The Doctor’s Advocate | Third Quarter 2013
An Ounce of Prevention

The Rising Tide: Perils of Opioid Use

by Howard Marcus, MD, FACP, Chair, Texas Alliance for Patient Access, and Chairman, The Doctors Company Texas Physician Advisory Board

In this article, Dr. Marcus describes the patient safety issues arising from the inappropriate administration of opioids.
—Robin Diamond, JD, RN; AHA Fellow–Patient Safety Leadership; Chief Patient Safety Officer, Department of Patient Safety

Medication-related errors currently represent 8 percent of The Doctors Company’s claims. Opioids now have the distinction of surpassing oral anticoagulants and anti-infectives as the leading cause of drug-related claims. Opioid-related claims involve both the inpatient and outpatient setting and include accidental overdose, misuse of multiple drugs with synergistic side effects, and iatrogenic overdose. Some cases have tragically resulted in death or encephalopathy due to respiratory depression.

The number of opioid prescriptions written in the United States has increased 400 percent in the past 20 years—an increase in legal opioid prescriptions that is far beyond the usage rate of illicit drugs, such as cocaine and heroin. It should come as no surprise that the number of drug poisoning–related emergency department visits, hospital admissions, and deaths involving natural and semi-synthetic opioid analgesics has also increased four-fold.

This increase in opioid use cannot be explained solely by an increase in the frequency of cancer and treatment of cancer-related pain. Rather, the proliferation of opioid prescriptions is largely the result of the widespread use of opioids for the management of chronic nonmalignant pain, such as back pain, myofascial pain, abdominal pain, and headache.

What can healthcare providers do to stem the tide of adverse effects from opioids? Consider the lessons learned from the following case, which illustrates the risk of iatrogenic respiratory depression due to opioids in combination with a benzodiazepine in a patient with inappropriate medication demands.

A 27-year-old male, 5 feet 8 inches tall, weighing 225 pounds (body mass index 34), with a history of asthma, presented to the emergency department. Although he denied alcohol, drug, or tobacco use, he had a long history of drug abuse and drug-seeking behavior—information unknown to the emergency physician. While in the emergency department, the patient told the physician, “I’ve used Dilaudid in the past, and 4 mg of IV Dilaudid helps my pain. That’s what I want, along with Benadryl 50 mg.” The patient was admitted to the hospitalist service to a monitored bed and treated for asthma exacerbation with bronchodilators and Solu-Medrol.

The hospitalist ordered Dilaudid 2–4 mg IV q3hr prn for pain. Subsequently, Ativan 2–4 mg IV q4hr, Benadryl, and trazodone were also ordered.

The following day, the hospitalist found the patient’s respiratory status improved, although he continued to complain of nonspecific pain. The patient was lethargic but arousable. The hospitalist reduced the Dilaudid to 2–4 mg IV q6hr, discontinued the Solu-Medrol, and transferred the patient to a nontelemetry unit.

That evening the patient requested and received Ativan and Dilaudid. His O2 on room air was 95 percent, pulse 86, and respirations 20.

An hour and a half later, respiratory therapy (RT) heard diminished breath sound with labored respirations. The O2 sat had decreased to 92 percent on room air, with heart rate at 100 and respirations at 22. RT did not inform the nurse or the physician of the change in respiratory status.

At midnight, the patient reported no pain, and his O2 sat was 97 percent on room air. The patient walked with the nurse, who charted he was “fine.” Thirty minutes later, the patient requested Dilaudid, Benadryl, and Ativan for complaints of abdominal pain at a level of 8 out of 10. The nurse administered Dilaudid 4 mg IV and Ativan 4 mg IV. Two hours later, the patient was unresponsive, could not be resuscitated, and died. An autopsy revealed acute bronchial asthma. Experts opine that the synergistic effect of the drugs, combined with the patient’s asthma, caused respiratory depression and the patient’s death.

Opioids are highly effective analgesics that activate mu, delta, and kappa receptors throughout the central and peripheral nervous systems. While activation of the mu receptor results in analgesia and euphoria, it also produces sedation and respiratory depression. Nonopioid central nervous system depressants—mainly anesthetics, alcohol, and benzodiazepines like Ativan—have a strong potential for synergistic respiratory depression when used in combination with opioids.

As this case illustrates, physicians must be wary of unreasonable patient demands for pain analgesia, and they must avoid prescribing large doses of opioids and/or potentially hazardous drug combinations.

Patient Safety

When physicians initiate opioid therapy for acute and chronic pain management, they must define the following parameters:

  • Is there a clear diagnosis with documentation of an adequate workup?
  • Is there organ impairment function (e.g., hepatic, renal, or chronic obstructive pulmonary disease with higher risk for respiratory depression)?
  • Does the patient have obstructive sleep apnea?
  • Has nonopioid therapy failed?
  • Are there risk factors for abuse and/or addiction of opioids, including any past illicit drug use, alcohol abuse, or history of substance use disorder?
  • Is there a family history of substance abuse or alcohol abuse?
  • Is there a history of depression or severe anxiety?
  • Is the patient using alcohol or taking any medications that could have synergistic adverse side effects?

Patients prescribed opioids for chronic nonmalignant pain also should sign an opioid treatment agreement that includes the following:

  • Agreement that lack of adherence may result in discontinuation of opioid therapy.
  • Informed consent, particularly regarding avoidance of alcohol and sedating drugs.
  • A prescription from only one physician and one pharmacy.
  • Agreement to take only as prescribed.
  • Responsibility for physical possession of written prescriptions and medications.
  • Refill requests only during regular office hours.
  • Agreement to participate in urine drug screens.

Know Your Regulations

Many regulators, including the U.S. Food and Drug Administration (FDA), Drug Enforcement Agency, state medical boards, state drug authorities, hospitals, and other agencies have taken notice of the increase in opioid use and are very concerned about the opioid-related epidemic of overdoses and fatalities. In addition, the information that follows can aid the physician when prescribing opioids.

The FDA’s Risk Evaluation and Mitigation Strategies (REMS) program for long-acting and extended-release opioids provides funding for continuing medical education programs to advance prescriber understanding and safe use of pain medications. (See “REMS: Opioid-Related Patient Safety and Liability” in the fourth quarter 2012 issue of The Doctor’s Advocate at www.thedoctors.com/advocate.)

Prescription monitoring programs now exist in many states. These programs allow qualified healthcare providers online access to all opioid prescriptions filled by a pharmacy within their state. Physicians can accurately determine whether patients are filling their prescriptions appropriately and/or whether they are doctor-shopping. For more information, see “Are Your Prescribing Practices Secure?

Medications Related to Patient Injuries

 

Sources

Travis County Medical Examiner 2011 Annual Report, Travis County, Texas.

Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med. 2003 Nov 13;349(20).

Darnall BD, Schatman, ME, Argoff CD, Ballantyne JC. Understanding opioids: Parts 1 and 2. www.medscape.com.

Von Korff M, Kolodny A, Devo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med. 2011 Sep 6;155(5).

UpToDate chapters: Opioid intoxication in adults and opioid abuse and dependence: overview and patient evaluation. www.uptodate.com.

The Joint Commission. Safe use of opioids in hospitals. Sentinel Event Alert. 2012 Aug 8(49). www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf.

FDA-required REMS program for serious drug risks. PDR Drug Alert. PDR.net website. www.pdr.net/pdr-drug-communications/drug-alert/?id=1000177.


The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.

The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.

The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

The Doctor’s Advocate is published quarterly by Corporate Communications, The Doctors Company. Letters and articles, to be edited and published at the editor’s discretion, are welcome. The views expressed are those of the letter writer and do not necessarily reflect the opinion or official policy of The Doctors Company. Please sign your letters, and address them to the editor.

The Doctor’s Advocate

Third Quarter 2013

Director's Forum
A Perfect Storm

An Ounce of Prevention
The Rising Tide: Perils of Opioid Use

Politically Speaking
Consumer Attorneys of California Attack MICRA

Ohio Physician Advisory Board Update

The Foundation News
Young Physicians Receive Prestigious Patient Safety Award

Two New Ways to Earn Complimentary CME Credits

The Back Page
Industry and Company News

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