- Local Residents Indicted in Multi-Million Dollar Ketamine Conspiracy (dea.gov)
Four people (Dr. Michael Kelly, Priscilla Orosco, Joyce James, Tamara Mitchell) have been charged in a $17 million health insurance fraud scheme involving the sale of ketamine to patients without a valid prescription…The four-count indictment alleges Mitchell was an owner of two pharmacies, Diamond and Save Rite, that sold controlled substances as part of a marketing scheme, rather than for legitimate medical need. Diamond Pharmacy and Save Rite almost exclusively sold compounded creams containing prescription drugs and ketamine to the public by using pre-signed prescriptions to fill orders for customers, who had the “right” insurance plans, according to the charges…Mitchell allegedly hired pharmacy technician Orosco and pharmacist James to conduct the day-to-day operations of the business…Diamond Pharmacy paid (Dr.) Kelly thousands of dollars per month to provide pre-signed prescriptions without examining patients. Diamond and Save Rite (pharmacies) then allegedly billed insurance companies for compounded creams containing controlled substances…the four…face up to 20 years in federal prison and a possible $250,000 maximum fine. They also face another 10 years for both the conspiracy to distribute and for aiding the distribution of Ketamine as well as a possible $500,000 fine.
- China toughens drug quality standards, rejects 13 applications (reuters.com)
China's food and drug regulator said late on Monday it had rejected applications for 13 new drugs, citing false or incomplete trial data, as the government toughens enforcement of quality standards…China Food and Drug Administration last month also rejected applications by eight Chinese companies for inadequate trial data related to generic drugs for heart problems, schizophrenia, pain, infections and other diseases…quality of locally made drugs is a priority for the government, which is pushing an ambitious program of healthcare reforms to reduce reliance on both generic and more innovative imported drugs.
- ASHP to Launch Comprehensive Digital Drug Information Resource (ashp.org)
ASHP today announced that it will release a comprehensive suite of its…drug information databases, including AHFS Drug Information®, in early 2016. Recruitment for beta testers will begin during ASHP’s 50th Midyear Clinical Meeting this week in New Orleans…The new product, AHFS® Clinical Drug Information, will provide clinicians with easy access to detailed drug information, including real-time drug and safety updates, direct links to more than 60,000 supporting evidence sources, and in-depth coverage of off-label uses… AHFS Clinical Drug Information will be available via Web browser as well as iOS and Android apps. Individual pricing will begin at $10 per month. The user interface will also integrate into clinical workflow solutions in hospitals and ambulatory care settings.
- Pfizer-Allergan Merger Raises Concerns That Fraud Is Part Of ‘Corporate DNA’ (forbes.com)
The massive Pfizer-Allergan merger is getting a lot of attention. It is one of the largest takeovers ever in the healthcare industry, worth an estimated $160 billion…But consider another number: The amount Pfizer, Allergan and their predecessor companies have paid to settle government healthcare fraud allegations in the US – a total of nearly $4.5 billion. That total doesn’t include close to $1 billion paid to settle related consumer actions…Add to that the six criminal pleas and four corporate integrity agreements that the companies and their predecessor subsidiaries have agreed to, and one might question whether cheating and corruption are part of their “corporate DNA.”… The duo’s “hall of shame” is staggering and impossible to overlook. Here are some of the settlements the two corporations and/or their predecessor companies have paid the US and states:
- Pfizer/Parke Davis/Warner Lambert — $430 million settlement and a criminal plea. (2004)
- Pfizer/Pharmacia & Upjohn Co. — $2.3 billion and a criminal plea. (2009)
- Allergan — $600 million and a criminal plea. (2010)
- (Allergan/Actavis) Forest Labs — $313 million and a criminal plea. (2010)
- Pfizer — $14.5 million. (2011)
- (Allergan/Actavis) Watson Pharmaceuticals — $1.7 million. (2012)
- Pfizer/Wyeth Pharmaceuticals — $491 million and a criminal plea. (2013)
- Allergan/Actavis/Watson Pharmaceuticals — $12.4 million. (2013)
- Pfizer/Wyeth — $35 million. (2014)
- Allergan/Warner Chilcott — $125 million and a criminal plea. (2015)
- 9 organizations urge Congress to oppose delay of Stage 3 (healthcareitnews.com)
Health IT Now, along with eight other organizations…are calling on Congress to stay the course on Stage 3 of the Meaningful Use EHR Incentive Program…Health IT Now describes itself as a broad-based coalition of patient groups, provider organizations, employers and payers…The coalition, along with eight other organizations made their pleas in a…letter…"We write to urge you to oppose any legislative changes to the meaningful use program, including delays in the timing of Stage 3, that do not also include reforms to improve the interoperable use of health information technology,"…"Delay without reform would rob taxpayers and patients of cost savings while doing absolutely nothing to make the program work well for overburdened doctors and hospitals."…The American Medical Association and 111 other national and state medical societies called for delay of Stage 3 in an earlier letter to leadership...
- British review calls for urgent cuts to antibiotic use in livestock (reuters.com)
Massive use of antibiotics in farming poses a critical threat to global public health and should be reduced dramatically to an internationally-agreed target…implementing a global target for agricultural antibiotic use won't be easy…but is vital if life-saving medicines designed to fight bacterial infections are to be kept effective, both for animals and for people…in many countries most of the use of antibiotics is in animals, rather than in humans…This creates a big resistance risk for everyone…Any use of antibiotics promotes the development and spread of so-called superbugs - multi-drug-resistant infections that can evade the medicines designed to kill them…estimated antibiotic and microbial resistance could kill an extra 10 million people a year and cost up to $100 trillion by 2050 if it is not brought under control..."We need international governments, policy makers and the agricultural industry to coordinate their actions and set tangible targets for the reduction and better use of antibiotics in animals."
- Affordable Care and Specialty Pharmacy (specialtypharmacytimes.com)
David Lassen, chief clinical officer at Prime Therapeutics, discusses implications for specialty pharmacy from health care reform.
- Strength in Numbers Cardiologists recognize the value of pharmacists on the healthcare team as they push for provider status. (aacp.org)The Role of the Clinical Pharmacist in the Care of Patients With Cardiovascular Disease Abstract (sub req) (sciencedirect.com)
The American College of Cardiology has recognized pharmacists as advanced practice providers, valuable to cardiovascular team-based care…sees this as an inspiring time, encouraging other historically physician-driven, non-pharmacist organizations to support pharmacists, as they push for healthcare provider status…“ACC recognizes that there’s a shortage of cardiologists,”…The ACC recognizes that there’s a lot of work to go around but not enough cardiologists to do it. They see the benefit of advanced practice providers, which includes pharmacists, nurse practitioners and physician assistants, and they believe that’s the way to make it happen…to offer care where care isn’t being given.”… With the ACC’s backing, there’s hope that other non-pharmacist organizations will support pharmacists...
- Tonix Pharma, U.S. Defense Department partner on PTSD drug (reuters.com)
Tonix Pharmaceuticals Holding Corp said it was teaming up with the U.S. Department of Defense to further develop its experimental PTSD drug, which if approved, could be the first treatment for the psychiatric disorder in more than 15 years…The Cooperative Research and Development Agreement with the Department of Defense will allow Tonix to gain access to and study military personnel who are on active duty…"Since we are specifically seeking a label for military-related PTSD for our drug, it's important to study these patients as the active duty personnel are closer to traumatic events, as opposed to veterans,"… Tonix's TNX-102 is currently being tested in mid-stage studies and has a long path to approval…Some analysts have called the drug a "dark horse" opportunity, which could be transformative for the company…The only two drugs currently approved for PTSD - Zoloft and Paxil - come with substantial side effects. Tonix's drug is intended to improve sleep quality in these patients, which is considered to be a crucial characteristic of the disease.
- Pharmacy Students Educate Community on OTC, Natural Products (pharmacytimes.com)
Pharmacy students from the Bill Gatton College of Pharmacy at East Tennessee State University recently held a free educational presentation on OTC and natural products…covered more than 2 dozen topics and offered community members a chance to ask questions…“The main inspiration for this event is the community in which ETSU Bill Gatton College of Pharmacy is located. We are within the heart of Appalachia where there is very prominent use of alternative medicine, such as supplements, herbal products, and natural products,”…“This is heavily engrained within our culture, and the goal of this presentation is to better inform our community.”…the students’ presentation would help the community understand that there are some potential risks associated with alternative medicine…“We hope to make them more informed and more capable of using these therapies in a safe manner,”…