scholarly journals Off-Label Prescribing in Pediatric Inpatients With Pneumonia in a Children's Hospitaal

2018 ◽  
Vol 16 (1) ◽  
pp. 25
Author(s):  
Hesty Utami Ramadaniati ◽  
Heni Safarini ◽  
Aishah A Regine
Keyword(s):  
Clinical Trials ◽  
Medical Records ◽  
Product Information ◽  
Drug Label ◽  
Off Label ◽  
National Drug ◽  
Different Types ◽  
Pediatric Use ◽  
Official Information ◽  
Study Hospital

Off-label is a term used in which a  drug prescribed outside the official information of the marketing authorization.  Off-label prescribing may occur as the result of several factors including  lack of clinical trials data involving pediatrics and suitable formulations for medicines commonly prescribed to this fragile population. Objective: This study aimed to estimate the nature and prevalence of off-label prescribing in pediatric inpatients with pneumonia. Material and Methods: a retrospective study was conducted in a study hospital using medical records from pediatric inpatients with pneumonia during the period of January-December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label based on the Indonesia National Drug Information (IONI) and British National Formulary for Children (BNFC). Thereafter, off-label drugs were categorized with a hierarchical system of age, indication, route of administration and dosage. Results: There were 1141 drugs with 77 different types of drug were administered to 207 patient during the study period. The data uncovered that 405 (35,5%) of the drug prescriptions were used off-label based on IONI, and 319 (28%) of the drug were used off-label based on BNFC. Based on IONI and BNFC, most off-label drugs were from anti infection drugs. Conclusion: The prevalence of off-label use in pediatric inpatients with pneumonia is not high. The off-label prescribing may not be necessarily  be considered irrational, yet this fact reveals that the use of drugs does not comply with the drug label. Clinical trials for pediatric drugs are essential to provide  complete product information for pediatric use.

scholarly journals OFF-LABEL AND UNLICENSED PRESCRIBING IN PEDIATRIC INPATIENTS WITH NEPHROTIC SYNDROME IN A MAJOR TEACHING HOSPITAL: AN INDONESIAN CONTEXT

2016 ◽  
Vol 10 (1) ◽  
pp. 355 ◽  
Author(s):  
Hesty Ramadaniati ◽  
Taralan Tambunan ◽  
Sondang Khairani ◽  
Happy S Adisty
Keyword(s):  
Nephrotic Syndrome ◽  
Product Information ◽  
Drug Information ◽  
High Rate ◽  
Standard Drug ◽  
Off Label ◽  
National Drug ◽  
High Prevalence ◽  
Major Teaching Hospital ◽  
Major Teaching

ABSTRACTObjective: To estimate the prevalence of off-label and unlicensed prescribing in pediatric inpatients with nephrotic syndrome in a major teachinghospital in Indonesia.Methods: A retrospective study was conducted in study hospital using medical records from pediatric inpatients with nephrotic syndrome during theperiod of January-December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label/unlicensed basedon the Indonesia National Drug Information (IONI). Thereafter, off-label drugs were categorized with a hierarchical system of age, indication, routeof administration, and dosage.Results: There were 1553 drugs with 94 different types of drug administered to 67 patients during the study period. The data uncovered that1023 (65.9%) of the drug prescriptions were used either off-label/unlicensed. Most off-label drugs (n=433, 42.4%) were from nondiureticsantihypertensive drugs. The most common drugs used in an off-label/unlicensed manner were prednisolone and lisinopril. The high rate of off-labeldrug use in children was mainly related to age (n=772, 75.5%). Pediatrics with nephrotic syndrome was vulnerable to off-label uses where everypatient received at least two off-label drugs. It seems that off-label prescribing in pediatric with nephrotic syndrome was not influenced by age orgender as every patient received off-label drugs.Conclusion: Despite the high prevalence of off-label use in pediatric patients with nephrotic syndrome, this use is supported by evidence-basedprescribing. Further, there remains a need for supporting clinical trials for pediatric drugs and updating IONI as the standard drug information inIndonesia to provide complete product information for pediatric use.Keywords: Off-label drug, Syndrome nephrotic, Inpatient, Pediatrics.

Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use

2013 ◽  
Vol 41 (3) ◽  
pp. 654-664 ◽  
Author(s):  
Marc A. Rodwin
Keyword(s):  
Clinical Trials ◽  
Drug Use ◽  
Drug Administration ◽  
Package Insert ◽  
Drug Label ◽  
Therapeutic Purpose ◽  
Off Label ◽  
Practice Of Medicine ◽  
Age Cohort ◽  
The One

The Food and Drug Administration (FDA) authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label.

scholarly journals Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Matisyahu Shulman ◽  
Roger Weiss ◽  
John Rotrosen ◽  
Patricia Novo ◽  
Elizabeth Costello ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Extended Release ◽  
Primary Outcome ◽  
Opioid Use Disorder ◽  
Drug Abuse Treatment ◽  
Opioid Use ◽  
National Drug ◽  
Retention In Treatment ◽  
Abuse Treatment

AbstractOpioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.

scholarly journals Melatonin in Cancer Treatment: Current Knowledge and Future Opportunities

Molecules ◽  
2021 ◽  
Vol 26 (9) ◽  
pp. 2506
Author(s):  
Wamidh H. Talib ◽  
Ahmad Riyad Alsayed ◽  
Alaa Abuawad ◽  
Safa Daoud ◽  
Asma Ismail Mahmod
Keyword(s):  
Clinical Trials ◽  
Current Knowledge ◽  
Biological Activities ◽  
Experimental Studies ◽  
Therapeutic Effects ◽  
Cell Proliferation Inhibition ◽  
Different Types ◽  
Solid Foundation

Melatonin is a pleotropic molecule with numerous biological activities. Epidemiological and experimental studies have documented that melatonin could inhibit different types of cancer in vitro and in vivo. Results showed the involvement of melatonin in different anticancer mechanisms including apoptosis induction, cell proliferation inhibition, reduction in tumor growth and metastases, reduction in the side effects associated with chemotherapy and radiotherapy, decreasing drug resistance in cancer therapy, and augmentation of the therapeutic effects of conventional anticancer therapies. Clinical trials revealed that melatonin is an effective adjuvant drug to all conventional therapies. This review summarized melatonin biosynthesis, availability from natural sources, metabolism, bioavailability, anticancer mechanisms of melatonin, its use in clinical trials, and pharmaceutical formulation. Studies discussed in this review will provide a solid foundation for researchers and physicians to design and develop new therapies to treat and prevent cancer using melatonin.

scholarly journals Rivaroxaban versus warfarin for the management of left ventricle thrombus

2021 ◽  
Vol 73 (1) ◽  
Author(s):  
Monirah A. Albabtain ◽  
Yahya Alhebaishi ◽  
Ola Al-Yafi ◽  
Hatim Kheirallah ◽  
Adel Othman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Left Ventricle ◽  
Surface Area ◽  
Median Time ◽  
Randomized Clinical Trials ◽  
Off Label Use ◽  
Duration Of Treatment ◽  
Off Label ◽  
Warfarin Group

Abstract Background Rivaroxaban has been recently introduced for the management of non-valvular intra-cardiac thrombosis with variable results. We aimed to compare the results of the off-label use of rivaroxaban versus warfarin in the management of patients with left ventricle (LV) thrombus. This research is a retrospective study conducted on 63 patients who had LV thrombus from January to December 2016. We compared patients treated with warfarin (n=35) to patients who had rivaroxaban (n=28), and study outcomes were time to thrombus resolution, bleeding, stroke, and mortality. Results The median duration of treatment was 9.5 (25th-75th percentiles: 6-32.5) months for rivaroxaban and 14 (3-41) months for warfarin. Thrombus resolution occurred in 24 patients in the warfarin group (68.6%) and 20 patients in the rivaroxaban group (71.4%). The median time to resolution in the warfarin group was 9 (4-20) months and 3 (2-11.5) months in the rivaroxaban group. Thrombus resolution was significantly faster in patients on rivaroxaban (p= 0.019). Predictors of thrombus resolution were thrombus surface area (HR: 1.21; CI 95% (1.0-1.46); p= .048) and the use of rivaroxaban (HR: 1.92; CI 95% (1.01-3.65); p= 0.048). There was no difference in stroke, bleeding, and mortality between both groups. Conclusion Rivaroxaban was as effective and safe as warfarin in managing patients with left ventricle thrombus. Larger randomized clinical trials are recommended to confirm our findings.

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

Morbidity of in-hospital purulent-septic infections of adults patients after different types of endovascular cardiosurgical operations

2020 ◽  
pp. 13-19
Author(s):  
Viktor Ivanovich Sergevnin ◽  
Larisa Gennadievna Kudryavtseva ◽  
Anna Igorevna Zolotukhina
Keyword(s):  
Medical Records ◽  
Heart Surgery ◽  
Surgical Intervention ◽  
Heart Rhythm ◽  
Community Acquired Pneumonia ◽  
Short Term ◽  
Intervention Community ◽  
Duration Of Surgery ◽  
Different Types ◽  
Low Incidence

An estimate of the incidence of nosocomial purulent-septic infections (GSI) of adult patients after various types of closed heart surgery according to the results of a study of medical records of 3275 patients is presented. It was established that the incidence rate of typical GSI after endovascular cardiac surgery was 3.1, with prenosological forms — 3.9 per 1000 operations. The main clinical options for postoperative GSI were infections in the field of surgical intervention, community-acquired pneumonia, urinary tract infection and bloodstream infection. There were no statistically significant differences between the incidence of GSI after stenting of the coronary arteries, operations for heart rhythm disturbances, stenosis of the carotid artery and other operations. The low incidence of GSI after closed heart surgery is due to the short duration of surgery, as well as the absence or short-term resuscitation of patients.

scholarly journals Efficacy and safety of maxillary sinus lifting with various types of grafting with implants insertion purposes: A review of the literature

2020 ◽  
pp. 31-45
Author(s):  
João de Paula Martins Júnior ◽  
Álvaro Nagib Atallah
Keyword(s):  
Clinical Trials ◽  
Maxillary Sinus ◽  
Bone Grafting ◽  
Randomized Clinical Trials ◽  
Bone Volume ◽  
Local Inflammatory Response ◽  
Average Percentage ◽  
Significant Difference ◽  
Different Types ◽  
Sinus Lifting

Context: Edentulous patients under the use of removable prosthesis face important restrictions, including sociocultural ones and, for this reason, the insertion of implants has become frequent in clinical dental practice. However, the success of the method will depend on the sort of different types of bone grafting, quality of donor area and the residual amount of bone left in insertion site. Purpose: the purpose of this study was to evaluate the effectiveness and safety of different types of bone grafts used in maxillary sinus lifting surgeries for implant insertion. Methods: systematic review of randomized clinical trials or quasi-randomized. We used the guidelines of the manual of systematic reviews from Cochrane Collaboration and a sensitive search strategy in three electronic databases has been built. Results: We included six randomized clinical trials from different regions of the world with 135 participants. Bone volume was 3% higher on the grafted site with autogenic bone pure, but not a statistically significant difference DM: 3 (-8.48-14.48), the average percentage between the vital and non-vital bone showed up 0.82% higher on the grafted site with FDBA + PRP. The average percentage of vital tissue was also 15.8% higher on the side where PRP was used. Conclusion: the available evidence is insufficient to recommend a specific type of bone grafting in sinus augmentation (lift) procedures to place a dental implant. There was no statistically significant difference for bone volume, sensory loss, local inflammatory response and loss of implants, among others. For this reason, new randomized controlled trials that evaluate the effectiveness and safety of different types of bone graft for lifting of the maxillary sinus are necessary. Key-words: Maxillary sinus. Grafting, survey, technique, materials.

scholarly journals Evaluation of Knowledge, Attitudes and Experience of off-label Drug Prescribing Practice among Physicians in Baghdad City Hospitals

2019 ◽  
Vol 28 (2) ◽  
pp. 115-123
Author(s):  
Aysha M. Shanshal ◽  
Ahmed H. Ataimish
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Pharmaceutical Companies ◽  
Cross Sectional ◽  
Off Label ◽  
Healthcare Settings ◽  
Prescribing Practice ◽  
Self Administered Questionnaire

Abstract The present study aims to assess the knowledge, attitude, and experience of off-label prescribing practice among physicians in Baghdad city hospitals. This cross-sectional study was performed through the period from November 1st 2018 to March 2019 at 17 hospitals, a self-administered questionnaire was utilized to collect data from the physicians, and the targeted hospitals were randomly selected at different regions in Baghdad City area. Out of the 400 distributed questionnaires to the physicians, 383 of them were returned completed, 57.2% indicated that they were reasonably familiar with the term “off label drug”, 57.7% mentioned that the most common medical reasons for the prescribing off-label drugs were unavailability of alternatives, 67.6%, 65.5% had concerns regarding its safety and efficacy respectively, 62.7% agreed that the (MOH) authority should provide an incentive to stimulate pharmaceutical companies to perform clinical trials in Iraqi patients, 49.1% believed that clinical trials that recruit volunteers involve ethical issues. Extensive efforts are required to implant programs, regulations and guidelines to control the off-label prescribing practice among the Iraqi healthcare providers who are authorized to prescribe medications at different healthcare settings.    

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