Statewide Standing or Protocol Order

Research SummaryPublished Dec 19, 2023

Establish a statewide framework that allows any pharmacist in the state (who meets qualifications specified in the protocol) to dispense naloxone without a patient-specific prescription under the pre-defined conditions outlined in the order. Unlike collaborative practice agreements, this policy does not require pharmacists to have a partnering prescriber.

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
No
Yes

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
No
Yes
Criteria Implementation Rating
Low Moderate High
Acceptability
No
No
Yes
Feasibility
No
No
Yes
Affordability
No
No
Yes
Equitability
No
No
Yes

Summary of Expert Comments

  • Experts expect this policy to increase naloxone pharmacy distribution significantly enough to yield meaningful decreases in fatal overdoses.
  • Experts think the policy is acceptable to the public because of its successful adoption without much public pushback.
  • Experts believe the policy could be feasible — conditional on pharmacist willingness and lack of opposition from prescribers concerned about professional scope creep.
  • Experts rated the policy as affordable because it eliminates the costs of prescriber office visits and has lower administrative costs compared to collaborative practice agreements.
  • Experts believe the policy to be equitable because it would increase the number of pharmacies where people can access naloxone while removing the need to access prescribers.

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)
 Agreement with all pharmacies in a state lowers important barriers for all patients to access naloxone through pharmacies (patient need to get a prescription, pharmacy need to arrange agreement with a prescriber). "Has the most potential to increase low barrier access to naloxone in pharmacies. Having a partnering prescriber is cumbersome"
Little-to-no N/A N/A
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 N/A N/A
Little-to-no
(selected)
 No credible mechanism linking statewide standing orders and OUD prevalence. "I don't see this getting those with OUD to enter remission without being connected to treatment in some meaningful way. I feel like most of these supply side policies will have limited impact on OUD without a treatment component"
Harmful Potential for revival from overdose could (1) have a small, indirect, and mechanistic impact on OUD prevalence due to increased survivorship (rather than new cases of OUD), (2) lead to continued opioid misuse, and (3) lead to the identification of cases. "Pharmacy provides easier access to health systems. During the naloxone dispensing process, hidden cases might 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 Could facilitate pharmacist identification of patients at risk for an overdose. "Would allow pharmacists in community pharmacies to identify at risk patients from a wider range of prescribers and would allow for more doses to be available in the community"
Little-to-no
(selected)
 No credible mechanism linking statewide standing orders and nonfatal overdoses. "I do not think this has an effect on the instances of overdoses"
Harmful Potential for revival from overdose could (1) have a small, indirect, and mechanistic impact on nonfatal overdoses due to increased survivorship and (2) lead to continued opioid misuse. "Survival increased nonfatal incidence"

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
(selected)
 Significant increase in naloxone pharmacy distribution (by removing the barrier of patients needing to get a prescription and pharmacies needing to arrange an agreement with a prescriber) would yield meaningful decreases in fatal overdoses. "Making Naloxone more accessible to anyone who wants it and removing the barriers to get it (such as seeking out a prescription from a doctor) would lead to more nonfatal opioid overdoses and less fatal opioid overdoses"
Little-to-no Concerns about not addressing pharmacist knowledge of and attitudes toward naloxone. "Addressing stigma among pharmacists is critical. Even for [buprenorphine], I have many arguments with pharmacists who refuse to stock it. I can bring them paper, or show them the evidence, but they just say they won't stock it, they refuse to, 'you can't make me.' How do we overcome this, especially for mom and pop pharmacy stores?"
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
(selected)
 Successful adoption without much public pushback (likely due to its commensurability with obtaining other types of medication from pharmacists). "Given how many states have done this with little blowback, it seems quite acceptable to the public"
Moderate N/A N/A
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
(selected)
 Feasible so long as pharmacists are willing to dispense naloxone without physician involvement and there is no opposition from prescribers concerned about professional scope creep. "Fairly easy to implement this policy as long as the pharmacist is willing to"
Moderate Concerns about getting pharmacists to stock and dispense naloxone. "Research has found that many pharmacists refuse to dispense naloxone even [with a] standing order. Education is necessary, followed by enforcement"
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
(selected)
 Eliminates costs associated with prescriber office visits. Added benefit of less administrative costs compared with collaborative practice agreements (i.e., one statewide policy versus multiple agreements). "This could both reduce societal costs by reducing fatal overdose, as well as reducing costs associated with seeking naloxone because it would not require an office visit, and instead someone could go to a pharmacy in the community whenever it is open. There would be lesser administrative costs for pharmacies compared to the collaborative practice model"
Moderate Depends on the costs of naloxone. "I am concerned that on this item, the 'policy' and the cost of the 'naloxone' are two different things. The naloxone can be pricy and there is not a crystal-clear mechanism to reimburse or pay private or chain pharmacies for doing this"
Low Creates costs for pharmacies. "Would require significant infrastructure if these are [centrally] located pharmacists without patient contact"

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
(selected)
 Increases the number of pharmacies where people can access naloxone while removing the need to access prescribers. "It could definitely increase health equity if a person could walk into any pharmacy and ask for naloxone"
Moderate Concerns about potential pharmacist bias and limited access to pharmacies. "Access gaps in places without pharmacies, patients without insurance coverage, pharmacists with stigma/other bias/discrimination"
Low N/A N/A
Cover: Statewide Standing or Protocol Order

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Statewide Standing or Protocol Order. Santa Monica, CA: RAND Corporation, 2023. https://www.rand.org/pubs/research_briefs/RBA3054-12.html.
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