9/17/2014. Monitoring Controlled Substances. Objectives. Presription Painkiller Overdose

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1 Monitoring Controlled Substances Nicole Paterson, PharmD BCPS And Michelle Herr, PharmD MTM Pharmacists 9/12/2014 Objectives Describe why we care about controlled substances Provide a few guidelines on controlled substances VA Opioid ICSI APA Review stategies to curb opioid abuse including use of Minnesota Prescription Monitoring Program, urine drug screens, controlled medidation agreement, and assessing the four As Presription Painkiller Overdose National Vital Statistics System. Drug overdose death rates by state

2 Nonmedical Use of Opioids Abused opioid drugs are obtained most frequently from friends or relatives The patients at highest risk of overdose obtained from doctor s prescriptions (27.3%) On prescription for days Overdoses strongly associated with being prescribed high dosages of opioids >100mg of morphine equivalents per day and with obtaining from multiple pharmacies and prescribers Jones CM, Paulozzi LJ, Mack KA. Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, JAMA Intern Med. 2014;():. doi: /jamainternmed Strategies to Curb Opioid Abuse Opioid assessment screening tools Urine drug testing Opioid Treatment Agreement Prescription Monitoring Programs Pill Counts Universal Precautions: 10 step process Reviewing opioid prescription data Monitoring prescribing practices Sehgal N, Manchikanti L, Smith HS et al. Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. Pain Physician 2012;15:ES67- ES92. Chronic Pain Guidelines APS/AAPM 2009 Clinical Guidelines for Opioid Use in Non-cancer pain al_evidence_report.pdf The Journal of Pain, Vol 10 (2) 2009; VA Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain _fulltext.pdf ICSI 2013 Health Care Guideline for Assessment and Manaement of Chronic Pain 2

3 Recommendations from APS/AAPM Before initiating chronic opioid therapy, clinicians should conduct a history, physical examination and appropriate testing, including an assessment of the risk of substance abuse, misuse, or addiction May consider trial if chronic pain is moderate or severe, pain is having an adverse impact on function or quality of life, potential benefit outweights harm Benefit to-harm evaluation should be performed and documented before and ongoing basis Strong recommendation, low quality of evidence, (APS/AAPM) Initial and Ongoing Assessment Chronic Pain Tool Examples Pain Assessment Brief Pain Inventory Functional or Quality of Life Functional Ability Questionairre (FAQ5) Psychological PHQ-9 The Four A s Analgesia Adverse drug Effects Activity Adherence ICSI 6 th ed Assessment and Management of Chornic Pain Accessed 5/2014 at Screening for Opioid Abuse Potential Good practice to determine risk of drug abuse prior to beginning of opioid therapy Screen before opioid initiation DIRE Tool Screening, Brief Intervention, Referral to Treatment(SBIRT) model for substance abuse Current Opioid Misuse Measure (COMM) Screener and Opioid Asessment for Patients in Pain (SOAPP) No one procedure or set of predictor variables that can identify chronic pain patients who are at-risk for opioid misue or abuse 3

4 DIRE Score-Patient Selection for Choronic Opioid Analgesia 9/17/2014 ICSI 6 th ed Assessment and Management of Chornic Pain Accessed 5/2014 at Controlled Medication Agreement When starting chronic opioid therapy (COT), informed consent should be obtained. A continuing discussion with the patient regarding COT should include goals, expectations, potential risks, and alternatives to COT (strong recommendation, low-quality evidence, APS/AAPM) Clinicinas my consider using a written COT management plan.(weak recommendation, low-quality evidence APS/AAPM) Letter templates: Narcotic Agreement QIC 4

5 Urine Drug Screening Strongly recommended that baseline UDT be conducted before initiated COT no studies have validated improved outcomes Random preferred over scheduled Frequency based on risk assessment Risk Low 1 or 2 Moderate 3 or 4 High # Urine Drug Tests/Year 4 or every month, office visit, or every drug refill Owen GT, Burton AW, Schade CM et al. Urine drug testing: current rrecommendations and best practices. Pain Physicians 2012;15:ES119-ES133 Urine Drug Tests Pros Has 1-3 day detection versus other methods Decrease risk of undiagnosed drug misuse problem Con-Defeating accuracy Urine swapping Diluting urine with water from sink or toilet bowl Buying commerically available products that change chemical profile (ph, etc) Chain of custody At Fairivew--MEDTOX Laboratories MedTox is an outside lab, LAB5736 or LAB5743 Select medications patient is on prior to submission Cost $488 Provide compliance monitoring not abuse TOXASSURE DIRECT: Physician Reference Line # Use for: Any result questions 5

6 Drugs that may cause false positives Drug Cannabinoids Opioids Amphetamines PCP Benzodiazepine ETOH Methadone Cross-Reactants (not all inclusive) NSAIDS, dronabinol, pantoprazole, riboflavin Poppy seeds, chlorpromazine, rifampin, dextromethorphan, quinine, diphenhdyramine Ephedrine, methylphenidate, trazodone, bupropion, desipramine, amantadine, ranitidine, phenylpropranolamine, pseudoephedrine, Vicks Vapor Spray Chlorpromazine, thioridazine, meperidine, dextromethorphan, diphenhydramine, doxylamine, ibuprofen, venlafaxine Oxaprozin, some herbal agents Asthma inhalers (sometimes) Propoxyphene, Seroquel Christo PJ et al. Urine drug testing in chronic pain. Pain Physician 2011:14: Another resource to consider: Pain Physicians 2012;15:ES119-ES133. Other resource for false positivies Pharmacist letter: PL Detail-Document, Urine Drug Testing. Pharmacist s Letter/Prescriber s Letter. March Minnesota Prescription Monitoring Program Database that collects prescription information on CII- CIV Based on controlled substances data entered by dispensers 2-10 day lag May do multi-state queries (ex: Wisconsin, SD) You may request to be Delegate Register on Delegate form, have it notorized Get log-in and have provider log-in and authorize delegate authorithy 6

7 New to the PMP effective July 1 st, 2014 Licensed Pharmacists who are providing pharmaceutical care for which access to the data may be necessary, to the extent that information relates specifically to a current patient for whom the pharmacist is providing pharmaceutical care and with the patient s consent will be authorized to access the data for the purposes stated. The law is silent on how that consent is garnered and therefore we are recommending you work with your organization s Data Privacy Compliance official as the MN Board of Pharmacy is unable to provide legal advice. Profile Universial Precautions: 10 Step Process 1. Comprehensive initial evaluation 2. Establish Diagnosis (conduct tests) 3. Establish medical necessity (lack of progress or as supplemental therapy) 4. Assess risk-benefit ratio 5. Establish treatment goals 6. Obtain Informed consent and agreement 7. Initial dose adjustment phase (up to 8-12 weeks) 1. Start low dose 2. Utilize opioids, NSAIDs and adjuvants 3. Discontinue for no efficacy or side effects 7

8 Universial Precautions: 10 Step Process continued 8. Stable phase Monthly refills Asses for four A s Analgesia Activity Aberrant behavior Adverse Effects 9. Adherence monitoring (MNPMP, UDT, pill counts) Unversial Precautions: 10 th Step Outcomes Sucessful-continue Stable doses Analgesia, activity No abuse, side effects Failed-discontinue Dose escalation No analgesia No activity Abuse Side effects Noncompliance Sehgal N, Manchikanti L, Smith HS et al. Prescription opioid abuse in chronic pain: a review of opioid abuse predictors and strategies to curb opioid abuse. Pain Physician 2012;15:ES67-ES92. Data utilization to monitor prescribed practices Providers evaluating whether their opioid prescribing patterns match those of their peers in the box - prescribing opioids in a usual and customary fashion similar to that of their collegues out of the box prescribing that deviates from usual prescribing habits of the majority of physicians Using prescription database and payer data Identify pt with larger than expected # of opioid prescriptions Identify larger prescription numbers 8

9 Addiction Universal Definitions Physical Dependence: a state of adaption manifested by a drug class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist Tolerance: state of adaption in which exposure to a drug induces changes that result in a diminution of one or more opioid effects over time APS-AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain Accessed 5/8/13 Addiction Definition A primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its develeopment and manifestations It is characterized by behaviors (one or more) Impaired control over drug use Compulsive use Continued use despite harm Cravings APS-AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain Accessed 5/8/13 Definitions Aberrent drug-related behavior: a behavior outside the boundaries of the agreed upon treatment plan Misuse: Use of a medication other than as directed or as indicated, wheather willful or unintentional, and whether harm results or not Abuse: Any use of an illegal drug, or the intentional selfadministration of a medication for a nonmedical puropse such as altering one s state of consciousness, e.g. getting high Diversion: The intentional transfer of a controlled substance from legitimate distribution and dipsensing channels Accessed 5/8/13 APS-AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain 9

10 Aberrant drug-related behaviors Selling prescripiton drugs Prescription forgery Stealing or borrowing drugs from others Injecting oral formulations Obtaining prescription drugs from nonmedical sources Concurrent abuse of alcohol or illicit drugs Multiple dose escalations or other noncompliance with therapy despite warnings Multiple episodes of prescription loss Repeatedly seeking prescriptions from other clinicinas or emergy rooms without infrorming prescriber or after warnings to desist Evidence of the deterioration in ability to function at work, in the family, or socially Repeated resistance to change therapy depsite adverse effects Portenoy RK, Payne R. Acute and chronic pain. In Lowinson JH, Ruiz P, Millman RB (eds): Comprehensive Textbook of Substance Abuse, 3rd Edition. Baltimore: Williams and Wilkins; 1997: Table 57.1, Page 564. Questions 10