Pharmacovigilance, also called clinical pharmacology, is the clinical use of a drug in treating patients with certain disorders and diseases. Adverse drug events (ADRs), which include deaths from drug toxicity, can lead to severe medical consequences, as revealed in numerous studies about adverse drug reactions (ADR). To increase awareness about and educate patients about ADRs, more research in the area of ADRs and pharmacovigilance is required.
In June 2020, the Food and Drug Administration (FDA) published a notice of intent to implement the National Pharmacy Ownership and Clinical Quality Improvement Organizations (NPHIA) guidelines on the regulation of pharmaceuticals and other medical products. The intention was to standardize the labeling and marketing of prescription and non-prescription drugs. The move resulted in the formation of the National Pharmacy Ownership and Clinical Quality Improvement Organizations (NPZA) and the National Institute for Drug Evaluation (NIDA).
Although the new regulations established guidelines for the safe handling of pharmaceuticals, the problems still exist. Most pharmaceuticals are still poorly regulated and there is a lack of training for healthcare professionals concerning adverse drug reactions and the pharmacovigilance system itself. This lack of knowledge leads to a large number of adverse drug reactions and emergency department visits because of accidental drug exposures.
Despite the introduction of more rigid rules by the FDA, the issues surrounding the use of pharmacovigilance are still largely unaddressed. Because the lack of regulation of pharmaceuticals in most countries worldwide has allowed dangerous drugs to be introduced into the general public with disastrous consequences, many countries have introduced strict regulation of the sale and distribution of prescription and over-the-counter medicines. These countries have limited the quantities available to consumers, require formal written informed consent for purchase, and require providers to display the ingredients of their medicines. Although these steps have reduced the availability of prescription and over-the-counter medicines in the marketplace, the number of deaths from prescribed medicines still continues to rise. Without strong pharmacovigilance efforts, these issues will only continue to persist.
No comments:
Post a Comment