THE OPIOID EPIDEMIC: WHAT PSYCHIATRISTS NEED TO KNOW Donna Vanderpool, MBA, JD Vice President, Risk Management Professional Risk Management Services, Inc. (PRMS) RUMC October 5, 2018
OPIOID EPIDEMIC: HOW DID WE GET HERE? 3 Waves of the Rise in Opioid Overdose Deaths: ▪ Wave 1: Rise in prescription opioid overdose deaths ▪ 1990s – 2009 ▪ 1996: OxyContin introduced ▪ 2000: Joint Commission touts pain as fifth vital sign ▪ Prescribers become increasingly open to opioid use ▪ 2007: in litigation against Purdue, executives acknowledge misbranding OxyContin (CDC, 2017)
OPIOID EPIDEMIC: HOW DID WE GET HERE? 3 Waves of the Rise in Opioid Overdose Deaths: ▪ Wave 2: Rise in heroin overdose deaths ▪ 2010 – 2012 ▪ Heroin is cheaper than prescription opioids (CDC, 2017)
OPIOID EPIDEMIC: HOW DID WE GET HERE? 3 Waves of the Rise in Opioid Overdose Deaths: ▪ Wave 3: Rise in synthetic opioid overdose deaths ▪ 2013 + ▪ Fentanyl ▪ 2015: opioid prescription rate was triple that of 1999 ▪ 2016: deaths caused by opioids exceeded total deaths from car accidents and gun violence in any single year ▪ 2017: President declares public health emergency (CDC, 2017)
OPIOID EPIDEMIC: HOW BAD IS IT? In 2016: ▪ 42,249 people died from opioid overdose ▪ ~116 overdose deaths every day ▪ 11.5 million people misused prescription opioids ▪ 17,087 deaths attributed to overdosing on commonly prescribed opioids ▪ 2.1 million people had a opioid use disorder ▪ Of those people who used heroin in past year: ▪ 3 out of 4 misused prescription opioids first ▪ 7 out of 10 also misused prescription opioids in the past year (HHS, 2018)
OPIOID EPIDEMIC: HOW BAD IS IT? In 2016: ▪ 19,413 deaths attributed to overdosing on synthetic opioids other than methadone ▪ 15,469 deaths attributed to overdosing on heroin ▪ 948,000 people used heroin ▪ 170,000 people used heroin for the first time (HHS, 2018)
OPIOID EPIDEMIC: HOW BAD IS IT? Prescription Opioid Use among Adults with Mental Health Disorders in the United States : ▪ Adults with mental health disorders are more likely to be prescribed opioids and remain on them long-term ▪ 16% of Americans who have mental health disorders receive over half (51.4%) of all opioids prescribed in the US ▪ 60 million of the 115 million prescriptions ▪ Of the adults with mental health disorders, 18.7% were opioid users ▪ Compared to only 5% of those without mental health disorders (JABFM, 2017)
OPIOID EPIDEMIC: HOW BAD IS IT? Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing : ▪ 1 in 3 Medicare Part D beneficiaries received a prescription opioid in 2016 ▪ ~ 500,000 beneficiaries received high amounts of opioids ▪ Almost 90,000 beneficiaries are at serious risk ▪ Extreme amounts of opioids ▪ Doctor shopping ▪ About 400 prescribers had questionable opioid prescribing patters for beneficiaries at serious risk (HHS OIG, 2017)
OPIOID EPIDEMIC: HOW BAD IS IT? 2018: ▪ Opioid prescribing declining since 2011 ▪ Receipt of MAT from treatment facilities increasing ▪ Consistent increases in number of patients receiving buprenorphine and naltrexone from pharmacies ▪ Dramatic increases in naloxone dispensing (SAMHSA, 2018)
OPIOID EPIDEMIC: HOW BAD IS IT? 2018: ▪ Youth prescription opioid misuse declining over past decade ▪ Heroin use stable among youth ▪ Prescription opioid misuse initiation and overall misuse declining ▪ Plateauing of overdose deaths involving commonly prescribed opioids ▪ Some states seeing a leveling off of overdose deaths (SAMHSA, 2018)
THE RESPONSE: VARIOUS INITIATIVES ▪ State ▪ Opioid task forces ▪ Restrictions on opioid prescribing ▪ Prescribing guidelines ▪ Mandated use of PMPs ▪ Lawsuits against Pharma ▪ Enforcement ▪ Federal ▪ Public Health Emergency declaration ▪ Guidelines ▪ CMS initiatives ▪ Enforcement
THE RESPONSE: ENFORCEMENT 2017: ▪ DOJ focus on prescribing and distributing opioids and other dangerous narcotics ▪ National takedown - largest healthcare fraud enforcement in history ▪ DOJ creates Opioid Fraud and Abuse Detection Unit ▪ Many types of criminal enforcement ▪ Fraud and abuse ▪ Diversion ▪ Etc. (DOJ, 2017)
THE RESPONSE: ENFORCEMENT 2018: ▪ DOJ: new “largest healthcare fraud enforcement in history” ▪ 601 individuals charged ▪ 76 physicians ▪ Including psychiatrist(s) ▪ > $2 billion in fraud losses ▪ > 13 million illegal dosages of opioids ▪ AG Sessions: One physician alone was charged with unlawfully prescribing more than two million dosage units of Oxycodone ▪ Defrauding Medicare of $112 million (DOJ, 2018)
RISKS OF PRESCRIBING OPIOIDS ▪ To patients ▪ To third parties ▪ To prescribing physicians
RISKS TO PATIENTS ▪ Side effects ▪ Including withdrawal ▪ Misuse ▪ OD ▪ Death ▪ Addiction ▪ Diversion
RISKS TO THIRD PARTIES ▪ Diversion ▪ Third party injury
RISKS TO PRESCRIBING PSYCHIATRISTS ▪ Civil litigation / medical malpractice ▪ Underprescribing for pain ▪ Overprescribing for pain ▪ Diversion, abuse, overdose ▪ Failure to recognize addiction ▪ Other ▪ Patient’s defense ▪ Third party actions
LIABILITY TO THIRD PARTIES Two lines of cases imposing liability: 1) Controlled substance (usually methadone) was ADMINISTERED despite risks that were known or should have been known 2) Controlled substance was PRESCRIBED without warning patient of known side effects that could impair driving
RISKS TO PRESCRIBING PSYCHIATRISTS ▪ Licensing board action ▪ DEA action ▪ Criminal action
COLLECT INFORMATION ▪ Patient ▪ Medications ▪ Treatment / standard of care ▪ Abuse / diversion ▪ Enforcement
COLLECT INFORMATION – ABOUT THE PATIENT ▪ History ▪ PMP* ▪ Urine screens* * Can provide important information that is not provided by patient
COLLECT INFORMATION – ABOUT THE MEDICATIONS ▪ Risk Evaluation and Mitigation Strategies (REMS) ▪ Strategy to manage known or potential serious risks associated with a drug product ▪ Required by the FDA to ensure the benefits of a drug outweigh its risks ▪ MedWatch
NEW SAFETY INFORMATION In response to new safety information, review the appropriateness of your prescriptions ▪ Communicate new information to patient – and document ▪ If medication is changed - › Document your decision-making process › Obtain informed consent › Document informed consent discussions ▪ If not clinically appropriate to change - › Document your decision-making process › Obtain updated informed consent › Document updated informed consent › Consider modifying patient monitoring › Do not hesitate to seek consultation
COLLECT INFORMATION – ABOUT TREATMENT / STANDARD OF CARE ▪ Medication-specific › Ex: opioids ▪ Patient-specific › Ex: C&A ▪ Expectations of regulators › State › Federal
DEA REGULATIONS Ex: 21 CFR 1306.04(A): “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose …by an individual practitioner…acting in the usual course of his professional practice ”
SPECIAL REQUIREMENTS FOR PRESCRIBING CONTROLLED SUBSTANCES VIA TELEPSYCHIATRY ▪ State law – may or may not allow ▪ Federal law – ▪ DEA registration required where patient is ▪ “One in - person visit” rule
FEDERAL REGULATION OF PRESCRIBING CONTROLLED SUBSTANCES ▪ Controlled Substances Act (as amended by the Ryan Haight Act) ▪ “No controlled substance that is a prescription drug…may be delivered, distributed or dispensed by means of the Internet without a valid prescription.” › Note: “dispense” is defined in §802(10) to include prescribing
FEDERAL REGULATION OF PRESCRIBING CONTROLLED SUBSTANCES ▪ Controlled Substances Act (as amended by the Ryan Haight Act) ▪ “Valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by – › A practitioner who has conducted at least 1 in-person medical evaluation of the patient, or a covering practitioner ▪ In-person medical evaluation means a medical evaluation that is conducted with the patient in the physical presence of the practitioner
COLLECT INFORMATION – ABOUT ABUSE / DIVERSION PROBLEM AREAS: 1) Failure to recognize doctor shoppers Red Flags ▪ Symptom incompatible with reported injury ▪ Visit physician some distance from home ▪ History of problems with no medical records ▪ Multiple accidents ▪ Insist on drug of choice ▪ Loss of prescription or medication ▪ Fails to provide or go for testing ▪ Takes more meds than directed ▪ Requests meds early ▪ Meds from multiple physicians ▪ Prescriptions filled at multiple pharmacies ▪
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