All adverse reactions suspected to have been caused by ASU drugs along with any other drugs
What is Pharmacovigilance?
Pharmacovigilance is the science of detection, assessment, Documentatin, understanding and prevention of adverse efect and any other drug related problems for safe and effective usage in humans. It is moral obligation of the persons who are dealing with public health issues.
What is adverse drug reaction (ADR)?
ADR is a response to a drug which is not expected, bad to the patient, noxious and unintended and which occurs at doses normally used in human being for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.
What to report?
All suspected drug interactions
Reactions to any other drugs which are suspected of significantly afecting a patient's management, including reactions suspected of causing; Death, Life threatening (Real risk of dying), Hospitalization, Disability (significant, persistent or permanent), Congenital anomaly, required intervention to prevent permanent impairment or damage, and any other intolerable discomfort.
Who can report?
Any health care professional like Nurse, Compounder, Doctor, Dentist, NGO, stake holders of ASU system of medicine or the person who has consumed the ASU medicines through the physician who has presceibed or the pharmacist from where it is purchased.
How to report?
In order to report the adverse drug reaction a special proforma is made availabel in all the Pharmacovigilance Centres and version of the proforma is also available on the website of Gujarat Ayurveda University, Jamnagar (www.ayurveduniversity.com) and will be made available on the website of PPC & RPC. Anybody who suspects to have experienced / observed an ADR is to be reported in the format to the nearest Pharmacovigilance Centre through any health care professional. Absolute confidentiality will be maintained regarding the identity of the informer.
What happens to the information submitted?
The received information on ADR will be handled in confidentiality. Peripheral Pharmacovigilance Centre will forward the information to the respective Regional Pharmacovigilance Centres who will carry out the causality analysis. Further this information will be forwarded to the National Pharmacovigilance Resource Centre. The data will be statistically analyzed and forwarded to the Dept. of AYUSH, Govt. of India for necessary action.