RESUMO
The present prospective observational study was carried out in a tertiary care hospital in New Delhi, India from May 2014 to June 2015 to report adverse drug reactions (ADRs) in patients with type 2 diabetes mellitus (T2DM) using antidiabetic drugs. A total of 220 patients (121 males, 99 females) were enrolled. ADRs were recorded on the prescribed form. Causality and severity assessment was done using Naranjo's probability scale and modified Hartwig and Siegel's severity scale, respectively. Commonly prescribed drugs were biguanides, peptide hormone and sulphonylurea. A total of 26 ADRs were recorded (16 in males and 10 in females). Most commonly observed ADRs were related to endocrine and gastrointestinal system. Severity assessment of ADRs showed seven (26.9%) ADRs as moderate, and 19 (73.1%) as mild. No severe reactions were observed. ADRs were mostly related to endocrine and gastrointestinal system. More information on prescribed drugs and their side effects is required for ensuring patient safety.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Sistema Endócrino/efeitos dos fármacos , Trato Gastrointestinal/efeitos dos fármacos , Adulto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/patologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Sistema Endócrino/patologia , Feminino , Trato Gastrointestinal/patologia , Humanos , Índia , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Centros de Atenção TerciáriaRESUMO
Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken. The National Coordination Centre was shifted from New Delhi to the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use. The culture of reporting of ADRs has achieved remarkable success, with 250 PvPI-established adverse drug monitoring centres all over India and provision of training to healthcare professionals. The programme is striving hard to build trust between the physician and the patient, thereby increasing patient safety and the confidence of people in the country's health system, in addition to the detection of substandard medicines and prescribing, dispensing and administration errors. The IPC-PvPI has now become a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. In spite of these achievements, several challenges are faced by the PvPI, like the monitoring of generic drugs, biosimilars, and disease-specific ADRs of antidiabetic, cardiovascular and antipsychotic drugs and, above all, creating awareness, which is a continual process. At the same time, the PvPI is trying to address other challenges like counterfeit drugs, antimicrobial resistance, and surveillance during mass vaccinations and other national programmes.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Monitoramento de Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Programas Médicos Regionais/tendências , Humanos , Índia , Organização Mundial da SaúdeRESUMO
Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs) to the database and can draw signals for regulatory decisions. To foster the culture of spontaneous reporting, India has launched paperless and simple modes of reporting ADRs such as Helpline and an Android application. This will help to create a national centre of excellence at par with global drug safety monitoring standards. With the increasing popularity of regional anaesthesia, adverse events may occur due to local anaesthetic drugs, techniques and adjuvants. Uncommon but clinically significant ADRs can be identified in a nationwide pharmacovigilance programme. Anaesthesiologists in India are encouraged to report local anaesthesia-related ADRs to the national pharmacovigilance database.
RESUMO
Pterostilbene (PS) is a well-recognized antioxidant that primarily exists in blueberries, grapevines and heartwood of red sandalwood. Interest in this compound has been renewed in recent years, and studies have found that PS possesses an array of pharmacological properties, including chemopreventive, antiinflammatory, antidiabetic, antidyslipidemic, antiatherosclerotic and neuroprotective effects. However, the greater in vivo bioavailability of PS, as compared to resveratrol, is an added advantage for its efficacy. This review provides a summary regarding the sources, pharmacokinetic aspects and pharmacodynamics of PS, with a focus on the molecular mechanisms underlying its protective effects against cancer, brain injuries and heart disease. Studies regarding the safety profile of PS have also been included. Based on the presently available evidence, we conclude that PS represents an active phytonutrient and a potential drug with pleiotropic health applications.
Assuntos
Estilbenos/farmacologia , Animais , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/patologia , Doenças do Sistema Nervoso Central/tratamento farmacológico , Doenças do Sistema Nervoso Central/patologia , Humanos , Neoplasias/tratamento farmacológico , Segurança , Estilbenos/efeitos adversos , Estilbenos/farmacocinética , Estilbenos/uso terapêuticoRESUMO
A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.