FDA Solicits Comments on the Collection of Information Related to Adverse Reporting for Outsourcing Facilities – APhA submits compounding comments to FDA.

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FDA Solicits Comments on the Collection of Information Related to Adverse Reporting for Outsourcing Facilities – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA has announced an opportunity for public comment on the proposed collection of certain information by the agency. A recently published Federal Register notice solicits comments on adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This information collection supports agency implementation of the Drug Quality and Security Act, which amended the FD&C Act by adding section 503B.

With respect to the collection of information, FDA invites comments on the following topics:

    1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
    2. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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SAMHSA Announces $930 Million Funding Opportunity for the 2018 State Opioid Response Grants Program – Drug for nerve pain boosts high for opioid abusers.

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SAMHSA Announces $930 Million Funding Opportunity for the 2018 State Opioid Response Grants Program – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

The Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting applications for the 2018 State Opioid Response Grants program through August 13, 2018. The program aims to address the opioid crisis by:

  • increasing access to medication-assisted treatment (MAT) using the three Food and Drug Administration (FDA)-approved medications for the treatment of opioid use disorder (OUD);
  • reducing unmet treatment need; and
  • reducing opioid overdose related deaths through the provision of prevention, treatment, and recovery activities for OUD, including prescription opioids, heroin, and illicit fentanyl and fentanyl analogs.

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FDA Approves First Generic of Drug Used to Treat Opioid Dependence – APhA submits compounding comments to FDA.

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FDA Approves First Generic of Drug Used to Treat Opioid Dependence – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA officials have approved the first generic versions of buprenorphine and naloxone (Suboxone, Mylan Technologies Inc and Dr. Reddy’s Laboratories SA) sublingual film to treat opioid dependence.

“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction. Patients addicted to opioids who are eventually treated for that addiction and successfully transition onto medicines like buprenorphine aren’t swapping 1 addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”

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Are These Symptoms of Old Age a Vitamin Deficiency? – Drug for nerve pain boosts high for opioid abusers.

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Are These Symptoms of Old Age a Vitamin Deficiency? – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Some vitamin deficiencies go unnoticed. You are eating healthy and doing everything right, but you have brain fog, low energy, frequent colds, and other infections. Maybe you have blotchy skin that you never had before, so you assume you are getting old, and resign to living with these symptoms. Maybe you do not even mention them to your doctor because you read that healthy people do not need vitamins, and you certainly are healthy.

But insidious vitamin deficiencies can make us miserable. The No. 1 offender discovered in the past 10 years is vitamin D deficiency (Table). Prior to this finding, it was thought that vitamin D deficiency was associated with only bad bones: osteomalacia in adults and rickets in children. These bone diseases usually occur when vitamin D levels are very low.

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Role of Pharmacists in Harm Reduction: Syringe/Needle Exchange – APhA submits compounding comments to FDA.

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Role of Pharmacists in Harm Reduction: Syringe/Needle Exchange – APhA submits compounding comments to FDA. – (866) 348-2889.

Historically, harm reduction (public health initiatives to minimize injurious social and physical consequences of human behavior) has successfully contributed to declining rates of teen pregnancy and HIV. As a result of the persistent opioid epidemic, a current harm reduction initiative focuses on reducing adverse consequences in drug users.

Previous studies prove that pharmacy-based syringe and needle exchange programs (NEPs) effectively reduce risk behaviors among people who inject drugs (PWID). Removing barriers to implementing NEPs in community pharmacies could increase clean needle accessibility. Offering clean needles at chain/supermarket and independent pharmacies allows the greatest potential to reduce harm because these businesses are convenient.

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Vitamin D Toxicity is Usually Preventable – Drug for nerve pain boosts high for opioid abusers.

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Vitamin D Toxicity is Usually Preventable – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Vitamin D deficiency seems to be fairly common, and for this reason it’s a common supplement. Did you know that Vitamin D is really a hormone, not technically a vitamin? This potent sterol hormone helps humans absorb and use calcium and phosphorus, and research is looking at its other roles in metabolism and disease.

Guidelines recommend an intake of 400 international units daily after age 4 years, and many adults now take 1000 international  units daily or more. When taken in doses that exceed what the patient needs, causing serum levels to exceed 250 mcg/L–1, Vitamin D can be toxic. Most references indicate that a level of 375 mcg/L–1 is associated with symptomatic toxicity.

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Pharmacist-Physician Collaborations Shown to be Mutually Beneficial – APhA submits compounding comments to FDA.

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Pharmacist-Physician Collaborations Shown to be Mutually Beneficial – APhA submits compounding comments to FDA. – (866) 348-2889.

Working together, pharmacists and physicians can forge a mutually beneficial collaboration that also benefits patients. At the American Pharmacy Purchasing Alliance’s PharmCon in Orlando, held late last week, experts with collaborative practice experience discussed why these partnerships are useful, and how they can effectively work.

Panelist Devin Patel, PharmD, manages a specialty compounding pharmacy. He said he helps to “bridge the gap” between physicians and pharmacists by offering informational sessions to medical practices in their offices. “A lot of physicians don’t understand different pharmacy services,” Patel said. “Physicians have such limited time in the day, and they struggle dealing with prior authorizations, and all these nuances.”

Sarah Hurty, MD, a practice transformation coach with Take Back Your Practice, said pharmacists can show physicians ways they can be of value to a practice, and how they can help lighten the work load. She encouraged pharmacists to help physicians see beyond the single act of dispensing medication. She pointed to  counseling patients about prescriptions and their dosing, and educating staff on gaps in care as areas that can be filled by pharmacists. “Physicians don’t even know what the gaps are,” said Hurty.

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Panel: Independent Pharmacies Need Changes to PBM Relationship – Drug for nerve pain boosts high for opioid abusers.

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Panel: Independent Pharmacies Need Changes to PBM Relationship – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Change is needed to create a better working relationship between pharmacy benefit managers (PBMs) and independent pharmacies, according to a panel of experts at the American Pharmacy Purchasing Alliance (APPA) conference in Orlando, FL. The 5 professionals appeared to share a common sentiment that current PBM practices are hurting the business of independent pharmacy, as well as the patients they serve.

Independent pharmacy owner James Wright, PharmD and former president of the Florida Pharmacy Association (FPA) president, discussed some of the issues his business experiences. To start, he said PBMs are often run by large companies that are in competition to independent pharmacies. The system creates an environment in which it is very difficult for an independent pharmacy to survive.

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Insurers Continue to Restrict Access to Hepatitis C Treatments – APhA submits compounding comments to FDA.

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Insurers Continue to Restrict Access to Hepatitis C Treatments – APhA submits compounding comments to FDA. – (866) 348-2889.

More than half of patients with hepatitis C are denied coverage by private insurers for life-saving treatments, according to a new study published in Open Forum Infectious Diseases.1 The number of patients denied coverage from public insurance also remains high.

Researchers from the Perelman School of Medicine at the University of Pennsylvania conducted a prospective analysis using data from more than 9000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Although highly effective, direct-acting antiviral drugs (DAAs) that treat hepatitis C are pricey, costing between $40,000 and $100,000. Both public and private insurers have restricted access to these life-saving medications due to the cost. Often, access is only approved to patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use. Patients with chronic hepatitis C who are denied therapy can experience continued progression and remain at risk for the development of liver complications, as well as adverse effects on organ systems outside of the liver.

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Glove and Stocking Pain: Hallmark of Peripheral Neuropathy – Drug for nerve pain boosts high for opioid abusers.

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Glove and Stocking Pain: Hallmark of Peripheral Neuropathy – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

People who have diabetes fear diabetic peripheral neuropathy (DPN), as it is common and the chance of developing this painful condition increases as disease duration increases. Half of people who have diabetes eventually develop DPN, and the warning signs are sensory symptoms that start in the distant periphery and progressing in a characteristic ‘glove and stocking’ way. In addition to causing unremitting pain, DPN is also associated with increased mortality. Patients often have difficulty sleeping, struggle to maintain a positive outlook, and are often unable to complete activities of daily living.

The journal Clinical Therapeutics has published a critical review on this topic that includes seminal and novel research in epidemiology, and offers insight into diagnosis of this common condition. Of great interest to pharmacists is their review of emerging pharmacotherapies.

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