Author: Peter

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The number of new coronavirus infections inside China - the source of the outbreak - was for the first time overtaken by fresh cases elsewhere...as U.S. markets turned negative on fears over the rapid global spread of the disease...Asia reported hundreds of new cases, Brazil confirmed Latin America’s first infection and the new disease - COVID-19 - also hit Pakistan, Greece and Algeria. Global food conglomerate Nestle suspended all business travel...U.S. health authorities, managing 59 cases so far - mostly Americans repatriated from a cruise ship in Japan - have said a global pandemic is likely…Stock markets across the world have lost $3.3 trillion of value in four days of trading, as measured by the MSCI all-country index...Wall Street reversed earlier gains on Wednesday afternoon on fears that the virus would spread across the United States, and oil prices dropped to their lowest level in over a year...READ MORE

On arrival for a pre-approval inspection for a Chinese heparin API maker, an FDA inspector was told that the plant had not started making products and was only doing equipment testing. The truth of the matter was hidden in a drum being snuck out the back. An intercepted container an employee was removing from the warehouse contained two batches of crude heparin manufactured two days earlier...That was just the beginning of the problems found during July 2019 inspection of Yibin Lihao Bio-technical, the API maker in Yibin Shi Sichuan, China. According to a warning letter, there were quality assurance records scattered in cabinets, on desks and on the floor of the QA office. Employees insisted they were for a grant application from the government and not manufactured products. Not true. The FDA would learn the records did correspond to manufactured heparin...READ MORE

In general, the number of licensed health care professionals is drastically lower in rural and frontier counties in Nevada than compared to the urban areas...With a shortage of health professionals across the state, it’s hard enough to find a doctor in Nevada. However, in many rural areas of the state it’s nearly impossible...Rural residents make up 10% of the state's population but live across 90% of the state's land mass. With smaller communities spread across large distances, getting access to proper healthcare can be difficult...The issues in getting healthcare in rural Nevada boil down to three things: workforce, money, and resources...READ MORE

Despite increased access to naloxone, many individuals in rural communities continue to face barriers to obtaining the medication…However, informed pharmacists can serve as an educational resource, even if their pharmacies do not have the medication in stock...Ongoing efforts to expand prescribing methods through the United States have helped to improve naloxone accessibility. In Georgia, specifically, a standing order decrees that any individual may obtain naloxone from a licensed pharmacy without a prescription. Despite the standing order, pharmacies have been slow to adopt stocking naloxone and dispensing the medication…READ MORE

Opioid makers and distributors who proposed paying almost $50 billion to resolve U.S. lawsuits over the addictive drugs are drawing more support from states, including California and New York, as pressure mounts for a deal before a trial starts next month...But nearly two dozen states and most of the cities and counties suing to hold the industry responsible for the havoc and high costs of the opioid epidemic say the terms still aren’t good enough...READ MORE

Two clinical trials testing potential treatments for the new coronavirus spreading from China are getting underway in Nebraska and Washington, marking a step forward in the U.S. efforts to find a therapy or vaccine for the pneumonia-like illness caused by the virus...The trial, which is designed to expand to include new centers and experimental drugs over time, will test first remdesivir, an antiviral originally developed by Gilead for use against the Ebola virus. Experts view the drug as among the more promising existing therapies for potential use against the new coronavirus, now called SARS-CoV-2...READ MORE

Although drug shortages due to the novel coronavirus disease outbreak haven’t occurred yet, the FDA and pharmacists are closely watching for potential shortages. Separately, pharmacists should urge Americans to get flu vaccinations and take a cautious approach with coronavirus…“While our primary concern is the health and safety of those affected by the virus, ASHP is concerned with the vulnerability of the pharmaceutical supply chain to threats like the coronavirus outbreak,” Michael Ganio, PharmD, BCPS, director of pharmacy practice and quality at ASHP...An estimated 80% of active pharmaceutical ingredient used in the US market comes from foreign sources. In addition, the FDA has recalled inspectors from China due to the outbreak, which could possibly lead to delays in manufacturing...READ MORE

Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses...Purdue is seeking authorization for a development agreement between its affiliate, Greenfield Bioventures, and an unnamed pharmaceutical company. The proposed agreement would allow Purdue to grant intellectual property related to the nalmefene injectable to its unnamed partner, which in turn, would license its autoinjector technology to Purdue...READ MORE

The federal government has released its long-awaited plan to reduce red tape and other administration snarls that create time-eating obstacles for doctors using health information technology...The Department of Health and Human Services' Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs, mandated by the 21st Century Cures Act, aims to reduce the effort and time required by clinicians to meet reporting requirements, record health information, and improve the functionality and intuitiveness of EHRs...READ MORE