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Prescription Drug Abuse

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1 Prescription Drug Abuse
Thomas E. Freese, PhD Pacific Southwest Addiction Technology Transfer Center UCLA Integrated Substance Abuse Programs UCLA David Geffen School of Medicine, Dept. of Psychiatry

2 Prescription (Rx) Drug Abuse: What’s the Problem?
phoenix may 2004 Prescription (Rx) Drug Abuse: What’s the Problem? I’m very delighted to be here today. I will be talking about the nature and trends were seeing with respect to Rx and OTC drug misuse, nationally and locally.

3 phoenix may 2004 What is Misuse? Misuse = “Non-medical use” or any use that is outside of a medically prescribed regimen Examples can include: Taking for psychoactive “high” effects Taking in extreme doses Mixing pills Using with alcohol or other illicit substances Obtaining from non-medical sources I want to first start off by defining what is considered or meant by “misuse”? -Virtually any Rx and OTC drug can be misused. -Misuse is considered to be using Rx and OTC drugs for non-medical purposes – in other words - any use that is outside of a medically prescribed regimen. 3

4 Methods of Prescription Diversion: Four Major Pathways
Pharmaceuticals manufactured lawfully, but stolen during distribution Medications obtained inappropriately from legitimate end-users Fraudulent prescriptions written on stolen prescribing pads “Doctor shopping” (e.g., a method where individuals see several doctors in an attempt to obtain multiple prescriptions without revealing what they are doing). Bullet #2: friends share prescription drugs, family members leave medicine in easily accessible places, etc. SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse.

5 The Prescription Drug Epidemic is Unique in Some Ways
Prescription drugs are not inherently bad When used appropriately, they are safe and vitally needed Threat comes from misuse, abuse, and diversion Just because prescription drugs are legal and are prescribed by an MD, they are not necessarily safer than illicit substances. SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse.

6 Factors Fueling the Epidemic
Increase in legitimate commercial production and distribution of pharmaceuticals Increase in marketing to physicians and public re: pain medications Physicians have become more willing to prescribe medications, esp. for pain management 150% increase in prescriptions written for controlled drugs Last bullet: 12 times the rate of increase in the population and almost 3 times the increase in prescriptions written for all other drugs SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse.

7 The Fateful Triangle: Pain and Prescription Opioid Abuse
Under treatment of pain Increasing availability of opioid analgesics Increased production and distribution Increase in the number of prescriptions filled Increased internet availability Increase in abuse of prescription opioids

8 Twin Epidemics: Prescription Drug Abuse and Unrelieved Pain
50 million Americans live with chronic pain An additional 25 million live with acute pain Mismanagement of pain has far reaching societal consequences. In fighting illicit misuse, must not hinder patients’ access to beneficial medical treatments. Prescription drugs are potent and must be monitored and managed appropriately (N. Katz, Tufts University). SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse.

9 Nature of the Link Between Increasing Opioid Prescribing for Non-cancer Pain and Abuse
Chronic use of prescription opioids for NCPC is much higher and growing faster in patients with MH and SUDs than in those without these diagnoses Clinicians should monitor the use of prescription opioids in these vulnerable groups to determine whether opioids are substituting for or interfering with appropriate MH and substance abuse treatment Edlund, Mark et al, Clinical Journal of Pain 2010

10 Diagnosing Addiction Opioid-maintained Pain Patients
No validated diagnostic criteria for addiction in pain patients; only “at risk” behaviors: Control Compulsive use Continue use despite harm Craving Identifying “at risk” patients: History Screening instruments Behavioral checklists Therapeutic maneuver

11 Webster, et al. Pain Med. 2005;6:432.
Opioid Risk Tool (ORT) Administration On initial visit Prior to opioid therapy Scoring 0-3: low risk (6%) 4-7: moderate risk (28%) > 8: high risk (> 90%) Webster, et al. Pain Med. 2005;6:432.

12 Aberrant Drug-Taking Behaviors
Probably more predictive Selling prescription drugs Prescription forgery Stealing or borrowing another patient’s drugs Injecting oral formulation Obtaining prescription drugs from non-medical sources Concurrent abuse of related illicit drugs Multiple unsanctioned dose ↑ s Recurrent prescription losses Probably less predictive Aggressive complaining about need for higher dose Drug hoarding during periods of reduced symptoms Requesting specific drugs Acquisition of similar drugs from other medical sources Unsanctioned dose escalation 1 – 2 times Unapproved use of the drug to treat another symptom Reporting psychic effects not intended by the clinician Passik and Portenoy, 1998

13 Hyperalgesia (Increased sensitivity to pain) can be opioid induced
Opioid-induced hyperalgesia Pain tolerance Solomon 1980 Hyperalgesic processes brought into play to counteract analgesic forces Bring pain tolerance back to normal level Opioid-induced analgesia

14 Commonly Misused Rx Drugs
phoenix may 2004 Commonly Misused Rx Drugs Classified in 3 classes Opiates: pain-killers Ex) Vicodin, OxyContin, Tylenol Codeine CNS Depressants (Sedatives/Tranquilizers): treat anxiety and sleep disorders Ex) Xanax, Ativan, Valium, Soma Stimulants: ADHD, weight loss Ex) Aderall, Ritalin, Concerta, Dexedrine, Fastin The categories of prescription drugs most widely used as illicit intoxicants and broadly recorded in many of the pertinent databases are: opiates, sedatives/ tranquilizers, and stimulants Commonly misused prescription drugs can be classified into the following 3 classes: Opioids used to treat pain – some examples include Vicodin, Tylenol with Codeine, OxyContin, and Percocet CNS Depressants used to treat sleep disorders and anxiety disorders – some examples include: barbiturates, benzodiazepines, and brands such as Klonopin, Nembutal, Soma, Valium, and Xanax 3) Stimulants: mainly prescribed to treat ADHD, including amphetamines, methylphenidate, and brands such as Adderall, Concerta, Dexedrine, and Ritalin. weight loss also abuse prescription stimulants such as Dexedrine and fastin.

15 A Global Look at Drug Abuse: World Drug Report, 2010
Updated 5/21/12 SOURCE: UNODC, World Drug Report, 2010.

16 Drug Prevalence in the United States
Marijuana = most commonly abused illicit drug Non-medical use of prescription drugs = 2nd most commonly abused drug category Prescription drug abuse is 3x more prevalent than illicit use of cocaine, crack, and hallucinogens LEAVE AS IS SOURCE: CA ADP, PDM Summary Report, 2009.

17 Past Year Non-Medical Psychotherapeutic Use: 2007 vs. 2010
Updated 5/21/12 SOURCE: SAMHSA, NSDUH, 2010 Results.

18 Percentage of US Population with Past Month Drug Use
phoenix may 2004 Percentage of US Population with Past Month Drug Use Updated 5/21/12 The number and percentage of persons aged 12 or older who were current nonmedical users of psychotherapeutic drugs in 2010 (7.0 million or 2.7 percent) were similar to those in 2009 (7.0 million or 2.8 percent) and to those in 2002 (6.3 million or 2.7 percent) SOURCE: SAMHSA, NSDUH, 2010 Results. 18

19 Past Year Rx Drug Misuse in the U.S.
16 million aged 12+ used a Rx drug (non-medically) in the past year Updated 5/21/12 SOURCE: SAMHSA, NSDUH, 2010 Results.

20 Specific Drug Used When Initiating Drug Use: NSDUH, 2010
phoenix may 2004 Specific Drug Used When Initiating Drug Use: NSDUH, 2010 Updated 5/21/12 SOURCE: SAMHSA, NSDUH, 2010 Results. 20

21 New Users of Psychotherapeutics
2.4 million persons aged 12 or older used psychotherapeutics non-medically for the first time within the past year 2.0 million for pain relievers 1.2 million for tranquilizers 624,000 for stimulants 252,000 for sedatives Average of 6,600 initiates per day. 2010 estimate was similar to 2009 rate, but significantly lower than 2004 rate (2.8 million). In 2010, the average age at first nonmedical use of any psychotherapeutics was 22.3 years 21.0 years for pain relievers, 24.6 years for tranquilizers, 21.2 years for stimulants, and 23.5 years for sedatives. Updated 5/21/12 SOURCE: SAMHSA, NSDUH, 2010 Results.

22 Treatment Admissions for Primary Prescription Drug Abuse: U.S.
(Percent of All Admissions) Updated 5/21/12 SOURCE: SAMHSA, Treatment Episode Data Set, 2009 results.

23 Californians in Treatment
34% 20% Updated 5/21/12 SOURCE: CA ADP, Fact Sheet: Californians in Treatment, FY 23

24 Prescription Drug-Related Emergency Department Visits
phoenix may 2004 Prescription Drug-Related Emergency Department Visits Out of 4.5 million drug-related ED visits in 2009: 1.1 million associated with non-medical use of prescription drugs (24.6% of all drug-related visits) Pain relievers (47.8%) were the most common type of medications involved in medical emergencies associated with nonmedical use of pharmaceuticals. Pain relievers seen more commonly were oxycodone (13.7%), hydrocodone (8.0%), and methadone (5.8%). Updated 5/21/12 Non-narcotic pain relievers, such as acetaminophen and nonsteroidal anti-inflammatory agents (e.g., ibuprofen, naproxen), were seen at lower levels of between 3 and 5 percent. Anxiolytics, sedatives, and hypnotics (drugs to treat anxiety and insomnia) were found in 33.6 percent of visits related to nonmedical use of pharmaceuticals. Benzodiazepines (anti-anxiety drugs) were involved in 29.0 percent of ED visits, with alprazolam (e.g., Xanax) indicated in 10.4 percent of such visits. Among other major categories of drugs, psychotherapeutic agents (antidepressants and antipsychotics) were involved in 12.3 percent of ED visits related to nonmedical use of pharmaceuticals, with respiratory agents and cardiovascular agents each involved in about 3 to 5 percent of these ED visits. Also appearing in the range of 3 to 5 percent were muscle relaxants and anticonvulsants. When population size and sampling error are taken into account, visits for nonmedical use of pharmaceuticals did not differ between males and females (349.2 and visits per 100,000 population, respectively). The rate of ED visits for patients in age categories between 18 and 34 were all over 500 visits per 100,000 population, with lower levels observed for younger and older patients. SOURCE: SAMHSA, Drug Abuse Warning Network, 2009 Results. 24

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27 Prescription Drug Use Among Teens

28 Young Brains Are Different from Older Brains
Alcohol and drugs affect the brains of adolescents and young adults differently than they do adult brains Adolescent rats are more sensitive to the memory and learning problems than adults* Conversely, they are less susceptible to intoxication (motor impairment and sedation) from alcohol* These factors may lead to higher rates of dependence in these groups *Hiller-Sturmhöfel., and Swartzwelder (NIAAA Publication 213) 28

29 Prescription Drug Abuse among U.S. High School Seniors
More than 12% of high school seniors said they had used opioid-based prescription drugs for non-medical purposes at least once in their lifetime. Eight percent did so within the past year. Reasons for use included: to relax, relieve tension, get high, experiment, relieve pain, or have a good time with their friends. Those who used the drugs for reasons other than pain relief were more likely to use other addictive drugs and have signs of addictive disorders. Heavy drinkers = 2 or more drinks per day every day. SOURCE: Join Together Online, August 6, 2009; NIDA, MTF Survey, 2008.

30 Age Distribution of Prescription Drug Misuse in the Past Year
COULDN’T FIND UPDATED FIGURE; MIGHT WANT TO LEAVE IN FOR SAKE OF ILLUSTRATION IN AGE BREAKDOWN, SINCE STATS HAVEN’T CHANGED MUCH RECENTLY… SOURCE: SAMHSA, NSDUH, 2006 Results.

31 SOURCE: SAMHSA, NSDUH, 2010 results.
Sources Where Pain Relievers were Obtained: Past Year Non-Medical Users Aged 12 or Older: 2010 Updated 5/21/12 The majority of individuals who use prescription drugs non-medically, for unintended purposes, obtain the drugs from friends or family members. SOURCE: SAMHSA, NSDUH, 2010 results. 31

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33 Over-the-Counter Drug Misuse among Young Adults
3.1 million year olds reported lifetime use of OTC cough and cold medications to get high 1 million reported past year use Even gender distribution Female year olds more likely to misuse OTC drugs than male counterparts 82% of lifetime OTC drug users also reported lifetime use of marijuana Lower rates of lifetime use of hallucinogens, ecstasy, or inhalants REMAINS THE SAME SOURCE: CA ADP, Rx Drug Summary Report, 2009.

34 Prescription Drug Use Among Older Adults

35 Potential Issues for Older Adults
phoenix may 2004 Potential Issues for Older Adults Prescription drug abuse begins with misuse due to inappropriate prescribing or lack of compliance Age-related physiological changes (metabolism and response) Greater likelihood of undiagnosed psychiatric and medical comorbidities Difficulties with complying with complex drug regimens Drug interactions Read slide SOURCE: CA ADP, Rx Drug Summary Report, 2009.

36 Rx Drug Abuse among Older Adults
phoenix may 2004 Rx Drug Abuse among Older Adults Older Adults account for 13% of US population but use 1/3 of all medications prescribed. 7.2 million (21.7%) receive at least 1 Rx annually. Older adults use Rx drugs 3 times more than the general population. On average, older persons take 4.5 medications per day. Nationally, 9.2 million (4.9%) of older adults abused Rx drugs in the last year while in California, 812,000 (3.7%). Read slide SOURCES: SAMHSA, 2006; NIDA, 2005 36

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38 What are opioids? Opiate: derivative of opium poppy
Morphine Codeine Opioid: any compound that binds to opiate receptors Semisynthetic (including heroin) Synthetic Oral, transdermal and intravenous formulations Narcotic: legal designation Heroin: semisynthetic derived from morphine Semisynthetic: derived by altering chemicals contained in opium

39 Opioids Instructions Introduce opioids by reading the slide to your audience. Point to the different pictures showing the different forms of opioids, including prescription drugs.

40 Opioids: Acute Effects
Euphoria Pain relief Suppresses cough reflex Histamine release Warm flushing of the skin Dry mouth Drowsiness and lethargy Sense of well-being Depression of the central nervous system (mental functioning clouded) Instructions Read the slide to your audience.

41 Effects of Opioids Sedation Pupil constriction Slurred speech
Impaired attention/memory Constipation, urinary retention Nausea Confusion, delirium Seizures Slowed heart rate Respiratory depression 1st 4: DSM criteria for opioid intoxication Also: itchiness, myoclonus

42 Long-Term Effects of Opioids
Fatal overdose Collapsed veins Infectious diseases Higher risk of HIV/AIDS and hepatitis Infection of the heart lining and valves Pulmonary complications & pneumonia Respiratory problems Abscesses Liver disease Low birth weight and developmental delay Spontaneous abortion Cellulitis Instructions Read the long-term effects of stimulant use to your audience Point to the areas of the body that are affected by the use of these drugs. Additional Information for Trainers Chronic users of opioids may develop collapsed veins, infection of the heart lining and valves, abscesses, cellulitis, and liver disease. Pulmonary complications, including various types of pneumonia, may result from the poor health condition of the abuser, as well as from heroin’s depressing effects on respiration. Heroin abuse during pregnancy and its many associated environmental factors (e.g., lack of prenatal care) have been associated with adverse consequences including low birth weight, an important risk factor for later developmental delay. In addition to the effects of the drug itself, street heroin may have additives that do not readily dissolve and result in clogging of the blood vessels that lead to the lungs, liver, kidneys, or brain. This can cause infection or even death of small patches of cells in vital organs. (Source: NIDA InfoFacts.)

43 Pain: The Fifth Vital Sign
JACHO Guidelines 2000: Mandated pain assessment and treatment Nurse and physician education required When opioids prescribed properly for pain, addiction rare in patients without underlying risk factors Vulnerabilities same as for other addictions: genetic, peer and social influences, trauma and abuse history Temperature, blood pressure, heart rate, respiration

44 Pain Control and Addiction
“Pseudoaddiction”: Presence of drug-seeking behavior in context of inadequate pain control Behavior stops with adequate pain relief Description of a clinical interaction (not a true diagnosis) Physical dependence with continued use, withdrawal syndrome produced by rapid dose reduction; occurs via neuroadaptation Not synonymous with addiction Also may see “hyperalgesia”: increased pain with increasing opioid doses

45 Opioid Withdrawal Dysphoric mood Nausea or vomiting Diarrhea
Tearing or runny nose Dilated pupils Muscle aches Goosebumps Sweating Yawning Fever Insomnia Also see protracted withdrawal – low energy, anhedonia, sleep disturbance, dysphoria, anxiety, craving for up to months

46 Opiates and Reward Opiates bind to opiate receptors in the nucleus accumbens: increased dopamine release

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48 Sedative-Hypnotics Used to treat anxiety and sleep disorders
Mechanism: enhances GABA acts to slow normal brain function Barbiturates Phenobarbital® Pentobarbital® Fioricet® (butalbital/acetaminophen/caffeine)

49 Sedative-Hypnotics Cont’d
Benzodiazepines Librium® (chlordiazepoxide HCL) Valium® (diazepam) Restoril® (tempazepam) Klonopin® (clonazepam) Ativan® (lorazepam) Xanax® (alprazolam) Non-benzo hypnotics Ambien® (zolpidem) Sonata® (zaleplon) Lunesta® (eszopiclone) Soma® (carisoprodol) Cross-tolerance with alcohol (GABA related) Soma: muscle relaxant, metabolized to mebprobamate (Miltown) Non-benzo hypnotics bind to alpha 1 subunit of GABA-A receptor; thus sedating without anxiolytic or anticonvulsant properties

50 Sedative-Hypnotic Effects
Sedation Slurred speech Incoordination Unsteady gait Impaired attention or memory Stupor or coma Overdose risk increased with opioids or in combination with other sedatives, including alcohol Toxicity: unsteady gait, impaired gag reflex, and blurry vision, obtundation

51 Sedative-Hypnotic Withdrawal
Increased pulse, blood pressure, or sweating Hand tremor Nausea or vomiting Transient hallucinations or illusions Agitation Anxiety Seizures

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53 Prescription Stimulants
Stimulants (i.e., amphetamines) are often prescribed to treat individuals diagnosed with attention-deficit hyperactivity disorder (ADHD). Substantial amounts of pharmaceutical amphetamines are diverted from medical use to non-prescription use. Amphetamines increase wakefulness and alertness and have been used by: The military, by pilots, truck drivers, and other workers to keep functioning past their normal limits Common amphetamines include Dexedrine (d-amphetamine), methamphetamine, Ritalin, and Adderall (dl-amphetamine). SOURCE: Erowid.org

54 Short-Term Effects Euphoria Increased energy/productivity
Increased concentration Decreased appetite Increased libido Decreased sleep *increased risk HIV/Hepatitis B&C transmission with increased libido/impulsivity *Short-term effects plus ease of manufacture and less stigma are what makes meth appealing to use among different groups. Also used to self-medicate depression/AHDH

55 Medical Risks Norepinephrine release causes constriction of blood vessels, elevated blood pressure and rapid heart rate Increased activity levels Dangerously high body temperatures Increased risk of seizures Potentially fatal arrhythmias, heart attack, or stroke

56 Stimulants: Withdrawal Symptoms
Dysphoric mood (sadness, anhedonia) Fatigue Insomnia or hypersomnia Psychomotor agitation or retardation Craving Increased appetite Vivid, unpleasant dreams Instructions Read the slide to your audience.

57 Over-the-Counter Drugs
Available without a doctor’s prescription Increasingly used among adolescents and young adults Cough and cold medications containing Dextromethorphan (DXM) Coricidin®, Robitussin®, Nyquil® Sleep aids Unisom® Antihistimines Benadryl ® Anti-nausea agents Gravol®, Dramamine®

58 Dextromethorphan Over-the-counter cough suppressant
Structurally related to morphine Mechanism: NMDA antagonist Dissociative psychedelic properties in excess doses (like ketamine, PCP) can produce distortions of the visual field, feelings of dissociation, distortions of bodily perception, excitement, as well as a loss of comprehension of time.

59 Fitting Pharmacotherapies into Treatment
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60 Four Legs of Addiction Think of this concept as a chair, with each leg representing a component of a patient’s treatment plan. Psychological Spiritual Biological Social All four legs are required to “support” the patient, and if one leg is missing, the chair will be unstable and unable to accomplish its goal. 60

61 Medical Treatments for Opioid Addiction

62 Partial vs. Full Opioid Agonist
death Full Agonist (e.g., methadone) Opiate Effect Partial Agonist (e.g. buprenorphine) . (e.g. Naloxone) Antagonist Dose of Opiate

63 Medications to Treat Addiction
Addiction is a chronic, relapsing brain disease characterized by compulsive use despite harmful consequences Medications as part of comprehensive treatment plan Treatment approaches: Medications (Bio) Therapy, lifestyle changes (Psycho-Social) Thorough evaluation and diagnosis essential Meds help but not a cure Screening/assessment covered in Module I FDA-approved vs. off-label meds…use in adolescents vs. adults.

64 Pharmacotherapy in Substance Use Disorders
Treatment of withdrawal (“detox”) Treatment of psychiatric symptoms or co-occurring disorders Reduction of cravings and urges Substitution therapy Other forms of relapse prevention/harm reduction: aversive conditions if use, restore impulse control, Prevention: use of psych med that may delay or prevent onset of SUD: ex: evidence of tx of ADHD may delay onset of SUD in adolescence, tx of ADHD with bupropion may reduce rates of initiation of tobacco use. Replacement therapy: NRT, methadone, buprenorphine

65 Naltrexone

66 Naltrexone General Facts
Generic Name: naltrexone hydrochloride Marketed As: ReVia (oral), Depade(oral), Vivvitrol (long acting injectable) Purpose: To discourage opioid use by reducing or eliminating the euphoric effects experienced by consuming exogenous administered opioids. Indication: In the treatment of alcohol dependence and for the blockade of the effects of exogenous administered opioids. Year of FDA-Approval: 1984

67 Appropriate Populations
Age Range: 18 to 65 years old Adolescents: Has not been tested or FDA-approved. Elderly: Pregnancy: Has not been adequately tested on pregnant or nursing women; Pregnancy Category C designation, used only if the potential benefit justifies the potential risk to the fetus. Polysubstance Abusers: Has not been adequately tested with this population. 67

68 Opioid Replacement Goals
Reduce symptoms & signs of withdrawal Reduce or eliminate craving Block effects of illicit opioids Restore normal physiology Promote psychosocial rehabilitation and non-drug lifestyle Basis of replacement therapy: replace w/ longer duration of action, less abuse potential, and better safety profile to prevent WD and craving.

69 Methadone

70 Methadone General Facts
(information from medication package insert) Generic Name: methadone hydrochloride Marketed As: Methadose and Dolophine (among others) Purpose: To discourage illicit opioid use due to cravings or the desire to alleviate opioid withdrawal symptoms. Indication: For the treatment of moderate to severe pain not responsive to non-narcotic analgesics; for detoxification treatment of opioid addiction; for maintenance treatment of opioid addiction, in conjunction with appropriate social and medical services. Year of FDA-Approval: 1964

71 Methadone General Facts
(information from medication package insert) Amount: maintenance dose of 80 to 120mg Method: mouth Frequency: once a day The effect of consuming food with methadone has not been evaluated and therefore, is not recommended. Abstinence requirements: must be abstinent from opioids long enough to experience mild to moderate opioid withdrawal symptoms. Initial dose will vary depending upon the client’s usage pattern, but should not exceed 40mg. Risk of Overdose: Just like with any opioid, overdose is possible. In the event of an overdose, appropriate medical treatment should be sought.

72 Methadone General Facts
(information from medication package insert) Pregnancy: Methadone is the preferred method of treatment for medication-assisted treatment for opioid dependence in pregnant women. An expert review of published data on experiences with methadone use during pregnancy concludes that it is unlikely to pose a substantial risk. But, there is insufficient data to state that there is no risk. Methadone has not been adequately tested on pregnant women. Therefore, methadone has a Pregnancy Category C designation, meaning that it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when using methadone with this population.

73 Methadone General Facts
(information from medication package insert) Pregnancy: Detoxification is relatively contraindicated unless done in hospital with monitoring. Babies born to mothers who have been taking opioids regularly prior to delivery may be physically dependent and may experience opioid withdrawal symptoms. It is known that methadone is excreted through breast milk, and a decision should be made whether to discontinue nursing or to discontinue the medication, taking into account the importance of the medication to the mother and continued illicit opioid use.

74 Methadone is the most studied medication for opioid addiction.
What does the research say? Methadone is the most studied medication for opioid addiction. 8-10 fold reduction in death rate Reduces opioid use Reduces crime Improves family and social functioning Increases likelihood of employment Improves physical and mental health Reduces spread of HIV Low drop-out rate compared to other treatments References: -A Medical Treatment for Diacetylmorphine (Heroin) Addiction A Clinical Trial With Methadone Hydrochloride Vincent P. Dole, MD; Marie Nyswander, MD . JAMA. 1965;193(8): -A clinical trial of buprenorphine: Comparison with methadone in the detoxification of heroin addicts Warren K Bickel PhD, Maxine L Stitzer PhD, George E Bigelow PhD, Ira A Liebson MD, Donald R Jasinski MD and Rolley E Johnson PharmD Baltimore, Md.; Clinical Pharmacology and Therapeutics (1988) 43, 72–78; doi: /clpt -Reducing the Risk of AIDS Through Methadone Maintenance Treatment John C. Ball, W. Robert Lange, C. Patrick Myers and Samuel R. Friedman; Journal of Health and Social Behavior Vol. 29, No. 3 (Sep., 1988), pp Published by: American Sociological Association.

75 Crime before and during Methadone Treatment at 6 programs
Crime Days Per Year Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991. (More recent supporting studies include: Bell, Mattick, Hay, Chan, & Hall – Methadone maintenance and drug-related crime, Journal of Substance Abuse, Volume 9, 1997, Pages Explaining the Effectiveness of Heroin-assisted Treatment on Crime Reductions. Rebecca Lobmann & Uwe Verthein. Law and Human Behavior Vol 33, Number 1,

76 Treatment Months Since Stopping Treatment
High Rate of Relapse to IV drug use after drop-out from Methadone Treatment Percent IV Users Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991 Treatment Months Since Stopping Treatment

77 Buprenorphine

78 Development of Tablet Formulations of Buprnorphine
Buprenorphine is marketed for opioid treatment under the trade names of Subutex® (buprenorphine) and Suboxone® (buprenorphine/naloxone) Over 25 years of research Over 5,000 patients exposed during clinical trials Proven safe and effective for the treatment of opioid addiction

79 Buprenorphine: A Science-Based Treatment
Clinical trials have established the effectiveness of buprenorphine for the treatment of heroin addiction. Effectiveness of buprenorphine has been compared to: Placebo (Johnson et al. 1995; Ling et al. 1998; Kakko et al. 2003) Methadone (Johnson et al. 1992; Strain et al. 1994a, 1994b; Ling et al. 1996; Schottenfield et al. 1997; Fischer et al. 1999) Methadone and LAAM (Johnson et al. 2000)

80 The Role of Buprenorphine in Opioid Treatment
Partial Opioid Agonist Produces a ceiling effect at higher doses Has effects of typical opioid agonists—these effects are dose dependent up to a limit Binds strongly to opiate receptor and is long-acting Safe and effective therapy for opioid maintenance and detoxification

81 Advantages of Buprenorphine in the Treatment of Opioid Addiction
Patient can participate fully in treatment activities and other activities of daily living easing their transition into the treatment environment Limited potential for overdose Minimal subjective effects (e.g., sedation) following a dose Available for use in an office setting Lower level of physical dependence

82 Advantages of Buprenorphine/Naloxone in the Treatment of Opioid Addiction
Combination tablet is being marketed for U.S. use Discourages IV use Diminishes diversion Allows for take-home dosing

83 Why Combining Buprenorphine and Naloxone Sublingually Works
Buprenorphine and naloxone have different sublingual (SL) to injection potency profiles that are optimal for use in a combination product. SL Bioavailability Injection to Sublingual Potency Buprenorphine 40-60% Buprenorphine ≈ 2:1 Naloxone 10% or less Naloxone ≈ 15:1 SOURCE: Amass et al., 2004.

84 Role of Medical Community
An estimated 70 percent of Americans (approx 191million) visit their primary care physician at least once every two years. Care for patients by prescribing needed medications Identify prescription drug abuse when it exists Help patients recognize abuse problems Support patients in seeking appropriate treatment.

85 Role of Prescription Drug Monitoring Program Community
Collection and analysis of controlled substance data Identification and investigation of illegal prescribing, dispensing and procurement Physician access can help decrease extent of doctor shopping Operational in 37 states

86 CURES: CA’s Prescription Drug Monitoring Program
Name: Controlled Substance Utilization Review and Evaluation System (CURES) Overseen by: CA Dept. of Justice, Bureau of Narcotic Enforcement Schedules Monitored: II, III, and IV Number of Prescriptions Collected Annually: 21 million (100 million entries to date) Number of Controlled Substance Dispensers: 155,000 Website:

87 Safe Drug Disposal Medicine Take-Back Programs
phoenix may 2004 Medicine Take-Back Programs Contact household trash and recycling service or pharmacist Disposal in Household Trash Mix medicines with an unpalatable substance such as kitty litter or used coffee grounds Place the mixture in a container or sealed plastic bag Throw the container in your household trash Flushing of Certain Medicines A small number of medicines that are especially harmful if misused Includes Opioid Medications FDA has a list of Medications that should be flushed Studies now showing that does not significantly impact water The categories of prescription drugs most widely used as illicit intoxicants and broadly recorded in many of the pertinent databases are: opiates, sedatives/ tranquilizers, and stimulants Commonly misused prescription drugs can be classified into the following 3 classes: Opioids used to treat pain – some examples include Vicodin, Tylenol with Codeine, OxyContin, and Percocet CNS Depressants used to treat sleep disorders and anxiety disorders – some examples include: barbiturates, benzodiazepines, and brands such as Klonopin, Nembutal, Soma, Valium, and Xanax 3) Stimulants: mainly prescribed to treat ADHD, including amphetamines, methylphenidate, and brands such as Adderall, Concerta, Dexedrine, and Ritalin. weight loss also abuse prescription stimulants such as Dexedrine and fastin.

88 Safe Drug Disposal phoenix may 2004 Throwing unused prescription drugs in trash may be best for environment: A new study Throwing away unused prescription drugs in the trash may be the most environmentally friendly option. The researchers compared the environmental impact of flushing medication, throwing it in the trash, and burning it. The study took into account how much of the drugs would enter the environment, as well as emission impacts from water treatment, transportation and burning of waste materials. The categories of prescription drugs most widely used as illicit intoxicants and broadly recorded in many of the pertinent databases are: opiates, sedatives/ tranquilizers, and stimulants Commonly misused prescription drugs can be classified into the following 3 classes: Opioids used to treat pain – some examples include Vicodin, Tylenol with Codeine, OxyContin, and Percocet CNS Depressants used to treat sleep disorders and anxiety disorders – some examples include: barbiturates, benzodiazepines, and brands such as Klonopin, Nembutal, Soma, Valium, and Xanax 3) Stimulants: mainly prescribed to treat ADHD, including amphetamines, methylphenidate, and brands such as Adderall, Concerta, Dexedrine, and Ritalin. weight loss also abuse prescription stimulants such as Dexedrine and fastin.

89 Safe Drug Disposal phoenix may 2004 Throwing unused prescription drugs in trash may be best for environment: A new study Flushing allows the highest levels of drugs to enter the environment, and creates more air pollution. Drug collecting and burning produce far greater emissions of greenhouse gases and other pollutants, largely due to the travel required for people to come to drop-off points, and to ship drugs for incineration. Throwing drugs out at home, uses an infrastructure that already exists for collecting household trash. The categories of prescription drugs most widely used as illicit intoxicants and broadly recorded in many of the pertinent databases are: opiates, sedatives/ tranquilizers, and stimulants Commonly misused prescription drugs can be classified into the following 3 classes: Opioids used to treat pain – some examples include Vicodin, Tylenol with Codeine, OxyContin, and Percocet CNS Depressants used to treat sleep disorders and anxiety disorders – some examples include: barbiturates, benzodiazepines, and brands such as Klonopin, Nembutal, Soma, Valium, and Xanax 3) Stimulants: mainly prescribed to treat ADHD, including amphetamines, methylphenidate, and brands such as Adderall, Concerta, Dexedrine, and Ritalin. weight loss also abuse prescription stimulants such as Dexedrine and fastin.

90 For more information, contact:
Thomas E. Freese, PhD


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