Showing posts with label Pharmacovigilance. Show all posts
Showing posts with label Pharmacovigilance. Show all posts

12 June, 2022

Counterfeit Medications


Counterfeit drugs have been defined as products deliberately and fraudulently produced and mislabeled with respect to identity and source to make it appear to be a genuine product. Counterfeit medications include drugs that contain no active pharmaceutical ingredient (API), an incorrect amount of API, an inferior-quality API, a wrong API, contaminants, or repackaged expired products. Some counterfeit medications may even be incorrectly formulated and produced in substandard conditions.

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21 February, 2021

Pharmacovigilance


Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.


Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.