Step 5: Delivery and follow-up.

The stage that separates a coordinator from a logistics company: outcome capture, pharmacovigilance, and next-cycle planning.

The fifth stage is the one most coordinators treat as a closing formality and we treat as a separate, named stage. A case is not complete when the unit arrives; it is complete when the patient has been treated, the outcome has been captured, and a plan for the next dose or the next cycle is in place. Delivery and follow-up is the stage that closes the loop, and the quality of this stage is what separates a coordinator from a logistics company.

Handoff to the local prescriber

The receiving institution, typically a hospital pharmacy or the treating specialist's clinic, performs the inbound inspection we have supplied a checklist for. Once the unit is accepted, dispensing is coordinated between the local pharmacy and the treating prescriber on the prescriber's schedule, not ours. We are available during this window but we do not interpose ourselves between the prescriber and the patient; the treating physician is the decision-maker for the administration. For institutional receivers, see the hospital pharmacy receiving protocol.

Outcome capture

After administration, we reach out to the prescriber, or to the family where the prescriber has delegated communication to them, to confirm the therapy was administered as planned, to confirm the patient tolerated the administration, and to capture any observations that warrant attention. The outcome capture is brief and specific; we are not attempting to run a clinical trial, and we do not collect data beyond what a thoughtful follow-up call would yield. The record is archived with the case.

Adverse events and pharmacovigilance

If an adverse event is reported, it is routed through our pharmacovigilance channel at [email protected]. Serious adverse events are reported to the FDA MedWatch program, to the manufacturer's global safety group where relevant, and to the destination country's regulator where required. The case record, including the full chain-of-custody and cold-chain documentation, is available to support any adverse-event investigation. Authentic product moving through a clean chain makes pharmacovigilance possible; our sourcing posture exists in part to make this stage meaningful rather than theatrical.

Next dose or next cycle

Most specialty therapies are multi-dose or multi-cycle. Before the case closes, we align with the prescriber on the next scheduled administration, the lead time we will need to coordinate the next unit, and the budget the family should plan for. For long-running therapies, we typically open a lightweight recurring case so that subsequent cycles can move through a shorter cycle-specific review rather than a fresh intake each time. For therapies where the prescriber is planning a dose or regimen adjustment, we re-enter clinical review for the adjusted plan before sourcing the next unit.

Documentation for the patient's file

At case close, we provide the prescriber and, on request, the family, with a closing documentation package for the patient's medical record. The package includes the administration confirmation, the outcome note, the full chain-of-custody record, the cold-chain data trace, and the pharmacovigilance status at close. Destination regulators and institutional partners sometimes request the same package for audit purposes; we provide it without charge to the entities entitled to receive it under the applicable privacy framework.

What closes a case versus what reopens it

A case is closed when the therapy has been administered, the outcome has been captured, and either the therapy is a one-time administration or the next cycle has been scheduled. A case reopens when an adverse event is reported after close, when the prescriber requests a case-file retrieval, or when a regulator or the manufacturer makes a case-specific inquiry. We retain case records for the period applicable privacy and regulatory frameworks require, and we do not purge early. When a case reopens, the same coordination team that handled the original case handles the reopen wherever the team is still in place.

What we measure for ourselves

Internally, we measure a handful of outcomes that matter to us: the share of cases that reach administration without a material chain-of-custody event, the share that reach administration inside the quoted timeline, the share that result in a reported adverse event, and the share that result in a written complaint at [email protected]. We publish these metrics annually in our compliance report to institutional partners. The metrics inform our process changes, and the process changes are versioned and documented rather than rolled out informally.

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.