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Drug Availability Reporting and Expectations Drug Availability Reporting and Expectations

Drug Availability Reporting and Expectations - PowerPoint Presentation

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Uploaded On 2023-11-04

Drug Availability Reporting and Expectations - PPT Presentation

iDare Melanie Singh Problem 2022 ended with 295 active drug shortages Although measures to mitigate drug shortages exist no tools exist to accurately predict drug shortages AI can be used to evaluate trends and predict drug shortages for implementation of protective measures ID: 1028359

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1. Drug Availability Reporting and Expectations (iDare)Melanie Singh

2. Problem2022 ended with 295 active drug shortagesAlthough measures to mitigate drug shortages exist, no tools exist to accurately predict drug shortagesAI can be used to evaluate trends and predict drug shortages for implementation of protective measuresReasons for Shortages“Drug Shortages Statistics.” ASHP, https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics?loginreturnUrl=SSOCheckOnly.

3. Role of Drug Supply Chain Shukar, Sundus, et al. “Drug Shortage: Causes, Impact, and Mitigation Strategies.” Frontiers in Pharmacology, vol. 12, 2021, https://doi.org/10.3389/fphar.2021.693426.

4. Data Accessible to FDA from Drug Supply ChainInventory/Production Data and Supply InterruptionsInventory/Supply Interruptions and Purchase/Sale RecordsSales/Market DataDrug Shortages Strategic Plan 2013 - Food and Drug Administration. https://www.fda.gov/media/86907/download.

5. FDA 2022 Focus Areas of Regulatory ScienceStrategic Initiative 1: Public Health Preparedness and ResponseMedical Countermeasures and Preparedness for Emerging Infectious DiseasesQuality of Compounded Drugs Strategic Initiative 3: Unleashing the Power of Data Artificial Intelligence Use of Real-World Evidence to Support Medical Product Development and Regulatory Decision-Making2022 Advancing Regulatory Science at FDA. https://www.fda.gov/media/161381/download.

6. FDA 2022 Cross Cutting Topics: Lifecycle of FDA-Regulated Products2022 Advancing Regulatory Science at FDA. https://www.fda.gov/media/161381/download.

7. Use AI to Analyze a Multitude of Data from Diverse Disciplines Factors that Affect Drug ShortagesEpidemiological factorsSupply and DemandBusiness DecisionsOpen-source databases available through organizations such as the CDC and WHO Stocks, quarterly reports, and drug priceRequired and voluntary submitted records to FDA

8. Use of AI to Predict Drugs Shortages Factors that Affect Drug ShortagesEpidemiological factorsSupply and DemandBusiness DecisionsEstablish trends to predict prevalence of ailmentsPredict volatility of drugs based on established trendsPredict ability of wholesalers and suppliers to meet expected pharmaceutical demand

9. Translating to Practice Develop a method to weigh the intensity of diverse factors which drive drug shortagesEstablish a ranking system to determine drugs susceptible to shortagesInvestigate cause to determine solution for minimize disruption