Frequently asked questions
What is Pharmacovigilance?
Pharmacovigilance is a critical function that ensures the safety and efficacy of medicines throughout their entire lifecycle. It involves continuously monitoring and evaluating medicines to identify and assess potential risks, optimize their safe use, and provide healthcare professionals and patients with up-to-date information. By doing so, pharmacovigilance plays a vital role in protecting public health and ensuring the appropriate use of medicines.
Is a product marketed by Olvin Pharmaceuticals effective and safe?
Pharmacovigilance covers multiple aspects of the medicine lifecycle after its market approval, making it one of the most fundamental functions within the life science of Olvin Pharma’s product.
At Olvin Pharma, the primary goal of pharmacovigilance is to safeguard product safety and efficacy.
The pharmacovigilance team conducts thorough analyses of medicine safety data and complies with the guidelines of the International Council for Harmonisation (ICH), Good Pharmacovigilance Practices (GVP) of the European Medicines Agency, and local regulations from Pakistan’s National Pharmacovigilance Centre (NPC) under the Drug Regulatory Authority of Pakistan (DRAP).
What can be reported as an adverse reaction?
The package insert, or patient information leaflet, serves as the primary source of product information, listing and detailing potential adverse drug reactions associated with a medicine’s use. To enhance understanding and ensure comprehensive safety information, any of the following should be reported: known or expected side effects; allergic reactions, such as skin rashes or swelling; adverse reactions in special populations (e.g., children, pregnant women); medication errors or dosing issues; interactions with other medications; product quality concerns or defects; and any unexpected reactions not mentioned in the product information.
Who can report an adverse reaction?
Adverse reactions can be reported by healthcare professionals, patients, caregivers, or anyone who has experienced or witnessed an adverse reaction due to our products.