scholarly journals PROBLEMS OF SIDE EFFECT OF USE OF THE MEDICINES OFF LABEL

2021 ◽  
pp. 60-67
Author(s):  
S. M. Drogovoz ◽  
K. O. Kalko ◽  
Ye. V. Bondarev ◽  
G. V. Belik ◽  
Yu. V. Stoletov ◽  
...  
Keyword(s):  
Cause Of Death ◽  
Side Effect ◽  
Drug Intake ◽  
Scientific Publications ◽  
Off Label ◽  
Positive Effects ◽  
Security Concerns ◽  
Increase In Risk

Drugs which as we hope, have to facilitate or save the patient's life sometimes cause the return ˗ the collateral reactions (CR) and even death. CR of drugs can be a cause of death not less, than sepsis and accidents. Often the wrong dispensing and also the medicines prescribed by off label is their reason (out of the instruction). The aim of the study. To analyze the frequency of manifestation of collateral reactions of medicines at their application of off label. Materials and methods. The analysis of foreign and domestic scientific publications concerning manifestation of collateral reactions of drugs at their application off label. Results. Today there are no concrete data on that how many deadly CR happen because of off label of drugs, but it is possible to estimate it, using information which is known: CR at drug intake of off label occur approximately by two-three times more often than at drug intake of on label (according to the instruction). It is established that lower or higher dose of medicine, than that which is specified in the instruction can lead to security concerns. Use of off label of medicines in doses is higher than those which were approved by the instruction, correlate with increase in risk of development of CR. It is established that prescription of medicines of off label is connected with higher risk of CR, than with their licensed alternatives, and hypotheses in literature concerning efficiency and harmlessness of off label of use of drugs not always are reliable. Conclusions. The doctor and the pharmacist need to remember that positive effects of application of off label of drugs have to have synergism with their safety that the medicine off label, very necessary for the patient, did not appear without the obligatory quality ˗ safety.

Lung Cancer in Brazil

2012 ◽  
pp. 426-431
Author(s):  
Gilberto Schwartsmann
Keyword(s):  
Lung Cancer ◽  
Cause Of Death ◽  
Public Health Problem ◽  
Lung Cancer Mortality ◽  
World Health ◽  
Cancer Type ◽  
Positive Effects ◽  
Incident Cancer ◽  
Health Organization ◽  
Tremendous Challenge

Overview: Cancer is now the second leading cause of death in Brazil (after cardiovascular diseases) and a public health problem, with around 500,000 new cases in 2012. Excluding nonmelanoma skin cancer, lung cancer is the second most incident cancer type in men, with 17,210 expected new cases. In women, it is the fifth most incident cancer, with 10,110 expected new cases. The estimated age-adjusted lung cancer mortality rate is about 13/100,000 for men and 5.4/100,000 for women. Lung cancer rates in men increased until the early 1990s and decreased thereafter, especially in the younger population. In contrast, a steady upward trend was observed for women. The positive effects in men were probably due to the successful anti-tobacco campaign conducted in Brazil over the last decades, which led to a decrease in the adult smoking population, from 32% in the early 1980s to 17% in the 2000s. Although the Brazilian National Cancer Institute is strongly committed to providing excellence in multimodality care to cancer patients, limitations in availability and adequate geographic distribution of specialists and well-equipped cancer centers are evident. Major disparities in patient access to proper staging and state-of-the-art treatment still exist. Considering that World Health Organization (WHO) officials estimate that cancer will become the number one cause of death in most developing countries, including Brazil, in the next decades, it is highly recommended for government authorities to implement firm actions to face this tremendous challenge.

Administration of label and off-label drugs by the subcutaneous route in palliative care: an observational cohort study

2020 ◽  
pp. bmjspcare-2020-002185
Author(s):  
Jesper Jørgen Jensen ◽  
Per Sjøgren
Keyword(s):  
Palliative Care ◽  
Drug Administration ◽  
Subcutaneous Administration ◽  
Drug Discontinuation ◽  
Subcutaneous Route ◽  
Scientific Publications ◽  
Prospective Data ◽  
Off Label ◽  
Injectable Drugs ◽  
Observational Cohort

BackgroundThe marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.AimTo assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.Material and methodsRetrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.ResultsDrugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.ConclusionSubcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.

Sustained Reductions in Children's Risk Taking from Peer-Communicated Behavioral Safety Norms

2020 ◽  
Vol 45 (6) ◽  
pp. 622-632
Author(s):  
Barbara A Morrongiello ◽  
Emily Weinberger ◽  
Mackenzie Seasons
Keyword(s):  
Risk Taking ◽  
Social Norm ◽  
Mood State ◽  
Positive Mood ◽  
Behavioral Safety ◽  
Safety Message ◽  
Positive Effects ◽  
Neutral Mood ◽  
Risk Taking Behaviors ◽  
Increase In Risk

Abstract Objective This research examined whether the positive effects of a peer-communicated social norm that reduces risk-taking behaviors persist over time and if a reminder of this peer-communicated safety message has any impact on this outcome. Methods Positive mood in 7- to 9-year olds was induced experimentally and risk taking intentions and behaviors were measured when the child was in a positive and neutral mood state and after they had been exposed to either a safety or neutral peer-communicated social norm message. A few weeks later, half of the participants who experienced the safety social norm message were exposed to a reminder of this message via a slogan and risk-taking measures were taken again when in a heightened positive mood state. Results Exposure to a safety norm successfully counteracted the increase in risk taking associated with a positive mood state. These effects persisted for several weeks regardless of whether the children were exposed to a reminder. Conclusion Manipulating peer social norms holds promise as an approach to produce reductions in children’s risk taking and these effects persist at least over several weeks.

scholarly journals Propranolol in Use for Treatment of Complex Infant Hemangiomas: Literature Review Regarding Current Guidelines for Preassessment and Standards of Care before Initiation of Therapy

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Andreas Fette
Keyword(s):  
Clinical Practice ◽  
Literature Review ◽  
Paradigm Shift ◽  
Standards Of Care ◽  
Current Evidence ◽  
Off Label Use ◽  
Off Label ◽  
Positive Effects ◽  
Initiation Of Therapy ◽  
Current Guidelines

In 2008, the positive effects of propranolol on infantile hemangiomas (IH) have been discovered serendipitously by Léauté-Labrèze and her coworkers. Since then, propranolol has been in use in allday clinical practice worldwide for treatment of IH. It even caused some kind of paradigm shift in the overall management of these lesions, though propranolol is still not FDA approved, respectively, in “off-label” use for this indication in the majority of institutions. Thus, the aim of this communication is to evaluate the literature for current evidence regarding guidelines for preassessment and standards of care before initiation of therapy.

scholarly journals «Off-label» use of botulinic toxin type A preparations in neurological practice

2018 ◽  
Vol 20 (2) ◽  
pp. 195-201
Author(s):  
L R Akhmadeeva ◽  
Kh P Derevyanko
Keyword(s):  
Botulinum Toxin ◽  
Therapeutic Option ◽  
Botulinum Toxin Type A ◽  
Case Series ◽  
Type A ◽  
Botulinum Toxin Type ◽  
Off Label Use ◽  
Off Label ◽  
Positive Effects ◽  
Label Use

The modern view on the application of botulinum toxin type A for the off-label use in neurology and foreign experience analysis are presented. The «off-label» category referred to any prescription of a medication in case of using it for unregistered indications, with product instruction violation or in the presence of contraindications including age restrictions. The sources of information about medicines were the leaflets of manufacturers of medicines and the State Register of Medicines. It is well known that Botulinum toxin type A is a good therapeutic option for treating children with cerebral palsy. Increased efficacy of regularly repeated cycles with Onabotulinumtoxin A in medication-overuse headache patients beyond the first year of treatment. Botulinum toxin type A is effective in the management of sialorrhea. Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction. Facing depression with botulinum toxin: positive effects on mood have been observed in subjects who underwent treatment of glabellar frown lines with botulinum toxin and, in an open case series, depression remitted or improved after such a treatment. Botox injection significantly improved foot dystonia, pain and lower limb functional outcomes in patients with Parkinson’s disease with deep brain stimulation. The paper describes the problems associated with the lack of clinical data about the possibility of using botulinum toxin type A in different conditions, emphasizes the need to organize clinical trials and educational programs for neurologists as well as more active implementation of protocols for the treatment of patients.

scholarly journals Lactiplantibacillus plantarum 299v (LP299V®): three decades of research

2021 ◽  
pp. 1-26
Author(s):  
E. Arvidsson Nordström ◽  
C. Teixeira ◽  
C. Montelius ◽  
B. Jeppsson ◽  
N. Larsson
Keyword(s):  
Clinical Studies ◽  
Iron Status ◽  
Human Consumption ◽  
Comprehensive Overview ◽  
Scientific Publications ◽  
Healthy Human ◽  
Positive Effects ◽  
Freeze Dried ◽  
Wide Range

This review aims to provide a comprehensive overview of the in vitro, animal, and clinical studies with the bacterial strain Lactiplantibacillus plantarum 299v (L. plantarum 299v; formerly named Lactobacillus plantarum 299v) published up until June 30, 2020. L. plantarum 299v is the most documented L. plantarum strain in the world, described in over 170 scientific publications out of which more than 60 are human clinical studies. The genome sequence of L. plantarum 299v has been determined and is available in the public domain (GenBank Accession number: NZ_LEAV01000004). The probiotic strain L. plantarum 299v was isolated from healthy human intestinal mucosa three decades ago by scientists at Lund University, Sweden. Thirty years later, a wealth of data coming from in vitro, animal, and clinical studies exist, showing benefits primarily for gastrointestinal health, such as reduced flatulence and abdominal pain in patients with irritable bowel syndrome (IBS). Moreover, several clinical studies have shown positive effects of L. plantarum 299v on iron absorption and more recently also on iron status. L. plantarum 299v is safe for human consumption and does not confer antibiotic resistance. It survives the harsh conditions of the human gastrointestinal tract, adheres to mannose residues on the intestinal epithelial cells and has in some cases been re-isolated more than ten days after administration ceased. Besides studying health benefits, research groups around the globe have investigated L. plantarum 299v in a range of applications and processes. L. plantarum 299v is used in many different food applications as well as in various dietary supplements. In a freeze-dried format, L. plantarum 299v is robust and stable at room temperature, enabling long shelf-lives of consumer healthcare products such as capsules, tablets, or powder sachets. The strain is patent protected for a wide range of indications and applications worldwide as well as trademarked as LP299V®.

scholarly journals Distressing Visual Hallucinations after Treatment with Trazodone

2017 ◽  
Vol 2017 ◽  
pp. 1-5
Author(s):  
Gustavo Santos ◽  
Ana Maria Moreira
Keyword(s):  
Emergency Department ◽  
Side Effect ◽  
Complete Resolution ◽  
Inpatient Treatment ◽  
Second Generation ◽  
Visual Hallucinations ◽  
Medication History ◽  
Off Label ◽  
Challenging Situation

Trazodone, a second-generation atypical antidepressant, is increasingly being used off-label, in the treatment of insomnia. Although generally well tolerated, trazodone treatment can be associated with some complications. We describe a case of a 60-year-old man who received trazodone for primary insomnia. He returned, to the emergency department, two days later with distressing visual hallucinations, which prompted inpatient treatment. Trazodone was discontinued, leading to a complete resolution of his visual hallucinations, and he was treated with mirtazapine for 6 months. There has been no relapse in a follow-up period of two years. Patients presenting with visual hallucinations without significant psychiatry history can be a challenging situation. We highlight the importance of careful anamnesis with an accurate medication history. Given the widespread use of trazodone, clinicians should be aware of this possible side effect.

scholarly journals Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast

2020 ◽  
Vol 12 (3) ◽  
pp. 275-281
Author(s):  
Eleftherios Ntouniadakis ◽  
Fredrik Landström
Keyword(s):  
Plaque Psoriasis ◽  
Side Effect ◽  
Side Effect Profile ◽  
Off Label ◽  
Psoriasis Arthritis ◽  
First Case ◽  
Disease Modifying ◽  
Rheumatic Drug

Apremilast (Otezla®) is a relatively novel orally administered non-biologic disease-modifying anti-rheumatic drug (DMARD) extensively used in the management of psoriasis and psoriasis arthritis, lately approved for treating oral ulcerations in Behçets disease. Its advantageous side effect profile together with its uncomplicated follow-up and monitoring when compared to other DMARDs facilitates even a broad off-label prescribing. Here, the first case of laryngeal pseudotumor in a patient treated with apremilast for plaque psoriasis is presented.

scholarly journals Kajian penggunaan obat misoprostol sebagai off-label pada pelaksanaan persalinan di Klinik Utama Al-Islam Bandung

2020 ◽  
Vol 7 (2) ◽  
pp. 53
Author(s):  
Ani Anggriani ◽  
Ida Lisni ◽  
Wildan Muttaqien
Keyword(s):  
Medical Record ◽  
Cause Of Death ◽  
Postpartum Hemorrhage ◽  
Labor Induction ◽  
Medical Record Data ◽  
Common Cause ◽  
Off Label ◽  
Record Data

<h1>Abstrak</h1><p> </p><p>Misoprostol sebagai <em>off-label</em> sering digunakan dalam tindakan persalinan baik untuk induksi persalinan maupun untuk pencegahan perdarahan pasca persalinan. Perdarahan pasca<em> </em>persalinan merupakan peyebab terbanyak pada kasus kematian akibat persalinan. Penelitian ini bertujuan untuk mengidentifikasi ketepatan penggunaan obat misoprostol sebagai <em>off-label</em> berdasarkan kriteria penggunaan medis dan ketepatan dosis yang diberikan kepada pasien. Penelitian ini merupakan penelitian observasional data rekam medis pasien yang dilakukan secara retrospektif di Klinik Utama Al-Islam Bandung. Penelitian dilakukan terhadap 87 data rekam medik pasien selama periode bulan Januari-Desember 2016. Hasil menunjukkan bahwa 100% penggunaan misoprostol sebagai <em>off-label</em> sesuai dengan kriteria penggunaan medis dan tepat dosis. Terdapat 64% dari total pasien yang diberikan misoprostol dengan total dosis sebesar 800 μg.</p><p> </p><p><strong>Kata kunci:</strong> Misoprostol, <em>Off-Label,</em> Persalinan</p><p align="center">  </p><h1><em>Abstract</em><em></em></h1><pre><em> </em></pre><pre><em>As off-label misoprostol is the most used in labor either for labor induction or for prevention of postpartum hemorrhage. Postnatal bleeding is the most common cause of death due to childbirth. The purpose of this research is to identify the accuracy of misoprostol used as off-label based on the criteria of medication and the dose accuration for the patient. An observational retrospective research on medical record data of patients at Al-Islam Main Clinic Bandung. During 2016 had 87 patient's data from January to December was obtained. The results showed that 100% of misoprostol is used as off-label following the criteria of medication and dose accuration. Therefore 64% of total patients had given misoprostol for 800 μg each.</em></pre><pre><em> </em></pre><p><strong><em>Keywords: </em></strong><em>Labor, Misoprostol, Off-Label</em></p>

scholarly journals Properties and use of rosemary (Rosmarinus officinalis L.)

2020 ◽  
Vol 66 (3) ◽  
Author(s):  
Katarzyna Pawłowska ◽  
Katarzyna Janda ◽  
Karolina Jakubczyk
Keyword(s):  
Antimicrobial Activity ◽  
Animal Feed ◽  
Rosmarinus Officinalis ◽  
Scientific Publications ◽  
Food Industries ◽  
Positive Effects ◽  
Home Cooking ◽  
Rosmarinus Officinalis L ◽  
Taste And Smell ◽  
Review Current

Rosemary (Rosmarinus officinalis L.) is a spice herb found in most cuisines and in many spice blends on the Polish market. It deserves special attention, not only because of its unique taste and smell, but also due to a composition that provides health benefits. Its antimicrobial activity has been proven in relation to bacteria, fungi (including yeast) and viruses. Positive effects on the metabolism of carbohydrates and lipids, and the function of the nervous system, as well as hepatoprotective properties have been demonstrated. The plant itself and the extracts and essential oils obtained from it are used in home cooking, and the cosmetic and food industries. It also finds applications in agriculture as an animal feed additive.The aim of the work was to review current scientific publications and present the properties and areas of use of rosemary .

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