Jennifer Placencia, PharmD, BCPPSCatherine Pham, PharmD

Opioid Stewardship in a Pediatric World

Disclosures

§ The following declare they have no relevant financial interest in relation to this activity

– Catherine Pham, presenter– Jennifer Placencia, presenter

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Objectives

1. Explain the scope of the opioid epidemic in the United States.

2. Describe the additional challenges that exist in a pediatric patient setting.

3. Design pain management plans and propose opioid use reduction strategies.

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Controlled Substance

§ A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V

https://www.deadiversion.usdoj.gov/

FentanylHydrocodone-APAPHydromorphoneMeperidineMethadoneMorphineOxycodone

APAP-codeineBuprenorphine

Guaifenesin-codeinePromethazine-codeine

Heroin

Tramadol

5https://www.hhs.gov/opioids/sites/default/files/2019-01/opioids-infographic_1.pdf

The Opioid Crisis

https://www.npr.org/2019/01/14/684695273/report-americans-are-now-more-likely-to-die-of-an-opioid-overdose-than-on-the-ro

The majority of drug overdose deaths involve an opioid. Opioid overdoses

accounted for more than 47,000 deaths in 2017, more than any previous year

on record. Of these opioid overdose deaths, approximately what percentage

involved a prescription opioid?

a. 20%

b. 40%

c. 60%

d. 80%

7https://www.hhs.gov/opioids/about-the-epidemic/index.html

The Opioid Crisis

Centers for Disease Control and Prevention. 2018 Annual Surveillance Report of Drug-Related Risks and Outcomes —United States. Surveillance Special Report, U.S. Department of Health and Human Services. Published August 31, 2018.

U.S. Opioid Epidemic

§ Opioid crisis declared as public health emergency by U.S. Department of Health and Human Services (HHS) in October 2017

§ HHS 5-Point Strategy– Improve access to addiction treatment & recovery services– Promote use of overdose-reversing drugs– Strengthen understanding of epidemic through better public

health surveillance– Provide support for cutting edge research on pain & addiction– Advance better practices for pain management

9https://www.hhs.gov/opioids/about-the-epidemic/index.html

Prescription Drug Abuse

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§ Misuse of prescription drugs

– Use without prescription

– Use in greater amounts,

more often, or longer than

directed

– Use in any other way not

directed to be used

§ Sources

– Friend/relative

(given, stolen, purchased)

– Valid prescription

– Drug dealer

§ Reasons for abuse of opioid

pain relievers

– Relieve physical pain

– Feel good, get high

– Relax, relieve tension

– Help with sleep

https://www.samhsa.gov/data/sites/default/files/report_3210/ShortReport-3210.html

Opioid Prescribing Rates, 2017

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§ Harris County, TX = 42.4 prescriptions/100 persons§ Texas = 53.1 prescriptions/100 persons

https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html

Dispensed Opioid Prescriptions in U.S.

12https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html

13https://www.cdc.gov/drugoverdose/pdf/pubs/2018-cdc-drug-surveillance-report.pdf

Corresponding Responsibility

§ Controlled substances must only be prescribed, dispensed, delivered, or administered for valid medical purposes and in the course of medical practice

§ “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription”

14https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm

CS Prescription Requirements

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§ Name, address, and date of birth or age of patient

– Owner name, owner address, animal species (veterinary rx)

§ Date of issue– Cannot be postdated

§ Earliest fill date, if schedule II rxto be filled at later date

§ Name and strength of medication

§ Quantity– Numerically, followed by number written

as a word (written rx)– Numerically (electronic rx)

§ Directions for use§ Intended use

– “Unless the practitioner determines the furnishing of this information is not in the best interest of the patient”

§ Name, address, DEA number, and telephone number of practitioner at usual place of business

– APRN/PA can only use forms that include delegating physician’s name & DEA number

§ Signature of prescriber– Manually signed

§ Written in ink or indelible pencil or typewritten

https://www.pharmacy.texas.gov/controlledsubstances.asp

New Schedule II Controlled Substance Prescription Pad§ EFFECTIVE September 1, 2018, the official prescription forms

will include additional security features to prevent fraud.– True watermark which is pressed into the paper and is visible

from either side in regular lights– The thermochromic ink (previously on the back of the form as

a red check) is now on the front of the form as an Rx symbol.

▫ This feature can be verified by rubbing the red “Rx” with your fingers, at which time it should fade and then reappear.

16https://www.pharmacy.texas.gov/CIIforms.asp

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New Schedule II Controlled Substance Prescription Pad

EFFECTIVE June 1, 2019, ALL official

prescription forms ordered prior to

September 1, 2018, will no longer be valid.

https://www.pharmacy.texas.gov/CIIforms.asp

Prescribing Practices

§ Prescribing CS– Schedule II: official written prescription form or electronic prescription, no refills, valid for 21 days

– Schedule III-V: can be written/electronic/facsimile/oral/telephonically communicated with no more

than 5 refills, valid for 6 months

§ Prescriptions may not be issued for purposes of general dispensing to

patients

§ Designated agents– Communicate and prepare prescriptions on behalf of practitioner

– Practitioner personally responsible for actions of agent

§ Delegation to APRN and PA– Prescriptive authority agreement

– Schedule II: hospice care patients

– Schedule III-V: prescription cannot exceed 90 days (including refill)

18https://www.pharmacy.texas.gov/controlledsubstances.asp

Lucille, an advanced practice registered nurse, has a prescriptive authority agreement with Dr. Adam Jones, MD. Assuming valid patient-practitioner relationship and legitimate medical need have been established, she is legally authorized to…

a. Call in a prescription to the pharmacy for hydrocodone-APAP 5 mg-325 mg tablets (#18, 1 tab PO Q4 PRN pain, 11 refills)

b. Fax a prescription to the pharmacy for oxycodone 1 mg/mL(#30, 1 mL PO Q6 PRN pain, 5 refills)

c. Write a prescription for morphine ER 15 mg tablets (#60, 1 tab PO BID, 8 refills)

a. Electronically submit a prescription to the pharmacy for tramadol 50 mg tablets(#12, 1 tab PO Q6 PRN pain, 1 refill)

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Naloxone Standing Order

§ Texas pharmacists can dispense and administer opioid antagonist (including necessary supplies) via physician-signed standing order

– Can dispense to any person at risk of opioid overdose

– Can dispense to family member, friend, or other caregiver

20https://www.pharmacy.texas.gov/files_pdf/TSBP%20Rules_MASTER%20FILE.pdf

Naloxone Administration

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§ Give for known or suspected opioid overdose

– Respiratory and/or central nervous system depression

§ Seek emergency medical care immediately after administration

– Additional dose may be given every 2-3 minutes

§ Severe opioid withdrawal may occur

§ Safety and efficacy established in all ages

http://www.drugfreenorthernmichigan.net/recovery/naloxone-saves-lives.html

Diversion

§ Any act or deviation that removes prescription medication from lawful purpose into illicit drug traffic

§ Texas Health and Safety Code 481.1285: Diversion of Controlled Substance

– Knowingly converts to the person’s own use or benefit a controlled substance to which the person has access by virtue of the person’s profession or employment

– Knowingly diverts to the unlawful use or benefit of another person a controlled substance to which the person has access by virtue of the person’s profession or employment

22https://www.dea.gov/diversion-control-division

What is a common risk point of controlled substance diversion in health systems?

a. Procurement

b. Preparation

c. Prescribing

d. Administration

e. Waste

23http://www.ajhp.org/content/early/2016/12/22/ajhp160919?sso-checked=true

Points of Controlled Substance Diversion

Procurement:§ Purchase order/packing slip removed from order§ Damage to the product container Preparation § Drug is replaced by similar looking substance or diluted with NS§ Multi-vial overfill is divertedPrescribing§ Prescription pads are stolen and used for forged prescriptions§ Patients alter their prescriptions Administration§ Medication is documented as given, but never administered§ Waste is not disposed of properly and is divertedWaste§ Waste is removed from disposal container§ Waste is replaced with similar looking substance

24http://www.ajhp.org/content/early/2016/12/22/ajhp160919?sso-checked=trueUsed with permission from Jeff Wagner

Why is Oversight Important?

§ Protect our patients– Care delivery by impaired provider– Failure to administer medications to patients in need– Exposure to blood-borne pathogens as a result of tampering

§ Protect our staff and providers– Criminal prosecution, civil liability, loss of license & fines– Separation/divorce, loss of custodial rights, financial loss, death

▪ Protect Texas Children’s– Liability- civil & regulatory– Negative publicity– Fines, loss/restriction of license

25http://www.ajhp.org/content/early/2016/12/22/ajhp160919?sso-checked=trueUsed with permission from Jeff Wagner

Recognizing Diversion

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§ Patients– “Strange” stories

▫ e.g. travelers, last-minute appointments, stolen medication

– Reluctance to cooperate▫ e.g. refusal of physical exam

or contact with previous providers

– Unusually high or low understanding of medications

§ Colleagues– Excessive work absenteeism– Alternating periods of high and

low work performance– Confusion, memory loss,

difficulty concentrating– Sloppy recordkeeping, heavy

drug “wastage”– Deterioration in personal

appearance, hygiene, handwriting

– Mood swings, changing attitude/behavior

https://www.aafp.org/fpm/2001/1000/p37.html, https://www.deadiversion.usdoj.gov/pubs/brochures/drug_hc.htm

How Can We Combat Abuse?

§ PMP checks§ Quantity limits or recommended default quantities§ Risk-assessments/screening▪ Opioid contracts/controlled substance agreements▪ Pill counts

§ Education– Patient/patient’s family– Health care professionals– Take-back of unused medications

▪ Legislation – restricting accessibility to opioids

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Texas Prescription Monitoring Program (PMP)

▪ PMP AWARxE

§ An electronic database used to collect and monitor prescription data for all Schedule II, III, IV, and V controlled substances dispensed by a pharmacy

– In Texas– Or to a Texas resident from a pharmacy located in another state– Pharmacies required to report all dispensed controlled substances

records to the PMP no later than the next business day after the prescription is filled

▪ The PMP also provides a venue for monitoring patient prescription history for practitioners and the ordering of Schedule II Texas Official Prescription Forms.

28 https://www.pharmacy.texas.gov/index.asp

29https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF

House Bill 2561 (The Sunset Bill)

§ Currently, pharmacists and prescribers are encouraged to check the PMP to help eliminate duplicate and overprescribing of controlled substances, as well as to obtain critical controlled substance history information.

§ Passed During 2017 Legislative Session– Beginning September 1, 2019, pharmacists and prescribers (other than

a veterinarian) will be required to check the patient’s PMP history before dispensing or prescribing opioids, benzodiazepines, barbiturates, or carisoprodol.

https://texas.pmpaware.net/login

30 https://www.pharmacy.texas.gov/index.asp

Texas Medicaid Prescription Limits

31https://www.txvendordrug.com/about/news/2018/01/morphine-equivalent-dose-limitations-traditional-medicaid-decrease

Challenges Within the Pediatric Patient Population

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§ Guidelines/recommendations are based off of adult population– Focus on MME equivalents

§ Risk assessment tools – screen the patient. It is more challenging to screen for the family’s risk.

§ Medication disposal – parents don’t want their child to be in pain so they often keep the medication “just in case”

33https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF

Sources of Abused OpioidsAges 12 or Older; 2013 and 2014

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From a friend or relative for freeFrom one doctorBought from friend or relativeStole from friend or relativeBought from drug dealer or other strangerFrom more than one doctor

SAMHSA, Center for Behavioral Health Statistics and Quality, National Surveys on Drug Use and Health (NSDUHs), 2013 and 2014.

35https://nabp.pharmacy/initiatives/awarxe/drug-disposal-locator/

https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1

https://www.walgreens.com/topic/pharmacy/safe-medication-disposal.jsp

Household Trash Disposal

38https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#household

FDA Flush List

Medication Disposal

39https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#household

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The medical team plans to initiate morphine treatment for a patient, which will be continued following discharge from the hospital. Today’s date is September 2, 2019.

§ What considerations would be important to think about before writing the prescription?

§ What counseling points would you like to review with the patient?

Abuse-Deterrent Formulations

§ Physical barriers – resistant to tampering (physical or chemical)§ Chemical barriers – addition of an opioid antagonist§ Aversion barriers – addition of substances that produce

unpleasant effects (if taken inappropriately)§ Prodrug barriers – meds must undergo biotransformation to

produce active ingredient§ Route-of-Administration barriers – resistant to physical

tampering due to limitations in administration

41http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2667599

Downside To Abuse-Deterrent Formulations

§ Some policy shifts enacted in response to the opioid crisis may have had adverse public health effects.

§ Opioid users with untreated addictions often turn to riskier illicit drugs.▫ Hepatitis C rates increased three times faster in states with the

highest non-medical OxyContin use.▫ Separate studies have shown that the OxyContin reformulation

also drove a spike in heroin-related deaths.

42https://www.statnews.com/2019/02/04/purdue-abuse-deterrent-oxycontin-hepatitis-c-infections/

Development & Approval of New Formulations

§ FDA has created four avenues to expedite these types of medications:

– Fast-track, Breakthrough Therapy, Priority Review & Accelerated Approval

§ National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) tracks drugs abuse trends on a national scale

– This information helps guide the development of abuse-deterrent formulations of medications▫ Do users inject certain medications most often? Do they

crush and inhale it? 43http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2667599

Pain Management Strategies

§ Utilize non-pharmacologic strategies– Child life– Pet therapy– Art therapy– Music therapy– Distraction Techniques– Positioning

§ Utilize non-opioid medications when reasonable – APAP or ibuprofen

▪ Reassess patient 3 days post-op to identify their pain needs

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The Pendulum Effect

§ The theory holding that trends in culture, politics, medicine, etc. tend to swing back and forth between opposite extremes.

45https://kerririchardson.com/the-pendulum-principle/

QUESTIONS?

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