Few could have missed last month's headlines trumpeting the launch of the UK's first over-the-counter (OTC) diet drug.
Orlistat, manufactured under the brand name Alli by GlaxoSmithKline (GSK), has been available on prescription in the UK since 1999. But overweight people are now able to get the drug direct from pharmacists for £50 for a month's supply. The pill, which blocks the absorption of fat, is aimed at adults with a Body Mass Index of 28 or above.
The launch of the drug achieved ‘exceptional' coverage across national print and broadcast media, according to GSK comms manager for consumer healthcare in the UK, Emma Boran. ‘Weight loss is a huge topic that is firmly on the news agenda and we were offering the first product of its kind,' she says.
The issue of self-medication is going to become more pressing: the switch of Alli from a prescription-only medicine to pharmacy (POM-to-P) forms part of the Government's plan to help the public take more responsibility for its own healthcare. Almost a decade ago, the Government released a list of disease areas in which it would accept switch applications, including hypertension and erectile dysfunction. High-profile switches include the chlamydia treatment Clamelle.
For drug firms with shrinking opportunities to develop prescription drugs, the POM-to-P switch is an attractive option to keep revenues coming in.
Simon Hackett, director of Pegasus PR, says: ‘Blockbuster drugs are extremely expensive to bring to market, with huge risks if they fail. They can also show a huge hole in a company's balance sheet when they go out of patent. The perfect POM-to-P switch is one that happens just before a medicine goes offpatent. OTC products are subject to less regulation and are quicker to market.'
In the past couple of years, as financial pressures have bitten the pharma industry, the flow of applications to move a drug to OTC sale has increased.
OTC drugs may offer a more reliable revenue stream, but making prescription drugs more easily available requires a highly complex communications plan. Careful lobbying of all parties needs to emphasise the benefits ofallowing easier access to the drug, as well as promoting systems the manufacturer has in place to ensure patients will know how and when to use it.
The Alli campaign (see boxes, below) depended on the participation of stakeholders and trade bodies including the Medicines and Healthcare products Regulatory Agency (MHRA) and the Royal Pharmaceutical Society of Great Britain (RPSGB). The MHRA helps to assess whether a product can be switched and communicates to the public how the switch will affect it. MHRA head of media relations Stephen Hallworth and his team are involved from the start of a reclassification process to help communicate to stakeholders. ‘We look at switches and assess whether there is something new or of value to the media,' he says.
The MHRA also works closely with the RPSGB and the National Pharmacy Association to share information.
But while the MHRA will help with media coverage, Hallworth is quick to stress: ‘We are not promoting the product, but providing people with a good understanding of the principles behind the reclassification. We want to give them an informed choice.' The MHRA's priority, he adds, is patient safety: ‘We have to get the right balance of making medicines more easily available but not compromising on safety.'
For the RPSGB, the comms challenge is to educate its pharmacist membership on each switch. Ruder Finn director of healthcare Andrew Knill says: ‘Pharmacists need to buy into the recommendation process so they need to be educated when a drug is switching.'
Training schemes and educational material are sent out by the drug maker, with the RPSGB and the MHRA, in the months leading up to a switch.
RPSGB director of policy and comms David Pruce says one of his key messages is that the process is not the same as buying a drug in the supermarket. It involves a consultation with a pharmacist, who may refuse to give the drug if it is not appropriate.
The MHRA has a list of switches in the pipeline that will see consumers playing a bigger role in their own healthcare, and keep communicators busy with the information process.
Graham Phillips Community pharmacist and proprietor, The Manor Pharmacy Group
As a pharmacist, I am really excited about getting involved in public health. In particular, I'm interested in dealing with wellbeing rather than treating illness. Alli forms part of the Government's healthy eating agenda, which means treating patients before they become unwell from being overweight.
When a drug is switching from prescription to OTC it is usually handled very professionally. It always involves a lot of preparation well before the launch, with individual and group training programmes, both in person and online.
GSK also provided mock-up training, which ran through the different scenarios we could encounter, such as interest from people who are lower than the BMI indicated for Alli's use. If we are properly prepared before launch, we can feel completely confident in case a mystery shopper is sent in by one of the newspapers. Alli isn't a brand new product.
This means we are already fully conversant with its side effects and able to provide counselling. We have been handing it out for years under prescription. But as we distribute the drug, we will become even more familiar with it.
Siân Boisseau Director, Virgo Health PR
The launch of Alli was the culmination of 18 months of planning. The licence for the reclassification was granted in January. We managed to achieve quite a lot of coverage around that story and then quickly move on to creating marketing materials.
The MHRA forbids any work until the licence is granted, so we had four months to create everything and get it to approve it.
After the licence was granted, we gave Alli to 60 people to trial. We agreed with the MHRA that people would use it pre-launch in accordance with guidance. After the launch, these people blogged about their experiences with the drug and spoke to journalists.
In February, we started reaching out to consumer publications with long lead times and did media house tours at IPC and NatMag. We wanted journalists to understand the product but not give away too many details. We then went to the media medics - commentators in the media who give out advice, such as Dr Hilary Jones.
We also reached out to nonhealthcare news journalists because we knew the story would be picked up in the main news pages. For this we paid for a special section in Press Gazette.
On launch day, we had about 40 journalists at our event, including European specialist titles, and ITV and BBC sent news crews. Overall, coverage was balanced, illustrating what Alli can help achieve and what it can't. Correct usage is important and this was communicated via every channel of the campaign.