ROLE AND IMPACT OF OVER-THE-COUNTER DRUGS IN EVERYDAY HEALTHCARE

• Author Information

  Vinamer Sood, Amiteshwar Singh, Neeraj, Navneet Sharma, Daljeet Masih

• Vinamer Sood, Amiteshwar Singh, Neeraj, Navneet Sharma, Daljeet Masih
• ROLE AND IMPACT OF OVER-THE-COUNTER DRUGS IN EVERYDAY HEALTHCARE

Abstract

Over-the-counter (OTC) medications are pharmaceutical products available to consumers without a prescription, signifying a drug’s favorable safety-toxicity profile for self administration under recommended guidelines. The transition of drugs from prescription-only (Rx) to OTC status is a complex, multifactorial process influenced by advances in pharmacology, regulatory policies, and evolving public health priorities. Historically, medications were widely accessible until increasing awareness of health risks led to stricter regulations in the early 20th century. Modern reclassification from Rx to OTC status is predicated on robust post-marketing surveillance data that affirm safety, low abuse potential, and minimal adverse interactions. Regulatory bodies such as the U.S. FDA and the European Medicines Agency (EMA) play pivotal roles in overseeing this process through stringent frameworks encompassing drug approval, labeling, and continuous safety monitoring. This regulatory oversight ensures that OTC medications maintain high standards of safety, quality, and efficacy, supporting their widespread use in self-care and public health strategies.

Keywords: Over-the-counter drugs, prescription to OTC switch, drug safety, FDA, EMA, regulatory framework, post-marketing surveillance, drug reclassification, self-medication, non prescription medications.