8.3 Naloxone Access & Opioid Antagonists

8.3 Naloxone Access & Opioid Antagonists

Quick Answer: Under 225 ILCS 85/19.1, a licensed pharmacist shall dispense an opioid antagonist in accordance with written, standardized procedures or protocols developed by the Department (IDFPR) with IDPH and IDHS, filed at the pharmacy before implementation and available to the Department on request. Illinois operationalizes access through the IDPH statewide opioid overdose reversal agent standing order and standardized procedure so pharmacies/pharmacists can furnish naloxone (and other covered agents such as nalmefene where the order includes them) without a patient-specific individual prescription. Before dispensing an opioid, the pharmacist shall inform patients that opioids are addictive and offer to dispense an opioid antagonist. Counsel on overdose recognition and response.

This section is pure public-health quality/safety (NABP Area 2.5-style thinking) plus therapy-access law. The General Assembly’s findings in 19.1 matter: rising opioid deaths + existence of a reversing antagonist → greater access for populations at risk.

Statutory Core: 225 ILCS 85/19.1

Legislative policy (exam “why”)

Section 19.1 opens with the policy that Illinois must expand access to opioid antagonists to avoid preventable deaths. On vignettes, answers that restrict access to “only patients with a formal OUD diagnosis,” “only first responders,” or “only with a new individual Rx every time” usually fight the statute’s purpose—unless another law truly imposes that limit (it does not for compliant standing-order dispensing).

Dispensing duty under standardized procedures

19.1(b) states that, notwithstanding contrary general or special law, a licensed pharmacist shall dispense an opioid antagonist in accordance with written, standardized procedures or protocols developed by IDFPR with IDPH and IDHS, which must be:

• Filed at the pharmacy before implementation, and
• Available to the Department upon request

Practice implication: Participation is not a casual drawer of samples with no procedure. The pharmacy must have the standardized procedure/protocol framework in place. The statewide standing order and Illinois Naloxone/Opioid Overdose Reversal Agent Standardized Procedure implement this public-health architecture.

Offer-when-dispensing-opioids rule

19.1(c) is highly testable:

Before dispensing an opioid, a pharmacist shall inform patients that opioids are addictive and offer to dispense an opioid antagonist.

Translate to behavior:

1. Opioid fill is happening →
2. Counsel on addiction risk (as the statute frames the warning) →
3. Offer antagonist co-dispensing / access

Failing to offer is not “optional customer service”—it is a statutory counseling/access step attached to opioid dispensing.

Definition of opioid antagonist

19.1(d): “Opioid antagonist” means a drug that binds to opioid receptors and blocks or inhibits the effect of opioids acting on those receptors, including but not limited to naloxone hydrochloride or any other similarly acting and equally safe drug approved by the FDA for treatment of drug overdose.

MPJE use:

• Naloxone is the classic example
• Newer agents (e.g., nalmefene when FDA-approved for overdose and included in the Illinois standing order/procedure updates) can fall within the similarly acting concept
• Do not invent that only one brand name is lawful forever

Statewide / IDPH Standing Order & Pharmacy Participation

Illinois Department of Public Health materials describe a statewide standing order authorizing eligible naloxone entities—including pharmacies and pharmacists licensed under the Pharmacy Practice Act—to obtain and/or distribute opioid overdose reversal agents (and related kit components as the order allows) to persons who may assist someone experiencing opioid-related overdose.

Who can receive / who can be served

Public-health framing includes:

• Persons at risk of overdose
• Family, friends, and others who may assist
• Not limited to “the patient who holds an OUD specialty clinic card”

Pharmacy participation expectations (exam-level)

Participating pharmacies/pharmacists typically must:

1. Hold lawful Illinois pharmacy/pharmacist licensure under 225 ILCS 85
2. Have knowledge of / follow the Illinois standardized procedure for opioid overdose reversal agents
3. Complete training that meets Act/procedure criteria (overdose prevention and recognition; administration techniques; importance of calling emergency services)
4. Report dispensing as directed—pharmacies shall report naloxone/nalmefene dispensing to the Illinois Prescription Monitoring Program (ILPMP) per IDPH procedure language
5. Stock and furnish product under the standing order without requiring a patient-named individual prescription when operating under the order

Non-pharmacy overdose education and naloxone distribution (OEND) programs have separate IDHS DOPP registration pathways; schools and libraries appear in expanded standing-order entity lists in public-health updates. For the MPJE pharmacist candidate, focus on pharmacy/pharmacist duties under 19.1 + standing order + procedure.

Counseling & Education: Recognition and Response

The standardized procedure educational content is the counseling outline exam writers expect:

Counseling is not optional theater. Stems that show a pharmacist silently bagging naloxone with no education fail the public-health purpose and procedure expectations.

Relationship to Ordinary Prescriptions & Controlled Substances

Important distinctions:

• Dispensing naloxone under standing order is an access pathway, not a statement that naloxone is a free-for-all controlled substance without records
• Reporting to ILPMP for antagonist dispensing (as procedure requires) is separate from “you may only give naloxone if the patient is already in the PMP as an opioid patient”
• Corresponding responsibility for opioid analgesic prescriptions still applies (later PMP/red-flag chapters)—naloxone access complements safe opioid dispensing; it does not replace legitimate medical purpose analysis
• Offer antagonist when dispensing opioids applies even when the opioid Rx is legitimate

Public-Health Policy Intent on the Exam

When two answers both sound “careful,” pick the one that matches access + education + protocol:

Favored themes

• Standing order / standardized procedure dispensing without individual Rx
• Offer antagonist with opioid dispensing
• Train laypersons and caregivers
• Reduce fatal overdose

Disfavored themes

• “Only physicians may ever provide naloxone”
• “Pharmacist needs a new patient-specific Rx every time” under the standing-order model
• “Refuse all requests from family members”
• “No counseling needed because it is OTC-ish in practice”

Exam Scenarios

Scenario A — Family member. A parent requests naloxone for a household member at risk. Pharmacy participates under the statewide standing order and standardized procedure. Dispense per procedure with education—not “come back with a specialty clinic Rx only.”

Scenario B — Opioid analgesic fill. Pharmacist dispenses oxycodone, never mentions addiction risk or offers antagonist. Violates 19.1(c) offer/inform step.

Scenario C — No protocol on file. Pharmacy “sometimes sells naloxone when corporate emails a coupon” but never files standardized procedures. Fails “filed at the pharmacy before implementation” structure.

Scenario D — Definition. Item asks whether only naloxone hydrochloride qualifies. Correct approach: statute’s including but not limited to + similarly acting FDA-approved overdose drugs (and current standing-order product list).

Common Traps

• Requiring individual Rx despite standing-order pathway
• Restricting to patients with documented OUD diagnosis only
• Skipping the offer when dispensing opioids
• Forgetting multi-agency protocol development (IDFPR + IDPH + IDHS)
• Omitting overdose recognition/response education
• Confusing ILPMP reporting of antagonist dispensing with a ban on access

Study Checklist

1. Cite 225 ILCS 85/19.1 as the Practice Act home for opioid-antagonist dispensing
2. Standardized procedures filed before implementation
3. Inform + offer when dispensing opioids
4. Define opioid antagonist broadly enough for naloxone and similar FDA-approved agents
5. Statewide/IDPH standing order = access without patient-specific Rx for participating pharmacies
6. Counsel: recognize → call 911 → administer → support breathing → stay

Section 8.4 expands remaining administration, CLIA-waived testing, and therapy management authorities.