Procena znanja i stavova o farmakovigilanci u populaciji studenata zdravstvenih nauka u Vojvodini

Abstract

UVOD: Svetska zdravstvena organizacija definiše farmakovigilancu kao “skup aktivnosti koje se odnose na prikupljanje, otkrivanje, procenu, razumevanje i prevenciju neželjenih reakcija na lek, kao i drugih problema u vezi sa lekom”, a njen krajnji cilj je zaštita javnog zdravlja. Stvaranjem uslova za organizovano i sistematično praćenje potencijalnih neželjenih reakcija, farmakovigilanca predstavlja esencijalnu aktivnost u regulatornom sistemu lekova, omogućavajući ranu detekciju neočekivanih, odloženih i/ili teških neželjenih reakcija na sve preparate i sredstva koja se koriste u preventivnoj i kliničkoj medicini. Osim potpunijeg definisanja bezbednosnog profila leka, jedan od glavnih ciljeva postmarketinškog praćenja i prijavljivanja neželjenih reakcija na lekove (NRL) je i preciznije definisanje odnosa koristi i potencijalnih rizika primene nekog leka u praksi, što u krajnjoj meri uvek vodi ka unapređenju jednog od važnih aspekata javnog zdravlja – bezbednosti pacijenta u procesu lečenja. Edukacija o farmakovigilanci i pridružrnim aktivnostima su važne kompetencije koje studenti zdravstvenih nauka treba da usvoje pre nego što diplomiraju i počnu da se bave kliničkom praksom. Imajući to u vidu, cilj ove studije je bio da se primenom novorazvijenog i validiranog upitnika procene znanja i stavovi o farmakovigilanci u populaciji studenata zdravstvenih nauka u AP Vojvodini, Srbija. METODE: Od februara do jula 2021. godine je sprovedena opservaciona studija preseka među studentima medicine, stomatologije, farmacije i zdravstvene nege na tri fakulteta koji obrazuju buduće zdravstvene radnike u AP Vojvodini. Novorazvijeni trodelni Upitnik za procenu znanja i stavova o farmakovigilanci za studente zdravstvenih nauka, UPZSFV (I - Upitnik o sociodemografskim karakteristikama ispitanika, II - Test znanja o farmakovigilanci za studente zdravstvenih nauka, TZFV i III - Upitnik za procenu stavova studenata zdravstvenih nauka, USFV) je putem Google Forms platforme dobrovoljno i anonimno popunilo ukupno 242 studenata zdravstvenih nauka, od kojih je 211 ispunilo kriterijum za uključivanje u studiju. REZULTATI: Nakon sprovedene ajtem analize, šest pitanja je isključeno iz TZFV-a. Vrednost ordinalne alfe konačne verzije TZFV sa 14 ajtema je bila dobra (αord = 0,83), kao i ostali statistički pokazatelji pouzdanosti. Testiranje pouzdanosti USFV je takođe pokazalo odlične performanse ove sekcije upitnika: αord = 0,91, za obe USFV subskale. Prosečan ostvareni TZFV skor je iznosio M=9,14 (SD=2,65; Me=10), u opsegu 0-14.Testiranjem je utvrđeno da su svi ispitanici statistički značajno znali više od 50% tačnih odgovora u testu, a najviši prosečni ostvareni TZFV skor je registrovan kod studenata integrisanih studija medicine (M=9,96; SD=1,81; Me=10). Kada su u pitanju stavovi ispitanika o farmakovigilanci, prosečni skor dobijen na PSFV subskali koja se odnosi na opšti stav o farmakovigilanci je iznosio M=31,98 (SD=3,68; Me=33), u opsegu 7-35. Prosečan skor na PSNRL subskali koja se odnosi na spremnost ispitanika da učestvuju u aktivnostima farmakovigilance je iznosio M=43,12 (SD=10,63; Me=45), u opsegu 13-65. Najviši PSFV skor su ostvarili studenti osnovnih akademskih studija zdravstvene nege (M=32,84; SD=2,59; Me=34), dok je najviši PSNRL skor registrovan među studentima integrisanih studija medicine (M=46,69; SD=8,03; Me=47,5). ZAKLJUČCI: Razvijen je i iscrpno statistički validiran prvi univerzalan, metodološki korektno i precizno osmišljen i naučno zasnovan upitnik sa dva psihometrijska instrumenta, koji se bez dodatnih prilagođavanja može koristiti za procenu znanja i stavova o farmakovigilanci kod studenata svih studijskih programa iz oblasti zdravstvenih nauka. Ispitanici u posmatranom uzorku su pokazali visok nivo znanja o farmakovigilanci, ostvarivši prosečni skor koji iznosi 65,29% od maksimalnog mogućeg. Istovremeno, istraživanjem je utvrđeno da u ispitivanoj populaciji preovlađuju vrlo pozitivni opšti stavovi prema farmakovigilanci, ali da ispitanici u proseku samo blago naginju pozitivnijim stavovima prema prijavljivanju neželjenih reakcija na lekove u budućoj praksi.

INTRODUCTION: Pharmacovigilance is defined by the World Health Organization as "a set of activities related to the collection, detection, assessment, understanding, and prevention of adverse drug reactions and other drug-related problems", with protecting public health as its ultimate goal. By creating conditions for organized and systematic monitoring of potential adverse reactions, pharmacovigilance is an essential activity in the regulatory system of drugs that allows early detection of unexpected, delayed, and/or severe adverse reactions to all preparations and agents used in preventive and clinical medicine. In addition to more fully defining the safety profile of a drug, one of the main goals of post-marketing monitoring and reporting of adverse drug reactions (ADRs) is to more precisely define the benefits and potential risks of a drug in practice, which ultimately leads to the improvement of one of the important aspects of public health - patient safety in the medical treatment process. Pharmacovigilance and related activities education are important competencies that healthcare sciences students should adopt before completing their studies and engaging in clinical practice. Considering this, the aim of this study was to assess pharmacovigilance knowledge and attitudes in a population of health sciences students in AP Vojvodina, Serbia, using a newly developed and validated questionnaire. METHODS: From February to July 2021, an observational cross-sectional study was conducted among students of medicine, dentistry, pharmacy, and nursing science at three faculties that educate future health professionals in Vojvodina. The newly developed three-part Questionnaire for Assessing Knowledge and Attitudes About Pharmacovigilance for Students of Healthcare Sciences, PVKAQ (I Demographic data section, II Pharmacovigilance Knowledge test, PVKT, and III Pharmacovigilance Attitude Questionnaire, PVAQ), was voluntarily and anonymously completed by a total of 242 health sciences students via the Google Forms platform, with 211 meeting the inclusion criteria for the study. RESULTS: After an item analysis, six questions were excluded from the PVKT. The final version of PVKT with 14 items had a good ordinal alpha value (αord = 0.83), as were other statistical indicators of reliability. PVAQ reliability testing also showed excellent performance of this section of the questionnaire: αord = 0.91 for both USFV subscales. The achieved average PVKT score was M = 9.14 (SD = 2.65; Me = 10), in the range of 0-14. Results of statistical testing showed that all respondents knew significantly more than 50% of the correct answers in the test, and the highest average PVKT score was achieved among students of integrated studies of medicine (M = 9.96; SD = 1.81; Me = 10). In contexts of respondents' attitudes toward pharmacovigilance, the average score on the PAPV subscale related to general attitude toward pharmacovigilance was M = 31.98 (SD = 3.68; Me = 33), in the range of 7–35. The average score on the PAADR subscale related to the willingness of the subjects to participate in pharmacovigilance activities was M = 43.12 (SD = 10.63; Me = 45), in the range of 13-65. The highest PAPV score was achieved by students of basic academic studies of nursing science (M = 32.84; SD = 2.59; Me = 34), while the highest PAADR score was registered among students of integrated studies of medicine (M = 46.69; SD = 8.03; Me = 47.5). CONCLUSIONS: The first universal, methodologically correct, precisely designed, and scientifically based questionnaire with two psychometric instruments was developed and thoroughly statistically validated, which can be used to assess knowledge and attitudes about pharmacovigilance among students from all healthcare sciences study programs without any additional adjustments. Respondents in the observed sample demonstrated a high level of pharmacovigilance knowledge, with an average score of 65.29% of the maximum possible. At the same time, the research found that very positive general attitudes towards pharmacovigilance prevailed in the examined population, but that respondents only slightly tended to have more positive attitudes toward reporting adverse drug reactions in future practice.