The role of Pharmacovigilance is to ensure patients safety by continuously monitoring and preventing adverse reaction of drugs. The rise in pharmacovigilance activities worldwide has resulted in an enormous demand for skilled and trained professionals in the field.
What is Pharmacovigilance Signal Management Process?
Implementation of the Signal Management process has aided in continuous improvement of health promotion and protection with clearer roles and responsibilities for safety issue detection .There is increased transparency and increasing use of validated scientific methods with a focus on simplification and increasing the efficiency. The signal management process consists of detection, validation, confirmation, analysis and prioritization, assessment and recommendation for action. Signal detection is a means of identifying new potential risks and thereafter developing risk minimization action plans to prevent or mitigate these risks at the earliest.
Toxicology is the scientific study of adverse effects that occur in living organisms due to chemicals or biologics. It involves observing and reporting symptoms, mechanisms, detection and treatments of toxic substances, in particular relation to the poisoning of humans. It includes environmental agents and chemical compounds found in nature, as well as pharmaceutical compounds that are synthesized for medical use by humans. These substances may produce toxic effects in living organisms including disturbance in growth patterns, discomfort, disease and death.
An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the use of a drug/biologic/medical device/therapy or their combination under normal conditions of use and is suspected to be directly or indirectly related. An ADR will usually require the drug to be discontinued or the dose reduced. Adverse drug reactions (ADRs) have been reported to be among leading causes of morbidity and mortality In order to promote monitoring and reporting of Adverse Drug Reactions (ADRs) by NABH accredited Hospitals to Pharmacovigilance Programme of India (PvPI), around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have started reporting ADRs as part of their pharmacovigilance activities mandated by the government.
Traditionally in India, the role of pharmacists is confined to pharmacies or hospitals with no specific job profile. But with The Pharmacy Council of India (PCI) recognizing Pharm.D (A Doctor of Pharmacy) course in India, there is an increase in the scope of pharmacy to meet the ever-growing needs of healthcare industry. There are potential non-traditional job opportunities for PharmD graduates in India in various areas. Continue reading
Pharmacovigilance, known as drug safety in simpler terms, is related to the detection, assessment, prevention and reporting of adverse reactions that result from the use of medicines. Adverse reaction can be defined as an unintended response to a drug or a medical device that is meant for the diagnosis, prevention and treatment of a disease. Pharmacovigilance educates patients on side effects of medicines, biological products like vaccines and herbal medicines. Continue reading
Pharmacovigilance is the branch of science that deals with the safety of drugs after they have been approved for use. It basically involves identification, evaluation, monitoring and prevention of adverse reactions associated with the usage of drugs. Pharmacovigilance is an important part of clinical research and plays a crucial role in avoiding drug related disasters and toxicity. Continue reading
Herbal medicine has been known to be effective in the treatment of various ailments since the beginning of human civilization. Ayurveda is a form of herbal therapy originated in India. Plants, their parts, metabolites and preparations are proven to have enormous therapeutic properties. The importance of herbal medicines has been overlooked with the rise of modern medicine, yet they never ceased to amaze the scientific world with their efficacy. Continue reading
The process of collecting safety profile of drugs during or after clinical trials is never complete but is a continuous endeavor. Generally thousands of patients are subjected to clinical trials however in some cases for example if drug gets orphan status few hundred are subjected to drug. In statistical viewpoint, if 1,000 clinical trial Continue reading
Over view of Pharmacovigilance
Pharmacovigilance (PV or PhV) is the science related to the detection, evaluation and prevention of adverse effects of drugs, biologics or medical devices. It includes the study of both short-term as well as long-term adverse effects experienced with the use of a therapeutic in a post-marketing or clinical trial setting. Pharmacovigilance is evolving as a strategic Continue reading