Wider use of naloxone said to prevent overdose deaths, but where is the data?

Rating

2 Star

Expanding Naloxone use could reduce drug overdose deaths and save lives

Our Review Summary

man appearing to have overdosed on pillsThis news release from the Centers for Disease Control and Prevention (CDC) advocates for wider use of the opioid antidote naloxone (narcan) among basic emergency medical staff to help prevent overdose deaths. But the argument it makes is confusing and not very well supported by the data in the study being reported on. The release tells us that there are “national guidelines that prohibit basic EMS staff from administering the drug as an injection” and that the “majority of states have adopted” these guidelines. But it never says why, which presumably is key to understanding the potential benefit versus the risks of allowing a broader group of EMS staff to administer the drug, even if doing so through nasal spray and not injection.

It can be argued that restrictions on the use of naloxone are based mainly on historical precedent rather than legitimate concerns about harms of wider use. In fact, the drug is increasingly handed out for use by family and friends of substance users at risk of overdose. But the release lacks this crucial context, and the study it describes can’t tell us whether relaxing restrictions on use of naloxone by EMTs would make a difference in health outcomes.

THE BIG ISSUE here is that this is a public health news release about advocacy for the use of naloxone, but the study does not demonstrate efficacy, and is not really about that. The study is important in demonstrating that naloxone is not provided as frequently by lower-level emergency staff, and that there exists potential for more administration if they were trained or otherwise permitted to use the drug. It is a leap to associate this with changing mortality rates; however, there is face validity in the proposition.

 

Why This Matters

This news release addresses the important and growing public health issue of opioid, particularly prescription opioid, overdose, and the challenges to more widespread use of an effective and low-risk antidote.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of costs, either of the drug itself or of providing more training to basic EMTs to achieve certification to administer it.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release does not quantify the benefits of allowing staff with less experience to administer this drug. It says only that, “advanced EMS staff were more likely than basic EMS staff to administer naloxone.”

It kind of quantifies some other things in relative terms. It says, for example, that “the rate of opioid overdose death was 45 percent higher in rural areas compared with urban areas.” OK. That’s a measure of the problem, although it would be nice to know how many deaths in absolute terms happened in rural areas in the year studied. It also says that “The use of naloxone by rural EMS staff, however, was only 22.5 percent higher when compared with urban EMS naloxone use.” But it is not known whether the rate of death was higher or lower in those patients who received or did not receive naloxone. Not knowing the absolute numbers here and not knowing whether naloxone actually made a difference in health outcomes when comparing rural areas to urban areas makes this number difficult to interpret.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release does not say anything about the potential risks here. The fact that lower level EMS staff have been banned from administering this drug suggests that it could be dangerous. However, the reality is that the risks of intranasal naloxone are not significant, so this should have been mentioned. The risk of an intramuscular injection are also low — more or less the same as the risk of any injection (minor bleeding, hitting a nerve, etc). The release should have mentioned the lack of risk and perhaps provided context for the strict regulation of naloxone use (which again is more historical than rational).

Part of what makes the release confusing is that it appears to be advocating for two things. It mentions multiple times that only staff with advanced training are allowed to administer the drug. And it says that “Naloxone can be given nasally to a person suspected of overdose, allowing basic EMS staff to administer the drug without injection.’ But then it also says that “CDC recommends expanding training on the administration of naloxone to all emergency service staff, and helping basic EMS personnel meet the advanced certification requirements.” Perhaps both statements are true, but the release does not make it clear whether the agency’s strategy is focused on the training or the expansion to basic staff.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This was an observational study of factors associated with naloxone administration across the country. It wasn’t an experiment designed to tell us whether relaxing restrictions on naloxone administration would have beneficial effects on overdose deaths. It’s problematic to use the publication of a study to make a bunch of policy and advocacy statements that are not based on evidence from the study that is the putative subject of the release.

The release doesn’t spend much time discussing the evidence. In fact, the release sums up the nature of the study in just one sentence: “National Emergency Medicine Service Information System data for 2012 were reviewed to better understand factors associated with naloxone administration, including demographic data, 911 call information, and details about the scene of an injury or illness as reported by EMS staff.”

That sentence begs many questions. How many people were included in the data? How many deaths? How many near misses? How often did naloxone save lives? How often did it cause harm? How accurate are these records? Are there areas — especially rural areas — that aren’t covered in the database? The questions could go on. None of them are answered.

Does the news release commit disease-mongering?

Satisfactory

There was no disease mongering. The release says that, “In 2013, more than 16,000 deaths in the United States involved prescription opioids, and more than 8,000 others were related to heroin.” Not to split hairs, but the study data being reported on were from 2012, and it would have be even more useful to supply data on 2012 deaths for comparison. Put in context with all  2.61 million deaths that occurred in the U.S. in 2012, deaths involving prescription opioids and heroin do not amount to a significant total. They are, however, preventable, and so it’s a worthy goal to reduce them.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

It’s clear that the release comes from the CDC, and the release links back to the CDC website, which makes it clear for anyone who might not know that the CDC is funded by the federal government (your tax dollars).

Does the news release compare the new approach with existing alternatives?

Satisfactory

We’re giving the release points here because it does something that most releases never do. It actually gives a nod to alternatives. In a quote from CDC Director Tom Frieden, it says, “Many of these deaths can be prevented by improving prescribing practices to prevent opioid addiction, expanding the use of medication-assisted treatment, and increasing use of naloxone for suspected overdoses.”

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The major point of this release is that not enough EMS staff are administering the drug. It could have been made more clear that the drug is widely available for EMS staff, but that only a select few EMS staff can administer it in most states. But we think this passes the test.

Does the news release establish the true novelty of the approach?

Not Satisfactory

It would have been helpful to put the research in the context of previous work. Naloxone is not new. But are the results being reported new and surprising? What was known about naloxone use among EMTs previously?

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

From the evidence presented, it is not justifiable to say that “Expanding Naloxone use could reduce drug overdose deaths and save lives.” Has it ever saved a life? Certainly. But that’s not made clear in this release. Would it save more lives if more people administered it? That’s a reasonable assumption, but it’s not something the study being reported on was designed to prove.

Total Score: 4 of 10 Satisfactory

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