FDA, FTC Crack Down on Unapproved, Illegally Marketed Opioid Cessation Products – Drug for nerve pain boosts high for opioid abusers.

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FDA, FTC Crack Down on Unapproved, Illegally Marketed Opioid Cessation Products – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA and the Federal Trade Commission (FTC) today issued joint warnings to companies selling unapproved opioid cessation products with deceptive claims about their ability to treat opioid addiction and withdrawal, according to a FDA press release.

The warning letters addressed marketers and distributors in violation of the Federal Food, Drug, and Cosmetic Act for the selling of 12 illegally marketed, unapproved opioid cessation products, according to the press release. The FDA emphasized that these products have not been demonstrated to be safe or effective and may be keeping patients from seeking appropriate, FDA-approved therapies for opioid addiction.

All of the companies use online platforms to make unsubstantiated therapeutic claims about their product’s ability to treat opioid addiction and withdrawal, according to the statement.

Overall, the FDA and FTC issued the joint warning letters to 11 companies for their products:

– Opiate Freedom Center (Opiate Freedom 5-Pack)
– U4Life, LLC (Mitadone)
– CalmSupport, LLC (CalmSupport)

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Cuts to 340B program went into effect on January 1 – APhA submits compounding comments to FDA.

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Cuts to 340B program went into effect on January 1 – APhA submits compounding comments to FDA. – (866) 348-2889

Disproportionate share hospitals and rural referral centers lost their bid to stop CMS from implementing cuts to a federal drug pricing program that supports health care services for low-income patients. The 340B program provides discounted outpatient drugs to eligible safety-net health care facilities.

Hospital group plaintiffs were seeking an injunction that would prevent slashes to reimbursement rates from taking effect on January 1, 2018, arguing that the cuts would cause irreparable harm by forcing the reduction or elimination of services and programs. U.S. District Court Judge Rudolph Contreras dismissed the case on procedural grounds, leaving open the question of whether CMS has the legal authority to reduce payments to 340B hospitals and opening the door for future court rulings.

The now-enacted CMS regulation reduces payments for 340B drugs paid under Medicare Part B by lowering the reimbursement rate from average sales price (ASP) plus 6% to ASP minus 22.5%—estimated to save pharmaceutical manufacturers $1.6 billion annually. CMS said that the savings will be redistributed to offset health care costs to all Medicare beneficiaries.

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‘Pharmacy deserts’ a growing health concern in Chicago, experts, residents say – Drug for nerve pain boosts high for opioid abusers.

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‘Pharmacy deserts’ a growing health concern in Chicago, experts, residents say – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Public health experts say that growing parts of more than a dozen poor neighborhoods in Chicago, primarily on the city’s South and West sides, are becoming “pharmacy deserts,” having limited access to a pharmacy. Research indicates that many of these neighborhoods in Chicago have a mix of characteristics, including having residents who tend to be low income, immigrants, and/or African American or Latino. Experts note that considering the expanding scope of services many pharmacies provide, they are increasingly important parts of the national health care conversation. “A lot of public attention focuses on insurance, but that’s not enough,” said Dima Qato, an assistant professor in the department of pharmacy systems, outcomes and policy at the University of Illinois at Chicago, who has studied pharmacy access for years.

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Can weight gain be caused by tamoxifen? – APhA submits compounding comments to FDA.

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Can weight gain be caused by tamoxifen? – APhA submits compounding comments to FDA. – (866) 348-2889

Tamoxifen is a medication that has been used to treat breast cancer for more than 30 years. Though linked to weight gain, most studies do not support the link.

Tamoxifen is a type of hormone therapy known as a selective estrogen receptor modulator (SERM). One of the brand names for tamoxifen is Nolvadex.

Tamoxifen works by attaching to the estrogen receptors in breast cells so that estrogen cannot bind to them. By preventing the estrogen in the breasts binding to the receptors, tamoxifen slows the growth and reproduction of estrogen-sensitive breast cancer cells.

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PTCB Updates Certification Exam Outline and Requirements for Education and Training – Drug for nerve pain boosts high for opioid abusers.

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PTCB Updates Certification Exam Outline and Requirements for Education and Training – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The Pharmacy Technician Certification Board (PTCB) has announced two significant changes to its Certified Pharmacy Technician (CPhT) Program that will take effect on January 1, 2020. The changes include a new Pharmacy Technician Certification Exam (PTCE) content outline and an updated education and training requirement. Both changes are supported by PTCB’s most recent job analysis of pharmacy technicians conducted in 2016.

The new PTCE content outline focuses the scope of the exam on core knowledge relevant across practice settings. The updated education and training requirement includes the completion of a PTCB-recognized education/training program or equivalent work experience. PTCB will implement an attestation process to identify PTCB-recognized programs and verify that recognized programs comply with PTCB standards and requirements.

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FDA Requires Labeling Update on Opioid-Containing Medicines to Treat Cough and Cold for Children and Adults – APhA submits compounding comments to FDA

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FDA Requires Labeling Update on Opioid-Containing Medicines to Treat Cough and Cold for Children and Adults – APhA submits compounding comments to FDA. – (866) 348-2889

Food and Drug Administration (FDA) is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. In addition, labeling for the medications will be updated with additional safety information for adult use. As noted in a news release, this update will include an expanded Boxed Warning notifying consumers about the risks of misuse, abuse, addiction, overdose, and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

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State-approved Telehealth Laws Became Effective January 1, 2018 – Drug for nerve pain boosts high for opioid abusers.

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State-approved Telehealth Laws Became Effective January 1, 2018 – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A number of state-approved telehealth bills take effect in 2018. The various state regulations affect a range of health care professions, including medicine, pharmacy, psychiatry, and dentistry. The following telehealth laws were approved in 2017, and became effective on January 1, 2018.

– Arkansas: Senate Bill (SB) 146 amends the definition of telemedicine, specifies requirements for establishing a professional relationship through telemedicine, and outlines requirements for a health care professional delivering services through telemedicine in a school setting to a minor who is enrolled in the Arkansas Medicaid program.

– California: Assembly Bill 401 establishes requirements for registered pharmacy technicians working at a remote dispensing site.

– Colorado: SB 207 creates a behavioral health crisis response system and crisis service facilities walk-in centers mobile response units, and addresses the role telehealth can play in these situations.

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Dramatic increase in ADHD prescriptions filled by reproductive-age women – APhA submits compounding comments to FDA.

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Dramatic increase in ADHD prescriptions filled by reproductive-age women – APhA submits compounding comments to FDA. – (866) 348-2889

New research shows that the number of privately insured U.S. women aged 15–44 years who filled a prescription for an ADHD drug rose 344% between 2003 and 2015, from 0.9% to 4%. According to the study, the number of women aged 25–29 years who filled an ADHD prescription increased by 700%, while there was a 560% increase among women aged 30–34 years. For the study, researchers looked at private insurance claims for 2.3 million–6.8 million women aged 15–44 years to see how many women filled ADHD medication prescriptions from outpatient pharmacies. The researchers noted that ADHD medicine prescriptions increased for all included age groups and in all U.S. geographic regions. The most commonly filled ADHD medicines in this group of women in 2015 were mixed amphetamine salts (Adderall), lisdexamfetamine (Vyvanse), and methylphenidate (Ritalin).

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GAO to FDA: Publish plans to issue or revise guidance on complex generic drugs – Drug for nerve pain boosts high for opioid abusers.

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GAO to FDA: Publish plans to issue or revise guidance on complex generic drugs – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA said it will announce plans to issue or revise guidance for complex generic drugs after the U.S. Government Accountability Office (GAO) on Tuesday recommended the agency do so. The GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs. The report noted some companies have criticized FDA’s progress in bringing generic versions of these complex drugs to market. “While some stakeholders cited product-specific guidance as helpful, representatives of four brand sponsors said the guidance does not adequately address the scientific complexities of NBCDs [nonbiological complex drugs],” GAO said. “Further, guidance for some NBCDs was revised numerous times without any advance notification to industry, according to representatives of generic drug sponsors.” GAO found that FDA approved generic versions of five of 28 drugs identified as complex generics prior to fiscal year 2017 and considered a range of data when assessing equivalence to the relevant brand-name drug.

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Do any weight loss pills really work? – APhA submits compounding comments to FDA

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Do any weight loss pills really work? – APhA submits compounding comments to FDA. – (866) 348-2889

When it comes to weight loss, there is no shortage of pills, drinks, and supplements claiming to help the weight fall off. But do weight loss pills help, and are they safe?
The best weight loss pills may contain one or more active ingredients intended to increase fat burning, decrease appetite, or reduce absorption of fat.

Not all weight loss pills and supplements are created equal. Certain pills may cause unpleasant side effects while others may not be proven to result in weight loss.

We will look at the following nine weight loss pills and supplements:

– Alli (orlistat)
– caffeine

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