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MODULE 39: HOSPITAL QUALITY METRICS & THE PHARMACIST’S ROLE
Section 4: The P&T Committee: How Evidence-Based Medicine Drives Policy
Go behind the scenes of one of the most powerful committees in the hospital. This section details the structure and function of the Pharmacy & Therapeutics Committee, focusing on how pharmacists use evidence-based medicine to build drug monographs, make formulary decisions, and create institution-wide medication policies.
SECTION 39.4
The Pharmacy & Therapeutics (P&T) Committee
The Conscience of the Hospital: Balancing Clinical Efficacy, Safety, and Cost.
39.4.1 The “Why”: The Central Nervous System of Rational Medication Use
In the outpatient world, prescribing can sometimes feel like the “wild west.” Driven by patient requests, direct-to-consumer advertising, and the influence of pharmaceutical sales representatives, providers have the autonomy to prescribe a vast and often bewildering array of medications. While this provides flexibility, it can also lead to irrational, unsafe, and extraordinarily expensive prescribing patterns. The hospital environment operates under a completely different philosophy, one that is built on the foundation of standardization, safety, and evidence. The primary engine and enforcer of this philosophy is the Pharmacy and Therapeutics (P&T) Committee.
The P&T committee is arguably the most powerful multidisciplinary committee governing clinical care within the hospital. Its mandate is to ensure that every medication used within the institution is the safest, most effective, and most cost-effective option available. It achieves this by creating and managing the hospital formulary—a curated, evidence-based list of medications that are approved for use. A drug’s inclusion on the formulary is not a matter of physician preference or industry marketing; it is the result of a rigorous, scientific evaluation led by pharmacists. The P&T committee serves as the hospital’s central nervous system for rational therapeutics, constantly weighing three critical factors in a delicate balance:
- Clinical Efficacy: Based on a critical appraisal of the best available scientific literature, does this drug work? More importantly, does it work better than our current standard of care?
- Patient Safety: What is the complete adverse effect profile of this drug? How does its risk of harm compare to other available options? Does it carry black box warnings or require intensive monitoring?
- Pharmacoeconomic Value: What is the total cost of using this medication? This includes not just the acquisition cost of the drug itself, but the cost of administration, monitoring, and treating its potential side effects. Is a new, expensive drug’s marginal clinical benefit worth its significantly higher cost?
In the era of value-based care, the P&T committee’s work has never been more critical. By standardizing care around a limited list of proven, cost-effective medications, the committee directly reduces clinical variability, a known driver of poor outcomes. By restricting the use of high-risk drugs, it prevents adverse events and reduces length-of-stay. And by making tough, evidence-based decisions about expensive new technologies, it ensures the hospital’s financial sustainability. Your ability to contribute to this process—by preparing evidence reviews, analyzing data, and enforcing formulary decisions—is one of the highest functions of a hospital pharmacist.
Retail Pharmacist Analogy: The Corporate “Planogram” Committee
Imagine you are a highly respected pharmacy manager who has been invited to corporate headquarters to participate in the annual “planogram” committee meeting for the OTC cold and flu aisle. Your committee’s task is to decide exactly which products will be carried in all 8,000 of the company’s stores for the upcoming season, and where they will be placed on the shelf.
The room is filled with experts: other top pharmacy managers (your “physician specialists”), marketing experts, and finance VPs (your “hospital administrators”). The debate begins over a new, brand-name, multi-symptom cough syrup.
- Efficacy: The marketers present data showing the new product has a novel formulation. You, the pharmacist, critically review its ingredients and conclude that while it’s new, its clinical effect is likely no better than the existing store-brand product.
- Safety: You raise a concern that the new product contains a high dose of an ingredient that is contraindicated in patients with hypertension, a common comorbidity in your customer base. The store-brand option does not have this issue.
- Cost: The finance VP presents a sobering analysis. The new product has a wholesale cost that is 400% higher than the store-brand, which would severely impact the aisle’s profitability.
After debate, the committee votes. They decide not to add the new, expensive product to the national planogram (the “formulary”). Instead, they decide to make the safer, cheaper, and equally effective store-brand the “preferred” agent. They create a new policy to train all pharmacists to recommend the store-brand first and place it at eye-level on the shelf. The expensive brand is relegated to a “non-formulary” status—it might be available by special order, but it won’t be promoted.
This is precisely the function of the P&T committee. It is a high-stakes, evidence-based process of selecting the safest, most effective, and most valuable options to create a standardized “planogram” for the entire hospital, ensuring every patient receives the best possible care while safeguarding the institution’s resources.
39.4.2 The P&T Process in Action: From Drug Monograph to Formulary Decision
A drug’s journey onto the hospital formulary is a formal, rigorous, and pharmacist-driven process. It is the antithesis of a casual decision made based on a sales pitch. The entire process revolves around a central, sacred document: the drug monograph. This is a comprehensive, unbiased, and evidence-based review of a medication, meticulously prepared by a clinical pharmacist for the P&T committee’s consideration.
The Trigger and the Task
A drug review is typically initiated by one of several triggers: a new drug approval by the FDA, a new major indication for an existing drug, a significant new safety warning, or a formal request from a physician who believes a non-formulary agent is essential for their practice. Once a drug is slated for review, the P&T chair assigns the task of preparing the monograph to a pharmacist, usually a clinical specialist with expertise in that therapeutic area (e.g., an oncology specialist reviews a new chemotherapy agent).
Masterclass Table: The Anatomy of a Gold-Standard Drug Monograph
The drug monograph is the cornerstone of the P&T decision. It is an exhaustive synthesis of all available evidence. A great monograph is not just a summary of facts; it is a critical analysis that guides the committee to a rational decision. Below is a breakdown of its essential components.
| Monograph Section | Content & Purpose | The Pharmacist’s Critical Task |
|---|---|---|
| 1. Introduction & Pharmacology | A concise overview of the drug: its class, mechanism of action, and approved indications. Sets the stage for the review. | Clearly and simply explain how the drug works. Avoid jargon where possible. State the specific question the monograph will answer (e.g., “This review will evaluate the efficacy, safety, and cost of Drug X for the treatment of heart failure compared to our current formulary agent, Drug Y.”). |
| 2. Clinical Efficacy Review | The heart of the monograph. A systematic review and critical appraisal of the landmark clinical trials that support the drug’s use. | This is where you showcase your drug literature evaluation skills. Do not simply summarize the trial’s conclusion. Critically appraise the study’s design (randomized, double-blind?), patient population, endpoints (clinically meaningful or surrogate?), and statistical significance (NNT, confidence intervals). Present the data in clear tables and charts. |
| 3. Comparative Efficacy Analysis | Directly compares the new drug to the hospital’s current formulary agent(s). This is what the committee most wants to know: Is it better? | Create a side-by-side table comparing the new drug vs. the old standard on key efficacy endpoints. If there are head-to-head trials, feature them prominently. If not, explain the limitations of comparing across different studies. Quantify the difference (e.g., “Drug X reduced mortality by an absolute risk reduction of 2.5% compared to Drug Y.”). |
| 4. Safety & Tolerability Profile | A comprehensive summary of the drug’s adverse effects, contraindications, and black box warnings. | Again, create a comparative table showing the rates of common and serious adverse events for the new drug versus the formulary incumbent. Calculate the Number Needed to Harm (NNH) for serious side effects. Highlight any unique safety concerns that require special monitoring. |
| 5. Pharmacoeconomic & Budget Impact Analysis | The financial evaluation. This section answers the question, “Can we afford this, and is it worth the cost?” |
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| 6. The Final Recommendation | The pharmacist’s clear, evidence-based recommendation to the committee. | Synthesize all of the above information into a definitive recommendation. There are typically three options:
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Masterclass within a Masterclass: How to Critically Appraise a Clinical Trial for P&T
Your credibility with the P&T committee hinges on your ability to dissect a clinical trial, not just read its abstract. Here’s a framework based on the PICO model (Patient, Intervention, Comparison, Outcome) that you learned in school, applied to the real world.
- Patient/Population: Were the patients in the trial similar to the patients in *your* hospital? Look at the inclusion and exclusion criteria. If a trial for a new heart failure drug excluded all patients with a GFR < 30 mL/min, its results may not be generalizable to your large population of patients with cardiorenal syndrome.
- Intervention: Was the drug dosed and administered in the trial the same way you would use it in practice? Was the treatment duration long enough to show a real effect?
- Comparison: What was the new drug compared to? Was it compared to a placebo, which makes it easy to show a benefit? Or was it compared to the “gold standard” active therapy that you currently use on your formulary? A trial showing a new drug is better than nothing is far less impressive than a trial showing it’s better than the best available therapy.
- Outcome: What was the primary endpoint? Was it a clinically meaningful outcome that patients care about (like mortality, stroke prevention, or symptom improvement)? Or was it a “surrogate endpoint” (like a change in a lab value, e.g., A1c or LDL cholesterol)? A drug that lowers a lab value but doesn’t make patients live longer or feel better is of limited value. Also, scrutinize composite endpoints. If the primary endpoint was a composite of “cardiovascular death, non-fatal MI, non-fatal stroke, and urgent revascularization,” you need to break it down. Was the benefit driven by a reduction in all four, or just by the “softer” endpoint of revascularization?
- Statistics & Bias: Look beyond the p-value. What is the absolute risk reduction and the Number Needed to Treat (NNT)? A statistically significant result (p < 0.05) might correspond to a tiny clinical effect (an NNT of 300). Who funded the study? Be aware of potential industry bias, although most major trials are well-conducted.
39.4.3 Beyond the Monograph: How the P&T Committee Drives System-Wide Policy
The P&T Committee’s influence extends far beyond simply approving or denying new drugs. It serves as the ultimate authority for all medication-use policies, creating the rules of the road that govern how medications are prescribed, dispensed, and administered throughout the entire institution. Pharmacists are not just participants in this process; they are often the primary authors and champions of these policies, using the P&T committee as the vehicle to implement system-wide safety and quality improvements.
Masterclass Table: Common P&T-Driven Medication Policies
| Policy / Protocol | Purpose & Rationale | The Pharmacist’s Role in Development & Implementation |
|---|---|---|
| Therapeutic Interchange Protocols | To standardize care and control costs by automatically substituting non-formulary drugs with their designated, therapeutically equivalent formulary counterparts (e.g., swapping a non-formulary PPI for the formulary PPI). This eliminates thousands of phone calls and ensures patients receive the hospital’s preferred, evidence-vetted agent. | Pharmacists perform the initial evidence review to prove the therapeutic equivalence of the agents in the proposed protocol. They draft the policy, present it to the P&T committee for approval, and then help the IT team build the necessary rules into the EMR. Frontline pharmacists are then empowered to execute the interchanges. |
| Medication Use Guidelines & Restrictions | To ensure high-cost, high-risk, or highly specialized medications are used only in appropriate, evidence-based situations. This prevents overuse, controls costs, and improves safety. | A clinical specialist pharmacist will draft the guideline based on national standards and local expert consensus. For example, an ID pharmacist will write the “Meropenem Use Guideline.” The guideline is presented to P&T for approval. Once approved, pharmacists act as the gatekeepers, reviewing all orders for restricted drugs against the guideline criteria and intervening when necessary. |
| Standardized Order Sets | To create pre-built, evidence-based order sets in the EMR for common conditions (e.g., Sepsis, Community-Acquired Pneumonia). This makes it easy for providers to do the right thing, ensuring all elements of guideline-directed medical therapy are ordered consistently. | Pharmacists are key members of the multidisciplinary teams that build and maintain these order sets. You will ensure the medication selections, default doses, and associated monitoring parameters within the order set reflect the latest clinical guidelines and P&T-approved policies. |
| Medication Shortage Management Policies | To create a fair, ethical, and clinically sound framework for rationing a critical medication during a national shortage. This prevents hoarding and ensures the limited supply goes to the patients who will benefit most. | When a shortage hits, the pharmacy department is the first to know. A pharmacist will immediately research alternatives and draft a conservation strategy. This is presented at an emergency P&T meeting for approval. The P&T-approved policy then gives the pharmacy the authority to implement the conservation measures across the hospital. |
Visualizing a Clinical Pathway: The IVIG Use Guideline
Below is a visual representation of how a P&T-approved guideline for a high-cost drug like Intravenous Immunoglobulin (IVIG) works in practice. This flowchart illustrates the decision points a pharmacist would navigate when reviewing an order.
Pharmacist Workflow for IVIG Order Review (P&T Approved Guideline)
1
New order for IVIG received in the pharmacy queue.
2
Pharmacist reviews patient’s chart. What is the documented indication for the IVIG?
Is the indication on the P&T Committee’s “Approved Tier 1” list?
(e.g., ITP, Kawasaki disease, GBS)
YES
Proceed to Step 3: Dosing Verification.
NO
Order is put on hold. Contact prescriber to discuss evidence and formulary alternatives. May require a formal non-formulary consult with the appropriate specialist service.
3
Verify dosing. Is the ordered dose (g/kg) and infusion rate appropriate for the approved indication and the patient’s weight and renal function?
Final Verification & Dispensing
If indication is approved AND dose is correct, pharmacist verifies the order. The IV is prepared and dispensed.
