Digitalni lijekovi

master's thesis

• Title (english): Digital medications
• Author: Elizabeta Paar
• Mentor: Mario Jug (mentor)
• Committee member: Mario Jug (predsjednik povjerenstva)
• Committee member: Anita Hafner (član povjerenstva)
• Committee member: Maja Ortner Hadžiabdić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2021-09-10, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Mentalne bolesti vodeći su globalni uzročnici morbiditeta i mortaliteta. Farmakološka terapija predstavlja temelj liječenja mentalnih bolesti, a adherencija na lijekove u njihovom slučaju izuzetno je važna zbog dugotrajnog liječenja i ozbiljnih posljedica ako se liječenje prijevremeno prekine. Shizofrenija je kompleksna kronična mentalna bolest koja se liječi antipsihoticima. Namjerna i nenamjerna neadherencija na antipsihotike predstavlja glavni problem u liječenju shizofrenije, koja se javlja zbog ozbiljnih nuspojava antipsihotika i zbog toga što bolesnik nije svjestan bolesti. Prvi odobreni digitalni lijek Abilify MyCite sadrži antipsihotik aripiprazol kao djelatnu tvar. Radi se o sustavu digitalne medicine koji uključuje tabletu sa probavljivim senzorom i djelatnom tvari, nosivi flaster, aplikaciju na pametnom telefonu i mrežni portal. Radi na principu prijenosa digitalnog signala sa senzora na nosivi flaster u trenutku kada senzor dođe u kontakt sa želučanom tekućinom. Podatci o primjeni lijeka, ali i drugi podatci o zdravstvenim i životnim navikama na mrežnom portalu dostupni su liječniku i osobama kojima bolesnik odobri pristup. Još jedan digitalni sustav koji se istražuje je ID-Cap sustav sa senzorom ugrađenim u kapsulu. Radi na principu prijenosa radio signala niskog inteziteta na uređaj za očitavanje u trenutku kada kapsula dođe u kontakt sa želučanom tekućinom. AiCure je sustav vizualnog prepoznavanja koji snima video i temelji se na analizi slike lica s ciljem provjere je li bolesnik uzeo propisan lijek. Sustavi digitalne medicine razvijeni su s ciljem poboljšanja adherencije što rezultira boljim zdravstvenim ishodima i smanjenim troškovima zdravstvene skrbi. Međutim, do sada nema kliničkih dokaza da digitalni lijekovi mogu dosljedno pratiti ingestiju u stvarnom vremenu ili poboljšati adherenciju. Zbog toga se postavlja pitanje je li pri odobrenju Abilify MyCite primijenjena evergrin strategija za produljenje roka trajanja lijeka Abilify. Nadalje, digitalne lijekove prate brojni etički problemi kao što su negativni utjecaj na autonomiju i privatnost bolesnika, subjektivni osjećaj prisile i kontrole, narušeno povjerenje u odnosu između liječnika i bolesnika i utjecaj farmaceutskih kompanija na liječnika. Napravljena je usporedba digitalnih lijekova s ostalim konvencionalnim i inovativnim terapijskim sustavima. Dok su digitalni lijekovi osmišljeni primarno s ciljem svakodnevnog praćenja ponašanja prilikom uzimanja lijekova, ostali inovativni terapijski sustavi osmišljeni su s ciljem poboljšanja svojstava i isporuke lijekova što posljedično dovodi do poboljšanja adherencije. Potrebno je provesti klinička istraživanja s naglaskom na procjenu adherencije i kvalitete života bolesnika koji uzimaju digitalne lijekove i educirati liječnike i bolesnike o inovativnim terapijskim sustavima.

Abstract (english)

Mental disorders are the leading global cause of mortality and morbidity. Pharmacological therapy represents the basis for treatment of mental disorders and medication adherence is in their case extremely important due to long-term treatment and serious consequences if the treatment is stopped prematurely. Schizophrenia is a complex chronic mental illness that is treated with antipsychotics. Intentional and unintentional non-adherence to antipsychotics is the main problem in treatment of schizophrenia, which occurs due to the serious side effects of antipsychotics and because the patient is unaware of the illness. The first approved digital medication Abilify MyCite contains the antipsychotic aripiprazole as the active substance. It represents the digital medicine system which contains a tablet with an ingestible sensor and active substance, a wearable patch, an application on a smartphone and a web portal. It works on the principle of transmitting the digital signal from the sensor to the wearable patch in the moment when the sensor comes into contact with gastric fluid. Data on drug ingestion, as well as other data on health and life habits on the web portal are available to the doctor and other individuals, to whom the patient grants access. Another digital system in research is the ID-Cap system, with a sensor built in the capsule. It works on the principle of transmitting a low-intensity radio signal to a reading device when the capsule comes into contact with gastric fluid. AiCure is a visual recognition system which records video and is based on facial image analysis to verify that the patient has taken the prescribed medication. Digital medicine systems have been developed with the explanation for improving adherence which results in better health outcomes and reduced healthcare costs. However, there is no clinical evidence which suggest that digital medications can consistently monitor medication ingestion in real time or improve adherence. Therefore, the question arises as to whether the Abilify MyCite approval has used evergreening to extend the lifetime of the medication Abilify. Furthermore, digital medications are accompanied by several ethical issues such as the negative impact on patient autonomy and privacy, the subjective feeling of coercion and control, the disturbed trust in the relationship between doctor and patient and the impact of pharmaceutical companies on doctor. The comparison of digital medications with other conventional and innovative therapeutic systems was made. While the digital medications are primarily designed to monitor medication-related behaviour on a daily basis, other innovative therapeutic system are designed to improve drug properties and delivery, which in turn can lead to improved adherence. Clinical research should be conducted with an emphasis on assessing the adherence and quality of life of patients who take digital medications, and doctors and patients should be educated about innovative therapeutic systems.

• Keywords: digitalni lijek; inovativni terapijski sustav; senzor; adherencija; antipsihotik
• Keywords (english): digital medication; innovative therapeutic system; sensor; adherence; antipsychotic
• Language: croatian
• URN:NBN: urn:nbn:hr:163:023252
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2023-09-10
• Created on: 2022-09-02 11:49:16