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Prescription-to-over-the-counter drug switches are always big news in the OTC aisles. Switched products contributed a third of the U.S. consumer health care product industry?s growth in the past five years and account for more than half of the top 14 highest-selling self-care brands, according to the Chicago-based market research firm Information Resources Inc. An aging population, increased desire by consumers to self-treat, and pressure to maximize health care dollars are all trends that will continue to fuel the category.
Experts estimate that $36 billion in potential Rx-to-OTC dollars could enter the market in the next few years, particularly in light of the Food and Drug Administration?s NSURE (Nonprescription Safe Use Regulatory Expansion) initiative. NSURE proposes that drugs previously deemed unsuitable for switches might be considered if manufacturers can incorporate technology applications that can help consumers use the products properly and effectively.
Switched products are also crucial to retailers. According to Dave Wendland, VP at Waukesha, Wis.-based Hamacher Resource Group, such products drive traffic as well as lift sales in their overall categories. Switched digestive health and vaginal yeast products increased sales across their entire categories, while some switches (such as nicotine replacement) create completely new OTC categories. Wendland says that patient use of nicotine replacement products increased 150 percent to 200 percent the first year the products were on the market as OTCs, suggesting that patients were willing to use the products, but were reluctant to visit their doctors for the necessary prescriptions.
Action in Allergy, Digestive Remedies
The allergy and digestive health categories have seen the most switched-status drugs in the past few years. ?These are segments where incidence is high and switched products represent huge dollar savings for the health care industry,? says Kyle Lentz, an analyst at Hamacher Resource Group.
Nexium 24HR, the nonprescription version of AstraZeneca?s Nexium (esomeprazole magnesium), is the most recent switched-category addition. The 20-milligram OTC version of the protein pump inhibitor (PPI) used to treat gastroesophageal intestinal reflux disease (GERD) is marketed by New York-based Pfizer, which in 2012 bought the rights to the OTC version from AstraZeneca, whose headquarters are in London.
Nexium, which had prescription sales of $3.9 billion in 2013, ?should get an initial bump from prescription customers who can now purchase the product over the counter,? says Lentz.
Wendland says that Pfizer has done a great job of collaborating with retail partners in bringing Nexium to market, a key to any switched brand?s success and an important consideration for retailers. ?Walmart used banners and window signs, and even advertised the launch in the frozen food aisle,? he notes.
To maximize sales in this key category, retailers need to let consumers know that the product is available. ?At launch, it needs to be in a minimum of four places in the store: in line, at the pharmacy counter, on an end cap and at the checkout,? advises Wendland.
New Allergy Category Entry
The massive allergy category had a significant Rx-to-OTC entry when Sanofi?s consumer health division, Chattanooga, Tenn.-based Chattem, received approval of Nasacort (triamcinolone acetonid) nasal spray in October 2013. ?Nasacort is an interesting product, since it?s used in conjunction with other allergy products,? says Lisa Buono, an IRI health care expert. ?Rather than stealing share from other products in the category, Nasacort sales are incremental.?
Buono adds that year to date, nasal corticosteroid sprays are a $63 million business. Other prescription nasal sprays, specifically GlaxoSmithKline?s Flonase (fluticasone propionate) and Merck?s Nasonex (mometasone furoate monohydrate), could be candidates for a switch and follow Nasacort onto the market. Private label products will also become a huge factor in the category, she believes.
While Nasacort OTC is indicated for use by adults and children as young as 2 years old, continued steroid use by children is a concern. Chattem is providing on-shelf education videos to retail outlets. ?Sanofi has used a new and different approach with an in-store video that?s several minutes long and essentially brings the warning label to life,? points out Laura Mahecha, a health care expert with Kline Market Research Healthcare Practice, in Parsippany, N.J.
Mahecha thinks that in-store education will become more prevalent in the OTC aisles. Kiosks, hotlines and telemedicine support could also become more prevalent and would be a great way for supermarkets without pharmacies to capture sales of switched products, even when a pharmacist isn?t available to advise patients, she adds.
Pharmacist Input Needed
Industry experts say that pharmacist accessibility is especially important when patients have over-the-counter access to drugs that were once available only with a prescription.
?With an increase in products moving from Rx to OTC status, consumers may be more likely to try to self-diagnose and treat medical conditions that would have formerly led them to seek medical attention,? says Anthony Provenzano, director of clinical programs at Boise, Idaho-based Albertsons. ?The pharmacist, being the most highly trained and most accessible medication expert, should always be sought out for advice before taking these ? or any ? medications.?
?With switches, there can be changes in dosage recommendations from what was recommended when the medication was available by prescription only, precautions about how long to use an OTC before seeking advice from a health care provider, and other precautions that a pharmacist can help with,? notes Maria Brous, spokeswoman for Lakeland, Fla.-based Publix Super Markets. ?In addition, the pharmacist can evaluate the other medications that the patient is taking to ensure that the OTC medication does not interact with any of those other medications.?
According to Anne Burns, VP of practice affairs at the Washington, D.C.-based American Pharmacists Association (APhA), pharmacists are often the only health professionals to see the big picture of a patient?s various drug regimens. ?Our health care system isn?t as coordinated as we?d like it to be, and even relatively safe medications can interact with other, chronic medications to create an issue for patients,? she says.
The input from a knowledgeable pharmacist will be even more critical if statins and drugs for erectile dysfunction become available over the counter. ?Pfizer is conducting a huge clinical trial on low-dose Lipitor that would be a turning point in the OTC category if it does get approved,? says Kline?s Mahecha, noting that Merck?s Mevacor was denied a switch three times, so experts will be watching the process closely.
Other Potential Switches
In the case of erectile dysfunction, Bridgewater, N.J.-based Sanofi has acquired the rights to market an OTC version of Eli Lilly?s Cialis, but approval is far from a slam-dunk: Concerns about recreational use and potential cardiovascular side effects have sidelined Pfizer?s efforts to switch Viagra.
Topical medications for acne, eczema and psoriasis are also likely candidates for a switch, according to Mahecha. Drugs to treat migraines and sleep aid prescription products could also be candidates for a switch in the next year or two.
?These are segments where incidence is high and switched products represent huge dollar savings for the health care industry.?
?Kyle Lentz, Hamacher Resource Group
?Walmart used banners and window signs, and even advertised the launch [of Nexium] in the frozen food aisle.?
?Dave Wendland, Hamacher Resource Group