FDA’s new efforts to advance antimicrobial stewardship in veterinary settings – Drug for nerve pain boosts high for opioid abusers.

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FDA’s new efforts to advance antimicrobial stewardship in veterinary settings – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA Commissioner Scott Gottlieb, MD, announced Tuesday plans for a new, 5-year blueprint for how the agency will advance antimicrobial stewardship in veterinary settings. The goal, he said, is to cut back on overuse of antimicrobial drugs and fight the increasing threat of resistance. The blueprint will include key goals, objectives, and actions that FDA’s Center for Veterinary Medicine will focus on in fiscal years 2019 through 2023. The new actions will focus on three main objectives: aligning antimicrobial drug product use with the principles of antimicrobial stewardship; supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.

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FDA announces two initiatives to modernize drug quality programs – APhA submits compounding comments to FDA.

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FDA announces two initiatives to modernize drug quality programs – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA unveiled on Thursday two new voluntary programs, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program. The programs were developed in response to stakeholder requests for ongoing dialogue about quality metrics, and to give industry ways to engage and inform FDA’s use of them in the future. Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, and Michael Kopcha, PhD, RPh, director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research, note the “programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.”

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FDA clears elagolix for endometriosis pain – Drug for nerve pain boosts high for opioid abusers.

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FDA clears elagolix for endometriosis pain – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA has cleared elagolix (Orilissa—AbbVie) for the treatment of moderate to severe pain associated with endometriosis. The drug, which is expected to be available next month, is the first oral gonadotropin-releasing hormone antagonist specifically developed for the treatment of this condition. Michael Severino, MD, chief scientific officer at AbbVie, noted that elagolix represents a “significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease.” According to AbbVie, data from two studies involving almost 1,700 women found that elagolix—at a dose of 150 mg once daily or 200 mg twice daily—led to significant reductions in daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex.

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FDA addresses bulk drug substances used for compounding – APhA submits compounding comments to FDA.

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FDA addresses bulk drug substances used for compounding – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA on Monday issued a compounding risk alert to warn health care providers, compounders, and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use. Serious adverse events associated with the use of cesium chloride and other cesium salts include abnormal heart rhythms, low potassium, seizures, fainting, cardiac arrest, and death. FDA also announced that it intends to move cesium chloride to category 2 under the agency’s interim policy on compounding with bulk drug substances under section 503A. Under the interim policy, a bulk drug substance placed in category 2 raises significant safety risks in compounding and is not subject to FDA’s enforcement policy on compounding with the bulk drug substance while the agency is formally evaluating that substance for use in compounding through the rulemaking process.

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Increase in fall-related deaths highlights importance of pharmacists – Drug for nerve pain boosts high for opioid abusers.

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Increase in fall-related deaths highlights importance of pharmacists – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

With recent reports of increasing fall-related deaths among patients 65 and older, pharmacists’ services are proving to be critical in efforts to curb this growing health threat.

“Many adults take multiple medications, with more than half of them using at least one medication with side effects that may increase the risk of falling,” said Grant Baldwin, PhD, MPH, director of the Division of Unintentional Injury Prevention at CDC’s National Center for Injury Prevention and Control. “Reviewing medications with a pharmacist or other provider is one of the most important steps older adults can take to reduce their fall risk.”

In partnership with APhA, CDC created STEADI: The Pharmacist’s Role in Older Adult Fall Prevention, a free CPE-accredited training program.

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FDA updates health care professionals and patients on recent valsartan recalls – APhA submits compounding comments to FDA.

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FDA updates health care professionals and patients on recent valsartan recalls – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA is updating health care professionals and consumers following a recent FDA press release about voluntary recalls of several drug products containing the active pharmaceutical ingredient (API) valsartan. Valsartan is used to treat high blood pressure and heart failure. FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient’s medical condition. Not all products containing valsartan are being recalled, and this update will clarify which valsartan-containing products are being recalled. The recalled products contain an impurity, N-nitrosodimethylamine (NDMA), in the API manufactured by China-based Zhejiang Huahai Pharmaceuticals.

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FDA: New efforts to empower consumers by advancing access to nonprescription drugs – Drug for nerve pain boosts high for opioid abusers.

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FDA: New efforts to empower consumers by advancing access to nonprescription drugs – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA announced Tuesday a new initiative to establish innovative approaches to increase access to a wider selection of nonprescription drug products for consumers. The goal, said FDA Commissioner Scott Gottlieb, MD, is to empower consumers “to self-treat common conditions and potentially some chronic conditions.” Gottlieb noted that not all prescription medications “can or should be available directly to consumers,” but certain types of drugs “are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them.”

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Antibiotic prescribing in retail clinics, urgent care centers, EDs, and traditional ambulatory care settings – APhA submits compounding comments to FDA.

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Antibiotic prescribing in retail clinics, urgent care centers, EDs, and traditional ambulatory care settings – APhA submits compounding comments to FDA. – (866) 348-2889.

Patients treated in urgent care centers were more likely to be prescribed antibiotics for antibiotic-inappropriate respiratory diagnoses, according to new research. The retrospective cohort study—from CDC’s Danielle L. Palms, MPH, and others—examined antibiotic prescribing among urgent care centers, retail clinics, emergency departments (EDs), and medical offices. Using data from the 2014 Truven Health MarketScan Commercial Claims and Encounters Database, the researchers looked at outpatient claims with facility codes for urgent care center, retail clinic, hospital-based ED, or medical office.

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FDA requires labeling changes for systemic fluoroquinolones – Drug for nerve pain boosts high for opioid abusers.

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FDA requires labeling changes for systemic fluoroquinolones – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA has required class-wide safety labeling changes for oral and injectable fluoroquinolones to strengthen the warnings about the risks of adverse effects, including effects on mental health and blood glucose metabolism. A comprehensive review of FDA’s adverse event reports and case reports in the medical literature led to the requirement.

The requirement stipulates that mental health adverse effects such as disorientation, agitation, nervousness, memory impairment, delirium, and disturbances in attention are to be listed separately from other central nervous system adverse effects on the label. Although current labeling notes blood glucose disturbances such as hyperglycemia and hypoglycemia, the labeling for all systemic fluoroquinolones must now explicitly state the potential risk of coma from hypoglycemia. FDA also issued a drug safety communication for patients and health professionals about hypoglycemic coma and mental health adverse effects associated with fluoroquinolones.

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FDA forms task force to address drug shortages – APhA submits compounding comments to FDA.

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FDA forms task force to address drug shortages – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA Commissioner Scott Gottlieb announced Thursday the creation of a task force to address persistent drug shortages in the United States. Although the number of new drug shortages has decreased since 2011, some medically necessary products continue to be in short supply. “Even shortages of a small number of key drugs can place a serious burden on providers,” Gottlieb noted. The new Drug Shortages Task Force—to be led by Keagan Lenihan, FDA’s associate commissioner for strategic initiatives—will seek holistic solutions to addressing the root causes for these shortages. Other members of the task force will include senior leaders from FDA, CMS, and the Department of Veterans Affairs.

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