DEA Reports Strong Turnout for 14th Prescription Drug Take-Back Day – APhA submits compounding comments to FDA.

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DEA Reports Strong Turnout for 14th Prescription Drug Take-Back Day – APhA submits compounding comments to FDA. – (866) 348-2889

More than 900,000 pounds of unneeded, unwanted, or expired prescription drugs were properly disposed of during the October 28, 2017 DEA National Prescription Drug Take-Back Day. DEA and its law enforcement partners set up over 5,300 temporary collection sites nationwide. This year, DEA notes that participation in the Take-Back program expanded on tribal lands, where 115 collection sites were set up. For more details about results from previous national take-back day events, visit DEA’s website.

NABP’s AWARXE® Prescription Drug Safety Program encourages consumer participation in DEA Take-Back Day events and provides information about the importance of safe drug disposal in helping to curb prescription drug abuse rates. Consumers who were unable to participate in the DEA Take-Back Day can find locations of permanent drug disposal sites in the US using AWARXE’s Drug Disposal Locator Tool.

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FDA Investigates Two Adverse Events Associated With Compounded Injectable Drugs – Drug for nerve pain boosts high for opioid abusers.

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FDA Investigates Two Adverse Events Associated With Compounded Injectable Drugs – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Food and Drug Administration (FDA) received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, LLC, located in West Palm Beach, FL. According to the report, a sample of the product was sent for testing and the pH was determined to be above 11.

In response to the reported adverse events, FDA conducted a for-cause inspection of United Pharmacy and collected samples from two batches of GAC injectable product. Analysis performed on the samples determined the pH to be 10.9, which is alkaline, and no glutamine was detected. The labels of the GAC injectable samples indicate that 10 mg/mL of glutamine, 100 mg/mL of arginine, and 200 mg/mL of carnitine are contained in 30 mL vials. A compounding risk alert indicates United Pharmacy recalled lots GAC-12 and GAC-13 on September 27, 2017.

Compounding pharmacies should be aware of safety information related to the physical and chemical attributes of their injectable products, including pH. Because compounded products are not evaluated by FDA for safety and effectiveness, health care professionals should query the compounding pharmacy about the safety information related to the physical and chemical attributes of the compounded products they plan to inject into patients.

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New Study Finds One in Five Drivers Use a Prescription Drug That Can Impair Driving Despite Warnings – APhA submits compounding comments to FDA.

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New Study Finds One in Five Drivers Use a Prescription Drug That Can Impair Driving Despite Warnings – APhA submits compounding comments to FDA. – (866) 348-2889

A new study, which analyzes data from the National Roadside Survey of Alcohol and Drug Use, 2013-2014, found that one in five drivers have taken prescription drugs that could impair driving despite having been warned about the risks. The authors of the study, “Receipt of Warnings Regarding Potentially Impairing Prescription Medications and Associated Risk Perceptions in a National Sample of U.S. Drivers,” indicate that of the 7,405 random drivers who completed the prescription drug portion of the survey, almost 20% reported recent use (within the past two days) of a potentially impairing prescription drug.

Lead study author Robin Pollini told Reuters Health that she hopes her research will remind physicians and pharmacists to thoroughly discuss the potential risks of medications with their patients. Compared to people who were prescribed antidepressants (62.6%) and stimulants (57.7%), those who were prescribed sedatives (85.8%) and narcotics (85.1%) were most likely to report receiving warnings about the potential of these drugs to affect driving from their health care provider, pharmacy staff, or medication label.

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UNAIDS announces nearly 21 million people living with HIV now on treatment – Drug for nerve pain boosts high for opioid abusers.

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UNAIDS announces nearly 21 million people living with HIV now on treatment – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A new report from UNAIDS points to the increase in HIV treatment access and highlights the right to health as the key to ending AIDS. According to the report, whereas 685,000 people living with HIV had access to antiretroviral therapy in 2000, that figure had increased to 20.9 million by June 2017. Key challenges now include ensuring that the 17.1 million people in need of treatment can access the medicines and putting HIV prevention back at the top of public health programming. The Right to Health report notes that the individuals most marginalized in society and most affected by HIV still face significant challenges in accessing the health and social services they need. In addition, the report gives a clear demonstration of the obstacles ahead in efforts to end the AIDS epidemic as a public health threat by 2030, as outlined in the 2016 United Nations Political Declaration on Ending AIDS. To reduce new HIV infections and AIDS-related deaths and ensure access to essential health services, funding for health needs to increase, the report says. The funding gap for HIV is estimated at $7 billion by 2020.

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Big changes could be in store for 2019 Medicare drug plans – APhA submits compounding comments to FDA.

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Big changes could be in store for 2019 Medicare drug plans – APhA submits compounding comments to FDA. – (866) 348-2889

For the first time in 3 years, the CMS regulatory agenda released a Medicare Advantage and Part D proposed rule. The Part D proposed rule is a platform for presenting major policy changes for public comment.

One of the sections of the new proposed rule intends “to clarify that the any willing pharmacy requirement applies to all pharmacies, regardless of how they have organized one or more lines of pharmacy business.” Currently, some Medicare drug plans drive patients towards “preferred” pharmacies, or charge patients higher copays at pharmacies that aren’t “preferred” but may, for example, be more geographically convenient, provide services beyond traditional services, or where they have established relationships with pharmacists. Under the current framework, not all pharmacies may become a “preferred” pharmacy, even if willing to meet a plan’s requirements, because they may not satisfy the plan’s definition of a certain type of pharmacy. Pharmacy groups have long advocated for inclusion of “any willing pharmacy” provisions that allow patients to use any pharmacy that agrees to accept a plan’s conditions. The proposed rule clarifies that Part D plan sponsors may not exclude pharmacies with unique or innovative care delivery models from participating on the basis of not fitting the correct pharmacy type classification. Rather, under the proposed rule, CMS will consider “similarly situated” pharmacies include any pharmacy that has the capability of complying with standard terms and conditions for a pharmacy type.

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FDA approves new treatment to prevent bleeding in certain patients with hemophilia A – Drug for nerve pain boosts high for opioid abusers.

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FDA approves new treatment to prevent bleeding in certain patients with hemophilia A – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA has approved emicizumab-kxwh (Hemlibra—Genentech) for the prevention or reduction of the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed Factor VIII (FVIII) inhibitors. “Today’s approval provides a new preventative treatment that has been shown to significantly reduce the number of bleeding episodes in patients with hemophilia A with Factor VIII inhibitors,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research and director of FDA’s Oncology Center of Excellence. “In addition, patients treated with Hemlibra reported an improvement in their physical functioning.” Emicizumab-kxwh is a preventative treatment given weekly via injection under the skin. The drug’s safety and efficacy were based on data from two clinical trials. In the first trial, which included 109 males aged 12 years and older with hemophilia A with FVIII inhibitors, patients taking emicizumab-kxwh experienced approximately 2.9 treated bleeding episodes per year compared with about 23.3 treated bleeding episodes per year for patients who did not receive prophylactic treatment. In addition, patients who received emicizumab-kxwh reported an improvement in hemophilia-related symptoms (painful swellings and joint pain) and physical functioning (pain with movement and difficulty walking) compared with patients who did not receive prophylactic treatment.

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Comparative effectiveness of XR naltrexone vs. buprenorphine-naloxone for opioid relapse prevention – APhA submits compounding comments to FDA.

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Comparative effectiveness of XR naltrexone vs. buprenorphine-naloxone for opioid relapse prevention – APhA submits compounding comments to FDA. – (866) 348-2889

New research indicates that extended release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) are both safe and effective for the prevention of overall opioid relapse, once initiated. The researchers note, however, that it was more difficult to initiate treatment with XR-NTX. The 24-week randomized controlled, comparative effectiveness trial, conducted at eight community-based inpatient services in the United States, involved 570 opioid-dependent adults. As expected, fewer participants successfully XR-NTX treatment compared with BUP-NX (72% vs. 94%). The 24-week relapse events were higher for XR-NTX than for BUP-NX (65% vs. 57%), with the difference due to early relapse among those unable to initiate XR-NTX. For participants successfully inducted, 24-week relapse events were similar across study groups. In the intention-to-treat population, opioid-negative urine samples and opioid-abstinent days favored BUP-NX compared with XR-NTX, but they were similar across study groups in the per-protocol population. Treatment-emergent adverse events did not differ between groups, save for mild-to-moderate XR-NTX injection site reactions. A total of five fatal overdoses were recorded: two in the NX-NTX group and three in the BUP-NX group.

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Pharmacist teams up with paramedics to prevent overuse of emergency services – Drug for nerve pain boosts high for opioid abusers.

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Pharmacist teams up with paramedics to prevent overuse of emergency services – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

If you can’t find Victoria Reinhartz, PharmD, on the campus of Lake Erie College of Osteopathic Medicine, where she is an assistant professor of pharmacy practice, chances are she’s in an emergency response vehicle on her way to see patients in their homes. Reinhartz is part of the Manatee County Community Paramedicine program, working alongside paramedics to keep patients out of ambulances and hospitals. The program is improving lives, saving money, and changing the way people think about pharmacists’ role in health care delivery.

Manatee County, FL, is designated as medically underserved and has a primary care physician shortage. “Even if our patients weren’t elderly, uninsured, homeless, or under the federal poverty level, we wouldn’t have enough physicians for them,” Reinhartz said.

Looking to ease the problem, Manatee obtained a grant to fund the Community Paramedicine program. The program targets patients in five categories: frequent falls, diabetes, mental health and substance abuse, chronic cardiovascular or respiratory diseases, and “high system utilizers”—those who frequently visit emergency departments and regularly call 911.

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Happy Thanksgiving Day 2017

Happy Thanksgiving Day 2017

Thanksgiving is not just for expressing thanks for what you have. It is also a time to be grateful for what your abundant future holds.

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Happy Thanksgiving Wishes to You & Your Family

Happy Thanksgiving Wishes to You & Your Family

May your Thanksgiving Holiday be blessed with an overwhelming sense of gratefulness and overflowing love.

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