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..

Digitalne tehnologije koje menjaju farmaceutsku praksu ‐ ključne koristi i izazovi

The WHO defines eHealth as the use of information and communication technologies (ICT) for health, e.g. treating patients, research, educating the health workforce, tracking diseases and monitoring public health” (1). eHealth covers the interaction between patients and health-service providers, institution-to-institution transmission of data, or peer-to-peer communication between health professionals. Under the term e-health, the terms m-health (use of mobile ICT devices for health purposes) and telehealth (use of telecommunication technologies for health purposes) also appear. The pharmacy is developing in the fields of e- pharmacy and telepharmacy. Many pharmacists use eHealth tools on a daily basis, whether it is dispensing electronic prescriptions, checking for medication interactions, providing support for adherence etc. Community pharmacists acknowledge the potential of Big Data and Artificial Intelligence (AI) for European health systems and consider these technologies as a useful tool to support healthcare professionals. However, in daily practice at national level, these tools shall be always accompanied by pharmacists’ expert and professional advice, in order to improve therapy effectiveness and offering the highest standard of pharmacy services to its patients (2). The trend of digitalization, including the digital economy has accelerated the pace at which new technologies are transforming the healthcare sector. Adaptation of national regulations to the use of ICT for the purpose of patient health care, as well as harmonization with European regulations in this area is recognized as one of the future challenges that need to be successfully overcome on the way to even safer and more efficient pharmaceutical health care in pharmacies.Svetska zdravstvena organizacija (SZO) definisala je e-zdravlje kao upotrebu informacionih i komunikacionih tehnologija (IKT) za zdravlje ljudi, npr. lečenje pacijenata, istraživanje, obrazovanje zdravstvenih profesionalaca, praćenje bolesti i monitoring javnog zdravlja (1). E-zdravlje obuhvata interakciju između pacijenata i zdravstvenih profesionalaca, razmenu informacija između zdravstvenih institucija, kao i međusobnu komunikaciju zdravstvenih profesionalaca (2). U kontekstu upotrebe IKT, ali u nešto užem smislu, pojavljuju se i pojmovi m-zdravlje (upotreba mobilnih IKT uređaja u svrhu zdravlja) i telezdravlje (upotreba telekomunikacionih tehnologija u svrhu zdravlja). Oblast farmacije razvija se u pravcima e-farmacije i telefarmacije. U brojnim apotekama danas su prisutni mnogi elementi e-zdravlja počev od izdavanja e-recepata, provere interakcija među lekovima, pružanja podrške pacijentima radi unapređenja adherence pomoću aplikacija na mobilnim telefonima, i sl. Farmaceuti zajedno sa oslalim zdravstvenim profesionalcima, sagledavaju značaj i potencijal brojnih podataka (engl. Big data) i veštačke inteligencije za unapređenje zdravstvenog sistema i smatraju ove tehnologije korisnim alatom za podršku zdravstvenim profesionalcima. Međutim, smatra se takođe da u rutinskoj praksi na nacionalnom nivou, upotreba ovakvih alata uvek mora biti praćena stručnim savetima farmaceuta, kako bi se obezbedila efikasnost terapije, a pacijentima obezbedile farmaceutske usluge koje zadovoljavaju najviše standard (2). Globalni trendovi digitalizacije i prelazak na digitalnu ekonomiju veoma su ubrzali tempo kojim nove tehnologije transformišu i zdravstveni sektor. Prilagođavanje nacionalne regulative upotrebi IKT u svrhu zdravstvene zaštite pacijenata, kao i harmonizacija sa evropskom regulativom u ovoj oblasti prepoznaje se kao jedan od budućih izazova koji treba uspešno savladati na putu ka još bezbednijoj i efikasnijoj farmaceutskoj zdravstvenoj zaštiti pacijenata u apotekama.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Perceptions of pharmacists and other healthcare professionals on marketed mobile applications used for self-management by type 2 diabetic patients: A systematic review

Purpose: To determine the level of awareness, beliefs and experience of healthcare professionals (HCPs) regarding mobile applications for self-management of type 2 diabetes mellitus. Methods: This review was done by searching the literature using three databases viz: PubMed, Web of Science and Scopus. Assessment of quality of studies was carried out using the scale of the Agency for Healthcare Research and Quality. The results were presented in accordance with the PRISMA 2020 guidelines. Results: The search strategy identified 725 unique research papers, 4 of which were included. A survey among pharmacists showed that 56 % of participants were aware of the existence of mobile health applications, and that 60 % of those who were aware recommended their use. In the multi-HCPs setting, depending on the study, apps recommendation rate varied from 45.5 to 62 %. Most of the participants (88 %) agreed that a mobile app would help strengthen their treatment recommendations to the patients (88 %), and 84 % also agreed that it would help patients manage diabetes better. Conclusion: Not much research has been done on this topic. Available data suggest that the awareness of HCPs regarding mobile applications is unsatisfactory, and that those familiar with these apps find them useful and are ready to recommend them to patients. There is need for further research and measures to increase awareness and knowledge of HCPs about available mobile applications, in order to ensure adequate support to patients with diabetes

Razlike med Spoloma pri Kazalnikih Samozdravljenja s Pomirjevali in Zdravili za Spanje: Rezultati Populacijske Študije v Srbiji

Previous studies among the Serbian population concluded that the trend of self-medication with tranquillizers and sleeping pills requires deeper study. The objective is to identify gender differences in socio-demographic, health, and health service predictors of self-medication with tranquillizers and sleeping pills in a Serbian population of 15 years old and above. This was a population-based, cross-sectional study. Data was extracted from the most recently available results of the Serbian National Health Survey of 2013. Multivariate logistic regression was used to determine independent self-medication predictors. The study included 14,623 participants, of which 51.77% were female. While 5.6% of the females reported self-medication with tranquillizers and sleeping pills, only 2.2% of males reported such practice (p<0.001). The presence of chronic disease, stress, and physical pain in the last month before the interview was significantly associated with an increased likelihood of self-medication with observed drugs in both genders. Age was the most significant socio-demographic predictor of self-medication in females, while in males it was unemployment. Women of 55-65 years of age showed a greater risk from self-medication with tranquillizers and sleeping pills in comparison to women of 15-24 years of age (aOR=4.75, 95% CI: 1.83-12.33). Unemployed males showed a greater tendency for such practice in comparison to employed (aOR=1.86, 95% CI: 1.19-2.91). The findings highlighted predictors of self-medication with tranquillizers and sleeping pills and important differences between genders, which may contribute to the design of gender-sensitive surveillance, identification, and the prevention of such undesirable practices through evidence-based and appropriately tailored public health actions

Samomedikacija antibioticima među studentima sesrtinstva u Srbiji: pilot studija

Healthcare professionals should serve as promoters of ra-tional antibiotic use in attempt to decrease antibiotics misuse within the process of self-medication. Current pilot study was undertaken with the aim to identify potential predictors of self-medication with antibiotics (SMA) and to describe SMA practice among nursing students in Serbia. Data have been collected dur-ing the period March-May, 2016 in Medical school of bachelor degree, in Belgrade. Self-reported questionnaire served as a data source. Descriptive statistic was used to analyse study sample characteristics. Chi-square test was used to test differences be-tween groups. Study sample have included 138 participants. Al-most half of them, 43.8%, practice SMA. Life style (smoking, al-cohol consumption, sleeping habits and physical activity) and so-cio-demographic characteristics (excepted school grade) were not shown as SMA determinants. Time & money savings were stated as the most frequent reason for SMA, while common cold, sore throat and cough were the most common conditions cured through SMA. Pharmacists’ recommendations and previous pos-itive experience were specified as the most important in the pro-cess of antibiotics selection, indicated by 50.0% and 37.5% par-ticipants, respectively. Amoxicillin was the most frequently used antibiotic in SMA, used by 50% of participants who practice SMA. High proportion of SMA and observed practice among nursing students in Serbia call for efforts with regards to relevant educa-tion about rational antibiotic use, actual clinical guidelines and potential consequences of misuse.Zdravstveni stručnjaci bi trebalo da služe kao pokretači ra-cionalne upotrebe antibiotika u pokušaju da se smanji zloupo-treba antibiotika kroz proces samomedikacije. Pilot studija je sprovedena sa ciljem da se utvrde potencijalni prediktori samomedikacije antibioticima (SMA) i da se opiše praksa SMA među studentima sestrinstva u Srbiji. Podaci su sakupljeni tokom perioda Mart-Maj 2016, u Višoj školi strukovnih studija u Be-ogradu, Srbija. Za sakupljanje podataka korišćen je upitnih za samo-popunjavanje. U analizi karakteristika ispitivanog uzorka korišćena je deskriptivna statistika. Hi-kvadrat test je korišćen za ispitivanje razlike između grupa. Ukupan broj učesnika u studiji bio je 138. Gotovo polovina, 43,8% je koristila SMA. Životni stil (pušenje, konzumiranje alkohola, navike u pogledu sna, fizička aktivnost) i socio-demografske karakteristike (izuzev godine studija) nisu pokazane kao SMA. Uštede u vremenu i novcu su navedene kao najčešći razlog za SMA, dok su prehlada, upala grla i kašalj najčešće indikacije tretirane kroz SMA. Preporuke farmaceuta i prethodno pozitivno iskustvo su navedeni kao najznačajniji faktori u odabiru antibiotika, što je tvrdilo 50,0% i 37,5% učesnika, redom. Amoksicilin je bio najčešće korišćen an-tibiotik koji je koristilo 50% učesnika kroz SMA. Visok procenat SMA i uočena praksa među studentima sestrinstva u Srbiji ukazuje na potrebe za relevantnom edukacijom u vezi sa racion-alnom upotrebom antibiotika, aktuelnim preporukama u klin-ičkim vodičima i potencijalnim posledicama nepoštovanja datih preporuka

Digitalna pismenost zdravstvenih radnika u apotekama

Professional standards require from healthcare professionals to possess a certain level of digital literacy. The aims of paper were: examination of the experience of healthcare professionals in pharmacies in the use of digital technologies, self-assessment of knowledge and skills, evaluation of attitudes and analysis of the needs for improvment of digital competencies. A special paper questionnaire was designed and used in the research, which was distributed to the pharmacy staff from AU “Benu“. 94,3% use digital technology at work every day, 89,8% of respondents using it for searching of medical and medicine information (89,8%). Only 9,7% of the respondents completed an additional formal program or course. Pharmacists assessed their digital literacy significantly higher than pharmaceutical technicians, 3,67±0,79 vs 3,44±0,63 (p<0,05). Most of them think that it is important to improve their digital literacy (agreement 4,62±0,95) and are motivated to do so through additional training or learning on their own (agreement 4,50±0,94). They understand benefits of new ways of communicating and data source and spontaneously accept the new technologies in the field of eHealth. A similar conclusion is mentioned in National strategy for digital skills development (1). Pharmacy professionals rate their digital literacy at 3,56, which could be compared with similar research from Canada (2), where computer literacy is mostly rated at 3. Considering the positive attitude towards using digital technologies in practice and high motivation for improving digital skills, it is expected that the pharmacists will quickly master technological innovations in the field of providing pharmaceutical services in the future.Današnji profesionalni standardi zahtevaju od zdravstvenih radnika u apotekama da poseduju određeni stepen digitalne pismenosti. Ciljevi rada bili su: ispitivanje dosadašnjih iskustava zdravstvenih radnika u apotekama kada je u pitanju upotreba digitalnih tehnologija, samoprocena stečenih znanja i veština, kao i ispitivanje stavova i analiza potreba za unapređenjem digitalnih kompetencija. Korišćen je posebno dizajniran upitnik u papirnoj formi koji je distribuiran zaposlenima u Apotekarskoj ustanovi „Benu“. Ukupno 94,3% ispitanika svakodnevno koristi digitalne tehnologije na poslu, dok za pretragu stručne medicinske literature i literature o lekovima digitalne tehnologije koristi 89,8% ispitanika. 9,7% ispitanika je završilo dodatni formalni program ili kurs. Farmaceuti svoju digitalnu pismenost procenjuju statistički značajno višom ocenom u odnosu na farmaceutske tehničare, 3,67±0,79 prema 3,44±0,63 (p<0,05).Većina njih smatra da je važno da unapređuje svoju digitalnu pismenost (slaganje sa izjavom 4,62±0,95) i motivisano je da to čini kroz dodatne obuke ili samostalno učenje (slaganje sa izjavom 4,50±0,94). Činjenica je zdravstveni radnici uviđaju benefit novih načina komunikacije i izvora informacija, odnosno na spontani način prihvataju nove tehnologije iz oblasti eZdravlja. Sličan zaključak se pominje i u Nacionalnoj strategiji za razvoj digitalnih veština (1). Zdravstveni radnici u apotekama svoju digitalnu pismenost ocenjuju ocenom 3,56, što bi se moglo uporediti sa rezultatom sličnog istraživanja koje je rađeno u Kanadi (2), gde je kompjuterska pismenost u najvećem broju ocenjena sa 3. Obzirom na pozitivan stav o korišćenju digitalnih tehnologija u praksi i visoku motivisanost za unapređenjem digitalnih veština, očekuje se da će farmaceuti u apotekama u budućnosti brzo ovladati tehnološkim inovacijama iz oblasti apotekarske delatnosti.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Pregled legislative republike srbije u oblasti fenomena sekundarnih žrtava kod farmaceuta zaposlenih u javnim apotekama

Following challenges in the global environment, technologies in pharmaceutical care, pressures to performance and timelines, community pharmacists are facing with impact of adverse healthcare outcomes on their health and wellbeing, described in literature as second victims phenomenon (1, 2). The aim of this paper is review of the national regulations in protection of pharmacists in traumatic situations during the healthcare. From January 2022 to May 2022, the websites of the Ministry of Health, the Pharmaceutical Chamber, the Paragraph, and the Legal Information System were searched using the keywords: patient safety, healthcare workers safety, regulations, pharmacists. The results showed that regulations protect patients, while healthcare workers, as second victims, are not protected. Patient safety is regulated through Law on Health Care, Law on Health Documentation and Records in Health, Ordinance on reporting, collecting, and monitoring adverse reactions to medical devices. The protection of healthcare workers is regulated from the aspect of working conditions, including interpersonal relations, through the Law on Safety and Health at Work, Law on Prevention of Abuse, Ordinance on Internship and Professional Exam of Health Workers and Associates, GPP Guide and Ethical Code of Pharmacists of Serbia. On the website of the Pharmaceutical Chamber, there is a section “Report violence”, which allows to fill the Questionnaire on violence against healthcare workers. After considering all the aspects, it is conluded that the protection of pharmacists and other healthcare workers in this context is not regulated, phenomenon is new and there is a room for discussion in adopting future regulations.Usled globalnih promena, učešća novih tehnologija, pritisaka vezanih za učinak i vremenske okvire, farmaceuti u javnim apotekama se suočavaju sa uticajem neželjenih ishoda farmaceutske zdravstvene zaštite na lično zdravlje i psihičko blagostanje, što se u literaturi opisuje kao fenomen sekundarnih žrtava (1, 2). Cilj ovog rada je pregled regulative Republike Srbije radi sagledavanja propisa koji uređuju zaštitu farmaceuta u situacijama nastalim kao posledica incidenta pri pružanju zdravstvene zaštite. U periodu januar 2022. - maj 2022. pretraživani su sajtovi: Ministarstva zdravlja, Farmaceutske komore, Paragrafa i Pravno informacionog sistema, po ključnim rečima: bezbednost pacijenata, bezbednost zdravstvenih radnika, regulativa, farmaceuti. Rezultati pretrage su pokazali da propisi štite pacijente, dok zdravstveni radnici kao sekundarne žrtve nisu pravno zaštićeni. Bezbednost pacijenata regulisana je kroz: Zakon o zdravstvenoj zaštiti, Zakon o zdravstvenoj dokumentaciji i evidencijama u oblasti zdravstva, Pravilnik o načinu prijavljivanja, prikupljanja i praćenja neželjenih reakcija na medicinska sredstva. Zaštita zdravstvenih radnika regulisana je iz aspekta uslova na radu, uključujući i međuljudske odnose, a kroz: Zakon o bezbednosti i zdravlju na radu, Zakon o sprečavanju zlostavljanja, Pravilnik o pripravničkom stažu i stručnom ispitu zdravstvenih radnika i saradnika, Vodič DAP i Etički kodeks farmaceuta Srbije. Na sajtu Farmaceutske komore Srbije, postoji sekcija pod nazivom „Prijavi nasilje“ koja omogućava i popunjavanje Upitnika o nasilju nad zdravstvenim radnicima u Srbiji. Kritičkim sagledavanjem iz više aspekata, zaključeno je da oblast zaštite farmaceuta i drugih zdravstvenih radnika u ovom kontekstu nije detaljno regulisana, da je fenomen u našoj regulativi nov i da postoji prostor za diskusiju prilikom donošenja buduće regulative.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

„Zelena” farmacija - preporuke za unapređenje farmaceutske prakse

Drug residues isolated from environment, such as soil and water, pose a direct threat to human and animal health, and appropriate regulations have been adopted at the European Union level to reduce and control pollution caused by drugs (1, 2). Accordingly, numerous professional debates have been initiated related to pharmacists’ professional responsibility. As a result, international professional associations of pharmacists have made recommendations for taking specific professional activities to protect the environment from the harmful effects of drugs, which will directly contribute to the implementation of adopted regulations (2, 3). Among the most important recommendations for improving pharmaceutical practice to contribute to green pharmacy are as follows: (i) taking actions to increase the public awareness on the prudent use of medicines and pharmaceutical waste collection, (ii) developing guidelines and information materials for healthcare professionals on the prudent use of pharmaceuticals, (iii) exploring the inclusion of environmental aspects for pharmaceuticals posing a risk to or via the environment in the pharmacy education and continuous professional development programs, (iv) developing and ensuring compliance with environmental quality standards for pharmaceuticals as a measure to promote greener manufacturing, (v) ensuring appropriate funding of pharmacy-led disposal and collection schemes for medicines, (vi) reducing pharmaceutical waste caused by leftover medicines by ensuring that systems are in place that encourage the prescription and dispensing of quantities of certain risk medicines in package sizes matching the duration of treatment, (vii) supporting the development of environmentally friendly practices and sustainability policies in pharmacies. There are numerous examples of good practices in European countries in pharmaceutical waste management. Among them are numerous examples of programs to improve citizens' awareness of the importance of returning unused or expired drugs to pharmacies, i.e. on dangers to the environment and public health if medicines are disposed with communal waste. In addition, there are many examples of good organization of pharmaceutical waste management, which emphasize the importance of cooperation between different stakeholders (i.e. pharmacies, pharmaceutical industries, distributors) and support of municipalities and national government. Adherence to adopted regulations for pharmaceutical waste management, and the recommendations of professional associations to improve pharmaceutical practice in the light of green pharmacy, with examples of good practice from developed countries, represents the basis of the pharmacists’ professional responsibility in the context of environmental protection from drug pollution.Ostaci lekova izolovani iz životne sredine, kao što su zemljište i voda, predstavljaju direktnu pretnju zdravlju ljudi i životinja, te su na nivou Evropske unije doneti odgovarajući propisi radi smanjenja i kontrole zagađenja uzrokovanog lekovima (1, 2). U skladu sa navedenom situacijom pokrenute su brojne debate na temu profesionalne odgovornosti farmaceuta, a kao rezultat stručnih diskusija, međunarodna strukovna udruženja farmaceuta donela su preporuke za preduzimanje konkretnih profesionalnih aktivnosti sa ciljem zaštite životne sredine od zagađenja lekovima, koje će direktno doprineti implementaciji usvojenih propisa (2, 3). Među najznačajnim preporukama za unapređenje farmaceutske prakse radi doprinosa „zelenoj” farmaciji navodi se sledeće: (i) sprovođenje aktivnosti sa ciljem povećanja svesti javnosti o značaju upotrebe lekova sa oprezom, kao i o prikupljanju i vraćaju u apoteku lekova sa isteklim rokom i neupotrebljenih lekova, (ii) izrada smernica i promotivnih materijala za zdravstvene radnike o racionalnoj upotrebi lekova, (iii) izučavanje nastavnih sadržaja sa temama iz oblasti rizika od upotrebe lekova za životnu sredinu u toku studija i programa kontinuirane edukacije, (iv) obezbeđenje odgovarajućih finansijskih sredstava za prikupljanje i odlaganje lekova na nivou apoteke, (v) usklađenost sa propisima za zaštitu životne sredine, kao mera za promovisanje „zelenije” proizvodnje lekova, (vi) smanjenje nastanka farmaceutskog otpada uzrokovano neupotrebljenim lekovima kroz podsticanje mera za propisivanja i izdavanje lekova u količini ograničenoj na period trajanja lečenja, (vii) podrška razvoju ekološki prihvatljivih praksi i pratećih propisa u apotekama (3). U zemljama Evropske unije danas postoje brojni primeri dobrih praksi u prikupljanju i pravilnom rukovanju farmaceutskim otpadom Među njima su brojni primeri programa za unapređenje svesti građana o značaju vraćanja lekovima sa isteklim rokom ili neupotrebljenih lekova u apoteke, tj. o opasnostima po životnu sredinu i javno zdravlje ukoliko se lekovi odlažu sa komunalnim otpadom. Pored toga, dosta je primera dobre organizacije procesa rukovanja farmaceutskim otpadom gde se ističe značaj saradnje različitih interesnih strana, tj. apoteka, farmaceutske industrije, distributera, kao i podrška lokalne samouprave i državne uprave. Poštovanje nacionalnih propisa za rukovanje farmaceutskim otpadom i preporuka profesionalnih udruženja za unapređenje farmaceutske prakse u svetlu „zelene” farmacije, imajući u vidu primere dobrih praksi iz razvijenih zemalja, predstavlja okosnicu profesionalne odgovornosti farmaceuta u kontekstu zaštite životne sredine od zagađenja lekovima.Drugi naučni simpozijum Saveza farmaceutskih udruženja Srbije sa međunarodnim učešćem, 28. 10. 2021. Beogra

Person-Centred Care Interventions in Pharmaceutical Care

This chapter is divided into four sections. The first section introduces the concept of person-centred care within pharmaceutical care delivery and provides a historical context. The second section focuses on the professionals and explores the role of person-centred pharmaceutical care as part of multi-disciplinary health services delivery teams. The third section focuses on the patient and describes the role of health literacy in the implementation of person-centred pharmaceutical care. The last section examines E-pharmacy services and the implementation of telepharmacy with implications for person-centred care

Pregled regulatornih zahteva u SAD, EU i Srbiji za softver – mobilnu aplikaciju kao medicinsko sredstvo – pregled najnovijih saznanja

The number of software - mobile applications intended for use in the field of people’s health and well-being is constantly increasing. The aim of this review is to compare regulations on software – mobile applications as medical devices in the United States of America (USA), European Union (EU) and Serbia, with reference on the efforts for international harmonization of the regulations. The goal is to increase awareness of the broader healthcare professionals’ (HCPs) audience about this topic. Publicly available information from official regulatory bodies websites was analyzed and synthesized for two regions and one country of interest. The results show differences in regulatory approaches in this area between two biggest medical device markets – the USA and the EU, while regulations in Serbia are being harmonized with the EU. Regulations clearly define criteria that software – mobile application needs to meet to be assessed as a medical device; on the other hand, they leave a number of applications that provide health-related services out of the regulated scope. Based on the increased awareness of regulations, recommendations for future research can be directed towards greater involvement of HCPs in patient counseling and decision making regarding the selection of mobile applications, to prevent the use of inadequate mobile applications and ensure that their patients are correctly using the right applications with positive effects on health and well-being.Broj mobilnih aplikacija namenjenih za zaštitu zdravlja i dobrobiti pacijenata/korisnika je u stalnom porastu. Cilj ovog preglednog rada bio je uporedna analiza propisa za softvere - mobilne aplikacije kao medicinska sredstva u Sjedinjenim Američkim Državama (SAD), Evropskoj uniji (EU) i Srbiji, sa osvrtom na napore za međunarodno usaglašavanje propisa. Namera je da se poveća upoznatost većeg broja zdravstvenih radnika o ovoj temi. Analizirane su i sintetizovane javno dostupne informacije sa sajtova zvaničnih regulatornih tela za dva regiona i jednu zemlju od interesa. Rezultati pokazuju razlike u regulatornim pristupima u ovoj oblasti između dva najveća tržišta medicinskih sredstava - SAD i EU, dok se regulativa u Srbiji usklađuje sa EU. Pregledani propisi jasno definišu kriterijume koje softveri - mobilne aplikacije moraju da zadovolje da bi se procenjivali kao medicinska sredstva; sa druge strane, oni ostavljaju jedan broj aplikacija koje pružaju usluge u oblasti zaštite zdravlja i/ili dobrobiti pacijenata/korisnika izvan regulisanog opsega. Na osnovu bolje upoznatosti sa regulativom, dalja istraživanja se mogu usmeriti ka nalaženju načina za većim angažovanjem zdravstvenih radnika u savetovanju pacijenata i donošenju odluka oko izbora mobilnih aplikacija, kako bi sprečili upotrebu neadekvatnih mobilnih aplikacija i osigurali da njihovi pacijenti pravilno koriste prave aplikacije sa pozitivnim efektima na njihovo zdravlje i blagostanje