Pharmaceutical Chemistry

Pharmacovigilance and Cosmetovigilance

Pharmacovigilance (PV or PhV), also described as drug safety of a drug when it is marketed, Pharmacovigilance is the part of the phase 4 of drug development which include the assessment, monitoring, collecting data, detecting errors, and prevention of adverse effects with pharmaceutical product. Pharmacovigilance can be defined as a surveillance on the market regarding the safety and efficacy of the drug, which are defined as any response to a drug which is adverse and lethal, which includes lack of efficacy (this happen when the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the changing of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, ,drug misuse,  abuse of a drug and drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

Cosmetovigilance is the continuous and arranged surveillance of the safety of cosmetics in terms of human health. The aim is to detect negative and long term damaging effects of cosmetic products, and to prevent them by taking appropriate measures. Regulations for cosmetic products is at most necessary as cosmetic products are being used by large population on daily basis, but these regulations are currently industry driven and some industries take lot of privilege on that. It is the duties of the manufacturers to estimate that components and ingredients are safe before they are being introduced into the market, and then to collect reports of adverse reactions.

• Regulation and prequalification
• Clinical Drug Safety
• Individual Case Safety Report