When we decline, and why.

There are cases we will not take. We say so plainly at intake, and we would rather return a candid decline within one business day than string a family along for a month before arriving at the same answer. This page explains the three categories under which we decline and what we refer to instead, so that a prescriber or family can plan accordingly.

Clinical safety

The first category is clinical. When our AI Clinical Review Agent flags a therapy choice as materially inconsistent with the current FDA label, the published body of evidence, or the specific patient's situation as described, we pause. A human licensed pharmacist reviews the flag, and if the concern holds up, we return a written decline that describes what we saw and why it matters. Typical triggers include a dose or schedule outside the approved range without a supporting rationale in the record, a known contraindication that the referring documentation does not address, a concerning drug-drug interaction in a polypharmacy case, and a therapy choice that our review suggests should be reconsidered in light of more recent data. We are not second-guessing the prescriber for its own sake; we are performing the pharmacy-level review that any US specialty pharmacy would perform on the same prescription. Where the concern can be addressed with a short note from the prescriber, we flag it and wait. Where the concern is structural, we decline.

Regulatory feasibility

The second category is regulatory. Named-patient programs are jurisdiction-specific, and for any given drug-country pairing there is a real answer to the question of whether the pathway is open, partially open, or closed. Our AI Regulatory Review Agent maintains that map in close to real time across the countries we serve; a human regulatory advisor reviews edge cases. If the destination country's health authority does not recognize a named-patient pathway for the indication in question, or recognizes it only under conditions the case cannot meet, we decline. We also decline when the paperwork timeline implied by the pathway is incompatible with the clinical urgency; a six-month customs clearance is not a service, it is a false promise. These declines are not negotiable at our end because the barrier is at the destination.

Sourcing compliance

The third category is sourcing. Every unit moves through DSCSA-serialized US specialty wholesale channels under a traceable chain of custody. If the therapy in question is one we cannot source through that chain, we decline rather than substitute. That means we do not fill orders with gray-market product, we do not arrange parallel imports, and we do not accept product that lacks a clean transaction history. We also decline when the cold-chain profile of the therapy is incompatible with the destination's logistics footprint in a way we cannot underwrite. When the chain is clean and the logistics are underwritable, we proceed; when either breaks, we stop.

What we refer to instead

When we decline, we do not leave the family or the prescriber stranded. The first referral is always back to the treating physician, who remains the appropriate decision-maker for the case and typically has relationships with local specialist networks that can pick up a clinically-declined case. For regulatory declines, we suggest the destination country's named-patient coordinator community, the manufacturer's global medical-access team, or a non-profit patient-assistance organization aligned to the disease. For sourcing declines, the referral is usually to the manufacturer directly, since many specialty manufacturers operate their own ex-US access programs that can bypass the chain-of-custody constraint we hold ourselves to. Where we know a specific peer organization that is a good fit, we name it. We would rather the family get treated than get treated by us.

What we do not do on a decline

We do not dispute a prescriber's clinical judgment in public. We do not publish case details. We do not charge for an intake that ended in a decline. We do not keep a family's paperwork on file beyond the retention window required by law. If a decline is reversed by new clinical information or a regulatory change, we re-open the case without additional fees. Our posture is that a clean decline, done early and in writing, is one of the most valuable things a specialty-access coordinator can offer. It protects the patient, it protects the prescriber, and it keeps the service honest.

Reviewed 2026-04-22 by Reserve Meds’s AI clinical and regulatory review agents. Human pharmacist-in-charge: Altima Care. Next scheduled review: 2026-10-22.