FDA debates expansion of switch paradigm
Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst.
The Food and Drug Administration public meeting that took place last month addressed a proposal to expand the switch paradigm by utilizing the latest in communications and diagnostics technology and/or incorporating the most accessible healthcare professional — the retail pharmacist — into the self-care decision protocol.
This would make prescription products available in the OTC space that go well beyond the latest series of complicated switches to hit the market — notably the emergency contraceptive Plan B One Step and Prilosec OTC. Both of those medicines were switched Rx-to-OTC with a dual prescription/nonprescription status. Plan B One Step is still prescription-only for women younger than 17 years, and Prilosec OTC is still prescription-only for a gastroesophageal reflux disease indication. The Drug Facts label on the OTC version instructs users to seek a doctor’s care if needed for more than two weeks.
But what the FDA and others heard over the course of that meeting wasn’t some kind of healthcare science fiction. The stage wasn’t being set for some future OTC Utopia where consumers appropriately self-select an OTC statin every time — the fact is the technology is already in the marketplace. In fact, just about everything needed is in place today, including the back-end infrastructure to support that technology and, on the clinical side, clinical skill sets among pharmacists who are proactively engaging their patients. Unlocking that technology could open up massive new OTC categories — it is projected that an OTC statin class could be worth $1 billion a year.
Market-driven technologies supporting compliance activities are the first to come to mind, suggested Chuck Parker, executive director of the Continua Health Alliance, when considering what tools are in place today that might facilitate a future complex switch. “That’s something that we already have in play in the marketplace,” he said. Something like cholesterol screening — a diagnostic tool that may improve appropriate self-selection of the aforementioned statin remedy — should become available in a retail setting, if not actually sold OTC, in the near future. “We have several companies that are working toward creating a standard to be able to capture that data in a relatively simple format, much like you would do with a glucometer,” Parker said.
The established back end of pharmacy communications also can help facilitate a future expanded switch model. “With the advent of SureScripts, we have a fairly robust and well-connected network now to track prescriptions and [to support] e-prescribing,” Parker said. “The evolution of that technology here in the United States is going to allow us to [engage] two-way communication much more effectively, not only to the physician who’s the prescriber but … [also] to the consumer level.”
In-store diagnostic tools that help improve compliance, contribute to a HIPAA-compliant health record and increase interception opportunities between pharmacists and patients are similarly in place. “We have a live [electronic medical record] today that’s actually sending patients data from the pharmacy directly into the patient’s health record at the physician’s office,” noted Ashton Maaraba, general manager and COO for PharmaSmart International. PharmaSmart has been featuring its Model PS-2000 With Connectivity, an in-store blood-pressure kiosk that integrates a “Smart Card” functionality to enable the transfer of blood-pressure and pulse readings through a secure HIPAA-compliant server and into an online patient health portal. “[This establishes] a link with the acute caregiver with a clinical specialist on-site,” he said. Already, supermarket pharmacies are incorporating that kiosk into their care protocol, Maaraba said, increasing pharmacist-patient interaction, augmenting that healthcare dialogue and then redirecting that patient to the dietitian across the aisle for additional advice on better health.
That pairing of Internet access with a patient identification tool could be a window into one potential future for pharmacy — a future where patients can self-identify a therapeutic need, sit down at a self-serve kiosk, identify themselves and proceed with an interactive online questionnaire to both improve appropriate self-selection and identify next steps. If blood pressure or pulse rates are pertinent, those tests can be administered at the kiosk. And if a patient has appropriately self-selected a therapy, that kiosk can generate a coupon receipt without which the therapy could not be purchased. It’s a self-selection tool that can both redirect a patient to a pharmacist consultation when necessary and pave the way to convenient access when not.
“Our kiosks are already programmed to do most of that,” Maaraba said, “including printing out the coupon.”
Perrigo to launch store-brand Mucinex equivalent
ALLEGAN, Mich. — Perrigo on Thursday announced that it has initiated shipments of its guaifenesin extended-release tablets in the 600-mg strength, a generic version of Mucinex.
The company expects to initiate its full-scale over-the-counter launch of the store-brand equivalent to Mucinex in blister packaging to its retail and wholesale customers before the end of its current fiscal year in June.
Mucinex 600-mg tablets has estimated annual sales of approximately $135 million, according to Perrigo.
Johnson’s Baby names new mom Hilary Duff spokeswoman for new charity arm
SKILLMAN, N.J. — Johnson’s Baby on Thursday announced the launch of a new charitable platform — Johnson’s Baby Cares. The program will support the healthy development of moms and babies while also addressing the basic care needs of families during crisis situations in the form of educational initiatives, product donations and financial assistance.
Beginning with a partnership with global children’s humanitarian organization Save the Children, the Johnson’s Baby Cares campaign kicks off by leveraging the support of actress and new mom Hilary Duff to assemble "Care Kits" that will be distributed to families in times of natural disasters.
Consumers are encouraged to support the charitable platform by visiting the Johnson’s Baby Cares tab on the Johnson’s Baby Facebook page.
"According to Save the Children, 90% of U.S. children live in areas at risk of natural disasters," stated Ivy Brown, marketing director of baby care at Johnson’s Baby and Desitin. "In addition, families worldwide are also impacted by various global natural disasters where mothers and babies are deprived of their most basic needs. We are launching this charitable platform to provide these mothers and caregivers with essential basic resources and simple tools that will lend support in times of unexpected crisis."
To assist families, the makers of Johnson’s Baby products, alongside parent company Johnson & Johnson, are making a multiyear, multimillion dollar contribution to Save the Children that will help create and sustain key initiatives, including:
A donation and distribution of thousands of Johnson’s Baby "Care Kits," providing families with baby care essentials immediately after a disaster. This commitment is an extension of the brand’s existing product donation efforts aimed to meet baby care needs in the U.S. and around the world;
Funding that enables Save the Children programming, such as Child Friendly Spaces, which supplies moms and children with safe areas to recover, play and experience the joy of being together as a family following a disaster; and
Vital training for health workers in developing countries through the "Helping Babies Breathe" program, which teaches basic techniques to prevent birth asphyxia, saving newborn lives.
Consumers can show their support of this campaign by purchasing any Johnson’s Baby product between April 15 and June 10 and redeeming a 50-cent coupon at retail stores, of which 25 cents will be donated to Save the Children. Throughout the rest of the year Johnson’s Baby will share additional ways consumers can get involved to help support Save the Children.