scholarly journals Incidence of unlicensed and off-label medication prescriptions at the Department of Paediatrics: what has changed after seven years?

2021 ◽  
Author(s):  
Petra Matalová ◽  
Lucie Belfínová ◽  
Kristýna Vrbicová ◽  
Jana Fürstová ◽  
Martin Wawruch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Czech Republic ◽  
Drug Prescriptions ◽  
University Hospital ◽  
Off Label ◽  
Prescribing Practice

Abstract BackgroundMany common drugs have not been registered for use in children. Therefore, they are sometimes prescribed as unlicensed or off-label. This study, performed at the Department of Paediatrics, University Hospital Olomouc, Czech Republic, evaluated off-label and unlicensed prescriptions. A similar study, conducted in 2013 by the same authors (P. Matalová – maiden name P. Langerová), showed that the number of off-label and unlicensed prescriptions was relatively low, compared to other studies. The goal of this study was to compare the frequency of off-label and unlicensed drug prescriptions, and to assess whether these prescriptions have declined.MethodsThe study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Paediatrics, University Hospital Olomouc during a period of six months. A total of 10,710 prescriptions for 5,243 children were processed.Results In our previous study, performed from January to June 2012, a total of 8,559 prescriptions for 4,282 children were processed. Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%). Seven years later, the same study in the same months was performed to ascertain the development in prescribing practice. In the 2019 study, the total number of prescriptions and patients was higher (18.8% vs. 22.2%, respectively) as was the number of off-label and unlicensed prescriptions (11.1% and 1.7%, respectively).ConclusionsThis study shows that the incidence of unlicensed and off-label drug prescriptions is not high, but paediatricians should avoid exposing children to unnecessary risks as well as depriving them of potentially effective pharmacotherapy. The goal was to highlight the need for clinical trials in paediatrics and to determine in which drugs the demand for also being registered for younger children is highest. The number of off-label and unlicensed prescriptions indicates a gap in registration processes and should provide a clue as to which drugs are candidates for having their SPCs changed.

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.    

scholarly journals Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

2021 ◽  
Author(s):  
C. Madeira ◽  
L. Hořavová ◽  
F. dos Santos ◽  
J. R. Batuca ◽  
K. Nebeska ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Czech Republic ◽  
Clinical Research ◽  
Systematic Search ◽  
European Countries ◽  
The Czech Republic ◽  
Research Outcomes ◽  
Funding Policies ◽  
Funding Agencies ◽  
First Time

Abstract Objectives Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.

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 Readiness to Participate in Psychiatric Research

2003 ◽  
Vol 48 (7) ◽  
pp. 480-484 ◽  
Author(s):  
Daniele Zullino ◽  
Philippe Conus ◽  
François Borgeat ◽  
Charles Bonsack
Keyword(s):  
Clinical Trials ◽  
Financial Incentive ◽  
University Hospital ◽  
Psychiatric Research ◽  
Willingness To Participate ◽  
Research Projects ◽  
Hospital Physician ◽  
Recruitment Process ◽  
Consent Rate ◽  
Retention Strategies

Background: The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Seeking patients' views about their experience in research projects may allow investigators to develop more effective recruitment and retention strategies. Methods: A total of 100 patients consecutively admitted to a psychiatric university hospital were interviewed with respect to their willingness to participate in a study. For a different study scenario, patients were asked whether they would be ready to participate if such a study were organized in the service and to indicate their reasons for refusing or for participating. Results: The general readiness to participate in a study ranged between 70% and 96%. The prospect of remuneration did not notably augment the potential consent rate. The most common and spontaneous motivation for agreeing to take part in a study was to help science progress and to allow future patients to benefit from improved diagnosis and treatment (87%). The presence or lack of a financial incentive was rarely chosen as an argument to agree (23%) or to refuse (7%) to participate. Patients relied mainly on their treating physicians when contemplating possible participation in a study (family physician [65%] and hospital physician [54%]). Conclusions: Clinicians and, in particular, treating doctors can play an important role in facilitating the recruitment process.

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.

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital

2006 ◽  
Vol 53 (3,4) ◽  
pp. 292-296 ◽  
Author(s):  
Hiroaki Yanagawa ◽  
Masako Nishiya ◽  
Toshiko Miyamoto ◽  
Michiyo Shikishima ◽  
Mitsuko Imura ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilot Study ◽  
Drug Approval ◽  
University Hospital

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 prescribing of quetiapine in HMP Elmley, a Category B remand prison: a re-audit

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S85-S85
Author(s):  
Nosa Igbinomwanhia ◽  
Kathleen McCurdy
Keyword(s):  
Mental Health ◽  
Royal College ◽  
Health Assessment ◽  
List Type ◽  
Physical And Mental Health ◽  
Off Label ◽  
The Past ◽  
Number Of Patients ◽  
Prescribing Practice ◽  
Potential Risks

AimsThis was a re-audit of off-label prescribing of quetiapine in order to identify the number of patients on off-label quetiapine in HMP Elmley, to monitor compliance by the Mental Health Inreach Team (MHIRT) psychiatrists with the Royal College of Psychiatrists guideline on off-license prescribing, to compare findings with the baseline audit and to identify areas for improvement.MethodAll patients on quetiapine in HMP Elmley were identified and their electronic patient record was reviewed against the standards outlined in the Royal College of Psychiatrists “Use of licensed medicines for unlicensed applications in psychiatric practice (2nd edition).ResultThere were 60 residents on off-license quetiapine prescription in HMP Elmley.Of this number, four had their prescription initiated by a general practitioner, either while in prison or in the community. Two residents were on quetiapine first prescribed while they were on admission in hospital. 5 patients had been initiated by the MHIRT psychiatrists. 38 residents were commenced off-license quetiapine by another psychiatrist, either while they were in the community or in another prison. In 17 patients, electronic records were inadequate to determine who had prescribed the quetiapine.The number of inmates prescribed off-label quetiapine in HMP Elmley had dropped from 82 to 60 in the 1 year since the initial audit. Of these figures, prescriptions initiated by the MHIRT psychiatrists, had dropped from 28.1% (23/82) to 8.3% (5/60).For those prescribed quetiapine by the HMP Elmley psychiatrists, notes were audited against the RCPsych guidelines: Licensed medication was considered first in 80.0%Risks and benefits were considered and documented in 80.0%The benefits and potential risks were explained to patient in 80.0%There was documentation of informed consent in 80.0%Quetiapine was started at a low dose and monitored in 100%No residents required withdrawal of medication due to ineffectiveness or adverse effects.Baseline physical health assessment was performed in 80.0%, though all had an ECG done.ConclusionOver the past year there has been an improvement in off-label antipsychotic prescribing practice within the MHIRT.However, the number of off-label antipsychotic prescriptions still remains high throughout the prison. There should be continued effort at minimizing off-label prescribing within the MHIRT, monitored by auditing. However, work needs to be done jointly with other prescribers, such as GP colleagues, in order to avoid unnecessary prescriptions and to monitor regularly the physical and mental health of those on off-label quetiapine.

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