Randy Easterling, MD, FAAFP

Medical Director / Addiction Specialist: Pathway Healthcare,

Vicksburg, MS

Addictionologist: Marion Hill Chemical

Dependency Unit River Region System, Vicksburg, MS

Member: Mississippi State Board of Medical

Licensure

Eric Bolling’s Son

Good Morning! I am from the government and I am here to help you!

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Revision of Part 2640, Chapter 1:Rules Pertaining to Prescribing, Administration, and Dispensing of Medications

Revisions have been on going for approximately

3 years.

Why So Long? History

Do we still have an Opioid/Prescription drug problem in the United States and in Mississippi?

In an October 5, 2017 Edition of USA Today

• Dr. Debra Houry – Director of the Centers for Disease Control and Prevention National Center for Injury Prevention and Control said, “it (opioids) is one of the few public health problems that is getting worse instead of better.”

United States Senator Lamar Alexander, Republican from Tennessee – Member of the Senate Health, Education, Labor and Pensions Committee said in an open hearing, “The Opioid Crisis is tearing our communities apart, tearing families apart, and posing an enormous challenge to health providers and law enforcement officials.”

In 2016:

• More than 11 million Americans misused Prescription Opioids

• One Million used Heroin

• 2.1 Million had an opioid use disorder due to Prescription Opioids or Heroin

• There is an continued increase in overdose deaths involving illicitly made Fentanyl and other highly potent synthetic opioids.

• More than 300,000 Americans have died of an opioid overdose since 2000. Data shows that in excess of at least 64,000 drug overdose deaths in 2016 (approximately 75-80% of which are opioid related). This is the highest number ever recorded in the United States in a single year.

Mississippi

Hopefully, the tide is slowly turning. But

remember, even with a decrease in Prescribing

and Dosage Units, Mississippi still ranks

among the highest States in terms of Prescribing

Opioids per 100 people.

What About The Magnolia StateIMS Health

• 2012 - Mississippi ranked 6th in the Nation with 120.2 Opioid Prescriptions per 100 people.

• 2015 - Mississippi ranked 5th in the Nation

• September, 2016 Mississippi ranked 4th in the Nation in Opioid Prescriptions per 100 people.

• 2017 – CDC data places Mississippi in a group of States ranked highest in the Nation at 96-143 Opioid Prescriptions per 100 people (WV, OH, KY, AL, TN, AR, LA) – Total of 13 States

• During the first 3 quarters of 2017, over 2.5 Million Opioid Prescriptions were dispensed in Mississippi

The Magnolia State

On average, one half of a million dosage units (pills) were

dispensed everyday in 2017

Opioid Prescription in Mississippi January-September, 2017, equaled

2,537,155 - Decrease of 6%

Opioid Dosage Units in Mississippi January-September, 2017, equaled

140,723,874 - Decrease of 7.5%

Opioid Victims

Now, back to the exciting part.

Part 2640, Chapter 1We will try to hit the high points and address areas of concern.

FIRSTIf you hear nothing else, HEAR this.

THERE IS NOTHING IN REVISION OF PART 2640 THAT PROHIBITS ANY PATIENT IN THE STATE OF MISSISSIPPI FROM GETTING PAIN PILLS (OPIOIDS) FOR A LEGITIMATE MEDICAL AND/OR SURGERICAL REASON.

Changes

(Revisions & Revisions)

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Pain Management

Definition

Rule1.2 Definitions

“Pain Management Practice” means a public or privately owned practice for which 30% or more of the patients are issued, on a regular or recurring basis, a prescription for opioids, barbiturates, benzodiazepines, carisoprodol (Soma), butalbital compounds, or tramadol for the treatment of chronic non-cancerous/non-terminal pain

Included in this definition is any practice that advertises and/or holds itself out to provide Pain Management Services.

Patients who are treated for pain resulting from terminal illness do not count against the percentage stated herein.

Rule 1.3 Registration for Controlled Substance Certificate

• If you provide medical care in a Pain Management Practice, you must review the PMP at each patient encounter in which a prescription for a controlled substance is issued

• Every Licensee must review the PMP at each patient encounter in which an opioid is prescribed for acute and/or chronic non-cancerous non-terminal pain

• Every Licensee whose practice is not a Pain Management Practice must utilize the PMP upon initial contact with new patients and at least every 3 months thereafter on any and all patients who are prescribed, administered, or dispensed controlled substances other than opioids

Exceptions

• Prescribers for Lomotil, Lyrica, Testosterone, and/or Amphetamines prescribed for patients under the age of 16 for the treatment of Attention Deficit Hyperactivity Disorder

PMP

• A copy of the PMP or reference to reviewing the PMP must be documented in the patient’s chart

• A properly registered designee of the licensee may run/obtain the report for the licensee

• Utilization of the PMP is not required when treating inpatients. However, upon discharge from the inpatient facilities, a PMP must be run if the patient is being discharged with a prescription for a controlled substance (other than exceptions mentioned previously)

Rule 1.4 – Maintenance of Records and Inventories

• Licensee must not prescribe, administer, or dispense any legend drug, controlled substance, or any drug having an addictive forming or addiction sustaining liability without a Good Faith prior examination and medical indication

• Exceptions – Via appropriate telemedicine as defined in Rule 1.5 of Part 2635, Calling in Refills, Taking call for a Practice Partner for a Short Term of Care etc…

Rule 1.7 – Use of Controlled Substances for Chronic (Non-Terminal) Pain

• NO Licensee shall order, prescribe, administer, or dispense any controlled substance or other drug having addiction forming or addiction sustaining liability for the purpose of “Detoxification Treatment” or “ Maintenance Treatment” and no Licensee shall order, prescribe, administer, or dispense any narcotic controlled substance for the purpose of “Detoxification Treatment” or “Maintenance Treatment” unless the Licensee is registered in accordance with Section 21U.S.C.823(g)

• Nothing in this paragraph shall prohibit a licensee from prescribing, ordering, administering, or dispensing controlled substances to prevent withdrawal until the patient is in treatment and/or to treat acute pain

Acute Pain

• Prescribe the lowest possible dose of Immediate Release Opioids

• Licensees are discouraged from prescribing or dispensing more than a 3 day supply of opioids for acute non-cancer/non-terminal pain and must not provide greater than a 10 day supply for acute non-cancer/non-terminal pain

• May order refills for the 10 day supply

• Additional 10 day supply, with 1 refill, may be issued if deemed medically necessary and only if supported by additional clinical evaluation

• Check PMP each time a Scheduled II Medication is prescribed for acute or chronic non-cancer/no-terminal pain

A recently published article with the British Medical Journal was led by Harvard Medical School Researchers. The study concluded:

• How long you take opioid painkillers after surgery is a much stronger risk factor for addiction and overdose than the dosage of opioids you take.

• The new study included more than 560,000 people who were prescribed opioids such as OxyContin or Percocet after surgery, None had a history of recent or chronic opioid use.

• Each additional week of opioid use increased the risk for addiction or nonfatal overdose by 20%. Each additional refill increased the risk by 44%. The first refill more than doubled the risk.

• Overall, about 5,900 study participants developed an opioid addiction or had a nonfatal overdose. One-Third of those misuse diagnosis occurred within a year of a patient’s surgery.

Warning

• It is a relative contraindication (Black Box Warning) to prescribe opioids concurrently with benzodiazepines and/or Soma for either chronic or acute pain.

• This may be done on a short term basis in the setting of an acute injury when opioids are required

• Prescribing opioids concurrently with benzodiazepines and/or Soma may be allowed under limited circumstances in which the combination is used to treat very specific Chronic medical conditions for which there is no other treatment modality available

PMP

• When licensee treats chronic non-cancerous/non-terminal and/or psychiatric conditions outside a Pain Management Practice, you MUST check a PMP at least every 3 months

Drug Testing

• Point of Service Drug Testing must be done at least 3 times per calendar year when Schedule II medications is written for the treatment of chronic non-cancerous/non-terminal pain

• Applies also for Benzodiazepines for Chronic Medical and/or psychiatric conditions which are non-cancerous/non-terminal

• All Hospice patients are exempt from Point of Service Drug Testing

Drug Utilization In Practice, January 2018

10 Step Assessment and Treatment Algorithm from the American Society of Interventional

Pain Physicians encourages the use of:

1. Comprehensive Patient Assessment

2. Use of Prescription Monitoring Programs

3. Urine Drug Screening

4. Pill Counts

Family Practice Management, February 14, 2018

Chronic Pain in Opioid Medication Policies should include frequent use of Prescription Monitoring Programs and Urine Drug Screening

Methadone

• The use of Methadone to treat Acute non-cancerous/non-terminal pain is prohibited

• The use of Methadone to treat Chronic non-cancerous/non-terminal pain is permissible within a Registered Pain Management Practice or when resulting from a referral to a Certified Pain Specialist

• If Methadone is prescribed to treat Chronic non-cancerous/non-terminal pain, it must be prescribed only by a Physician

Rule 1.10 Prescription Guidelines –

Controlled Substances

• Prescriptions for Benzodiazepines must be limited to a 1 month supply with NO more than 2 Refills or a 90 day supply with NO Refills

Rule 1.11

• Prior to the initial issuance of an Opioid and/or Benzodiazepine for the treatment of Chronic non-cancerous/non-terminal pain, each patient in a Pain Management Practice must have an in person evaluation by a Registered Pain Management Physician

Nashville Mayor