According to the Food and Drug Administration (FDA), the accidental overdose of opioids has increased over the past decade.1 A multiyear study from Ontario, Canada, reports 251 deaths from Dilaudid (hydromorphone) due to oral and IV overdose.2 A West Virginia study reports 234 deaths from oral overdose of narcotics in 2006 alone.3 The Doctors Company claims database contains multiple cases of Dilaudid overdose resulting in morbidity and mortality.
There are multiple reasons for these adverse events, including changes in approaches to pain management, a relatively recent change in recommended IV Dilaudid dose, and an increased risk for respiratory depression due to concomitant factors that may go unrecognized.
Spurred by the 2001 Joint Commission on the Accreditation of Healthcare Organization’s pain management standards, patient comfort has become a high priority. But has safety been compromised? Appropriate pain management should include providing rapid and effective pain control without placing the patient at risk for harm.4 However, error reports indicate possibly over-aggressive attempts involving narcotics to relieve pain.5
Alcohol, other opioids, and central nervous system depressants (sedative-hypnotics) can potentiate the respiratory depressant effects of Dilaudid.6 Seventy-seven percent of morbidity due to opiates occurs in the first postoperative day. Additional risk factors are patients over age 65 and comorbidities such as chronic obstructive pulmonary disease (COPD), kidney disease, congestive heart failure, and sleep apnea.7
Routine monitoring of vital signs by nursing staff may fail to recognize early signs of respiratory depression. Bradypnea is a poor predictor of desaturation and may be a late or absent finding,8 and pulse oximetry may not be an accurate monitoring tool for patients receiving supplemental oxygen.9 When pain is ameliorated and the patient falls asleep, he or she may slip unnoticed into respiratory depression and apnea.
The following cases from The Doctors Company closed claim file will illustrate these points:
Patient safety organizations and the FDA have become concerned. The Institute for Healthcare Improvement (IHI) 5 Million Lives Campaign has focused on safe pain management and narcotic use. IHI recommends standardized hospital protocols for initiation and maintenance of narcotics and the provision for rapid bedside administration of reversal agents (naloxone) if respiratory depression occurs.
The Institute for Safe Medication Practices (ISMP) has compiled recommendations to help reduce patient harm from narcotics:
In an effort to minimize narcotic-related respiratory depression, one large hospital group simplified narcotic administration by removing meperidine/promethazine from the hospital formulary and choosing Dilaudid as the analgesic of choice but with rigorous controls. Hospital regulations now require an automatic advisory that the recommended Dilaudid dose is 0.2–0.5 mg IV whenever Dilaudid is ordered, a maximum dispensing limit of 1 mg per dose, reassessment of respiratory and pain status 15–30 minutes after a Dilaudid dose, and a focused education program for physicians and nurses emphasizing the relative Dilaudid-to-morphine ratio of 7:1. [Seton Medical Center, Austin, Texas; Department of Patient Safety written memo, March 2009]
In February 2009, the FDA announced the development of a Risk Evaluation and Mitigation Strategy (REMS) for Opioids to ensure that their benefits continue to outweigh the risks. Dr. John K. Jenkins, director of the FDA’s new drug center, stated that “what we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products.”12 Drug manufacturers, healthcare professionals, patient and consumer advocates, representatives of the pain and addiction treatment communities, and medical liability insurers are attending a series of FDA-sponsored meetings to formulate effective solutions for the appropriate use of opioid drug products.13
This article originally appeared in The Doctor’s Advocate, third quarter 2009, www.thedoctors.com/advocate.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. 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.