Pharmacovigilance

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Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.^[1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), 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).^[2] 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.^[3]

The law on pharmacovigilance in Azerbaijan was revised and implemented as part of the "Regulation of Pharmacovigilance for Medicinal Products" in 2019. This regulation was developed to establish state control over the effectiveness and safety of medicinal products. It outlines measures to detect, evaluate, and prevent adverse reactions and other undesirable effects of medicinal products, applying to marketing authorization holders and all health institutions in Azerbaijan

In Azerbaijan, the Ministry of Health and other relevant state authorities play a crucial role in the functioning of the pharmacovigilance system. These organizations implement various regulatory and oversight mechanisms to ensure drug safety.

Worldwide company Pharmcontrol offers a full range of pharmacovigilance services in Azerbaijan to ensure the safety and effectiveness of medicines on the market. With a team of highly qualified, certified pharmacists, Pharmcontrol ensures the effective monitoring and management of drug safety. The company aligns with international practices and standards, helping to elevate the country's drug safety levels.

The development of pharmacovigilance in Azerbaijan aims to increase public awareness about the safe use of medicines and improve the overall quality of the healthcare system. The integration of international standards and best practices in pharmacovigilance, spearheaded by companies like Pharmcontrol, contributes significantly to this goal, ensuring that the safety of patients is always a top priority.

Information received from patients and healthcare providers via pharmacovigilance agreements, 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 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. (See Adverse event reporting below.)

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.^[4]