ADS Capstone Chronicles Revised

‭2‬

‭1 Introduction‬ ‭Adverse‬ ‭reactions‬ ‭to‬ ‭pharmaceutical‬ ‭drugs‬ ‭are‬ ‭a‬‭growing‬‭public‬‭health‬‭issue.‬‭There‬‭are‬ ‭many‬ ‭aspects‬ ‭to‬ ‭consider‬ ‭when‬ ‭deciding‬ ‭to‬ ‭take‬ ‭a‬ ‭new‬ ‭drug‬ ‭and‬ ‭the‬ ‭potential‬ ‭for‬ ‭harmful‬ ‭side‬ ‭effects.‬ ‭Consumers‬ ‭may‬ ‭lack‬ ‭the‬‭information‬‭necessary‬‭to‬‭make‬‭informed‬ ‭decisions‬ ‭and‬ ‭can‬ ‭be‬ ‭influenced‬ ‭by‬ ‭the‬ ‭business‬ ‭agenda‬ ‭of‬ ‭doctors,‬ ‭health‬ ‭insurance,‬ ‭and‬ ‭pharmaceutical‬ ‭companies.‬ ‭Historically,‬‭there‬‭is‬‭a‬‭lot‬‭of‬‭ambiguity‬‭about‬ ‭the‬‭adverse‬‭effects‬‭of‬‭drugs‬‭because‬‭clinical‬ ‭trial‬ ‭research‬ ‭often‬ ‭has‬ ‭bias,‬ ‭small‬ ‭sample‬ ‭sizes,‬ ‭and‬ ‭thus‬ ‭cannot‬ ‭account‬ ‭for‬ ‭nuanced‬ ‭individual‬ ‭differences‬ ‭related‬ ‭to‬‭side‬‭effects‬ ‭(Galeano & Paccanaro, 2022).‬ ‭This‬ ‭project‬ ‭compiles‬ ‭various‬ ‭sources‬ ‭of‬ ‭drug‬‭information‬‭from‬‭government‬‭agencies‬ ‭and‬ ‭academic‬ ‭repositories‬ ‭to‬ ‭create‬ ‭user-friendly‬ ‭applications‬ ‭of‬ ‭drug-related‬ ‭data.‬‭Individuals‬‭can‬‭benefit‬‭from‬‭a‬‭resource‬ ‭that‬‭displays‬‭information‬‭about‬‭the‬‭potential‬ ‭of‬ ‭an‬ ‭adverse‬ ‭reaction‬ ‭from‬ ‭specific‬ ‭drugs,‬ ‭including‬ ‭the‬ ‭compound,‬ ‭price,‬ ‭and‬ ‭demographics‬ ‭of‬ ‭the‬‭patient‬‭in‬‭question.‬‭By‬ ‭modeling‬ ‭risk‬ ‭for‬ ‭adverse‬ ‭effects‬ ‭through‬ ‭assessment‬ ‭of‬ ‭drug‬ ‭composition‬ ‭and‬ ‭historical‬‭ADR‬‭data,‬‭users‬‭can‬‭assess‬‭patient‬ ‭risk‬ ‭for‬ ‭certain‬ ‭drugs‬ ‭in‬ ‭a‬ ‭comprehensive,‬ ‭precise, automated application.‬ ‭2 Background‬ ‭According‬ ‭to‬ ‭the‬ ‭Centers‬ ‭for‬ ‭Disease‬ ‭Control‬ ‭and‬ ‭Prevention‬ ‭(CDC),‬ ‭48.6%‬ ‭of‬ ‭Americans‬ ‭have‬ ‭used‬ ‭prescription‬ ‭drugs‬ ‭in‬ ‭the‬ ‭past‬ ‭30‬ ‭days‬ ‭(CDC,‬ ‭2023).‬ ‭The‬ ‭pharmaceutical‬ ‭drug‬ ‭industry‬ ‭made‬ ‭almost‬ ‭900‬ ‭billion‬ ‭dollars‬ ‭in‬ ‭2022‬ ‭and‬ ‭is‬ ‭expected‬ ‭to‬ ‭grow‬ ‭5.36%‬ ‭year-over-year‬ ‭from‬ ‭now‬ ‭until‬ ‭2030,‬ ‭gaining‬ ‭another‬ ‭4‬ ‭billion‬ ‭in‬ ‭profits‬ ‭(1.3‬ ‭trillion‬ ‭dollars)‬ ‭with‬ ‭the‬ ‭advancements‬ ‭of‬ ‭AI‬ ‭in‬ ‭drug‬ ‭manufacturing‬ ‭and‬ ‭research‬ ‭(Yahoo‬ ‭Finance,‬ ‭2024).‬ ‭The‬ ‭pharmaceutical‬ ‭industry‬ ‭has‬ ‭a‬ ‭history‬ ‭of‬ ‭underreporting‬‭adverse‬‭events‬‭due‬‭to‬‭bias‬‭in‬

‭clinical‬ ‭trial‬ ‭research,‬ ‭mislabeling‬ ‭drugs‬ ‭or‬ ‭misleading‬ ‭marketing‬ ‭to‬ ‭gain‬ ‭market‬ ‭share,‬ ‭promoting‬‭off-label‬‭uses‬‭of‬‭drugs‬‭to‬‭increase‬ ‭profits,‬ ‭and‬ ‭using‬ ‭financial‬ ‭coercion‬ ‭by‬ ‭giving‬ ‭healthcare‬ ‭providers‬ ‭attractive‬ ‭kick-backs‬‭for‬‭prescriptions‬‭(Pharmaceutical‬ ‭Technology,‬ ‭2019).‬ ‭This‬ ‭history‬ ‭highlights‬ ‭the‬ ‭financial‬ ‭priorities‬‭of‬‭the‬‭industry‬‭rather‬ ‭than patient safety.‬ ‭Pharmaceutical‬ ‭manufacturers‬ ‭have‬ ‭out-priced‬ ‭rates‬ ‭of‬ ‭inflation‬ ‭year-over-year‬ ‭since‬ ‭the‬ ‭start‬ ‭of‬ ‭the‬ ‭global‬ ‭COVID‬ ‭pandemic‬ ‭(U.S.‬ ‭Department‬ ‭of‬ ‭Health‬ ‭and‬ ‭Human‬ ‭Services‬ ‭[HHS],‬ ‭2023).‬ ‭To‬‭ease‬‭the‬ ‭financial‬ ‭burden‬ ‭of‬ ‭drug‬ ‭costs,‬ ‭the‬ ‭Biden‬ ‭administration‬ ‭passed‬ ‭the‬ ‭Inflation‬ ‭Reduction‬ ‭Act‬ ‭in‬ ‭2022‬ ‭(HHS,‬ ‭2024)‬ ‭which‬ ‭requires‬ ‭pharmaceutical‬ ‭manufacturers‬ ‭to‬ ‭reimburse‬ ‭Federal‬ ‭agencies‬ ‭for‬ ‭drug‬ ‭costs‬ ‭higher‬ ‭than‬ ‭the‬ ‭rate‬‭of‬‭inflation.‬‭The‬‭efforts‬ ‭of‬ ‭the‬ ‭government‬ ‭highlight‬ ‭the‬ ‭need‬ ‭for‬ ‭pharmaceutical‬‭drug‬‭regulation.‬‭An‬‭analysis‬ ‭by‬ ‭the‬ ‭FDA‬ ‭shows‬ ‭that‬ ‭generic‬ ‭drug‬ ‭production‬‭increases‬‭competition‬‭for‬‭market‬ ‭share‬ ‭which‬ ‭leads‬ ‭to‬ ‭lower‬ ‭drug‬ ‭costs‬ ‭overall‬ ‭for‬ ‭consumers‬‭(FDA,‬‭2023a).‬‭Given‬ ‭the‬ ‭influence‬ ‭of‬ ‭this‬ ‭industry‬ ‭on‬ ‭consumer‬ ‭health‬ ‭and‬ ‭finances,‬ ‭adverse‬ ‭events‬ ‭that‬ ‭result‬ ‭from‬ ‭taking‬ ‭pharmaceutical‬‭drugs‬‭are‬ ‭a‬ ‭public‬ ‭health‬ ‭concern‬ ‭and‬ ‭burden,‬ ‭especially as the industry continues to grow.‬ ‭Adverse‬ ‭reactions‬ ‭and‬ ‭high‬ ‭drug‬ ‭prices‬ ‭affect‬ ‭vulnerable‬ ‭populations‬ ‭like‬ ‭the‬ ‭elderly,‬ ‭people‬ ‭with‬ ‭chronic‬ ‭or‬ ‭terminal‬ ‭illnesses,‬ ‭and‬ ‭low-income‬ ‭families.‬ ‭If‬ ‭a‬ ‭patient‬ ‭pays‬ ‭a‬ ‭high‬ ‭cost‬ ‭for‬ ‭prescriptions,‬ ‭and‬ ‭then‬ ‭suffers‬ ‭from‬ ‭an‬ ‭adverse‬ ‭reaction‬ ‭which‬‭requires‬‭additional‬‭medical‬‭treatment,‬ ‭the‬ ‭additive‬ ‭burden‬ ‭for‬ ‭people‬ ‭impacts‬ ‭not‬ ‭only‬ ‭physical‬ ‭health,‬ ‭but‬ ‭also‬ ‭financial‬ ‭stability‬ ‭and‬ ‭mental‬ ‭health.‬ ‭Since‬ ‭1968,‬‭the‬ ‭FDA‬ ‭has‬ ‭been‬ ‭collecting‬ ‭reports‬‭of‬‭adverse‬ ‭drug‬ ‭events‬ ‭from‬ ‭the‬ ‭public‬ ‭to‬ ‭increase‬ ‭pharmaceutical‬ ‭manufacturer‬ ‭accountability‬

152

Made with FlippingBook - Online Brochure Maker