scholarly journals An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

2014 ◽  
Vol 27 (1) ◽  
pp. 32-36
Author(s):  
Monika Szkultecka-Debek ◽  
Mariola Drozd ◽  
Karina Jahnz-Rozyk ◽  
Nina Kiepurska ◽  
Joanna Mazurek ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Medicinal Products ◽  
Disease Area ◽  
Significant Cost ◽  
The Public ◽  
Polish Society ◽  
Costs Of Treatment ◽  
The Common ◽  
Public Payer

Abstract The project was performed within the Polish Society for Pharmacoeconomics (PTFE). The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

scholarly journals An adverse events potential costs analysis based on Drug Programs in Poland. Dermatology focus

2014 ◽  
Vol 27 (3) ◽  
pp. 183-186
Author(s):  
Monika Szkultecka-Debek ◽  
Mariola Drozd ◽  
Nina Kiepurska ◽  
Agnieszka Janowska ◽  
Piotr Paprzycki ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Direct Costs ◽  
Drug Reactions ◽  
Significant Cost ◽  
Total Cost ◽  
The Public ◽  
Polish Society ◽  
Costs Of Treatment ◽  
Public Payer

ABSTRACT The aim of the project, carried out within the Polish Society for Pharmacoeconomics (PTFE), was to estimate the potential costs of treatment of the side effects which (theoretically) may occur as a result of treatments for the selected diseases. This paper deals solely with dermatology related events. Herein, several Drug Programs financed by the National Health Fund in Poland, in 2012, were analyzed. The adverse events were selected based on the Summary of Product Characteristics of the chosen products. We focused the project on those potential adverse events which were defined in SPC as frequent and very frequent. The results are presented according to their therapeutic areas, and in this paper, the focus is upon that which is related to dermatology. The events described as ‘very common’ had an incidence of ≥ 1/10, and that which is ‘common’ - ≥ 1/100, <1 /10. In order to identify the resources used, we, with the engagement of clinical experts, performed a survey. In our work, we employed only the total direct costs incurred by the public payer, based on valid individual cost data in February 2014. Moreover, we calculated the total spending from the public payer’s perspective, as well as the patient’s perspective, and the percentage of each component of the total cost in detail. The paper, thus, informs the reader of the estimated costs of treatment of side effects related to the dermatologic symptoms and reactions. Based on our work, we can state that the treatment of skin adverse drug reactions generates a significant cost - one incurred by both the public payer and the patient.

scholarly journals Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

2020 ◽  
Author(s):  
Nigel Kirby ◽  
Victoria Shepherd ◽  
Jeremy Howick ◽  
Sophie Betteridge ◽  
Kerenza Hood
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Adverse Events ◽  
Medicinal Products ◽  
Flesch Reading Ease ◽  
Information Leaflets ◽  
Potential Benefits ◽  
Nocebo Effects ◽  
Trial Participants ◽  
Participant Information

Abstract Background Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). However, little is known about how information on potential side effects is provided to trial participants. In this study we aimed to increase the evidence-base in this area by identifying the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry. Eligible studies were placebo controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK in three targeted clinical areas (cancer, musculoskeletal conditions and mental and behavioural disorders). Ongoing and recently completed (within three years) trials were included. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results PILs from 33 studies were included. Most of the patient information leaflets were ranked as ‘fairly easy to read’ or ‘difficult to read’ according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33 64%). Discussion Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. In comparison to the adverse effects, potential benefits from the intervention and/or study were described less often and by shorter text. Participants were commonly presented with adverse effects ahead of any potential benefits.

scholarly journals Safety of adjuvant gemcitabine plus cisplatin chemotherapy in a patient with bilateral ureteral cancer undergoing hemodialysis

2021 ◽  
Author(s):  
Yumiko Goto ◽  
Kent Kanao ◽  
Kazuhiro Matsumoto ◽  
Ikuo Kobayashi ◽  
Keishi Kajikawa ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Standard Dose ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Old Japanese ◽  
Left And Right ◽  
The Common ◽  
Grade 3 ◽  
Stimulating Factor

AbstractAn 80 year old Japanese man with bilateral ureteral cancer underwent laparoscopic bilateral nephroureterectomy and lymph-node dissection. The pathological stage of the left and right ureteral tumors was pT3pN0M0. He received two courses of adjuvant gemcitabine and cisplatin chemotherapy while undergoing hemodialysis. The standard dose of gemcitabine and 50% of the standard dose of cisplatin were administered on the same day. Hemodialysis was started 6 h after gemcitabine administration and 1 h after cisplatin administration. The side effects were evaluated according to the Common Terminology Criteria for Adverse Events v4.0. In the first course, Grade 4 side effects including leukopenia, neutropenia, and thrombocytopenia were observed. He was treated with granulocyte colony-stimulating factor and platelet transfusion. Because the second course was administered without reducing the doses, granulocyte colony-stimulating factor was administered prophylactically, and Grade 4 side effects were reduced to Grade 3. Gemcitabine plus cisplatin chemotherapy can be administered safely in a patient with advanced ureteral cancer undergoing hemodialysis by adequately managing adverse events.

scholarly journals Intelligibilis – підвалини впливу на читача як інструмент залучення цільової зарубіжної аудиторії часопису „Arcana”

2021 ◽  
pp. 257-271
Author(s):  
Олександр Янішевський ◽  
Keyword(s):  
Editorial Policy ◽  
Practical Implementation ◽  
Common Denominator ◽  
Related Factors ◽  
The Public ◽  
Material Resources ◽  
Box Office ◽  
Polish Society ◽  
The Common

Following the publishing profile of the Arcana magazine, which has been published in Krakow for over a quarter of a century, it can be noticed that over the last four years (starting from 2016) this bimonthly has been trying to get out of the niche of traditional national-Christian values and join the category of magazines -for the conservative community of Polish society. The adopted editorial policy is evidenced by the declaration in issue 138 (6/2017): „Today, our main duties are not promotion, but creating real mental foundations for the practical implementation of Polish national interest”. This means that „Arcana” (the title translates from Latin as „mystery”) cannot be reduced to the role of a two-month collection of random material, but is a cognitively engaged magazine with a strictly defined social position. Each significant party needs more and more new supporters to support its arguments, points of view and position. Often the space for extensive development is outside the „maternal territory”, as „home voids” can run out fairly quickly, failing to keep up with internal, so to speak, introverted events and changes. Instead, the public plays the first role of the audience that came to the premiere curiously, leaving a certain amount of material resources in front of the box office. The greater the availability, the more resources remain on hand. This means that when entering the outer reading orbit, the following factors must be considered: a) finding answers to the cultural questions of „not your” consumers; b) the expected ’average’ level of intelligence of the target reader; c) the possibility of imposing on the reader their topics for discussion; d) other closely related factors that may result from the laws of random processes. The factors that attract new unfamiliar audiences may act cumulatively or individually; both partially and completely; intertwining, creating a certain „intertextual” discourse and contradicting each other. The common denominator here is the focus on intelligence, not the middle class.

scholarly journals A Retrospective Cross-Sectional Study Assessing Self-Reported Adverse Events following Immunization (AEFI) of the COVID-19 Vaccine in Bangladesh

Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1090
Author(s):  
Arifa Sultana ◽  
Saimon Shahriar ◽  
Md. Rafat Tahsin ◽  
Sabiha Rahman Mim ◽  
Kazi Rubiya Fatema ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Electronic Media ◽  
Cross Sectional Study ◽  
Therapeutic Window ◽  
Sectional Study ◽  
Short Term ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
The Common

Background: The Oxford–AstraZeneca vaccine (Covishield) was the first to be introduced in Bangladesh to fight the ongoing global COVID-19 pandemic. As this vaccine had shown some side-effects in its clinical trial, we aimed to conduct a study assessing short-term adverse events following immunization (AEFIs) in Bangladesh. Method: A cross-sectional study was conducted on social and electronic media platforms by delivering an online questionnaire among people who had taken at least one dose of the COVID-19 vaccine. The collected data were then analysed to evaluate various parameters related to the AEFIs of the respondents. Results: A total of 626 responses were collected. Of these, 623 were selected based on complete answers and used for the analysis. Most of the respondents were between 30–60 years of age, and 40.4% were female. We found that a total of 8.5% of the total respondents had been infected with the SARS-CoV-2 virus. Our survey revealed that out of 623 volunteers, 317 reported various side-effects after taking the vaccine, which is about 50.88% of the total participants. The majority of participants (37.07%, 231/623) reported swelling and pain at the injection site and fever (25.84%, 162/623); these were some of the common localized and generalized symptoms after the COVID-19 vaccine administration. Conclusion: The side-effects reported after receiving the Oxford–AstraZeneca vaccine (Covishield) are similar to those reported in clinical trials, demonstrating that the vaccines have a safe therapeutic window. Moreover, further research is needed to determine the efficacy of existing vaccines in preventing SARS-CoV-2 infections or after-infection hospitalization.

Cutaneous Adverse Events during Vemurafenib Therapy

2014 ◽  
Vol 18 (4) ◽  
pp. 223-228 ◽  
Author(s):  
Shivani Felicia Chandrakumar ◽  
Jensen Yeung
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Squamous Cell ◽  
Case Series ◽  
Stage Iv ◽  
Therapeutic Benefit ◽  
Braf V600e ◽  
Life Threatening ◽  
The Common ◽  
Dose Reductions

Background: Vemurafenib, an oral agent that selectively targets the BRAF V600E mutation, has recently emerged as the mainstay of treatment in patients with BRAF-positive stage IV melanoma. A spectrum of cutaneous adverse events has been associated with vemurafenib, ranging from benign rashes to malignant side effects such as keratoacanthoma and squamous cell carcinoma. Objective: In this article, we review clinical data regarding the frequency and severity of the common dermatologic side effects associated with vemurafenib; case series and noncontrolled studies evaluating the safety of vemurafenib therapy are used to further characterize these adverse events. Conclusion: Benign vemurafenib-induced side effects generally tend not to be severe or life threatening, with most patients managed by dose interruptions, dose reductions, or topical therapies. Squamous cell carcinomas and keratoacanthomas associated with vemurafenib therapy are easily treated by simple excision of the lesion without discontinuation of vemurafenib. Thus, awareness of potential adverse events coupled with routine dermatologic assessment and timely management will allow for optimal therapeutic benefit in patients receiving vemurafenib therapy.

Complications during cisplatin-based primary chemotherapy in patients with testicular cancer: Is there a need for thromboembolic prophylaxis?

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 371-371
Author(s):  
David J. K. P. Pfister ◽  
Daniel Porres ◽  
Ingrid Wolsky ◽  
Andrea K. Thissen ◽  
Axel Heidenreich
Keyword(s):  
Pulmonary Embolism ◽  
Side Effects ◽  
Adverse Events ◽  
Testicular Cancer ◽  
Clinical Stage ◽  
Primary Treatment ◽  
Thromboembolic Prophylaxis ◽  
Therapeutic Anticoagulation ◽  
Risk Patients ◽  
The Common

371 Background: Cisplatin-based chemotherapy is an integral part of the multimodal therapy of patients with testicular cancer. The purpose of this analysis is to evaluate the chemotherapy associated side effects of primary treatment in a modern patient cohort and to correlate them to clinical stage and IGCCCG risk profile. Methods: We retrospectively analyzed charts of patients with testicular cancer in our institution from January 2003 until today. A total of 88 patients received systemic treatment, among those 74 as a primary treatment with 2 to 4 cycles of PEB. Side effects had been categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4. Results: 46 of 74 patients receiving PEB had at least one side effect. The most common side effects were haematotoxic with leucopenia in 34 (45.9%), febrile neutropenia in 10 (13.5%), gastrointestinal in 22 (29.7%), and thromboembolic events in 10 (14.8%) of the patients including three therapy associated deaths. Adverse events in clinical stage I are low. Nevertheless there is one therapy associated death due to neutropenic fever. Although there are no differences in haematotoxic AEs in clinical stage II and III there is a significant trend of developing pulmonary embolism. Patients with clinical higher than stage IIb and intermediate/poor prognosis have the highest risk of pulmonary embolism (20% ). Conclusions: In patients with curative treatment with PEB there are significant AE´s. To reduce therapy associated morbidity and mortality, supportive treatment with granulocyte stimulating factor and therapeutic anticoagulation should be discussed at least in high-risk patients.

scholarly journals Side Effects Reported by Jordanian Healthcare Workers Who Received COVID-19 Vaccines

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 577
Author(s):  
Osama Abu-Hammad ◽  
Hamza Alduraidi ◽  
Shaden Abu-Hammad ◽  
Ahmed Alnazzawi ◽  
Hamzah Babkair ◽  
...  
Keyword(s):  
Side Effects ◽  
Healthcare Workers ◽  
Healthcare Professionals ◽  
The Public ◽  
Systemic Side Effects ◽  
The Common ◽  
Larger Sample ◽  
Local Side

Background Distribution of COVID-19 vaccines has been surrounded by suspicions and rumors making it necessary to provide the public with accurate reports from trustworthy experts such as healthcare professionals. Methods We distributed a questionnaire in Jordan among physicians, dentists and nurses who received a COVID-19 vaccine to explore the side effects (SE) they encountered after the first or the second dose of one of three vaccines namely: AstraZeneca Vaxzevria (AZ), Pfizer-BioNTeck (PB), and SinoPharm (SP) vaccines. Results A total of 409 professionals participated. Approximately 18% and 31% of participants reported no SE after the first dose and second dose, respectively. The remainder had mostly local side effects related to injection site (74%). Systemic side effects in the form of fatigue (52%), myalgia (44%), headache (42%), and fever (35%) prevailed mainly after the first dose. These were significantly associated with AZ vaccine, and age ≤ 45 years (p = 0.000 and 0.01, respectively). No serious SE were reported. Conclusions We can conclude that SE of COVID-19 vaccines distributed in Jordan are within the common range known so far for these vaccines. Further studies are needed to include larger sample size and longer follow-up period to monitor possible serious and long-term SE of the vaccines.

scholarly journals Plastic cannulae versus metal needle cannulation in haemodialysis: Results of an international survey from the nurse perspective

2021 ◽  
pp. 112972982110667
Author(s):  
Ilaria de Barbieri ◽  
Davide Sisti ◽  
Veronica Strini ◽  
Helen Noble ◽  
Maria Teresa Parisotto ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cross Sectional Survey ◽  
Maturation Period ◽  
Cross Sectional ◽  
Considerable Saving ◽  
The Public ◽  
Care Association ◽  
The Common ◽  
The Difference ◽  
Metal Needle

Background: In haemodialysis is key to successfully obtaining cannulation of the arteriovenous fistula (AVF). The literature agrees that cannulation, failing in the initial maturation period, can lead to delayed dialysis, haematoma, scarring, needle phobia and loss of confidence in the cannulator. The introduction of plastic cannulae for haemodialysis has changed cannulation practice positively, preventing frequent complications such as infiltration or trauma. Despite that, most countries have continued to use metal cannulation, in particular in Europe. This study investigates the common use of plastic cannulae versus metal needles for cannulation in dialysis units and explores the implications of focusing on the side effects of cannulation. Methods: The study is a cross-sectional survey. A questionnaire was created by a team of experts from the European Dialysis Transplant Nurse Association/European Renal Care Association (EDTNA/ERCA) to address the study's aims and sent online to nurse members. Results: Data collected suggested a strong resistance towards using plastic cannulae, with few respondents claiming to use these cannulas. Most of the respondents were female (74%), Europeans, working in nephrology for more than 10 years and most worked in the public sector. There was a strong correlation between the use of plastic cannulae and fewer adverse events in elbow located AVF and newly created or fragile AVF. Conclusions: The results are in line with the current literature. Possible resistance to the use of the plastic device includes the difference in cost between the two devices in favour of metal needles. However, it should be considered that the lower number of adverse events, in particular infiltration and haematoma caused by the metal needle, involves a considerable saving both in money and in terms of time and distress for the patient.

Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria

2021 ◽  
pp. 174113432110176
Author(s):  
Stefka Stoyanova ◽  
Emanuil Yordanov ◽  
Emil Hristov ◽  
Iva Parvova ◽  
Hristo Tzachev ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Drug Utilization ◽  
National Standards ◽  
Insurance Fund ◽  
National Council ◽  
Medicinal Products ◽  
The Public ◽  
Data Exclusivity ◽  
Public Data ◽  
Costs Of Treatment

The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.

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