are we dealing with drug seeking patients? i left my ... · the accepted treatment of these...
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Are We Dealing with Drug Seeking Patients?
I Left My Prescription in My Hotel; Can I Get A New One?
This course was developed for the Tennessee Dental Hygienists’ Association by
Frieda Pickett, RDH, MS, Revised in 2020 by Lynn Russell, RDH, EdD
This is a continuing education course presented by the Tennessee Dental Hygienists’ Association for one
(1) credit hour to meet Tennessee requirements for a course on chemical dependency. To earn credit the
article must be read and the test that follow be scored at 80% or better to be accepted to meet state
requirements for the continuing education credit. A certificate of credit will be mailed within two (2)
weeks of completing the online course and should be placed in an official file for verification of earning
the credit(s).
Background- Information re: Opioid Overdose Deaths
Drug overdose deaths continue to increase in the United States.
• From 1999 to 2016, more than 630,000 people have died from a drug overdose.
• Around 66% of the more than 63,600 drug overdose deaths in 2016 involved an opioid.
• In 2016, the number of overdose deaths involving opioids (including prescription
opioids and illegal opioids like heroin and illicitly manufactured fentanyl) was 5 times
higher than in 1999.
• On average, 115 Americans die every day from an opioid overdose (CDC, 2016) From
1999-2016, more than 350,000 people died from an overdose involving any opioid,
including prescription and illicit opioids (CDC MMWR, 2016).
• In 2012, health care providers wrote 259 million prescriptions for opioid pain medication,
enough for every adult in the United States to have a bottle of pills (Paulozzi et al., 2014).
Opioid prescriptions per capita increased 7.3% from 2007 to 2012, with opioid
prescribing rates increasing more for family practice, general practice, and internal
medicine compared with other specialties (Levy et al., 2015). Rates of opioid prescribing
vary greatly across states in ways that cannot be explained by the underlying health status
of the population, highlighting the lack of consensus among clinicians on how to use
opioid pain medication.
This rise in opioid overdose deaths can be outlined in three distinct waves.
1. The first wave began with increased prescribing of opioids in the 1990s, with overdose
deaths involving prescription opioids (natural and semi-synthetic opioids and methadone)
increasing since at least 1999.
More than 191 million opioid prescriptions were dispensed to American patients in
2017—with wide variation across states. From 1999 to 2014, more than 165,000 persons
died from overdose related to opioid pain medication in the United States
Health care providers in the highest prescribing state, Alabama, wrote almost three times as
many of these prescriptions per person as those in the lowest prescribing state, Hawaii.
Studies suggest that regional variation in use of prescription opioids cannot be explained by
the underlying health status of the population. The most common drugs involved in
prescription opioid overdose deaths include:
• Methadone
• Oxycodone (such as OxyContin®)
• Hydrocodone (such as Vicodin®)3
To reverse this epidemic, we need to improve the way we treat pain. We must prevent abuse,
addiction, and overdose before they start.
2. The second wave began in 2010, with rapid increases in overdose deaths
involving heroin.
Heroin use has increased sharply across the United States among men and women, most age
groups, and all income levels. Some of the greatest increases occurred in demographic
groups with historically low rates of heroin use: women, the privately insured, and people
with higher incomes.
About Heroin:
• Heroin is an illegal, highly addictive opioid drug.
• A heroin overdose can cause slow and shallow breathing, coma, and probable
death.
• Heroin is often used along with other drugs or alcohol; this is dangerous because
it increases the risk of overdose.
• Heroin is most often injected but is can be smoked and/or snorted. When people
inject heroin, they are at risk of serious, long-term viral infections such as HIV,
Hepatitis C, and Hepatitis B, as well as bacterial infections of the skin,
bloodstream, and heart.
As heroin use has increased, so have heroin-related overdose deaths. Between 2010 and 2016,
the rate of heroin-related overdose deaths increased by a factor of 5 – more than 15,469 people
died in 2016.
So, what can be done?
1. Reduce prescription opioid abuse
2. Prevent people from starting heroin by reducing prescription opioid abuse
3. Improve opioid prescribing practices when you can and help identify those that may be
high risk
4. Ensure access to prevention services
5. Ensure that people have access to integrated prevention services, including access to
sterile injection equipment from a reliable source, as allowed by local policy.
6. Ensure access to Medication-Assisted Treatment
What is Medication-Assisted Treatment (MAT)?
Treat people addicted to heroin or prescription opioids with MAT which combines the use of
medications (methadone, buprenorphine, or naltrexone) with counseling and behavioral
therapies.
People who are addicted to prescription opioids are 40 times more likely also to be addicted to
heroin.
Naloxone
Often a heroin overdose may be circumvented by the use of naloxone. Naloxone, a life-saving
drug that can reverse the effects of an opioid overdose when administered in time.
3. The third wave began in 2013, with significant increases in overdose deaths involving
synthetic opioids – particularly those involving illicitly-manufactured fentanyl (IMF). The IMF
market continues to change, and IMF can be found in combination with heroin, counterfeit
pills, and cocaine. Pharmaceutical fentanyl is a synthetic opioid pain reliever, approved for
treating severe pain, typically advanced cancer pain. It is 50 to 100 times more potent than
morphine. It is prescribed in the form of transdermal patches or lozenges and can be diverted
for misuse and abuse in the United States. Most recent cases of fentanyl-related harm,
overdose, and death in the U.S. are linked to illegally made fentanyl. It is sold through illegal
drug markets for its heroin-like effect. It is often mixed with heroin and/or cocaine as a
combination product—with or without the user’s knowledge—to increase its euphoric effects.
Introduction
If two patients come to your office complaining of severe pain and requesting painkillers, could
you tell which one is suffering from genuine dental-related pain and the one who is abusing or
diverting the medication for nondental uses?
Some stories are dead giveaways. For example, a patient may claim "My pills fell into the
toilet.", “the dog ate my pills”, I left my pills in the hotel where I stayed on a recent trip”
Relief-Seeking vs. Drug-Seeking Behavior
Most individuals that have been employed in a dental office can relay stories that suggest a
patient has come to the dental office seeking pain medication for nondental uses. Some patient's
stories are hard to gauge, even after a routine exam is complete. The clinical exam may reveal a
condition that appears to be related to discomfort but may be minimal. In contrast, patients may
be exhibiting behaviors associated with abuse or diversion but may be doing so because their
pain is undertreated. It is very difficult to understand another person’s pain…even what may be
causing it.
Patients who engage in aberrant behaviors are not necessarily abusing narcotic medication.
"They may appear to be drug seekers," said Yvonne D'Arcy, MS, CRNP, CNS, pain
management and palliative care nurse practitioner, Suburban Hospital, Johns Hopkins Medicine,
Bethesda, Maryland. "But I prefer to call them 'relief seekers' because their pain is significantly
undertreated."1
Individuals who are long-standing patients in the practice may achieve getting unnecessary pain
medication due to the fact they are patients of record. Most of us have come to believe that drug
seekers are new patients that come in for emergency treatment. Though the practice represents a
common situation, we must also be able to analyze the likelihood that long standing patients may
also seek narcotic pain medication unnecessarily.
The accepted treatment of these patients is to examine the teeth and surrounding structures for
some indication that the patient may be in pain and actually needs a prescription to manage that
pain. Unfortunately, there are substance abusers that allow teeth to become seriously damaged in
order to “qualify” for a narcotic pain prescription. In these cases, the individual may claim lack
of funds to pay for removing the tooth, and that he or she will return after “payday” to have the
tooth removed and he just needs something to get them through until then.
What are the signs of a drug-seeking patient?
Certain behaviors are red flags, such as no obvious oral disease but the patient claiming to be in
“excruciating pain” or a patient with dental disease who wants to delay treatment but requests a
prescription for opioid analgesic medication. Be aware of the patient who tells you the exact pain
drug that “works for them” and knows the exact dosage for the medication.
The patient might appear to be impatient or obsessive. Beware of the patients who call repeatedly
during and after office hours demanding refills, or who don't show up for appointments and then
suddenly demand an immediate appointment. Some patients ask to be the last appointment of the
day, hoping that you'd like to get them out of the office quickly and will prescribe whatever they
want. Other indicators include negative mood changes, an intoxicated or foggy state, unkempt
appearance, requests for early renewals, and increased dosing without authorization.
Does the Physical Evidence Fit the Story?
The clinical examination and questioning about the history of the painful episode is one of the
most important factors in determining the degree of pain associated with the situation. Chronic
oral disease is associated with a low level of pain whereas acute infection is associated with a
painful outcome. The dentist must decide if the observed disease is chronic or acute. One must
also be aware of the possibility of a low pain tolerance for the patient.
The Patient's History
Note the difference between an acute episode and a chronic pain condition, investigate the
history of the pain. Is the description of the injury consistent with the patient's current
complaints? How long ago did the pain start? On a scale of 1-10, with ten being unbearable what
is the current pain level? Is there anything that makes it worse? Is the pain keeping them awake
at night? What has been tried to alleviate the pain? How much did they take and when?
Careful questioning can reveal inconsistencies in the patient's story. For example, complaints of
constant, unchanging pain may be exaggerated, especially when a minor oral issue is observed.
Pain usually fluctuates through the course of the day, so a complaint of “It hurts all day and there
is no stopping of the pain” is suggestive of drug seeking behavior.
Additional clues involve factors not directly related to the history of the oral disease or injury,
The medical history may reveal the patient has a history of abusing alcohol or illicit drugs. Is
there a history of arrests or troubles with law enforcement? Has the patient ever been abused?
These are factors sometimes associated with substance abuse.
It's also wise to check the patient's history of narcotic drug use over time. It is difficult to tell
when a patient is genuinely in pain or if the patient is misusing medication, without following
him or her over time and looking for patterns of drug seeking behavior.
Other ways to identify drug seekers
Screening tools can be helpful. Some authorities recommend use of the Current Opioid Misuse Measure®
(COMM), a 17-item measure designed to identify aberrant drug-related behaviors in patients with chronic
pain who are receiving opioids.
Some questions from the COMM:
1. In the past 30 days, how often have you had trouble with thinking clearly or had memory problems?
2. In the past 30 days, how often do people complain that you are not completing necessary tasks? (i.e.,
doing things that need to be done, such as going to class, work or appointments)
3. In the past 30 days, how often have you had to go to someone other than your prescribing physician to
get sufficient pain relief from medications? (i.e., another doctor, the Emergency Room, friends, street
sources)
4. In the past 30 days, how often have you taken your medications differently from how they are
prescribed?
5. In the past 30 days, how often have you seriously thought about hurting yourself?
A second tool, the Addiction Behaviors Checklist (ABC), is a 20-item questionnaire designed to track
behaviors characteristic of opioid addiction in chronic pain populations. Designed to track behaviors
characteristic of addiction related to prescription opioid medications in chronic pain patients. Items are
focused on observable behaviors noted both during and between visits. ABC is focused on longitudinal
assessment and tracking of problematic behaviors.
Addiction behaviors—since last visit (Examples of questions)
1. Patient used illicit drugs or evidences problem drinking*
2. Patient has hoarded meds
3. Patient used more narcotic than prescribed
4. Patient ran out of meds early
5. Patient has increased use of narcotics
Addiction behaviors- current
1. Patient expressed a strong preference for a specific type of analgesic or a specific route of
administration
2. Patient expresses concern about future availability of narcotic
3. Patient reports worsened relationships with family
4. Patient misrepresented analgesic prescription or use
The PADT (Copyright Janssen Pharmaceutica Products, L.P. ©2003 All rights reserved) is a
clinician-directed interview; that is, the clinician asks the questions, and the clinician records the
responses. The Analgesia, Activities of Daily Living, and Adverse Events sections may be
completed by the physician, nurse practitioner, physician assistant, or nurse. The Potential
Aberrant Drug-Related Behavior and Assessment sections must be completed by the physician.
The PADT helps to determine if the patient's self-reported pain is clinically significant, if the
patient's functional status has improved with pain reliever(s) taken in the past or the present, if
the patient is experiencing side effects from medication, and if the patient is exhibiting aberrant
behaviors.
Here is an example of the PADT
Ask the patient the questions below, except as noted.
If zero indicates “no pain” and ten indicates “pain as bad as it can be,” on a scale of 0 to 10, what is your
level of pain for the following questions?
1. What was your pain level on average during the past week? (Please circle the appropriate number)
0 1 2 3 4 5 6 7 8 9 10
2. What was your pain level at its worst during the past week?
0 1 2 3 4 5 6 7 8 9 10
3. What percentage of your pain has been relieved during the past week? (Write in a percentage between
0% and 100%.) __________________________________________
4. Is the amount of pain relief you are now obtaining from your current pain reliever(s) enough to make a
real difference in your life?
Please indicate whether the patient’s functioning with the current pain reliever(s) is Better, the Same, or
Worse since the patient’s last assessment with the PADT.* (Please check the box for Better, Same, or
Worse for each item below.)
Better Same Worse
1. Physical functioning
2. Family relationships
3. Social relationships
4. Mood
5. Sleep patterns
6. Overall functioning
Are there side effects? Such as: Nausea, Vomiting, constipation, Itching, Mental Fog, Sweating, Fatigue?
Potential Aberrant Drug-Related Behavior This section must be completed by the physician or Dentist
Please check any of the following items that you discovered during your interactions with the patient.
Please note that some of these are directly observable (e.g., appears intoxicated), while others may require
more active listening and/or probing. Use the “Assessment” section below to note additional details.
1. Purposeful over-sedation
2. Negative mood change
3. Appears intoxicated
4. Increasingly unkempt or impaired
5. Involvement in car or other accident
6. Requests frequent early renewals
7. Increased dose without authorization
8. Reports lost or stolen prescriptions
9. Attempts to obtain prescriptions from other doctors
10. Uses pain medication in response to situational stressor
11. Insists on certain medications by name
12. Abusing alcohol or illicit drugs
13. Hoarding (i.e., stockpiling) of medication
14. Arrested by police
15. Victim of abuse
Is your overall impression that this patient is benefiting (e.g., benefits, such as pain relief, outweigh side
effects) from opioid therapy?
Note: these are excerpts and are not the complete documents
Does the Story Check Out?
As an RDH, we often have the ability to interview other family members or listen when patients may
confide in us. Consider HIPAA violations when discussing with family; family members can be helpful
to find out the patient’s history of substance abuse or problems with law enforcement. Asking patients
for concrete evidence to support their story is important
Once a patient claimed that his pills had been confiscated by the Transportation Security Administration
on a recent flight. "I asked to see his airplane ticket to prove that he had indeed been on the flight. He
couldn't produce it."
Do your due diligence. The dentist may be able to communicate with other professionals who
have had contact with the patient. This includes other dentists, physicians as well as nurses,
mental health professionals, and pharmacists. Examine the medical history to determine if other
health professionals are listed. A primary care physician may be more likely to know the entire
family and could therefore place the drug-seeking behavior into perspective.
Drug-seeking behavior doesn’t happen as an isolated incident.
As you evaluate a patient's request for drugs, look at the “big picture.”
As an example, an 80-year-old patient with physical problems may keep asking for early refills
on her pain medication. She might have severe pain or might be abusing her medication. It may
also be that she has a family member living with her or a caregiver, opening the possibility that
one of them is abusing pain medication. Different motivations can exist.
The Offenders May Surprise You
Patients who want drugs aren't always looking to use them for their own physical purposes.
Some patients who are engaged in drug-seeking behavior may be using drugs as a source of
revenue. They may be selling prescribed pain medications as a means of adding to their finances.
There are reports of the elderly with legitimate prescriptions for hydrocodone, who sell their medications.
These aren’t always motivated by greed but by the need to pay for basic living expenses. If this behavior
is observed and verified oral healthcare professionals should refer patients to appropriate services that
address socioeconomic and psychosocial needs.
Be careful about stereotyping individuals. If you get pulled into an apparently believable story
that doesn't ultimately turn out to be true, it's often because you made assumptions about the
patient -- pastor, police officer, grandparent.
Educate Your Patients
Patients need to learn how to communicate with their physicians. The clinician may need to
explore why the patient might be reluctant to do this. Some patients are afraid that you'll judge
them or won't listen to their concerns.
Some patients may have unrealistic expectations. They may think that their pain will completely
resolve after treatment, and when that doesn't happen, they often adjust their dosage, usually
escalate their dose. Patients must be educated about what they can realistically expect after
treatment. Patients should be told that many studies show that dental pain is best resolved with
nonsteroidal anti-inflammatory agents, such as ibuprofen. In many studies these types of
analgesics work better than opioids. If opioids are prescribed for strong dental pain, prescribers
should prescribe opioid analgesics for no more than 7 to 10 days.
Federal Regulations
Extended-release, long-acting (ER/LA), and immediate-release (IR) opioid analgesics, such as
hydrocodone, oxycodone, and morphine, are powerful pain-reducing medications that have both
benefits as well as potentially serious risks. The FDA has determined that a Risk Evaluation and
Mitigation Strategy (REMS) is necessary for all opioid analgesics intended for outpatient use to
ensure that the benefits of these drugs continue to outweigh the risks. The Opioid Analgesic
REMS, approved on September 18, 2018, is one strategy among multiple national and state
efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription
opioid analgesics.
The REMS program requires that training be made available to all health care providers (HCPs)
who are involved in the management of patients with pain, including nurses and pharmacists. To
meet this requirement, drug companies with approved opioid analgesics will provide unrestricted
grants to accredited continuing education providers for the development of education courses for
HCPs based on the FDA’s Opioid Analgesic REMS Education Blueprint for Health Care
Providers Involved in the Treatment and Monitoring of Patients with Pain (APPENDIX A). The
FDA believes that all HCPs involved in the management of patients with pain should be
educated about the fundamentals of acute and chronic pain management and the risks and safe
use of opioids so that when they write or dispense a prescription for an opioid analgesic, or
monitor patients receiving these medications, they can help ensure the proper product is selected
for the patient and used with appropriate clinical oversight.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent
pain for serious and chronic conditions (list of ER/LA opioid products). The misuse and abuse of
these drugs have resulted in a serious public health crisis of addiction, overdose, and death. Although
these products are not commonly used in dentistry, it is not assured they would not be prescribed
for oral pain. Opioid agents combined with acetaminophen (Lortab, Vicodin, others), ibuprofen
(Vicoprofen) or aspirin (Empirin with codeine) are the agents most likely to be used in dentistry.
Since these agents contain an opioid, it is possible to develop an addiction to the combination
products and they are in schedule C of the Drug Enforcement Administration.
The REMS is part of a multi-agency Federal effort to address the growing problem of
prescription drug abuse and misuse. The REMS introduces new safety measures to reduce risks
and improve safe use of ER/LA opioids. Recommendations for individuals who prescribe these
agents to consider other agents with less potential for addiction was made, while rules for
continuing to provide access to these medications for patients in pain was approved.
Conclusion
The history of opioid therapy vacillates. Opioids were once withheld from suffering patients
largely due to fear of addiction. Then prescribers went to the other extreme, and opioids were
liberally dispensed, without regard to danger, and, unfortunately, with a tendency to trivialize the
risk of possible addiction. Patients were usually not told of the risk for dependence. Practitioners
prescribed drugs with the potential to cause dependence on a long term basis. This practice led to
many individuals becoming addicted to prescribed narcotic analgesics. Evidence based research
reveals nonnarcotic analgesics can relieve oral pain very effectively and should be the first
choice when deciding on pain relief.
Many clinicians report having trepidation about opioid use and misuse. It is stressful to manage
pain for their patients when addiction may be the end result (Jamison et al., 2014). Primary care
providers are committed to the belief that opioids are effective in controlling pain, that addiction
is very possible with prolonged use, and long-term opioid use is over prescribed for those
individuals with non-cancer pain (Wilson et al.,2013). Attitudes and beliefs as well as trends in
opioid prescribing and subsequent overdose emphasize the need for better clinician education in
opioid prescribing. Clinical practice guidelines dedicated to prescribing are able to improve
clinician knowledge, alter prescribing practices, and ultimately benefit the patient (Haegerich et
al., 2014).
The current state of regulatory examination has resulted in a new reluctance to prescribe opioids.
What's needed is a balance between the extremes. This means adequate patient assessment and
historical information regarding the pain experience, rational pharmacology decisions,
application of principles of addiction medicine to the treatment plan, and tailoring therapy to the
level of oral pain and risk level of each individual patient.
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Appendix A
FDA Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of
Patients with Pain September 2018
Introduction FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers
Involved in the Treatment and Monitoring of Patients with Pain
Background
In July 2012, FDA approved the Extended-Release and Long-Acting (ER/LA) Opioid Analgesic Risk
Evaluation and Mitigation Strategy (ER/LA REMS) to ensure that the benefits of ER and LA opioid
analgesics used in the outpatient setting outweigh the risks. That REMS was modified, and the new
Opioid Analgesic REMS includes, in addition to ER/LA opioid analgesics, all immediate-release (IR)
opioids used in the outpatient setting that are not already covered by another REMS program. The Opioid
Analgesic REMS is intended to support other national efforts underway to address the misuse and abuse
of prescription opioid analgesics.
As part of the Opioid Analgesic REMS, all opioid analgesic companies must provide the following:
• Education for health care providers (HCPs) who participate in the treatment and
monitoring of pain. For the purpose of the Opioid Analgesic REMS, HCPs will include
not only prescribers, but also HCPs who participate in the treatment and monitoring of
patients who receive opioid analgesics, including pharmacists and nurses.
• Education will be offered through accredited continuing education (CE) activities.
These activities will be supported by unrestricted educational grants from opioid
analgesic companies.
• Information for HCPs to use when counseling patients about the risks of ER, LA, and IR
opioid analgesic use.
To facilitate the development of CE educational materials and activities as part of the Opioid Analgesic
REMS, FDA has also revised the education blueprint ― originally designed to facilitate development of
CE educational materials under the ER/LA REMS. FDA has completed the revisions to the FDA
Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with
Pain (FDA Blueprint), following publication of a draft version and consideration of received public
comments.
The FDA Blueprint contains a high-level outline of the core educational messages that will be included in
the educational programs developed under the Opioid Analgesic REMS. The FDA Blueprint focuses on
the fundamentals of acute and chronic pain management and provides a contextual framework for the safe
prescribing of opioid analgesics. The core messages are directed to prescribers, pharmacists, and nurses,
but are also relevant for other HCPs who participate in the management of pain. The course work is not
intended to be exhaustive nor a substitute for a more comprehensive pain management course.
FDA Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of
Patients with Pain September 2018
2
Accrediting bodies and CE providers will ensure that the CE activities developed comply with the
standards for CE of the Accreditation Council for Continuing Medical Education, 1,2 or another CE
accrediting body, depending on the target audience’s medical specialty or health care profession.
FDA is making the FDA Blueprint, approved as part of the Opioid Analgesic REMS, available on the
REMS@FDA Website (www.fda.gov/REMS), where it will remain posted for use by CE providers as
they develop the CE materials and activities. A list of the REMS-compliant CE activities supported by
unrestricted educational grants from the opioid analgesic companies to accredited CE providers will be
posted at www.opioidanalgesicREMS.com as that information becomes available.
Reasons Why HCP Education Is So Important
Adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate
prescribing, abuse, and misuse of opioids have emerged as major public health problems. It is critical that
HCPs are knowledgeable about the risks associated with opioid analgesics as they pertain to their patients
as well as from a public health perspective. The data continue to show problems associated with
prescription opioid analgesics.
• In 2015, over 52,404 Americans died from drug poisonings, and of these, 24% or approximately
12,570 deaths involved opioid analgesics.3
• Based on the 2016 National Survey on Drug Use and Health (NSDUH), an estimated 11.5
million Americans aged 12 or older misused a prescription pain reliever in the past year ― with
hydrocodone, oxycodone, and codeine products being the most commonly reported.4
• The most common source of pain relievers in the 2016 NSDUH was “a friend or relative”
(53%). “A physician’s prescription” was the second most common source, reported by
approximately 35% of respondents.5
The nation is facing competing public health problems: the need to adequately treat a large number of
Americans with acute and chronic pain and an epidemic of prescription opioid abuse.
1 Accreditation Council for Continuing Medical Education. 2016. Accreditation Requirements. Criteria for CME
Providers-Accreditation Criteria. Accessed July 2018. 2Accreditation Council for Continuing Medical Education. 2016. Accreditation Requirements. Criteria for CME
Providers-Standards for Commercial Support. Accessed July 2018.
3https://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.pdf. Accessed July 2018.
4 Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health
indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication
No. SMA 17-5044, NSDUH Series H-52). Rockville, MD: Center for Behavioral Health Statistics and Quality,
Substance Abuse and Mental Health Services Administration. 5 Ibid.
FDA Education Blueprint for Health Care Providers Involved in the Treatment and
Monitoring of Patients with Pain September 2018
Described in the 2011 report by the National Academies of Science, Engineering, and Medicine
(NASEM), Relieving PAIN in America, A Blueprint for Transforming Prevention, Care, Education, and
Research,6 100 million Americans suffer from common chronic pain conditions; fewer than half of
Americans undergoing surgery report adequate pain relief; and 60% of Americans visiting the emergency
department with acute painful conditions receive analgesics.
The increasing availability of prescription opioids since the 1990’s has been accompanied by an epidemic
of opioid addiction. The Substance Abuse and Mental Health Services Administration’s National Survey
of Drug Use and Health has shown that most people who use prescription analgesics “nonmedically”
obtain them from friends or family, who it is believed obtained the drugs from a doctor’s prescription.7
Some of the immediate consequences of untreated or undertreated pain include reduced quality of life,
impaired physical function, and high economic costs. Chronic pain is associated with physical disability,
fear, anger, depression, anxiety, and reduced ability to carry out the roles of family member, friend, and
employee. It is critically important that HCPs have all the information they need to properly treat their
patients and safely manage their pain. It is also critical for HCPs to understand when opioid analgesics
are the appropriate treatment and how to implement best practices to ensure their patients’ safety. A 2017
report by NASEM, Pain Management and the Opioid Epidemic: Balancing Societal and Individual
Benefits and Risks of Prescription Opioid Use, describes the challenges of providing adequate pain
management and calls for the establishment of “comprehensive pain education materials and curricula”
for HCPs.8
Having broad knowledge about how to manage patients with pain can create the opportunity for HCPs to
consider all options for pain management, including nonpharmacologic and non-opioid pharmacologic
options, and to reserve opioids for when non-opioid options are inadequate and when the benefits of the
opioids are expected to outweigh the risks. This information can also aid HCPs in identifying and
intervening when encountering obstacles that may reduce access to nonpharmacological and non-opioid
medication options. Fully informed HCPs can help contribute to national efforts to address opioid
addiction and reduce opioid misuse and abuse.
http://www.nationalacademies.org/hmd/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-
TransformingPrevention-Care-Education-Research.aspx. Accessed July 2018.
https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf, Table 6.53A.
Accessed July 2018.
http://nationalacademies.org/hmd/Reports/2017/pain-management-and-the-opioid-epidemic.aspx. Accessed July
2018.
FDA Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring
of Patients with Pain September 2018
Purpose of the Opioid Analgesic REMS HCP Educational Effort Following completion of educational
activities under the Opioid Analgesic REMS, HCPs should be knowledgeable about the following.
• The fundamental concepts of pain management, including definitions and mechanisms of pain
• How to assess patients in pain, identifying risk factors for abuse and addiction
• The range of therapeutic options for managing pain, including nonpharmacologic approaches and
pharmacologic (non-opioid and opioid analgesics) therapies
• How to integrate opioid analgesics into a pain treatment plan individualized to the needs of the patient
• How to safely and effectively manage patients on opioid analgesics in the acute and chronic pain
settings, including initiating therapy, titrating, and discontinuing use of opioid analgesics
• How to counsel patients and caregivers about the safe use of opioid analgesics, including proper storage
and disposal
• How to counsel patients and caregivers about the use of naloxone for opioid overdose
• When referral to a pain specialist is appropriate
• The fundamental elements of addiction medicine
• How to identify and manage patients with opioid use disorder
In addition, HCPs will gain an understanding of current information about safe opioid practices and about
current Federal9 and State regulations, national guidelines,10 and professional organization11 and
medical specialty guidelines on treating pain and prescribing opioids. HCPs will also become familiar
with the use of naloxone and with the importance of its availability for use by patients and caregivers both
in the community and in the home.
9 For example, see https://www.deadiversion.usdoj.gov/21cfr/cfr/2106cfrt.htm and
https://www.deadiversion.usdoj.gov/21cfr/21usc/829.htm. Accessed July 2018.
10 For example, see Dowell D, Haegerich TM, Chou R. 2016. CDC Guideline for Prescribing Opioids for Chronic
Pain –United States, 2016. MMWR Recomm Rep 2016; 65 (No.RR-1): 1-49. Accessed July 2018.
11 For example, see Federation of State Medical Boards’ Guidelines for the Chronic Use of Opioid Analgesics.
Accessed July 2018.
FDA Education Blueprint for Health Care Providers Involved in the Treatment and
Monitoring of Patients with Pain September 2018
Section 1: The Basics of Pain Management
I. THE NEED FOR COMPREHENSIVE PAIN EDUCATION
The FDA Blueprint was developed with two, competing, U.S. public health concerns in mind, (1)
the large number of Americans with acute and chronic pain and (2) the epidemic of prescription
opioid abuse.
1. Providing health care providers (HCPs) with a thorough understanding of the risks associated
with opioids can give HCPs the opportunity to consider all pain management options, including
nonpharmacologic and pharmacologic options, prescribing opioids only when non-opioid
options are inadequate and when the benefits of using an opioid are expected to outweigh the
risks.
2. When HCPs have information about the risks of opioid misuse and abuse, they will be better
able to create opportunities for patient counseling and other strategies to reduce these risks.
II. DEFINITIONS AND MECHANISMS OF PAIN
Pain can be categorized according to its duration, underlying pathophysiology of the original
insult, and whether a central sensitization component has developed. An understanding of these different
categorizations can help direct therapeutic decisions.
When defining, and classifying pain, the following should be taken into consideration:
1. Biological significance of pain (survival value
2. Relationship between acute and chronic pain
3. Distinction between nociceptive and neuropathic pain
III. ASSESSING PATIENTS IN PAIN
HCPs should be knowledgeable about how to assess each patient when initiating a pain management
program. When appropriate, evidence-based, standardized scales and tools can be used to document pain
characteristics and guide management decisions throughout treatment, noting the strengths and
weaknesses regarding specificity and sensitivity of these scales.
Important elements of an initial assessment should include the following:
1. Patient history
2. Screening tools to evaluate the known risk factors for development of chronic pain after an
acute injury or disease
3. Screening tools to evaluate the known risk factors for opioid use disorder (OUD) or abuse
4. Queries of state prescription drug monitoring programs (PDMPs)
5. Pain assessment scales/tools
6. Functional assessment scales
7. Physical examination
8. Family planning, including information about use of contraceptives, pregnancy intent/status
and plans to breastfeed
9. Psychological and social evaluation
10. Diagnostic studies when indicated
Section 2: Creating the Pain Treatment Plan
A comprehensive pain treatment plan should be developed and customized to the needs of the individual
patient. The treatment plan should include the types of therapies planned, the goals of treatment, and an
explanation of the patient and prescriber roles and responsibilities. The goals of treatment should be
based on (1) expected outcomes of pain reduction; (2) improvement in functional outcomes impaired by
pain (e.g., activities of daily living); and (3) quality of life.
If HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic
treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat
patients with pain, attempts should be made to address these barriers. The overall treatment approach and
plan should be well documented in the patient record, including written agreements and informed
consent/patient provider agreements (PPAs) that reinforce patient-provider responsibilities and avoid
punitive tones.
I. COMPONENTS OF AN EFFECTIVE TREATMENT PLAN
1. The goals of treatment, including the degree of improvement in pain and function when
function has been impaired by pain
2. Possible constituents of the treatment plan, including nonpharmacologic approaches and
pharmacologic therapies
3. Patient/prescriber/health care team interactions, including Patient responsibilities/compliance with the plan
Responsibilities of the prescriber and health care team, including patient monitoring
Plans for reviewing functional goals
Use of supplemental medication for intermittent increases in pain
Use of PPAs
II. GENERAL PRINCIPLES OF NONPHARMACOLOGIC APPROACHES
Pain can arise from a wide variety of causes. There are a number of nonpharmacologic and self-
management treatment options that have been found to be effective alone or as part of a comprehensive
pain management plan, particularly for musculoskeletal pain and chronic pain. Examples include, but are
not limited to, psychological, physical rehabilitative, and surgical approaches, complementary therapies,
and use of approved/cleared medical devices for pain management. HCPs should be knowledgeable
about the range of treatment options available, the types of pain that may be responsive to those options,
and when they should be used as part of a multidisciplinary approach to pain management. HCPs should
also be aware that not all nonpharmacologic options have the same strength of evidence to support their
utility in the management of pain, and some may be more applicable for some conditions than others.
III. GENERAL PRINCIPLES OF PHARMACOLOGIC ANALGESIC THERAPY
A variety of analgesics, including non-opioid and opioid medications, are available for use to manage
pain symptoms. HCPs should be well informed about the range of analgesics available and the types of
pain that may be responsive to those analgesics.
A. Non-opioid medications When using non-opioid medications in pain management, HCPs should be
knowledgeable about the following:
1. Mechanism of action of analgesic effect
2. Indications and uses for pain management
3. Routes of administration and formulations used in pain management
4. Initial dosing, dose titration, dose tapering (when appropriate) for analgesia
5. Contraindications
6. Adverse events, with emphasis on labeled warnings
7. Drug interactions ― both pharmacodynamic and pharmacokinetic
B. Opioid analgesic medications
Opioid analgesic medications can be used successfully as a component of pain management.
However, opioids carry risks not present with most non-opioid analgesics, specifically the risks
of addiction, abuse and misuse, which can lead to respiratory depression, overdose and death. Therefore,
it is the responsibility of HCPs to be knowledgeable, not just about the presence of such risks, but about
how to weigh these risks before prescribing an opioid and about how to properly manage patients who are
prescribed opioids, both for short-term and long-term use.
When using opioid analgesics as part of pain management, HCPs should be knowledgeable about the
following:
1. General precautions
a. Even at prescribed doses, opioid analgesics carry the risk of misuse, abuse, opioid use disorder,
overdose, and death
b. Importance of the appropriate use of PDMPs13 and their use as a clinical decision support tool
c. DSM-5 (R) criteria (or the most recent version) for OUD and the concepts of abuse (taking an
opioid to get high) vs. misuse (taking more than prescribed for pain or giving to someone else in
pain)14
d. The concepts of tolerance and physiological dependence and how they differ from OUD
(addiction)
e. Recognition that some opioid analgesics (e.g., Transmucosal Immediate Release Fentanyl
products, some ER/LA products) are safe only for opioid-tolerant patients
2. Mechanism of action and analgesic effect
3. Types of opioids (full agonists, partial agonists)
4. Indications and uses for pain management
5. Range of opioid analgesic products available for pain management and their related safety concerns
a. Routes of administration including oral, transmucosal, transdermal
b. Release characteristics of immediate release (IR), extended-release (ER), long-acting (LA)
c. Abuse-deterrent formulations (ADFs)
• Definition of ADF based on the FDA guidance for industry, Abuse-Deterrent Opioids –
Evaluation and Labeling15
• Recognition that all ADFs have the same potential for addiction and overdose death as
non-abuse-deterrent opioids
• How to understand FDA-approved ADF product labeling
6. Initial dosing, dose titration, dose tapering (when appropriate) for analgesia
a. Concepts and limitations of the conversion charts in labeling and the limitations of relative
potency or equianalgesic dosing tables in literature
b. Interindividual variability of response
c. Special populations
• Pregnant, postpartum, breastfeeding, and neonatal opioid withdrawal syndrome
• Renal and hepatic impairment
• Children and adolescents
• Genetic and phenotypic variations
• Older adults
• Sleep disorders
• Common and uncommon psychiatric disorders
7. Contraindications
8. Adverse Events
a. Medication errors
b. Periods of greater risk for significant respiratory depression, including at treatment initiation
and with dose increases
c. Serious adverse drug reactions (including overdose and death)
d. Labeled warnings e. Common adverse drug reactions
9. Drug interactions
a. Pharmacokinetic interactions based on metabolic pathway
b. Pharmacokinetic and pharmacodynamic interactions with alcohol
c. Concerns with particular drug–drug interactions, including, but not limited to:
• Benzodiazepines and other central nervous system depressants, including alcohol
• Monoamine oxidase inhibitors
• Antidiuretic hormone drugs
10. Key safety strategies for use with opioid medications
a. Dosing instructions including daily maximum
b. Safe storage to reduce risk of accidental exposure/ingestion by household contacts, especially
children/teens and to reduce risk of theft
c. Naloxone products for use in the home to reduce risk of overdose deaths in patients and
household contacts
d. Proper disposal of used (e.g., transdermal systems) and unused opioids
e. Pain management after an opioid overdose
f. Driving and work safety
For example, see https://nccih.nih.gov. Accessed July 2018.
SAMHSA Prescription Drug Monitoring Programs: A Guide for Healthcare Providers. Accessed July
2018American Psychiatric Association DSM-5-Opioid Use Disorder Diagnostic Criteria. Accessed July 2018
See FDA guidance for industry Abuse-Deterrent Opioids —Evaluation and Labeling. Accessed July 2018.
FDA Education Blueprint for Health Care Providers Involved in the Treatment and
Monitoring of Patients with Pain September 2018
IV. MANAGING PATIENTS ON OPIOID ANALGESICS
HCPs should be knowledgeable about the appropriate use of opioids in patients with acute and chronic
pain, including the importance of balancing potential benefits with the risks of serious adverse outcomes
such as overdose and death.
A. Initiating treatment with opioids ― acute pain
1. Patient selection ― consider when an opioid is an appropriate option and consult the
PDMP
2. Dosing — as needed vs. around-the clock dosing, prescribing an appropriate quantity
based on the expected duration of pain, i.e., the least amount of medication necessary to
treat pain and for the shortest amount of time
3. Naloxone for home use ― prescribe and discuss the use of naloxone products and the
various means of administration
4. Screening tools for risk of abuse
B. Initiating treatment with opioids ― chronic pain
1. Patient selection
a. Differences in benefit and risk and expected outcomes for patients with
chronic pain, palliative care, or end-of-life care
b. Differences in initiating treatment in opioid nontolerant vs. opioid-tolerant
patients
2. Dosing
a. As needed vs. around-the-clock
b. How to determine a safe initial dose
c. Safe conversion from other opioids
3. Considerations in opioid selection
a. IR or ER/LA
b. Special precautions with methadone
c. Products restricted to opioid-tolerant patients
4. When and how to use an opioid or non-opioid analgesic to supplement pain management
C. Ongoing management of patients on opioid analgesics
1. Periodic review of pain and functional goals
2. Review adverse events at each visit
• Eliciting signs or symptoms of opioid abuse
• Screening for endocrine function may be recommended
• Importance of adverse event reporting and mechanisms to report
3. Review refill history/review PDMP
4. How to determine when an opioid analgesic is no longer necessary/beneficial
D. Long-term management
1. Evaluation of the patient with worsening pain for changes in underlying condition and for
signs of OUD before increasing opioid dosage
2. Changing opioid medications
• Concept of incomplete cross-tolerance when converting patients from one
opioid to another
• Concepts and limitations of the conversion charts in labeling and the limitations
of relative potency or equianalgesic dosing tables in literature
3. Monitoring of patient adherence to the treatment plan, especially regarding misuse and
abuse:
• Perform medication reconciliation ― recognize, document, and address aberrant drug-related
behavior
• Determine if nonadherence is due to inadequate pain management
• Understand the utility and interpretation of urine drug testing (e.g., screening and confirmatory
tests) and use as indicated
• Screen and refer for substance use disorder treatment when concerns arise
E. How to recognize and intervene upon suspicion or identification of an OUD
HCPs should understand how to monitor patients taking opioid analgesics and identify the signs and
symptoms of opioid misuse, abuse, and OUD and be knowledgeable about how to begin the process of
intervention upon suspicion of an OUD.
F. When to consult with a pain specialist
HCPs should be knowledgeable about when referral to a pain management specialist is indicated,
including identifying patients at high risk for OUD and patients unable to achieve adequate pain
management.
G. Medically directed opioid tapering
HCPs should be knowledgeable about how to safely taper opioid analgesics, including how to
recognize and manage signs and symptoms of opioid withdrawal.
HCPs should be knowledgeable about the particular risks associated with tapering during
pregnancy.
H. Importance of patient education
HCPs should recognize their role in reducing the risks associated with opioid analgesics through
patient education at initiation of an opioid and throughout long-term management.
1. Inform patients about pain management expectations and managing pain through different
pharmacologic and nonpharmacologic modalities.
2. Use the Patient Counseling Guide: What You Need to Know About Opioid Pain Medicines
as part of discussion with patients and caregivers when prescribing opioid analgesics.
3. Counsel the patient about the following:
a. Importance of adherence to prescribed dosing regimen
b. Patients should use the least amount of medication necessary to treat pain and for the
shortest amount of time
c. The risk of serious adverse events that can lead to death
d. The risk of addiction that can occur even when product is used as recommended
e. Known risk factors for serious adverse events, including signs and symptoms of
overdose and opioid-induced respiratory depression, GI obstruction, and allergic
reactions, among others
f. The most common side effects, along with the risk of falls, working with heavy
machinery, and driving
g. When to call the prescriber (e.g., managing adverse events, ongoing pain)
h. How to handle missed doses
i. The importance of full disclosure of all medications and supplements to all HCPs
and the risks associated with the use of alcohol and other opioids/benzodiazepines
j. Product-specific concerns, such as not to crush or chew ER products; transdermal
systems and buccal films should not be cut, torn, or damaged before use, etc.
k. How to safely taper dose to avoid withdrawal symptoms
l. Safe storage and disposal, risks of theft by family members and household visitors
m. Never share any opioid analgesic with another person
n. How and when to use naloxone products and their various means of administration
o. Seeking emergency medical treatment if an opioid overdose occurs
p. How to report adverse events and medication errors to FDA (1-800-fda-1088 or via
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM1639
19.pdf)
V. ADDICTION MEDICINE PRIMER
HCPs should be knowledgeable about the basic elements of addiction medicine and be familiar
with the definition, neurobiology, and pharmacotherapy of OUDs. In particular, stigmatizing or blaming
language should be replaced with language that acknowledges that addiction, is a disease. The term
opioid use disorder should be used when referring to the use of opioids, rather than other substances.
It should also be noted that there may be a different approach with a patient who misuses an opioid
analgesic by taking the product differently than prescribed for the purpose of managing pain, in contrast
to the patient who abuses an opioid analgesic with the intent of getting high. HCPs should be familiar
with the following:
1. The neurobiology of OUD (addictive cycle)
2. Use of screening tools to identify patients at risk, based on known risk factors, and to identify
patients developing signs of opioid dependence or addiction as early as possible.
3. Management of OUD, including the types of pharmacologic and nonpharmacologic treatments
available and when to refer to an addiction medicine specialist.
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (Copyright 2013). American Psychiatric
Association
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (Copyright 2013 American Psychiatric
Association reclassified as substance use disorder16 in the revised Diagnostic Statistical Manual–V,
CE Article Post-Test: Are We Dealing with Drug Seeking Patients?
I Left My Prescription in My Hotel; Can I Get A New One?
Test Questions
1. What % of deaths in 2016 involved an opioid?
a. 25%
b. 50%
c. 33%
d. 66%
2. According to research, the highest prescribing state for opioids is
a. Arkansas
b. Alabama
c. Alaska
d. Arizona
3. The most common drugs involved in prescription overdose deaths include
a. Methadone
b. Oxycodone
c. Hydrocodone
d. All of the above
4. The elderly patient suspected of drug seeking behavior may request additional doses of
pain medication due to which of the following reasons?
a. Family members are taking the elderly person’s analgesic pills
b. The current dose does not take care of the pain.
c. Pain pills have dropped in the toilet.
5. Heroin use
a. Has increased in use for women
b. Can cause coma before death
c. Is often used with other drugs and alcohol
d. A and B are correct
e. All of the above are correct
6. Opioid analgesics for oral pain are to be prescribed for no more than
a. 3 to 4 days
b. 7 to 10 days
c. 30 days
d. 60 days
7. People who are addicted to prescription opioids are ____ times more likely to be
addicted to heroin.
a. 20
b. 25
c. 40
d. 50
8. A 17-item measure designed to identify aberrant drug-related behaviors in patients with
chronic pain who are receiving opioids
a. COMM
b. PADT
c. MMWR
d. ABC
9. The REMS program requires that training be made available to all health care providers
(HCPs) who are involved in the management of patients with pain, including nurses and
pharmacists.
a. TRUE
b. FALSE
10. As part of the Opioid Analgesic REMS, all opioid analgesic companies must provide
a. Education for healthcare providers
b. Continuing education credit
c. Counseling information
d. All of the above
Are We Dealing with Drug Seeking Patients?
I Left My Prescription in My Hotel; Can I Get A New One? (1 Hr.)
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