CHPPC Module 32, Section 1.3: Non-Formulary Request Tactics
MODULE 32: FORMULARY, NON-FORMULARY & THERAPEUTIC INTERCHANGE—WITHOUT FRICTION

Section 32.3: Non-Formulary Request Tactics: Temporary Approvals, Care Continuity

Mastering the structured process for evaluating and managing exceptions to the formulary rulebook.

SECTION 32.3

Non-Formulary Request Tactics

From “No” to “Yes, if…”: The pharmacist’s guide to managing exceptions with process and professionalism.

32.3.1 The “Why”: The Escape Hatch in the Social Contract

If the formulary is a social contract, then the non-formulary request process is its essential and well-defined escape hatch. No formulary, no matter how thoughtfully designed, can account for every possible clinical scenario. There will always be patients with rare diseases, unique allergies, or treatment failures to multiple formulary agents. There will always be new, breakthrough drugs for which a formulary review is still pending. The non-formulary request process is the formal, documented pathway that allows for a “conscious uncoupling” from the formulary when clinically justified. It is the system’s acknowledgment that the patient’s individual needs must, in certain circumstances, override the institution’s standardized approach.

Your role in this process is to be the fair and impartial administrator of that escape hatch. You are the gatekeeper, but a thoughtful and reasonable one. Your job is not to find a reason to say “no”; it is to apply a consistent set of clinical and operational criteria to determine if the request meets the threshold for a “yes.” This requires a shift in mindset. You are no longer just a pharmacist verifying an order; you are a P&T committee representative, a clinical steward, and a supply chain analyst, all rolled into one. You must be able to rapidly assess the clinical evidence, consider the logistical challenges of procurement, and document the decision-making process with precision.

A well-managed non-formulary process is critical. If it is too lenient, the formulary becomes meaningless—a suggestion rather than a standard. Costs spiral, inventory becomes unmanageable, and the safety benefits of standardization are lost. If it is too draconian and inflexible, it creates immense friction with the medical staff, delays necessary care, and can lead to providers finding unsafe “workarounds” to get the drugs they want. Your challenge is to operate in the “Goldilocks zone”—a process that is rigorous but fair, evidence-based but responsive, and standardized but capable of handling true exceptions. This section will provide the tactical playbook for achieving that balance.

Retail Pharmacist Analogy: The Prior Authorization Specialist

Think of your role as a prior authorization (PA) specialist. When an insurance plan rejects a non-preferred medication, you don’t just give up. You have a formal process to appeal that decision. The formulary is the list of “preferred” drugs; the PA is the non-formulary request process.

What do you do? You become a detective and an advocate.

  • Gather the Evidence: You look at the patient’s profile. You know the insurance company will only approve the exception if there’s a valid clinical reason. You ask: Has the patient already tried and failed the preferred formulary agents? Do they have a documented allergy or intolerable side effect to the formulary options?
  • Fill Out the Formal Request: You don’t just call the insurance company and say, “The doctor wants it.” You fill out their specific PA form. You provide the patient’s diagnosis, the list of failed formulary drugs (the “why”), and the specific clinical rationale for the exception. This is the Non-Formulary Request Form.
  • Understand the Approval Types: Sometimes the insurance grants a full, open-ended approval. But often, they grant a temporary approval. For example, they might give a “Continuity of Care” override for 30 days for a new patient to give the doctor time to switch to a formulary agent, or a “Vacation Override” for an early refill. You have to understand and manage these limited approvals.

Your role in managing hospital non-formulary requests is identical. You are the one who ensures the formal process is followed, that the clinical justification is sound, and that the terms of the approval (e.g., is it for this admission only?) are clearly understood by everyone. You are the expert navigator of the exceptions process.

32.3.2 The Decision Algorithm: A Framework for “Yes, If…”

When a non-formulary request lands on your desk, you need a consistent mental framework to evaluate it. The goal is to move from a binary “yes/no” decision to a more nuanced “Yes, if…” model. This approach signals to the provider that you are trying to find a path to approval, but that it is contingent on meeting a set of clear, objective criteria. This is the foundation of a fair and defensible process.

Masterclass Flowchart: The Non-Formulary Request Triage
Non-Formulary Drug is Ordered
Step 1: The Initial Screen
Have you first offered and discussed the preferred formulary alternative(s) with the prescriber?
Yes, and provider accepted? PROCESS COMPLETE
No, provider insists on non-formulary?
Step 2: The Justification Gauntlet – “Does this request meet one of the Big Three criteria?”
This is the core of your clinical evaluation.
Criterion 1: Formulary Failure / Allergy / Intolerance

Has the patient tried and failed all appropriate formulary agents, OR do they have a documented allergy or intolerable side effect to them?

Criterion 2: No Formulary Alternative Exists

Is this for a unique indication or mechanism of action for which no formulary drug is a reasonable substitute (e.g., a new orphan drug)?

Criterion 3: Continuity of Care

Is this a critical, chronic medication that the patient was taking immediately prior to admission, where a switch could cause destabilization (e.g., a specific anti-epileptic, antipsychotic, or transplant drug)?

Step 3: The Decision & Action
Based on the answers above…
NO criterion met? Deny request; re-engage provider to switch to formulary.
YES, a criterion is met?
ACTION: Grant Temporary Approval & Initiate Procurement
“Yes, we can approve this if you complete the non-formulary request form documenting the rationale. This approval will be for this admission only.”

32.3.3 Deep Dive into the “Big Three”: Justifying the Exception

Your decision to approve or deny a non-formulary request must be based on a consistent application of criteria. The “Big Three” justifications cover the vast majority of legitimate requests. Your job is to guide the prescriber to articulate their request in one of these categories and to document it accordingly.

Masterclass Table: The “Big Three” Justifications in Detail
Justification What It Means The Pharmacist’s “Gotcha” Checklist
1. Formulary Failure / Intolerance This is the most common and strongest argument. The provider is asserting that the P&T Committee’s preferred agents have already been tried and were either ineffective or caused an unacceptable side effect or allergic reaction for this specific patient.

You must verify this claim. Don’t just take it at face value.

  • Review the MAR: Does the patient’s chart actually show a trial of the formulary agents? At what dose and for how long?
  • Define “Failure”: Was it a true therapeutic failure (e.g., persistent hypertension despite max-dose lisinopril and HCTZ) or just an incomplete trial?
  • Define “Intolerance”: Is there a documented allergy in the chart? For a side effect, how severe was it? (e.g., a bit of nausea vs. angioedema are very different).
  • The Script: “Dr. Smith, I see your request for non-formulary olmesartan. To process this, I need to document the failure of our formulary ARB, losartan. Can you tell me what dose of losartan the patient was on and why it was ineffective?”
2. No Formulary Alternative The request is for a drug with a unique mechanism of action, indication, or dosage form that cannot be replicated by any item on the formulary. This is common with orphan drugs, newly approved medications, or specialized formulations.

Your job is to confirm that no reasonable alternative truly exists.

  • Think Mechanistically: Does this drug really offer something no other drug does? (e.g., an order for sacubitril/valsartan (Entresto) for heart failure has a unique mechanism that cannot be replicated by just losartan).
  • Check Indications: Is it being used for a novel, evidence-based indication?
  • Consider Compounding: For a dosage form issue (e.g., a request for a liquid that’s non-formulary), can your pharmacy compound a liquid from the formulary solid dosage form?
  • The Script: “Hi Dr. Davis, I see the request for ivacaftor. I agree, as a CFTR potentiator for this patient’s specific cystic fibrosis mutation, we have no formulary alternative. I’ll begin the procurement process. Please complete the non-formulary request form at your convenience.”
3. Continuity of Care The patient was taking a critical, chronic, non-formulary medication at home, and abruptly stopping or changing it upon admission poses a significant clinical risk. This is the “do no harm” principle.

The key is to define “critical.” Not all home meds qualify.

  • High-Risk Drug Classes: This justification is STRONGEST for anti-epileptics, antipsychotics, anti-rejection meds (transplant), and some complex chemotherapy or rheumatology agents. Switching these can destabilize a patient.
  • Lower-Risk Classes: This justification is WEAKEST for drug classes with multiple, easily interchangeable members (e.g., statins, PPIs, ACE inhibitors). A patient on rosuvastatin at home can almost always be safely managed on atorvastatin in the hospital.
  • The “Own Meds” Question: Can the patient use their own home supply of the medication during their hospital stay? This is often the safest and fastest solution if hospital policy allows.
  • The Script: “Hi Dr. Wilson, I’m verifying the admission meds for your patient with epilepsy. I see she’s on lamotrigine XR at home, which is non-formulary for us. To ensure continuity of care, we can absolutely approve this for her stay. Has the family brought in her home supply? If not, I’ll need you to fill out the request form so I can order it from our wholesaler.”

32.3.4 The Art of the Temporary Approval: Setting Boundaries

One of your most powerful tools is the temporary approval, also known as a “restricted” or “admission-only” approval. This is your default response for nearly all non-formulary requests that meet the criteria. A full, unrestricted addition of a drug to the formulary is a major decision that can only be made by the P&T committee. Your role is to solve the immediate clinical problem for the patient in front of you, not to make a permanent policy change from the central pharmacy.

The temporary approval is a brilliant tactic because it allows you to say “yes” while still maintaining control. It grants access to the needed medication but with clear boundaries and an expiration date. This prevents a one-time exception for a specific patient from becoming a permanent backdoor onto the formulary for all patients.

Communicating the Boundaries: The Right Phrases

When you grant an approval, your language is critical. It must be clear that this is a time-limited exception. This prevents future confusion and manages expectations.

  • The Core Script: “Dr. Brown, based on the clinical scenario you’ve described, we can grant a temporary approval for this medication for the duration of this patient’s admission.“
  • For Continuity of Care: “We can approve the use of their home medication, [Drug Name], while they are an inpatient. Please be aware that this will not be supplied on their discharge prescription, as that will need to be converted to a formulary alternative.”
  • When Procurement is Needed: “I have approved the request and will order the medication now. Please be aware that since we have to get this from our wholesaler, it may take 4-6 hours to arrive in the pharmacy. Is there a formulary agent we can use as a bridge in the meantime?”

This clear communication establishes you as the manager of the process, sets realistic expectations about timing, and reinforces the temporary nature of the exception.