Family group

Making the switch: how we’re improving access to proven medicines

Switching a medicine from prescription (Rx) to over-the-counter (OTC) places the power of managing everyday health conditions with the patient.

Switching a medicine from prescription (Rx) to over-the-counter (OTC) places the power of managing everyday health conditions with the patient. It means that instead of going to your doctor for a prescription, you can head into a pharmacy or shop and get it over the counter.

Today, we look for ways to take charge of our own health, and make decisions about our healthcare. At GSK, we are determined to help people across the world improve their health, and ‘switching’ is just one of the many ways we can do this.

otc infographic
Rx to OTC switches

Not every prescription medicine makes it through the rigorous ‘switch’ application process. In order to successfully switch a medicine we need to bring together expertise from across our consumer healthcare business, together with regulatory knowledge and insights from our pharmaceutical business.

A strategy of switching products is pursued when we’re confident there is an acceptable risk/benefit profile for patients to diagnose, treat and manage their condition without the need for a prescription from their doctor. 

Switching a medicine involves gathering large amounts of scientific data on the safety and efficacy of the product, for submission to regulators. In the case of one of our recent ‘switches’ – moving  our prescription-only allergy relief medicine Flonase, to OTC –the process involved gathering data from 43 clinical studies and submitting 600,000 pages of data to the US Food and Drug Administration (FDA). Demonstrating clear evidence to show patients were able to diagnose, treat and manage their own nasal allergy symptoms without a doctor’s supervision, was also crucial.  

Brian McNamara, CEO for Consumer Healthcare at GSK, said: “Switching a product from prescription-only to OTC is a unique and exciting situation. We are improving patient access to our medicines in a very tangible way.”

Which medicines have we switched in the past?

We have switched a variety of medicines over time, the first being Zovirax – our cold sore treatment – which was established as an OTC treatment in 1992.

Timeline showing product switches from prescription to over the counter

Most recently, our allergy relief treatment Veramyst nasal spray, which was previously available as a prescription-only medication, has been switched to an OTC product – Flonase Sensimist – initially available to consumers in the US. Our consumer healthcare business aims to make a prescription medicine available to consumers OTC every five years.

Commenting on this switch, Theresa Agnew, Chief Marketing Officer at GSK Consumer Healthcare US, said: “Our experience with switches tells us that allergy sufferers really appreciate new, clinically proven options and we’re committed to exploring other areas where patients could be empowered to diagnose and treat their every day health conditions.”

The launch of Flonase Sensimist as an OTC product in the US has benefited from our fast-moving consumer goods capabilities within consumer healthcare, securing 23 miles of shelf space and nearly one million bottles on the shelf.  As a result, the 50 million people suffering from serious nasal allergies in the US can now access this medicine without needing a prescription. This could go some way towards helping the 50% of allergy sufferers in the US who reported they were not completely satisfied with their existing prescription treatment.

At GSK, we’re well-placed to switch established prescription medicines to OTC treatments where appropriate, due to the specialist knowledge we hold within our Consumer Healthcare and Pharmaceuticals businesses. Our innovative scientists, researchers and commercial experts are focused on delivering the best medicines to patients, through the easiest route possible for them. The impact that switching medicines, such as Flonase Sensimist, can have on patients is nothing to sniff at.