Best Practices for Prescribing Controlled Substances Dr. Merrill Norton Pharm.D., D.Ph, ICCDP-D Clinical Associate Professor University of Georgia College of Pharmacy mernort@uga.edu
Georgia Composite Medical Board The updated GCMB ruling states, Effective January 1, 2018, every physician not subject to Rule 360-15-.01(3) who maintains an active DEA certificate and prescribes controlled substances, except those holding a residency training permit, shall complete at least a one time three or more hours of AMA PRA Category 1 CME that is designed specifically to address controlled substance prescribing practices. The controlled substance prescribing CME shall include instruction on controlled substance prescribing guidelines, recognizing signs of the abuse or misuse of controlled substances, and controlled substance prescribing for chronic pain management. Any controlled substances prescribing guidelines coursework taken within two years of [the physician s] last renewal will count toward this requirement. Completion of this requirement may count as three hours toward the CME requirement for license renewal.
What Are Qualifying Education Topics? Best practices in prescribing controlled substances Chronic pain management Recognizing signs of misuse and abuse
Federation of State Medical Boards Guidelines for Chronic Use of Opioid Analgesics Updated in April 2017 Recommended national guideline Link to model policy in resource document 4
Good Medical Practices Access to appropriate and effective pain relief Improve the quality of life for patients who suffer pain Reduce the morbidity due to untreated or inappropriately treated pain Effective pain management part of quality medical practice for all patients Knowledgeable about pain management and prescribing requirements 5
Has the pendulum swung too far?
The Problem IOM Report 2011 100 million American suffer from chronic pain $635 billion yearly in treatment & lost productivity Chronic pain exceeds diabetes, heart disease and cancer combined NIH Drug Abuse 2015 Why are so many people dying of drug overdoses in the US?
The Dilemma Can we treat pain effectively without addiction? 1. Obtain relevant patient information 2. Use screening instruments 3. Manage medications 4. Monitor the patient 5. Document Document Document!
Abuse and Misuse of Controlled Substances Concurrent use of opioids and benzodiazepines increase risk of overdose death by 18-31%. Opioids Benzos Risk *Jones CM, McAninch JK. Emergency department visits and overdose deaths from combined use of opioids and benzodiazepines. Am J Prev Med 2015;49:493-501.
Benzodiazepines Abuse Physical Signs Speech problems Incoordination Dizziness Disorientation Poor memory Inability to concentrate Sedation Decreased blood pressure Decreased respirations Coma
Benzodiazepine Abuse Behavioral Signs Conflicts in relationships Poor performance at school or work Financial issues Multiple prescribers Early medication refills Legal issues Use with other depressant drugs
Fundamental Tenets of Responsible Opioid Prescribing Patient Evaluation & Selection Individualized Treatment Plan Periodic Review & Monitoring Patient Education on Risk of Opioids
Ask and Listen Tools for Evaluation of Pain: Patient Evaluation Pain Assessment The Numeric Rating Score (NRS) The Visual Analogue Scale (VAS) The Verbal Rating Score (VRS) The Wong Baker FACES Pain Scale Universal Pain Assessment Tool Brief Pain Inventory, Short Form (cancer pain) Pediatric Pain Questionnaire Howell D, et al. Assessment and Management of Pain (Rev. 2007). RNAO Clinical Best Practice Guidelines. Retrieved from: http://rnao.org/storage/29/2351_bpg_pain_and_supp.pdf.
Patient Evaluation: Tools for Assessing Addiction Risk Tools for Assessing Addiction Risk ORT: Opioid Risk Tool DIRE: Diagnosis, Intractability, Risk, Efficacy Information Guide SOAPP: Screener and Opioid Assessment for Patients with Pain Information Guide SOAPP-R: Screener and Opioid Assessment for Patients with Pain Revised Information Guide SISAP: Screening Instrument for Substance Abuse Potential Information Guide www.opioidrisk.com.
Tools for Assessing Pain Pain Measurement Scales 0-10 scale / faces pain rating scale McGill Pain Questionnaire
Tools for Assessing Addiction Risk Opioid Risk Tool Clinician Form Family History of Substance Abuse Personal History of Substance Abuse History of preadolescent sexual abuse Psychological disorders (ADD, OCD, Bipolar,depression) SOAPP 14 Q - Screener and Opioid Assessment Tool
Patient Evaluation What to Document: medical history and physical examination Nature and intensity of pain Current and past treatments for pain Underlying or coexisting diseases or conditions Effect of pain on physical and psychological function History of substance abuse Presence of one or more recognized medical indications for the use of controlled substances
Written Treatment Plan Prior to beginning treatment Objectives determine treatment success Goals are pain relief and improved function Describe further diagnostic evaluations Possible other treatments After treatment begins Adjust drug therapy patient s individual needs Utilize non-opioid treatment modalities Rehabilitation program Document functional goals
Treatment Plan: Guidelines Functional Goals Progress in physical therapy Better sleeping patterns Increased activities of daily living Return to work Increased social activities Regular exercise
Treatment Plan: Opioid Management Diagnosis Patient goals Maximize quality of life Improved level of function Ways to help patient reach goals Follow-up instructions
Informed Consent Between prescriber and patient Prescriber policies and expectations Balance risks and benefits Reasons for change or discontinuation Adverse effects Dependence and substance use disorder Overdose and death
Treatment Agreement Patient goals for pain and function Safe medication use Secure medication storage and disposal One physician / One pharmacy Drug screening and use of PDMP Prescriber coverage for care and refills 22
Patient Education Safe use of opioid medication Storage and disposal of medication Drug screening, pill counts and PDMP Termination strategies for chronic therapy.
Urine Drug Screening Patients are taught Purpose for testing What screened for Actions based on results Cost to patient Patients should disclose What they expect Prescriptions or other drugs using Time and dose of last opioids
Medical Record Guidelines Consents and agreements History and physical examination Risk assessment Treatments Medications prescribed Instructions or patient education Ongoing monitoring Evaluations and consultations PDMP queries Information on past treatment
Signs of Opioid Abuse/Misuse Misuse Incorrect use By patient Mismanaged By physicians Dated Duped Disabled Dishonest Non-medical Illegal use Not prescribed Took for euphoria Doctor shopping Forgery Robberies Pill Mills AMSP
Signs of Opioid Abuse: Withdrawal After stopping or decreasing chronic use After use of antagonist (reversal agent) Opposite to agonist effects DSM-5 criteria: 3+ (minutes to days): Unhappy mood Muscle aches Tearing/runny nose Pupillary dilation Goose bumps or sweating Nausea/vomiting Diarrhea, fever, yawning AMSP 27
Signs of Opioid Abuse: Overdose Blue tinged skin Face very pale Throwing up Passing out Choking sounds or a gurgling/snoring noise Body very limp Pale, clammy skin Breathing very slow, irregular, or stopped Pulse slow or absent No response to stimulation
Best Practices for Prescribing & Preventing Diversion 1. The Federation of State Medical Boards (FSMB) Guidelines for Chronic Use of Opioid Analgesics adopted April 2017 2. American Society of Clinical Oncology Policy Statement on Opioid Therapy: Protecting Access to Treatment for Cancer-Related Pain issued May 2016 3. The American Pain Society (APS) and American Academy of pain Medicine (AAPM) Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic non-cancer pain published in February 2009
Prescription Drug Monitoring Programs (PDMP)
Key Precautions for Prescribing Controlled Substances Select appropriate candidates Follow evidencebased protocol Recognize and intervene
Take Home Messages Prescription drug abuse is the fastest growing drug problem in America. Physicians and other prescribers are in the best position to help prevent prescription drug abuse and diversion Lack of knowledge about addiction, appropriate pain management & risk are key contributing factors to prescription drug abuse & diversion.
Bibliography Hwang CS, Kang EM, Kornegay CJ, Staffa JA, Jones CM, McAninch JK. Trends in the concomitant prescribing of opioids and benzodiazepines, 2002-2014. Am J Prev Med 2016;51:151-60. Jones CM, McAninch JK. Emergency department visits and overdose deaths from combined use of opioids and benzodiazepines. Am J Prev Med 2015;49:493-501. Dasgupta N, Funk MJ, Proescholdbell S, Hirsch A, Ribisl KM, Marshall S. Cohort Study of the Impact of High-dose Opioid Analgesics on Overdose Mortality. Pain Med 2016;17:85-98. Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert AS. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ 2015;350:h2698. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA 2013;309:657-9. Jones CM, Paulozzi LJ, Mack KA; Centers for Disease Control and Prevention (CDC). Alcohol involvement in opioid pain reliever and benzodiazepine drug abuserelated emergency department visits and drug-related deaths - United States, 2010. MMWR Morb Mortal Wkly Rep 2014;63:881-5.