FDA approves new Dr. Reddy’s injectable drug
HYDERABAD, India — The Food and Drug Administration has approved an injected drug for the bone marrow disorder myelodysplastic syndrome made by Dr. Reddy’s Labs, the company said Tuesday.
Dr. Reddy’s announced the approval of azacitidine injection in the 100-mg-per-vial strength. The drug is a generic version of Celgene’s Vidaza, and Dr. Reddy’s plans to launch the product in the near future.
Vidaza had sales of about $378.5 million during the 12-month period ended in July, according to IMS Health.
At least 23,000 die from antibiotic-resistant infections each year, CDC finds
ATLANTA — Antibiotic-resistant bacteria sicken more than 2 million people per year and kill at least 23,000, according to a new study by the Centers for Disease Control and Prevention.
And the costs go beyond human health and life. According to a study by Tufts University, direct healthcare costs and costs to society for lost productivity from the infections could be as high as $55 billion per year.
The culprit, the CDC said, is misuse of antibiotics. Antibiotics are the most commonly prescribed drugs used in human medicine, but up to 50% of those prescribed are not needed or are not effective as prescribed, and many more are used in food-producing animals to promote growth, despite that being unnecessary.
"Every time antibiotics are used in any setting, bacteria evolve by developing resistance," CDC Office of Antimicrobial Resistance director Steve Solomon said. "This process can happen with alarming speed. These drugs are a precious, limited resource — the more we use antibiotics today, the less likely we are to have effective antibiotics tomorrow."
The problem has become particularly severe for such bacteria as gonorrhea, carbapenem-resistant enterobacteriaceae and Clostridium difficile. C. difficile, a severe infection that causes diarrhea, causes about 250,000 hospitalizations and 14,000 deaths per year in the United States.
"Antibiotic resistance is rising for many different pathogens that are threats to health," CDC director Tom Frieden said. "If we don’t act now, our medicine cabinet will be empty, and we won’t have the antibiotics we need to save lives."
In addition to making people more susceptible to infections, antibiotic resistance could make specialty drug care more difficult. Many treatments for rheumatoid arthritis, cancers, organ transplants and joint replacements are dependent on the ability to fight infections with antibiotics.
Antibiotic resistance is a natural part of the evolutionary process of bacteria, the CDC said, and it can’t be stopped, but it can be slowed down. To address the problem, the CDC recommends such strategies as preventing infections, tracking antibiotic-resistant infections, improving use and stewardship of antibiotics and developing drugs and diagnostic tests.
Taking pharmacy’s case to health leadership
Are you and your fellow pharmacists ready to start explaining health insurance exchanges and other aspects of the rapidly unfolding health reform law to patients?
Apparently, the thousands of pharmacists who staff CVS Caremark’s more than 7,500 stores are. The chain showcased a new patient outreach effort Sept. 13 by hosting Kathleen Sebelius, secretary of Health and Human Services, at one of its stores in Orlando, Fla., and in the process made a strong case for pharmacy’s value as a national healthcare resource.
The store tour gave CVS Caremark CEO Larry Merlo a chance to make that case with Kathleen Sebelius, the federal government’s top health official. On display: the chain’s extensive, companywide information and outreach program, aimed at helping patients sort through the confusing menu of insurance options served up by the Patient Protection and Affordable Care Act.
That includes the choices that will be available through the health insurance exchanges mandated by the health reform law. The time to prepare for those choices is short: open enrollment in the exchanges is supposed to be available to Medicaid patients Oct. 1, and the health plans participating in the exchanges are required to begin providing coverage to those patients as of Jan. 1, 2014.
To help patients navigate the new coverage landscape opened by the ACA, said Merlo, CVS will host some 5,000 in-store educational events with health insurance experts, including representatives of state exchanges and local health plans who will explain the new insurance program. Its stores will also host free health screening events this month.
Sebelius seemed impressed, and expressed appreciation for CVS’ “commitment to providing Americans with the information they need about the Health Insurance Marketplace.”
The store tour dovetailed nicely with an opinion piece issued the same day by Steven Anderson, president and CEO of the National Association of Chain Drug Stores. In a column dated Sept. 13, Anderson cites remarks made by the HHS secretary who also points to the high degree of trust Americans have for pharmacists. “In an NACDS opinion survey,” he writes, “more than nine-out-of-ten respondents said they had a great deal or some confidence in their local pharmacist as a source of health advice in general — including 43 percent who said they had a ‘great deal’ of confidence in their pharmacist.”
If you’re a pharmacist who deals directly with patients, please share your own thoughts and your own encounters with patients regarding health insurance exchanges and other aspects of the ACA. As always, your feedback is appreciated.