Pharmacovigilance Programme of India

Kumar, Duvvuru Ashok; Reddenna, Languluri

doi:10.24926/iip.v6i1.371

Cited by 6 publications

(3 citation statements)

References 24 publications

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“…It was made mandatory to report all suspected adverse drug reactions to PvPI and over time it evolved into a robust well defined system for monitoring and reporting adverse drug reactions and serves several roles such as identification, quantification and documentation of drug related problems which are responsible for drug-related injuries. 8 Morphological patterns of exanthem can be scarlatiniform, rubelliform or morbilliform. Exfoliative dermatitis is characterized by erythema and scaling involving 90% or more of body surface area (BSA) which may initially start as exanthem sometimes.…”

Section: Discussionmentioning

confidence: 99%

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Analysis of cutaneous adverse drug reactions in a tertiary care hospital in South Tamil Nadu

Murthy¹,

K.²,

Palanivel

et al. 2022

Int J Basic Clin Pharmacol

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Background: Cutaneous adverse drug reactions (CADRs) are among the most frequently reported adverse drug reactions (10 to 30%) with overall incidence of 6.2/1000 cases in India and 8% of hospitalisation among Dermatology inpatients. The aim was to analyse the CADRs with reference to its prevalence, causative drugs, morphological patterns, polypharmacy and drug reaction severity by Hartwig’s severity assessment scale.Methods: This study was a retrospective study done in the Department of Dermatology, Venereology and Leprosy (DVL) over a period of 5 years (2015 to 2019) from CADR registers. Mean, standard deviation and chi square test were used for statistical analysis. P≤0.05 was considered as statistically significant.Results: A total of 134 cases of CADRs were encountered which comprised 0.2% (2/1000) of total OP census with equal gender ratio and involved most commonly the younger adults. The drug groups mainly responsible were anticonvulsants (24.7%) followed by non-steroidal anti-inflammatory drugs (NSAIDS) (22.5%), antibiotics (20.9%) followed by antiretrovirals (ART) and antituberculous drugs (ATT). The common morphological patterns were acute exanthem (32.2%), exfoliative dermatitis (14.9%) and toxic epidermal necrolysis (14.2%). Over the counter drugs accounted for 25.6% of cases. Around 38.1% were on polypharmacy. In this study, 15.7% had mild CADR, 53.7% had moderate and 30.6% had severe drug reactions with 2.2% mortality based on the Hartwig’s severity assessment scale. Commonest cause of severe CADRs was anticonvulsants and benign CADRs was NSAIDS.Conclusions: Proper history taking and documentation of data, recollection of sequence of events by the patient and drug re-challenge will help us in deciding the causative drug preventing further occurrence.

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Section: Discussionmentioning

confidence: 99%

“…The Pharmacovigilance Programme of India (PvPI) was started by the Government of India on July 14, 2010. 8 Reporting of ADRs and reviewing them is of paramount importance as it helps to predict the frequency of occurrence of drug reaction to specific drugs and susceptibility and patterns of manifestation in the population studied.…”

mentioning

confidence: 99%

Analysis of cutaneous adverse drug reactions in a tertiary care hospital in South Tamil Nadu

Murthy¹,

K.²,

Palanivel

et al. 2022

Int J Basic Clin Pharmacol

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“…implementing the pharmacovigilance program/ pharmacovigilance program of India (PvPI) in 2014. [2][3][4] PvPI provides a toll-free number 1800-1803-024 to make drug safety information available for the Indian population. Besides suspected ADR/ADE reporting form, PvPI has generated medicine side-effect reporting form for consumers and patients in their regional or local language.…”

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confidence: 99%

A study on the knowledge, attitude and practice of junior doctors to adverse drug event reporting in a tertiary care hospital, Manipur

Manohar¹,

Akham²,

Singh³

et al. 2022

Int J Basic Clin Pharmacol

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Background: The aim of the present study is to find out the ways to improve the status of adverse drug effect (ADE) reporting to the pharmacovigilance centres.Methods: The present study is a cross-sectional study with purposive sampling. Descriptive statistics is used for analysing the data from the questionnaire using frequencies and percentages.Results: The response on the questionnaire was 77.7%. The 90 participants knew the definition of ADE. The 91 participants want to report the ADEs of newly marketed drugs. Only 70 participants know about the existence of PvPI. The 80 participants did not consider all OTC drugs to be safe. 95 participants opined that all Herbal and non-allopathic drugs are not safe. The 69 participants replied that no ADE monitoring centre was available in SHIJA hospitals and research institute Pvt. Ltd. Though 90 participants knew the definition of ADE, only 85.1% of them considered to report it as a professional obligation. Maximum ADEs are seen with skin, paediatric and elderly patients as opined by 57.4% of the participants. Varied opinions of occurrence of ADEs according to the participants with polypharmacy was 70.3% and with foods and drinks was 40.6%. Although 85.1% participants have the attitude of reporting ADE, only 63.4% participants have good clarity when reporting and filling the ADE forms with careful observation of the risks and behaviour of the patients.Conclusions: To promote ADE reporting, a regular awareness cum sensitization programme coupled with CME program is necessary at various levels of health-care providers.

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The development of a pharmacovigilance system in Bahrain

Abdulrasool

2022

Saudi Pharmaceutical Journal

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Pharmacovigilance Programme of India

Abstract: IntroductionThe world health organization (WHO) initiated a program for reporting all adverse reactions possessed by drugs. Further awareness about adverse drug reactions has resulted in the emergence of the practice and science of pharmacovigilance.

Cited by 6 publications

References 24 publications

Analysis of cutaneous adverse drug reactions in a tertiary care hospital in South Tamil Nadu

Analysis of cutaneous adverse drug reactions in a tertiary care hospital in South Tamil Nadu

A study on the knowledge, attitude and practice of junior doctors to adverse drug event reporting in a tertiary care hospital, Manipur

The development of a pharmacovigilance system in Bahrain

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