Background
Opioids have been available for therapeutic use for decades having previously been used primarily for cancer patients with pain (malignant pain). Long term use of these medications in patients without cancer (non-malignant) was feared because of the risk of addiction. These treatment thoughts had changed for many physicians during the 1980s after the observations and publications of scientific papers reporting long term use of these medications in non-malignant pain appeared safe. Many physicians started to propose that opioids could be used for non-cancer pain. Coinciding with this new way of thinking, Purdue Pharma started marketing oxycontin (1). By the end of the 1990s many doctors were starting to prescribe opioids for not only malignant but also nonmalignant pain.
Misconceptions About Opioids Many unproven thoughts about opioids were popularized and greatly influenced prescribing habits from the 1990s to the present:
- Opioid induced addiction is rare; these medications are safe.
- Physicians should not let patients suffer when there is an effective available opioid therapeutic.
- Stopping opioid therapy is a simple thing to do.
What we have subsequently seen in patients has not coincided with these thoughts. Addiction and adverse events can become apparent at a previously considered low dose of opioids (50 mg morphine equivalents a day (roughly equal to 5 Vicodin)) and increase as the dose increases (2). There are many medications shown to be equivalent to opioids in providing relief for many pain problems. If opioid use has been sustained over short periods of time, the opioid consumer’s brain can actually change so that once the medicine is stopped; they may have a continued sense or need to use an opioid; this is addiction(3).
Extent of Problem
With the proliferation of opioid prescriptions an opioid epidemic has appeared. Between 1999 and 2014, opioid related drug deaths sky rocketed over 165,000 lives with deaths attributed to opioids; this equates to 78 people dying per day and is now a more common way to die then automobile related fatalities. With these deaths come an increased amount of litigation on improper prescribing. Experienced expert witnesses are being asked to testify in both civil and criminal cases. On an average day, 650,000 opioid prescriptions are dispensed; four thousand in this group will initiate nonmedical use of the opioids (4). Directly correlated to the iatrogenic opioid epidemic is an illicit heroin epidemic (5).
CDC Guidelines This year, 2016, the government has clearly responded to this problem. In March, the CDC produced guidelines for opioid prescribing (7). In August of this year, the US Surgeon General has sent a letter to all prescribing health care practitioners encouraging them to end the opioid crisis and to follow the CDC recommendations (6).
Best Practice in Prescribing Opioids
An Answer From The CDC (Centers for Disease Control and Prevention)
Prescribing opioids with good intentions (ie. Reducing pain in a patient) is no longer satisfactory for individuals with nonmalignant pain. The CDC guidelines have become a new measuring stick on opioid therapy. They are intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death. Points from the guidelines are discussed below (7).
Preffered Treatment for Chronic Pain Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.
Immediate Release Opioids When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting opioids. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.
Risk Factors for Opioid-Related Harm Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.
History of Controlled Substances Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.
Urine Drug Testing When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.
Federal Government Standards
To prescribe, dispense or administer controlled substances, the physician must be registered with the DEA, licensed by the state in which he or she practices, and also complies with applicable federal and state regulations (10). The Federation of State Medical Boards has produced a Model Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain (11).
The goal of this Model Policy is to provide state medical boards with a guideline for assessing physicians’ management of pain, so as to determine whether opioid analgesics are used in a manner that is both medically appropriate and in compliance with applicable state and federal laws and regulations.
Medical Records Every physician who treats patients for chronic pain must maintain accurate and complete medical records. Information that should appear in the medical record includes the following:
- Copies of the signed informed consent and treatment agreement.
- The patient’s medical history.
- Results of the physical examination and all laboratory tests.
- Results of the risk assessment, including results of any screening instruments used.
- A description of the treatments provided, including all medications prescribed or administered (including the date, type, dose and quantity).
- Instructions to the patient, including discussions of risks and benefits with the patient and any significant others.
- Results of ongoing monitoring of patient progress (or lack of progress) in terms of pain management and functional improvement.
- Notes on evaluations by and consultations with specialists.
- Any other information used to support the initiation, continuation, revision, or termination of treatment and the steps taken in response to any aberrant medication use behaviors.
Legal Issues
Several significant events have happened in the civil and criminal judicial system this year. Dr. Tseng was sentenced 30 years to life for the three deaths related to her opioid prescribing (8). A university hospital and an internist in its employ were told to pay a man $17 million dollars for making him an addict (9). Clearly, problems when prescribing opioids can have a devastating effect on both the community as well as the prescriber. Despite a prescriber’s best intent, they may be held liable in civil or criminal court over how they provided opioids and health care to one or more individuals. Counsel representing these prescribers should consider these 7 points:
- Did the problem alleged in the lawsuit actually occur? A medical examiner (ME) may state that the deceased died due to an overdose of a medication or a group of medications but did that actually occur. You need to know the experience of the ME and whether they have the breath of training and knowledge to account for all of the possibilities for why someone dies. Your expert witness should be able to give an approximation of the likelihood that other diseases may have caused death.
- Do the allegations have support in the medical records? Many times charges that are made are either not supported or even negated in the documentation.
- Who is filing the suit? Is their goal fiduciary or retaliatory? Understanding their objective will help guide counsel.
- Was the opioid prescribed according the FDA guidelines? Some of the strongest support for your client may be derived by pointing to governmental standards and noting that your client in fact did what the government said was acceptable.
- Was the opioid prescribed according to the CDC guidelines? These guidelines contain recommendations for primary care physicians but many are using it as a standard to evaluate all physicians.
- Does your physician belong to a national medical organization? If so, cross check to see if your client has prescribed within the standards they promulgate.
- Did your physician document the risks involved in the use of opioids? All areas of medicine have risks and informed consent implies that the patient has accepted the risks relayed by your client.
Conclusion
There is little doubt that we are in the midst of an opioid epidemic. Physicians who prescribe opioids are at increased risk of both civil and criminal prosecutions. Counsel representing these physicians will want to use experts who are experienced clinicians and expert witnesses.
About the Author Dr. Anthony Guarino is a nationally recognized pain management and opioid expert and a celebrated clinician, teacher, author, expert witness, and researcher. His interest in pain management began during his undergraduate work at Yale University, and developed further during graduate studies in religion at Yale Divinity School. He completed a medical degree at the University of Maryland, an internship in medicine at Sinai Hospital in Baltimore and an anesthesiology residency and formal training in pain management at the Johns Hopkins Hospital. Dr. Guarino serves as director of pain management services for Washington University at Barnes Jewish West County Hospital where he evaluates and treats not only the area of pain but the whole person. Dr. Guarino regularly is called upon to consult and testify in cases including complications from opioid related issues.
He can be reached at (314) 580-4609, aguarino@msn.com, www.painstrategy.com.
- http://www.latimes.com/projects/oxycontin-part1/
- http://www.agencymeddirectors.wa.gov/
- https://www.mentalhelp.net/articles/addiction-changes-the-brain-s-communication-pathways/
- http://www.hhs.gov/sites/default/files/Factsheet-opioids-061516.pdf
- http://time.com/4274651/obama-opioid-addiction-summit/
- http://www.cnn.com/2016/08/25/health/us-surgeon-general-letter-doctors-opioid-use/
- http://www.cdc.gov/drugoverdose/prescribing/guideline.html
- http://www.latimes.com/local/lanow/la-me-ln-doctor-murder-overdose-drugs-sentencing-20160205-story.html
- http://www.stltoday.com/news/local/columns/tony-messenger/messenger-st-louis-jury-sends-million-message-in-opioid-abuse/article_b7628f83-0e94-5bc7-a2a8-38a12ab6d7d6.html
- Controlled Substances Act of 1970 (CSA). Federal Register (CFR). Public Law No. 91-513, 84 Stat. 1242.
- http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf
