Suchergebnisse

Quality improvement in healthcare consists of systematic and continuous actions that lead to a measurable improvement in healthcare services. Most important goals for improvement in healthcare are safe, effective, patient-centres, timely, efficient, equitable healthcare. Definition of the integrated care includes initiatives seeking to improve outcomes of care by overcoming issues of fragmentation through co-ordination of services of providers along the continuum of care. Different countries of EU Member States are at different stages in the development of integrated care systems. Most countries reported continuously working on several initiatives to strengthen integration and coordination of care, such as pilot projects, implemented targeted programmes and strategies and adopted methods for cooperation. Many countries have taken initiatives on legislation, reorganisation and reimbursement systems. Integrated care can be seen to be both, a design of healthcare and a framework to achieve person-centred, efficient and safe care. Only a small number of EU Member States have developed specific indicator sets to assess integrated care. Measuring the performance of integrated care has to take into account the objectives of a health system and also needs to reflect the complexity of integrated care systems. ; Unapređenje kvaliteta u zdravstvu sastoji se od sistematskih i kontinuiranih aktivnosti, koje vode do merljivog poboljšanja zdravstvenih usluga. Najvažniji ciljevi za poboljšanje zdravstvene zaštite su sigurna, efikasna, usmerena ka pacijentu, pravovremena, pravična zdravstvena zaštita. Definicija integrisane zdravstvene zaštite uključuje inicijative koje nastoje da poboljšaju zdravstvene ishode, tako što će se prevazići problemi fragmentacije kroz koordinaciju usluga pružalaca usluga tokom pružanja zdravstvene zaštite. Različite zemlje članice Evropske unije nalaze se u različitim fazama razvoja integrisanih sistema zdravstvene zaštite. Većina zemalja ima usvojen koncept kontinuiranog rada na nekoliko inicijativa za jačanje integracije i koordinacije zdravstvene zaštite, kao što su pilot projekti, implementirani ciljani programi i strategije i usvojene metode za saradnju. Mnoge zemlje su preduzele inicijative u izmeni legislative kao i reorganizacije politika refundacije troškova zadravstvene zaštite. Integrisana zdravstvena zaštita se može smatrati i dizajnom zdravstvenog sistema i okvira za postizanje efikasne, sigurne zdravstvene zaštite, usmerene ka pojedincu Samo mali broj zemalja članica EU je razvio specifične indikatore za procenu integrisane zdravstvene zaštite. Merenje performansi integrisane zdravstvene zaštite mora da obuhvati ciljeve zdravstvenog sistema, a takođe treba da odražava složenost integrisanih sistema zdravstvene zaštite.

On the basis of the Law on Medicines and Medical Devices of the Republic of Serbia, a magistral medicine means a medicine prepared in the pharmacy according to a prescription (formula) for an individual patient - user. In practice, the more need is for ex tempore production of vaginal preparations in the pharmacy and galenic laboratory. Due to the small number of registered vaginal gel products on the world market, and even less on our own market, their production in the pharmacies is very important. The aim of this study was to examine the possibilities of development the vaginal gel carriers with different hydrophilic polymers, in the pharmacy, in accordance with the requirements of the European Pharmacopoeia. For their production we used three different mediums for gelation: Carbopol® 940, Carbopol® Ultrez 10 and Pemulen® TR 1 NF. All formulations show similar organoleptic properties during the observed period of time. Measured pH values of carrier formulations do not differ significantly compared to the normal pH values of vaginal fluid. Optimal value for viscosity has a formulation A1 (formulation with Carbopol® 940), thus that formulation is our recommendation for the development of vaginal gel carrier. Because of the complicated procedure of registration of the generic drug, recommended formulation for vaginal gel carrier, as magistral medicine, has a great importance for patients who require precise adjustment of therapy. ; Na osnovu Zakona o lekovima i medicinskim sredstvima koji je na snazi u našoj zemlji, magistralni lek je lek izrađen u apoteci na osnovu recepta (formule) za određenog bolesnika - korisnika. U praksi se sve više javlja potreba za ex tempore izradom vaginalnih preparata u uslovima apoteka i galenskih laboratorija. Usled malog broja registrovanih preparata, tipa vaginalnih gelova, na svetskom tržištu, ali manje na našem, veoma je važna njihova magistralna izrada u uslovima apoteke. Cilj ovog rada bio je ispitivanje mogućnosti izrade nosača za vaginalne gelove sa različitim hidrofilnim gelirajućim sredstvima u uslovima apoteke u skladu sa zahtevima Evropske farmakopeje. Za njihovu izradu korišćena su sledeća gelirajuća sredstva: Carbopol® 940, Carbopol® Ultrez 10 i Pemulen® TR 1 NF. Sve tri formulacije pokazuju slična organoleptička svojstva u posmatranom vremenskom periodu. Izmerene pH vrednosti formulacija nosača ne odstupaju značajno u odnosu na normalnu pH vrednost vaginalne tečnosti. Najoptimalniji viskozitet ima formulacija A1 (sa Carbopolom® 940), koja je ujedno i naša preporuka za nosač u izradi vaginalnih gelova. S obzirom na komplikovan postupak registracije generičkog leka, predložena formulacija nosača za vaginalne gelove, kao magistralnog leka, od velikog je značaja za primenu kod bolesnika kojima je neophodno precizno podešavanje terapije.

Adherence is tremendously important for efficiency and safety of pharmacotherapy and has a significant influence on its clinical, economic and humanistic outcomes, which can be observed both on the individual level of the patient as well as on the overall healthcare system. The inadequate degree of adherence is a long-lasting and widely present problem which can have immense and long-term consequences. Therefore, the issue of adherence is a big challenge for medical professionals in clinical practice. The concept of adherence is based on cooperation between patients and medical team members in the process of therapy management. It is focused on patients and implies a two-way transfer of information, agreement and shared responsibility for success in realization of adequate therapy regime and defined goals. Although there are numerous methods for adherence assessment, the evaluation of this parameter is still considered problematic. The complexity of adherence can be seen in its multidimensionality since numerous factors which individually and in mutual interaction affect medicine-taking behavior and thus create a framework that determines the achieved level of adherence have been identified and analyzed. Considering the fact that poor adherence is one of the main preventable causes of unsatisfactory therapy results and excessive costs of medical care, it is evidently necessary to ensure a high quality base in the form of knowledge, skills and motivation at the healthcare system level for adherence evaluation and improvement, as well as a multidisciplinary approach based on coordinated activities of healthcare policy creators, researchers and medical professionals. ; Adherenca je izuzetno važna za efikasnost i bezbednost farmakoterapije i značajno utiče na njene kliničke, ekonomske i humanističke ishode, što se može pratiti kako na individualnom nivou bolesnika, tako i na celokupnom zdravstvenom sistemu. Neadekvatan stepen adherence odavno je prisutan i široko rasprostranjen problem koji može imati velike i dugoročne posledice. Zato pitanje adherence predstavlja veliki izazov za zdravstvene profesionalce u kliničkoj praksi. Koncept adherence je utemeljen na saradnji bolesnika i članova zdravstvenog tima u procesu upravljanja terapijom. U potpunosti je orjentisan ka bolesniku i podrazumeva dvosmerni transfer informacija, dogovor i podeljenu odgovornost za uspešnost u realizaciji adekvatnog terapijskog režima i definisanih ciljeva. Iako postoji veliki broj metoda za procenu ostvarenog stepena adherence, još uvek se evaluacija ovog parametra smatra problematičnom. Kompleksnost adherence ogleda se u njenoj multidimenzionalnosti, budući da je identifikovan i proučen veliki broj faktora koji pojedinačno i u međusobnoj interakciji utiču na ponašanje bolesnika u vezi sa terapijom i tako kreiraju okvir koji determiniše ostvareni stepen adherence. Budući da je nizak stepen adherence jedan od glavnih preventabilnih uzroka nezadovoljavajućih terapijskih ishoda i prekomernih troškova zdravstvene zaštite, evidentna je potreba da se obezbedi kvalitetna baza u formi znanja, veština i motivacije na nivou zdravstvenog sistema za evaluaciju i unapređenje adherence, kao i multidisciplinaran pristup, koji je zasnovan na koordinisanim aktivnostima kreatora zdravstvene politike, istraživača i zdravstvenih profesionalaca.

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.

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 cross­sectional 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. ; Retke bolesti su heterogena grupa životno ugrožavajućih ili hronično onesposobljavajućih oboljenja, koja se prema kriterijumima evropske regulative javljaju sa učestalošću od najmanje jednog prema 2000 stanovnika. Uprkos tome što su retke u populaciji, one predstavljaju važan medicinski i socijalni problem sa kojim se susreću zdravstveni sistemi širom sveta. Procene su da samo u Republici Srbiji od retkih bolesti boluje skoro pola miliona ljudi. Ciljevi ovog pilot projekta bili su da se procene opšta i specifična znanja farmaceuta o retkim bolestima, regulativi u vezi sa lekovima za lečenje retkih bolesti i njihovoj dostupnosti u Republici Srbiji i utvrde stavovi farmaceuta o značaju retkih bolesti i dostupnosti terapije za bolesnike. Prospektivna studija preseka obuhvatila je farmaceute koji rade na teritoriji niškog ogranka Farmaceutske komore Srbije. Prikupljanje podataka obavljeno je tokom 2012. godine pomoću strukturiranog, anonimnog upitnika, posebno konstruisanog prema ciljevima istraživanja, a za obradu podataka korišćene su metode deskriptivne statistike i korelaciona analiza. Upitnik je potpuno popunilo 139 farmaceuta, pretežno ženskog pola (89,2%), prosečne starosti 43,4 ±9.1 godine. Više od polovine ispitanih farmaceuta (67%) ne zna da 6-8% populacije u EU boluje od neke retke bolesti, dok 51,8% smatra, što je pogrešno, da je prevalenca u Evropi manja od 5 na 10 000 ljudi. Većina ispitanika (66,9%) zna da u Srbiji ne postoji Registar retkih bolesti. Nedovoljna informisanost farmaceuta ukazuje na nesigurnost u poznavanju osnovnih regulatornih zahteva u vezi sa retkim bolestima i lekovima za njihovo lečenje. Većina ispitanika se u svojim stavovima zalagala za uspostavljanje regulatornih instrumenata za promovisanje istraživanja i razvoja lekova za retke bolesti.

Introduction. Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. Objective. The aim of the study was to analyze clinical cases with the outcomes leading to the changes in regulatory­ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the introduction of the ethical principles into clinical trials. Methods. This was a descriptive research (methods of analysis and documentation; desk analysis of the secondary data). Results. By analyzing the cases from the secondary sources as well as clinical and ethical outcomes, it may be noticed that the codes, declarations and regulations have been often preceded by certain events that caused their adoption. Moral concern and public awareness of the ethical issues have initiated not only the development of numerous guidelines, codes, and declarations, but also their incorporation into the legislative acts. Conclusion. It is desirable that ethical instruments become legally binding documents, because only in this way will be possible to control all phases of the clinical trials and prevent abuse of the respondents. ; Uvod. Svako kliničko ispitivanje, pored naučnih, mora da zadovolji i etičke kriterijume. Osnovni etički principi u kliničkim ispitivanjima su: neškodljivost, dobročinstvo, poštovanje autonomije i princip pravednosti. Cilj rada. Cilj rada je bio da se analiziraju klinički slučajevi čiji su ishodi doveli do promena u regulatorno­etičkom okviru u vezi s kliničkim ispitivanjima i ishodi kliničkih ispitivanja koja su uticala na uvođenje etičkih principa. Metode rada. Istraživanje je bilo deskriptivno, a primenjene su metoda dokumentacione analize i desk­analiza sekundarnih podataka. Rezultati. Analizom slučajeva iz sekundarnih izvora, te kliničkih i etičkih ishoda, može se primetiti da su kodeksima, deklaracijama i pravilima prethodili događaji koji su uzrokovali njihovo donošenje. Moralna briga i svest javnosti o etičkim problemima pokrenule su razvoj brojnih smernica, kodeksa i deklaracija i njihovo uvrštavanje u zakonska akta. Zaključak. Ukoliko se regulativa svih faza kliničkih ispitivanja zasniva na etičkim postavkama, kontrola i ishod su bazirani na humanim osnovama i prava su mera dobrobiti društva i pojedinca.

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 cross­sectional 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.

Free PMC article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6591668/pdf/10.1177_2042098619854014.pdf ; Background: The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria]. Methods: Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015-November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drug-regulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied. Results: PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8-21.7% not marketed PIMs) and less than 20% of PIMs were available as over-the-counter medications (except in Turkey, 46.4-48.1%). Conclusions: The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017-2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits. ; This project received funding from the EU COST Action IS1402 initiative 'Ageism: a multi-national, interdisciplinary perspective' (2015–2018), and from the European Union's Horizon 2020 research and innovation program EUROAGEISM H2020 under the Marie Sklodowska-Curie grant agreement no. 764632 (2017–2021). It was also supported by the project INOMED (reg. no. CZ. 02.1.01/0.0/0.0/18_069/0010046): the pre-application research into innovative medicines and medical technologies, cofunded by the EU, by SVV 260 417 and the scientific program PROGRESS Q42 at the Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University, Czech Republic. ; info:eu-repo/semantics/publishedVersion

[Abstract] Background: The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria]. Methods: Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015–November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drugregulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied. Results: PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8–21.7% not marketed PIMs) and less than 20% of PIMs were available as over-thecounter medications (except in Turkey, 46.4–48.1%). Conclusions: The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017–2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits. ; European Commision; project INOMED CZ.02.1.01/0.0/0.0/18_069/0010046

Background: The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria]. Methods: Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015-November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drug-regulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied. Results: PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8-21.7% not marketed PIMs) and less than 20% of PIMs were available as over-the-counter medications (except in Turkey, 46.4-48.1%). Conclusions: The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017-2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits.