Switching Drugs from Rx to OTC status – A Regulatory Perspective

Initially drugs are available for consumption to the public only after con sulting with a healthcare professional and obtaining a prescription for the same. However, to enhance consumer access to a safe and effective drug, it is possible to ‘switch’ the same to over-the-counter status after the initial prescription marketing if the post-marketing safety data of the prescription version of the medication reiterates the safety, effectiveness and ease of use of the drug. This is known as a ‘Prescription-to-OTC Switch’. Prescrip tion to OTC Switches are supported by a large number of driving factors such as increasing consumer awareness, growth of the self-medication movement, pharmaceutical companies’ attempts to increase sales and government efforts to curtail public spending on prescription products for minor, self-treatable ailments. It is estimated that nearly 40% of all OTC medication available today in the US was once upon a time marketed as a prescription drug. The therapeutic indications that are considered appropriate for self-treatment are also evolving – from minor afflictions like cough and cold in the past to allergic rhinitis in the present. Rx to OTC switching is responsible for the availability of several safe and effective drugs for the self-treatment of a multitude of indications like diarrhea, heartburn, nasal congestion etc.