Risk Management: Safe Prescribing Practices

in Mental Health

Carolyn Buppert, MSN, JD

Law Office of Carolyn Buppert, P.C.

www.buppert.com

buppertcarolyn@gmail.com© 2018 Carolyn Buppert

Disclosures

This presenter has no conflicts of interest,

commercial support, or off-label use to

disclose

Objectives

1. Describe cases against nurse practitioners involving prescribing for mental health conditions

2. Discuss risk management strategies

4 things an advanced practice clinician should never do when prescribing

•Pre-sign a prescription• Or, fill in a scrip pre-signed by someone else

•Prescribe without conducting and documenting an evaluation

•Prescribe a medication not specified on the collaborative agreement or authorized by state law

•Prescribe CS for self, friend or relative

Never pre-sign prescriptions

Cases:

Georgia MD served 8 months in federal prison for pre-signing prescription blanks so that, on his day off, the NPs he worked with could refill Rx's for chronic pain patients

Georgia PA sentenced to 41 months in prison for giving out pre-signed prescriptions while physician away for a week

NP recently lost her license for filling in pre-signed prescription

Here is the legal language

“All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner.” 21 CFR §1306.05

Never prescribe without conducting and documenting an evaluation

• Three risks

•Malpractice •Loss of license•Prosecution for prescribing controlled drugs without a legitimate medical purpose

Elements of malpractice

•Duty of care

•Breach of the standard of care

• Injury

•Causal relationship between the injury and the breach of the standard of care

Malpractice case involving prescribing without conducting and documenting an evaluation

Case:

• NP saw a 15-year-old girl at a CHC 2 days after the patient visited an ED with c/o nausea, abdominal pain and vomiting

•NP Rx'd anti-nausea medication and Prozac

•NP’s notes indicated she was treating depression

•NP told the patient to return in a month

Malpractice

•3 weeks later…patient hanged herself

•Suffered catastrophic brain injury

•Died 3 years later. During those 3 years, she required round-the-clock care

•Family sued the CHC, claiming the NP should not have prescribed Prozac because there were no signs of clinical depression

Malpractice

•Family claimed the FDA had issued a warning against prescribing Prozac for adolescents• They were correct

• FDA says Rx Prozac only for major depression

•NP argued her clinical evaluation supported a diagnosis of depression and the suicide attempt followed a breakup and family fight

•NP argued the medication played no part

Malpractice

•Damage award: $3,459,902

•FDA has approved Prozac for treatment of adolescents with major depressive disorder • NP had not documented having used a depression

screening tool, such as Beck or Reynolds

•No documentation of major depressive disorder

•NP breached standard of care

Risk of loss of license for not documenting an evaluation

Case:

NP prescribed for family, colleagues, friends

Did this for the friends’ conveniencePrescribed a controlled drug for friend

Friendship soured

Friend reported NPNP lost license

What were the NP’s infractions?

•No documentation of evaluation to justify prescriptions for friends, family or colleagues• Did not notify primary providers that she was prescribing

or refilling Rx’s

•Used prescription pad of former employer

•Prescribed for individual with known substance abuse problem

What about the NP’s collaboration agreement?

•Collaboration agreements don’t cover prescribing outside the workplace

•This NP was in Oregon, where collaboration is not required

•But in most states, there would be an additional problem for an NP prescribing for friends, family, self or colleagues

Additional malpractice cases involving psych and prescribing

Hand-off problem:

Man who killed his father during a psychotic episode filed suit against his psychiatrists and a nurse practitioner, claiming

• They failed to properly treat his mental illness• Did not insure his ongoing treatment when his primary

psychiatrist left the practice, leaving his case for a new clinician

Lesson learned

•Ensure continuity of care • When clinicians leave a practice• When a clinician is away

NP discontinued psych meds; patient assaulted coworker

•NP saw a new patient, recently discharged from hospital

•NP did not have old records

•Patient wanted to d/c psych meds

•NP agreed

•Patient returned in several weeks and attacked a staff member

•Staff member sued the NP for negligence

What we learn from this case

•For new patients with major psychiatric illness• Get old records and/or speak with previous providers

•Seek consultation before discontinuing antipsychotic medications• Miller, JJ. (2013) Discontinuing Medications: When, Why,

and How-to at

http://www.psychiatrictimes.com/cme/discontinuing-medications-when-why-and-how

NP failed to recognize suicide risk

Case:

•NP certified in child/adolescent psychiatry treated a 16-year-old for anxiety and depression

•After 6 months, patient overdosed on oxycodone belonging to stepfather

•Brain hypoxia, required care in facility

•Parents alleged negligence in treating depression

•Settlement: “High six figures”

Malpractice risk reduction strategies

•Prepare for hand-offs when a clinician is away

•Off-hours coverage

•Get old records before changing therapy

•Always ask the suicide risk questions

What controlled drugs do you prescribe?

•Antipsychotics?

•Mood stabilizers?

•Antidepressants?

•Antianxiety medications? Benzodiazepines?

•Stimulants?

•Muscle relaxers?

•Opioids?

•Buprenorphine?

How to manage your risk

•Benzodiazepines or muscle relaxers

•When combined with opioids, this cocktail is a killer•Get a full medication list, and don’t add a benzo for someone already on an opioid•Check state prescription drug monitoring registry

•Stimulants

•If treating ADD, send the patient for testing to confirm

•Buprenorphine – Get a waiver, training

Prescribing scheduled medications for

•Chronic non-cancer pain • Here is where the risk lies

•There is little controversy about prescribing pain medication for• Cancer-related pain• Acute, short-term non-cancer pain

Until several years ago, there were few guidelines on prescribing opioids for pain

Now, there are many, from

•State medical boards

•State health departments

•Medical societies

•CDC• See References

Common elements in guidelines

• Initial evaluation

• Affirm patient's identity• History, physical, urine screen, diagnostic tests to

ascertain diagnosis, screen for risk of abuse, depression• Affirm not pregnant, has reliable birth control method• Obtain old records or speak with previous provider• Check with state prescription drug monitoring program• Try, and document, trial of non-opioid• Establish a diagnosis that justifies the need for an opioid

Common elements in guidelines

•Choice of medication• Don't use benzos or sedatives concomitantly

Choice of medication, continued

• Avoid prescribing Methadone, unless you are a Methadone clinic

• Unusual pharmacokinetics compared with other opioids• Long half-life• Elderly are particularly susceptible to overdose

• Other drugs inhibit metabolism• Can induce torsade de points• Methadone clinics don't use state prescription drug

monitoring programs

Guideline elements

• Written agreements

• With patient, develop and document a treatment plan, with measurable goals (increase function, decrease pain)

• Patient agrees • this is a trial (90 days, at most) , may be discontinued

• agrees to use only one provider and pharmacy for pain meds

• agrees to drug testing

• agrees has been informed of risks (respiratory depression, etc.)

• agrees to safeguard medication

• agrees to keep pain diary, log daily activities

• agrees to refill process

Guideline elements

• Monitoring, with visit #2 and on

•5 A's• Analgesia• Activity ( function, overall quality of life)• Adverse events• Aberrant behavior• Affect

• Urine testing at least twice/year

• If greater than 80 morphine milligram equivalents/day, seek pain management consultation (See References for how to calculate MME)

Guideline elements

• Discontinuing opioid therapy (via taper)

• When condition is resolved• Intolerable side effects• Ineffective analgesia after trial

• Quality of life does not improve• Functioning deteriorates• Aberrant medication use

• Taper - 10% dose reduction /week over 6-8 weeks

Tools to use

• Opioid risk tool (ORT)

Points issued based on • Family history of substance abuse• Personal history of substance abuse• Age• History of pre-adolescent sexual abuse• Psychiatric illness

• Webster, Pain Med, 2005 at http://www.opioidrisk.com/node/884

If a patient is "high risk"

•More frequent visits, monitoring, urine tests

More Tools

• Pain intensity and interference (pain scale)• Mental health (PHQ-9, GAD, CAGE-AID)• Functional assessment (PEG)• Sheehan Disability Scale

• Source for tools above: http://www.mbc.ca.gov/licensees/prescribing/pain_guidelines.pdf

Do we have a new "standard of care"?

Standard of care comes into play:

- When clinician sued for malpractice

- When clinician reported to licensing board

- When clinician accused of a crime -- drug trafficking or running a pill mill

If sued/reported/accused, expect to be asked which guidelines you are following

Best practice when prescribing opioids --Always

•Conduct and document and evaluation that justifies the Rx

•Apply the tools cited

•Check out the patient on the state prescription drug monitoring website

•Document an unsuccessful trial on non-opioids

•Have a written agreement with the patient • What the patient agrees he has been told

• Patient's responsibilties

Best practice when prescribing opioids --Always

•Evaluate progress every month

•Document follow-up evaluation of 5 A's

•Urine testing at least twice/year

•Calculate MME for every dose change

•Taper and discontinue Rx's if goals aren't being met, and/or or refer to pain specialist

DEA expectations

• DEA expects clinicians to

• Prescribe appropriately (for a “legitimate medical purpose”)

• Make reasonable efforts to prevent abuse

Common characteristics of drug abuser (from the DEA)

•Unusual behavior in the waiting room

•Assertive personality, often demanding immediate action

•Unusual appearance - extremes of either slovenliness or being over-dressed

•May show unusual knowledge of controlled substances and/or gives medical history with textbook symptoms or gives evasive or vague answers to questions regarding medical history

Common characteristics of drug abuser (from the DEA)

•Reluctant or unwilling to provide reference information. Usually has no regular doctor and often no health insurance

•Will often request a specific controlled drug and is reluctant to try a different drug

•Generally has no interest in diagnosis - fails to keep appointments for further diagnostic tests or refuses to see another practitioner for consultation

Common characteristics of drug abuser (from the DEA)

•May exaggerate medical problems and/or simulate symptoms

•May exhibit mood disturbances, suicidal thoughts, lack of impulse control, thought disorders, and/or sexual dysfunction

•Cutaneous signs of drug abuse• http://www.deadiversion.usdoj.gov/pubs/brochures/drugabuser.htm#resp

Common scamsObese person scam

Grandparent scam

Pail while traveling scam

Hyperactive child scam

Toothache scam

Stolen records scam

I'm an addict scam

Good Samaritan MD scam

Racehorse scam

Police report scam

Friend in MD's office scam

Blood in the urine scam

Altered script scam....

Red flags – Stop and reconsider the prescription when

•Early refill requests

•Specific request for a particular drug

•Claim that certain drugs do not help•Reluctant to change medications

•Drug screens negative for prescribed drug

•Claims that drugs were lost

•You get an anonymous tip•Obtains drugs from multiple providers

•Uses more than one pharmacy

DEA’s “recurring concomitance of condemned behavior”

•Clinician prescribed inordinately large quantity of controlled substances

• Issued large numbers of prescriptions

•No physical examination documented

•Warned the patient to fill prescriptions at different drug stores

• Issued prescriptions to a patient known to be delivering the drugs to others

DEA’s “recurring concomitance of condemned behavior”

•Prescribed controlled drugs at intervals inconsistent with legitimate medical treatment

•Used street slang rather than medical terminology for the drugs prescribed

•No logical relationship between the drugs prescribed and treatment of the condition allegedly existing•Wrote more than one prescription for same drug at

one visit • United States v. Rosen, 582 F.2d 1032, 1035-1036 (5th Cir.

1978).

How clinicians get caught

How clinicians get caught

•The office, practice or clinic is identified or suspected of being a “pill mill”

• “Pill mill”: An operation in which a doctor, clinic or pharmacy prescribes and/or dispenses narcotics without a legitimate medical purpose

•Clinician may investigated, even if prescribing appropriately

Can you terminate a patient? Yes

• “I cannot continue to prescribe for you because I don’t want to harm you”

•Don’t terminate in the middle of an acute episode of illness

•Give 30-day notice

•You need not offer a replacement clinician, though some experts say you should

When prescribing, always

•Follow a current guideline or drug reference

•Document prescriptions written, transmitted verbally or refilled

• Inform the patient of precautions and possible side effects

•Understand what else the patient is on and how those meds might interact

Always order a consultation when prescribing opioids and

•Pain is not well controlled

•Patient has history of substance abuse

•Multiple symptoms require management

•Patient requests increasing doses

•Patient unable to care for self and caregivers are inconsistent, strained, or burned out

•Patient with major or untreated psychopathology

•You suspect medication abuse

Thank you for coming!

References

• Miller, JJ. (2013) Discontinuing Medications: When, Why, and How-to at http://www.psychiatrictimes.com/cme/discontinuing-medications-when-why-and-how

• DEA manual for practitioners at www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html

Resources

•Prescription Drug Monitoring Programs• http://www.nascsa.org/rxMonitoring.htm

•DEA manual for practitioners• www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html

•How to calculate Morphine Milligram Equivalents • https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose

-a.pdf

References

• Broglio, K. and Cole, B. (2014) Prescribing Opioids in Primary Care: Avoiding perils and pitfalls, The Nurse Practitioner, 39 (6): 30-37

• Buppert, C. (2015) New Standard of Care for Prescribing Opioids• https://www.medscape.com/viewarticle/842994_3

• Buppert, C. (2017) Prescribing: Preventing Legal Pitfalls, www.buppert.com

• Buppert, C. (2015) Frequently Asked Legal Questions Keeping Nurses Awake at Night, www.buppert.com

References

• Chou, R., and Argoff, CE. (2014) 11 Tips for Better Opioid Prescribing, Medscape neurology --www.medscape.com/viewarticle/831323

• Franklin, G. (2014) Opioids for chronic non-cancer pain: A position paper of the American Academy of Neurology, Neurology, Vol. 83 No. 14, 1277-1284 at http://www.neurology.org/content/83/14/1277.full

• CDC Guidelines, January 2016 at http://www.cdc.gov/drugoverdose/prescribing/guideline.html