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ebe934f 2a3badd | 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 | # Pharma domain — knowledge base documents
# Retrieved by RAG pipeline, grounded against in faithfulness check
# Each entry: id, title, content (2-4 sentences, retrieval-friendly), tags
documents:
- id: pharma_001
title: "Prior Authorization and Formulary Pre-Approval"
content: >
Prior authorization (formulary pre-approval) is a requirement by a payer that a
prescriber obtain approval before a specific drug is dispensed and covered.
The prescriber submits clinical justification; the payer reviews against formulary
criteria and responds within 72 hours for standard requests or 24 hours for urgent cases.
Denied requests can be appealed once with additional clinical documentation.
tags: [prior-auth, formulary, coverage]
- id: pharma_002
title: "Generic vs Brand Drug Names"
content: >
Every approved drug has a generic name (the active ingredient, non-proprietary) and
one or more brand names assigned by manufacturers.
Generic names are used in clinical guidelines and regulatory filings; brand names
appear in marketing materials and some payer formularies.
Substituting a brand drug with a generic equivalent requires explicit prescriber
or payer authorization in some jurisdictions.
tags: [drug-name, generic, brand]
- id: pharma_003
title: "Adverse Events and Safety Signals"
content: >
An adverse event is any undesirable medical occurrence in a patient administered
a medicinal product, regardless of causal relationship.
A safety signal (pharmacovigilance alert) is a pattern of adverse events that
suggests a previously unknown or incompletely documented causal relationship
between a drug and an outcome.
Adverse events must be reported to the regulatory authority within 15 days for
serious unexpected events and 90 days for expected events.
tags: [adverse-event, safety, pharmacovigilance]
- id: pharma_004
title: "Drug-Drug Interactions and Contraindications"
content: >
A drug-drug interaction (contraindication) occurs when one drug affects the activity
of another when both are administered together.
Interactions range from minor (monitoring recommended) to contraindicated (combination
must not be used). Severity classifications follow the clinical pharmacology guidelines
maintained in the formulary interaction database.
Prescribers are alerted at point-of-care when a contraindicated combination is entered.
tags: [drug-interaction, contraindication, safety]
- id: pharma_005
title: "Clinical Guidelines and Prescribing Pathways"
content: >
A treatment protocol (clinical guideline / prescribing pathway) is an evidence-based
document specifying the recommended sequence of therapies for a given condition.
Pathways are reviewed annually and updated when new efficacy or safety data emerges.
Payers use pathway adherence as a criterion in coverage decisions; deviation requires
documented clinical rationale.
tags: [protocol, guideline, treatment]
- id: pharma_006
title: "Formulary Coverage Tiers"
content: >
A formulary is a list of drugs covered by a payer, organized into tiers (benefit tiers)
that determine patient cost-sharing. Tier 1 is typically lowest cost (generics);
higher tiers carry higher copays. Moving a drug to a higher tier requires
a formulary committee review and a minimum 60-day notice to prescribers.
tags: [formulary, coverage, tier]
- id: pharma_007
title: "Dosage Adjustment and Titration"
content: >
A dosage adjustment (dose modification / titration step) is a change to a patient's
prescribed dose based on clinical response, tolerability, renal or hepatic function,
or drug interaction. Titration schedules specify the starting dose, increment size,
and minimum interval between increases. Adjustments outside the approved titration
schedule require prescriber documentation and may trigger a prior authorization review.
tags: [dosage, titration, dose]
- id: pharma_008
title: "Patient Consent and Enrollment Authorization"
content: >
Informed consent (enrollment authorization) is the process by which a patient
receives and acknowledges sufficient information about a treatment or study
to make a voluntary decision. For clinical trials, consent must be obtained
before any study procedure. Consent forms are version-controlled; if the
protocol changes materially, re-consent is required.
tags: [consent, enrollment, patient]
- id: pharma_009
title: "Clinical Trials and Investigational Programs"
content: >
A clinical trial (investigational program) is a structured study that evaluates
the safety or efficacy of a drug, device, or intervention in human subjects.
Trials are classified by phase: Phase I tests safety in a small cohort,
Phase II assesses efficacy and side effects, Phase III compares against
standard treatment at scale. Enrollment eligibility is defined by inclusion
and exclusion criteria in the protocol.
tags: [clinical-trial, study, investigational]
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