‘This pain is killing me...’

Medication Safety in Pain Management

Jayne Pawasauskas, PharmD, BCPS

Clinical Associate ProfessorURI College of Pharmacy

Pharmacy Specialist – Pain ManagementKent Hospital

Learning Objectives• Understand concepts of medication safety

pertaining to patients using opioids for pain management– Identify risks of opioid-related adverse events

& strategies to minimize these occurrences– Recognize and prevent Rx drug abuse in

context of pain management• Discuss safe use, storage, and disposal of

prescription drugs• Discuss research findings on patients’

behaviors and perceptions of medication safety

Disclosures

Current:Speakers’ Bureau & Advisory Board:

Cadence Pharmaceuticals

Previous:Speakers’ Bureau: PricaraConsultant: Inflexxion, Painedu.org Grant Funding: Purdue Pharma

• Focus on accidental opioid overdoses

• Database from 2004 – 2011 on opioid-related ADEs• 47% wrong dose • 29% improper patient monitoring• 11% others (e.g.drug interactions, excessive

doses)

Risks for Respiratory Depression

• Sleep apnea• Morbid obesity (BMI

>30) with high risk of sleep apnea

• No recent opioid use• Post-op; thoracic or

upper abdominal• Functional status• Older age• Smoker

• Longer length of time given anesthesia during surgery

• Receiving other sedating drugs: benzo’s, antihistamines, sedative, CNS depressants

• Pre-existing cardiac or pulmonary dz; major organ failure

Patient-Specific Risk Factors• 48 y.o. ♂ • Problem list: diverticulitis with multiple

abdominal surgeries, recent colectomy with complications; arthritis, anxiety, pain

• 4W• BMI = 32.7• + tobacco: 1 ppd (addressed in ID consult)• + EtOH, h/o pancreatitis• No documented respiratory, cardiac, renal or

hepatic disease• Combination of CNS depressant drugs

Pharmacokinetic Example

Pharmacokinetic InfoTmax T 1/2

Oxycodone CR 2.5hrs 5-8hrsOxycodone IR 1.5hrs 4hrsLorazepam IV 15-20 min 12-14hrsHydromorphone IV 15 min 2.3hrs

Narcan Narcan Narcan

Multimodal Analgesic Approach

Opioids-2 agonistsNMDA antagonistsAcetaminophen

Opioids-2 agonistsLocal anesthetics NSAIDs

COXIBsLocal Anesthetics

Recommendations

• Full body skin assessment– E.g. look for fentanyl

or buprenorphine patch; incisions from implanted pumps

• Assess respirations– set frequency

• Consider when dose changes or addition of more opioids

• High-risk opioids identified – Methadone– Fentanyl– IV hydromorphone

• Use technology to reduce system errors– SmartPumps– CPOE– PCA to reduce risk of

oversedation

PCA PK

Sam et al. Journal of Clinical Anesthesia (2011) 23, 102–106

PCA PK

Sam et al. Journal of Clinical Anesthesia (2011) 23, 102–106

Peak M6G at ~25 hours

Considerations with PCA• Weigh risks/benefit of continuous +

demand vs. demand only– Start with demand only if pt opioid naïve

• Risk for respiratory depression can be greatest on POD 1– Depending on what else is on board

Predictors of Naloxone Utilization

• Patients who received naloxone at Kent Hospital at any point between October 1st 2011 and September 30th 2012 were included.

• Exclusion criteria: no opioid use within the 24 hours previous to naloxone administration, naloxone used within 24 hours of being admitted, or if naloxone was used in either the post anesthesia care unit or operating room.

169 patients received

naloxone from inpatient Pyxis

records between

10/1/2011 and 9/30/2012

25 patients received naloxone Within 24

hours of being admitted

13 patients did not receive any

opioid medications in the 24 hours

prior to naloxone

66 patients received

naloxone while in either the OR

or PACU

65 patients are eligible for the experimental group in this

study

Methods• Data collected by review of electronic

medical record (EMR): patient age, BMI, smoking history, use of any CNS-depressant medications, current or past, renal disease, cardiac disease, respiratory disease, or hepatic disease.

• Matched to patients who did not require naloxone by daily MED– Ave = 86 mg

Results…

0 1 2 3 4 5 6 7 8 90

5

10

15

20

25

30

Control GroupNaloxone Group

Number of Risk Factors

Num

ber

of P

atie

nts

Risk Factor Grouping Graph

PRESCRIPTION DRUG ABUSE

US Office of National Drug Control Policy

2011 Prescription Drug Abuse Prevention Plan

• Education. A crucial first step in tackling the problem of prescription drug abuse is to educate parents, youth, and patients about the dangers of abusing prescription drugs, while requiring prescribers to receive education on the appropriate and safe use, and proper storage and disposal of prescription drugs.

• Monitoring. Implement prescription drug monitoring programs (PDMPs) in every state to reduce “doctor shopping” and diversion, and enhance PDMPs to make sure they can share data across states and are used by healthcare providers.

US Office of National Drug Control Policy

• Proper Medication Disposal. Develop convenient and environmentally responsible prescription drug disposal programs to help decrease the supply of unused prescription drugs in the home.

• Enforcement. Provide law enforcement with the tools necessary to eliminate improper prescribing practices and stop pill mills

What is Prescription Drug Abuse?

Taking a medication that a doctor prescribed for someone else

Taking more of a medication that a doctor prescribed for you

Taking a medication that a doctor prescribed for you differently than how he/she intended

?

Heath Care Providers Patient/Community

SAMHSA, 2011 National Survey on Drug Use and Health

REMS

PMPs

CME/CE Programs

Regulations/protocols

Consensus statements

Patient Contracts

Individual educational activity

Public Service Announcements

Community-based drug disposal

Camps such as Y2Y International

Heath Care Providers Patient/Community

Local Data• Series of studies to assess patients’

behaviors & perceptions about various aspects of medication safety– Intent to capture data from a variety of

settings• Adult out-patient family medicine practice• Adult in-patient acute care hospital• Parents of patients at a pediatric in-patient

acute care hospital• College students at a public university

Adult OutpatientsThundermist Health CenterItem (n=100) ResponseShared Your Medications 10%

“Wanted to help,” “They ran out of theirs”, “They couldn’t afford theirs”

Shared With You 29%

Locked 65% never

Patients with CS rx’s were more likely to report someone sharing meds with them (p=0.004) and saving unused meds for another time (p=0.05), as opposed to disposing

Adult Outpatients, con’t• 21% reported they would save unused

medications for a later time/need– 56% would get rid of them by either

flushing or throwing in trash: flush (62%) or throw in the trash (38%)

– 11.5% reported proper disposal• Drug drop-off locations/DEA take-back, or

proper home disposal

Adult Parents of Pediatric PatientsUMass Memorial Children’s Hospital

Item (n=80) ResponseShared Your Medications 21%

“They asked me,” “Wanted to help with their medical problem,” “They didn’t have time to go to their doctor”Shared With You 23%

Alleviation of symptoms, 1 ADR

Locked 54% never

Parents <25 y.o. were more likely to monitor storage of Rx meds in the home (p=0.041), compared to older age groups.

Adult Parents, con’t• 18% reported they would save unused

medications for a later time/use– 71% would flush or throw in trash

• 53% reported they had talked to their kids about Rx drug abuse– 6% no answer– 41% did not talk to their kids

• ‘age too young’• many had teen-aged children• Parents > 35 y.o. were more likely to have had

discussions with their kids (p=0.003)

Education• In the US, an average of 2,000 teenagers

EVERY DAY use prescription drugs without a doctor's guidance for the first time

• Youth 12-17 years old, 2.8% reported past-month nonmedical use of prescription medications

• Prescription and over-the-counter drugs are among the most commonly abused drugs by 12th graders, after alcohol, marijuana, synthetic marijuana and tobaccohttp://teens.drugabuse.gov/drug-facts/prescription-drugs

College StudentsURI Health Services

Item (n=333) ResponseWitnessed Sharing of Rx Meds 28%Shared Your Medication 27%

“To help them with their medical condition,” “didn’t see a reason not to”

Shared With You 41%Alleviation of symptoms

Locked 77% neverDisposal 52.6% save; of those who would

dispose, 81% throw in trash

Aberrant Drug BehaviorsMore Predictive

• Selling prescription drugs• Prescription forgery• Stealing or borrowing another

patient’s drugs• Obtaining prescription drugs

from non-medical sources• Concurrent abuse of illicit

drugs• Multiple unsanctioned dose

escalations• Recurrent prescription losses

Less Predictive• Aggressive complaining about

need for higher doses• Drug hoarding during periods of

reduced symptoms• Requesting specific drugs• Acquisition of similar drugs

from other medical sources• Unsanctioned dose escalations

1-2 times• Unapproved use of the drug to

treat another symptom• Reporting psychic effects not

intended by the clinician

Passik et al. Oncology 1998;12(4):517-521.

“What Can I Do?”• Prescription Drug

Monitoring Program

• Inventory/Crime Prevention

• Education – Counseling– Drug Storage– Drug Disposal

• Communication– Prescribers– Parents/Adolescents

• Therapy assessment and monitoring – Interaction– Alternative

treatments– Recognition

Opioids: Symptoms to Watch For…Overdose

• ↓ level of consciousness• Pinpoint pupils• ↓ Heart rate• ↓ Respiratory rate

– Patient may appear cyanotic (blue lips & nails)

• Seizures• Muscle spasms• Unarousable

Withdrawal

Early: agitation, anxiety, muscle aches, lacrimation, rhinorrhea, diaphoresis, yawning, chills, drug cravings

Late: abdominal cramping, diarrhea, dilated pupils, N/V, piloerection, dysphoria, akathesia, insomnia, tachycardia or hypertension

Opioids/NarcoticsDrug Names Street Names

Oxycodone (OxyContin, Percocet, Percodan)

Hillbilly heroin, OC, oxy, percs, cotton, kicker

Morphine (Avinza, Kadian, MSContin, Roxinol)

Dreamer, hows, Miss Emma, Mister Blue, Unkie

Hydrocodone (Vicodin, Lortab, Lorcet)

Vikes, Hydros, Watson 387

Codeine EmpirinFentanyl (Duragesic, Actiq, Lazanda, Onsolis, Abstral, Fentora)

Dance fever, goodfellas, jackpot, incredible hulk, murder 8

Hydromorphone (Dilaudid, Exalgo)

Methadone (Dolophine, Methadose) Fizzies, amidone

Meperidine (Demerol)

BenzodiazepinesOverdose

• CNS Depression• Ataxia• Slurred speech• Respiratory

depression• Coma

Withdrawal• Severe sleep disturbance• Irritability• Tension/anxiety/panic• Tremor, Diaphoresis• Difficulty concentrating/

cognition• Dry retching/nausea/abd pain• Weight loss• Palpitations, Headache• Muscle pain/stiffness• Hallucinations, seizures,

psychosis

Sedatives & DepressantsBenzodiazepines Street NamesDiazepam (Valium), Triazolam (Halcion) Candy, downers,

sleeping pills, tranksAlprazolam (Xanax), Clonazepam (Klonopin)Lorazepam (Ativan), Temazepam (Restoril)Barbiturates

Phenobarbital & Primadone Barbs, reds, red birds, phennies, tooies, yellows, yellow jackets

SecobarbitalPentobarbitalMephobarbitalButalbital (Fioricet, Fiorninal)Sleep AidsZolpidem (Ambien), Zaleplon (Sonata)Eszopiclone (Lunesta)

A-minus, zombie pills

Non-controlled Rx drugs

Not all drugs that are abused are controlled substances

Gabapentin (Neurontin)

• Alcohol/cocaine abusers• Doses ranged up to 7200 mg/day• Creates relaxation, ‘laid back’ feeling,

euphoria, giggling, similarity to marijuana-like effects, addicts report suppression of cravings; some report negative effects (‘zombie-like’ feeling)

Gabapentin (Neurontin)• Cocaine users were more likely to

snort powder from the capsules• Withdrawal symptoms reported to

include disorientation, confusion, tachycardia, diaphoresis, tremulousness, and agitation

Quetiapine (Seroquel)• Often prescribed to treat anxiety,

especially in substance abuse populations

• Many request and abuse it for sleep potential– ‘come down’ from a ‘high’– Mix with other drugs of abuse to achieve

a more calm ‘high’

SSRIs: Examples of Fluoxetine Abuse• Reports of taking 80-140 mg of

fluoxetine• Sometimes in combination with alcohol

– Caused increased energy, talkativeness, mood elevation and slight “jitters”

– One reported it was unlike “speed” because she also felt numb and calm

– One experienced an amphetamine-like effect requiring trazodone and diazepam to sedate him at night

• Withdrawal symptoms not noted fluoxetine has long t½

Serotonin SyndromeNEJM 2005;352:1112-20.

Over-the Counter Medications• Dextromethorphan (Robitussin)

– Serotonin syndrome– Change in mental status, autonomic

hyperactivity, neuromuscular abnormalities• Pseudoephedrine (Sudafed)

– Diaphoresis, mydriasis , ↑ heart rate, hyperthermia

• Diphenhydramine (Benadryl)– Delirium, hallucinations, urinary retention,

mydriasis, ↑ heart rate, hyperthermia

Kent Hospital ED • For chronic and chronic-intermittent

pain• ‘Prescriptions for opioid pain medicine

given on discharge from the ED will be for no more than a 3-day supply with no refills.”– Adapted from the American Academy of

Emergency Medicine Guidelines, 2013

Take Home Naloxone• Naloxone and Overdose Prevention

Education Program of Rhode Island www.noperi.org

Accessed from www.noperi.org

Education• Drug is intended for patient only

– Do NOT share medication with others

• The Controlled Substances Act of Title 21 FDA US Code 13 – "knowingly or intentionally to possess a controlled

substance" not lawfully obtained from a doctor could lead to a year in prison or a $5,000 fine, or both on a first conviction

– Penalty for a second offense doubles the penalties

Education• Increase in malicious administration of

pharmaceuticals to children– Mean number of 160 cases per year– In 51% of cases, at least 1 sedating agent

• Analgesics• Stimulants/street drugs• Sedatives/hyponotics/antipsychotics• Cough and cold preparations• Ethanol

Yin S. The Journal of Pediatrics 2010

Proper Drug Storage

• Massachusetts Law– Pharmacy dispensing schedule II, III,

IV or V prescription drugs shall make available prescription lock boxes for sale at each store location.• Within 50 feet of pharmacy

counter and readily viewable by public upon picking up prescription

• Maintain a stock of lockboxes • Encourage consumers buying

over-the-counter or prescription medications to purchase one

Drug Disposal• TakeAway Environmental Return

System ™ – Envelope with instructions on what

can/cannot be mailed – For purchase at local pharmacies

• DEA take-back days– http://www.deadiversion.usdoj.gov/

drug_disposal/takeback/

Drug Disposal• Rhode Island drop-off locations for

unwanted non-controlled prescription and over-the-counter drugs – Ocean Healthmart Pharmacy– Baker’s Pharmacy of Jamestown– Newport Prescription Center– Simpson’s Pharmacy– East Side Prescription Center– Oxnard Pharmacy

Drug Disposal• Medication drop boxes located in

over 20 police department buildings for controlled substances

Drug Disposal•  If none available

– Take pills out of container & mix with coffee grounds/kitty litter• Throw out in sealable bag such as Ziploc bag • Make unappealing to both children and pets

• Flushing is NOT an option– Water contamination

Summary• Appropriate prescribing and dispensing of

(pain) medications is not enough• We should take every opportunity to

provide patient education• Even brief encounters can make a

difference– “It’s not safe to share medications. A drug may work

just fine for you, but could be deadly to someone else.”

– “Don’t keep unused medications in your home. There are many convenient places you can go to drop off unwanted/unused medications.”