Pharmacovigilance: reporting requirements throughout a product’s lifecycle

Abstract

Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pharmaceuticals is extremely important. Pharmacovigilance is a key component of drug safety regulatory processes and is paramount for ensuring the safety profile of medications used to treat patients. All participants in the healthcare system, including healthcare providers and consumers, should understand and meaningfully engage in the pharmacovigilance process; healthcare providers should integrate pharmacovigilance into everyday practice, inviting feedback from patients. This narrative review aims to give an overview of the main topics underlying pharmacovigilance and drug safety in pharmaceutical research phase after the authorization of a drug in the United States. The US Food and Drug Administration guidance and post-approval regulatory actions are considered from an industry perspective. Plain language summary Regulatory processes that ensure the safety of drugs is monitored Government agencies regulate the safe use of medicinal products. By determining and enforcing pharmacovigilance, the monitoring of drugs for potential risks, they safeguard the welfare of consumers of medicines. Comprehensive, documented methods for evaluating the safety of a drug during its development and its subsequent use allow identification of any risks associated with the drug’s use throughout its lifetime. The comprehensive identification of safety issues associated with a drug is improved when all parties involved in the development and use of drugs participate in the pharmacovigilance process. For example, clinicians should regularly ask their patients if they are experiencing any issues with their treatment, and patients should be encouraged to report problems they encounter with a particular medication to their healthcare provider. This narrative review provides an overview of the main topics underlying pharmacovigilance and drug safety after approval of a drug in the United States. Guidelines and actions from the US Food and Drug Administration are considered from an industry perspective.

CDK4/6 inhibitors in drug-induced liver injury: a pharmacovigilance study of the FAERS database and analysis of the drug–gene interaction network

“…Notably, our study revealed previously undetected hepatotoxic adverse events associated with CDK4/6is. While clinical trials have focused on laboratory-sensitive AEs, spontaneous reporting data have provided essential real-world insights, emphasizing the significance of vigilant pharmacovigilance for identifying rare adverse reactions ( FDA, 2009 ; Lucas et al, 2022 ). AE analysis of palbociclib revealed liver-related signals (ascites, liver disorders, increased liver function), consistent with increased risk in new and long-term users ( Beachler et al, 2021 ; Finn et al, 2021 ).…”

Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database

“…Pharmacovigilance is scientific and data gathering activity relating to the detection, monitoring, understanding, and prevention of adverse events (AEs) for a medicine, which is a key component of drug safety regulatory processes and principally involves the identification and evaluation of safety signals associated with the use of a medicinal product ( Lucas et al, 2022 ). Medicine safety monitoring is a continuous and dynamic process throughout all the phases of the life cycle of a drug because although drug safety evaluation is very rigorous and thorough in a pre-clinical trial, these studies are conducted on limited numbers of patients that are selected based on strict eligibility criteria, meaning they do not fully represent real-world populations in limited duration, and it is difficult to detect rare and long-term adverse reactions (ADRs) ( Trifirò and Crisafulli, 2022 ).…”

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis

“…While safety assessments in clinical trials offer insights into AEs within the indicated population, these studies have limitations due to their duration and predefined patient criteria. Consequently, potential safety concerns may emerge in real-world settings that were not apparent during clinical trial evaluations [9]. No substantial evidence has been accumulated to address the uncertainty regarding the association of GLP-1RA with suicide or self-injury to date.…”