Naloxone Co-Prescribing Laws that Consider More Than Opioid Dosage

Research Brief

Require doctors to prescribe naloxone to patients who have other risk indicators for opioid overdose above and beyond taking high doses of opioid painkillers (e.g., patients in opioid treatment programs, patients with a prior history of opioid use disorder or overdose).

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 think the policy could increase naloxone pharmacy distribution but have minimal effects on other outcomes because fatal overdoses mostly occur with illicit opioids.
  • Experts have acceptability concerns because patients may resent being told they need naloxone and being asked invasive questions. Providers may also resent being told what medications to prescribe.
  • Experts have concerns about prescribers following the mandate and uncertainty about which indicators to use beyond dosage.
  • Experts have affordability concerns due to the number of opioids prescribed, the potential for incentivizing naloxone manufacturers to inflate prices, and the potential for waste if wrong indicators were used.
  • Experts are concerned that this policy relies on health care access and may invite subjectivity into deciding who receives naloxone.

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)
Increase in prescriptions could lead to increased distribution. “I would expect this to increase prescriptions, and expect that more of these prescriptions would be filled”
Little-to-no Depends on the number or type of additional criteria, and patient follow-up with pharmacies. “Co-prescribing laws are more effective to target individuals receiving opioids for chronic pain. As additional risk factors are considered above and beyond the opioid dosage, it will reduce the number of patients meeting the criteria”
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. “In the process of determining whether the patient meets the criteria for naloxone prescriptions, hidden cases could be identified”

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 Including criteria beyond opioid dose could lead to intervening on mechanisms of overdoses in general. “Possibly could have a small effect. If providers/prescribers are now recognizing some [patients] at high risk for opioid misuse/accidental OD [overdose], previous OD history etc. To get it out to these patients also means it is more likely to get to a community of [patients] who could benefit from increased access to naloxone more generally if [the patient] belongs to or participates with a community of others who might be at high risk of OD also”
Little-to-no

(selected)
No credible mechanism linking naloxone co-prescribing requirements and nonfatal overdoses. “I don’t think naloxone access has much if any impact on the prevalence of nonfatal opioid overdose”
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 [naloxone] 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 Increases access of naloxone to populations at risk for fatal overdoses. “Putting Naloxone in the hands of anyone who has a history of OUD would lead to more nonfatal opioid overdoses and less fatal opioid overdoses”
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 and other factors associated with overdose. “More acceptable than only considering high dosages as [this policy] is more inclusive to a broader population”
Moderate

(selected)
Potential for negative reactions from patients being labeled as persons needing naloxone and being asked additional questions, which they may perceive as invasive. Potential negative reactions from providers being told what medications to prescribe and when to prescribe them and difficulty in obtaining this information (e.g., data privacy protections). “Trust in doctors goes a long way, but this [policy] does involve asking more personal questions. And, depending on what the naloxone decision is based on, could trigger some resistance”
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 N/A N/A
Moderate

(selected)
Concerns about prescribers following the mandate (e.g., through regulation, enforcement, and oversight) and uncertainty about which indicators to use beyond dosage. “Determining the mix of risk factors triggering co-prescription will be challenging and likely inconsistent. More importantly, implementing screening for problematic use — while a worthy endeavor — is a challenge for many providers. Identifying prior history of SUD [substance use disorder] can be a challenge due to data sharing issues”
Low Concern about prescribers’ inability to obtain which information about the indicators to use beyond dosage. “Right now (unless COVID-19 related laws stay in place), this isn’t feasible due to sharing of medical records. [The Health Insurance Portability and Accountability Act allows] for greater flow of information on SUD records”

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. “The addition of these higher risk groups improves affordability, or cost-effectiveness, over simply targeting high dose prescription opioids as these groups are more likely to use naloxone either due to their own use or the use of close contacts”
Moderate

(selected)
Concerns about a significant number of opioids still being prescribed, the perceived possibility of further incentivizing pharmaceutical manufacturers to inflate naloxone prices, and the potential for subsequent waste in resources if the wrong indicators (beyond dosage) were used. “Information about OUD treatment, overdose risks, are currently not generally shared in the medical record and it would be extremely expensive to overcome”
Low Concerns that a significant number of opioids still would be prescribed. “There is a large number of people at risk and currently few receiving naloxone. Mandating naloxone would incur financial costs to individuals and patients”

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 Inclusion of additional risk criteria could increase the prescription of naloxone to more vulnerable populations at high risk of overdose. “This policy would result in more focused naloxone co-prescribing to people who are at increased risk”
Moderate

(selected)
Concern that this policy relies on access to both pharmacies and prescribers and that greater subjectivity (compared with the more objective criterion of using only prescribed opioid dosages) could increase the opportunity for interpersonal biases to yield further inequities. “Delivered through the health care system, so those with poor access may not get naloxone. Also, as we move from an objective measure (dose) to subjective ones, more possibilities for racial bias to creep into assessments of who needs naloxone”
Low Policy misses anyone not being prescribed opioids, and non-dosage questions could lead to increased stigmatization or missing vulnerable populations who would benefit from naloxone but from whom information could not be obtained. “Getting all the OUD history and treatment into the patient record could exacerbate stigma [related to] substance use and racial bias and increase disparities in access to healthcare”

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