Aim: The purpose of this review was to explore the overall scenario of pharmacovigilance, its aims, challenges, and recommendations pertaining to dentistry for further improvements. Materials and methods: Literature search was done with the help of the Endnote software, followed by vigilantly arranging the material in a coordinated way. Results: Adverse drug reactions (ADRs) are among the top 10 leading causes of all-cause mortality. In order to reduce the harm to the patients and serve the public health mission, there is a definite need for developing mechanisms for evaluating and monitoring the safety of medicines in India. Therefore, the requirement for developing a well-organized pharmacovigilance system is imperative. Different countries have developed their own reporting guidelines for pharmacovigilance. The reporting guidelines are conceived to adapt to the specific requirements of any country and the prime focus of these adverse event reporting systems is improving the patient’s health and safety. The Central Drugs Standard Control Organization (CDSCO) has initiated a nation-wide pharmacovigilance program in India. It aims to protect the health of the patients by assuring drug safety under the aegis of Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. In dentistry, the science of pharmacovigilance is rarely applied and its practice among dental health professionals, including reporting of ADRs, is minimal. However, studies have shown that the dental professionals comprehend the importance of pharmacovigilance and its application in dentistry. Conclusion: It is essential to foster a sense of trust among patients regarding the medicines they use, to ensure that risks in drug use are anticipated and managed. This will eventually enhance the confidence of patients on the healthcare delivery system in general. Clinical significance: The practice of dentistry involves prescribing various medications for patient use. It is therefore the duty of the dentist to comprehend and identify the adverse effects of the drugs. Dentists should also know about the right channel for reporting any instances of ADRs. They should also strive toward increasing the awareness among patients regarding possible side effects so that any untoward consequences can be avoided. This will be an invaluable aid in furthering the public health mission of improving the health of the populations.
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