Breaking down barriers to antimicrobial stewardship in small hospitals – APhA submits compounding comments to FDA.

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Breaking down barriers to antimicrobial stewardship in small hospitals – APhA submits compounding comments to FDA. – (866) 348-2889

Owing to their success in promoting patient safety at larger institutions, various national regulatory and accreditation agencies have mandated that all hospitals, regardless of size, implement antimicrobial stewardship programs (ASPs).

In 2015, 73% of U.S. hospitals had fewer than 200 beds, and 10% had fewer than 25 beds, many of which hold critical access hospital (CAH) designation, according to a recent study in Clinical Infectious Diseases. With 20%–50% of antibiotic use being unnecessary or inappropriate, and with similar usage rates, spectrums of antibiotics, and rates of drug-resistant bacteria compared with larger facilities, smaller hospitals may encounter barriers concerning resources while executing ASP initiatives.

“Antimicrobial resistance is one of the most problematic issues facing modern medicine,” explained Michael Klepser, PharmD, FCCP, FIDP, professor of pharmacy practice at Ferris State University College of Pharmacy in Big Rapids, MI. “Additionally, antibiotic-related adverse events are the most common cause of drug-related emergency room visits.

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Pharmacists in Puerto Rico help their communities after Hurricane Maria – Drug for nerve pain boosts high for opioid abusers.

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Pharmacists in Puerto Rico help their communities after Hurricane Maria – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Despite Puerto Rico’s utter devastation after Hurricane Maria, pharmacists and pharmacy staff who live there are going above and beyond serving patients in their communities, said Justin Coyle, PharmD, senior director of pharmacy operations at Walgreens.

“Team members have lost their homes and need basic needs like food, fuel, water, clothing, and shelter,” Coyle said. “Not only are they experiencing the storm as residents of Puerto Rico, they’re helping their community, and they’re helping their patients.”

Before the hurricane hit, the pharmacy chain had plans in place to account for team members being safe, Coyle said, adding that Walgreens pharmacy staff were coming together and helping each other out. “What that looks like is as simple as: ‘Are you okay?’”

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FDA Approves Zika Virus Blood Screening Test – APhA submits compounding comments to FDA.

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FDA Approves Zika Virus Blood Screening Test – APhA submits compounding comments to FDA. – (866) 348-2889

FDA officials have approved the first test for screening Zika virus in blood donations. The test is intended for use by blood collection establishments and not for individual diagnosis of infection.

The cobas Zika test is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, as well as from living organ donors.

In August 2016, the FDA issued a final guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or a licensed (approved) test when available.

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Hurricane damage in Puerto Rico leads to fears of drug shortages nationwide – Drug for nerve pain boosts high for opioid abusers.

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Hurricane damage in Puerto Rico leads to fears of drug shortages nationwide – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Major pharmaceutical firms and federal officials are scrambling to prevent national shortages of critical drugs for treating cancer, diabetes, and heart disease that are manufactured at 80 plants in hurricane-ravaged Puerto Rico. The U.S. territory has become one of the world’s biggest centers for pharmaceutical manufacturing, with its factories making 13 of the world’s top-selling brand-name drugs. Drug companies are confronting a range of obstacles on the island, including locating enough diesel fuel for generators to run their factories. “Some of these products are critical to Americans,” FDA Commissioner Scott Gottlieb told a congressional panel this week. “A loss of access could have significant public health consequences.” Gottlieb, who visited FDA staff in Puerto Rico last week, told the House Energy and Commerce Committee’s subcommittee on Health: “We have a list of about 40 drugs that we’re very concerned about. It reflects maybe about 10 firms.” Thirteen of the drugs, Gottlieb said, are “sole-source.” The biggest problem, he said, was not damage to the factories, but the instability of the electric supply. Manufacturers are worried that a long-term lack of connection to a major power grid could jeopardize their products, and they are also wary of relying on the more limited electrical grids that the territory is likely to activate as a first step to restoring power.

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New FDA Webinar Presents an Overview of Agency’s Drug Information Resources – APhA submits compounding comments to FDA.

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New FDA Webinar Presents an Overview of Agency’s Drug Information Resources – APhA submits compounding comments to FDA. – (866) 348-2889

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research is presenting a series of continuing education webinars targeted toward students and health care providers who wish to learn more about FDA and drug regulation. The webinars are presented by FDA staff and will allow participants to interact with staff in a question-and-answer format.

The next webinar, “An Overview of FDA Resources,” will be held October 17, 2017, at 1 PM (EDT). This webinar will discuss drug information resources on the FDA website that health care providers can use to respond to questions and promote safe drug use. To register for this event, visit the FDA website.

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Law Enforcement Discovers Fake Steroid and Prescription Drug Lab, Arrests Three Florida Residents – Drug for nerve pain boosts high for opioid abusers.

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Law Enforcement Discovers Fake Steroid and Prescription Drug Lab, Arrests Three Florida Residents – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Three Florida residents have been arrested for their involvement in a steroid and fake prescription pill lab in North-West Florida. United States postal inspectors determined that large amounts of steroid and fake prescription drug ingredients were being shipped from China to various locations in southern Alabama and northern Florida, according to court documents. As noted in a Department of Justice news release, it is alleged that the three residents were using these raw materials and two large scale presses to mass produce pills in an illegal drug lab discovered near Chipley, Florida. They also were allegedly advertising the drugs for sale online. In the lab, law enforcement found a large amount of steroids in the form of vials, finished pills, and raw powder, and four types of fake prescription drugs that were falsely labeled as Viagra®, Cialis®, Accutane, and Clomid.

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Hundreds of Rogue Online Drug Sellers Shut Down During Operation Pangea X – APhA submits compounding comments to FDA.

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Hundreds of Rogue Online Drug Sellers Shut Down During Operation Pangea X – APhA submits compounding comments to FDA. – (866) 348-2889

As part of Operation Pangea X, the tenth annual International Internet Week of Action (IIWA), FDA took action against more than 500 websites that illegally sell potentially dangerous, unapproved prescription drugs to United States consumers. These actions were part of a major global operation to target illegal drugs being marketed online, and shipped and distributed through the postal system directly to American consumers. FDA also issued 13 warning letters to operators of 401 websites and worked with internet registrars to seize nearly 100 website domain names.

During IIWA, which ran from September 12-19, 2017, FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at international mail facilities in Chicago, Miami, and New York. These screenings resulted in nearly 500 parcels being detained for appropriate FDA compliance follow up. Parcels found in violation of the Federal Food, Drug, and Cosmetic Act will be refused entry into the country, indicates an FDA news release.

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Reducing the hurdles for complex generic drug development – Drug for nerve pain boosts high for opioid abusers.

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Reducing the hurdles for complex generic drug development – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA Commissioner Scott Gottlieb discusses his agency’s efforts to advance new policies aimed at bringing more competition to the drug market. FDA announced on Monday new policies “aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs.” The agency is undertaking a number of efforts to ensure that the pathways for approval for generic versions of complex drug products are as efficient as possible. Gottlieb notes that “manufacturers of complex generic drugs face a number of challenges in developing their products and demonstrating that their products meet the approval requirements for generic drug applications (ANDAs), including establishing that they are bioequivalent to and have the same active ingredient as the brand-name drug.” FDA is issuing a draft guidance to assist ANDA applicants and prospective ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs. It is also issuing a draft guidance to help applicants determine when submission of ANDAs for certain complex products, known as peptides, would be appropriate.

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APhM: 20 questions to start conversations with patients – APhA submits compounding comments to FDA.

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APhM: 20 questions to start conversations with patients – APhA submits compounding comments to FDA. – (866) 348-2889

Pharmacists know they’re the most accessible health care provider. But how much do patients know about pharmacists and the patient care services they provide?

In celebrating this year’s American Pharmacists Month (APhM), pharmacists are encouraged to reach out to their patients. First, open the lines of communication through conversations around making sure the patient understands the medication. Once relationships with patients are built, medication adherence is more likely.

This is all in keeping with the APhM slogan “Know Your Pharmacist—Know Your Medicine,” which recognizes that patients can better know their medications when they get to know their pharmacist.

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FDA approves new treatment for certain advanced or metastatic breast cancers – Drug for nerve pain boosts high for opioid abusers.

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FDA approves new treatment for certain advanced or metastatic breast cancers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA approved on September 28 abemaciclib (Verzenio—Eli Lilly) for the treatment of adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy. Abemaciclib is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. Additionally, it is approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized. “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. Common adverse effects of abemaciclib include diarrhea, low levels of certain white blood cells, nausea, abdominal pain, infections, fatigue, low levels of red blood cells, decreased appetite, vomiting, and headache.

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