Rx to OTC switch: An overview

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The success of a drug molecule or formulation lies in its switching over to OTC (over the counter) genre from prescription drugs (Rx) over the years. No doubt critical therapy like chemotherapy, cardio medicines and others cannot /should not be promoted as OTC.

At the same time, over the years, because of continuous marketing, learning and sharing general and technical information by patients and associated people, incessant awareness programs by government and companies, advancements in medical and pharmaceutical technology, efforts to minimize side effects (and increase in patient compliance) by research and development department of innovator or other pharmaceutical companies.

Bottom-line is that if sliding of a drug from prescription to OTC category is harmless and consumer friendly (here friendly means no need of medical supervision, minimum and trivial unwanted effects etc), then there is no harm in becoming of a drug’s OTC item. Following is a cycle how once upon a time prescription drug gets status of OTC medication.

Rx-to-OTC switch refers to the transfer of well tested and accepted prescription medicine to nonprescription (OTC) status. The process is scientific and data-driven and much regulated task. For a formulation to be an OTC item, it must have a wide therapeutic window, besides having very clear and broad user information on labels to ensure proper use without any unwanted stuff. As per consumer healthcare products association, “More than 100 OTC ingredients, strengths, or indications are on the market today that were available only by prescription less than 40 years ago, owing to Rx to OTC conversation”.

Such categories of medicines as antihistamines, pain killers, heartburn reducers (antacids etc), nicotine replacement therapies, vaginal yeast infection treatments etc are now easily available at pharmacy without a need to furnish prescription to pharmacist.

Access to needed medicinal products at retail counter eases the lives of millions of regular patients. The next in the sequence is conversion of an OTC drug to an FMCG (fast moving consumer goods). I sign out here with a question for readers, Is it a good sign that a prescription drug becomes an OTC and then an FMCG good? More demand means more patients pool; means more ill persons in a society?

-Dr. Amit Gangawal