Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

Thota, Prasad; Thota, Anusha; Medhi, Bikash; Sidhu, Shabir; Kumar, Pramod; Selvan, V Kalai; Singh, Gyanendra

doi:10.4103/picr.picr_29_17

Cited by 16 publications

(11 citation statements)

References 4 publications

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“…NCC-PvPI issued 56 drug safety alerts from March 2016 to June 2017. 8 Paediatric patients are a vulnerable group as many new drugs are marketed without sufficient clinical trials in this age group, thereby increasing the risk of drug toxicity. 3 Knowledge of drug safety is limited in the paediatric population due to ethical considerations, with the exceptions of paediatric oncology and vaccinations.…”

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confidence: 99%

Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital

Kurma

Manchu

Amancharla

et al. 2019

Int J Contemp Pediatr

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Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.

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confidence: 99%

Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital

Kurma

Manchu

Amancharla

et al. 2019

Int J Contemp Pediatr

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“…[ 16 ] AGEP is not listed in summary of product characteristics and patient information leaflet of cefixime marketed in India, the United Kingdom,[ 17 ] and also in the United States. [ 18 ] Initially NCC-PvPI issued a drug safety alert based on the information received till July 2016[ 19 ] same shall be intimated through website and newsletter to HCP's and consumers to implement targeted or stimulated spontaneous reporting system in India. [ 20 ] After implementation of stimulated reporting system, few more cases were received.…”

Section: Discussionmentioning

confidence: 99%

Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India

Kumar¹,

Kalaiselvan²,

Kumar³

et al. 2018

Indian J Pharmacol

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BACKGROUND:Cefixime is a widely used third-generation cephalosporin schedule H1 drug, which is prescribed for the treatment of otitis media, respiratory tract infections, and uncomplicated urinary tract infections and is effective against infections caused by Enterobacteriaceae and Haemophilus influenzae species in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), has received rare individual case safety reports (ICSRs) for acute generalized exanthematous pustulosis (AGEP) associated with the use of cefixime.MATERIALS AND METHODS:IPC, NCC-PvPI also acts as a national collaborating center for pharmacovigilance activities under the aegis of Ministry of Health and Family Welfare, Government of India; moreover, it is a member country in global pharmacovigilance system, World Health Organization-Uppsala Monitoring Centre, Sweden. There are more than 250 government/corporate medical colleges and hospitals acting as regional adverse drug reaction monitoring centers, actively functioning under PvPI. Furthermore, various stakeholders including consumers and pharmaceutical industries also play a significant contribution. NCC-PvPI receives spontaneous ICSRs from various stakeholders.RESULTS:NCC-PvPI, IPC has received a total of four spontaneous ICSRs for cefixime-induced AGEP. After clinical evaluation of reported ICSRs, a strong causal relationship was established between AGEP and cefixime and was supported by published literature and histopathological examination of skin. Based on the statistics with positive information component (IC025 Value: 0.17) and proportionality relative risk (PRR:3.4), PvPI considered cefixime-associated AGEP may be a potential signal.CONCLUSION:Hence, initially, AEGP is considered by PvPI as drug safety alert in July 2016. Therefore, to enhance the safety of population in rational usage of medication, as a result, there is a need for physicians and health-care professionals to sensitize about serious adverse reaction while prescribing the cefixime as signal in India.

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“…Out of these, 1.8% are fatal. 2 In a recent study by Patel TK et al, the incidence of ADRs that lead to hospitalization in Indian hospitals was 2.85% while that of ADRs developed in hospitalization was 6.34%. 3 The increasing burden of ADR in current scenario is responsible for increased morbidity and mortality which eventually affects patient safety.…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance programme of India: revival of the renaissance

Gadhade

Hiray

Aherkar

et al. 2018

Int J Basic Clin Pharmacol

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Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

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Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

Cited by 16 publications

References 4 publications

Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital

Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital

Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India

Pharmacovigilance programme of India: revival of the renaissance

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