Implementation of legal regulations related to drug advertising in Serbia from the second half of the 19th to the first half of the 20th century

Nedostatak propisa o oglašavanju lekova u prvoj polovini XIX veka u Srbiji, omogućio je oglašivačima da daju preuveličane, često lažne tvrdnje o dejstvu reklamiranih lekova, nudeć i ih kao univerzalne lekove za sve bolesti. Odsustvo informacija o sadržaju potencijalno opasnih supstanci, placebo efeketi i samomedikacija, bili su značajni faktori njihove dugotrajne popularnosti, ali i kritike od strane kreatora zdravstvene politike. Cilj rada je prikazati hronologiju regulative u oglašavanju lekova u Srbiji. Korišć ene su metode dokumentacione analize i desk analize sekundarnih podataka. Implementacijom zakonskih propisa o oglašavanju lekova prvo je regulisano označavanje lekova. Pravilnik Stalnog stručnog saveta za ispitivanje i kontrolu lekova (1926.) zabranjivao je promet neregistrovanih lekova, oglašavanje postojećih lekova pod drugim nazivima i oglašavanje lekova jakog dejstva u dnevnoj štampi. Pravilnik o oglašavanju lekova i lekovitih specijaliteta u dnevnim listovima ili drugim načinom (1931) određuje sadržinu teksta oglasa čiji je sadržaj kontrolisao Stalni stručni savet za ispitivanje i kontrolu lekova (1). Regulacija oglašavanja lekova u Srbiji je evoluirala u posmatranom periodu, prateći stalne promene u društvenom, tehnološkom i političkom okviru, uz održavanje visokog nivoa odgovornosti kreatora politike i farmaceuta u zaštiti zdravlja stanovništva.The lack of regulations on drug advertising in the first half of the 19th century in Serbia enabled advertisers to make exaggerated, often false claims about the effect of advertised drugs, offering them as universal remedies for all diseases. Lack of information on the content of potentially dangerous substances, placebo effects and self-medication, were significant factors in their long-term popularity, but also criticism by health policy makers. The aim of this paper is to present the chronology of regulations in drug advertising in Serbia. Methods of documentation analysis and desk analysis of secondary data were used. The implementation of legal regulations on drug advertising first regulated the labeling of drugs. The Rulebook of the Permanent Expert Council for the Testing and Control of Medicines (1926) prohibited the sale of unregistered medicines, the advertising of existing medicines under other names and the advertising of strong drugs in the daily press. The Ordinance on the Advertising of Medicines and Medicinal Specialties in Daily Newspapers or in Other Manners (1931) determines the content of the text of an advertisement whose content was controlled by the Permanent Expert Council for Testing and Control of Medicines (1). The regulation of drug advertising in Serbia has evolved in the observed period, following the constant changes in the social, technological and political framework, while maintaining a high level of responsibility of policy makers and pharmacists in protecting the health of the population.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Medicines Policy and Drugstores in Serbia Until the Second World War

The paper analyzes the effects of medicines policy on the functional separation of pharmacy and drugstore businesses from the early 19th century to the Second World War. Attempts to maintain personal and professional interests in the delivery of medicines prompted the long-standing dispute between pharmacists and druggists over the control and trade of drugs and poisons. The issue of state control generated complex processes that emphasized the professional role of pharmacists as providers of pharmaceutical services and druggists as wholesalers of medicines

Prikaz jednog nadzora nad kvalitetom rada apoteka u Beogradu 1888. godine

In the ninth decade of the 19 th century, significant changes took place in the regulation of work in pharmacies. Medical Department of the Ministry of Internal Affairs dealt with difficulties in establishing a pharmacy network in the newly liberated parts of Serbia, as well as one state chemist, as a regular member of all the boards of supervision in Serbia. The paper aims to present the results of a regular supervision of the quality of work of six out of seven existing pharmacies in Belgrade in 1888 (except for one newly opened which was inspected at the opening). Method of historical analysis by using the primary and the secondary data sources was applied. The supervision included the control of staff, equipment, content and quality of medicines in the pharmacies. The Board of Supervision consisted of the state chemist, Dr. Ferdinand Shams, a city physicist and a representative of the Belgrade police authority. One of the pharmacies completely fulfilled the conditions, four pharmacies fulfilled partially, while only one pharmacy did not fulfill the conditions at all, provided by the Law on Regulation of the Medical Profession and Public Health (1881) (1). The subsequent control of work, carried out six months later, showed that irregularities were only partially corrected. The Board left the owners 45 days to correct all the identified irregularities. Supervision of the pharmacy affairs in Belgrade at the end of the 19th century pointed out the irregularities needed to be eliminated in order to continue working.U devetoj deceniji XIX veka nastale su značajne promene u regulisanju rada apoteka. Sanitetsko odeljenje Ministarstva unutrašnjih dela suočavalo se, kako sa poteškoćama u uspostavljanju mreže apoteka u novooslobođenim krajevima Srbije, tako i sa jednim državnim hemičarom, kao redovnim članom svih komisija za nadzor u Srbiji. Cilj rada je da se prikažu ishodi redovnog nadzora nad kvalitetom rada šest, od postojećih sedam apoteka u Beogradu 1888.godine (izuzev jedne novootvorene koja je bila pregledana pri otvaranju). U radu je primenjena metoda istorijske analize uz korićenje primarnih i sekundarnih izvora podataka.Nadzor je obuhvatao kontrolukadrova, opreme, sadržaja i kvaliteta lekova u apotekama. Komisiju su činili: državni hemičar dr FerdinandŠams, gradski fizikus i predstavnik policijske vlasti Beograda. Jedna apoteka je u potpunosti ispunjavala predviđene uslove, četiri apoteke su delimično ispunjavale uslove, dok jedna apoteka uopšte nije ispunjavala uslove predviđene Zakonom o uređenju sanitetske struke i čuvanju narodnog zdravlja (1881) (1). Naknadna kontrola rada, obavljena šest meseci kasnije, pokazala je da su delimično ispravljene nepravilnosti u radu. Komisija je vlasnicima ostavila treći rok od 45 dana za ispravku svih utvrđenih nepravilnosti. Nadzor nad apotekarskim poslovanjem u Beogradu krajem XIX veka ukazao je na niz nepravilnosti koje su morale biti otklonjene kako bi se nastavilo sa radom.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Etička pitanja u pedijatrijskim kliničkim studijama: izazovi i problemi kod pacijenata s rijetkim bolestima

Pedijatrijske rijetke bolesti u posljednjih nekoliko godina zaokupljaju veću pažnju javnosti zbog podizanja svijesti o problemima oboljelih i članova njihovih porodica ili staratelja i kroz unapređenje zakonskih propisa u vezi s kliničkim ispitivanjima lijekova u pedijatrijskoj populaciji. Profesionalna odgovornost zdravstvenih radnika u istraživanju i razvoju lijekova za liječenje rijetkih bolesti u dječjoj populaciji nadilazi okvire zaštite djece kao vulnerabilnih subjekata u istraživanjima jer su djeca oboljela od rijetkih bolesti dvostruki “terapijski siročići”. Polazeći od zakonskih propisa koji se odnose na pedijatrijske kliničke studije, autori obrađuju etičke principe i načela s posebnim osvrtom na pravednost, autonomiju, neškodljivost i informiranost, fokusirajući se na postupak dobivanja suglasnosti uz punu obaviještenost roditelja ili staratelja u davanju suglasnosti (engl. consent) i uz traženje pristanka djeteta (engl. assent), ovisno o njegovoj dobi

Мedicinske misije u Balkanskim ratovima kroz prizmu istorijskih izvora

In the first half of the 19th century, the Principality of Serbia began to work on developing the health service and educating medical staff by sending students abroad to study medicine, because there was no Medical Faculty. The aim of the paper is to present the participation of foreign medical missions in providing assistance to Serbia during the Balkan wars. Method of historical analysis by using the primary and the secondary data sources was applied. The new wave of war, which followed in the second decade of the 20th century, pointed to the lack of personnel, medical and pharmacy equipment. The lack of medical staff was compensated by medical missions from abroad. During the First Balkan War, Serbia was visited by 16 medical missions from all parts of Europe and Scandinavia with a total of 185 doctors. Only Russia sent eleven medical missions and thus took the leading position in providing assistance. The mission consisted of 28 doctors, 11 intendants, 2 pharmacists, 86 mercy nurses and 160 nurse assistants. In the Second Balkan War, England and Scotland, Denmark, Belgium, the Netherlands, Sweden, Norway, Germany, Russia, Hungary and Austria provided medical assistance with 85 doctors (1). All missions were consistent with love and dedication in saving lives, financing medical staff, medical supplies and hospital equipment. The courage and humanity of foreign missions was awarded the Order of Saint Sava.Kneževina Srbija je u prvoj polovini 19. veka počela da radi na razvijanju zdravstvene službe i edukaciji lekarskog kadra slanjem studenata u inostranstvo na studije medicine, jer Medicinskog fakulteta nije bilo u Kneževini. Cilj rada je da se prikaže učešće stranih medicinskih misija u pružanju pomoći Srbiji za vreme balkanskih ratova.U radu je primenjena metoda istorijske analize uz korićenje primarnih i sekundarnih izvora podataka. Novi ratni talas, koji je usledio u drugoj deceniji 20. veka, ukazao je na nedostatak personala, sanitetske i apotekarske opreme. Nedostatak medicinskog personala bio je nadoknađen medicinskim misijama iz inostranstva. Za vreme Prvog balkanskog rata zabeležen je dolazak 16 medicinskih misija iz Evrope i Skandinavije, sa ukupno 185 lekara. Rusija je uputila jedanaest sanitetskih misija i time zauzela vodeće mesto u pružanju pomoći. Misiju je činilo 28 lekara, 11 ekonoma, 2 farmaceute, 86 milosrdnih sestara i 160 bolničara. U Drugom balkanskom ratu Engleska i Škotska, Danska, Belgija, Holandija, Švedska, Norveška, Nemačka, Rusija, Mađarska i Austrija su pružile medicinsku pomoć sa 85 lekara (1). Sve misije su sa ljubavlju i predanošću bile dosledne u spašavanju života, finansiranju medicinskog kadra, sanitetskog materijala i bolničke opreme. Hrabrost i humanist stranih misija odlikovana je dodeljivanjem Ordena Svetog Save.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

Doprinos farmaceuta razvoju zdravstvene kulture u Vranju krajem 19. i u prvoj polovini 20. veka

Introduction Healthcare enlightenment and healthcare culture in Vranje and its region were under Turkish influence until the liberation in 1878, when the organisation of education, schooling and healthcare were initiated in the Vranje region Objective The aims of this study were to shed light on the beginning of the development of pharmaceutical personnel, and their contribution to healthcare culture development in Vranje and its region, with a focus on healthcare legislation and its impact on pharmaceutical service availability, and the analysis of pharmaceutical personnel development within the healthcare services. Methods We used the methods of documentation analysis and the desk analysis of the secondary information. Results At the beginning of the 19th century healthcare services in Vranje were still inexistent. After the liberation from the Turks, Naum's medical office with pharmacy was opened in Vranje. Although it did not comply with regulations, it presented the only formal source of supply of medications and sanitary material, and as such it gave its contribution to healthcare service at that time in Vranje. Mr ph. Stevan Varjacic, 1st class pharmacy assistant, worked at a temporary hospital from 1880 until January 1881, supplying with medications soldiers and residents of Vranje. The development of pharmaceutical schooling began in 1883, when a pharmacy was opened by the pharmacist Velimir Karic according to the Law on Healthcare Organization and People's Healthcare Maintenance. By the end of the 1930s there were ten civilian healthcare institutions in Vranje, even three of which were pharmacies. By the end of 1948, they were nationalized, and were renamed the City National Pharmacy of Vranje. Conclusion By the end of the 10th century, passing of the legislation on the regulations of pharmaceutical industry within healthcare services had an impact on Vranje that resulted in opening pharmacies with educated pharmaceutical personnel. Pharmacy owners changed, and the quality and continuity of medical supplies was always secured.Uvod Zdravstvena prosvećenost i zdravstvena kultura u Vranju i vranjskom kraju bili su pod turskim uticajem do 1878. godine, kada je nakon oslobođenja od Turaka počela organizacija prosvete, školstva i zdravstva u ovom kraju. Cilj rada Ciljevi rada su bili osvetljavanje početaka razvoja apotekarskog kadra i doprinos farmaceuta razvoju zdravstvene kulture u Vranju i vranjskom kraju s osvrtom na zdravstvenu regulativu i njen uticaj na dostupnost usluga apotekarske službe i analizu razvoja farmaceutskog kadra u okviru zdravstvene službe. Metode rada Korišćene su metode dokumentacione analize i desk-analiza sekundarnih podataka. Rezultati Početkom 19. veka zdravstvena služba u Vranju još nije postojala. Nakon oslobođenja od Turaka u Vranju je radila ordinacija s apotekom felčera Nauma, koja je, iako nije bila usklađena s propisima, bila jedini formalni izvor snabdevanja lekovima i sanitetskim materijalom i kao takva dala doprinos tadašnjoj zdravstvenoj službi u Vranju. U privremenoj vranjskoj bolnici od 1880. godine do januara 1881. godine radio je apotekarski pomoćnik prve klase magistar farmacije Stevan Varjačić, a lekovima su se snabdevali vojnici i stanovnici Vranja. Razvoj školske farmacije počinje 1883. godine otvaranjem apoteke farmaceuta Velimira Karića u skladu s tada važećim Zakonom o uređenju sanitetske struke i o čuvanju narodnog zdravlja. Krajem tridesetih godina 20. veka u vranjskom kraju je radilo deset civilnih zdravstvenih ustanova, od kojih su čak tri bile apoteke. One su krajem 1948. godine podruštvljene i promenile naziv u 'Gradska narodna apoteka u Vranju'. Zaključak Postojanje zakonske regulative o uređenju farmaceutske delatnosti u okviru zdravstvene službe uticalo je na to da Vranje krajem 19. veka dobije apoteke sa školovanim farmaceutskim kadrom. Vlasnici apoteka su se menjali, ali kvalitet i kontinuitet u medicinskom snabdevanju uvek je bio obezbeđen

EVALUATION OF PHARMACISTS’ KNOWLEDGE AND ATTITUDES REGARDING RARE DISEASES AND ORPHAN DRUGS

Rare diseases (RD) are very heterogenic group of disorders affecting less than 5 out of 10.000 people in the European Union (EU), at the same time putting them in danger or disabling them chronically. It is estimated that only in Serbia almost half a million people suffer from some RD. In spite of rarity, they represent an important medical and social problem. The aims of this pilot project were to evaluate the pharmacists` general knowledge and specific knowledge regarding RD, regulatory requirements and availability of drugs for the RD in the Republic of Serbia as well as pharmacists` attitudes and understanding of the health public importance of RD and drugs` availability. The prospective cross- sectional KAP study was conducted during 2012, on a convenient sample of the community pharmacists from the territory of the Niš branch of Pharmaceutical Chamber of Serbia. The questionnaire was fully completed by 139 pharmacists; 89.2% were females with mean age of 43.4±9.1 years. More than half of the respondents (66.9%) knew that there was no Register of RD in Serbia, but did not know the estimated percentage of the EU population suffering and the prevalence of RD (67%, 51.8%, respectively). Insufficient information about the problem points to insecurity in basic epidemiology and regulatory knowledge. The majority of the respondents supported the establishment of the regulatory instruments for the promotion of the research and development of the orphan drugs for RD

Prva apoteka u Vranju sa diplomiranim farmaceutom i njen dalji razvoj

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Prevention of polymicrobial biofilms composed of Pseudomonas aeruginosa and pathogenic fungi by essential oils from selected Citrus species

Mixed microbial infections caused by Pseudomonas aeruginosa and pathogenic fungi are commonly found in patients with chronic infections and constitute a significant health care burden. The aim of this study was to address the potential polymicrobial antibiofilm activity of pompia and grapefruit essential oils (EOs). The mechanism of antimicrobial activity of EOs was analysed. EOs of pompia and grapefruit inhibited fungal growth with MIC concentrations between 50 and 250 mg L-1, whereas no effect on P. aeruginosa growth was observed. Both citrus EOs inhibited formation of bacterial and fungal monomicrobial biofilms in concentrations of 50 mg L-1 and were efficient in potentiating the activity of clinically used antimicrobials in vitro. The concentration of 10 mg L-1 EOs inhibited mixed biofilm formation composed of P. aeruginosa and Aspergillus fumigatus or Scedosporium apiospermum. Citrus EOs affected quorum sensing in P. aeruginosa and caused fast permeabilisation of Candida albicans membrane. Pompia and grapefruit EOs potently inhibited biofilm formation and could be used for the control of common polymicrobial infections

Dostupnost lekova za retke bolesti - komparativna analiza legislativnih zahteva između Srbije, Hrvatske i Makedonije

Access to orphan drugs (In EU regulation Orphan Drugs are referred as Orphan Medicinal Products (OMP)) is a key role in determining whether patients with rare diseases (RDs) will receive adequate and efficient treatment. The objective of this article is to identify differences in patient access to orphan drugs in 3 pharmaceutical markets: Serbia, Croatia and Macedonia. Patient access was defined: as the market access (availability) and affordability (financial accessibility). We analysed the legislative requirements for the authorisation process and made a cross country comparison. Retrospective cross-sectional analysis was done on drug lists in selected countries and a cross-comparison between the List of Orphan Drugs in Europe (LODE) for a six-month period (May 2014-October 2014). We included all 179 OMPs marketed in EU in our analysis, which had received market authorization in Croatia upon its membership in the EU. Total number of marketed drugs in Serbia was 59 (32.96%) drugs and in Macedonia 52 (29.05%) drugs. However, market authorization does not guarantee patient access to any given drug, so only 39.11% of OMPs could be accessed by Croatian patients (70 drugs).The number of refunded drugs in Serbia and Macedonia was smaller (32 and 20, respectively) which makes respectively, 17.88% and 11.17% of drugs on the LODE. The present study showed some variations between countries in selected indicators of availability and access to orphan drugs. Patients in Croatia had greater number of registered and refunded drugs, but in Serbia more than a half of registered OMPs could be refunded from National Health Insurance Fund. Macedonia had smaller number of inhabitants and also had the smaller number of patients from certain RDs which results in lower total number of OMPs.Dostupnost lekova za retke bolesti (orfan lekovi, u EU regulativi koristi se izraz na engleskom Orphan medicinal products, OMP) igra važnu ulogu u tome da li će bolesnici sa retkim bolestima imati pristup efikasnoj i adekvatnoj terapiji. Ciljevi ovog rada su da se identifikuju razlike u pristupu bolesnika orfan lekovima u tri odabrane zemlje: Srbiji, Hrvatskoj i Makedoniji. Pristup orfan lekovima definisana je kao: tržišna pristupačnost (dostupnost) i priuštivost (finansijska pristupačnost). Analizirali smo legislativne zahteve u procesu stavljanja leka u promet i uradili komparaciju među posmatranim zemljama. Retrospektivnom studijom preseka poredili smo nacionalne liste lekova posmatranih zemalja i Listu orfan lekova u EU, za period od šest meseci (maj-oktobar 2014.). Od ukupno 179 OMP, koliko ih je u tom periodu bilo sa dozvolom za stavljanje u promet u EU, u Srbiji je bilo registrovano 59 (32,96%), u Makedoniji 52 (29,05%), dok su u Hrvatskoj učlanjenjem u EU svi registrovani lekovi postali tržišno dostupni. Međutim, dozvola za stavljanje u promet nije i garancija da bolesnik ima pristup datom leku, pa je samo 39,11% lekova sa dozvolom za stavljanje u promet bilo na listi lekova koje se refundiraju u Hrvatskoj (70 OMP). Broj lekova kojima bolesnici imaju pristup preko nacionalnih fondova zdravstvenog osiguranja u Srbiji i Makedoniji su manji (32 OMP i 20OMP, respektivno), što čini da je priuštivost lekova u Srbiji tek 17,88% , a u Makedoniji 11,17% od liste orfan lekova u EU. Broj lekova, fizička i finansijska pristupačnost u analiziranim zemljama nije ista, dok je u Hrvatskoj bolesnicima dostupan najveći broj registrovanih lekova, u Srbiji se više od polovine registrovanih OMP može refundirati o trošku RFZO. Makedonija zbog manjeg broja stanovnika ima manji broj obolelih od RB, što rezultira manjim brojem OMP