WHAT PSYCHIATRISTS NEED TO KNOW Donna Vanderpool, MBA, JD Vice - - PowerPoint PPT Presentation

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

• pioid 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

• utweigh 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

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

PROBLEM AREAS:

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

2) Diversion

▪

Possible indicators

▪

Inordinately large quantity of controlled substances was prescribed

▪

Large numbers of prescriptions were issued

▪

No physical exam

▪

Physician warned patient to fill prescriptions at different pharmacies

▪

Physician issued prescriptions to patient known to be delivering drugs to

• thers

▪

Physician prescribed controlled substances at intervals inconsistent with legitimate medical treatment

▪

Physician used street slang rather than medical terminology for drugs prescribed

▪

No logical relationship between drugs prescribed and treatment of alleged condition

PROBLEM AREAS:

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

3) Excessive / Unauthorized Prescribing 4) Internet Prescribing PROBLEM AREAS:

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

Document: ▪ Legitimate reason for prescribing ▪ Analysis of prior records ▪ Adequate history and physical examination ▪ History of drug abuse ▪ Supporting x-rays, etc. ▪ Continued re-evaluation of pain relief and function ▪ Treatment plan

SUGGESTIONS

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

Document (Continued): ▪ Patient’s compliance with meds and treatment ▪ Amount of controlled substances prescribed ▪ Amount used since last visit ▪ Amount of dosages remaining ▪ Amount of pain relief ▪ Improvement in function ▪ Evidence of abuse / diversion

SUGGESTIONS

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

▪ Pain management contract ▪ Pill counts ▪ Surprise drug testing ▪ PMP ▪ Adhere to clinical guidelines

SUGGESTIONS

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

COMMON CHARACTERISTICS OF THE DRUG ABUSER

▪ From the DEA:

› Unusual behavior in waiting room › Assertive personality, often demanding immediate action › Unusual appearance › Unusual knowledge of controlled substances and/or textbook symptoms › Evasive or vague answers to questions regarding medical history

(DEA brochure)

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

(CONTINUED)

› Reluctant or unwilling to provide reference information › No regular doctor; no health insurance › Will request a specific controlled drug and is reluctant to try a different drug › No interest in diagnosis; fails to keep appointments for further diagnostic tests or refuses to see another practitioner for consultation › Exaggerates medical problems and/or simulates symptoms › Cutaneous signs of drug abuse

(DEA brochure)

U.S. V. ROSEN, 582 F2D 1032 (1978)

“We are, however, able to glean from reported cases certain recurring concomitance of condemned behavior, examples of which include the following:

1) An inordinately large quantity of controlled substances was prescribed. 2) Large numbers of prescriptions were issued. 3) No physical examination was given. 4) The physician warned the patient to fill prescriptions at different drug stores. 5) The physician issued prescriptions to a patient known to be delivering the drugs to others.

U.S. V. ROSEN, 582 F2D 1032 (1978)

6) The physician prescribed controlled drugs at intervals inconsistent with legitimate medical treatment. 7) The physician involved used street slang rather than medical terminology for the drugs prescribed. 8) There was no logical relationship between the drugs prescribed and treatment of the condition allegedly existing. 9) The physician wrote more than one prescription on

• ccasions in order to spread them out.

(CONTINUED)

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

MODUS OPERANDI / SCAMS USED

▪ From the DEA:

› Must be seen right away › Wants an appointment toward end of office hours › Calls or comes in after regular business hours › Traveling through town, visiting friends or relatives › Feigning physical problems

(DEA brochure)

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

MODUS OPERANDI / SCAMS USED

▪ From the DEA (Continued):

› Feigning psychological problems › States that specific non-narcotics do not work or he is allergic to them › States prescription has been lost or stolen › Requests refills more than originally prescribed › Pressures by eliciting sympathy or guilt › Utilizes a child or elderly person when seeking stimulants or narcotics

(DEA brochure)

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

MODUS OPERANDI / SCAMS USED

▪ From the MO Task Force:

› Obese person scam › Grandparent scam › Pain while traveling scam › Hyperactive child scam › Forged or stolen records scam

(MO, 2011)

COLLECT INFORMATION – ABOUT ABUSE / DIVERSION

MODUS OPERANDI / SCAMS USED

▪ From the MO Task Force (Continued):

› Help me, I’m an addict scam › Police report scam › Friend in doctor’s office scam › Asleep at wheel scam › Aggravated stump scam

(MO, 2011)

COLLECT INFORMATION - ENFORCEMENT

Who are your regulators?

▪ Federal DEA works closely with state licensing boards and state local law enforcement ▪ Majority of investigations of controlled substance laws are done by state authorities ▪ DEA will also conduct investigations of federal law

COLLECT INFORMATION - ENFORCEMENT

▪ Primary agency charged with policing the issuance and dispensing of controlled substances ▪ ~ 5,000 Special Agents, ~ 600 Diversion Investigators ▪ $2.018 billion 2015 budget ▪ Per CSA: must be a legitimate medical purpose and must be acting in usual course of practice ▪ Penalties: imprisonment, fines, loss of DEA license

DOJ / DEA

COLLECT INFORMATION - ENFORCEMENT

▪ CSA authorizes DEA to enter controlled premises and conduct periodic inspections ▪ Buprenorphine prescribers:

▪ “Inspection” – investigators look at records for buprenorphine patients ▪ Need log of buprenorphine patients and prescriptions in location listed on DEA registration ▪ “Audit” – if also dispenses, will look at meds received and dispensed

DEA VISITS

KEVINMD.COM

“A DEA agent explains how to fight the opioid crisis and mitigate DEA risk”

• Dennis Wichern

(Wichern, 2018)

COLLECT INFORMATION – CRIMINAL ENFORCEMENT

▪ Focus of government

▪ Prescribing in large quantities ▪ Prescribing without checking PMP ▪ Prescribing for patients who fatally overdose ▪ Inappropriate prescribing to Medicare beneficiaries ▪ Etc.

▪ Plan ahead!

▪ May need criminal defense attorney on speed dial

COMMUNICATE

▪ With patient ▪ With others

▪ Treaters ▪ Family / significant others

COMMUNICATE – ASSESSMENT AND MONITORING

▪ Conduct thorough patient examination, interview, and assessment ▪ Consider standardized assessment and documentation tool

› Especially for pain ▪ Ex: PADT from Janssen

COMMUNICATE – INFORMED CONSENT

Standard Elements:

▪ Nature of proposed medication ▪ Risks and benefits of proposed medication

› Including potential for tolerance, dependence, addiction, overdose

▪ Alternatives to proposed medication ▪ Risks and benefits of alternative treatments ▪ Risks and benefits of doing nothing

Plus:

▪ Prescribing policies ▪ Reasons for which medication may be changed or stopped

COMMUNICATE – INFORMED CONSENT

“MATERIAL RISK”

▪ Disclose risk if SEVERE, even if infrequent ▪ Disclose risk if FREQUENT, even if not severe ▪ Disclose possible driving impairment ▪ Golden Rule

COMMUNICATE – TREATMENT AGREEMENT

▪ Can Cover:

› Intended benefits of using controlled substances › Risks of the treatment – tolerance, dependence, abuse addiction › Prescription management – security of meds

COMMUNICATE – TREATMENT AGREEMENT

• Can Cover (Continued):

› Office policies

▪ Only one prescriber ▪ Only one pharmacy ▪ Not replacing lost or stolen prescriptions ▪ Prohibiting dose or frequency increased by patient ▪ Use of PMP ▪ Random pill counts ▪ Random urine screening

› Termination for

▪ Failure to adhere to treatment plan ▪ Aberrant Behavior

› Etc.

COMMUNICATE – DISPOSAL OF UNUSED MEDICATIONS

The FDA’s “Disposal of Unused Medicines: What You Should Know”

(FDA, 2018)

COMMUNICATE – WITH OTHERS

▪ Other providers:

› Covering › PCP, specialists › Consultants

▪ Family

› Remember: safety = exception to confidentiality

CAREFULLY DOCUMENT

Document your decision-making process ▪ What you did in treatment and why ▪ What you considered, but rejected and why

CAREFULLY DOCUMENT

Generally:

▪ Medication log ▪ Evaluation ▪ Medial indication for prescription ▪ Treatment plan

› Initial › Updated

▪ Treatment agreement, if any

› Subsequent discussions about agreement

CAREFULLY DOCUMENT

Generally (Continued):

▪ Informed consent

› Patient Education Materials

▪ Ongoing assessment

› Adherence to treatment plan › Medication monitoring › Aberrant behavior

▪ Referral / consultation, if necessary ▪ Basis for clinical decision-making

CAREFUL DOCUMENTATION

Remember:

▪ There’s no such thing as a perfect record ▪ Defense attorneys can work with adequate records ▪ Defense attorneys cannot work with no records or altered records

CAREFUL DOCUMENTATION

Professional Judgment – Bottom Line:

▪ By articulating the basis for medical decisions in the record, the psychiatrist’s professional medical judgment will be clear and available to defend the psychiatrist against allegations of malpractice.