A tool by Firecrawl · uses 7 tools · Healthcare

Formulary addition evidence pack

Use when a P&T committee pharmacist or drug information specialist prepares a formulary review for a newly approved drug. Pulls the approval history and label, the pivotal and ongoing trials with results, published evidence from PubMed and early real-world adverse event reports, then drafts a sourced monograph with a recommendation.

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Tools it calls

Each tool's price and track record across every agent today. Empty means the call worked and found nothing.

ToolPriceMedianSuccessEmpty

FDADrug applicationsPrice5 creditsMedian–Success–Empty–
FDADrug labelsPrice5 creditsMedian–Success–Empty–
ClinicalTrials.govSearchPrice5 creditsMedian88 msSuccess100%Empty30.3%
ClinicalTrials.govStudyPrice5 creditsMedian65 msSuccess99.2%Empty0%
PubMed and PMCSearchPrice5 creditsMedian558 msSuccess99.2%Empty28.2%
PubMed and PMCArticlePrice5 creditsMedian291 msSuccess98.8%Empty0%
FDADrug eventsPrice5 creditsMedian–Success–Empty–

Instructions

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# Formulary addition evidence pack

For one newly approved drug and its intended indication. The monograph must separate what the label says from what trials and early use show.

## 1. Approval and label

1. Find the application with @[FDA · Drug applications](alexandria:fda-gov/records/drug_applications) (query = brand or generic name): approval date, pathway, priority review, submission history.
2. Read @[FDA · Drug labels](alexandria:fda-gov/records/drug_labels): indications, dosing, boxed warnings, contraindications, interactions.

## 2. Trial evidence

3. Search @[ClinicalTrials.gov · Search](alexandria:clinicaltrials-gov/clinical-trials/search) (intervention, condition). Separate completed pivotal trials from ongoing ones.
4. Open the pivotal trials with @[ClinicalTrials.gov · Study](alexandria:clinicaltrials-gov/clinical-trials/study) (nct_id, include_results): comparator, primary endpoint, enrollment, posted results.

## 3. Published and real-world evidence

5. Search @[PubMed · Search](alexandria:pubmed-ncbi-nlm-nih-gov/publications/search) (drug name plus indication; sort by date). Read key papers with @[PubMed · Article](alexandria:pubmed-ncbi-nlm-nih-gov/publications/article): design, effect size, funding.
6. Sample early reports with @[FDA · Drug events](alexandria:fda-gov/records/drug_events) (query patient.drug.medicinalproduct:<name>). Report counts are signals, not incidence.

## Write the monograph

- **Summary:** place in therapy versus current formulary options.
- **Efficacy table:** trial, comparator, endpoint, result, NCT and PMID.
- **Safety:** label warnings, trial adverse events, FAERS signals with caveats.
- **Recommendation:** add, add with restrictions, or defer, with criteria for use.
- **Sources:** application number, label id, NCTs, PMIDs, FAERS query. Say what could not be found, including any cost data.

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