Hepatic injury and pancreatitis during treatment with serotonin reuptake inhibitors: data from the World Health Organization (WHO) database of adverse drug reactions

2003 ◽  
Vol 18 (3) ◽  
pp. 157-161 ◽  
Author(s):  
Olav Spigset ◽  
Staffan H??gg ◽  
Andrew Bate
2021 ◽  
Vol 2 (2) ◽  
pp. 19-26
Author(s):  
Janmejay Pant ◽  
Harneet Marwah ◽  
Ripudaman M Singh ◽  
Subhajit Hazra

Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.


Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah

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.


2017 ◽  
Vol 79 (07) ◽  
pp. 526-527

Coenen M et al. [Recommendation for the collection and analysis of data on participation and disability from the perspective of the World Health Organization]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2016; 59: 1060–1067 Um eine gleichberechtigte Teilhabe an der Gesellschaft von Menschen mit Behinderung zu ermöglichen, werden zunächst Daten zu vorhandenen Einschränkungen gebraucht. Erst wenn diese detailliert erhoben wurden, können Konzepte zur Beseitigung von Problemen entwickelt werden. Ein standardisiertes Erhebungsinstrument für alle Aspekte der Funktionsfähigkeit fehlte jedoch bisher.


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