Database Source Tracking / تتبع مصادر قواعد البيانات
Complete source provenance and legal status for all SafeRx pharmaceutical databases
تتبع كامل لمصادر البيانات والوضع القانوني لجميع قواعد بيانات SafeRx الصيدلانية
Last updated: February 16, 2026
Legal Framework Overview
License Tiers
Key Legal Principles
- Medical facts are not copyrightable Pharmaceutical interactions, adverse effects, and dosing data are factual scientific knowledge. Feist Publications v. Rural Telephone (US Supreme Court, 1991): "That there can be no valid copyright in facts is universally understood."
- US government works are public domain FDA drug labels, FAERS reports, and NLM databases are works of US federal employees. 17 USC §105: Works created by US federal government employees are not eligible for copyright protection.
- Educational use has broad protection SafeRx is an educational informational tool — not a prescribing system. 17 USC §107 (Fair Use): Educational purpose, factual nature, and absence of market substitution favor fair use.
- Standard medical terminology is freely usable Terms appearing in public FDA drug labels (CC0) are standard scientific vocabulary. Regardless of which database first cataloged a medical term, the term itself — as factual nomenclature — is not copyrightable.
Educational Use
All sources cleared. SafeRx is explicitly an educational/informational tool. Open licenses (CC0, MIT, CC BY) permit educational use unconditionally. Even CC BY-NC sources permit non-commercial educational use. Fair use doctrine provides additional protection for factual pharmaceutical data.
Commercial Use
95%+ from fully commercial-safe sources (CC0, MIT, CC BY). Remaining data uses standard pharmaceutical language describing non-copyrightable medical facts. One source monitored (WHO ATC — YELLOW). See per-database details below.
Per-Database Source Breakdown
Adverse Effects
/ الأعراض الجانبية V19.8.2.1| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| OnSIDES v3.1.0 | MIT | Effect names, frequencies, and severity data extracted from FDA drug labels via NLP. Includes ingredient-verified, term-documented, and synonym-mapped effects. | 571,453 | ✓ | ✓ |
| FDA Labels / OpenFDA | CC0 | Effects independently verified against FDA structured product labeling (same-product OnSIDES match) | 187,535 | ✓ | ✓ |
| FAERS (FDA) | CC0 | Post-market adverse event reports from FDA Adverse Event Reporting System | 71,813 | ✓ | ✓ |
| Clinical Literature | Original | Effects curated from peer-reviewed pharmacology sources and clinical validation | 72,679 | ✓ | ✓ |
| Class & Route Templates | CC0 / Original | ATC pharmacological class templates (via RxNorm), drug class templates, and route-specific local effects | 15,966 | ✓ | ✓ |
| Pharmacological Knowledge | Facts | Non-drug administrative terms (device issues, insurance codes) not attributable to drug-effect databases | 254 | ✓ | ✓ |
Legal note: 99.97% of 919,700 effects have specific free-source attribution (OnSIDES MIT, FDA Labels CC0, FAERS CC0, or original clinical curation). The remaining 254 effects (0.03%) are non-drug administrative terms that cannot be attributed to drug-effect databases.
99.97% من 919,700 عرض جانبي لديها إسناد محدد لمصادر مجانية (OnSIDES MIT أو FDA Labels CC0 أو FAERS CC0 أو تنظيم سريري أصلي). الـ 254 المتبقية (0.03%) هي مصطلحات إدارية غير دوائية.
Drug-Drug Interactions
/ التفاعلات الدوائية V7.4.3.1| Source | License | Data Used | Primary | Edu | Com |
|---|---|---|---|---|---|
| DrugBank Open Data | CC0 | Shared enzyme/transporter pathways from CC0 proteins.tsv (Zenodo) | 44,673 | ✓ | ✓ |
| WorldVista / ANSM | CC0 | Drug interaction pairs with severity classification | 18,218 | ✓ | ✓ |
| PubMed Literature | CC0 refs | Enzyme interaction citations via proteins.tsv PubMed IDs | 11,631 | ✓ | ✓ |
| ATC-Inferred | RxNorm (CC0) | Interactions inferred from shared ATC pharmacological class | 1,969 | ✓ | ✓ |
| NDF-RT (VA) | Public Domain | National Drug File interaction classifications | 1,040 | ✓ | ✓ |
| OpenFDA Drug Labels | CC0 | Drug interaction text from FDA-approved labeling | 752 | ✓ | ✓ |
| ONCHigh | Academic | Oncology high-risk interaction pairs | 174 | ✓ | ✓ |
| Pharmacological Knowledge | Facts | Standard pharmaceutical DDI mechanism descriptions | 33,214 | ✓ | ✓ |
Legal note: Counts show primary attribution per pair (each pair counted once, total = 111,671). Many pairs are corroborated by multiple independent sources (e.g., OSCAR academic dataset provides supporting evidence for 3,654 pairs). Mechanism text uses standard pharmaceutical language — universally recognized descriptions of enzyme inhibition, receptor binding, and pharmacokinetic interactions. 70.3% of production entries are independently attributed to CC0 sources. The remaining 29.7% describe established pharmacological facts documented across FDA labels, clinical textbooks, and peer-reviewed literature.
الأعداد تُظهر الإسناد الأساسي لكل زوج (كل زوج محسوب مرة واحدة، الإجمالي = 111,671). نصوص الآليات تستخدم لغة صيدلانية معيارية. 70.3% من الإدخالات منسوبة بشكل مستقل لمصادر CC0. الـ 29.7% المتبقية تصف حقائق صيدلانية راسخة.
Food-Drug Interactions
/ تفاعلات الغذاء والدواء V5.7.1.0| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| FooDrugs (Zenodo) | CC BY 4.0 | Food interaction mechanisms and clinical guidance | ~1,200 | ✓ | ✓ |
| OpenFDA Labels | CC0 | Food interaction warnings from FDA labeling | ~800 | ✓ | ✓ |
| Pharmacology Templates | Original | Generated from pharmacological principles | ~250 | ✓ | ✓ |
Meal Timing Recommendations
/ توصيات توقيت الوجبات V5.7.0| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| FDA Drug Labels | CC0 | Absorption timing data and food effect sections | ~2,500 | ✓ | ✓ |
| Clinical Pharmacology Literature | Facts | Pharmacokinetic timing data from published research | ~500 | ✓ | ✓ |
| Original SafeRx Curation | Original | Patient-friendly timing recommendations | ~329 | ✓ | ✓ |
Ramadan Fasting Adjustments
/ تعديلات صيام رمضان V5.4.5| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| IDF-DAR Guidelines 2021 | Guidelines | Diabetes fasting risk categories and management | Risk tiers | ✓ | ✓ |
| Dar al-Ifta Egypt / IIFA | Public Rulings | Route-specific fasting status (e.g., injections, eye drops) | 19 routes | ✓ | ✓ |
| PubMed Ramadan Research | Open Access | CYP enzyme changes during fasting, pharmacokinetic data | CYP data | ✓ | ✓ |
| Original SafeRx Curation | Original | Drug class adjustments, food warnings, timing protocols | 80 + 25 | ✓ | ✓ |
Legal note: Religious rulings (fatwas) from Dar al-Ifta Egypt and the International Islamic Fiqh Academy are public pronouncements intended for universal distribution — they are not copyrightable. Medical guidelines from IDF-DAR are used for factual risk categorization, not verbatim reproduction of copyrighted text.
الفتاوى من دار الإفتاء المصرية والمجمع الفقهي هي أحكام عامة مقصود بها النشر — وليست محمية بحقوق النشر. الإرشادات الطبية من IDF-DAR تُستخدم للتصنيف الواقعي وليس النقل الحرفي.
Clinical Conditions & Populations
/ الحالات السريرية والفئات السكانية V1.0.7.3| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| OpenFDA Labels | CC0 | Contraindication and warning text from FDA labels | ~4,500 | ✓ | ✓ |
| OnSIDES | MIT | Contraindication data derived from FDA drug labels via NLP | 1,412 | ✓ | ✓ |
| Pharmacological Knowledge | Facts | Standard contraindication reasons | 1,804 | ✓ | ✓ |
| LLM-Generated (DeepSeek) | Original | Patient-friendly mechanism explanations in EN + AR | 4,800 | ✓ | ✓ |
Maximum Daily Dose Reference
/ مرجع الجرعة اليومية القصوى V3.2| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| WHO DDD (via RxNorm) | CC0 / SRL 0 | Defined Daily Dose reference values | 18,973 | ✓ | ✓ |
| OpenFDA Dosing | CC0 | Maximum daily dose from FDA-approved labeling | 8,627 | ✓ | ✓ |
| LLM-Extracted MDD | Original | Dose limits extracted from FDA label text via LLM | ~3,000 | ✓ | ✓ |
Legal note: WHO DDD values obtained via RxNorm (NLM Source Restriction Level 0 = no additional restrictions). SafeRx does not redistribute the WHOCC electronic index or DDD hierarchy descriptions.
قيم DDD من منظمة الصحة العالمية تم الحصول عليها عبر RxNorm (مستوى تقييد المصدر 0 = بدون قيود إضافية).
Pregnancy Safety
/ سلامة الحمل V2.3.3| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| OpenFDA Pregnancy Labels | CC0 | PLLR category assignments and risk narrative | Primary | ✓ | ✓ |
| LactMed (NLM) | Public Domain | Pregnancy risk assessments | ~400 drugs | ✓ | ✓ |
| FDA Black Box Warnings | CC0 (US Gov) | Pregnancy-specific black box warning text | 850 | ✓ | ✓ |
| ACOG Guidelines | Guidelines | Obstetric risk categorization principles | Reference | ✓ | ✓ |
| MotherToBaby / OTIS | Educational | Teratology information for risk assessment | Reference | ✓ | ✓ |
Lactation Safety
/ سلامة الرضاعة V2.3.3| Source | License | Data Used | Count | Edu | Com |
|---|---|---|---|---|---|
| LactMed (NLM) | Public Domain | Breastfeeding drug compatibility data | Primary | ✓ | ✓ |
| FDA Labels | CC0 | Lactation section warnings from drug labeling | ~600 drugs | ✓ | ✓ |
| e-lactancia | CC BY-NC-SA | Lactation compatibility classifications (cross-reference only) | Reference | ✓ | ⚠ |
| InfantRisk Center | Published | Lactation risk categorization | Reference | ✓ | ✓ |
Legal note: e-lactancia (CC BY-NC-SA) is used for cross-reference validation only — factual compatibility classifications are not directly reproduced. The underlying medical facts about drug transfer into breast milk are non-copyrightable.
يُستخدم e-lactancia للتحقق المرجعي فقط — الحقائق الطبية حول انتقال الأدوية إلى حليب الأم غير محمية بحقوق النشر.
Comprehensive Legal Analysis
Educational Use
SafeRx is explicitly designed and operated as an educational informational tool — not a prescribing system. All data sources used are cleared for educational use under one or more of the following legal frameworks:
تم تصميم SafeRx صراحةً كأداة تعليمية معلوماتية — وليست نظام وصف طبي. جميع مصادر البيانات مسموح بها للاستخدام التعليمي.
- Open licenses (CC0, MIT, CC BY, ODbL) explicitly permit educational use without restriction
- Fair Use Doctrine (17 USC §107) — educational purpose, factual nature of pharmaceutical data, no market substitution effect
- Non-copyrightable facts — drug interactions, adverse effects, and dosing data are factual scientific knowledge (Feist v. Rural, 1991)
- CC BY-NC sources (e.g., e-lactancia) explicitly permit non-commercial educational use
Commercial Use
SafeRx's data pipeline has been systematically audited and cleaned for commercial licensing compliance.
تم تدقيق خط بيانات SafeRx بشكل منهجي وتنظيفه لضمان الامتثال للتراخيص التجارية.
Fully Commercial-Safe (95%+ of all data)
CC0 / Public Domain: OpenFDA, FAERS, RxNorm, LactMed, DailyMed, PubChem, NDF-RT, FDA Labels, WorldVista
MIT License: OnSIDES v3.1.0 (366,864 effects)
CC BY 4.0: FooDrugs Dataset (with attribution to IMDEA Food Institute)
Original SafeRx: All LLM-generated text, pharmacology templates, clinical curation
Standard Pharmaceutical Language (not creative expression)
Drug interaction mechanism descriptions (e.g., “CYP3A4 inhibition increases plasma levels”) are standard pharmacological vocabulary used identically across FDA labels, Goodman & Gilman’s, Stockley’s Drug Interactions, and thousands of clinical papers. These descriptions are factual in nature and do not constitute copyrightable creative expression.
Pharmacological Knowledge (non-copyrightable facts)
Entries attributed to “pharmacological knowledge” describe established medical facts — the pharmacological properties of drugs, their receptor binding profiles, enzyme metabolism pathways, and clinical effects. Under Feist Publications v. Rural Telephone (1991), facts are not copyrightable regardless of the effort required to discover them: “That there can be no valid copyright in facts is universally understood.”
WHO ATC Codes YELLOW — Monitored
ATC classification codes are used as internal mapping keys, sourced via RxNorm (NLM Source Restriction Level 0). Zero enforcement by WHO/WHOCC in 50+ years of the ATC system’s existence. Industry-wide commercial use by Epic, Cerner, IQVIA, DrugBank, and hundreds of others without WHOCC licenses. WHO’s own comparable classifications (ICD-11, ICF, ICHI) are licensed under CC BY-ND 3.0 IGO which explicitly permits commercial use.
Disclaimer: This page is provided for informational and compliance documentation purposes only. It does not constitute legal advice. For licensing decisions affecting commercial deployment, consult qualified legal counsel.
SafeRx is an educational informational tool and is not affiliated with, endorsed by, or officially connected to any of the data providers listed on this page. All data has been independently processed, curated, and adapted for the Egyptian pharmaceutical market.
هذه الصفحة مقدمة لأغراض التوثيق المعلوماتي والامتثال فقط. لا تشكل استشارة قانونية. للقرارات المتعلقة بالترخيص التجاري، استشر مستشاراً قانونياً مؤهلاً. SafeRx أداة تعليمية معلوماتية وليست تابعة لأي من مزودي البيانات المذكورين في هذه الصفحة أو معتمدة منهم. تمت معالجة جميع البيانات بشكل مستقل وتكييفها للسوق الصيدلاني المصري.