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The pharmacy industry’s role in the 340B Drug Pricing Program continues to expand...latest analysis finds that nearly 18,000 pharmacy locations contract with 340B-eligible covered entities. That accounts for more than one in four U.S. retail, mail, and specialty pharmacy locations...Walgreens remains the biggest player, with about the same number of locations as those of Walmart, CVS, Rite Aid, Kroger, and Albertsons combined...Amidst the contract pharmacy boom...what’s really going on. How many prescriptions do contract pharmacies provide at discounted prices to uninsured, underinsured, and low-income patients? Who is really benefiting from the contract pharmacy business?…a 340B contract pharmacy doesn’t earn traditional spreads and dispensing fees. They instead profit from fees paid by the 340B entity. Given providers’ substantial profit opportunities, a 340B entity can afford fees that often far exceed a pharmacy’s typical profits from dispensing a third-party-paid prescription...There are many other profit opportunities...The extensive use of 340B contract pharmacies allows hospitals and other providers to benefit from 340B drug discounts earned from commercially paid prescriptions dispensed by contract pharmacies...Do needy patients benefit? No one knows. Covered entities are not specifically obligated to share any 340B savings with financially needy or uninsured patents, nor are they required to disclose how they use profits from the 340B program...

The next time that employees at Xiamen Origin Biotech want to lie to regulators about what they are doing, they may want to make sure that the doors to nearby rooms are closed...During an inspection last January of its facilities in the southeastern Chinese province of Fujian, an employee told a US Food and Drug Administration inspector that the company did not keep any drugs on location. But while they reviewed company operations in a conference room, the inspector happened to notice that an adjacent room was being used to warehouse relabeled medicines...The same Xiamen employee also thought nothing of telling the inspector that the company had stopped relabeling drugs in January 2015. But during the inspection, the FDA staffer reviewed a list of exported drugs that showed Xiamen had distributed them until January 2016...Pharmaceutical and ingredients manufacturers in China and India have come under intense scrutiny in recent years due to a series of disturbing events...the flow of FDA warning letters about companies based in these countries receives added attention, sometimes deservedly so. Xiamen, for instance, also lied to its customers, according to the FDA...The company falsified and omitted information on certificates of analysis...which are supposed to verify the veracity of its products...

Drug abuse, including misuse of prescription drugs, remains at alarmingly high levels...Feeding this epidemic, the National Association of Boards of Pharmacy says, are rogue Internet drug outlets illegally dispensing prescription controlled substances...illicit online drug sellers "hiding behind sleek websites" are making it easier for people struggling with drug abuse to purchase controlled-substance medications. However, since these rogue websites often sell counterfeit and tainted substances, buyers can raise the risk of overdose and death...researchers used popular search engines (Google, Bing and Yahoo), shopping websites (eBay, Craigslist, Yahoo! Shopping, Overstock.com, Etsy, Oodle, eCRATER, Bonanza, Sell.com, Blujay and Alibaba) and social media sites (YouTube and Twitter) to gauge the availability of the opioids Demerol, Dilaudid, Duragesic, Exalgo, Kadian, Lorcet, Lortab, Percocet, Roxicet, Vicodin and Zohydro. Opioids were easiest to find and readily available by using search engines, the researchers discovered. Still, no matter which online avenue was used, researchers found that the final destination was a dedicated website selling opioids illegally.

Five Southern Nevada hospitals were among six statewide that received only one star in a controversial five-star rating system unveiled...by the Centers for Medicare &Medicaid Services....Two Nevada hospitals got four stars: Mesa View Regional Hospital in Mesquite and Renown South Meadows Medical Center in Reno...The ratings, which use stars to denote the overall quality of hospitals, are meant to "help individuals, their family members and caregivers compare hospitals in an easily understandable way,"...The results, available on the Hospital Compare portion of the Medicare website, have been met by opposition by many hospitals locally and across the country who say the ratings use unreliable information and punish teaching facilities as well as hospitals that serve low-income patients...The five Southern Nevada hospitals receiving one-star ratings were: University Medical Center, St. Rose Dominican Hospitals-Siena Campus, Desert Springs Hospital Medical Center, Valley Hospital Medical Center, and Sunrise Hospital and Medical Center...UMC CEO Mason VanHouweling took issue with the rating system, saying the measure treats all facilities the same, despite differences in the patients they may see..."In other words, the rating system fails to account for unique, multifaceted or high-acuity patients that may come through a trauma, burn or transplant center," he said.

Most health policy experts knew, and many warned, that the Affordable Care Act would lead to massive consolidation in the health care industry, including hospitals, physicians’ practices, and especially health insurers. Now the Justice Department is pushing back by opposing the mergers of four large health insurers—Aetna with Humana and Anthem with Cigna —as they try to survive the Obamacare wasteland...The Obama administration defended its opposition by claiming the mergers would reduce competition. Attorney General Loretta Lynch explained, "If allowed to proceed, these mergers would fundamentally reshape the health insurance industry." That’s rich, since nothing has reshaped the health insurance industry more than Obamacare—and by design...Obama officials dismiss the health insurer losses, claiming that many of the insurers are still profitable. But that’s because health insurers often have several lines of business, some of which may be profitable even as they lose hundreds of millions of dollars selling in Obamacare exchanges. No responsible board of directors will let such losses continue indefinitely...Policyholders will likely be receiving the notice that their premiums are rising or policy is being canceled in September or October—just before the election...

Drug, biologic and biosimilar companies’ comments on Food and Drug Administration draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label...FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product…

• Amgen says it...believes a biosimilar label should include a summary of the clinical data, including immunogenicity data, used to demonstrate biosimilarity or interchangeability…
• Pfizer said...biosimilars should not be labeled "as though they were small molecule generic drugs" and that it "recommends that biosimilar labeling include a statement reflecting whether interchangeability has been assessed."
• Merck & Co...says "that a single blanket approach applicable to all biosimilar products is not appropriate, and may cause unnecessary confusion among stakeholders."...recommends that rather than using such blanket statements, FDA take a risk-based approach for each biosimilar…
• Boehringer Ingelheim says that it "does not agree that a biosimilar label needs to include a ‘biosimilarity statement,’...Such information is not ‘essential scientific information needed by health care practitioners for the safe and effective use of a drug.’
• Sandoz...says... "It is self-evident that the very act of highlighting the indications that are extrapolated is being proposed by some groups in order to raise doubts as to the safety and efficacy of the biosimilar for those indications, and perhaps to also imply inferiority of biosimilars across the board.

Medicare Advantage and other supplemental Part D plans encourage medication adherence to achieve higher star ratings... This rating system measures insurance plan quality, as higher quality plans improve patient outcomes and minimize costs. Adherence represents 10.9% and 29.5% of Medicare Advantage and supplementary plans’ star ratings, respectively...Community pharmacies...have initiated automatic refill programs to improve adherence. These programs have the added benefit of boosting insurance plans’ star ratings...(CMS) confidently assumes that patients of brick-and-mortar pharmacies use their refills if they pick up the prescriptions...researchers reported that an automated prescription refill program improved medication adherence of Medicare Part D patients...Easing barriers to refilling prescriptions enhances adherence, and reinforced adherence enhances pharmacy sales directly and indirectly. Insurance companies prefer pharmacies that strengthen their star ratings; they’re less likely to engage with pharmacies with mediocre adherent patient populations from coverage, and they provide bonuses to pharmacies for high adherence...Future studies assessing the impact of automatic refill programs should develop a superior method of measuring actual medication intake.

A coalition of pharmacy industry organizations has asked congressional leaders to weigh proposals that would free certain biologic drugs from adherence to U.S. Pharmacopeia standards...the American Pharmacists Association and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing concern about proposals by the Food and Drug Administration and a provision in Section 11 of the FDA and NIH Workforce Authorities Modernization Act that would exempt certain biologics — including biosimilars — from USP public standards for quality, including the naming of biologic and biosimilar medicines...USP’s work provides a uniform quality standard, clarity for health care practitioners and confidence for patients...Pharmacists rely on USP quality standards. Removing requirements to adhere to these standards will raise additional questions and concerns about the safety of these emerging products...Our organizations share a commitment to patient safety and, as such, we believe that biologics and biosimilars should be required to have the same nonproprietary names based on existing standards and mechanisms...the pharmacy industry groups said in the letter. "Given the broad and negative implications of such potential naming proposals, as well as their controversial nature, we are requesting that FDA not finalize current guidance and proposals and that legislation not include these provisions."

On February 1, 2016, the Centers for Medicare & Medicaid Services released its Final Rule interpreting the provisions of the 2010 health care reform law that address the Medicaid Drug Rebate Program. While much of the Final Rule speaks to drug manufacturer rights and responsibilities in the MDRP, significant portions are directly applicable to chain drug stores...the Final Rule addresses (a) reimbursement for multisource drugs dispensed to Medicaid patients, (b) changes in the Average Manufacturer Price (AMP) that will impact pharmacy reimbursement for multisource products, (c) reimbursement for single-source drugs dispensed to Medicaid patients and (d) changes to the dispensing fees pharmacies will receive for dispensing drugs to Medicaid patients...An overarching theme expressed in the Final Rule is CMS’ desire to move states away from their historic practice of overpaying for ingredient cost while simultaneously underpaying for dispensing fees...If the Final Rule plays out as anticipated, in the coming year ingredient cost reimbursement will fall for single- and multiple-source products, but dispensing fees will rise...This reflects a desired shift away from a "spread-based" model of pharmacy Medicaid participation toward a "service-based" model. It’s currently unclear if the increased fee income to pharmacies will balance the lost reimbursement revenue.

• Multisource product ingredient cost reimbursement
• Changes in AMP affecting multisource drug reimbursement
• Single-source product ingredient cost reimbursement
• Medicaid pharmacy dispensing fees

• Must I Get an ID on My Patient? - ChaoFen (Stacy) Tan, PharmD Candidate
• Prescription Over-the-Counter Products
• FDA Calls for Review of Opioids Policy, Announces Action Plan
• More Selected Medication Safety Risks to Manage in 2016 - ISMP
• Manufacturer Drug Labeling, Packaging, Nomenclature - Per Liter Electrolyte Content on Various Sizes of Manufacturers' IV Bags
• Patient Education - Discharging Patients Who Do Not Understand Their Discharge Medications
• Compliance News
• USP Publishes Chapter on Handling Hazardous Drugs in Health Care Setting
• FDA Provides Training Video on Keeping Medications Safe in Emergency Situations
• FDA Requires Class-Wide Labeling Changes for IR Opioid Analgesics
• FDA Issues Alert Regarding All Unexpired Sterile Drug Products Produced by Medaus Pharmacy
• E-Prescribing - Who Can Send Electronic Prescriptions? - Melissa Hampton, PharmD Candidate