Dr. Gustin's Blog

Narcan and ER Treatment of Opiate Overdose

Details: Published: Saturday, 05 January 2019 16:01

Recently published in the Acad. Emerg. Med. December 28, 2018

Most patients who overdose on opioids can be safely discharged from the emergency department (ED) as early as an hour after prehospital administration of the opioid antagonist naloxone, the study has found.

Opioid-related ED visits nearly doubled in the United States from 2005 to 2014.

The researchers conducted a prospective study to validate the early discharge rule practiced at St. Paul's Hospital, Vancouver, Canada, which allows for discharge after 1 hour for those in whom the following six criteria are within normal limits: ambulation, oxygen saturation (> 95%), respiratory rate (>10 and <20 breaths/min), temperature (>35.0° C and <37.5° C), heart rate (>50 and <100 beats/min), and Glasgow Coma Scale score (15).

The study included 538 adult patients who presented by ambulance to the ED from 2016 to 2017, who had been administered at least one dose of naloxone before entering the hospital, and who underwent evaluation by an emergency medicine provider 1 hour after naloxone administration. (The typical observation period at the hospital is 4 hours.) The mean age of the patients was 33.4 years, and 69.5% were male.

The researchers examined whether clinical judgment, the St. Paul's Early Discharge Rule, or both, when utilized 1 hour after prehospital administration of naloxone, could predict who would have an adverse event (AE) within 24 hours.

AEs occurred in 82 patients (15.4%), but none died within 48 hours. The most common AEs were need for supplemental oxygen (11.3%), repeat naloxone for hypoventilation (3%), and assisted ventilation (2.6%).

Overall, the rule had a sensitivity of 84.1% (95% confidence interval [CI], 76.2 - 92.1), a specificity of 62.1% (95% CI, 57.6 - 66.5), and a negative predictive value of 95.6% (95% CI, 93.3 - 97.9). The inability to mobilize normally had the greatest sensitivity (58.0%) for predicting AEs; an abnormal temperature had the greatest specificity (99.1%). The rule failed to predict AEs in just 13 of 538 cases (2.4%).

These results are in line with the derivation study by the rule's originators, which found that the AE rate was 16% and the negative predictive value was 99%.

Only one patient in the study whose 1-hour evaluation results were normal subsequently needed additional naloxone following another presumed heroin overdose.

When used in tandem with healthcare provider judgment, the rule had a sensitivity of 87.8% (95% CI, 80.7% - 94.9%), a specificity of 53.0% (95% CI, 48.4% - 57.7%), and a negative predictive value of 96.0% (95% CI, 93.5 - 98.4%). Used together, provider judgment and the St. Paul's Early Discharge Rule predicted AEs in all but 10 of 529 patients (1.9%) .

"Applying the prediction rule for patients for whom providers have a low clinical suspicion for AEs is a reasonable approach for risk stratifying patients for early discharge following naloxone administration for suspected opioid overdose," the authors write. They add, however, that the rule should be used with caution in cases of known oral or mixed overdose. They also call for further study to determine the rule's effectiveness in the context of overdoses of different drugs, drug combinations, and routes of administration.

Acad Emerg Med. Published online December 28, 2018. Full text

Medication Errors: #3 Cause of Death in U.S.

Details: Published: Thursday, 23 June 2016 23:58

Medical error is the third leading cause of death in the United States, after heart disease and cancer, according to findings published in a recent issue of the British Medical Journal.

As such, medical errors should be a top priority for research and resources, say authors Martin Makary, MD, MPH, professor of surgery, and research fellow Michael Daniel, from Johns Hopkins University School of Medicine in Baltimore, Maryland.

FDA Declares Quinolones Drug Non-Gratis

Details: Published: Saturday, 11 June 2016 23:56

Fluoroquinolones like Cipro, Avelox, and Levaquin are commonly used by clinicians to treat a host of bacterial infections including, urinary tract infections, pneumonia, diarrhea, sinusitis, bronchitis and others. Because of common musculoskeletal complications the FDA recently made rulings.

The US Food and Drug Administration (FDA) said today that unless they lack other treatment options, patients with uncomplicated infections should not receive fluoroquinolones, given the risk for disabling and potentially permanent adverse events.

Medication Errors and Mortality

Details: Published: Saturday, 04 June 2016 18:59

Medical error is the third leading cause of death in the United States, after heart disease and cancer, according to findings in the British Medical Journal, 253:i2139, 2016.

Adverse Reactions to Anti-Histamines

Details: Published: Saturday, 04 June 2016 18:51

Antihistamines are amongst the most widely prescribed drugs. Although easily tolerated by most, there are clearly adverse reactions in some patients, especially children. Here is a summary of a new study that documents these problems.

Antihistamines are associated with a variety of adverse reactions in children, including headaches, sleepiness, rashes, behavioral changes, and convulsions, new research suggests.

A New Hallucinogen: "Legal LSD"

Details: Published: Wednesday, 20 April 2016 16:13

A novel psychoactive substance, or "legal high," that has hallucinogenic effects and potentially severe adverse effects is being sold to partygoers as lysergic acid diethylamide (LSD).

Although the use of 25I-NBOMe, also known as "legal LSD," is currently relatively rare, it is sold under various names and in a range of forms, making it difficult for users to know what they are taking and for clinicians to develop effective treatments.

Opioid Policy Changed by FDA

Details: Published: Monday, 07 March 2016 00:25

FDA Unveils Sweeping Changes to Opioid Policies

In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency's approach to opioid medications.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Robert Califf, MD, the FDA's Deputy Commissioner for Medical Products and Tobacco, said in a news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

SINGLE-PAYER System Will Not Work in the U.S.

Details: Published: Monday, 07 March 2016 00:23

Single-Payer System: Why It Would Ruin US Healthcare

Single-Payer Would Be Bad for Doctors

A single-payer system—government-run healthcare for all—sounds like a noble ideal, but things quickly fall apart in the execution, according to its critics.

Michel Accad, MD, a cardiologist in San Francisco, says that because a single-payer system makes healthcare virtually free, "demand is almost unlimited," and the government has to set limits on what will be provided. Dr Accad writes a blog called "Alert & Oriented," which provides alternative views on healthcare systems.

Fentanyl Fatalities Increasing

Details: Published: Wednesday, 16 December 2015 21:12

The Centers for Disease Control and Prevention (CDC) has issued a warning regarding increases in fentany drug confiscations and a potential increased risk for fentanyl-related overdose fatalities.

According to the CDC, reports from the National Forensic Laboratory Information System, a program of the Drug Enforcement Administration's (DEA's) Office of Diversion Control, indicate there has been a significant increase in the confiscation of illicit fentanyl by authorities from 2012 to 2014, raising concerns that these drug seizures may be a proxy for increased overdose risk.

Narcan Nasal Spray approved by FDA

Details: Published: Sunday, 22 November 2015 15:57

An intranasal form of naloxone hydrochloride (Narcan, Adapt Pharma, Inc), a drug that stops or reverses opioid overdose, has been approved by the US Food and Drug Administration (FDA) under a fast-track approval process.

Naloxone hydrochloride has long been given by intramuscular injection to stop or reverse the effects of opioid overdose, in particular respiratory depression. It usually works within 2 minutes but must be given quickly to prevent death.

The nasal form will be easier for first responders and others to deliver, and will eliminate the threat of contaminated needle sticks. Until now, unapproved naloxone kits have combined the injectable form of naloxone with an atomizer to administer the drug nasally.

No assembly is required for the approved nasal product, and anyone can administer it, even those without medical training. The product can be given to adults and children. It is sprayed into one nostril while the patient lies on his or her back, and can be repeated if needed. The FDA cautions that the person administering the drug should still seek immediate medical attention for the patient.

Drug overdose deaths have risen steadily for the past decade and now surpass motor vehicle crashes as the leading cause of injury death in the United States. The increase is due in large part to prescription drug overdoses, as well as a rise in heroin use.

"Combating the opioid abuse epidemic is a top priority for the FDA," Stephen Ostroff, MD, acting FDA commissioner, said in an FDA news release. "We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose."

The approval follows an expedited review of data from clinical trials in which nasal administration achieved the same or higher levels of naloxone as those obtained with intramuscular injection, and in about the same amount of time.

The FDA's priority review program facilitates approval of drugs that are expected to significantly improve the safety or effectiveness of the prevention, treatment, or diagnosis of a serious medical condition. The FDA approved the nasal spray in less than 4 months.

Narcan Nasal Spray to Counter Opiate Overdose Approved by FDA

"We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication — a critical attribute for this emergency life-saving drug," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

The National Institute on Drug Abuse (NIDA) designed and conducted clinical trials to determine that the intranasal formulation worked as quickly and effectively as the injectable form. NIDA then worked with its partners in the private sector to obtain approval from the FDA.

"This easy-to-use intranasal formulation will no doubt save many lives," Nora Volkow, MD, director, National Institute on Drug Abuse at the National Institutes of Health, explained in the news release. "While prevention is the ultimate goal, the drug's successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now."

Health and Human Services Secretary Sylvia M. Burwell proposed a targeted strategy for addressing the opioid epidemic that includes increasing access to and use of naloxone in March. In July the FDA sponsored a public workshop at which addiction and advocacy groups demanded expanded availability of the lifesaving drug.

Naloxone nasal spray can cause severe opioid withdrawal in patients who are opioid dependent.