With patients increasingly expected to manage their conditions with advice from a pharmacist rather than their GP, the rise of self-medication is one of the most significant recent trends in healthcare provision.
The Government wants ten drugs per year reclassified from prescription-only medicines (POM) to products that can be sold over the counter (OTC) at a pharmacy.
The Medicines and Healthcare products Regulatory Agency (MHRA) has decided that these drugs should cover 12 therapeutic categories, such as statins and hypertension treatments. Those already reclassified to OTC status include GlaxoSmithKline's Flixonase Allergy Nasal Spray and Novartis' Aller-eze eye drops.
But repositioning a brand that consumers are likely to have little or no knowledge of presents a raft of challenges. PROs want to be working on a switch campaign at least six months before launch - ideally nine or even 12 months ahead - yet there is a limit to what they can say before a drug gets an OTC licence.
Healthcare regulatory body PAGB publishes a medicine advertising code, updated a year ago, which includes guidelines on how PROs can communicate to consumers and healthcare professionals.
With four keywords - 'honest, truthful, responsible and balanced' - the PAGB claims to go beyond legal requirements in restricting what the OTC medicines industry can do.
Essentially, until the day a POM gets its OTC licence and becomes available at pharmacies, PROs cannot speak to consumers about it. 'But before that you can start building awareness about the fact that more medicines are moving to OTC,' says Kirstie Pace, PAGB media and PR manager.
Message development, particularly the translation of medical-speak into language that consumers understand, is crucial. However, the targets in any switch from POM to OTC are not just consumers, but pharmacists and their assistants. Providing them with relevant training and education, allowing them to understand what is changing and why they should be recommending a brand to their customers is an integral requirement.
'Eighty-five per cent of OTC medicines are asked for by name,' says Tim Herman, managing director of Healthworld Advertising London - part of Ogilvy Healthworld.
'There's no point doing a lot of direct-to-consumer PR if it's going to fall on deaf ears when they reach the pharmacy,' adds Angie Wiles, Virgo Health joint managing director.
In addition to medical education work, much of this communication can be done through media relations. Gary Paragpuri, news editor of trade title Chemist & Druggist, says: 'Our readers are main targets so a POM to OTC switch is news. You don't have to dress it up.'
Perhaps the most high-profile example so far of a successful switch is last year's switch of Zocor Heart-Pro, manufactured by McNeil, then called Johnson & Johnson MSD (see box, p28). The switch of the anti-cholesterol treatment was controversial, with some media queasy about the move.
'It was a very difficult project,' says Paul Jarman, managing director of Ozone, which worked on the switch. 'The news was in the public domain and stakeholders could say things we couldn't defend ourselves against.'
In common with other switches, PR material had to be approved by the MHRA - 'a task in itself', says Jarman. And this is only the start of it. While pharmacists are a well-informed audience, POM to OTC moves represent uncharted journeys in terms of fulfilling prescriptions and recommending brands to patients. 'Pharmacists are trained medical professionals who have been prescribing statins for 20 years, but it is a different matter when they are consulted about heart issues,' says Jarman.
Tone is therefore important, which means PR may even have a more broad educational role in switch campaigns. Pharma Times managing editor Geoff Frew says pharmacists might require more general reassurance about switches. 'It's not the pharmacy industry pushing this, it's the authorities,' he says. 'The industry is fairly uncertain.'
This has serious implications. For example, it's one thing to recommend that customers ask their GP for a branded medicine, but it is another to prescribe it yourself, and pharmacists are worried about their position should patients suffer side effects.
'What happens if something goes wrong, if there's a liver problem, for example?' asks Frew. This is one reason why PROs primed to expect ad professionals to be sniffy about PR's contribution may be surprised - they agree that PR can put information across that ads simply can't. Ian Busby, client services director of ad agency Paling Walters, says: 'You shouldn't underestimate the PR component because it gives us a chance to talk to doctors, opinion leaders and patients. It is incredibly important for establishing the credentials of a brand and is vital in ensuring that consumers know it is available.'
A GSK spokesperson who worked on the POM to OTC switch of its ulcer treatment Zanprol last year, says its campaign was based around a relatively simple message: that this product could prevent symptoms rather than relieve them.
'But when switches are more complex, advertising becomes less useful,' the spokesperson says. 'There is a greater level of detail you can get across in an editorial piece compared with a printed ad.'
But the fact remains that however the marketing mix shakes down, if you don't get pharmacists and their assistants on board then it doesn't matter how good your campaign is. You can forget about consumers.
HYOSCINE, SCOPODERM (NOVARTIS)
A 1.5mg patch applied behind the ear of patients, Scopoderm is indicated for the prevention of travel sickness symptoms. It is a highly seasonal market, but is valued at £7m and helps prevent nausea, vomiting and vertigo for up to 72 hours.
Aimed at adults and children aged over ten, the brand was launched exclusively through Boots outlets at a premium price compared with traditional motion sickness products. Part of the strategy was to eschew a full launch, although it is believed that the brand will be rolled out to all pharmacies in the second half of this year. Until then the company has advised consumers unable to source Scopoderm to discuss alternative treatments with their pharmacist.
Although largely targeted at pharmacists, the PR campaign has also involved sponsoring a website, travel-sickness.co.uk. Scopoderm TTS, a POM based on the same active ingredient, is still used to fulfil NHS prescriptions.
OMEPRAZOLE, ZANPROL (GLAXOSMITHKLINE)
Marketed exclusively by AstraZeneca as Losec until the UK patent expired in 2002, omeprazole was moved from POM to OTC by GlaxoSmithKline under the name Zanprol last year. The heartburn treatment - an area seen as a big burden for GPs - was given its OTC licence last October as part of the manufacturer's Zantac range of gastrointestinal products.
Handled entirely in-house, there were some press ads but little PR directed at the consumer for the switch. 'If you don't get the pharmacist behind it, then the switch will never work,' says a GSK spokesperson.
The main message to pharmacists was that Zanprol is not simply used to relieve symptoms but to prevent them occurring altogether. 'We didn't want to turn GPs off because the active ingredient is still available on prescription, but this had to be more about targeting pharmacists than reassuring doctors,' the spokesperson adds.
SIMVASTATIN, ZOCOR HEART-PRO (McNEIL)
Given an OTC licence in July 2004, Zocor was steeped in controversy - allowing statins to be sold over the counter was always going to be more than a medical issue.
It was also a political one, with the suggestion that the UK public were being used as guinea pigs with the release of this cholesterol-lowering product for self-medication.
Focusing on pharmacist education, PR included a media relations campaign with the pharmacy press, including features, supplements, press releases and the supply of training manuals. The PR team also highlighted the seven million people in the UK likely to have a heart attack in the next ten years - while ensuring it did not scare off its audience.
The product was positioned as a way of mitigating that risk, with case studies used in the consumer press. An eight-week promotion in the Daily Express outlined the importance of a more general wellbeing programme, including weight loss and more exercise in addition to taking Zocor.