‘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.”
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