There has been a flurry of media coverage about over-the-counter (OTC) drug switches lately, spurred by the news that Pfizer had acquired the future marketing rights for OTC Nexium, one of the top-selling prescription drugs that loses patent exclusivity in 2014.
Stay tuned for more news like this as other blockbuster prescription drugs go off patent and pharmaceutical companies seek ways to extend their lifecycle. The future of medicine will undoubtedly involve the broader availability of drugs that once required a doctor's supervision. The challenge is aligning all the stakeholders involved, as OTC switches, with all their potential benefits, also pose risks.
PR professionals play a big role in OTC switches; in fact no discipline is better suited to build consensus among third-party groups, build anticipation and demand, and educate consumers about health conditions and proper use of these new medications.
Based on a hearing it held in March, it appears the Food and Drug Administration will be more flexible in approving OTC switches under the right conditions. The timing couldn't be more right. As consumers play an increased role in their health care, OTC switches are planned for established categories like allergy, heartburn, and pain, as well as new OTC categories like high blood pressure, diabetes, overactive bladder, migraine, insomnia, and asthma.
In considering a switch, the FDA must consider the safety and effectiveness of the product, the benefit-to-risk ratio, and whether consumers can understand the label well enough to safely use the product without consulting a healthcare provider.
Pharma companies are obviously supportive of OTC switches, as they extend the life cycle of their one-time blockbuster drugs. But what about other stakeholders?
Broader access to drugs should be welcome news to most consumers. A study by Booz & Company found that 240 million Americans use OTC medicines and 60 million of them would forgo treatment if OTC medicines were not available. OTC availability could reduce the cost of treatment, as well as the time and cost involved in a doctor visit. This will benefit patients with non-serious or embarrassing conditions like overactive bladder, as well as patients with chronic conditions like migraine who have already seen a doctor and just want a medication refill.
The industry is considering a number of measures to ensure consumers use these drugs appropriately, including diagnostic tests, online self-screeners, health kiosks, and pharmacist consultations.
Private and government payers support the concept because it means, in theory, fewer doctor visits and a shift of the cost of drugs to the consumer, as plans typically don't pay for OTC medications. The Booz study reported OTC medicines reduce US healthcare costs by $102 billion annually and that on average, every dollar spent by consumers on OTC medicine saves the healthcare system $6 to $7.
For the most part, pharmacists, who have long sought to elevate their role, favor OTC switches because of the increased opportunities to provide counsel to their customers. The National Association of Chain Drugstores, however, has expressed some concern about the potential for large costs to train pharmacists.
Physicians may be a tougher sell. Doctors and other health providers have obvious concerns about misdiagnosis and treatment, undermining physician-patient relationships, and drugs masking potentially more serious disorder. However, many physicians feel that if there is a way to keep patients with less serious or chronic conditions in the loop, they can focus on treating more serious disorders.
Public relations professionals play important roles in education and building advocacy and awareness during all phases of the switch process. We establish coalitions of healthcare providers, payers, and consumer and patient advocates to assess the risks and benefits of drug classes for OTC switch and report on their findings. We create and deliver consumer and health professional education programs. And we build widespread awareness of the drug and the switch along the way.
OTC switches will be good for our profession. But more importantly, they have enormous potential to improve the health of millions of people who ignore conditions that could be easily treated or, despite the Affordable Care Act, just don't like visiting the doctor.
Debra Gaynor is chief business strategist at Marina Maher Communications.