scholarly journals Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients

Pharmacy ◽  
2018 ◽  
Vol 6 (4) ◽  
pp. 108 ◽  
Author(s):  
Siraj Sundaran ◽  
Anjali Udayan ◽  
Keerthi Hareendranath ◽  
Basil Eliyas ◽  
Babu Ganesan ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Causality Assessment ◽  
Hospital Setting ◽  
Adr Reporting ◽  
Reporting Programs ◽  
Monitoring Service ◽  
Assessment Scales

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries.

scholarly journals Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reactions Found in a Tertiary Care Teaching Hospital

2018 ◽  
Author(s):  
Siraj Sundaran ◽  
Anjali Udayan ◽  
Keerthi Hareendranath ◽  
Basil Eliyas ◽  
Babu Ganesan ◽  
...  
Keyword(s):  
Healthcare Professionals ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Hospital Setting ◽  
Common Type ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Reporting Programs ◽  
Monitoring Service ◽  
Assessment Scales

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of drugs. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The drugs most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer drug use. Similar ADR reporting programs are necessary to educate and to improve awareness among the healthcare professionals in developing countries.

scholarly journals Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Safety Data ◽  
Regulatory System ◽  
Basic Structure ◽  
Reaction Reporting ◽  
Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

scholarly journals A Qualitative Evaluation of Adverse Drug Reaction Reporting System in Pakistan: Findings from the Nurses’ Perspective

2020 ◽  
Vol 17 (9) ◽  
pp. 3039
Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Qualitative Interviews ◽  
Qualitative Evaluation ◽  
Adr Reporting ◽  
Willingness To Report ◽  
And Training

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.

scholarly journals Classification and applying pharmacovigilance principles to study adverse drug reaction and its management

2017 ◽  
Vol 6 (11) ◽  
pp. 2537
Author(s):  
Srihitha Pendota ◽  
Sre Akshaya Kalyani Surabhineni ◽  
Abhinay Sharma Katnapally ◽  
Dharanija Porandla ◽  
Sandeep Kumar Beemreddy
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Causality Assessment ◽  
Causal Relation ◽  
Drug Event ◽  
Multiple Drug ◽  
Different Types ◽  
Multiple Drug Therapy ◽  
Assessment Scales ◽  
Reason For Admission

Adverse drug reaction (ADR) is an unwanted, undesirable effect of medication resulting in mild to severe effect on the patient. This review explains definitions of ADR and it differentiation with adverse drug event, medication error. ADRs may cause increased length of stay or initial reason for admission and are major cause of morbidity and mortality worldwide. Risk factors for ADR occurrence include age, gender, patients with multiple diseases and multiple drug therapy (polypharmacy). ADRs are classified into different types based on the mechanism and onset of reaction. The causal relation between suspected drug and reaction can be assessed by using causality assessment scales. The severity and preventability of ADR can be assessed by severity assessment scale and preventability scale respectively. Clinical Pharmacists play an important role in monitoring and management of ADRs.

Adverse drug reaction (ADR) reporting and follow-up in a hospital setting: A patient's perspective

2017 ◽  
Vol 13 (4) ◽  
pp. e29
Author(s):  
Matthew W. Scott ◽  
Michael McDonough ◽  
Grace Wong ◽  
Richard Summers ◽  
M Joy Spark
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Hospital Setting ◽  
Adr Reporting ◽  
Patient’S Perspective

Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting

2017 ◽  
Vol 123 ◽  
pp. 122-129 ◽  
Author(s):  
Annamaria Mascolo ◽  
Cristina Scavone ◽  
Maurizio Sessa ◽  
Gabriella di Mauro ◽  
Daniela Cimmaruta ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Definition Of

scholarly journals Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study

2021 ◽  
Vol 12 (2) ◽  
pp. 1276-1282
Author(s):  
Yamuna Devi M. S. ◽  
Saratha Muthukumar ◽  
Kaavya S.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Drug Effects ◽  
Indian Languages ◽  
Cross Sectional ◽  
Adr Reporting ◽  
The Government

The adverse drug reaction (ADR) reporting system in India came into existence in 2010 through an initiative by the Government, the Pharmacovigilance Programme of India (PvPI), considering the social and economic consequences of drug effects. Though the system is functioning effectively for almost a decade, there has been a lacuna in reporting due to the lack of awareness among the patients who are the direct consumers. Medicine side-effects reporting is the newest initiative started in 2014 by PvPI, and the forms for consumer reporting is made available in over 10 different Indian languages like Tamil, Hindi, etc. It is imperative to determine the level of awareness among the public regarding drug side-effects and the existence of a National Programme to monitor the same, especially in a country like India with a population of nearly 1.38 billion. The aim of this study was to determine the awareness among the general population about the ADR reporting system in India. This cross-sectional study was done over a period of one year amongst the general public in South India. Data was collected from about 338 participants using a standardized questionnaire and analyzed descriptively using SPSS statistical software version 24. The overall response rate was 93.8%, and the mean age was 35.62 ± 10.43 years. Though the respondents had sufficient knowledge (66%) about ADRs, their awareness about the reporting system was very poor (19%). Reporting through phone (78%) was preferred over-reporting through specific forms (10%). To conclude, our study emphasizes that public participation and awareness are crucial in strengthening the existing system of Pharmacovigilance.

SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR TRANSPLACENTAL AND TRANSMAMMARY ROUTES IN THOSE ≤1 YEAR IN THE UK 2001–2010

2015 ◽  
Vol 101 (1) ◽  
pp. e1.21-e1
Author(s):  
Nicki-Jayne Russell ◽  
Mark Turner ◽  
Dan Hawcutt
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Yellow Card ◽  
Exposure Data ◽  
Yellow Card Scheme ◽  
Spontaneous Adverse Drug Reaction ◽  
Route Of Exposure ◽  
The Uk

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme, YCS) to collect suspected adverse drug reaction (ADR) data. We describe the Yellow card reports received for patients aged ≤1 year across a 10 year period (2001–10).MethodsThe MHRA supplied YCS data for patients aged ≤1 year from the years 2001–2010. This analysis includes all reports involving transplacental, transmammary, or paternal route of exposure. Data were analysed to include number, type and outcome of ADRs.ResultsThere were 279 reports, including 249 different medications (a YCS may contain ≥1 medication). The most commonly reported drugs were fluoxetine (n=25), citalopram (n=22), paroxetine (n=19) and venlafaxine (n=19). The outcome of the ADR was death in 10.4% of reports. Doctors reported 75.4% (n=215) of reports, however only 3.9% (n=11) were from the parent/carer. Gender was documented in 66% cases and gestation was stated in only 15% of reports.ConclusionsDespite many women requiring medications in pregnancy and while lactating, very few YCS reports were received over a 10 year period. Current MHRA advice is for all suspected ADRs in children following transplacental or transmammary exposure to be reported. Strategies to improve reporting in this neglected population are urgently needed.

Knowledge, Attitudes, and Practice of Hospital Pharmacists Regarding Pharmacovigilance and Adverse Drug Reaction Reporting in Japan

2019 ◽  
pp. 001857871985145
Author(s):  
Tomonori Kobayashi ◽  
Aoi Noda ◽  
Taku Obara ◽  
Masami Tsuchiya ◽  
Kazutoshi Akasaka ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Reporting System ◽  
Outcome Measure ◽  
Response Rate ◽  
Adverse Drug Reaction Reporting ◽  
Personal History ◽  
Hospital Pharmacists ◽  
Adr Reporting ◽  
History Of

Background: The importance of pharmacovigilance in Japan is gradually being recognized. However, Japanese pharmacists’ knowledge of and perspectives on pharmacovigilance have been examined only in some areas of Japan. Objective: The objective of this study was to clarify the knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting among hospital pharmacists in Japan. Setting: A questionnaire survey among Japanese hospital pharmacists. Method: The questionnaire was distributed to 48 028 pharmacists during a 3-month period between January and March 2017. Main Outcome Measure: The prevalence of hospital pharmacists who understood pharmacovigilance and the ADR reporting system. Results: Of the respondents (response rate; 9.9% = 4760/48 028), 21.9% were <30 years of age, 27.3% were ≥50 years of age, and 46.7% were women. In response to the question “Have you ever heard of the term ‘pharmacovigilance’?,” 12.4%, 33.8%, and 47.4% answered “I understand what it is,” “I have heard of it, but I do not understand what it is,” and “I do not know what it is,” respectively. Pharmacists who understood the term “pharmacovigilance” were also more frequently acquainted with its associated terms and actions. And, 69.7% of respondents wished to acquire more information on pharmacovigilance and 50.9% did not have a personal history of ADR reporting. The most common reason for ADR nonreporting was “It was a well-known adverse drug reaction” (44.5%). Conclusions: Our results suggest that more aggressive promotion of pharmacovigilance and of the ADR reporting system among Japanese pharmacists is needed.

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