Authors’ Reply to Alain Braillon’s Comment on “Proactive regional pharmacovigilance system versus national spontaneous reporting for collecting safety data on concerning off-label prescribing practices: An example with baclofen and alcohol dependence in France’’

Drug Safety ◽  
2017 ◽  
Vol 40 (4) ◽  
pp. 361-362
Author(s):  
Marine Auffret ◽  
Julien Labreuche ◽  
Alain Duhamel ◽  
Sylvie Deheul ◽  
Olivier Cottencin ◽  
...  
Keyword(s):  
Alcohol Dependence ◽  
Spontaneous Reporting ◽  
Safety Data ◽  
Pharmacovigilance System ◽  
Prescribing Practices ◽  
Off Label ◽  
System Versus

Spontaneous Reporting of Adverse Drug Reaction Among Health Professionals In Kpone-Katamanso District, Ghana

2021 ◽  
Author(s):  
Morrison Asiamah ◽  
Kwadwo Owusu Akuffo ◽  
Pricillia Nortey ◽  
Nina Donkor ◽  
Anthony Danso-Appiah
Keyword(s):  
Health Professionals ◽  
Spontaneous Reporting ◽  
Effective Means ◽  
Cross Sectional Study ◽  
Health Concern ◽  
Pharmacovigilance System ◽  
Cross Sectional ◽  
Logistic Regression Models ◽  
Adequate Knowledge ◽  
Statistical Adjustment

Abstract Background: Spontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern. Method: A questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR.Result: Overall, 77.6% (208) of the 268 respondents had witnessed ADR; however, only 17.3% of the respondents have ever reported an ADR to the FDA. Health professionals who had adequate knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had very good knowledge of spontaneous reporting of ADR. After statistical adjustment, Age (AOR=2.26, 95%CI= 1.25–4.10), Fear of Legal Consequences (AOR=0.15, 95%CI=0.41–0.51), Time Constraint (AOR=0.3, 95%CI=0.10–0.91), Pharmacovigilance training (AOR= 18.78, 95%CI= 5.46–64.59) and Unavailability of Reporting form (AOR=0.28, 95%CI=0.09– 0.88) were found to be significantly associated spontaneous reporting of ADR. Conclusion: The proportion of health professionals in the Kpone-Katamanso District who spontaneously report observed ADR is low. Our findings underscore the need for the FDA to intensify awareness through media sensitization and engage all relevant stakeholders on the need for the entire population to report ADR.

New users of antipsychotic medication: A population-based cohort study of occupational outcome measures in relation to antipsychotic on-label and off-label prescribing practices

2016 ◽  
Vol 31 ◽  
pp. 66-71
Author(s):  
L. Baandrup ◽  
M. Kruse
Keyword(s):  
Cohort Study ◽  
Labor Market ◽  
Antipsychotic Medication ◽  
Health Care Services ◽  
Prescribing Patterns ◽  
Antipsychotic Treatment ◽  
Combination Regimen ◽  
Linear Regression Models ◽  
Prescribing Practices ◽  
Off Label

AbstractBackgroundTreatment with antipsychotic medication is thoroughly investigated in schizophrenia and bipolar disorder but is also widely applied for a diversity of off-label conditions, despite an uncertain risk-benefit ratio. This study examined the relationship between antipsychotic prescribing patterns and labor market affiliation, considering both authority approved and off-label prescriptions and the relation to polypharmacy.MethodsRegister-based cohort study using a dataset of 71,254 new antipsychotic users with a psychiatric diagnosis. Labor market affiliation and duration of welfare payments were analyzed using linear regression models and duration analysis. The analyses were adjusted for the following confounding variables: age, gender, diagnosis, marital status, length of education, and utilization of mental health care services.ResultsThe majority of new antipsychotic users received welfare payments for prolonged periods of time during the observation period, even more so for individuals treated with antipsychotic polypharmacy or other antipsychotic combination regimens. The risk of permanently leaving the labor market was also associated with antipsychotic combination regimen.ConclusionsAntipsychotic treatment, especially in combination with other antipsychotics or other psychotropic drugs, could serve as a marker of subjects with increased need for support to maintain the labor market affiliation. However, causality cannot be inferred from an observational study because of residual confounding that could not be adjusted for in this study.

scholarly journals Off-Label Prescription of Hydroxycarbamide (Hydroxyurea, HU) for Severe Anemia: Preliminary Results from European Non-Interventional, Multicentric, Prospective Escort-HU Study

Blood ◽  
2017 ◽  
Vol 130 (Suppl_1) ◽  
pp. 758-758
Author(s):  
Mariane De Montalembert ◽  
Gylna Loko ◽  
Jerome Clouzeau ◽  
Valentine Brousse ◽  
Frederic Galacteros ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Expert Panel ◽  
Safety Data ◽  
Incidence Rates ◽  
Cell Disease ◽  
Advisory Committees ◽  
Off Label ◽  
Preliminary Results ◽  
The Mean

Abstract HU is licensed in Europe in the prevention of recurrent painful vaso-occlusive crises (VOC) including acute chest syndromes in adults, adolescents and children older than 2 years with sickle-cell disease (SCD). However, based on US and European expert panel recommendations (Yawn 2014, Habibi 2015) and results from placebo-controlled clinical trials, HU could be useful in SCD patients with severe anemia without VOC since it has been demonstrated to increase total Hb level (Wang 2011) and to decrease the need for blood transfusion. We hereby present preliminary results on effectiveness and safety data related to the prescription of HU for anemia from ESCORT-HU (European Sickle Cell Disease COhoRT - HydroxyUrea), a multicentric, prospective, non-interventional European study designed to collect long-term safety data on HU in SCD population. Between January 2009 and June 2017, 1841 patients were enrolled from 63 centers in France, Germany, Greece and Italy, amongst which 126 patients (6.8%) were started on HU for anemia from 34 centers. Of these 126, 96 were HU-naive. These HU-naive patients treated for anemia ('anemic' subpopulation) were selected for analysis to evaluate effectiveness and safety of HU in this indication and compared with data in HU-naive patients treated for other SCD indications. Demographic data and Hb genotypes are displayed in Table 1. The mean age, distribution of gender, Hb genotype and the mean HU dose at initiation were comparable in the 'anemic' subpopulation and the 'non-anemic' HU-naive cohort. Not surprisingly, mean Hb level at initiation was markedly lower in the 'anemic' subpopulation (7.07 ± 0.88 g/dl) than in the 'non-anemic' HU-naive cohort (8.71 ± 1.51 g/dl), with a lower proportion of patients with history of VOC and SCD-related hospitalization prior to HU initiation. The mean HU dose after 6 months was comparable in both groups (15.6 ± 3.83 mg/kg/day and 15.4 ± 4.11 mg/kg/day, respectively). Variation of blood parameters are displayed in Table 2. Similarly to what has been observed previously, a dramatic rise in Hb concentration (> 2 g/dl) was observed. This increase was comparable in absolute value to the increase observed in non-anemic patients. An increase in HbF was observed in the "anemic" subpopulation, with a near 2-fold increase in %HbF, markedly in children. Changes in reticulocyte counts were inconclusive due to small number of patients in the dataset. Safety of HU in the population of patients treated for anemia was evaluated by comparing incidence rates of non-SCD related adverse events (AEs) in HU-naive patients treated for anemia with the 'non-anemic' HU-naive ESCORT-HU subpopulation (Table 3). With mean follow-up periods of 18.3 months in 'anemic' subpopulation and 34.2 months in 'non-anemic' HU-naive cohort, preliminary results showed no striking difference in the incidence rate of reported AEs (total and serious) between the two populations (112.5% vs 139.8%, respectively for incidence rate of total AEs), and in the distribution of AEs by System Organ Class (SOC), at least in SOC where the number of adverse events was large enough to allow for comparison between the groups. Similarly, when focusing on AE causally related to HU (as judged by the investigators), the most frequently reported toxicity in the 'anemic' population was myelosuppression (anemia, neutropenia thrombocytopenia, pancytopenia reported in 4 children, one event each), as in the 'non-anemic' HU-naive cohort, with comparable incidence rates. In conclusion, even though HU is not licensed in Europe in severe chronic anemia, European and US expert panel guidelines recommend treatment with HU in this indication. Data from ESCORT-HU observational study on a subset of SCD patients treated off label in this indication confirmed total Hb level increase while the safety profile of HU in this subpopulation did not differ significantly from the 'non-anemic' HU-naive population. Disclosures De Montalembert: Novartis: Consultancy, Honoraria, Research Funding; Addmedica: Consultancy, Honoraria, Research Funding. Brousse: Add Medica: Membership on an entity's Board of Directors or advisory committees. Galacteros: Addmedica: Membership on an entity's Board of Directors or advisory committees.

scholarly journals Off-label use of combined antiretroviral therapy, analysis of data collected by The Italian Register for HIV-1 infection in Paediatrics in a large cohort of children.

2021 ◽  
Author(s):  
Elena Chiappini ◽  
Catiuscia Lisi ◽  
Vania Giacomet ◽  
Paola Erba ◽  
Stefania Bernardi ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
T Lymphocyte ◽  
Highly Active Antiretroviral Therapy ◽  
Safety Data ◽  
Undetectable Viral Load ◽  
Antiretroviral Drugs ◽  
Older Children ◽  
Off Label ◽  
Increased Risk ◽  
Hiv 1

Abstract BackgroundEarly start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children < 2 years of age and 60% in those aged 2–12 years, due to the lack of adequate paediatric clinical studies on pharmacokinetics, pharmacodynamics and drug safety in children.MethodsAn observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018.Results22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR:2.41; 95%IC 1.13–5.19; P = 0.024). Moreover, children < 2 years of age were at increased risk for receiving off-label HAART with respect to older children (OR:3.24; 95%IC 1063 − 7.3; P = 0.001). Even if our safety data regarding off-label regimens where poor, no adverse event was reported.ConclusionThe prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

scholarly journals No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19 (Preprint)

2020 ◽  
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Public Health ◽  
Real World ◽  
Generic Drugs ◽  
Antiplatelet Agent ◽  
Safety Data ◽  
Drug Repurposing ◽  
Extensive Literature ◽  
Off Label ◽  
Drug Candidates ◽  
Track Record

UNSTRUCTURED Real-world drug repurposing—the immediate “off-label” prescribing of drugs to address urgent clinical needs—is an indispensable strategy gaining rapid traction in the current COVID-19 crisis. Although off-label prescribing (ie, for a nonapproved indication) is legal in most countries, it tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, in urgent public health crises, it is often the only realistic source of a meaningful potential solution. To be considered for real-world repurposing, drug candidates should ideally have a track record of safety, affordability, and wide accessibility. Although thousands of such drugs are already available, the absence of a central repository of off-label uses presents a barrier to the immediate identification and selection of the safest, potentially useful interventions. Using the current COVID-19 pandemic as an example, we provide a glimpse at the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and pleiotropically target the underlying pathophysiology that makes COVID-19 so dangerous. Having previously fast-tracked this paper to publication in summary form, we now expand on why cimetidine/famotidine (histamine type-2 receptor antagonists), dipyridamole (antiplatelet agent), fenofibrate/bezafibrate (cholesterol/triglyceride-lowering agents), and sildenafil (phosphodiesterase-5 inhibitor) are worth considering for patients with COVID-19 based on their antiviral, anti-inflammatory, renoprotective, cardioprotective, and anticoagulation properties. These examples also reveal the unlimited opportunity to future-proof public health by proactively mining, synthesizing, and cataloging the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

scholarly journals Gabapentinoids: pharmacokinetics, pharmacodynamics and considerations for clinical practice

2020 ◽  
Vol 14 (2) ◽  
pp. 104-114 ◽  
Author(s):  
Mahindra Chincholkar
Keyword(s):  
Neuropathic Pain ◽  
Clinical Practice ◽  
Perioperative Period ◽  
The Elderly ◽  
Prescribing Practices ◽  
First Line ◽  
Off Label ◽  
Conflicting Evidence ◽  
Appropriate Prescribing ◽  
Prescription Rates

The gabapentinoids are often recommended as first-line treatments for the management of neuropathic pain. The differing pharmacodynamic and pharmacokinetic profiles can have implications for clinical practice. This article has summarised these key differences. In addition to their use in managing neuropathic pain, gabapentinoids are increasingly being used for off-label conditions despite the lack of evidence. Prescription rates for off-label conditions have overtaken that for on-label use. Similarly, the use of gabapentinoids in the perioperative period is now embedded in clinical practice despite conflicting evidence. This article summarises the risks associated with this increasing use. There is increasing evidence of the potential to cause harm in vulnerable populations such as the elderly and increasing prevalence of abuse. The risk of respiratory depression in combination with opioids is of particular concern in the context of the current opioid crisis. This article describes the practical considerations involved that might help guide appropriate prescribing practices.

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