Naloxone Co-Prescribing Laws Based Only on Opioid Dosage

Research Brief

Require doctors to prescribe naloxone to patients taking high doses of opioid painkillers.

A panel of experts rated how they expect this type of policy to affect four outcomes: naloxone distribution through pharmacies, opioid use disorder (OUD) prevalence, rates of nonfatal opioid overdose, and opioid overdose mortality. Another panel of experts rated the policy on four implementation criteria: acceptability to the public, feasibility of implementation, affordability from a societal perspective, and equitability in health effects.

Policy Recommendations According to Expert Ratings

Oppose Uncertain Support
No
Yes
No

Summary of Expert Ratings

Outcomes Effect Rating
Harmful Little-to-no Beneficial
Naloxone Pharmacy Distribution
No
No
Yes
OUD Prevalence
No
Yes
No
Nonfatal Opioid Overdose
No
Yes
No
Opioid Overdose Mortality
No
Yes
No
Criteria Implementation Rating
Low Moderate High
Acceptability
No
Yes
No
Feasibility
No
Yes
No
Affordability
No
Yes
No
Equitability
No
Yes
No

Summary of Expert Comments

  • Experts expect this policy to substantially increase naloxone pharmacy distribution, but it may have minimal effects on all other outcomes because it focuses only on prescribed opioids.
  • Experts think the policy only moderately acceptable due to negative reactions from patients being told they need naloxone and providers being told what medications to prescribe.
  • Experts have feasibility concerns regarding prescribers following the mandate (e.g., through regulation, enforcement, and oversight).
  • Experts have concerns about affordability due to the number of opioids prescribed and the possibility of incentivizing naloxone manufacturers to inflate prices.
  • Experts are concerned that this policy relies on access to both pharmacies and prescribers — and for an issue (chronic pain) with documented racial and ethnic treatment disparities due to systemic racism and interpersonal biases.

Outcome Summaries

Naloxone Pharmacy Distribution

Amount of naloxone dispensed through retail pharmacies (e.g., chain pharmacy stores, independent community pharmacies).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial

(selected)
Strong empirical evidence for this policy, a sizeable number of people receive high-dose opioids, and decreased stigmatization of naloxone. “Large increase due to number of people on high dosage opioids (relative to number of people previously getting prescribed naloxone)”
Little-to-no Depends on the cost to the person filling their prescription and the size of the population receiving high-dose opioids. “Even with insurance, the expense may deter people. Receiving a naloxone prescription is not the same as filling a naloxone prescription”
Harmful N/A N/A

Opioid Use Disorder Prevalence

Percentage of the general population with a pattern of opioid use leading to clinically and functionally significant impairment, health problems, or failure to meet major responsibilities.

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial Could influence patient behavior before OUD develops. “Could convey risk in a way that influences people’s behavior before OUD develops”
Little-to-no

(selected)
No credible mechanism linking naloxone co-prescribing requirements and OUD prevalence. “I do not think this has an effect on the underlying prevalence of opioid use disorder”
Harmful Potential for revival from overdose could have a small, indirect, and mechanistic impact on OUD prevalence due to increased survivorship and screening for OUD. “Less stigma, more identification of hidden cases”

Nonfatal Opioid Overdose

Per capita rates of nonfatal overdose related to opioids, including opioid analgesics (e.g., oxycodone), illegal opioids (e.g., heroin), and synthetic opioids (e.g., fentanyl).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial Evidence that this policy decreases opioid-related emergency department (ED) visits (a proxy for nonfatal overdoses). “Coffin et al. demonstrated that co-prescribing of naloxone to individuals prescribed opioids decreases opioid-related ED visits”[1]
Little-to-no

(selected)
No credible mechanism linking naloxone co-prescribing requirements and nonfatal overdoses. “Naloxone only impacts the severity of overdose not the incidence or prevalence”
Harmful Potential for revival from overdose could have a small, indirect, and mechanistic impact on nonfatal overdoses due to increased survivorship. “As pharmacy distribution increases, more and more people who are likely to use it will get it, thereby increasing the number of nonfatal overdoses via a reduction in fatal overdoses (assuming increased distribution will not significantly impact OUD prevalence, which I do not believe it will)”

Opioid Overdose Mortality

Per capita rates of fatal overdose related to opioids, including opioid analgesics (e.g., oxycodone), illegal opioids (e.g., heroin), and synthetic opioids (e.g., fentanyl).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial People taking high-dose opioids previously without naloxone and unaware of their risk would now have naloxone and be aware of its importance. “Most individuals receiving long-term opioids do not realize their risk. Requiring a naloxone prescription will have a positive impact on these individuals”
Little-to-no

(selected)
Policy only impacts prescribed opioids, and fatal overdoses mostly occur with illicit opioids. “Most of the [overdoses] are not from prescription opioids, they are from illicit opioids (fentanyl)”
Harmful N/A N/A

Implementation Criteria Summaries

Acceptability

The extent to which the policy is acceptable to the general public in the state or community where the policy has been enacted.

Implementation Rating Summary of Expert Opinion Representative Quotations
High Public is increasingly aware of the risk associated with high doses of prescribed opioids. “I think most people would accept this as the risk of overdose with high doses of opioid painkillers is well known by now”
Moderate

(selected)
Potential for negative reactions from patients being labeled as persons needing naloxone and from providers being told what medications to prescribe and when to prescribe them. “Prescribers do not like being told what or when to prescribe medications. There is quite a bit of stigma still associated with naloxone and that overdose is just something that happens to people who ‘have a problem with opioids.’ To this end, I’ve experienced reluctance from people accepting co-prescribed naloxone, but this is usually quelled with some education and discussion”
Low N/A N/A

Feasibility

The extent to which it is feasible for a state or community to implement the policy as intended.

Implementation Rating Summary of Expert Opinion Representative Quotations
High Feasible if easy to integrate with existing systems. “Should be able to integrate this with the same process by which the person gets their opioids”
Moderate

(selected)
Concerns about prescribers following the mandate (e.g., through regulation, enforcement, and oversight). “Programs like this (i.e., some [risk evaluation and mitigation strategies]) are often not followed by providers [because] there are no mechanisms that ensure that providers follow the guidance”
Low N/A N/A

Affordability

The extent to which the resources (costs) required to implement the policy are affordable from a societal perspective.

Implementation Rating Summary of Expert Opinion Representative Quotations
High Cost-effectiveness makes the policy affordable. “Cost-effective due to reduced morbidity and mortality related to overdoses, first responders, and emergency room care”
Moderate

(selected)
Significant number of opioids would still be prescribed, and there is the perceived possibility of further incentivizing pharmaceutical manufacturers to inflate naloxone prices. “Because the U.S. health care system writes so many prescriptions, naloxone co-prescribing costs can add up quickly”
Low Significant number of opioids still would be prescribed. “Research shows that only a small minority of patients who receive high doses of opioids are co-prescribed naloxone. Thus, a large expansion of patients getting co-prescribed would result in additional costs to individuals and payers”

Equitability

The extent to which the policy is equitable in its impact on health outcomes across populations of people who use opioids.

Implementation Rating Summary of Expert Opinion Representative Quotations
High Objective criteria could remove bias in prescribing naloxone. “If integrated with the opioid-prescribing process and followed, it could reach disadvantaged patients/those who face discrimination. Hypothetically, it could [be] used [with] the power of [health information technology] algorithms to eliminate bias in who gets a naloxone script”
Moderate

(selected)
Concern that this policy relies on access to both pharmacies and prescribers — and for an issue (chronic pain) with documented racial and ethnic treatment disparities due to systemic racism and interpersonal biases. “I think this policy could have multiple effects on equity. On the one hand, it would increase naloxone access regardless of documented diagnosis of OUD, which is good. However, there are racial disparities in provision of pain medication, so this policy may not result in an increase in naloxone distribution among people of color (in addition to existing poorer pain control). It would also not take into account other factors that may result in increased overdose risk that aren’t opioid dosage related (other sedating medications, co-morbidities, etc). Finally, as with the other prescriber related laws, it requires access to a prescriber, which differs by geography, race, and income”
Low Policy misses anyone not being prescribed opioids. “This places people in a category and neglects those who still benefit from naloxone”

Notes

  • [1] Coffin, P. O., Behar, E., Rowe, C., Santos, G. M., Coffa, D., Bald, M., & Vittinghoff, E. (2016). “Nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain.” Annals of Internal Medicine, 165(4), 245–252.

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