- Publikační typ
- abstrakt z konference MeSH
Objectives: The aim of this study was to characterize the reimbursement policy for orphan drugs (ODs) in Central and Eastern European (CEE) countries in relation to the availability and impact of clinical evidence, health technology assessment (HTA) procedure, selected economic indicators, and the drug type according to indications. Materials and methods: A list of authorized medicines with orphan designation and information about active substance, Anatomical Therapeutic Chemical (ATC) classification, and therapeutic area was extracted from the web-based register of the European Medicines Agency (EMA). A country-based questionnaire survey was performed between September 2021 and January 2022 in a group of selected experts from nine CEE countries (an invitation was sent to 11 countries). A descriptive and statistical analysis was conducted to determine statistical significance, correlations, between the drug or country characteristic and the positive recommendation or reimbursement of ODs.Results: The proportion of reimbursed orphan drugs differed between countries, ranging from 17.7% in Estonia to 49.6% in Hungary (p < 0.001). The odds that ODs were reimbursed were reduced in countries with a "strong" level of impact of drug safety and efficacy on reimbursement decisions (p=0.018), the presence of other additional specific clinical aspects (e.g., genomic data) considered in the reimbursement decision (p < 0.001) and mandatory (without exception) safety assessments (p=0.004). The probability that ODs were reimbursed was increased in countries with a "moderate" level of impact of drug safety and efficacy on reimbursement decisions (p=0.018), when reimbursement decisions are dependent on the EMA registration status and orphan drug designation (p < 0.001), the presence of the "positive HTA recommendation guarantees reimbursement" policy (p < 0.001), higher GDP per inhabitant (p=0.003), and higher healthcare expenditure (p < 0.001). Conclusion: We found that there are differences among CEE countries in the reimbursement of orphan drugs, and we identified aspects that may influence these differences. Safety, efficacy, and specific clinical aspect issues significantly influenced reimbursement decisions. Antineoplastic and immunomodulating agents drugs were the largest group of ODs and increased the chance of getting a positive recommendation. The higher GDP per inhabitant and healthcare expenditures per inhabitant were positively linked to the chance that an OD receives reimbursement.
- Publikační typ
- časopisecké články MeSH
Inhalačné prípravky patria medzi preferovanú formu liekov v terapii respiračných ochorení, akými sú priedušková astma a chronická obštrukčná choroba pľúc (CHOCHP), kedy na liečbu používame bronchodilatanciá, resp. kontrolné liečivá. Hlavným cieľom nášho výskumu bolo zistiť všeobecné poznatky verejných lekárnikov o jednotlivých inhalačných systémoch (IS) vydávaných v lekárňach. Informácie potrebné k vyhodnoteniu sme získali prostredníctvom anonymného dotazníkového prieskumu realizovaného v období 09/2020 – 01/2021, ktorý prebiehal v tlačenej a v elektronickej forme. Použitý dotazník bol vlastnej konštrukcie, anonymný, tvorený so sociodemografických údajov (vek, pohlavie, bydlisko – kraj) a 22 výskumných otázok. V rámci prieskumu bolo sledované použitie bronchodilatancií aj inhalačných kortikosteroidov. Prieskumu sa celkovo zúčastnilo 115 respondentov, z toho žien bolo 86 (75 %) a mužov 29 (25 %). Najviac respondentov bolo vo vekovej kategórii do 23 – 29 rokov 45 (39 %). Zo zozbieraných dát vyplýva, že 62 respondentov (53,91 %) sa s výdajom inhalátorov stretáva niekoľkokrát denne, pričom prevažujú aerosólové inhalátory (MDI), čo uviedlo 78 (67,83 %) lekárnikov. Väčšinou sa stretávajú lekárnici s pacientmi trpiacimi prieduškovou astmou 80 (69,57 %) a v terapii sú najviac preskribované bronchodilatanciá 74 (64,35 %). Celkovo 60 respondentov (52,17 %) poskytuje informácie o správnej aplikácií inhalačných liekov na požiadanie pacienta a len 46 (40 %) respondentov ich poskytuje automaticky. Z výsledkov prieskumu vyplýva, že najmenej vedomostí mali verejní lekárnici o nebulizéroch a taktiež o používaní inhalačných nástavcoch. Drvivá väčšina zúčastnených 90 (78,26 %) uviedla, že po ukončení štúdia neabsolvovala žiadnu vzdelávaciu aktivitu zameranú na správnu aplikáciu inhalačných prípravkov v rámci kontinuálneho vzdelávania. Až 95 (82,61 %) respondentov má záujem o makety IS v lekárni, 103 (89,97 %) lekárnikov má záujem o informačné materiály pre vlastné samoštúdium a 110 (95,65 %) respondentov o letáky a brožúry o IS pre pacientov. Pozitívnym zistením prieskumu bolo, že väčšina opýtaných 101 (87,83 %) má záujem sa v budúcnosti ďalej vzdelávať v danej problematike. Z výsledkov nášho prieskumu vyplýva, že vedomosti našich respondentov o IS sú na dostačujúcej úrovni. Väčšina nami oslovených lekárnikov vie poskytnúť pacientom základné informácie týkajúce sa správnej aplikácie inhalačných liekov.
Inhaled medications are considered a preferred dosage form of medicine to treat respiratory diseases, such as bronchial asthma and chronic obstructive pulmonary disease (COPD), when bronchodilators or, more precisely, controlled drugs for treatment are used. The main objective of our research was to find out community pharmacists' general knowledge of particular inhalation systems (IS) dispensed in pharmacies. All data necessary for the evaluation have been obtained by an anonymous survey questionnaire carried out between September 2020 and January 2021, which was done both in printed form and online. The questionnaire was self-construction, anonymous, consisting of sociodemographic data (age, gender, residence address – region) and 22 research questions. Both the administration of bronchodilators and inhaled corticosteroids were monitored in the survey. A total of 115 respondents participated in the survey, 86 females (75%) and 29 males (25%). Most of the respondents, 45 (39%), were aged between 23 and 29. The data show that 62 respondents (53.91%) encounter inhaler dispensing several times a day, with the prevalence of aerosol inhalers (MDI), which was confirmed by 78 pharmacists (67.83%). Most of the time, pharmacists meet patients with bronchial asthma, 80 (69.57%), and bronchodilators are prescribed for therapy mainly, 74 (64.35%). In total, 60 respondents (52.17%) provide patients with information on proper administration of inhaled medicines at their request, and only 46 of the respondents (40%) do it without being asked. The survey outcomes show that community pharmacists have minimum knowledge of nebulizers and also of the use of inhalator attachments. The vast majority of participants, 90 (78.26%), say that since they graduated, they haven't attended any education courses aimed at proper administration of inhaled medications as part of their constant education. Up to 95 respondents (82.61%) are interested in IS mock-ups in a pharmacy, 103 pharmacists (89.97%) in information materials for their self-study, and 110 respondents (95.65%) in IS leaflets and brochures for patients. A positive finding of the survey is that the majority of the respondents, 101 (87.83%), are interested in further educating themselves to get knowledge of this matter in the future. Our survey outcomes show that our respondents' knowledge of inhalation systems (IS) is sufficient. Most of the pharmacists who participated in the survey can provide patients with basic information regarding the proper administration of inhaled medicines.
Secondary prevention of peripheral arterial disease (PAD) includes administration of antiplatelet agents, and adherence to medication is a requirement for an effective treatment. The aim of this study was to analyse adherence measured using the proportion of days covered (PDC) index separately in persistent and non-persistent patients, and to identify patient- and medication-related characteristics associated with non-adherence in these patient groups. The study cohort of 9178 patients aged ≥ 65 years in whom PAD was diagnosed in 1/-12/2012 included 6146 persistent and 3032 non-persistent patients. Non-adherence was identified as PDC < 80%. Characteristics associated with non-adherence were determined using the binary logistic regression model. In the group of persistent patients, 15.3% of subjects were identified as non-adherent, while among non-persistent patients, 26.9% of subjects were non-adherent to antiplatelet medication. Administration of dual antiplatelet therapy (aspirin and clopidogrel) and a general practitioner as index prescriber were associated with adherence in both patient groups. Our study revealed a relatively high proportion of adherent patients not only in the group of persistent patients but also in the group of non-persistent patients before discontinuation. These results indicate that most non-persistent PAD patients discontinue antiplatelet treatment rapidly after a certain period of adherence.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Medicines that are based on known molecules and are further developed to address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers are called value-added medicines (VAMs). The evaluation process of VAMs is heterogeneous across countries, and it has been primarily designed for originator pharmaceuticals with confirmatory evidence collected alongside pivotal clinical trials. There is a mismatch between evidence requirements by public decision-makers and evidence generated by manufacturers of VAMs. Our objective was to develop a core evaluation framework for VAMs. METHODS: Potential benefits offered by VAMs were collected through a systematic literature review and allocated to separate domains in an iterative process. The draft list of domains and their applicability were validated during two consecutive virtual workshops by health policy experts representing countries with different economic statuses, geographical and decision-making contexts. RESULTS: Based on 158 extracted studies, the final consensus on the evaluation framework resulted in 11 value domains in 5 main clusters, including unmet medical needs, health gain (measured by health care professionals), patient-reported outcomes, burden on households, and burden on the health care system. CONCLUSIONS: The proposed framework could reduce the heterogeneity in value assessment processes across countries and create incentives for manufacturers to invest in incremental innovation. However, some domains may not be equally relevant or accepted in all countries, therefore the core framework needs thorough adaptation in specific jurisdictions.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers. AREAS COVERED: The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines. The proposed evaluation framework may provide a starting point for practices based on which VAMs can be exempted from generic pricing mechanisms or can be integrated into the reimbursement and procurement system, allowing for price differentiation according to their added value. Besides evidence from RCTs, pricing and reimbursement decision processes of VAMs should allow for ex-ante non-RCT evidence for certain domains. Alternatively, relying on ex-post evidence agreements-such as outcome guarantee or coverage with evidence development-can also reduce decision uncertainty. CONCLUSIONS: The core evaluation framework for VAMs could trigger changes in the existing pricing, reimbursement and procurement practices by improving the appraisal of the added value created by incremental innovation.
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
Cieľom práce bolo vyhodnotiť spotrebu antibiotík v sektore ambulantnej starostlivosti na Slovensku v roku 2020 v porovnaní s rokom 2019 a vypočítať ukazovatele kvality ambulantného používania antibiotík v sledovanom období. Zdrojom informácií za rok 2020 o spotrebe antibiotík (ATC skupina J01) sú údaje o výdaji liekov, ktoré boli čerpané z NCZI. Hlavným ukazovateľom popisujúcim spotrebu antibakteriálnych liečiv na systémové použitie je počet DDD na 1000 obyvateľov za deň (DID). Ako zdroj spotreby antibiotík boli za rok 2019 použité údaje z Európskeho systému dohľadu, ktorý poskytlo Slovensko a vydalo ho Európske centrum pre ochranu pred chorobami. Najčastejšie užívanými antibakteriálnymi liečivami na systémové použitie v ambulantnej starostlivosti v roku 2020 boli iné betalaktámové antibiotiká (J01D), makrolidy, linkozamidy a streptogramíny (J01) a betalaktámové antibiotiká, penicilíny (J01C), s hladinami 3,30 DID, 3,30 DID a 3,27 DID, v uvedenom poradí. Pozorovali sme úrovne spotreby 1,66 DID pre tetracyklíny (J01A), 1,14 DID pre chinolónové antibiotiká (J01M), 0,41 DID pre sulfónamidy a trimetoprim (J01E), 0,07 DID pre iné antibakteriálne liečivá (J01X) a 0,01 DID pre ostatné antibiotiká (J01B, J01G a J01R kombinácie). Celkovo sa spotreba antibiotík v sektore ambulantnej starostlivosti na Slovensku počas pandémie COVID-19 v roku 2020 v porovnaní s rokom 2019 výrazne zmenila.
The aims of this study was to compare the data on the consumption of antibiotics in the outpatient care sector for Slovakia from 2019 to 2020 and to calculate quality indicators for outpatient antibiotic use. The data source on the consumption of antibiotics (ATC group J01), is the sales data from the NCZI. The main indicator describing the consumption of antibacterials for systemic use is the number of DDDs per 1000 inhabitants per day (DID). The data released by the European Centre for Disease Protection were used as the source for antibiotic consumption for 2019. The most frequently consumed antibacterials for systemic use in the outpatient care sector in 2020 were other beta-lactam antibacterials (J01D); macrolides, lincosamides and streptogramins (J01); and betalactam antibacterials, penicillins (J01C), with the levels of 3.30 DID, 3.30 DID and 3.27 DID, respectively. Consumption levels of 1.66 DID for tetracyclines (J01A), 1.14 DID for quinolone antibacterials (J01M), 0.41 DID for sulfonamides and trimethoprim (J01E), 0.07 DID for other antibacterials (J01X), and 0.01 DID for other antibiotics (J01B, J01G and J01R combined) can be seen. Overall, antibiotic consumption in the outpatient care sector did significantly change in Slovakia from 2019 to 2020 as a result of the COVID-19 pandemic.
- Klíčová slova
- definovaná denní dávka,
- MeSH
- antibakteriální látky * terapeutické užití MeSH
- lidé MeSH
- spotřeba léčiv * statistika a číselné údaje MeSH
- ukazatele kvality zdravotní péče MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- Geografické názvy
- Slovenská republika MeSH
BACKGROUND: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percentage of HTA recommendations and reimbursement decisions for oncology OD. In addition, the study was designed to elucidate the impact of reimbursement of these drugs on the public budget and the agreement between HTA recommendations and reimbursement decisions in the analysed countries. A questionnaire survey was used to collect data on the reimbursement status, HTA recommendation, marketing authorisation, and public expenses on reimbursement in 2014, 2015, and 2016 for all oncology drugs with an orphan designation by the European Medicine Agency in 2017 in Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovakia. The agreement between the HTA recommendation and reimbursement status was assessed using the kappa coefficient. The Pearson's correlation was used to analyse the relationship between gross domestic product (GDP) and GDP per capita and reimbursement expenses. RESULTS: A total of 36 drugs were analysed (25% conditionally approved; 5.56% approved under exceptional circumstances). The share of reimbursed drugs ranged from 11.11% in Latvia to 41.67% in Poland. The highest share of positive recommendations was observed for Bulgaria and Estonia (36.11%), and the lowest, for Latvia (11.11%). The agreement varied from 0.4 for Poland to 1 for Latvia, Hungary, and Slovakia. Expenses were correlated with GDP (0.95 [0.81-0.99]), and not with GDP per capita (0.54 [- 0.136 to 0.873]). Expenses per capita were not correlated with GDP per capita (0.52 [- 0.15 to 0.87]). CONCLUSIONS: In Hungary, Latvia, and Slovakia, a positive recommendation was associated with a reimbursement, and a negative one, with the lack of reimbursement. The reimbursement of oncology OD is associated with a growing burden for public budget, and the expenses are correlated with the total GDP. The highest share of drugs with any recommendation was observed in Poland, and the lowest, in Latvia and Romania. The share of reimbursed drugs was the lowest in Latvia and the highest in Poland.
- MeSH
- hodnocení biomedicínských technologií * MeSH
- léčivé přípravky * MeSH
- lidé MeSH
- postup MeSH
- výroba orphan drugs MeSH
- zdravotní politika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Evropa MeSH
- Lotyšsko MeSH
- Polsko MeSH
The effectiveness of statins in secondary prevention of peripheral arterial disease (PAD) largely depends on patients' adherence to treatment. The aims of our study were: (a) to analyze non-adherence during the whole follow-up in persistent patients, and only during persistence for non-persistent patients; (b) to identify factors associated with non-adherence separately among persistent and non-persistent patients. A cohort of 8330 statin users aged ≥65 years, in whom PAD was newly diagnosed between January 2012-December 2012, included 5353 patients persistent with statin treatment, and 2977 subjects who became non-persistent during the 5-year follow-up. Non-adherence was defined using the proportion of days covered <80%. Patient- and statin-related characteristics associated with non-adherence were identified with binary logistic regression. A significantly higher proportion of non-adherent patients was found among non-persistent patients compared to persistent subjects (43.6% vs. 29.6%; p < 0.001). Associated with non-adherence in both persistent and non-persistent patients was high intensity statin treatment, while in non-persistent patients, it was employment and increasing number of medications. In patients with a poor adherence during their persistent period, an increased risk for discontinuation may be expected. However, there is also non-adherence among persistent patients. There are differences in factors associated with non-adherence depending on patients' persistence.
- Publikační typ
- časopisecké články MeSH
Úvod: Diabetes mellitus 2. typu (DM) je ochorenie, ktoré v súčasnosti nadobúda pandemický charakter. Základom úspešnej terapie tohto ochorenia je predovšetkým včasná diagnostika a vhodne nastavená liečba. Rovnako ako úloha lekára v terapii ochorenia je potrebná aj iniciatívnosť a snaha motivovať pacienta k dodržiavaniu jednotlivých režimov zo strany verejného lekárnika. Cieľ: Cieľom výskumu bolo zanalyzovať a vyhodnotiť dodržiavanie farmakologickej a nefarmakologickej liečby u pacientov trpiacich diabetes mellitus a možnosti ovplyvnenia zo strany verejného lekárnika. Metodika: Informácie potrebné k vyhodnoteniu sme získali prostredníctvom anonymného dotazníkového prieskumu realizovaného za obdobie 7 mesiacov a na základe osobných konzultácií lekárnika s pacientom. Výsledky: Prieskumu sa zúčastnilo 117 respondentov, z toho 67 (57 %) žien a 50 (43 %) mužov. Najväčšie zastúpenie mali respondenti vo veku 60 – 74 rokov (48 %). Až 84 % respondentov trpelo diabetes mellitus 2. typu. Čo sa týka dodržiavania nefarmakologickej liečby (režimových a diétnych opatrení) väčšina respondentov či už pri porovnaní vzhľadom na pohlavie (96 % žien a 76 % mužov), alebo vzhľadom na vek (v každej vekovej kategórii nad 80 %) uviedla, že uvedené opatrenia dodržiavajú. Pri farmakologickej liečbe až 83 % žien a 79 % mužov dodržiavalo stanovenú farmakologickú liečbu. Takisto aj po vyhodnotení vzhľadom na vek bolo zistené, že v každej vekovej kategórii (okrem respondentov vo veku od 75 a viac rokov) stále dodržiavalo stanovenú farmakologickú liečbu viac než 70 % respondentov, vo veku od 60 do 74 rokov to bolo až 88 % respondentov. Čo sa týka hladiny glykémie nalačno u 49 % žien a 38 % mužov bola menej ako 7 mmol/l. Celkovo u 10 % pacientov na základe pravidelných konzultácii s lekárnikom prišlo k zlepšeniu hladín glykémie nalačno. Záver: Na základe získaných výsledkov môžeme konštatovať, že v našej vybranej vzorke väčšina pacientov dodržiavala farmakologickú aj nefarmakologickú liečbu. Pri zlepšení adherencie k liečbe zohráva dôležitú úlohu aj lekárnik. Prostredníctvom poskytovania odborných vedomostí a znalostí pacientom pri výdaji lieku alebo poskytovaním individuálnych konzultácií pacientov môže lekárnik motivovať pacienta k dodržiavaniu nielen farmakologickej, ale aj nefarmakologickej liečby a tým zvýšiť aj samotnú adherenciu pacienta k liečbe.
Background: Diabetes mellitus type 2 (DM) is a disease which is becoming pandemic these days. A successful treatment of chronic diabetes mellitus depends on early diagnosis and proper treatment. Just as the role of the doctor in treating the disease is important, so the community pharmacist plays an important role in taking the initiative in motivating patients to adhere to individual treatment regimes. Objective: The main aim of the study was to analyze and assess patient adherence to pharmacological or non-pharmacological treatment, including the influence of the community pharmacist on that. Method: All necessary data for the assessment were collected by anonymous questionnaire survey methods conducted within 7 months, as well as by personal consulting among pharmacists and patients. The results were assessed according to patients’ gender and age. Results: 117 respondents got involved in the survey, with 67 (57%) females and 50 (43%) males. The majority were aged 60–74 (48%), 84% suffered from diabetes mellitus type 2. Adherence to non-pharmacological treatment (regime and dietary measures) was 96% in females and 76% in males according to gender, and over 80% in each age category. Adherence to pharmacological treatment was up to 83% in females and 79% in males. According to age, over 70% adhered to pharmacological treatment all the time in each age category (except for 75+), with up to 88% aged 60–74. Conclusion: According to the outcomes, we can observe that in our selected sample of patients the majority followed pharmacological or non-pharmacological treatment. The pharmacist also plays an important role in improving adherence to treatment. By providing patients with their expertise and professional knowledge while drug dispensing or individual conselling, the pharmacist can motivate the patient to follow not only pharmacological but also non-pharmacological treatment and thereby increase patient adherence itself to treatment.
- MeSH
- adherence k farmakoterapii MeSH
- adherence pacienta MeSH
- diabetes mellitus 2. typu * terapie MeSH
- farmaceuti MeSH
- farmaceutické služby MeSH
- lidé středního věku MeSH
- lidé MeSH
- průzkumy a dotazníky MeSH
- selfmonitoring glykemie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
