RESUMO
Misuse of antimicrobials has become one of the grave concerns of public health. In last two decades, this has been largely contributing in the emergence of antimicrobial resistance (AMR) among all the pathogens. A 2013 report of Centres for Disease Control and Prevention, USA figured that at least 2 million people get an antibiotic-resistant infection every year and as many as 23,000 people lost their life. A multi-country survey in Southeast Asia region conducted by World Health Organization (WHO) in 2015, identified several gaps in knowledge and awareness about the optimal use of antimicrobials and AMR. Following this, the Ministry of Health and Family Welfare (MoHFW), Government of India, developed National Action Plan in the year 2017 to combat AMR. Pharmacovigilance Programme of India (PvPI) being a flagship programme of MoHFW holds the responsibility of ensuring safety of medicines used by India population and has recently identified AMR as one of the strategic priorities. This article intends to provide insights of the recent attempts and deliberate efforts made by PvPI in the containment of AMR in India and it also intends to sensitize healthcare fraternity on restricting AMR in public interest.
RESUMO
The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Documentação/métodos , Documentação/normas , Farmacovigilância , Humanos , Índia , Controle de Qualidade , Organização Mundial da SaúdeRESUMO
BACKGROUND: The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI. METHODS: Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures. The effectiveness of the proposed methods was assessed by applying them to 4 drug-ADR combinations. RESULTS: The proposed methods were easy to apply and relevant to the Indian context. In selected methods, the information component value was more specific, whereas the proportional relative risk was more sensitive. CONCLUSIONS: The proposed methods may help in the identification of new signals in Indian individual case safety reports.
RESUMO
The global ophthalmic formulations (OFs) market is expanding dramatically with the approval of new drug formulations for a variety of ophthalmic indications by competent authorities in various countries. In India, the Central Drug Standards Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts for approval and setting the standards for OFs, respectively. In fulfillment of the requirements of the Drugs and Cosmetics Act of 1940, the IPC is publishing an official book of standards for drugs known as the Indian Pharmacopoeia (IP). There are 44 ophthalmic active pharmaceutical ingredients (APIs) and combinations approved by CDSCO as of 2011; the IP 6th edition (2010) prescribes the quality standards monographs for 41 ophthalmic APIs and formulations. The IP monograph of OFs also includes description, identification, impurities, assay, and specific tests. In addition, the IPC is publishing the National Formulary of India (NFI), which covers 23 OFs for the diagnosis and treatment of various eye diseases. Both the IP and NFI play a significant role in monitoring and improving the safety and efficacy of medicines, with specific emphasis on OFs.
