Analysis of impact of life style, socio-economic factorsand health status on the use of medicines in pregnancy

Uvod i ciljevi. Upotreba lekova u trudnoći čest je razlog brige lekara koji ih propisuju i trudnica koje ih koriste. Iako bi bilo veoma korisno poznavati rizične populacije trudnica koje imaju veću verovatnoću upotrebe lekova u toku trudnoće, mali je broj studija koje su se bavile istraživanjima u ovoj oblasti. Uloga i doprinos farmaceuta u procesu izdavanja ili prodaje lekova trudnicama mogu biti ključni za bezbednu primenu lekova u trudnoći. Cilj disertacije bio je da se istraži upotreba lekova u periodu od šest meseci pre i tokom trudnoće, da se izvrši evaluacija upotrebljenih lekova prema anatomsko-terapijsko-hemijskoj (ATC) klasifikaciji, prema riziku za plod i režimu izdavanja (na recept i bez recepta (samomedikacija)), zatim, da se ispita da li postoji povezanost između faktora životnog stila, socio-ekonomskih faktora i zdravstvenog stanja ispitanica i upotrebe lekova pre i tokom trudnoće, kao i da se ispita na koji način pomenuti faktori utiču na upotrebu navedenih klasa lekova. Cilj je bio i da se ispita potencijalni doprinos farmaceuta kod upotrebe lekova u trudnoći. Metode istraživanja. Radi postizanja postavljenih ciljeva sprovedene su dve studije. Prva studija bila je multi-centrična i sprovedena je u šest domova zdravlja i pet apoteka na teritoriji opština Vračar, Voždovac, Lazarevac, Loznica, Čačak i Subotica, u periodu mart 2009 – mart 2010. Prikupljanje podataka sprovedeno je upitnikom specijalno dizajniranim za potrebe studije. Trudnice su upitnik popunjavale samostalno, bez pomoći zdravstvenih radnika, anonimno, dobrovoljno i volonterski. Prikupljeni su podaci o socio-ekonomskim karakteristikama, životnom stilu i zdravstvenom statusu ispitanica, kao i o upotrebi lekova u periodu od šest meseci pre i tokom trudnoće. Radi klasifikovanja lekova prema riziku za plod korišćena je klasifikacija američke Agencije za hranu i lekove (Food and Drug Administration - FDA). Upotreba lekova izražavana je kao proporcija žena izložena leku ili ATC grupi ili podgrupi lekova. Razlike u upotrebi lekova između različitih grupa analizirane su upotrebom McNemar-ovog testa. Univarijantna i multivarijantna logistička regresija korišćene su da bi se odredili faktori značajno povezani sa upotrebom lekova. Kao mere povezanosti između faktora i upotrebe lekova korišćeni su direktni odnos šansi (odds ratio – OR) i korigovan odnos šansi (adjusted odds ratio – aOR) uz prikazivanje 95% intervala pouzdanosti (confidence intervals - CI)...Background and Aims. Drug use in pregnancy is often a reason of concern for mothers and their physicians. However, only few studies investigated predictors of drug use in pregnancy. The role and contribution of pharmacists in the process of drug dispensing could be very important for improvement of safe drug use in pregnancy. The aim of dissertation was to investigate prescription and over the counter drug use among Serbian women in the 6 months before pregnancy and in the first 6 months of pregnancy, and to evaluate the drugs used according to anatomical-therapeutic-chemical classification, according to the risk for the fetus and according to dispensing status (proscription (Rx) or over-thecounter (OTC)). The aim was also to examine if a significant association between socio-economic factors, life style and health status of women and drug use exist, as well as to investigate how much these factors impact drug use before and during pregnancy. Finally, the aim was to investigate a potential contribution of pharmacist in safe drug use in pregnancy. Methodology. Two studies were carried out in order to gain all the aims. The first study was multi-center and performed in the six maternity care units and five community pharmacies (municipalities: Vračar, Voždovac, Lazarevac, Loznica, Čačak i Subotica) during the period from March 2009–March 2010. A selfreporting questionnaire was used as a data source. Participation in the study was voluntarily and anonymous. Data according to socio-economic characteristics, life style, health status and drug use six months before and during pregnancy were collected. Food and Drug Administration (FDA) risk classification system was used to determine the risk of used drugs for the fetus. Proportion of women exposed to drugs or class of drugs. Differences between subgroups were assessed using McNemar’s test on paired proportions. Logistic regression was used to identify factors associated with medication use. Adjusted odds ratios (aOR) and 95 % confidence intervals (CI) were used as association measures. Data analysis was performed using SPSS software package (SPSS 18.0 for Windows, SPSS Inc., Chicago, IL, USA). The study was performed after obtaining approval from The Board of Management and The Human Research Ethics Committee..