5 Key lessons to making a POM to P switch a success

Thinking back to the day I was asked to work on the first POM to P switch (from prescription only medication status to selling over the counter in pharmacy)…I was working as a trainee on the Janssen Pharmaceutical (part of J&J) graduate trainee programme, and I was seconded to the medical department to work as a Clinical Research Assistant helping to run a multi-centre drugs trial!

Whilst I have a science degree I hadn’t envisaged my future in the medical department. So when the head of the new Janssen Pharmacy Division stuck his head around my office door and said ‘I hear you’ve got your sights set on a career in marketing. How would you like to come and work on the new switch product’, I jumped at the chance.

Since this first experience, I’ve learnt 5 key lessons that make a POM to P switch a success.

Lesson 1.

Ensure your drug has the efficacy and safety data to support the indication you want to have included in your SmPC and PIL when it switches to OTC. Don’t be put off if the first attempt is rejected, regroup and try again!

When I joined the marketing team at Janssen, Imodium (loperamide) had already switched from POM to P. The sales team had started selling it into pharmacy. We’d come up against some objections from pharmacists; and understandable lack of confidence about selling what they viewed as an Rx product, over the counter (OTC); concerns centred around indications, dose, side effects etc.

I knew from my time in the medical department that the company had already worked for at least 4 years on the switch project and had had a few attempts to switch loperamide. In the end what convinced the regulators to approve the switch was that the dossier already had trials and data to support the use of the product for use in acute diarrhoea (Travellers’ diarrhoea). By some good planning, or more likely serendipity, someone way back when, during the drug development of loperamide had had the foresight to see the potential for the use of loperamide in acute conditions such as Travellers’ diarrhoea.

Lesson 2.

Make sure you think well ahead about branding and pricing structure.

As part of the switch application it’s important to think about how the product is going to be used. for instance for Imodium two capsules is often all that is required to stop the diarrhoea, so it was important to ensure a range of pack sizes were included in the dossier including 2’s, as it is a popular size.

Remember this was the early 1980’s and this was the first POM to P switch. So this was new for all stakeholders concerned. There were concerns in some quarters about whether consumers should be able to purchase what they viewed as a potent Rx product over the counter. Plus the fact that pharmacy customers didn’t know anything about the product or that it was now available OTC.

So, in order to advertise the product to the consumer, legislation at the time meant we had to change the brand name. So we launched the consumer version of loperamide; Arret. This provided an opportunity to ensure pricing across the franchise was aligned and the pricing set to ensure enough margin to support consumer advertising.

Lesson 3.

Provide education, training and support for the whole pharmacy team to ensure they can recommend the brand with confidence. Make sure KOL’s and stakeholders are on-side ahead of the launch to ensure a supportive environment for the switch. The next task was to ensure we could engage pharmacists in supporting and recommending the OTC sales of loperamide. Given the concerns about appropriateness of advertising, there was a clear education job required to inform, educate and ultimately to provide pharmacists with knowledge to recommend with confidence. It was also clear that consumers often present in pharmacy and ask the counter staff for advice. So, a whole team approach was taken to the training programme.

In reality when consumers presented in pharmacy, the team often felt more comfortable recommending Imodium rather than Arret. Even so, the important thing is that consumers were being driven to pharmacy to ask for advice about the condition. Our job was to ensure the pharmacy staff were equipped to deal with this.

A comprehensive training package was put in place to support the brand. Not just focusing on the indication and the product, but also on a more holistic approach to treatments with advice on adequate rehydration therapies. Providing clear concise hints and tips for staff to help with recommendation. Putting quality training at the heart of brand support in pharmacy became a key component of ongoing brand support in pharmacy and was one of the key success factors for the growth of the pharmacy business over subsequent years.

Driven by the need to supply quality training management to the industry. Precision was set up by Matthew Caldwell-Nichols in 1995. As one of the founding members of the Janssen Pharmacy team his vision was to provide quality pharmacy data to the industry, and to build training platforms and programmes for many of the top 10 OTC companies. Allowing them to support the trade with ongoing quality training programmes. This database and its platform capabilities are still very much part of Precision’s work within the industry today.

Lesson 4.

Develop advertising that is truly memorable. That is sympathetic to the needs of the market and has the appropriate tone of voice. Having worked with the profession to provide support for their learning. It was time to educate the consumer about the availability of a highly effective treatment for diarrhoea being available for the first time over the counter. Clearly, with such a sensitive subject, the advertising had to be developed with the appropriate tone of voice. Through extensive consumer research, humour and not showing ‘real people’, was chosen as the creative route to develop. The resulting memorable cartoon character was developed to embodied all the emotions of someone suffering from travellers’ diarrhoea. The Montezuma’s revenge campaign was born.

The result of this advertising campaign was to drive consumers into pharmacy and launched a whole new category of medicines which grew business for both brands. However, the long history and track record of Imodium as the safe effective treatment known and trusted by the profession and consumers alike, coupled with clarification on branding in consumer advertising, meant that the Arret had done its job and strategic focus was switched to Imodium which won the day!

Lesson 5.

Plan your NPD pipeline and do it now!

I left Janssen (J&J) in 1992 and even then, we were in discussion about a new oral dispersal formulation for Imodium. According to the current SmPC the original marketing authorisation (MA) was granted in 2003 - only a decade later!! So, the moral of the story is to start early on your NPD pipeline.

Final thoughts.

One of the keys to success of any brand is to broaden the distribution through a switch to GSL (General Sales List).

To do this requires a body of data from real-time use as an OTC product. Not so long ago this would have been amassed through an organised PMS study (Post Marketing Surveillance study). As highlighted in Michelle Riddles recent Pharma Intelligence article on the future of switches. This data collection is being made increasingly easy to amass through the gathering of real-world data, often via wearable technology.

Advance in health-tech was very much on display at the recent Giant Health expo in London. Where thousands of innovators gathered at Europe's largest festival of health-tech innovation, to showcase leading innovations from around the world. This is an accelerating area of healthcare development and provided a hugely inspiring and creative environment.

Whilst health-tech and increasing awareness of selfcare drives the agenda at the consumer end of the customer journey. I will leave you with a parting thought sparked by Neil Lister’s presentation at the recent Pharmacy Show. When challenged by a pharmacist on relinquishing the sales of P medicines to GSL. He proposed that the real challenge for industry is to get more switch applications into the ‘POM, P, GSL funnel’. So that we have more effective medicines available for the consumer. Then, if pharmacy staff are well trained and continue to be supported by the OTC industry. Consumers will come back to pharmacy as the place to get the best information, support and advice on healthcare issues.

Pharmacist organising products on a shelf