Author: Peter

…the 2012 fungal meningitis outbreak connected to the New England Compounding Center…brought to light that standards for safe compounding do exist, but their enforcement may be inconsistent. So…<797> was revised having patient safety in mind, by making the standards for compounding sterile preparations as clear as possible to practitioners… Expert Panel was charged with taking a fresh look at the chapter from beginning to end and making recommendations for improved clarity and responding to stakeholder input…They have…helped tailor its language to make it clearer to users and regulators… As a user of <797>, I encourage you to get involved in USP’s the standard-setting process and comment on the revised chapter, which was pre-posted for public comment on September 25, 2015.

University of Mississippi pharmacy students recently spent a week in Honduras to provide medical services for those who could not afford health care…pharmacy students Mary Claire Jarrell, Tate Davis, and Christine Hayden assisted with drug selection, dosage, and patient counseling at several medical clinics…It was very rewarding to see the students take ownership of the process [of running a pharmacy] and watch them passionately care for the patients and their families…

MannKind…has laid off workers as part of a reorganization effort amid slower-than-expected revenue from the company’s main product (Afrezza, insulin inhalation) …job cuts this year - as part of an ongoing effort of "right-sizing the company to reflect anticipated demand and operational needs."… aimed at providing a more efficient operating structure…

Millennium Health LLC is struggling to wrangle enough support for a debt restructuring plan that would allow it to settle a federal billing probe by a deadline this week,… Millennium is negotiating the terms for a bankruptcy filing at the same time that it’s finalizing a $275 million settlement of a federal investigation into its billing practices,..The Department of Justice has said it must have a plan to pay the sum by the end of this week…

Vetter will invest approximately 300 million Euros ($335 million) to expand and upgrade its manufacturing facilities...The upgrades are being driven by a changing healthcare market that is affected by issues such as increasingly complex molecules, smaller batch sizes, and more stringent regulatory requirements. Expansion of three sites in Germany will add capacity for logistic services and drug-product manufacturing using an improved system for aseptic processing.

Pharmaceutical companies that make minor tweaks to brand-name drugs in order to blunt competition from cheaper generic treatments may be violating antitrust laws, the Federal Trade Commission said…known as "product-hopping," harms consumers who save billions of dollars each year through generic competition and undermines laws that allow pharmacists to automatically substitute brand-name drugs with low-cost copycats, …"Such conduct could deprive generic companies of their most efficient means of distribution -- automatic substitution at the pharmacy -- and, as a result, maintain the brand’s monopoly through illegal means,"

Celebrate and Spread the Word....The goal of American Pharmacists Month is to promote your profession and get the attention you deserve among your peers, patients and community. We’ve filled this site with ideas for activities and events that spotlight pharmacists’ contributions toward improving medication use and advancing patient care in all practice settings. Use these ideas throughout October—and all year long—to inspire your celebrations! Remember to email any coverage, clips and event photos to aphm@aphanet.org.

• Get the Message to the People
• Ways to Celebrate In Your Practice
• Roles for Student Pharmacists and APhA-ASP Chapters
• Role for Pharmacy Technicians
• APhA Foundation’s Pharmacists Care Campaign

FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan). Naloxone has been the standard of emergency treatment for opioid overdose …only injectable formulations of naloxone are currently approved for use…FDA has granted priority review to Adapt Pharma’s naloxone...nasal spray, which was previously given a fast track designation…

Firms raise prices frequently as they try to make as much money as possible before patents expire, recoup their investments, and make up for the high failure rate of pharmaceutical research…data from Wolters Kluwer’s PriceRx...shows why the implied threat of price controls has pharma investors running so scared. The average price increase for products made by specialty pharmaceutical companies, which concentrate on pricier drugs, was 16% in 2012, 29% in 2013, 22% in 2014, and 19% so far in 2015…Valeant is the biggest standout. …has pursued a strategy of buying out other companies and drugs, slashing R&D budgets, and dramatically increasing prices. Its average price increase so far this year is 66%.

David Lassen, chief clinical officer at Prime Therapeutics, discusses the potential long term impact from biosimilars on the specialty drug landscape.