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Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Senate Health Committee Chairman Lamar Alexander...is offering drafts of two pieces of legislation aimed at addressing the opioid crisis...One measure would attempt to limit overprescribing by allowing the Food and Drug Administration to require drug manufacturers to package certain opioids in blister packs, which would allow for a set dose, such as a seven-day supply...Rather than restrict the number of days on opioid prescriptions, James Madara, CEO of the American Medical Association, wrote a letter...suggesting further research "that specifically identifies best practices in settings ranging from surgical to the emergency department."...Alexander's other proposal involves improved coordination between the FDA and Customs Border Protection. The bill would look to improve the ability to find and seize illegal drugs, such as fentanyl, at the border. It would seek to ensure the two agencies have the technology, facilities and staffing needed...

The FDA released a draft version of guidance covering compounding, called "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry," directed primarily at outsourcing facilities, addressing the use and qualification of bulk substances in compounding...The proposed rules are an extension of The Drug Quality and Security Act...which identified outsourcing facilities as its own category, separate from traditional compounders...Active pharmaceutical ingredients must be accompanied by a monograph from an appropriate governing party (if a monograph exists), must be made in a facility that has prior approval, and must come with a certificate of analysis (to prove they been characterized)...The agency proposes two specific ways to tell if a compounded drug at an outsourcing facility is safe: whether attributes of the approved drug may make it unsuitable to treat certain patients for particular conditions (including whether the compounded drug is intended to address that attribute), and second, if certain factors for each substance being proposed for use in a compounded drug product – specifically, "its physical and chemical characterization, possible or known safety issues, evidence or lack of thereof of effectiveness, and historical use" — would preclude its use by a third-party facility...The agency says the plan will "clarify and appropriately tailor the policies for traditional compounding pharmacies and the outsourcing facilities that may supply a broader market."...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

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National Pharmacy Compliance News

• FDA Requires Labeling Update on Opioid-Containing Cough and Cold Medicines
• Latest NDTA Shows Opioids Pose Significant Impact to Public Health
• FDA Recognizes Eight European Drug Regulatory Authorities Capable of Conducting Inspections
• Incorrect Use of Insulin Pens at Home Can Cause Severe Hyperglycemia
• FDA Advises on Opioid Addiction Medications and Benzodiazepines
• Only About 3% of Pharmacies and Other Entities Voluntarily Maintain a Prescription Drug Disposal Bin, GAO Reports
• One in Five Drivers Uses a Prescription Drug That Can Impair Driving Despite Receiving Warnings
• PTCB CPhT Program Earns Accreditation From the American National Standards Institute

The Food and Drug Administration is planning to survey 2,000 healthcare professionals to better understand how prescription drug promotion affects the decisions they make...Promotional activities include meetings with pharmaceutical sales representatives, presentations given at industry-sponsored events, and journal or direct mail advertisements. In 2012, drugmakers spent north of $24 billion marketing their products to physicians, according to data cited by the FDA..."Although HCPs (healthcare professionals) are learned intermediaries, like most people, they may rely on heuristics in making decisions and may have cognitive biases in the type of information they attend to at any given time. They may be persuaded by strong statements and may not have the time to ascertain accuracy of such information," the FDA wrote in a notice posted on the Federal Register on March 15..."There is little qualitative research on people’s attitudes to promotion, and this is a major gap," the organization said. "In order to understand people’s perspectives and values more clearly, in‐depth interviews are needed...

Israel will invest nearly 1 billion shekels ($287 million) in a project to make data about the state of health of its population available to researchers and private companies, Prime Minister Benjamin Netanyahu said...Almost all of Israel’s nine million citizens belong to four health maintenance organizations who keep members’ records digitally, thus comprising a huge medical database...This is a major asset and we want to make it accessible to researchers and developers in order to achieve two things: one is preventive medicine, and the second is personal medicine tailored to each individual...Nadav Davidovitch, head of the Public Health School at Ben Gurion University in southern Israel, said the country’s push to harness big data for healthcare had huge potential, but also held risks in terms of privacy and medical confidentiality...private companies would profit by using a publicly-funded database while continuing to make some medication unaffordable to many patients...mechanisms would be put in place to keep information anonymous while protecting privacy, information security and restricting access as part of the government project...Patients will be able to refuse the use of their information for research...

It says that the Regional Emergency Medical Services Authority (REMSA) and Renown Health have both entered into agreements with the Northern Nye County Hospital District for a phased expansion of services over the next year...“The Northern Nye County Hospital District is proud to collaborate with REMSA and Renown to expand on the much-needed services for the thousands of residents in central Nevada,” said Justin Zimmerman, a Northern Nye County Hospital District Board Trustee. “Together, we are innovating rural healthcare delivery, creating new ways for residents to access medical care while preserving their local, independent way of life.”...Future phases of the REMSA expansion will include locally-based, 24/7 Community Paramedics, as well as community wellness and public education initiatives...Renown, in partnership with the Northern Nye County Hospital District, will be expanding on the care already being provided to residents since it opened the medical group in June 2016 at the former Nye Regional Medical Center, 825 S. Main Street...

Governor Brian Sandoval announced...that the second meeting of his Opioid State Action Accountability Task Force will take place April 18th in Carson City...The 1 p.m. meeting will be held in the Old Assembly Chambers at the state Capitol Building...the Task Force will hear a status report of crosscutting initiatives and status reports on track one – prescriber education and guidelines; track two – treatment options and third-party payers; track three – data collection and intelligence sharing; and track four – criminal justice investigations...“This Task Force has the specific task of reviewing the policies and programs that have been put into place to address the opioid epidemic in our state,” Sandoval added. “I am looking forward to hearing reports on the progress being made to combat this epidemic.”...

The case of Insys Therapeutics has played out for several years as suspicions first cropped up in 2014 that the company aggressively marketed its powerful opioid painkiller Subsys, often for off-label uses. Now, the feds have charged five...physicians for taking bribes from the drugmaker in exchange for writing more scripts...In addition to the new complaint, authorities announced that two former Insys employees have taken guilty pleas and are cooperating with the government...doctors Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea face up to 20 years in prison for their alleged participation in the scheme...Allegations against Insys and its former management have been piling up in recent years, and in October, authorities made their way to the company's billionaire founder John Kapoor, charging him with racketeering and other felonies... Prosecutors say the company set up a "speakers bureau" to recruit doctors to write more Subsys scripts, holding "sham" speaking events... the company used the events to funnel money to doctors in exchange for more Subsys scripts, even though many of the prescriptions were outside of the drug's FDA label...