CDC picks APhA Foundation to put diabetes prevention program in pharmacies – APhA submits compounding comments to FDA.

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CDC picks APhA Foundation to put diabetes prevention program in pharmacies – APhA submits compounding comments to FDA. – (866) 348-2889

CDC has selected the APhA Foundation, in partnership with the Kroger Co. and Solera Health, to build infrastructure within community pharmacies to expand access to an innovative evidence-based lifestyle change program designed to prevent or delay the onset of type 2 diabetes among adults with prediabetes.

Called Project IMPACT: Diabetes Prevention, the program will deliver the CDC-recognized National Diabetes Prevention Program (National DPP) curriculum to at least 7,500 at-risk adults in underserved communities in the United States over the next 5 years.

Pharmacists, dietitians, and technicians at Kroger pharmacy locations will be trained to deliver the National DPP curriculum, and Solera Health—a preventive care benefits manager—will support community outreach efforts with its technology platform. The program’s hybrid model of care will combine face-to-face, telehealth, and digital technology solutions so that providers can tailor the program to the participants and help them successfully complete the program.

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Upcoming FDA Webinar to Discuss Biosimilars – Drug for nerve pain boosts high for opioid abusers.

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Upcoming FDA Webinar to Discuss Biosimilars – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) 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, “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the US,” will be held December 5, 2017, at 1 PM (EST). This webinar will provide an overview of the regulatory framework for biosimilar products, including information on terminology and the general requirements of the approval pathway for biosimilars. To register for this event, visit the FDA website. Previous webinars are available on the FDA website at www. fda. gov/ DDIWebinars.

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Energy and Commerce Committee Investigates Imported or Domestic Pill Press Machines, Requests Details From DEA – APhA submits compounding comments to FDA.

7Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

Energy and Commerce Committee Investigates Imported or Domestic Pill Press Machines, Requests Details From DEA – APhA submits compounding comments to FDA. – (866) 348-2889

The House of Representatives Committee on Energy and Commerce is investigating the problem of imported or domestic illicit pill presses that can produce thousands of pills an hour. In a recent letter to DEA Acting Administrator, the Committee asks for more detailed information about pill press machine commerce and seizure data. During an October 2017 full Committee hearing, questions were raised whether DEA needed additional authorities to help the agency improve its enforcement actions against pill presses.

At a March 2017 hearing before the Subcommittee on Oversight and Investigations, DEA stated that traffickers of fentanyl and fentanyl analogues ship industrial pill presses directly into the US from China and operate fentanyl pill press mills domestically. Although DEA must be notified of the importation of a pill press under US law, foreign pill press vendors often mislabel the equipment or send it disassembled to avoid law enforcement detection. Additionally, industrial pill press machines are widely available on the internet.

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DEA mandates reduction in opioid manufacturing for 2018 – Drug for nerve pain boosts high for opioid abusers.

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DEA mandates reduction in opioid manufacturing for 2018 – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

DEA’s finalized annual aggregate production quotas (APQs) for 2018 mandate a 20% reduction in the amount of opiate and opioid medication—including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl—that may be manufactured in 2018. Quotas are aimed at preventing a diversion while simultaneously satisfying annual needs.

APQs establish the total amount of opioids and other controlled substances necessary to meet the estimated medical, scientific, research, industrial, and export needs for 2018 and to maintain adequate reserve stocks. DEA says 2018’s cuts are a response to reduced demand.

Quotas may be appealed at any time during the year on the basis of increased sales or exports, new manufacturers entering the market, new product development, or product recalls.

Critics of DEA’s decision have expressed concerns that the reduced quota could lead to drug shortages and negatively affect pain management patients’ access to treatment.

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Hospitals can improve high-alert med safety procedures with self-assessment – APhA submits compounding comments to FDA.

14676_graphic_standard_062716Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

Hospitals can improve high-alert med safety procedures with self-assessment – APhA submits compounding comments to FDA. – (866) 348-2889

Hospitals in the United States are required to identify and maintain active lists of high-alert medications, which isn’t hard to do. But when it comes to the next step of developing safety procedures for high-alert medications, the task can become more challenging.

For example, double-checks are usually a standard intervention for high-alert medications, according to Dan Degnan, PharmD, CPPS, FASHP, senior project manager at the Center for Medication Safety Advancement at Purdue University College of Pharmacy in West Lafayette, IN. But too often, not enough attention is given to the quality, documentation, and structure associated with double-checks of high-alert medications.

The Institute for Safe Medication Practices (ISMP) knows about these concerns and others and released a new tool to help hospitals, long-term care facilities, and certain outpatient facilities evaluate best practices related to high-alert medications, as well as identify opportunities for improvement and track experiences over time. After completing the assessment, participants are encouraged to submit their findings to ISMP anonymously via a secure internet portal and in turn see how they compare to demographically similar organizations through a weighted score—in essence giving hospitals a means for improvement.

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As health care changes, insurers, hospitals and pharmacies team up – Drug for nerve pain boosts high for opioid abusers.

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As health care changes, insurers, hospitals and pharmacies team up – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Now that federal officials have quashed the mega-mergers proposed by the biggest insurers and blocked a deal between two large community pharmacy chains, established players in the health care industry are venturing beyond their traditional lines of business. Companies are actively looking for partners that will provide an entree into new businesses or a new supply of customers. CVS Health, which started as a community pharmacy chain, operates a large PBM as well as walk-in clinics in its stores. By combining with Aetna, which covers about 22 million people, CVS would be able to direct members to its own mail-order and pharmacy business and to its walk-in clinics, located in its stores, for much of their care. By sharing in the profits or losses of these ventures, the parties say they work more closely to make sure a patient gets the right medicine or has access to a doctor at a nearby clinic instead of resorting to an emergency room. However, employers that purchase coverage on behalf of their workers may have difficulty determining how much they are paying for a given medicine or a particular service, says Edward Kaplan, a senior vice president at Segal Consulting. There is already a lack of transparency when it comes to drug prices, and employers may have even less information if the insurer and the PBM are the same entity.

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PTCB Completes Beta Exam for the Sterile Compounding Certification Program – APhA submits compounding comments to FDA.

16511-pharmacy-board-standard-041216Alabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

PTCB Completes Beta Exam for the Sterile Compounding Certification Program – APhA submits compounding comments to FDA. – (866) 348-2889

The Pharmacy Technician Certification Board (PTCB) has successfully completed the PTCB Certified Compounded Sterile Preparation Technician (CSPT) Program beta exam. The beta exam is a critical step in developing an exam for CSPT candidates that is psychometrically sound and meets industry standards for validity. The PTCB CSPT Exam Development Committee, which is comprised of pharmacists and PTCB-Certified Pharmacy Technicians (CPhTs), was responsible for the development of two 90-question forms for the CSPT beta exam. Internal and external consultants conducted a three-part analysis of the CSPT beta exam, which included item analysis, end of exam survey analysis, and time analysis.

“PTCB’s standards are rigorous, and we are confident that those PTCB CPhTs who earn the CSPT™ will stand out as highly qualified to meet today’s expectations in sterile compounding safety,” said PTCB Executive Director and Chief Executive Officer Everett B. McAllister, RPh, MPA, in a news release. The CSPT certification program will launch in December 2017.

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FDA Issues Public Health Advisory Related to Risks Associated With Kratom – Drug for nerve pain boosts high for opioid abusers.

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FDA Issues Public Health Advisory Related to Risks Associated With Kratom – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Food and Drug Administration (FDA) issued a public health advisory related to increasing concerns about the risks associated with the use of kratom, a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. The agency is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence. FDA warns consumers to not use any products labeled as containing kratom or its psychoactive compounds, such as mitragynine and 7-hydroxymitragynine. Although there are no FDA-approved uses for kratom, the agency knows people are using kratom to treat conditions like pain, anxiety, and depression, and that this substance is being actively marketed and distributed for these purposes, indicates FDA Commissioner Scott Gottlieb, MD, in a statement.

FDA has taken action against kratom-containing dietary supplements. The agency identified kratom products on two import alerts, and is working to prevent shipments of kratom from entering the US. Additionally, FDA has detained hundreds of shipments of kratom at international mail facilities. The agency also used its authority to conduct seizures and to oversee the voluntary destruction of kratom products.

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FDA approves first two-drug regimen for certain patients with HIV – APhA submits compounding comments to FDA.

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FDA approves first two-drug regimen for certain patients with HIV – APhA submits compounding comments to FDA. – (866) 348-2889

FDA on Tuesday approved dolutegravir + rilpivirine (Juluca—ViiV Healthcare), the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. The regimen is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of the regimen. “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, MD, director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research. The regiment’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Results showed the regimen was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs. The most common adverse events in patients taking the regimen were diarrhea and headache. Serious adverse events include skin rash and allergic reactions, liver problems, and depression or mood changes.

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Use of health care databases to support supplemental indications of approved medications – Drug for nerve pain boosts high for opioid abusers.

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Use of health care databases to support supplemental indications of approved medications – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Researchers at Brigham and Women’s Hospital and Harvard Medical School have found that, under certain circumstances, database studies may help justify requests to use an FDA-approved drug for a new purpose. These real-world analyses offer evidence of medication use and outcomes in patients receiving routine care, which can validate findings in clinical trial populations. To support this argument, the investigators performed a cohort study to determine if information derived from a national health care database would uphold the results of a randomized study that prompted a supplemental indication for telmisartan. Using claims data and propensity score matching, they compared cardiovascular outcomes in 4,665 patients who initiated telmisartan use and 4,655 patients who began taking ramipril. The results of the database analysis dovetailed with findings from the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET), which documented a like composite risk of stroke, myocardial infarction, stroke, and hospitalization for congestive heart failure with both medications. Moreover, the study tied telmisartan to a significantly lower risk of angiodema compared with ramipril.

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