Akila Srinivasan

Phase 4 studies, also known as post-marketing surveillance (PMS) studies, are a crucial step of drug development and are carried out after marketing approval of the drug. The objective is to obtain detailed information on the safety and effectiveness in a real-world setting of the newly approved drug or device. Since Phase 3 trials are carried out for a shorter duration in a population of few hundreds to few thousands, they may not be able to detect all adverse effects, especially those that are rare or those that occur on chronic use of the drug or device. The methodology for post-marketing surveillance is chosen based on the objectives of the study and each comes with its own share of advantages and limitations. A major proportion of Phase 4 studies are observational in nature; however, there are some clinical trial-based designs, which are performed depending on the requirements. Periodic submission of aggregate safety reports is a regulatory requirement during Phase 4 of drug development. This chapter seeks to provide an overview of post-marketing surveillance studies and their importance in drug development.

Drug information centre (DIC) is a facility that provides independent and unbiased information on drugs to healthcare professionals for the benefit of patients. DICs critically assess the relevant literature and provide timely response to drug-related queries. A well-functioning DIC has access to information database and tools. Being medically qualified, clinical pharmacologists are well-suited to provide recommendations to treating physicians in the management of adverse drug reactions (ADRs), detection of drug-drug interactions, and medication reconciliation in patients on polypharmacy. DICs contribute to rational drug use by providing accurate and independent information. DICs can also help in minimizing risk of ADRs and reducing healthcare costs incurred due to management of ADRs. Antimicrobial resistance is a global threat and DICs can play their part by guiding antibiotic selection and judicious use of designated antimicrobials.