scholarly journals P13 Serious adverse reactions and off label and unlicensed drug use in children – decade of pharmacovigilance study in Serbia

2019 ◽  
Vol 104 (6) ◽  
pp. e22.2-e22
Author(s):  
M Bajcetic ◽  
J Joksimovic
Keyword(s):  
Drug Use ◽  
Adverse Reactions ◽  
Drug Formulation ◽  
System Organ Class ◽  
List Type ◽  
Age Group ◽  
Sources Of Information ◽  
Antimicrobial Drugs ◽  
Off Label ◽  
Life Threatening

BackgroundOff label (OL) and unlicensed (UL) drug use in children is a widespread global problem. Previous study showed that only 66% of all available drugs for children is with licence in Serbia.1 Data on safety of medicines in children remain lacking, so the key intervention for the effective use of medicine is safety monitoring. Therefore, the aim of this study is to evaluate safety implication of OL and UL drug use in children up to 12 years old.MethodWe conducted a retrospective study based on reports of suspected adverse reactions (ADRs) collected from 2008. to 2018. by Medicines and Medical Devices Agency of Serbia, using the Medical Dictionary for Regulatory Activities and organized by System Organ Class. Sources of information about medicines including vaccines (license, drug formulation, etc.) are the Summary of Product Characteristics and Serbia´s official drug registry.ResultsWithin 10 years, we observed 1595 ADRs. Vaccines, antineoplastic and antimicrobial drugs were the most frequently pharmacotherapeutic subgroups involved. Out of total number of observed ADRs, 433 (28%) were serious; 189 of them led to hospitalization, 31 to life threatening conditions and 7 were fatal. More than a half (63%) of serious ADRs were detected in children for the age group of 28 days - 23 months, followed by the age group of 2 to 11 years (34%) and finally by age group of 0 to 27 days (3%). Serious ADRs were detected in boys (55%) as well as in girls (45%). Out of total number of registered only 3% (46) of ADRs were associated with off-label use; 18 of them were serious, 7 led to life threatening conditions and 3 were fatal.ConclusionThis research provided new insight on the factors such as OL and UL use, that might increase the risk of serious ADRs in children.ReferencesBo&zbreve;ić B, Stupar S, Stupar D, Babić U, Bajčetić M. Availability of pediatric-evaluated formulations in Serbia. Indian J Pharmacol 2017 Mar-Apr;49(2):189–193Disclosure(s)Nothing to disclose

scholarly journals Reasons for and frequency of off - label drug use

2015 ◽  
Vol 68 (1-2) ◽  
pp. 35-40 ◽  
Author(s):  
Svetlana Golocorbin-Kon ◽  
Ivana Ilickovic ◽  
Momir Mikov
Keyword(s):  
Drug Use ◽  
Professional Associations ◽  
Medical Community ◽  
Age Group ◽  
Sources Of Information ◽  
Off Label Use ◽  
Daily Work ◽  
Off Label ◽  
Regulatory Bodies ◽  
Label Use

Introduction. The application of drugs in accordance with the marketing authorization issued by the regulatory authority is considered on-label use, while off-label drug use frequently occurs in medical practice. It includes the application of drugs beyond approved indications, for unapproved age group, with different dosage regimens or different administration route. Medical specialists frequently prescribe an off-label drug in pediatrics, neonatology, geriatrics, psychiatry and oncology. Some countries have established registers of off-label drugs and guidelines for their prescribing and administration. The aim of the paper is to review practices in off-label drug use in order to satisfy the attitude of regulatory bodies and professional associations regarding the off-label use of drugs. Material and Methods. The sources of information used are articles published in scientific journals and information from the official websites of regulatory agencies. Results and Discussion. The most common reasons why physicians decide to prescribe off-label drugs are primarily the absence of drugs for a particular indication or those for a particular age group. In their daily work, doctors prescribe drugs for an off-label use based on their own or other colleague?s experience. There is no general agreement on off-label use of drugs at the national or international level, but more and more doctors? associations and regulatory bodies approve off-label drug use in compliance with certain scientific and legal requirements. Conclusion. Off-label drug use has its place in practice and it has been widely accepted by the medical community and by itself it is not a violation of the standards of healthcare. Off-label use is common in our country and worldwide, and it is necessary to establish a registry for off-label drug use.

73 Off-label use and safety of drug use in vascular anomalies

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e53-e55
Author(s):  
Laurence Gariépy-Assal ◽  
Simon Marcoux ◽  
Jerome Coulombe ◽  
Julie Powell ◽  
Sandrine Essouri ◽  
...  
Keyword(s):  
Drug Use ◽  
Vascular Anomalies ◽  
Abnormal Development ◽  
Off Label Use ◽  
Significant Safety ◽  
Off Label ◽  
Safety Concerns ◽  
Increased Risk ◽  
Life Threatening ◽  
Label Use

Abstract Primary Subject area Clinical Pharmacology and Toxicology Background Vascular anomalies (VA) represent a heterogeneous group of disorders associated with an abnormal development and proliferation of blood and/or lymphatic vessels displaying variable clinical presentations and severity. Infantile hemangiomas, venous, and lymphatic malformations, for example, are commonly encountered in children. Other, less frequent diagnostics include Klippel-Trenaunay syndrome and PIK-3CA-related overgrowth spectrum (PROS). Severe phenotypes can alter organ function and/or lead to pain and chronic functional impairment, and are associated with significant morbidity and mortality. Management includes surgical, interventional radiology, and pharmacologic modalities. Drugs are administered by systemic (e.g., oral, intravenous) or local (topical, intralesional) routes, or by sclerotherapy (endovascular or percutaneous venous, lymphatic, or arterial injection). Off-label drug use is common in pediatrics and in rare diseases, two characteristics applying to vascular anomalies (VA). Off-label use is associated with an increased risk of adverse drug reactions. Objectives To quantify off-label drug use in VA and assess its safety. Design/Methods A guidelines search was conducted to extract a list of drugs used in VA management. The labelling status and safety of each drug was assessed based on the product monograph, Micromedex, and the FDA data. A drug was considered to have significant safety concerns if a black box warning (the FDA’s most stringent warning dedicated to serious or life-threatening risks) or if a serious adverse drug reaction was reported in at least 1% of the patients (leading to hospitalization, congenital malformation, persistent or significant disability or incapacity, life-threatening condition, or death). Results Among 87 drugs, 13 were unlicensed and 73 off-label. Figure 1 describes the reason for considering the 73 drugs off-label. Among 74 licensed drugs, only the oral solution of propranolol hydrochloride (Hemangeol®) for the treatment of infantile hemangiomas (IH) is approved. 98.9% of the drugs are used off-label or unlicensed. Except infantile hemangioma, all other VA are exclusively treated with off-label drugs. Significant safety issues concerned 73% of the drugs and were more frequent among systemic than locally delivered drugs (Figure 2). Conclusion This first study determining the rate of off-label drug use in vascular anomalies shows that off-label drug use in VA is the rule and not the exception. Significant safety concerns are common. It is needed to carefully weigh risk and benefits for every patient when using systemic and local treatments carrying safety concerns. Patients and families should be openly informed and involved in the decision-making process.

scholarly journals Off-label use in Palliative Care – more common than expected. A retrospective chart review

2021 ◽  
Author(s):  
Vera Hagemann ◽  
Claudia Bausewein ◽  
Constanze Rémi
Keyword(s):  
Palliative Care ◽  
Clinical Practice ◽  
Drug Use ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Palliative Care Unit ◽  
List Type ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

AbstractObjectiveOff-label drug use seems to be integral to palliative care pharmacotherapy. Balancing potential risks and benefits in the context of limited therapeutic options is challenging. To provide specific support for clinicians in dealing with off-label use, it is essential to understand off-label use in everyday clinical practice.The aim of this pilot study was to quantify and describe off-label use in a palliative care unit.MethodsRetrospective chart review of all adult patients treated on a palliative care unit in 10/2017. All data on drug use e.g. indication, dose, route of administration were extracted and matched with the prescribing information. Identified off-label use was subsequently compared with recommendations in the relevant literature. The main outcome measure was frequency and type of off-label drug use.Results2,352 drug application days (d) and 93 drugs were identified for 28 patients. Of all drugs, 47 (51%) were used off-label at least once. Most off-label uses concerned indication (57%), followed by mode of administration. In drugs highly relevant to palliative care the rate of off-label use was as high as 67%. The extent to which off-label therapy was supported by literature was very variable and ranged from 0 to 88%.ConclusionsThis single-unit data confirms the high prevalence of off-label use in palliative medicine and demonstrates that off-label use in palliative care is very multifaceted. The data presented allows for a more precise characterization of various aspects of off-label use in order to derive concrete further measures for research and clinical practice.What is already known on this subjectOff-label drug use is likely to be common in palliative care, but detailed data is very limitedOff-label drug use is a potential threat for patient safetyPhysicians state to make therapeutic decisions based on their own experience, due to a lack of available evidence and lack of support in assessmentWhat this study addsoff-label use in palliative care is multifacetedthe mode of administration (e.g. combination with other drugs in a syringe driver) is beside indication a common reasons for off label usethe proportion of off-label use without sound evidence is high.

scholarly journals Drug safety monitoring in the Republic of Sakha (Yakutia)

2020 ◽  
pp. 77-80
Author(s):  
A.A. Everstova ◽  
◽  
I.I. Bubiakina ◽  
A.A. Kuzmina ◽  
I.Sh. Malogulova ◽  
...  
Keyword(s):  
Information System ◽  
Nervous System ◽  
Adverse Reactions ◽  
Safety Monitoring ◽  
Antimicrobial Drugs ◽  
Drug Safety Monitoring ◽  
Automated Information System ◽  
Life Threatening ◽  
The Republic ◽  
Clinically Significant

The aim of the research is analysis of frequency and nature of adverse reactions during the use of drugs in the Republic of Sakha (Yakutia) according to automated information system of Russian Federal Service for Surveillance in Healthcare “Pharmacovigilance” (Roszdravnadzor “Pharmakonadzor”). Material and methods. Data from the AIS Roszdravnadzor “Pharmakonadzor” in the Republic of Sakha (Yakutia) for the period from 2014 to 2019 were used for the analysis. It should be noted that since April 1, 2019 data collection is carried out using the modified notification form. Results. For the period of 2014-2019 300 reports (292 primary and 8 repeated) on adverse reactions and cases of therapeutic ineffectiveness of drugs were registered. According to the leading criterion concerning person’s life severity, there were notifications on 20 deaths of patients, 60 life-threatening cases, 1 case of disability, 105 cases of hospitalization or prolongation of its terms, 35 clinically significant event cases. It was noted, that mainly, antimicrobial drugs and drugs for nervous system treatment caused adverse reactions. Conclusion. Report frequency on drugs adverse reactions or lack of therapeutic effect in the region was assessed as insufficient. There should be additional training for medical workers on the procedure for implementing pharmacovigilance in medical organizations, correct notification filling, which ensures reports completeness and its quality

Off-Label Use and Safety of Drug Use in Vascular Anomalies

Dermatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Niina Kleiber ◽  
Laurence Gariépy-Assal ◽  
Jérôme Coulombe ◽  
Simon Marcoux ◽  
Sandrine Essouri ◽  
...  
Keyword(s):  
Drug Use ◽  
Oral Solution ◽  
Vascular Anomalies ◽  
Significant Safety ◽  
Safety Issues ◽  
Off Label ◽  
Safety Concerns ◽  
Increased Risk ◽  
Threatening Condition ◽  
Life Threatening

<b><i>Background:</i></b> Off-label drug use is associated with an increased risk of adverse drug reactions. It is common in pediatrics and in rare diseases, which are two characteristics applying to vascular anomalies (VA). <b><i>Objectives:</i></b> The aim of this work was to quantify off-label drug use in VA and assess its safety. <b><i>Methods:</i></b> A review was conducted to extract a list of drugs used in VA management. A drug was considered to have significant safety concerns if a black box warning was present or if a serious adverse drug reaction (SADR) was reported in at least 1% of the patients (SADR is defined as a noxious and unintended response to a drug that occurs at any dose and results in hospitalization, prolongation of existing hospitalization, congenital malformation, persistent or significant disability or incapacity, life-threatening condition, or death). The labelling status and safety of each drug was assessed based on the product monograph, Micromedex, and the FDA data. <b><i>Results:</i></b> We found that 98.9% of the inventoried drugs were used off-label or unlicensed for VA management. Only the oral solution of propranolol hydrochloride (Hemangeol®) for the treatment of infantile hemangiomas is approved. Significant safety issues concerned 73% of the drugs and were more frequent among systemic than locally delivered drugs. <b><i>Conclusions:</i></b> Off-label drug use in VA is the rule and not the exception. Significant safety concerns are common. It is necessary to carefully weigh risk and benefits for every patient when using systemic and local treatments carrying safety concerns. Patients should be openly informed and involved in the decision-making process.

Off-label drug use in breast cancer therapy

Oncoreview ◽  
2017 ◽  
Vol 7 (2) ◽  
pp. 83-87
Author(s):  
Tomasz Jankowski ◽  
Monika Urbaniak
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Drug Use ◽  
Breast Cancer Therapy ◽  
Off Label

Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

2020 ◽  
Vol 15 (3) ◽  
pp. 181-189
Author(s):  
Omotayo Fatokun
Keyword(s):  
Informed Consent ◽  
Drug Use ◽  
Perceived Risk ◽  
Adverse Drug Events ◽  
Community Pharmacists ◽  
Risk Minimization ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Off Label ◽  
Written Informed Consent

Background: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia. Objectives: This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures. Methods: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia. Results: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002). Conclusion: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

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