ce New FDA Approved Drugs & Vaccines
INTRODUCTION
The ultimate goal of the healthcare system is to maintain patient safety and reduce medical errors. Pharmacy personnel are uniquely poised to signifi- cantly improve patient safety and reduce medication errors because of their accessibility to patients and prescribers. In a conventional community pharmacy setting, pharmacy technicians perform tasks that are almost exclusively related to medication dispensing, such as properly storing, handling, and prepar- ing medications for use by physicians or patients. Increasingly, trends in laws and practice standards in many US states call for pharmacy technicians and other pharmacy support personnel to accept greater accountability beyond medication dispensing, thus adding to their responsibilities for patient outcomes. Studies show that the expanding role of technicians in advanced patient care is essential to pharma- cists being able to better allocate their time and resources to provide clinical services. Some exam- ples of expanded pharmacy technician roles are: • providing immunizations • performing time-intensive administrative tasks related to medication therapy
management (MTM) • obtaining patient histories prior to clinical ser- vices being provided by a pharmacist • completing product verification. Pharmacy technicians who understand the classes, interactions, mechanisms of action, adverse effects, and common side effects of medications can be an invaluable resource to the pharmacist who is focus- ing on delivering patient care. 1 A knowledgeable technician can perform his or her job-related duties confidently and can assist pharmacists more effi- ciently with minimal supervision; a knowledgeable technician knows the right questions to ask and can recognize “red flags” when engaging with patients; a knowledgeable technician can better collaborate with other healthcare providers who may not be as familiar with prescription drugs. Staying informed of newly approved medications and maintaining familiarity with their prescribing information is just one way that certified pharmacy technicians can ensure a successful transition into these expanding roles.
BACKGROUND
Many new drugs and vaccines are approved by the US Food and Drug Administration (FDA) every year. In 2023, 55 new drugs were approved, 3 which is the highest number of annual new drug approvals since 2018. 3,4 Twenty drugs (36%) were designated as first-in class products, which are agents that have novel molecular mechanisms of action that are dif- ferent from currently approved therapies. Four drugs (7%) were designated as first-in indica- tion products, which are agents that are the first to be approved for a particular indication. 5 By treatment area, orphan drugs for rare diseases and oncology drugs were the largest portion of new drug approvals
(51% and 23%, respectively) in 2023. Other notable approvals include new uses of already marketed products, such as new indications, expanded patient populations, and new formulations. This article will review a select number of novel agents and vaccines approved in 2023 for the treatment and prevention of diseases in the therapeutic areas of neurology, endocrinology, cardiology, infectious diseases, ophthalmology, and women’s health (excluding rare diseases and cancer). The indica- tions, mechanisms of action, safety profiles, storage and handling instructions, and notable drug interac- tions for these agents will be discussed. Additionally, a new drug approved earlier in 2024, though not yet available, will also be introduced.
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