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Where AI Can Help Specialty Pharmacy and Where Pharmacist Judgment Matters

By Ron Lanton III, Sosa Law, Senior Partner: Lanton, Lanton &amp

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Even after a specialty prescription is approved, getting the medicine to the patient can still take time. The pharmacy may be missing a chart note, waiting for benefit verification or an authorization response, working through financial support, or arranging delivery. Since those steps can involve several organizations and systems, one delay can hold up the entire prescription. For the patient, the result is simple: the medicine still has not arrived.

AI may help specialty pharmacies manage some of this administrative work. It can sort documents, flag missing information, route tasks, and help staff see which cases need attention first. Pharmacy leaders still need to decide which tasks are suitable for automation, what information a tool can use, and who checks its work.

The Work Around the Prescription

Specialty pharmacy involves much more than dispensing. Teams coordinate with prescribers, health plans, manufacturers, distributors, and patients. They confirm benefits, obtain authorizations, arrange delivery, explain medication use, and follow up on side effects or missed refills. When one handoff is delayed, the rest of the process can stall.

Much of this work repeats from one prescription to the next, yet each case can be different. Records may be incomplete, plan requirements may conflict, or key information may be spread across a fax, portal, electronic health record, and phone note. Experienced staff know when a missing document is routine and when a case needs a call to the prescriber or payer.

AI may help with parts of that process. A tool could spot a missing lab result in an authorization packet, summarize records already received, or route a task to the right queue. It could also flag cases nearing a deadline or patients who have not completed a required step. That may reduce the time staff spend searching for information and entering it more than once.

Start With One Task

Choose one workflow and decide what improvement should look like before testing a tool. A pharmacy could measure whether it takes less time to assemble an authorization packet, whether avoidable resubmissions decline, or whether staff reach patients before a scheduled refill is missed. Use measures the pharmacy already tracks, such as time to therapy, complete submissions, abandonment, refill gaps, and staff time.

A small test will also show where the system falls short. It may misread a scanned document, miss an exception in a plan rule, or summarize an outdated policy. Staff should be able to check the source material behind an output and correct it without fighting the software. A generated summary should help someone review the record; it should not replace the record.

Keep Clinical Decisions With Pharmacists

Administrative support and clinical judgment are different functions. AI can organize information for a pharmacist or another qualified professional. It should not decide whether a patient is appropriate for therapy, how to handle a clinical concern, or whether an exception needs escalation.

Patient messages need review too. Automated reminders can be useful, while a message about a missed dose, side effect, or treatment interruption may call for a conversation with a pharmacist. Patients need a clear way to reach a person, and staff need a defined path for urgent concerns. When a tool's output affects a patient's care, qualified people should understand how it was produced and remain involved.

The U.S. Food and Drug Administration's January 2026 clinical decision support guidance explains how the agency views certain software functions used to support clinical decisions. Whether a product falls within FDA oversight depends on its intended use and how it functions. A pharmacy workflow tool should not be assumed to be a medical device simply because it uses AI. 

Know Where Patient Information Goes

Specialty pharmacy systems contain sensitive information about diagnoses, medicines, insurance, and treatment. Before sharing that information with an AI vendor, pharmacy leaders should know what data the tool receives, where it is processed, how long it is kept, whether it can be used to train other models, and who can access it. A vendor handling protected health information for a covered entity may have business associate obligations under HIPAA. HHS discusses third party AI chatbots that use patient information in this context. 

The contract should spell out what the vendor may do with the data, how it will protect it, who else may access it, how quickly it must report an incident, how it returns or deletes information, and what records the pharmacy can review.

Check the Results After Launch

The review should continue after a pilot is approved. Pharmacies should check results across medications, payers, patient groups, document formats, and sites. They should record errors and near misses, look for patterns in cases sent for manual review, and make sure staff know when to disregard or correct an output. 

A governance plan should identify who owns the tool, who reviews its output, what records are kept, and who can pause its use. The National Institute of Standards and Technology's AI Risk Management Framework offers a voluntary way to identify and manage risks through design, deployment, and use. Pharmacies can connect that work to familiar controls for quality review, privacy and security, training, escalation, and incident reporting.

Give Time Back to Care Teams

Specialty pharmacy leaders do not need to automate every step in the patient journey. They can start with a task that consumes staff time and contributes to avoidable delays, test whether a tool improves it, and keep a qualified person responsible for results that affect a patient’s care. If the tool cannot show what it relied on, cannot be checked, or cannot be corrected, it is not ready for that workflow.

AI is useful when patients receive timely support and staff can focus on cases that need their attention. A tool may take routine work off the team's plate, but pharmacists and staff remain responsible for checking the results, helping patients, and making decisions that affect care.

Selected Sources

1. U.S. Food and Drug Administration, Clinical Decision Support Software, final guidance, January 2026.

2. U.S. Department of Health and Human Services, Business Associates, HIPAA guidance.

3. National Institute of Standards and Technology, Artificial Intelligence Risk Management Framework (AI RMF 1.0).

  • By Ron Lanton III
  • 2026-10-22 11:46:24

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