Takeda’s US subsidiary launched its proton pump inhibitor dexlansoprazole last February under the name Kapidex. No one thought they’d have to find a new name a year later.
But shortly after the launch, the company began getting reports of dispensing errors. Some were due to prescription misreading, others to simple, honest mistakes. The two drugs causing all the confusion were AstraZeneca’s Casodex (bicalutamide) and Actavis’ Kadian (morphine sulfate extended-release), treatments for prostate cancer and chronic pain, respectively.
The number of incident reports was actually quite small: less than 20 out of over a million prescriptions. Still, Takeda decided not to take any chances and expedited reporting to the FDA. They released sales reps into the healthcare professional population to increase awareness of the name confusion, published announcements in journals—and saw a decrease in incidents.
Before the company could breathe a sigh of relief, though, the numbers started climbing again. That’s when Takeda’s conversation with the FDA took on a new urgency. “The FDA recognized the fact that lots of patients have come to rely on this medication,” said Robert Spanheimer, Takeda’s VP of medical and scientific affairs in North America. “Both parties knew how important it was to not have gaps in patient care.”
So Takeda swiftly came up with a list of possible names and sent them off to the FDA for review. After some back-and-forth, they agreed on Dexilant.
Name changes can be confusing for consumers as well as professionals, so as early as next week the company will send out an army of reps to educate pharmacists and pharmacy technicians about the switch—which is just the name, by the way. The formula and approved indications are the same, Spanheimer stressed.
What’s really interesting about this story isn’t the name switch; it’s the fact that the FDA and a pharma company worked together harmoniously—and quickly—to nip a potential fiasco in the bud. All those promises of a more efficient FDA seem to be the real deal….For now, at least.
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Reps Allowed Access; Just Make an Appointment
SK&A released the results of its latest physician survey, and it turns out that most docs are happy to meet with sales reps as long as they make an appointment in advance.
In fact, 98 percent of offices that allow sales reps to make office calls see 20 reps per week.
“That’s how many reps step through the door,” said Jack Schember, director of marketing, SK&A. “And by that we mean reps that were allowed in to drop off promotional materials, drug samples for signature, attempt to see the physician, or have an appointment for a meeting.”
Schember admits that SK&A has no benchmark to compare the data against, as this is the first time that company has asked the question as part of its Physician Access Survey, which surveyed more than 200,000 medical offices.
There is no data on how many of these sales calls are repeat visits from the same rep, or what companies they represent.
Of the physicians interviewed, 49.6 percent said that they require an appointment to meet with a rep. That’s up from 38.5 percent in 2008. Doctors in smaller practices appear to be the most likely to demand appointments, but they are also more likely to meet with reps, because they own the practice.
On the other hand, “doctors in larger practices are requiring appointments because their policies are governed by corporate owners, such as medical groups and health systems,” Schember said. “In some cases, pharma reps have to apply through the corporate owner for clearance to visit a single office.”
Physicians in specialties such as diagnostic radiology, pathology, and neuroradiology are the most likely to deny all access to reps, while diabetes specialists are the most likely to meet with a rep. Just make sure to schedule an appointment ahead of time.