ADS Capstone Chronicles Revised

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‭to‬‭grow,‬‭particularly‬‭for‬‭the‬‭growing‬‭elderly‬ ‭population‬ ‭who‬ ‭use‬ ‭Medicare‬ ‭and‬ ‭low-income‬ ‭families‬ ‭who‬ ‭use‬ ‭Medicaid‬ ‭(HHS,‬ ‭2022).‬ ‭The‬ ‭concern‬ ‭of‬ ‭adverse‬ ‭reactions‬‭is‬‭compounded‬‭by‬‭increasing‬‭costs‬ ‭of‬ ‭drugs‬ ‭(HHS,‬ ‭2023).‬ ‭Tools‬ ‭are‬ ‭needed‬ ‭to‬ ‭identify‬ ‭patient‬ ‭risk‬ ‭of‬ ‭adverse‬ ‭drug‬ ‭reactions,‬ ‭through‬ ‭the‬ ‭lens‬ ‭of‬ ‭precision‬ ‭seeks‬ ‭increase‬ ‭pharmaceutical‬ ‭accountability,‬ ‭increase‬‭data‬ ‭accessibility,‬ ‭and‬ ‭increase‬ ‭model‬ ‭applicability‬ ‭and‬ ‭interpretability.‬ ‭These‬ ‭overarching‬ ‭objectives‬ ‭will‬ ‭guide‬ ‭the‬ ‭data‬ ‭science‬ ‭workflow‬ ‭to‬ ‭produce‬ ‭useful‬ ‭deliverables‬ ‭and‬ ‭tools‬ ‭for‬ ‭consumers‬ ‭and‬ ‭developers.‬ ‭The‬ ‭USA’s‬ ‭free-market‬ ‭economy‬ ‭creates‬ ‭a‬ ‭unique‬ ‭situation‬ ‭where‬ ‭pharmaceutical‬ ‭companies‬ ‭are‬ ‭gate-keepers‬ ‭to‬ ‭human‬ ‭survival.‬ ‭Drug‬ ‭information‬ ‭is‬ ‭portrayed‬ ‭to‬ ‭the‬ ‭public‬ ‭via‬ ‭advertising‬ ‭which‬ ‭can‬ ‭be‬ ‭unrealistic‬ ‭and‬ ‭does‬ ‭not‬ ‭give‬ ‭people‬ ‭a‬ ‭comprehensive‬ ‭set‬ ‭of‬ ‭factors‬ ‭to‬ ‭assess.‬ ‭The‬ ‭creation‬ ‭of‬ ‭high-quality‬ ‭systems‬ ‭that‬ ‭integrate‬ ‭and‬ ‭track‬ ‭adverse‬ ‭events‬ ‭to‬ ‭pharmaceutical‬ ‭drugs‬ ‭holds‬ ‭drug‬ ‭manufacturers‬ ‭accountable‬ ‭for‬ ‭safe‬ ‭and‬ ‭accurate‬ ‭reporting,‬ ‭and‬ ‭therefore‬ ‭protects‬ ‭vulnerable‬ ‭populations.‬ ‭This‬ ‭project‬ ‭increases‬ ‭pharmaceutical‬ ‭accountability‬ ‭by‬ ‭analyzing‬ ‭data‬ ‭and‬ ‭revealing‬ ‭relevant‬ ‭insights.‬ ‭The‬‭data‬‭sources‬‭that‬‭hold‬‭information‬‭about‬ ‭pharmaceutical‬ ‭drugs‬ ‭are‬ ‭scattered,‬ ‭and‬ ‭although‬ ‭they‬ ‭are‬ ‭public,‬ ‭they‬ ‭are‬ ‭not‬ ‭in‬ ‭a‬ ‭format‬ ‭that‬ ‭is‬ ‭understood‬ ‭by‬ ‭the‬ ‭general‬ ‭population.‬ ‭Thus,‬ ‭the‬ ‭data‬ ‭needed‬ ‭to‬ ‭make‬ ‭informed‬ ‭decisions‬ ‭about‬ ‭drug‬ ‭side‬ ‭effects‬ ‭needs‬ ‭to‬ ‭be‬ ‭processed‬ ‭and‬ ‭packaged‬ ‭in‬ ‭an‬ ‭accessible‬ ‭form.‬ ‭This‬ ‭project‬ ‭will‬ ‭increase‬ ‭data‬ ‭accessibility‬ ‭by‬ ‭creating‬ ‭a‬ ‭public‬ ‭to‬ ‭public health.‬ ‭2.2 Objectives‬ ‭This‬ ‭project‬

‭application‬ ‭for‬ ‭ADR‬ ‭outcome‬ ‭and‬ ‭a‬ ‭public‬ ‭dashboard‬ ‭of‬ ‭graphical‬ ‭information.‬ ‭The‬ ‭code‬ ‭workflow‬ ‭is‬ ‭also‬ ‭publicly‬ ‭available‬ ‭in‬ ‭GitHub to increase reproducibility.‬ ‭Adverse‬ ‭reactions‬ ‭to‬ ‭pharmaceutical‬ ‭drugs‬ ‭are‬ ‭complex‬ ‭problems‬ ‭and‬ ‭all‬ ‭individual‬ ‭differences‬ ‭cannot‬ ‭be‬ ‭assessed‬ ‭during‬ ‭clinical‬ ‭trial‬ ‭phases.‬ ‭Assessment‬ ‭for‬ ‭risk‬ ‭factors‬‭and‬‭side‬‭effects‬‭goes‬‭beyond‬‭just‬‭the‬ ‭chemical‬‭composition‬‭of‬‭drugs.‬‭This‬‭project‬ ‭will‬ ‭expand‬ ‭upon‬ ‭work‬ ‭done‬ ‭by‬ ‭others‬ ‭to‬ ‭take‬‭a‬‭step‬‭towards‬‭a‬‭precision‬‭public‬‭health‬ ‭model‬ ‭of‬ ‭adverse‬ ‭drug‬ ‭reactions.‬ ‭This‬ ‭project‬‭will‬‭increase‬‭model‬‭applicability‬‭and‬ ‭interpretability‬ ‭by‬ ‭including‬ ‭economic‬ ‭variables‬ ‭like‬ ‭drug‬ ‭prices‬ ‭and‬ ‭individual‬ ‭differences‬‭like‬‭age,‬‭sex,‬‭and‬‭weight‬‭into‬‭the‬ ‭probability of adverse outcomes.‬ ‭3 Literature Review‬ ‭Since‬ ‭the‬ ‭inception‬ ‭of‬ ‭the‬ ‭FAERS,‬ ‭many‬ ‭tools‬ ‭have‬ ‭been‬ ‭created‬ ‭to‬ ‭increase‬ ‭accessibility‬ ‭of‬ ‭information‬ ‭for‬ ‭the‬ ‭general‬ ‭public.‬ ‭In‬ ‭2017,‬ ‭the‬ ‭FAERS‬ ‭dashboard‬‭was‬ ‭deployed‬ ‭to‬ ‭allow‬ ‭people‬ ‭to‬ ‭search‬‭through‬ ‭aggregated‬ ‭statistics‬ ‭of‬ ‭the‬ ‭adverse‬ ‭drug‬ ‭reaction‬‭(ADR)‬‭data‬‭(FDA,‬‭2023b).‬‭This‬‭is‬‭a‬ ‭useful‬ ‭tool‬ ‭for‬ ‭broad‬ ‭trends‬ ‭in‬ ‭the‬‭data,‬‭but‬ ‭other‬‭factors‬‭are‬‭important‬‭to‬‭consider‬‭when‬ ‭evaluating‬ ‭pharmaceutical‬ ‭products.‬ ‭The‬ ‭dashboard‬ ‭does‬ ‭not‬ ‭display‬ ‭all‬ ‭of‬ ‭the‬ ‭available‬ ‭data‬ ‭in‬ ‭the‬ ‭FAERS‬ ‭database‬ ‭that‬ ‭could‬‭be‬‭of‬‭interest.‬‭The‬‭National‬‭Library‬‭of‬ ‭Medicine‬‭created‬‭a‬‭website‬‭called‬‭DailyMed‬ ‭which‬ ‭displays‬ ‭drug‬ ‭label‬ ‭information‬‭from‬ ‭the‬ ‭FDA,‬ ‭but‬ ‭this‬ ‭source‬ ‭is‬ ‭also‬ ‭limited‬ ‭to‬ ‭one‬‭type‬‭of‬‭information‬‭(National‬‭Library‬‭of‬ ‭Medicine,‬ ‭n.d.).‬ ‭Because‬ ‭each‬ ‭of‬ ‭these‬ ‭sources‬ ‭offers‬ ‭a‬ ‭narrow‬ ‭perspective,‬ ‭combining‬ ‭sources‬ ‭of‬ ‭drug‬ ‭information‬ ‭can‬ ‭increase‬‭data‬‭quality‬‭and‬‭insights.‬‭Modeling‬ ‭FAERS‬ ‭data‬ ‭can‬ ‭be‬ ‭improved‬ ‭by‬ ‭sourcing‬ ‭information‬ ‭about‬ ‭chemical‬ ‭compounds‬ ‭(DrugBank,‬ ‭2024;‬ ‭National‬ ‭Center‬ ‭for‬ ‭Biotechnology‬ ‭Information‬ ‭[NCBI],‬ ‭2024),‬

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