Impact of orphan drugs on Latvian budget

Publisher Copyright: © 2016 Logviss et al.Background: Number of orphan medicinal products on the market and number of rare disease patients, taking these usually expensive products, are increasing. As a result, budget impact of orphan drugs is growing. This factor, along with the cost-effectiveness of orphan drugs, is often considered in the reimbursement decisions, directly affecting accessibility of rare disease therapies. The current study aims to assess the budget impact of orphan drugs in Latvia. Methods: Our study covered a 5-year period, from 2010 to 2014. Impact of orphan drugs on Latvian budget was estimated from the National Health Service's perspective. It was calculated in absolute values and relative to total pharmaceutical market and total drug reimbursement budget. A literature review was performed for comparison with other European countries. Results: Orphan drug annual expenditure ranged between EUR 2.065 and 3.065 million, with total 5-year expenditure EUR 12.467 million. It constituted, on average, 0.84 % of total pharmaceutical market and 2.14 % of total drug reimbursement budget, respectively. Average annual per patient expenditures varied widely, from EUR 1 534 to EUR 580 952. The most costly treatment was enzyme replacement therapy (Elaprase) for MPS II. Glivec had the highest share (34 %) of the total orphan drug expenditure. Oncological drugs represented more than a half of the total orphan drug expenditure, followed by drugs for metabolic and endocrine conditions and medicines for cardiopulmonary diseases. Three indications: Ph+ CML, MPS II, and PAH accounted for nearly 90 % of the total orphan drug expenditure. Conclusions: Budget impact of orphan drugs in Latvia is very small. It increased slightly over a period of five years, due to the slight increase in the number of patients and the number of orphan drugs reimbursed. Current Latvian drug reimbursement system is not sufficient for most orphan drugs.publishersversionPeer reviewe

Rare diseases and orphan drugs : Latvian story

Publisher Copyright: © 2014 Logviss et al.; licensee BioMed Central Ltd.Background: Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries. Methods: We used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly available data from the state agencies, and directly contacted drug manufacturers and wholesalers. Results: National plan for rare diseases was developed and approved in 2013. Although there are no official designated centers of expertise as well as no specific register for rare diseases. Newborns are screened for only two disorders: phenylketonuria and congenital hypothyroidism. Currently 34 orphan drugs are available on Latvian market. Three medicines (8.8%) are included in the reimbursement drug list, all indicated for Ph + CML. 15 drugs (44.1%) were reimbursed within the framework of individual reimbursement system, and five drugs (14.7%) were provided within the program of medicinal treatment of rare diseases in children. Conclusions: Majority of orphan drugs authorized in the EU are not available in Latvia, moreover those drugs that are available are often not accessible because they are insufficiently reimbursed. Besides, approval of the national plan might be an important step towards improving situation in the field of rare diseases.publishersversionPeer reviewe

In vitro and ex vivo antibacterial activity of levofloxacin against Pasteurella multocida and Escherichia coli isolated from rabbits (Oryctolagus cuniculus) – A preliminary study

Funding Information: This study was funded from the Riga Stradins University doctoral grant. Funding Information: The authors sincerely thank Dr. Aneliya Milanova (Trakia University, Bulgaria) and Dr. Cristina Vercelli (University of Turin, Italy) for their scientific advice and help. Publisher Copyright: © 2023 The Authors. Journal of Veterinary Pharmacology and Therapeutics published by John Wiley & Sons Ltd.Levofloxacin veterinary formulations are available in Argentina, China and India for the use in dogs, cattle, pig and sheep, but not currently in the rabbit. Only the extra-label use in rabbits is possible. Levofloxacin is not labelled for veterinary use in the EU or the USA. The activity of levofloxacin against rabbit pathogens Pasteurella multocida (P. multocida) and Escherichia coli (E. coli) was evaluated. Minimum inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) were determined in broth and serum for 10 P. multocida isolates and 5 E. coli isolates from rabbits. One isolate of each bacterial species was used for the time-killing curve study in vitro and ex vivo. In vitro AUC24/MIC ratios were used for building the inhibitory pharmacodynamic Imax model. The P. multocida MIC were 0.008–0.5 μg/mL, MBC – 0.015–0.5 μg/mL. Escherichia coli MIC was 0.008–0.03 μg/mL and MBC – 0.03–0.25 μg/mL. Bacterial counts were reduced to the limit of detection after 24 h with levofloxacin concentrations of 2 MIC and higher. All serum samples from rabbits treated with levofloxacin eliminated the bacteria within 24 h. AUC24/MIC ratios for bacteriostatic, bactericidal and bacterial elimination effects for P. multocida and E. coli isolates were 21, 29 and 75 h and 27, 32 and 60 h, respectively. Proposed daily doses against P. multocida (MIC = 0.015 μg/mL) and E. coli (MIC = 0.03 μg/mL) isolates were calculated as ≤0.91 and ≤1.43 mg/kg, respectively. Fluoroquinolones are categorized by WHO as ‘highest priority critically important antimicrobials’. Considering the increasing importance of antimicrobial stewardship, antimicrobials from a lower importance category that are active against the isolate of interest should be used in preference to fluoroquinolones. Fluoroquinolone use in veterinary medicine should be based on antimicrobial susceptibility testing in order to mitigate the risk to public health and prevent the spread of bacterial resistance.Peer reviewe

Characteristics of clinical trials in rare vs. common diseases : A register-based Latvian study

Publisher Copyright: © 2018 Logviss et al. This is an open ccess article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and eproduction in any medium, provided the original author and source are credited.Background Conducting clinical studies in small populations may be very challenging; therefore quality of clinical evidence may differ between rare and non-rare disease therapies. Objective This register-based study aims to evaluate the characteristics of clinical trials in rare diseases conducted in Latvia and compare them with clinical trials in more common conditions. Methods The EU Clinical Trials Register (clinicaltrialsregister.eu) was used to identify interventional clinical trials related to rare diseases (n = 51) and to compose a control group of clinical trials in non-rare diseases (n = 102) for further comparison of the trial characteristics. Results We found no significant difference in the use of overall survival as a primary endpoint in clinical trials between rare and non-rare diseases (9.8% vs. 13.7%, respectively). However, clinical trials in rare diseases were less likely to be randomized controlled trials (62.7% vs. 83.3%). Rare and non-rare disease clinical trials varied in masking, with rare disease trials less likely to be double blind (45.1% vs. 63.7%). Active comparators were less frequently used in rare disease trials (36.4% vs. 58.8% of controlled trials). Clinical trials in rare diseases enrolled fewer participants than those in non-rare diseases: In Latvia (mean 18.3 vs. 40.2 subjects, respectively), in the European Economic Area (mean 181.0 vs. 626.9 subjects), and in the whole clinical trial (mean 335.8 vs. 1406.3 subjects). Although, we found no significant difference in trial duration between the groups (mean 38.3 vs. 36.4 months). Conclusions The current study confirms that clinical trials in rare diseases vary from those in non-rare conditions, with notable differences in enrollment, randomization, masking, and the use of active comparators. However, we found no significant difference in trial duration and the use of overall survival as a primary endpoint.publishersversionPeer reviewe

Key Learning Outcomes for Clinical Pharmacology and Therapeutics Education in Europe: A Modified Delphi Study.

Harmonizing clinical pharmacology and therapeutics (CPT) education in Europe is necessary to ensure that the prescribing competency of future doctors is of a uniform high standard. As there are currently no uniform requirements, our aim was to achieve consensus on key learning outcomes for undergraduate CPT education in Europe. We used a modified Delphi method consisting of three questionnaire rounds and a panel meeting. A total of 129 experts from 27 European countries were asked to rate 307 learning outcomes. In all, 92 experts (71%) completed all three questionnaire rounds, and 33 experts (26%) attended the meeting. 232 learning outcomes from the original list, 15 newly suggested and 5 rephrased outcomes were included. These 252 learning outcomes should be included in undergraduate CPT curricula to ensure that European graduates are able to prescribe safely and effectively. We provide a blueprint of a European core curriculum describing when and how the learning outcomes might be acquired

Statinu grupas HMG CoA reduktazes inhibitoru lipidmodulejosas un pleiotropas darbibas petijums

Separate summary in Latvian and English, 55 p.Available from Latvian Academic Library / LAL - Latvian Academic LibrarySIGLELVLatvi

Reintroduction of sturgeon, Acipenser oxyrinchus, in the Gulf of Riga, East-Central Baltic Sea

Atlantic sturgeon, Acipenser oxyrinchus Mitchill, inhabited and spawned in the territorial waters of Latvia from the early Neolithic. The A. oxyrinchus population in this area started to decline from the end of seventeenth century. By the twentieth century, just several sturgeon catches were documented. In 2012, Latvia joined the initiative to reintroduce native A. oxyrinchus. From 2013 to 2015, the Institute of Food Safety, Animal Health, and Environment (BIOR) released 4,500 A. oxyrinchus juveniles aged 1+ and 2+. The majority of sturgeon juveniles released inhabit the Gulf of Riga and Pärnu Bay and marine areas among the Estonian islands. Nearly all of the sturgeon released exhibit remarkable growth. The absence of visible pathologies suggests that the A. oxyrinchus individuals are in excellent condition. Increases in size and the absence of visible pathologies also suggest that A. oxyrinchus has a sufficient food base. Additionally, results indicate that there is free space in the food web for native Atlantic sturgeon. Sturgeon is caught primarily in salmon traps and other commercial fishing nets deployed at depths of 4-10mor by anglers. While we do not have complete information about the fates (dead or alive) of all sturgeons caught, approximately half of them that were reported by fishers were released back into the sea alive and healthy

Estimated trial enrollment and duration.

<p>(A) Enrollment in Latvia. (B) Enrollment in the EEA. (C) Enrollment in the whole clinical trial. (D) Trial duration.</p

Clinical trials in rare diseases.

<p>Clinical trials in rare diseases.</p

Characteristics of clinical trials in rare vs. non-rare diseases.

<p>(A) Primary endpoints. (B) Randomization. (C) Masking. (D) Comparators.</p