Making the switch

pharmafile | November 5, 2003 | Feature | Sales and Marketing |  P, POM, switch 

Switching is not a given and a successful POM to P transition requires considerable research and planning to extend unique consumer benefits identified at launch.

Historically, switching a drug from prescription-only medicine (POM) to over-the-counter status, either with pharmacist supervision as a pharmacist-only (P) product or more widely available as a general sales list (GSL) product, has been viewed as an option for a very small number of products post-patent expiry.

Canesten, Zantac, Zovirax, Claritin, Nurofen, Pepcid AC and Tagamet are all good examples of successful OTC switches in recent years, and are characterised by all belonging to well-established areas of self-medication.

Radical measures to increase the number of products switched from POM to P looks set to broaden the horizons of the OTC market considerably, potentially including some of the pharmaceutical industry's biggest prescription medicines.

A list drawn up as part of a Medicines and Healthcare products Regulatory Agency project, included drugs in 12 therapeutic categories, taking in statins, hypertension treatments, PPIs and even Viagra, as potential candidates for switching.

The changes, which came into effect at the start of April 2002, concerned the way the legal status of medicines is awarded in the UK. They would, the Department of Health (DoH) promised, more than halve the time it takes to make a POM to P switch. Launching the changes in May 2002, then Health Minister Lord Hunt called on the pharmaceutical industry to switch more of its products to P status. "If the changes I set out are to make a real difference, the rate and pace of change must increase. In the last ten years some 50 substances have been removed from prescription only status and made more accessible. I now want to see the number of changes double. That's the challenge and it's now up to all the players to deliver," he said.

Although the proposals received a muted response at the time, since April 2002, 12 products had been re-classified, nine from P to GSL and three from POM to P with more to come at various stages of the re-classification process.

The three products that have so far been switched to P status are: athlete foot treatment Transdermal Grisol spray (griseofulvin 1%), GlaxoSmithKline Flixonase Allergy Nasal Spray (fluticasone proprionate 0.05%) and NovartisAller-eze eye drops for allergic rhinitis (azelastine hydrochloride). According to the DoH the first such switch to be made under the new process, GlaxoSmithKline Flixonase had been completed three months faster than if the old process had been used.

Successful switching

Any company considering a POM to P switch, must ask a number of key questions of its marketers, the consumer and the product itself.

According to Martin Szczerbiak, Switch Brand Development Director for GlaxoSmithKline Consumer Healthcare division, one of the key drivers to switching a product is if it can bring a unique new benefit to consumers.

"From launch you need a unique selling proposition (USP) and you have to retain this, not just at launch, but in subsequent years. There has to be a consumer difference to the product and we undertake a lot of research to determine if there is one before we switch a product," he said. "If we can find a unique consumer proposition, then we would question whether the product should be switched at all." Once you have a suitable proposition, companies must focus on communicating the product merits as effectively as possible.

Novartis Consumer Health Marketing Manager Margaret Young says: "What happens so often in our industry is that we get so excited about the technology and the molecule that we forget about what the consumer end benefit is. You can come to market without making sure the consumer understands exactly what you are offering them."

In terms of communication, switching your product puts you into a radically different world of marketing possibilities. Mainstream consumer advertising can now be possible and awareness among consumers can be directly addressed.

Novartis developed Voltarol Emulgel as a prescription drug 30 years ago. The P version of the drug, fittingly named Voltarol Emulgel P, is indicated for external application for symptomatic relief of pain and inflammation. It was first launched as an OTC product in Switzerland in 1985 and came to the UK OTC market in May 2002.

"When we launched Voltarol, we did so as if it were a consumer brand because, even though it is a P licensed product, we still needed to generate mass awareness of the product," adds Young. Novartis' promotion of Voltarol used the full marketing mix available, including television advertisements, targeted promotions and advertorials, to raise awareness among prospective users.

When planning your promotional campaign one of the first and most obvious steps should be to highlight who will be supervising the purchasing decision.

"Unlike POM  products, where you have to make sure the GP and healthcare professionals know exactly what they can tell the consumer, with P products you have to focus on pharmacists and counter pharmacy assistants," she says.

This brings about a new way of looking at the process. "It can be the case that a pharmacist would offer  a known existing rememdy, rather than recommending a new product as a first-line treatment. Then, if a customer returns, the pharmacist has a potential alternative solution which they can then offer to them. To inform and educate pharmacists of new products requires a lot of training and education."

Timing is key

As with any product, the earlier you can get it to market the higher its potential market share and therefore its potential sales.

"Our view is that if you're not first you're really going to be on the back foot if somebody gets in there ahead of you. So for us in making an assessment you have to be first to market. If we don't feel we can be first, we would really think long and hard about launching," says Szczerbiak.

Once the decision has been made to switch a product from POM to P, achieving this prior to patent expiry to capitalise on the protection this provides brings great advantages.

Young continues: "It is ideal if you can switch ahead of the patent [expiry], because it does give you some sort of protection. The reality is that you create that protection if you cannot put together a consumer proposition in a compelling way that is protection itself then you've lost your advantage immediately."

Bringing parties together

In order to manage a successful early POM to P switch both pharmaceutical and consumer sides of the company need to be talking and agree on a strategy. Szczerbiak says this is critical and should happen very early on in the switch process so that it becomes an enabler and not a barrier to switch.

"Our approach is that switches should be good for the whole company and if that is not possible then we would not switch."

For Young communication is also the key: "The most important thing that we find is that you do need to be speaking to your pharmaceutical colleagues as soon as possible in this process. The earlier you are considering a project as a consumer-oriented product the better it will be."

Having decided to switch your brand, another way to keep it in consumer minds is to keep it moving by modifying and innovating the offering. This is more easily facilitated if pharma and consumer sides of a company are communicating well in advance of the switch.

Szczerbiak says you should ideally have a lead-time of five years before switching to be able to sufficiently innovate with the product.

"It is then hugely important that innovation then becomes not just an ongoing process but a way of life driving through line extensions, new indications and claims.

Revenue growth

Sales growth following a sustained campaign of innovation has been seen at Boots with its management of Nurofen. After switching Nurofen to an OTC product in 1983, Boots waited 11 years before introducing innovation. But when in 1994 the company began the process with the Cold and Flu reformulation, it took the first step towards achieving nearly three-fold revenue growth between 1994 and 2001.

In those years the company continued its stream of innovation, introducing Plus, Caplets, Advance, Nurofen Children, Long Lasting and Liquid Capsule versions of the products and switching it again in 1996 to a GSL category of the product.

"With Nurofen, sales growth followed innovation, in terms of line extensions and indications, and this had to apply not just to the product itself, but also on the claims and propositions surrounding it. It is a constant process and a classic case of innovation actually being able to drive the business," Szczerbiak notes.

He suggests assessing the health of the innovation for your brand when it's still on the pharmaceutical side and then deciding pre-switch if you still want to invest. "Continuing to manage the product through the life-cycle after the switch is key, but it's pointless just sitting there and saying 'OK, sales aren't moving, better invent a new product These things take years."

Young is also clear on this point: "In this day and age you can't rely on a single entity of your product. You need to investigate potential range extensions at the very early stage to ensure that one maintains the momentum established from launch as a P product.

One leading example of a product that has enjoyed success through continued innovation is Bayer anti-fungal treatment Canesten. On the back of a strong prescription heritage, Canesten was originally switched as a treatment for thrush/vaginal yeast infection. Since then Bayer expanded the treatment indications to apply to nappy rash, sweat rash, athlete foot and cystitis with Canesten Once, Canesten Cream, Canesten Hydrocortisone, Canesten Once Daily and Canesten Oasis a mixture of P and GSL products. Consequently, between 1993 and 2002 UK sales almost doubled.

"Before you start introducing different forms and different indications it is critical a thorough approach to segmentation is carried out to determine the consumer needs, attitudes and behaviours in the markets you operate. The benefit of doing this well leads to a much stronger brand and business," says Szczerbiak.

A blockbuster switch

Looming on the horizon is one of the biggest POM-P switches – omeprazole, the generic form of AstraZeneca's blockbuster Losec. As Losec, the drug is one of the biggest sellers of all time and made AstraZeneca $5.7 billion in 2000. However, since its UK patent expired in April last year, sales have been decimated by generic competition, with the majority of England's 4.5 million prescriptions in 2002 being generic.

The reclassification process of omeprazole began in May 2003, initiated by Galpharm Healthcare, with the company seeking to switch omeprazole 10mg Gastro-resistant tablets from POM to P. The MHRA consultation process on the switch ended on 27 June 2003 and the MHRA and Committee on the Safety of Medicines are currently considering the responses. The CSM has already concluded the POM-P switch can be made safely.

The MHRA has agreed with generics manufacturer Galpharm to discourage patient long-term use of the drug without pharmacist consultation. Measures include limiting packet sizes to 28 tablets. The authority says pharmacists are already familiar with the diagnosis of gastro-oesophageal reflux disease (GORD) following the switch of GlaxoSmithKline's treatment Zantac.

The DoH expects Galpharm's application to be finalised shortly. Although AstraZeneca has vigorously defended its patents on omeprazole, it has not tried to switch the product in the UK from POM to P itself, preferring instead to launch Nexium (esomeprazole), to replace Losec. This is in marked contrast to company policy in the US, where an OTC version of the drug has recently been launched that will be marketed by Procter & Gambol as Prilosec OTC.

To switch or not to switch

The combination of prospective generic Losec availability from pharmacists and the expansive  list of drug categories that could be switched from POM to P is a heady one, but caution is  advised.

`"You have to ask yourself 'Is this drug appropriate to switch, do we fully understand the consumer and their condition, what are the attitudes amongst healthcare professionals'. These and other questions need answering through research and consultation before reaching a decision," says Szczerbiak. "We have to understand what choices the consumer has, and sometimes it remains more appropriate for them to continue to go to the doctor and for the product to remain prescription only.

Martin Szczerbiak and Margaret Young were speaking at Marketing Week's Revitalising Your Retail Pharmacy Marketing Strategies conference in May 2003.