/**
* Enhanced Weekly Regulatory Monitoring Prompt
* Implements AI Assistant Prompt Enhancement PRD specifications
* Automated weekly pharmaceutical regulatory intelligence report with surveillance queries
*/
import { EnhancedPrompt, WorkingExample } from './enhanced-base.js';
import { PromptExecutionResult } from '../types/index.js';
import { MonitoringArgsSchema, FdaSearchType } from '../types/fda.js';
import { z } from 'zod';
interface MonitoringArgs {
company_name?: string;
therapeutic_area?: string;
drug_name?: string;
brand_name?: string;
current_date: string;
}
export class WeeklyMonitoringPrompt extends EnhancedPrompt<MonitoringArgs> {
constructor() {
super(
'fda_weekly_surveillance_report',
'Automated weekly pharmaceutical regulatory intelligence report with surveillance queries for monitoring regulatory activity, safety signals, and supply chain intelligence.',
{
company_name: z.string().optional().describe('Company name to monitor for regulatory activity'),
therapeutic_area: z.string().optional().describe('Therapeutic area/class to monitor'),
drug_name: z.string().optional().describe('Drug name to monitor for regulatory activity'),
brand_name: z.string().optional().describe('Brand name to monitor for regulatory activity'),
current_date: MonitoringArgsSchema.shape.current_date.describe('Current date in YYYY-MM-DD format for the monitoring report')
}
);
}
protected async execute(
params: MonitoringArgs,
_requestId: string
): Promise<PromptExecutionResult> {
const { company_name, therapeutic_area, drug_name, brand_name, current_date } = params;
// Use placeholders if not provided
const companyName = company_name || '[COMPANY]';
const drugName = drug_name || '[DRUG_NAME]';
const brandName = brand_name || '[BRAND_NAME]';
const monitoringTarget = company_name || therapeutic_area || drug_name || brand_name || 'target entity';
// Base prompt content with corrected queries
const basePrompt = `Today is ${current_date}. Create automated weekly monitoring for ${monitoringTarget} with these surveillance queries (calculate date ranges accounting for 1-week FDA data processing delay):
**1. Core Regulatory Intelligence**
1a. Weekly regulatory submission activity - sponsor analysis:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.submission_status_date:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "general",
"limit": 10,
"fields_for_general": "sponsor_name"
}
1b. Weekly regulatory submission activity - brand names:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.submission_status_date:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "general",
"limit": 10,
"fields_for_general": "openfda.brand_name"
}
1c. Weekly regulatory submission activity - submission class:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.submission_status_date:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "general",
"limit": 10,
"fields_for_general": "submissions.submission_class_code"
}
1d. Weekly regulatory submission activity - submission dates:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.submission_status_date:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "general",
"limit": 10,
"fields_for_general": "submissions.submission_status_date"
}
2a. Priority review pipeline - sponsors:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.review_priority:\\"PRIORITY\\"",
"search_type": "general",
"limit": 8,
"fields_for_general": "sponsor_name"
}
2b. Priority review pipeline - brand names:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "submissions.review_priority:\\"PRIORITY\\"",
"search_type": "general",
"limit": 8,
"fields_for_general": "openfda.brand_name"
}
3a. Company focus - submissions:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\"",
"search_type": "general",
"limit": 10,
"fields_for_general": "submissions.submission_type"
}
3b. Company focus - submission dates:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\"",
"search_type": "general",
"limit": 10,
"fields_for_general": "submissions.submission_status_date"
}
**2. Safety Intelligence**
4a. Weekly adverse events count:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "receivedate:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "adverse_events",
"count": "patient.drug.medicinalproduct",
"limit": 10
}
4b. Targeted safety signals - serious events:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drugName}\\" AND serious:1 AND receivedate:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt",
"limit": 8
}
4c. Brand-specific safety signals:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "patient.drug.openfda.brand_name:\\"${brandName}\\" AND serious:1 AND receivedate:[LAST_WEEK_START+TO+LAST_WEEK_END]",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt",
"limit": 8
}
**3. Supply Chain Intelligence**
5a. Current shortages - company analysis:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "status:\\"Current\\" AND company_name:\\"${companyName}\\"",
"search_type": "shortages",
"limit": 10,
"fields_for_shortages": "generic_name"
}
5b. Current shortages - reason analysis:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "status:\\"Current\\" AND company_name:\\"${companyName}\\"",
"search_type": "shortages",
"limit": 10,
"fields_for_shortages": "shortage_reason"
}
5c. Drug-specific shortages:
- Tool: fda_info
- EXECUTE EXACTLY:
{
"method": "lookup_drug",
"search_term": "status:\\"Current\\" AND generic_name:\\"${drugName}\\"",
"search_type": "shortages",
"limit": 10,
"fields_for_shortages": "company_name"
}
**Parameter Syntax & Field Reference:**
- **Date ranges**: \`receivedate:[YYYYMMDD+TO+YYYYMMDD]\` for adverse events, \`submissions.submission_status_date:[YYYYMMDD+TO+YYYYMMDD]\` for regulatory activity
- **Dynamic date calculation**: AI will automatically calculate date ranges based on "Today is ${current_date}" in prompt:
- \`[LAST_WEEK_START+TO+LAST_WEEK_END]\` → Calculate **three weeks ago** Monday-Sunday from the stated current date
- \`[LAST_MONTH_START+TO+LAST_MONTH_END]\` → Calculate **two months ago** full month from the stated current date
- **CRITICAL**: Always use the YEAR from the "Today is ${current_date}" statement, never use hardcoded years
- **Processing delay**: Use data from 2-3 weeks ago for adverse events, 1-2 weeks ago for regulatory submissions due to different reporting timelines
- **Format**: Always use YYYYMMDD format (Year-Month-Day with no separators)
- **Calculation method**: Count backwards from the stated current date to find the appropriate week/month, then convert to YYYYMMDD format
- **Field requirements**: Single field per fields_for_general parameter, no comma separation
- **Count parameters**: Remove .exact suffix from count fields
- **Search syntax**: Use boolean operators \`AND\`, \`OR\`, quote values properly
- **Placeholders**: Replace [COMPANY] with sponsor name, [DRUG_NAME] with generic name, [BRAND_NAME] with brand name
**Field Interpretation:**
- Submission class codes: Priority, Standard, Fast Track, Breakthrough
- Review priority: PRIORITY (expedited), STANDARD (normal timeline)
- Adverse event dates: receivedate (when FDA received the report)
- Shortage status: Current (active), Resolved (ended), To Be Discontinued
**Output Format:**
1. **Executive Summary** (3 bullet points): Key developments, emerging risks, competitive threats
2. **Regulatory Activity Table**: New approvals, submissions, status changes with dates
3. **Safety Alerts** (2 bullet points): Notable adverse event patterns, regulatory communications
4. **Supply Chain Status** (2 bullet points): Active shortages, resolution progress
5. **Strategic Implications** (1 paragraph): Impact assessment and recommended actions
Format as readable bullet points and paragraphs, not as JSON or structured data.
**Automation Setup:**
- Schedule weekly execution with date range auto-adjustment
- Configure stakeholder distribution lists
- Set up threshold alerts for significant developments
Execute each query sequentially and generate a comprehensive weekly pharmaceutical regulatory intelligence report.`;
// Build enhanced prompt with AI assistant guidance
const enhancedPrompt = this.buildEnhancedPrompt(
basePrompt,
this.getPrimarySearchType(),
this.getPromptSpecificExamples()
);
return this.createPromptResult(
`Enhanced Weekly Pharmaceutical Regulatory Intelligence Report for ${monitoringTarget}`,
enhancedPrompt
);
}
/**
* Get prompt-specific working examples for weekly monitoring
*/
protected getPromptSpecificExamples(): WorkingExample[] {
return [
{
name: "Weekly Regulatory Activity",
description: "Monitor regulatory submissions from last week",
query: {
method: "lookup_drug",
search_term: "submissions.submission_status_date:[20240901+TO+20240907]",
search_type: "general",
limit: 10,
fields_for_general: "sponsor_name"
},
expectedFields: ["sponsor_name"],
notes: "Date format: YYYYMMDD. Calculate date ranges from current_date parameter"
},
{
name: "Priority Review Pipeline",
description: "Find drugs in priority review status",
query: {
method: "lookup_drug",
search_term: "submissions.review_priority:\"PRIORITY\"",
search_type: "general",
limit: 8,
fields_for_general: "openfda.brand_name"
},
expectedFields: ["openfda.brand_name"],
notes: "PRIORITY must be quoted. Shows expedited review drugs"
},
{
name: "Weekly Adverse Events",
description: "Count adverse events received in specific week",
query: {
method: "lookup_drug",
search_term: "receivedate:[20240901+TO+20240907]",
search_type: "adverse_events",
count: "patient.drug.medicinalproduct",
limit: 10
},
expectedFields: ["patient.drug.medicinalproduct"],
notes: "Remove .exact suffix from count parameter"
},
{
name: "Current Drug Shortages",
description: "Monitor active shortages for specific companies",
query: {
method: "lookup_drug",
search_term: "status:\"Current\" AND company_name:\"PFIZER\"",
search_type: "shortages",
limit: 10,
fields_for_shortages: "generic_name"
},
expectedFields: ["generic_name"],
notes: "Use fields_for_shortages for shortage data, single field only"
}
];
}
/**
* Get the primary search type for this prompt
*/
protected getPrimarySearchType(): FdaSearchType {
return 'general';
}
}
