New Tennessee law formally recognizes pharmacists as providers – Drug for nerve pain boosts high for opioid abusers.

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New Tennessee law formally recognizes pharmacists as providers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Tennessee saw major provider status legislation take effect on July 1. “Pharmacists as Providers” (HB 405/SB 461) gives Tennessee pharmacists formal recognition as providers through managed health insurance issuers, including reimbursement and inclusion in medical networks, as providers of care.

The Tennessee Pharmacists Association (TPA) worked with legislators, managed health insurance issuers, and key pharmacy advocacy groups to introduce and pass the bill. “This legislation creates exciting new opportunities for pharmacists and also increases patient access to essential care and services,” said Micah Cost, PharmD, MS, TPA executive director.

This landmark legislation provides a pathway for pharmacists who are acting within the scope of their license or certification under state law to be credentialed with managed health insurance issuers and enable them to participate, receive referrals, and be reimbursed for covered services or indemnification.

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ICU Medical and Apace Packaging Recall Products – APhA submits compounding comments to FDA.

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ICU Medical and Apace Packaging Recall Products – APhA submits compounding comments to FDA. – (866) 348-2889

ICU Medical, Inc, is voluntarily recalling one lot of 0.9% sodium chloride injection, USP 1000 mL, to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. The recall affects National Drug Code (NDC) 0409-7983-09 and lot number 61-841-FW, which expires January 1, 2018. As noted in a safety alert posted to FDA’s website, the affected product was manufactured in the US by Hospira, a Pfizer company, on February 1, 2016, and was distributed nationwide to Hospira customers between April 14, 2016, and February 2, 2017.

Apace Packaging, LLC, is voluntarily recalling one lot of cyclobenzaprine HCl tablet, USP 5 mg, 50-count unit dose (NDC 50268-190-15 and lot number 16710), and one lot of amantadine HCl capsule, USP 100 mg, 50-count unit dose (NDC 50268-069-15 and lot number 16710) to the retail level. These products have been recalled due to potential mislabeling. A small number of cartons containing cyclobenzaprine HCl tablets, 5 mg unit dose blister cards, may potentially be mislabeled as amantadine HCl capsules, USP 100 mg.

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FDA Issues Draft Guidance Addressing Delayed Enforcement of DSCSA Requirements Related to Product Identifiers – Drug for nerve pain boosts high for opioid abusers.

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FDA Issues Draft Guidance Addressing Delayed Enforcement of DSCSA Requirements Related to Product Identifiers – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA issued a draft guidance for industry that informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. The compliance policy outlined in the draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017, and November 26, 2018. While manufacturers work to meet product identifier requirements, they must comply with other Drug Supply Chain Security Act (DSCSA) requirements, indicates FDA’s website. Before FDA begins work on the final version of the guidance, the agency is accepting either electronic or written comments by September 1, 2017, which may be submitted following the instructions provided in the Federal Register.

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FDA to Require New Training for Opioid Prescribers – APhA submits compounding comments to FDA.

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FDA to Require New Training for Opioid Prescribers – APhA submits compounding comments to FDA. – (866) 348-2889

Food and Drug Administration (FDA) has introduced a new Risk Evaluation and Mitigation Strategy (REMS) plan to address the opioid epidemic. Manufacturers of immediate release (IR) opioid analgesic products will be required to provide new training to providers who write IR opioid prescriptions. At the agency’s Scientific Meeting on Opioids on July 10, 2017, FDA Commissioner Scott Gottlieb, MD, stated the new REMS will include modifications to the existing Blueprint for prescriber education, which describes the content of the education.

As one part of the education for prescribers of IR and extended-release/long-acting opioids, the agency will broaden information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic).

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Several states limiting the length of opioid analgesic prescriptions – Drug for nerve pain boosts high for opioid abusers.

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Several states limiting the length of opioid analgesic prescriptions – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

At least 17 states have enacted rules to curb the number of opioid analgesics doctors can prescribe. Some—including Arizona, Connecticut, Delaware, Massachusetts, New Jersey, and Ohio—have passed laws limiting the duration of initial opioid prescriptions to 5 or 7 days. Others are passing dosage limits. In Kentucky, a law went into effect last month capping opioid prescriptions for acute pain to 3 days. CDC last year issued guidance for providers, recommending shorter durations for opioid prescriptions, stating that 3 days should be sufficient and a course of more than 7 days “will rarely be needed.” According to a CDC study, patients who use such drugs for longer periods of time are more likely to end up addicted to them. Sens. John McCain (R-AZ) and Kirsten Gillibrand (D-NY) introduced federal legislation in April to limit an initial opioid prescription to 7 days. It would not apply to the treatment of chronic pain, cancer, hospice or palliative care.

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FDA to expand public education campaign to focus on prevention of youth e-cigarette use – APhA submits compounding comments to FDA.

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FDA to expand public education campaign to focus on prevention of youth e-cigarette use – APhA submits compounding comments to FDA. – (866) 348-2889

FDA announced Tuesday that it will pursue a strategic, new public health education effort aimed at discouraging children from using e-cigarettes and other electronic nicotine delivery systems (ENDS). FDA will expand this fall its “The Real Cost” public education initiative to include messaging for teenagers about the risks of using these products, and it will develop a full-scale campaign to launch next year. The efforts are part of FDA’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to education youth about the risks associated with using all tobacco products. “While we pursue a policy that focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes, and to help move those who cannot quit nicotine altogether onto less harmful products, we will also continue to work vigorously to keep all tobacco products out of the hands of kids,” said FDA Commissioner Scott Gottlieb, MD. “Educating youth about the dangers of tobacco products has been a cornerstone of our efforts to reduce the harms caused by these products. Including e-cigarettes and other ENDS products in our prevention work not only makes sense, it reflects the troubling reality that they are the most commonly-used tobacco product among youth.”

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Association of dissemination of an educational communication tool with docusate administration – Drug for nerve pain boosts high for opioid abusers.

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Association of dissemination of an educational communication tool with docusate administration – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Canadian researchers examined how docusate administration is affected when clinicians are presented with a message to discontinue its use. The OTC stool softener is often prescribed in community and hospital settings. However, several studies and review articles have questioned the product’s efficacy in the prevention of constipation. In a quasi-experimental pre-post study of acute care and continuing care facilities serviced by Alberta Health Services (AHS), an interrupted time series analysis was conducted to assess the association of an educational communication tool with docusate administration over a 2-year period. A Drugs & Therapeutics Backgrounder was disseminated to all pharmacists in December 2014. The academic detailing tool was used to help pharmacists in supporting drug stewardship and was supplemented by online, interactive webinars. Among all the facilities of the AHS predicted docusate administration declined more than 50% from preintervention [474 defined daily doses (DDDs) per 1,000 inpatient–days (PDs)] to 18 months after the intervention (214 DDDs/1,000 PDs). There was no statistically significant change in administration of the comparable laxatives over the study period. According to the researchers, “A straightforward communication tool supported by live question-and-diagnosis sessions was associated with decreased docusate administration across our organization.

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Alabama Pharmacist Defense Lawyer

Alabama Pharmacist Defense Lawyer – Kreps Law Firm, LLC

Alabama State Board of Pharmacy is stop 1 for this morning. Always enjoy being in this building helping our clients who are Alabama Pharmacists, Pharmacies or Technicians. – Kreps Law Firm, LLC

Call TODAY! Do not wait! (866) 348-2889

www.alabamapharmacistdefenseattorney.com/Pharmacist_Defense_Attorney.html

Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

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Florida officials confirm first case of sexually transmitted Zika – APhA submits compounding comments to FDA.

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Florida officials confirm first case of sexually transmitted Zika – APhA submits compounding comments to FDA. – (866) 348-2889

For most Americans, especially pregnant women, concerns about Zika virus disease are a distant memory. However, travelers, and partners of travelers, to high-risk areas still need to take extra precautions if recent news from Florida is any indication. According to the Florida Department of Health, officials have confirmed the state’s first case of sexually transmitted Zika virus disease.

While the individual had no travel, their partner recently traveled to Cuba and was ill with symptoms consistent with Zika, according to a statement from the Florida Department of Health. The case has been confirmed in Pinellas County and both individuals have tested positive for Zika virus disease.

The risk of sexually transmitted Zika virus disease is well-established. In addition to standard mosquito bite prevention, CDC has been urging individuals, especially pregnant women, to use condoms during sex or not have sex if their partner lives in or has traveled to Zika virus disease-risk areas. (CDC has a current list of areas with high rates of Zika virus disease).

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FDA approves glecaprevir-pibrentasvir for HCV – APhA submits compounding comments to FDA.

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FDA approves glecaprevir-pibrentasvir for HCV – APhA submits compounding comments to FDA. – (866) 348-2889

FDA approved on Thursday glecaprevir–pibrentasvir (Mavyret—AbbVie) for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. The combination drug is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. This is the first treatment of 8 weeks duration approved for all HCV genotypes 1-6 in adults without cirrhosis who have not been previously treated. The standard treatment length was previously 12 weeks or more. “This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. Clinical trials involving about 2,300 adults with HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with mild cirrhosis found that 92%–100% of patients who received glecaprevir–pibrentasvir for 8, 12, or 16 weeks duration had no detectable virus in their blood 12 weeks after treatment completion.

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