Product Requirements Document: E-Prescription System

Executive SummaryCopy Anchor Link

Product OverviewCopy Anchor Link

The E-Prescription System enables healthcare providers to electronically create, manage, and transmit prescriptions directly to pharmacies through the Surescripts network. This eliminates paper prescriptions, reduces errors, improves patient safety, and ensures regulatory compliance while maintaining our own UI for prescription capture.

Business ObjectivesCopy Anchor Link

• Eliminate Paper Prescriptions: Achieve 95% electronic prescription rate
• Improve Patient Safety: Reduce medication errors by 50% through drug interaction checking
• Regulatory Compliance: Meet all state and federal e-prescribing requirements
• Provider Efficiency: Reduce prescription time from 5 minutes to 2 minutes
• Patient Satisfaction: Enable same-day prescription availability at pharmacies

Success MetricsCopy Anchor Link

• Prescription transmission success rate > 98%
• Provider adoption rate > 90% within 3 months
• Average prescription creation time < 2 minutes
• Patient notification delivery rate > 95%
• Zero critical security incidents

User PersonasCopy Anchor Link

Primary UsersCopy Anchor Link

1. Prescribing Provider (Doctor/NP/PA)Copy Anchor Link

Goals:

• Quickly prescribe medications during or after patient encounters
• Ensure patient safety through clinical decision support
• Manage refills efficiently
• Track prescription status

Pain Points:

• Manual prescription writing is time-consuming
• Difficulty tracking if patients filled prescriptions
• Managing controlled substance regulations
• Remembering patient's preferred pharmacies

2. Medical AssistantCopy Anchor Link

Goals:

• Prepare prescriptions for provider review
• Handle refill requests
• Manage prescription-related patient communications

Pain Points:

• Coordinating between providers and pharmacies
• Managing prescription status inquiries
• Processing refill requests

3. PatientCopy Anchor Link

Goals:

• Receive prescriptions quickly at preferred pharmacy
• Track prescription status
• Request refills easily
• Understand medication instructions

Pain Points:

• Waiting for prescriptions at pharmacy
• Not knowing if prescription was sent
• Difficulty requesting refills

User Stories & Acceptance CriteriaCopy Anchor Link

Epic 1: Prescription CreationCopy Anchor Link

User Story 1.1: Create New PrescriptionCopy Anchor Link

As a prescribing provider
I want to create and send electronic prescriptions
So that patients can receive medications quickly and safely

Acceptance Criteria:

• Provider can search medications by name (brand/generic)
• System displays drug strengths, forms, and routes
• Provider can specify dosage, frequency, duration, and quantity
• Provider can add patient instructions (SIG)
• System performs drug-drug interaction checking
• System performs allergy checking against patient record
• Provider can select dispense as written or allow substitution
• Prescription is transmitted to selected pharmacy within 10 seconds

User Story 1.2: Use Prescription TemplatesCopy Anchor Link

As a prescribing provider
I want to use and create prescription templates
So that I can quickly prescribe common medications

Acceptance Criteria:

• System provides pre-built templates for common conditions
• Provider can create custom templates from existing prescriptions
• Provider can modify template values before prescribing
• Templates are searchable by name or condition
• Provider can organize templates into categories
• Templates include complete prescription information

User Story 1.3: Prescribe During EncounterCopy Anchor Link

As a prescribing provider
I want to add prescriptions during patient encounters
So that all clinical decisions are documented together

Acceptance Criteria:

• Prescriptions can be added from encounter workflow
• Prescriptions are linked to encounter record
• Multiple prescriptions can be created in one session
• Prescriptions can be saved as draft and sent later
• All prescriptions for encounter can be sent together

Epic 2: Pharmacy ManagementCopy Anchor Link

User Story 2.1: Select PharmacyCopy Anchor Link

As a prescribing provider
I want to easily select patient's pharmacy
So that prescriptions go to the right location

Acceptance Criteria:

• Search pharmacies by name, address, or ZIP code
• View pharmacy details (hours, phone, address)
• See patient's preferred pharmacies list
• View recently used pharmacies
• Select mail-order pharmacies when appropriate
• Save new pharmacy as patient preference

User Story 2.2: Manage Preferred PharmaciesCopy Anchor Link

As a patient
I want to set my preferred pharmacies
So that my prescriptions go to convenient locations

Acceptance Criteria:

• Patient can designate primary pharmacy
• Patient can save multiple pharmacy preferences
• System remembers last used pharmacy
• Provider sees patient's preferences during prescribing

Epic 3: Clinical Decision SupportCopy Anchor Link

User Story 3.1: Drug Interaction CheckingCopy Anchor Link

As a prescribing provider
I want to see drug interaction warnings
So that I can prevent adverse events

Acceptance Criteria:

• System checks against current medications
• Display interaction severity (Major/Moderate/Minor)
• Show clinical significance and recommendation
• Allow override with documented reason
• Check interactions with OTC medications
• Include herbal/supplement interactions

User Story 3.2: Allergy CheckingCopy Anchor Link

As a prescribing provider
I want to see allergy warnings
So that I can avoid allergic reactions

Acceptance Criteria:

• System checks against documented allergies
• Display allergy severity and reaction type
• Show cross-sensitivity warnings
• Prevent prescribing with severe allergies
• Allow override with clinical justification

Epic 4: Refill ManagementCopy Anchor Link

User Story 4.1: Prescribe RefillsCopy Anchor Link

As a prescribing provider
I want to authorize refills
So that patients have continuous medication access

Acceptance Criteria:

• Specify number of refills (0-11)
• Set refill expiration date
• Track remaining refills
• Receive alerts when refills are exhausted
• Support PRN refill authorization

User Story 4.2: Process Refill RequestsCopy Anchor Link

As a prescribing provider
I want to efficiently handle refill requests
So that patients receive timely medication refills

Acceptance Criteria:

• View pending refill requests queue
• See medication history and compliance
• Approve/deny with one click
• Send refill to same or different pharmacy
• Add notes to refill authorization

Epic 5: Prescription TrackingCopy Anchor Link

User Story 5.1: Track Prescription StatusCopy Anchor Link

As a prescribing provider
I want to see prescription delivery status
So that I know patients received medications

Acceptance Criteria:

• View real-time prescription status
• See transmission confirmation
• Track pharmacy receipt acknowledgment
• Monitor fill status (when available)
• View failure reasons and retry options

User Story 5.2: Prescription HistoryCopy Anchor Link

As a prescribing provider
I want to view prescription history
So that I can make informed clinical decisions

Acceptance Criteria:

• View all prescriptions for a patient
• Filter by date range, medication, status
• See prescribing provider and date
• Export prescription list
• View discontinued medications

Epic 6: Controlled Substances (Phase 2)Copy Anchor Link

User Story 6.1: EPCS PrescribingCopy Anchor Link

As a prescribing provider
I want to electronically prescribe controlled substances
So that I can comply with DEA requirements

Acceptance Criteria:

• Two-factor authentication for controlled substances
• DEA number validation
• Audit trail for all controlled prescriptions
• Comply with state PDMP requirements
• Support Schedule II-V medications

Epic 7: Patient CommunicationCopy Anchor Link

User Story 7.1: Prescription NotificationsCopy Anchor Link

As a patient
I want to receive prescription notifications
So that I know when to pick up medications

Acceptance Criteria:

• SMS/Email notification when prescription sent
• Include pharmacy name and address
• Provide pickup timeframe estimate
• Include basic medication information
• Option to opt-out of notifications

Feature SpecificationsCopy Anchor Link

MVP Features (Phase 1 - Q3 2024)Copy Anchor Link

Core PrescribingCopy Anchor Link

• New prescription creation
• Generic/brand selection
• Dosage, frequency, quantity specification
• Patient instructions (SIG)
• Dispense as written option
• Basic refill authorization (0-11)

Drug Database IntegrationCopy Anchor Link

• RxNorm drug database (free tier)
• Basic drug search and selection
• Standard dosage forms and strengths
• Common SIG templates

Pharmacy NetworkCopy Anchor Link

• Surescripts network integration
• Pharmacy search and selection
• Preferred pharmacy management
• Transmission confirmation

Clinical Decision SupportCopy Anchor Link

• Basic drug-drug interaction checking
• Allergy cross-checking
• Override capability with reason

Prescription ManagementCopy Anchor Link

• Save as draft
• Send individually or batch
• Cancel/void prescription
• Basic prescription history
• Print backup option

Security & ComplianceCopy Anchor Link

• Provider authentication
• Basic audit logging
• HIPAA compliance
• State e-prescribing compliance

Phase 2 Features (Q4 2024)Copy Anchor Link

Advanced Clinical SupportCopy Anchor Link

• First Databank integration
• Formulary checking
• Prior authorization alerts
• Dosage range checking
• Pediatric/geriatric dosing

Controlled SubstancesCopy Anchor Link

• EPCS certification
• Two-factor authentication
• DEA number management
• PDMP integration
• Enhanced audit trails

Enhanced WorkflowsCopy Anchor Link

• Prescription templates library
• Refill request queue
• Medication history import
• Real-time eligibility checking

Phase 3 Features (Q1 2025)Copy Anchor Link

Patient EngagementCopy Anchor Link

• Patient portal integration
• Medication reminders
• Refill request submission
• Prescription status tracking
• Medication education materials

Analytics & ReportingCopy Anchor Link

• Prescription analytics dashboard
• Provider prescribing patterns
• Controlled substance reports
• Failed prescription analysis
• Compliance reporting

Advanced IntegrationCopy Anchor Link

• Insurance formulary real-time check
• Prior authorization submission
• Medication adherence tracking
• Clinical outcome correlation

Technical RequirementsCopy Anchor Link

Integration RequirementsCopy Anchor Link

Surescripts IntegrationCopy Anchor Link

• Connection Type: REST API v2.0
• Authentication: OAuth 2.0 with certificate-based security
• Message Format: NCPDP SCRIPT Standard 2017071
• Encryption: TLS 1.2 minimum
• Throughput: Support 100 concurrent prescriptions

Drug DatabaseCopy Anchor Link

• Primary: RxNorm (free, NIH maintained)
• Secondary: First Databank (Phase 2)
• Update Frequency: Daily updates
• Offline Cache: 7-day local cache

Data RequirementsCopy Anchor Link

Prescription Data ModelCopy Anchor Link

{
  prescriptionId: "UUID",
  patientId: "UUID",
  providerId: "UUID",
  encounterId: "UUID (optional)",
  medicationDetails: {
    name: "string",
    genericName: "string",
    rxNormCode: "string",
    strength: "string",
    form: "string",
    route: "string"
  },
  dosing: {
    dosage: "string",
    frequency: "string",
    duration: "string",
    quantity: "number",
    refills: "number",
    daw: "boolean"
  },
  pharmacy: {
    ncpdpId: "string",
    name: "string",
    address: "object",
    phone: "string"
  },
  status: "draft|sent|received|filled|cancelled",
  timestamps: {
    created: "ISO8601",
    sent: "ISO8601",
    received: "ISO8601"
  }
}

Performance RequirementsCopy Anchor Link

• Prescription creation: < 5 seconds
• Pharmacy search: < 2 seconds
• Drug interaction check: < 3 seconds
• Prescription transmission: < 10 seconds
• System availability: 99.9% uptime

Security RequirementsCopy Anchor Link

• HIPAA compliant data handling
• Encryption at rest and in transit
• Provider authentication required
• Audit trail for all actions
• Session timeout after 15 minutes
• Role-based access control

Compliance RequirementsCopy Anchor Link

Federal RegulationsCopy Anchor Link

• DEA requirements for controlled substances
• HIPAA privacy and security rules
• Medicare Part D e-prescribing standards
• FDA drug database requirements

State RequirementsCopy Anchor Link

• State-specific e-prescribing mandates
• PDMP reporting requirements
• Prescription validity periods
• Tamper-resistant prescription alternatives

Certification RequirementsCopy Anchor Link

• Surescripts certification process (3-6 months)
• NCPDP Provider ID registration
• EPCS certification (Phase 2)
• State board of pharmacy registration

User Experience RequirementsCopy Anchor Link

Desktop ExperienceCopy Anchor Link

• Single-page prescription workflow
• Keyboard navigation support
• Auto-save every 30 seconds
• Quick access to recent prescriptions
• Minimal clicks to complete prescription

Mobile/Tablet ExperienceCopy Anchor Link

• Responsive design for tablets
• Touch-optimized controls
• Larger tap targets (44px minimum)
• Simplified workflow for mobile
• Offline draft capability

AccessibilityCopy Anchor Link

• WCAG 2.1 AA compliance
• Screen reader compatibility
• Keyboard navigation
• High contrast mode support
• Clear error messages

Risk AssessmentCopy Anchor Link

High RisksCopy Anchor Link

1. Surescripts Certification Delay
   • Mitigation: Start certification immediately, have print backup
2. Network Downtime
   • Mitigation: Queue and retry system, print option
3. Drug Database Accuracy
   • Mitigation: Daily updates, multiple database sources

Medium RisksCopy Anchor Link

1. Provider Adoption
   • Mitigation: Training program, gradual rollout
2. Pharmacy Integration Issues
   • Mitigation: Extensive testing, phased rollout
3. State Compliance Variations
   • Mitigation: Legal review, configurable rules engine

Implementation TimelineCopy Anchor Link

Pre-Development (Month 1)Copy Anchor Link

• Surescripts certification initiation
• NCPDP ID registration
• Legal compliance review
• Drug database selection
• Technical architecture design

MVP Development (Months 2-4)Copy Anchor Link

• Core prescription workflow
• Surescripts integration
• Drug database integration
• Pharmacy network setup
• Basic clinical checks

Testing & Certification (Month 5)Copy Anchor Link

• Surescripts testing
• Security audit
• User acceptance testing
• Provider training development
• Compliance validation

Pilot Launch (Month 6)Copy Anchor Link

• Limited provider rollout
• Performance monitoring
• Feedback collection
• Issue resolution
• Process refinement

General Availability (Q3 2024)Copy Anchor Link

• Full provider rollout
• Patient notifications
• Analytics dashboard
• 24/7 support

Success CriteriaCopy Anchor Link

Launch Metrics (First 30 Days)Copy Anchor Link

• 50% of providers actively prescribing
• 90% prescription success rate
• < 2% error rate
• Average time to prescribe < 3 minutes

Steady State Metrics (90 Days)Copy Anchor Link

• 90% provider adoption
• 98% prescription success rate
• 100-200 prescriptions per day
• 95% patient notification delivery
• < 5 support tickets per 100 prescriptions

AppendicesCopy Anchor Link

A. Prescription Modification WorkflowCopy Anchor Link

When a prescription needs to be modified after sending:

1. Provider selects "Cancel" for original prescription
2. System sends cancellation to Surescripts
3. Provider creates new prescription with modifications
4. System links cancelled and new prescriptions
5. Audit trail maintains full history

B. Error Handling ScenariosCopy Anchor Link

1. Network Timeout: Queue prescription, retry every 5 minutes for 1 hour
2. Invalid Data: Display specific field errors, prevent submission
3. Pharmacy Closed: Warn provider, suggest alternatives
4. Drug Not Found: Suggest alternatives, allow free text with warning

C. Print Prescription FormatCopy Anchor Link

When electronic transmission fails:

1. Generate tamper-resistant prescription format
2. Include all required elements per state law
3. Add security features (watermark, sequence number)
4. Log printed prescription in system
5. Require manual pharmacy confirmation

Document Version: 1.0
Last Updated: November 2024
Author: Product Management Team
Reviewers: Clinical, Technical, Compliance Teams