Congress exempts pharmacies from ‘red flags’ rule
ALEXANDRIA, Va. — Congress handed community pharmacies a Christmas present in December, voting to exempt them from burdensome accounting requirements imposed by the Federal Trade Commission.
Both the House and Senate approved bipartisan legislation that removes community pharmacies and other small businesses from new requirements by the FTC and six other federal agencies regarding credit and debit card use. The so-called “red flags” rule, geared toward financial institutions and other creditors, requires such entities to develop and implement identity theft prevention and detection programs.
Independent pharmacies, in particular, have long sought legislative relief from the new rule, saying it would impose huge financial burdens on small-scale drug store operators by forcing them to scale up their automation and electronic reporting capabilities with expensive new systems.
The National Community Pharmacists Association hailed the votes in the House and Senate. “Community pharmacists appreciate passage of this bipartisan, bicameral legislative solution exempting pharmacies and other small businesses from the onerous FTC red flags rule, which is intended for financial institutions,” said NCPA EVP and CEO Kathleen Jaeger. “Thanks to the House … and the Senate vote, … community pharmacists can continue providing expert medication counseling and other services without an additional regulatory burden.”
Jaeger singled out several lawmakers in both houses for their efforts on behalf of pharmacy owner-operators. Among them: Reps. John Adler, D-N.J., Barney Frank, D-Mass., and Spencer Bachus, R-Ala., in the House; and Sens. Mark Begich, D-Alaska, and John Thune, R-S.D., who authored bipartisan legislation earlier this year to exempt many small businesses from the new rule. Key to passage in the Senate, Jaeger said, was additional support from Sens. Chris Dodd, D-Mass., and Richard Shelby, R-Ala.
“We commend Sens. Begich, Dodd, Shelby and Thune for their hard work to ensure that reasonable consumer protections can go forward without unduly burdening pharmacists and other providers with unnecessary, time-consuming requirements,” Jaeger said.
Dodd was quoted by the Congressional Record as saying that the legislation “makes clear” that pharmacists and “other types of healthcare providers and other service providers will no longer be classified as ‘creditors’ for the purposes of the red flags rule just because they do not receive payment in full from their clients at the time they provide their services, when they don’t offer or maintain accounts that pose a reasonably foreseeable risk of identity theft.”
ReportersNotebook — Chain Pharmacy, 1/10/11
Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.
U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said. The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome.
T he FDA has approved Sagent Pharmaceuticals’ topotecan hydrochloride for injection, a generic version of GlaxoSmithKline’s chemotherapy drug Hycamtin, Sagent said. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health. Topotecan is used in patients who have recurrent small-cell lung cancer sensitive disease or cervical cancer.
An FDA advisory committee has recommended approval for an investigational diet pill. Orexigen Therapeutics and Takeda Pharmaceutical announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.
In the past, the agency declined to approve such diet pills as Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s Meridia (sibutramine) be removed from the market due to safety concerns.
Johnson & Johnson made its courtship with Dutch biotech company Crucell official by acquiring all of the company for $2.3 billion, the two companies said.
J&J said it would maintain Crucell’s headquarters in Leiden, Netherlands, and keep it as the center for vaccines within J&J’s pharmaceuticals division. It also would keep the company’s senior management and “generally” keep its current staff intact.
Navajo pharmacist fills patient education gap
TSAILE, Ariz. — Some people enter the twilight years of college without a clue of what they want to do, only to decide at the last minute. Others, like pharmacist Terry Teller, know early on.
For Teller, a member of the Navajo Native American tribe originally from Lukachukai, Ariz., helping to heal people is part of his heritage, with multiple generations of medicine men and women on both sides of his family.
Teller had several healthcare-related jobs, including research and working as a nurse’s aid. He considered medical school before working with a pharmacist at an Indian Health Service facility in Tsaile, Ariz., which inspired him to go to pharmacy school at the University of New Mexico, where he earned his doctor of pharmacy degree in 2007.
“From all of those, I found I really didn’t want to do the direct patient care a doctor would provide,” Teller told Drug Store News. He now divides his time between work as a staff pharmacist at Tsaile and as a weekend relief pharmacist at Walmart stores in Farmington and Gallup, N.M.
At Walmart, Teller often finds himself using a skill uncommon among pharmacists: his ability to speak the Navajo language, which his parents speak and he studied in high school and college. As the only pharmacist in his area who speaks the language, he’s often in high demand, particularly among elderly customers. “Once they know I speak Navajo, once they know I can explain things, I get held up on the floor for a while,” Teller said.
One issue that accompanies speaking in a different language is cultural attitudes. “One of the challenges is having [the customers] understand that these medications will work, because there is a struggle to tell them, especially if they’re very traditional in thought. A lot of them have the mindset that they need a ceremony, and their high blood pressure or blindness will disappear,” Teller said, noting that patients often will attend ceremonies and use traditional herbal remedies, creating a need to consult references to Navajo herbal medicines and online databases to prevent potential drug interactions.
Another issue is the way illness is discussed in Navajo culture. Teller can’t tell a patient directly that he or she has a disease and will encounter certain symptoms, but instead must frame it in indirect terms, such as saying that if “a person” had a disease, he or she might encounter this or that symptom. “If I tell them [directly], in the traditional Navajo mindset, it’s like cursing them,” Teller said.
According to the Centers for Disease Control and Prevention, Native Americans and Alaska Natives have the highest rates of diabetes in the 10- to 19-year-old age category. Apache County, where Lukachukai is located, and neighboring McKinley County, N.M., have diabetes prevalence rates greater than 10.6%, according to the CDC.
Most diabetes patients strive to keep their A1c levels below 7%, but Teller sometimes encounters patients with levels of 14%. Heart disease rates among Native Americans and Alaska Natives also are among the highest in the country, with the CDC reporting hypertension rates of 28% and high cholesterol rates of 30%.
Any program working to reduce those rates requires public awareness, but that’s part of what got Teller into pharmacy in the first place. “For me, why I wanted to get into pharmacy was that I didn’t like direct patient care, but where I get a lot of my enjoyment is with patient education,” he said.