Introduction: The appreciable growth in pharmaceutical expenditure has resulted in multiple initiatives across Europe to lower generic prices and enhance their utilization. However, considerable variation in their use and prices. Objective: Assess the influence of multiple supply and demand-side initiatives across Europe for established medicines to enhance prescribing efficiency before a decision to prescribe a particular medicine. Subsequently utilize the findings to suggest potential future initiatives that countries could consider. Method: An analysis of different methodologies involving cross national and single country retrospective observational studies on reimbursed use and expenditure of PPIs, statins, and renin-angiotensin inhibitor drugs among European countries. Results: Nature and intensity of the various initiatives appreciably influenced prescribing behavior and expenditure, e.g., multiple measures resulted in reimbursed expenditure for PPIs in Scotland in 2010 56% below 2001 levels despite a 3-fold increase in utilization and in the Netherlands, PPI expenditure fell by 58% in 2010 vs. 2000 despite a 3-fold increase in utilization. A similar picture was seen with prescribing restrictions, i.e., (i) more aggressive follow-up of prescribing restrictions for patented statins and ARBs resulted in a greater reduction in the utilization of patented statins in Austria vs. Norway and lower utilization of patented ARBs vs. generic ACEIs in Croatia than Austria. However, limited impact of restrictions on esomeprazole in Norway with the first prescription or recommendation in hospital where restrictions do not apply. Similar findings when generic losartan became available in Western Europe. Conclusions: Multiple demand-side measures are needed to influence prescribing patterns. When combined with supply-side measures, activities can realize appreciable savings. Health authorities cannot rely on a “spill over” effect between classes to affect changes in prescribing.
Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
Introduction. Information on antibiotic utilization in the Republic of Srpska is limited. The aim of this study was to analyze antibiotic utilization in the community from 2007 to 2011 and to compare this data with antibiotic use in other European countries. Materials and Methods. We did a population-based study to analyze systemic antibiotic utilization by an outpatient population using Anatomical Therapeutic Chemical/Defi ned Daily Dose methodology. The results were expressed as the defi ned daily dose (DDD) per 1000 inhabitants per day. The data were obtained from the annual reports of the Agency for Drugs and Medical Devices of the Republic of Srpska and Public Health Institute. Results. Outpatient use of systemic antibiotics ranged between 21.51 DDD in the year with the highest use (2010) and 17.01 DDD in the year with the lowest use (2011). Penicillins were the most frequently prescribed antibiotic group, and amoxicillin was the most frequently prescribed drug. Cefalexin was the most frequently prescribed cephalosporin. Increased use of a second-generation cephalosporin, cefuroxime constituted almost a third of cefalexin consumption in 2011. Second-generation quinolones, mostly ciprofl oxacine, accounted for about 70% of total quinolones consumption, with rising third-generation drugs also in proportion to the increasing use. Erythromycine was the most frequently used macrolide, followed by long-acting azithomycin. Conclusion. Outpatient use of systemic antibiotics in the Republic of Srpska, at about 19 DDD, does not exceed that in Europe. As in other European countries, a shift between generations of drugs was noted for antibiotic use. Additional studies, including monitoring of seasonal variation impact on antibiotic use, are needed.
Background: Multiple reforms have been introduced in the Republic of Srpska to enhance prescribing efficiency. Objectives: First, assess their influence on utilization and expenditure on proton-pump inhibitors, statins and renin–angiotensin inhibitor drugs. Second, assess whether the Republic can obtain low prices for generics. Third, suggest additional reforms that could be introduced. Methods: Observational study of all ambulatory care patients between 2003 and 2010. Defined daily doses (DDDs) and DDDs per 1000 inhabitants per day used for measuring changes in utilization. Reimbursed expenditure used as health insurance perspective. Results: Increasing utilization in all three classes. Utilization of angiotensin-receptor blockers principally limited by prescribing restrictions. Reimbursed expenditure/DDD in all three classes decreased by up to 82% in 2010 versus 2004, appreciably improving prescribing efficiency for the statins. Increased utilization of esomeprazole at higher reimbursed expenditure/DDD, and similarly angiotensin-converting enzyme-inhibitor combinations at higher expenditure versus single drugs, limited the ability to fully capitalise on these reductions. Conclusion: Multiple measures helped lower expenditure/ DDD, providing hope to countries with small populations. Additional measures are planned to further improve prescribing efficiency in the Republic of Srpska.
Self‐medication with antibiotics adds to the global risk of increased spread of bacterial resistance. Attitudes and behavior of health professionals also may reinforce self‐medication with antibiotics. The aim of this study was to determine whether self‐medication with antibiotics is possible in our community pharmacies and to what extent, and to evaluate the behavior and service of pharmacy health professionals regarding non‐prescription antibiotic dispensation.
Background The aim of this study was to analyze the total outpatient utilization of antibacterials for systemic use (ATC class J01) and the outpatient utilization of antibiotics on the reimbursable medication list of the Health Insurance Fund, in the Republic of Srpska, in 2007 and 2008. Methods In the retrospective study outpatient utilization of prescription-only antibacterials for systemic use dispensed in pharmacies was analyzed. Anatomical therapeutic chemical/defined daily dose methodology was used to monitor drug utilization. Results It was observed that penicillins accounted more than 50% of both total and reimbursable antibiotic use, and that broad-spectrum penicillins were more prescribed than narrow-spectrum. Amoxicilline was the most prescribed antibiotic. Cephalosporins, namely cefalexin, were widely prescribed as well as tetracyclines and combination of sulfametoxazole and trimethoprim. Increased utilization of a macrolide antibiotic claritromycin was observed. The list of reimbursable antibiotics was comprised of the first-generation antibiotics. Utilization of all reimbursable antibiotics increased in 2008, except phenoxymethylpenicillin, due to marketing authorization renewal process. Conclusions The outpatient utilization of antibiotics was comparable with trends worldwide. Utilization increase of almost all reimbursable antibiotics suggested that more patients were able to achieve their rights deducible form the health insurance, and that the spending out-of pocket for medicines was reduced. Utilization of amoxicillin, solely or in combination with clavulanic acid, as the most prescribed antibitotic was similar to other countries. Antibiotics are important and widely used medicines.1,2 In human medicine, about 80-90% of antibiotics are used in outpatient and the rest in hospitalized patients.3 Overuse and/or misuse of antibiotics have significant consequences, such as increased costs, therapeutic failure, drug toxicity, drug interactions, and bacterial resistance. In developing countries, on average, 35 per cent of the total health budget is spent on antibiotics.4 Antimicrobial drug resistance is a rapidly increasing global problem.5,6 Prevalence of resistance is positively correlated with prescribed outpatient antibiotic use at national level. Although antibiotics are prescription-only medicines, actual consumption may also include self-medication.2,6,7 Cultural factors to play important role in the consumption of antibiotics.8,9 Thus, information on the trends, patterns, and determinants of antibiotic consumption is essential to determine areas where improvement is needed. Until recently, information on outpatient antibiotic consumption in various countries was limited. In 2001, Cars et al.3 published comparable outpatient antibiotic use in fifteen European countries. A compulsory reporting of health institutions to Drug Regulatory Agency of the Republic of Srpska (DRA) on drugs utilization started in year 2006, when a related by-law came into action.10 Up to 2006, there were no comprehensive data available for analysis of total outpatient antibiotic utilization in the Republic of Srpska. Therefore, only the data on utilization of drugs on the reimbursable medication list of the Republic of Srpska Health Insurance Fund (HIF) were available and reliable source for analysis on drugs utilization and prescribing patterns.11,12 The aim of this study was to analyze the total outpatient utilization of antibiotics classified in ATC group J01 and the outpatient utilization of antibiotics on the reimbursable medication list of the Health Insurance Fund, in 2007 and 2008. Methods The outpatient utilization of all prescription-only drugs and the outpatient utilization of drugs on the reimbursable 23 Marković-Peković et al. medication list of the Health Insurance Fund was analyzed (Table 2), using anatomical therapeutic chemical/defined daily dose methodology (ATC/DDD methodology). The ATC system classifies the drugs into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties. The drugs were classified into ATC groups by its international non-proprietary name (INN), and the results were expressed as a DDD per thousand inhabitants per day (DDD/ TID). The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults, and its use in DDD/TID is to enable a study of the extent of medicine utilization in a defined area and its changes over certain time period. The DDD/TID is a useful indicator for national and international comparisons, especially when areas to be compared have different number of inhabitants.13, 14 Hereafter in this article, the acronym DDD should be taken to indicate DDD/TID. Utilization of antibacterials for systemic use (ATC class J01) dispensed in the pharmacies in 2007 and 2008 was analyzed, excluding antifungals, antibacterials for tuberculosis, antitumoral and topical antibiotics. According to the Law on Medicines, antibiotics are prescriptiononly medicines, prescribed by family practitioners and dispensed in the pharmacies by pharmacists, through individual prescription forms.15 Utilization statistics were retrieved from the DRA16 and HIF database, unpublished data are available upon request. List of medicines reimburesd by the HIF is published in the Republic of Srpska Official Gazzette.17,18 Results The obtained results were presented in a systematic way using different ATC levels, starting with the utilization data of the main anatomical groups (Table 1), followed with the pharmacological subgroups of the antiinfectives for systematic use (group J) (Fig. 1), and subsequently presenting the results of the chemical subgroups (Table 2) and active substances (Table 3). Both total outpatient drugs utilization and utilization of the reimbursable drugs were increased in this period, for 10% and 26%, respectively. Total utilization of antibacterials for systemic use (J01) in 2008 decreased for 18%, while the utilization of reimbursable antibiotics increased for 2% (Table 1). In total antibiotic utilization, beta-lactam penicillins were the most prescribed subgroup, followed by the subgroups of other beta-lactam antibacterials (cephalosporins), and tetracyclines. An increase in utilization of sulfonamides and trimethoprim and quinolones subgroups was observed, while the utilization of macrolides, lincosamides and streptogramins subgroup decreased. The most prescribed reimbursable antibiotic subgroup also belongs to beta-lactam penicillins. An increase in utilization was noted in subgroup of tetracyclines, while the utilization decreased in subgroups of macrolides, lincosamides and streptogramins and quinolone antibiotics (Fig.1). TOTAL DRUGS UTILIZATION REIMBURSABLE DRUGS UTILIZATION ATC 2007 2008 ATC 2007 2008 DDD Percentage DDD Percentage DDD Percentage DDD Percentage C 174,54 37,37 213,67 41,45 C 159,77 65,54 201,55 65,61 N 72,45 15,51 70,05 13,59 A 26,76 10,98 38,21 12,44 A 57,05 12,22 66,49 12,90 N 19,61 8,04 22,46 7,31 B 51,94 11,12 59,03 11,45 R 12,71 5,21 12,44 4,05 M 22,00 4,71 24,42 4,74 J 9,60 3,94 9,78 3,18 R 20,23 4,33 21,60 4,19 B 2,76 1,13 6,27 2,04 S 17,41 3,73 20,91 4,06 H 4,03 1,65 6,14 2,00 J 22,06 4,72 17,72 3,44 S 3,37 1,38 4,32 1,41 Other groups 29,33 6,28 21,62 4,19 Other groups 5,15 2,11 6,04 1,97 Total utilization 467,01 100 515,51 100 Total utilization 243,76 100 307,21 100 Key: C, cardiovascular system; N, nervous system; A, alimentary tract and metabolism; B, blood and blood forming organs; M, musculo-skeletal system; R, respiratory system; S, sensory organs; J, antiinfectives for systemic use; H, systemic hormonal preparations; DDD=DDD/TID, defined daily dose per thousand inhabitants per day. table 1. Outpatient utilization of drugs dispensed in pharmacies: total utilization of all prescription-only drugs and utilization of reimbursable drugs, in terms of DDD/TID and percentage, ranked by 2008 24 Scripta Medica Vol. 41 • No 1 • May 2010. It was observed that penicillins accounted for more than 50 per cent of both total and reimbursable antibiotic use. Broad-spectrum penicillins were four to five times more prescribed than the narrow-spectrum penicillins. In 2008, the total utilization broadand narrow-spectrum penicillins decreased for 19% and 44%, respectively. The use of broad-spectrum reimbursable penicillins rose for 3 per cent, while the use of narrow-spectrum decreased for 4% (Table 2). Combination of amoxicillin with clavulanic acid, accounted for about 3% of the total antibiotic use, with utilization decrease. This combination was not available at the reimbursable drugs list (Table 2 and Table 3). Subgroup of tetracyclines represented about 10% of both the total and the reimbursable antibiotic utilization. Doxycycline accounted for 90% of the total tetracycline utilization, and was the only tetracycline reimbursed by the HIF (Table 2 and Table 3). The utilization of sulfonamides and trimethoprim combination accounted for 10% of the total antibiotic utilization, and about 16% of reimbursed antibiotics, with an increased use noted (Table 2 and Table 3). In 2008, total utilization of cephalosporins subgroup decreased, and first-generation was the most prescribed, with a noted decrease of 4%. Utilization of the secondand third-generation of cephalosporins decreased in 2008 (Table 3). Cefalexin was the only cephalosporin antibiotic reimbursed by HIF, with 8% utilization increase in 2008 (Table 3). In 2008, total use of macrolides decreased for 19% and the fluoroquinolones increased for 12%, while reimbursable utilization of these both subgroups decreased (Table 2). As shown in Table 3, amoxicilline was the most used antibiotic, and ten times more prescribed than ampicilin in 2007. We noticed that in 2008 total amoxicilline use decreased, while the reimbursed one increased for 21% and 3%, respectively. The total use of benzathine phenoxymethylp
The objective of this study was to analyse cardiovascular medicines utilisation patterns in Republic of Srpska (Bosnia and Herzegovina) over the 2002–2006 period.
Sažetak. U trendu porasta ukupnih troškova za zdravstvo, kontinuirano praćenje upotrebe lijekova и zdravstenom sistemu omogućava sagledavanje zdravstvenog stanja stanovništva, farmakoterapijskih navika doktora i trendova и propisivanju, stepena racionalnosti upotrebe lijekova, te upoređivanja istih sa svjetskim kretanjima. Cilj ovog rada je bio da se analizira upotreba lijekova koji se izdaju na teret Fonda zdravstvenog osiguranja Republike Srpske и periodu 2003-2004. godina. Retrospektivnom studijom analizirana je upotreba lijekova sa pozitivne liste Fonda zdravstvenog osiguranja Republike Srpske 2003-2004. godine. Podaci su obrađeni prema ATC/DDD metodologiji, a rezultati izraženi brojem DDD/1.000 osiguranih lica/dan. Prikazana su i materijalna izdvajanja za lijekove sa pozitivne liste, izraženo и milionima konvertibilnih maraka. U 2004. godini je došlo do porasta upotrebe lijekova od 21% izraženo brojem DDD, a materijalna izdvajanja su porasla za 25% и odnosu na prethodnu godinu. Najveéa je upotreba lijekova и grupama za kardiovaskularne bolesti (ACE inhibitori i Ca blokatori), lijekova koji djeluju na sistem za varenje i metabolizam (antidijabetici i antiulkusici), koji djeluju na nervni sistem (antiepileptici i anksiolitici), te sistemski antiinfektivi. U obe godine najveéi su troškovi bili izdvojeni za lijekove и liječenju kardiovaskularnih oboljenja. Porast upotrebe lijekova, kao i povećanje troškova и zdravstvu zahtijeva detaljnu analizu, primjenom farmakoekonomskih metoda koje bi trebalo da pomognu pri donošenju odluka о raspodjeli raspoloživih sredstava. Na osnovu ovakvih podataka država тога kontinuirano da prilagođava zdravstevnu politiku и skladu sa standardnim kliniâkim smjernicama i medicini zasnovanoj na dokazima, kako bi farmakoterapiju učinila racionalnom i dostupnom cjelokupnom stanovništvu.
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