused classes of prescription drugs • Opioids, such as OxyContin and Vicodin, which are most often prescribed to treat pain; • Central nervous system (CNS) depressants, such as Valium and Xanax, which are used to treat anxiety and sleep disorders; and • Stimulants, which are prescribed to treat certain sleep disorders and attention deficit hyperactivity disorder (ADHD), and include drugs such as Ritalin and Adderall.

6. If You Decide that Opioid Therapy for Chronic Nonmalignant Pain is Indicated for Your Patient Consider use of the California Prescription Monitoring Program to check history of patient’s prescriptions for controlled substances (http://ag.ca.gov/bne/cures.php) In order to obtain access to the PDMP system Prescribers and Pharmacists must first register with CURES by submitting an application form electronically at https://pmp.doj.ca.gov/pmpreg/. In addition, your registration must be followed up with a signed copy of your application and notarized copies of your validating documentation which includes: Drug Enforcement Administration Registration, State Medical License or State Pharmacy License, and a government issued identification. You can mail your application and notarized documents to: Bureau of Narcotic Enforcement (BNE) Attn: PDMP Registration P.O. Box 160447 Sacramento, CA 95816 To obtain a CURES report complete form available at: http://ag.ca.gov/bne/pdfs/BNE1176.pdf

7. If You Decide that Opioid Therapy for Chronic Nonmalignant Pain is Indicated for Your Patient Have a Treatment Plan/Informed Consent (documentation of risk/benefit) on the chart (DGIM has a Treatment Agreement that can be used) Treatment Agreement (use for those at high risk for abuse/addiction) One physician/one pharmacy UDS when requested Agreement to return for pill count when asked to do so Medication Levels Number/frequency of all refills Reason for discontinuation (violation of agreement, misuse of medication, abuse of other substances)

8. Informed Consent SPECIFIC RISKS OF THE TREATMENT (long-term opioid use): • Side effects (short and long term) • Physical dependence, tolerance • Risk of drug interactions or combinations (respiratory depression) • Risk of unintentional or intentional misuse (abuse, addiction, death) • Legal responsibilities (disposing, sharing, selling) Paterick et al., 2008

9. If You Decide that Opioid Therapy for Chronic Nonmalignant Pain is Indicated for Your Patient Check urine drug screen initially and periodically to show: Illicit drug use highly correlated with opioid abuse/addiction Confirm use of the drug you’re prescribing POS tests may be less sensitive, but quick answer If patient disputes result/becomes angry/defensive: send to lab for UDS with GC/MS confirmation (more expensive and will take longer, but most accurate (‘gold standard’)

10. If You Decide that Opioid Therapy for Chronic Nonmalignant Pain is Indicated for Your Patient Pill counts should be part of management Should be done by licensed personnel only May be most useful early in treatment and can be combined with urine toxicology at a nursing or pharmacist visit (no MD visit needed)

11. If You Decide that Opioid Therapy for Chronic Nonmalignant Pain is Indicated for Your Patient Periodic review: Evidence of analgesia Treat side effects Enhanced social/employment functioning Overall improved quality of life Family assessment Unsatisfactory: review other options You can always get a consultation: Pain specialists Psychiatrist (co-occurring mental illness is common) Addiction specialist

12. Risks/Concerns of Chronic Opioid Therapy • “Causing Addiction” in persons without abuse or dependence history with opioids • “Feeding” an existing addiction • Causing a relapse in a patient in stable remission • Diversion of medication by a patient with or without pain None of these risks are adequately quantified for any patient population, but they are not negligible

13. Identification of Prescription Opioid Abusers Deterioration in home/work Resistance to changes in therapy Use of drug by injection or nasal route Early refills Lost/stolen prescriptions Doctor shopping Prescription forgery Abuse of other substances Frequent ED visits Unauthorized dose increases Nonmedical use Refuses UDS/referral to specialist

14. Approaching Patient with Aberrant Medication-Taking Behavior • Take non-judgmental stance • Use open-ended questions • State your concerns about the behavior • Examine the patient for signs of flexibility • Is the patient more focused on specific opioid or pain relief? • Approach as if they have a relative contraindication to controlled drugs (if not absolute contraindication) • Take pressure off yourself by referring to clinic policies Passik & Kirsh, 2005

15. What to do if Your Patient Develops a Substance Use Disorder with Prescribed Opioids Therapeutic Options: Combination of medication treatment plus psychosocial/psychotherapeutic interventions: Inpatient (usually detoxification; short term pharmacotherapy) followed by: Residential Intensive outpatient Individual/Group Drug Counseling +/- Maintenance pharmacotherapy Know the options in your community

16. Treatment for Opioid Dependence Pharmacotherapy Options (following medical withdrawal) Antagonist Treatment (naltrexone) Opioid Assisted Therapy Methadone Buprenorphine Psychotherapies (motivational interviewing, Relapse Prevention, educational groups, substance abuse group therapy; individual drug counseling, 12-Step)

17. Medical Withdrawal: Should not be Used Alone Use of medications to gradually reduce physical dependence Taper off of opioids High relapse rate without ongoing treatment (>90% within 1 year)

18. Maintenance Medications Antagonist treatment: Naltrexone 50 mg/d (oral) Blocks opiate agonist effects Infrequently used: Physician lack of knowledge of treatment Poor acceptance by patients Has been shown to be effective in motivated groups (health care professionals, those in criminal justice system) Formulations: tablet, once a month injectable (alcohol indication currently) Could be difficult to implement if patient has a pain syndrome, but could be considered if other analgesic interventions were provided

19. Maintenance Medications Methadone Most widely utilized pharmacotherapy for opioid dependence Schedule II drug Specialized treatment programs must be used if patient has opioid addiction Restricted numbers of take-home doses Induces tolerance to acute dose of opioid Does not induce full tolerance to all opioid effects (e.g. sedation at peak plasma concentration) Reduced crime, increased employment, improved health, decreased risk related to diseases common to drug users (HIV, Hep C)

20. Maintenance Medications Buprenorphine Opioid partial agonist Lower abuse liability Schedule III Available by prescription Waiver needed for physician to be able to prescribe Only CSAT/DEA waivered physicians can prescribe (no PAs, NPs) Allows for office-based treatment of opioid dependence

21. Clinical Expectations for Chronic Opioids • Pts on chronic opioids with suspected/ high risk of misuse should be on DGIM pain agreement • All exam rooms should contain the following in the bottom forms drawer: • Pain Agreements (requires pt signature) • General Patient Information Sheets for Opioids • For more detail, precepting rooms contain: • General Medicine Opioid Policies • General Opioid Prescribing Guidelines

22. Case Study Ms. B. is a 43 y.o. woman recently moved to the Bay area who presents with a complaint of knee pain resulting from a MVA 10 yrs ago and pain in her joints. Physical examination is unremarkable. She brings a record from an evaluation she had at a pain treatment center several months ago which recommended methadone treatment. You prescribe methadone 10 mg TID, but she returns complaining that her pain continues. Gradually her dose increases to 80 mg daily, she still requests more methadone. You decide to check the California Prescription Monitoring Program and find that you are one of 3 doctors prescribing methadone and that her daily dose appears to be 260 mg. On query she admits that she is seeing multiple physicians, but insists that her pain is intolerable if she doesn’t have all of this medication. What should you do?

23. Case Study The patient shows signs of methadone addiction. She is requesting increasing methadone for relatively minor complaints that cannot be verified with objective data, there is evidence that she is doctor shopping, her total daily dose of methadone is very high, but you note that she does not appear intoxicated indicating high tolerance for the drug. Because of the high dose of methadone, it would be very difficult to taper the methadone in the primary care clinic. The patient would best be served by referral to a methadone maintenance program. In such a program she can be treated for her opioid addiction; this would include either maintenance or gradual taper. She is also not a candidate for buprenorphine because her dose of methadone is too high to convert (she must be on <40 mg methadone daily to be changed to buprenorphine).

24. Conclusions Prescription narcotic abuse and associated addiction increasing Consider non-opioid treatment options for chronic pain If chronic opioids are to be used: Treatment Agreement/Informed Consent Good documentation of treatment plan and responses Get releases at outset for other treatment providers, family member(s) important to therapy Know the options for referral in your community Effective pharmacotherapies and psychotherapies available for substance use disorders Some available treatments make it possible to treat medical/mental disorders and opioid dependence (i.e.: buprenorphine)

25. References • Monitoring the Future, 2007. • 2005 & 2006 National Survey on Drug Use and Health: National Findings,” SAMHSA, September 2006 & 2007. • Office of National Drug Control Policy (ONDCP) www.ondcp.gov • Maxwell, J.C. 2006. Trends in the abuse of prescription drugs. Gulf Coast Addiction Technology Transfer Center, 1-14. • Paulozzi, L.J., Budnitz, D.S., Xi, Y, 2006. Increasing deaths from opioid analgesics in the United States. Pharmacoedidemiology and Drug Safety 15, 613-7. • Fishbain DA, Rosomoff HL, Rosomoff RS: Drug abuse, dependence, and addiction in chronic pain patients. Clin J Pain. 1992; 8:77-85. • Balantyne JC, Mao, J. Opioid therapy for chronic pain. N Engl J Med, 2003; 349:1943-53. • Gourlay D, Heit H. Universal Precautions in Pain Medicine: The treatment of chronic pain with or without the disease of addiction. Medscape Neurology and Neurosurgery. 2005 7(1). • Paterick TJ, Carson GV, Allen MC, Paterick TE: Medical informed consent: general considerations for physicians. Mayo Clinic Proc, 2008 83:313-9. • CSAT, Methadone-Associated Mortality: Report of a National Assessment, 2003 • Passik SD, Kirsh KL. Managing pain in patients with aberrant drug-taking behaviors. J Supportive Oncology, 2005; 3:83-6. • Principles of Addiction Medicine, Ries R etal (eds), pp 99-112, 2009. • Textbook of Substance Abuse Treatment, Gallanter M, Kleber H, pp 215-235, 2008.