Opioid Stewardship in a Pediatric World - Jennifer L. Placencia, PharmD, BCPPS Clinical Pharmacy Specialist - Pain, Palliative Care and Opioid ...
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Opioid Stewardship in a Pediatric World Jennifer L. Placencia, PharmD, BCPPS Clinical Pharmacy Specialist – Pain, Palliative Care and Opioid Stewardship January 21, 2021
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. Outline the steps to take to reduce the impact of the
opioid epidemic on patients.
2
Controlled Substance
A medication or other substance, or immediate precursor, included
in schedule I, II, III, IV, or V
Fentanyl
Heroin Hydrocodone
Hydromorphone
Meperidine
Methadone
Morphine
Oxycodone
APAP-codeine
Buprenorphine
Ketamine
Tramadol
Guaifenesin-codeine
Promethazine-codeine
Pregabalin
https://www.deadiversion.usdoj.gov/
https://www.hhs.gov/opioids/sites/default/files/2019-01/opioids-infographic_1.pdf
4
The Opioid Crisis
This now makes opioid overdose a Top 5 cause of death
behind heart disease, cancer, chronic lower respiratory
disease and suicide.
https://www.tmc.edu/news/2019/01/odds-of-dying-for-the-first-time-opioid-overdoses-exceed-car-crashes/
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%
https://www.hhs.gov/opioids/about-the-epidemic/index.html
6
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
https://www.hhs.gov/opioids/about-the-epidemic/index.html
8
Prescription Drug Misuse
Misuse of prescription drugs Reasons this occurs
– Use without prescription – Relieve physical pain
– Use in greater amounts, – Feel good, get high
more often, or longer than – Relax, relieve tension
directed – Help with sleep
– Use in any other way not
directed to be used
Sources
– Friend/relative
(given, stolen, purchased)
– Valid prescription
– Drug dealer
https://www.samhsa.gov/data/sites/default/files/report_3210/ShortReport-3210.html
9
Opioid Prescribing Rates, 2018
Texas = 47.2 prescriptions/100 persons (down from 53.1 prescriptions/100 persons in 2017)
Harris County, TX = 37.9 prescriptions/100 persons (down from 42.4 prescriptions/100 persons in 2017)
https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html
10Dispensed Opioid Prescriptions in U.S.
https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html
11https://www.cdc.gov/drugoverdose/pdf/pubs/2019-cdc-drug-surveillance-report.pdf
12Why Are We Worried When We Take Care of Pediatrics?
Medication Child
Diversion Ingestion
Neglect Adolescents
13Why Are We Worried When We Take Care of Pediatrics?
Medication
Diversion
14Sources of Abused Opioids
4%
3%
From a friend or relative for free
5%
4% From one doctor
Bought from friend or relative
11%
51% Stole from friend or relative
Bought from drug dealer or other
stranger
From more than one doctor
22%
Other
Ages 12 or Older; 2013 and 2014
1
5
SAMHSA, Center for Behavioral Health Statistics and Quality, National Surveys on Drug Use and Health (NSDUHs), 2013 and 2014.How Can We Prevent Diversion?
Medication
Storage
Disposal
Checking
Pill Counts
the PMP
16https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF
17Storage
Opioids should
be kept in their They should be
Ideally, they stored in a place
original package should be stored
so they are not They should be that medications
in a locked box are not usually
kept out of reach that only the
accidently of children
confused for kept (such as a
user or caregiver bathroom or
another has the key to kitchen cabinet)
medication
18https://nabp.pharmacy/initiatives/awarxe/drug-disposal-locator/
19https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1
https://www.walgreens.com/topic/pharmacy/safe-medication-disposal.jsp
FDA Flush List Household Trash Disposal
https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicin
22 es/ucm186187.htm#householdMedication Disposal
https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#household
23Medication Disposal
Rx Destroyer®* ALL-PURPOSE Formula
Rx Destroyer™ patented formula controls: Fast dissolving formulation breaks
medications down quickly
Specialty formulated activated carbon process allow for increased capacity
Container system automatically controls internal pressure
1. Load medications into the bottle* (Pills, Capsules, Tablets, Liquids, Lozenges, Transdermal Patches,
Fentanyl Lollipops, Suppositories)
2. Tightly replace cap
3. Gently shake to mix solution over medications
4. Store in a safe and secure location…use until full
5. Bottle is full when contents are within 2 inches from cap – DO NOT OVERFILL
6. Discard bottle and its contents into common trash or according to business process and regulations.
7. Always follow institutional policies, local, state, tribal and federal disposal regulations for compliance.
*Outer shell of capsules and patch material will NOT dissolve.
*Sole brand name available in the US
24 https://www.rxdestroyer.comMedication Disposal
Drug Buster®* Drug Disposal System
▪ Solution starts to dissolve medications and pills on contact
▪ Safe and effective for use on tablets, capsules, creams, patches and more
▪ This irreversible process begins immediately, taking just 15 minutes to break down
pharmaceuticals into a chemically inactive slurry that can be safely put in the regular trash.
*Sole brand name available in the US
25
https://www.medline.com/jump/product/x/Z05-PF19622Medication Disposal
Dispose Rx®*
Contain a blend of patented and proprietary solidifying materials
When water and the DisposeRx® powder are added to drugs in the prescription vial and
shaken, the medications are dissolved and then chemically and physically sequestered in
a viscous polymer gel made from materials that are FDA approved for oral medications.
Reduces the environmental impact caused by improper disposal of medications and
prevents those medications from polluting our water supply.
*Sole brand name available in the US
26 https://disposerx.com/Medication Disposal
Deterra®* pouch
Made from environmentally sound materials
– Allows for the degradation of the plastic pouch and zipper through the use of organic
additives that are consumed by microbes found in landfills. The result is the release of
water and carbon dioxide, with little organic biomass left behind. This greatly reduces
the amount of material left in landfills
▪ Medications will be retained within the activated carbon used in Deterra® even when
exposed to acidic solutions that may be found in a landfill setting
*Sole brand name available in the US
27 https://deterrasystem.com/Medication Disposal
Medication Disposal Envelopes
Patients can use these envelopes to dispense of both controlled
(Schedules II-V*) and non-controlled substances
– Medications should be put in envelopes in their original containers
– Liquids must be placed in a sealed/zip-locked plastic bag before being
placed inside the envelope
Specially-designed nondescript packaging
Unique tracking information
Has a prepaid USPS label so patients can just fill them and mail them
Company treatment facility is a DEA Registered Reverse Distributor and
Collector
28 https://www.sharpsinc.comMedication Disposal
Trial Methods Results
Effect of Drug Disposal Randomized clinical trial enrolled 202 Primary outcome: proper opioid disposal (using a drug disposal bag
Bag Provision on Proper guardians of children 1 to 17 years of or a FDA disposal method)
Disposal of Unused age who underwent otolaryngologic or
Opioids by Families of urologic surgery at the outpatient Intention to treat analysis
Pediatric Surgical Patients: surgery centers from June to Dec Control group: 50 of 89 guardians reported proper disposal (56.2%)
A Randomized Clinical 2018 Study group: 66 of 92 reported proper disposal (71.7%) [p = .03]
Trial.
Both groups received standard Per protocol analysis:
postoperative discharge instructions Control group: 50 of 77 guardians reported proper disposal (64.9%)
on opioid use, storage, and disposal Study group: 66 of 77 guardians reported proper disposal (85.7%)
Study group was also provided a drug
disposal bag containing activated
charcoal and instructions for use
All participants completed a baseline
survey and a follow-up survey 2 to 4
weeks postoperatively to discharge.
29 Lawrence AE, JAMA Pediatr. 2019;173(8)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.
30 https://www.pharmacy.texas.gov/index.asphttps://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requirements_for_Accredited_Hospitals1.PDF
31House Bill 2561 (The Sunset Bill)
Pharmacists and prescribers have always been 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 March 1, 2020, pharmacists and prescribers (other than a
veterinarian) were required to check the patient’s PMP history before
dispensing or prescribing opioids, benzodiazepines, barbiturates, or
carisoprodol.
▫ Exceptions: oncology and hospice patients
https://texas.pmpaware.net/login
32 https://www.pharmacy.texas.gov/index.aspRed Flags
• A group of people presenting prescriptions for the same • The specialty or practice of the prescriber doesn’t match the
controlled substance at about the same time. diagnosis or the patient (eg, a pediatrician prescribing a
• A group of people presenting prescriptions that have the same controlled substance for treatment of rheumatoid arthritis in an
address. adult).
• The same drug and quantity for every person presenting a • Possible state or federal action pending against the prescriber.
prescription from the same prescriber.
• Unexplained geographical anomalies, such as great distances • Unexplained signs/behaviors in a person presenting the
between the prescriber and the pharmacy or the pharmacy prescription such as nervous behaviors, slurred speech, excessive
and the person’s address on the prescription. (this is fairly talkativeness, unsteady gait, pinpoint pupils, or perspiration.
common for our hospital setting because patients travel here
from multiple locations but may be a red flag in clinic settings)
• Use of street names/slang when referring to medicines.
• Prescriptions for “cocktails,” such as an opioid, a
benzodiazepine, and a muscle relaxant. • Prescriptions for drugs with opposite effects (eg, stimulants and
depressants).
• A mismatch between the stated diagnosis and the medicine
on the prescription.
• Prescription content differs from typical medical usage.
• Prescription appears to be photocopied or altered (eg, erasure
marks, ink run, bleeding of background patterns). • Prescription appears “too good” (eg, directions written with no
common abbreviations, handwriting doesn’t appear to be the
prescriber’s).
PHARMACY
https://www.pharmacy.texas.gov/files_pdf/Corresponding_Responsibility_Brochure.pdfRed Flags (Specific to Reviewing the PMP)
• Pharmacy or Prescription Drug Monitoring Program (PDMP)
records indicate early refills on controlled substances.
• Pharmacy or PDMP records indicate multiple prescribers of similar
drugs for a person (must be cautious if reviewing hospital
discharges)
• Persons pay cash for controlled substances, but use insurance for
prescriptions for other medicines.
• Or they use insurance for controlled substances, but cash on the next
prescription for that medication
PHARMACY
https://www.pharmacy.texas.gov/files_pdf/Corresponding_Responsibility_Brochure.pdfPill Counts
A patient must bring in the unused portion of their opioid prescription. The
pills are then counted and compared to how many should be there.
May be routine, random or targeted
– Frequency is determined by risk
▪ Challenges:
– Patients are unable to make appointment
– Patients will borrow or rent pills
▪ Probably most beneficial soon after the prescription is obtained
– This strategy is more likely to catch a “seller” versus a “user”
35 Viscomi CM. Clin J Pain. 2013;29(7).Why Are We Worried When We Take Care of Pediatrics?
Medication
Diversion
Neglect
36So what does that mean for the children? 37
Often coincides with
cigarette use in the home Children are at a greater
risk of later mental health
which has additional risk
and behavioral problems
for children's health
Parental
Substance Use
Children commonly
Home environment is often experience educational
unsanitary/unsafe delays and inadequate
medical and dental care
AAP COMMITTEE ON SUBSTANCE
38 USE AND PREVENTION. Pediatrics. 2016;138(2)Why Are We Worried When We Take Care of Pediatrics?
Medication Child
Diversion Ingestion
Neglect
39More adults taking opioids = More opioids in
homes where children live
ACCIDENTAL INTENTIONAL
INGESTION INGESTION
40Safe Storage
The Poison Prevention Packaging Act (PPPA) requires
products to be packaged in child-resistant packaging
– Packing must be both child-resistant and senior-friendly.
▫ Child-resistant packaging: a package that is significantly
difficult for children under the age of five to open or
obtain a harmful amount of the contents within a
reasonable time.
- 80% of the children cannot be able to open the
package during a full ten minutes of testing where
they are given hints on how to open it at the 5 minute
mark
▫ Senior-friendly packaging:
- 90% of the adults must be able to open and properly
close the package during a five minute testing period
- They must also be able to open and properly close
package in a subsequent one minute test
https://www.safekids.org/sites/default/files/med_2018_infographic_final.pdf
41
https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/PPPAPediatric Opioid Related Admissions
Opioid ingestion in children 6 and under account for highest
number of ER visits in pediatric patients
Trial Methods Results
Opioid-Related Critical Retrospective analysis of 3,647 hospital admissions d/t opioid ingestion
Care Resource Use in Pediatric Health Information
US Children’s Hospitals System from 2004 to 2015 1/3 of the hospitalizations involved children under 6
- Methadone was ingested in 20% of these cases
Identified hospital admission for
opioid ingestion 42.9% required admission to the PICU
- PICU admission
- Use of naloxone, Rate of PICU admissions doubled in time period
vasopressors and ventilation
Within the PICU admissions:
• 37% required mechanical ventilation
• 20.3% required vasopressors
Annual deaths went from 2.8% to 1.3% [p < 0.001]
42
Kane JM. Pediatrics. 2018;141(4)More adults taking opioids = More opioids in
homes where children live
ACCIDENTAL INTENTIONAL
INGESTION INGESTION
43Why Are We Worried When We Take Care of Pediatrics?
Medication Child
Diversion Ingestion
Neglect Adolescents
44Opioid Poisonings
Trial Methods Results
Analysis of 207,543 Retrospective analysis of data
Opioid- Pediatric
children with acute from 55 poison control centers Related Opioid- Opioid as the
True
Exposure Related Primary
opioid poisonings from that make up the NPDS Calls Exposure Substance
Exposure
Calls N = 207, 543
the United States N=
N = 246, 901
N = 214, 666
1,002,947
National Poison Data Jan 2005 – December 2018
System (NPDS) Trends were assessed over three
time periods Age distribution is bimodal with peaks in toddler/preschool
and teenage/adolescent age groups
Pediatric patients (Adolescents
Deaths from opioid overdose tripled between 1999 and 2015
– 0.8 per 100,000 to 2.4 per 100,000
For every opioid death, there is an expected 120 emergency room
visits and 20 substance use treatment admissions
Trial Methods Results
Associations Retrospective analysis of 725 pts had an opioid overdose 1 in 1600 (0.06%)
Between Opioid 1,146,412 privately insured Overall rate of overdose events: 28 per 100,000
Prescribing Patterns adolescents (11-17 years old) observed patient-years
and Overdose
Among Privately Used MarketScan data set in Increased risk:
Insured Adolescents United States during the time Number of tablets prescribed
period of January 2007 – - >30 opioid tablets compared toAdditional
Changes In
Legislation
47Days Supply Limit on Opiods
House Bill 2174: Beginning September 1, 2019, for the treatment of acute
pain, a provider may not issue a prescription for an opioid in an amount
exceeding a 10-day supply, nor provide for a refill of an opioid for acute pain.
– The Texas Medical Board interprets this rule to mean a provider, when prescribing
an opioid for acute pain, may not write the prescription for more than a 10 day
supply and cannot include any refills on the prescription. However, the patient may
see the provider in a follow up appointment and receive another opioid prescription
for up to 10 days with no refills. The law does not limit how many times this may
occur.
▫ Acute pain means the normal, predicted, physiological response to a stimulus such
as trauma, disease and operative procedures. Acute pain is time limited, such as
post-op recovery or pain after a broken bone. Exemptions: Chronic pain, cancer care,
hospice/palliative care or treatment of substance addiction
48Mandatory e-Prescribing
Effective January 1, 2021, Texas Health and Safety Code,
§§481.0755 requires that prescriptions for controlled substances
are to be issued electronically - except in limited circumstances, or
unless a waiver has been granted by the appropriate agency.
Exemptions: Research medications, non-patient specific
medications, out of state pharmacies that have their own
regulations, etc.
Waivers can be issued by the Texas Medical Board, usually
due to economic hardships or technological limitations.
49Pain 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
50Challenges Within the Pediatric Patient Population
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”
51The Pendulum Effect
The theory holding that trends in culture, politics, medicine, etc.
tend to swing back and forth between opposite extremes.
https://kerririchardson.com/the-pendulum-principle/
5253
References
1. AAP COMMITTEE ON SUBSTANCE USE AND PREVENTION. Medication-Assisted
Treatment of Adolescents With Opioid Use Disorders. Pediatrics. 2016;138(3):e20161893.
2. Groenewald CB, Zhou C, Palermo TM, et al. Associations Between Opioid Prescribing
Patterns and Overdose Among Privately Insured Adolescents. Pediatrics.
2019;144(5):e20184070.
3. Kane JM, Colvin JD, Bartlett AH, et al. Opioid-Related Critical Care Resource Use in US
Children’s Hospitals. Pediatrics. 2018;141(4):e20173335.
4. Lawrence AE, Carsel AJ, Leonhart KL. Effect of Drug Disposal Bag Provision on Proper
Disposal of Unused Opioids by Families of Pediatric Surgical Patients: A Randomized
Clinical Trial. JAMA Pediatr. 2019;173(8):e191695. doi:10.1001/jamapediatrics.2019.1695
5. Megan E. Land, Martha Wetzel, Robert J. Geller, Pradip P. Kamat & Jocelyn R. Grunwell
(2019): Analysis of 207,543 children with acute opioid poisonings from the United States
National Poison Data System, Clinical Toxicology, DOI:10.1080/15563650.2019.1691731.
6. Smith VC, Wilson CR, AAP COMMITTEE ON SUBSTANCE USE AND PREVENTION.
Families Affected by Parental Substance Use. Pediatrics. 2016;138(2):e20161575.
7. Viscomi CM, Covington M, Christenson C. Pill counts and pill rental: unintended
entrepreneurial opportunities.Clin J Pain. 2013;29(7):623-4.
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