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While the healthcare sector emerges glorified in terms of advancements, science, and technology, the alarming need for pharmacovigilance is one the rise. Pharmacovigilance is the branch of science which deals with collecting, monitoring, researching, assessing and evaluating details how healthcare providers develop and identify the medications and biologics. Whenever there is an investigation on the new drug, pharmacovigilance measures play a critical role in every phase of a product’s lifecycle. The process involved in pharmacovigilance involves the wide understanding of requirements can be daunting even for seasoned industry pros.

In the United States, every pharmaceutical product, including drugs, biologics, and medical or diagnostic equipment are subject to federal regulations, enforced by the FDA (Food and Drug Administration). During clinical research and development of a pharmaceutical product, the FDA has to approve the nature of development in terms of safety in regard to the submission of expedited reports for serious and unexpected adverse events and confirmed signals occurring in association with the drug or biologic under development. 

As Pharmacovigilance has evolved as an important department in the healthcare industry that deals with the detection, assessment, and monitoring of side effects of drugs available in the market, every pharmaceutical industry needs experts who acquired professional training on Pharmacovigilance.  It covers hospitals, medical clinics etc. that use high levels of drugs.

Pharmacovigilance is essential to maintain health standards while researching and manufacturing healthcare products. Some medicinal drugs use hazardous compounds, which must be monitored closely during the manufacturing process in order to keep the environment contamination-free and avoid any accidental spilling or leakage of those hazardous elements.

The application of Pharmacovigilance is discussed below:

Guidelines to regulate industry contamination

Pharmacovigilance supplies various guidelines to manufacturers so that it can avoid any contamination in pharmaceutical factories. These guidelines are used to conclude the criteria and determining the nature of drug as hazardous or not. These also emphasize on the significance of educating and training professionals in handling these hazardous drugs. The guidelines further exhort the companies to establish suitable drug handling areas as well as ensure the safe removal of contaminated waste.

Safety norms on Diagnostic and Medical Equipment

In order to make sure that the newly invented medical devices are safe and secure to utilize, Pharmacovigilance isolates certain rules and regulations that ensure minimal exposure to toxic drugs, risks and thus reducing the risks of both short term and long term illnesses caused due to exposure to these drugs.

A more efficient device is the closed system drug transfer device. This device protects the workers by enabling leak-free transfer of hazardous substances. Its main function is to maintain the sterility of the drug while at the same time prohibiting any toxic agents to escape into the surrounding environment. This device has certainly reduced the contamination level of hazardous drugs in its surroundings.

Courtesy the guidelines provided by healthcare agencies and the availability of modern safety equipment, it has become easier to carry out Pharmacovigilance.

Conclusion

By following these guidelines and handling safety devices properly, the risk to hazardous drugs can be contained to a large extent, and that is exactly the main aim of Pharmacovigilance

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