GSK shares real-world example on how to improve switch through technology
SILVER SPRING, Md. — GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.
GSK created a prototypical healthcare kiosk that channeled a patient through nine algorithms and assisted him or her in making an appropriate treatment decision for use of an OTC statin, in this case Mevacor — branded Cardiocare as part of the presentation.
And while GSK’s prototype was housed in an actual kiosk, GSK VP wellness category, global regulatory and quality David Schifkovitz noted this kind of funneling program, where each screen poses a question and directs the consumer to the most-appropriate next screen depending upon the answer, easily can be translated to a smartphone app.
In the example of "Cardiocare," the questionnaire walked patients through a series of questions such as their gender, age, knowledge of cholesterol condition and contributing risk factors to their condition — is there a history of heart disease in their family? Based on the patient’s answers, the end screen would either recommend use of the statin or explain why this statin may not be appropriate for self-selection.
Funneling patients toward the most appropriate self-selection conclusion isn’t the only advantage to a program like this, Schifkovitz said. "There’s the ability with this technology to incorporate education into the algorithm itself."
GSK’s experience with developing a Mevacor-based question protocol was borne out of the company’s partnership with Merck when that company last attempted to switch Mevacor in 2007. The absence of appropriate self-selection helped scuttle that switch application. Merck had improved self-selection scores in a consumer label-comprehension study from two years prior (2007 vs. 2005). To help consumers with self-selection, Merck made label revisions, including a highlighted age-exclusion graphic on the front of the package and a stronger warning against the use of Mevacor Daily in women who are pregnant or could become pregnant.
In the usage study based on consumers’ knowledge of their LDL levels, 98% of consumers appropriately chose not to take the medicine, but only 16% of those who chose to take the medicine did so appropriately.
FDA opens dialogue of incorporating technology, pharmacy into switch paradigm
SILVER SPRING, Md. — The Food and Drug Administration’s director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.
Those new pathways to improve access included the use of improved communication technology that could enhance the Drug Facts Label, such as making available instructional videos for public consumption, a codified mechanism that would incorporate a pharmacist consultation or diagnosis before a medicine was made available, and a model where pharmacists would serve as physician extenders for medicines treating chronic conditions.
"We’re not considering altering the process of the [over-the-counter] switch itself," Woodcock told attendees. But the agency is interested in exploring ways that the pharmacy community and/or advanced communication technology can augment access to nonprescription medicines, and, where appropriate, to create an avenue where patients can be redirected to a medical home. Woodcock also suggested that new regulations governing this new switch paradigm would be necessary.
Pharmacists are "cautiously optimistic" on the proposal to incorporate pharmacists in the administration of medicines not yet considered appropriate for over-the-counter access, Eric Juhl, director of federal public policy for the National Association of Chain Drug Stores, stated in his opening remarks. Any rule-changing would need to recognize the increased costs pharmacy would necessarily incur under such a model, including both counseling time and administrative costs. Juhl also cautioned that this new paradigm should not be used to restrict access to medicines already available over the counter (e.g., pseudoephedrine). "The time of the pharmacist is limited, as is the space behind the counter," Juhl said.
Juhl also suggested that pharmacy operators already are contributing to improved, more efficient and less costly health care through collaborative practice agreements, now allowed in 34 states, where pharmacy operations and physician groups collaborate care to help improve prescription-drug compliance and convenient access to care.
Immunizations are another example where the expansion of a pharmacist’s purview helped improve access and increase utilization of health care — for the 2010/2011 influenza season, pharmacists administered more than 20 million influenza vaccines, noted Tom Menighan, EVP and CEO for the American Pharmacists Association. "Immunizations [also are] a good example where the business process developed once the rulemaking was put into place," Menighan said, but reiterated Juhl’s concerns that pharmacists be adequately reimbursed for any contribution under a new switch paradigm.
The hallmark of OTC medicines is the consumers’ ability to pick a product off the shelf, read the package label, and appropriately and safely self-select the medicine to treat their condition, noted Scott Melville, president and CEO for the Consumer Healthcare Products Association. Tools and technologies, beyond the traditional Drug Facts label, can assist consumers in making appropriate OTC selections — diagnostic tests, health kiosks, smartphones, self-screeners and pharmacist consultations all can help consumers accurately recognize conditions and select and use an appropriate medicine. “Ultimately, we envision a future where innovative switches are made possible by tools and technologies on a data-driven case-by-case basis,” Melville said.
The meeting, which is scheduled to end at 4 p.m. on Thursday before resuming Friday, is being webcast live by the agency here.
TheraPearl names new president, VP sales in support of retail expansion
JESSUP, Md. — TheraPearl on Wednesday named Daniel Baumwald president and Thomas Keeney VP sales.
Baumwald has been with the company since its inception in 2009, coming from Glaceau Vitaminwater/Coca-Cola where he was national account manager. Baumwald will assume management of the TheraPearl team, along with the company’s overall direction as it continues to expand.
Keeney will lead TheraPearl’s sales team and its retail market expansion. Keeney previously served four years as VP sales and field marketing with Hint, a company that produces and distributes naturally flavored, sugar-free water.