Author: Peter

Blood-testing start-up Theranos took a number of management missteps that led to its most recent tangle with health regulators...For several months, federal health regulators have raised concerns about the accuracy of the company's blood-testing technology...the Centers for Medicare and Medicaid Services threatened to impose stiff sanctions on the company — including a ban that could prohibit Theranos CEO Elizabeth Holmes from owning or running a lab for at least two years...Theranos has never been forthcoming about its test results...If Theranos is ultimately sanctioned, however, it could spell out the company's demise...

Current political debates...have highlighted specialty pharmacy in a less than favorable manner. When stories in national publications focus on the "Pharma Bro" and question relationships between pharmaceutical manufacturers and specialty pharmacies, we are bound to receive negative attention...The challenges we are currently facing could have dire consequences, and it is because of these challenges that we must participate in advocating for our industry. As a profession, we need to invest our time to gather together, speak up, and interact with our government officials at all levels...As a voice for our industry, we are a voice for our patients. We have the ability and responsibility to speak up, not only for ourselves, but also for the individuals who trust us with their care...Access and affordability of specialty medications are critical. Our patients have unique needs, as well as safety and care issues, and we must be a voice for them on the legislative and regulatory side...The key to winning the hearts and minds of legislators is approaching legislative issues the same way you approach your work every day: patients first. Demonstrate that your primary goal is having a positive impact on your patients’ well-being rather than your own bottom line...For more information on this topic, I encourage you to attend the panel, "The Practice of Specialty Pharmacy and Our Government Representatives" at the upcoming Armada Specialty Pharmacy Summit, on May 3, 2016. Armada, the largest US conference for specialty pharmacy, is an opportunity to learn about relevant industry topics, network with peers, and gain real insight into key issues...

MURs are carried out by pharmacists, who offer patients health, diet and medicines management advice....The NHS pays £28 ($39) for each MUR (medication utilization review) carried out; MURs are capped at 400 per pharmacy to prevent abuse...Boots stores have been found to be using that number as a target to aim for, rather than a maximum...pharmacists...reported being pressured into conducting MURs whether patients needed them or not...With...big companies answering to shareholders before patients, there really is the risk of profits being the highest priority before patient care...It’s always a risk when we have a shareholder interest being first and foremost...restrictions in Australia to limit pharmacy ownership to pharmacists, they’re accountable to the public as they’re registered health professionals under a national scheme...Australian guidelines could offer protection to any pharmacists subject to similar pressure to provide services...We (pharmacists) have a responsibility, with taxpayer funds, that they’re used appropriately in targeting the right patients to get the best outcomes...Directing pharmacists to undertake, or be expected to deliver a certain number of reviews, irrespective of the suitability or eligibility of that patient, could possibly be considered incitement or directing unprofessional conduct under the national law...Boots makes it clear to staff that services should not be carried out ‘inappropriately’...All of its staff are ‘empowered’ to use their professional judgement to assess the appropriateness of offering services...

A lawmaker wants to allow California addicts to use heroin, crack and other drugs at supervised facilities to cut down on overdoses, joining several U.S. cities considering establishing the nation's first legal drug-injection sites...The proposal...comes as San Francisco, Seattle, New York City and Ithaca, New York, weigh ordinances to set up the facilities, citing the success of a site operating in Canada since 2003...law enforcement has opposed the move in California, saying it will worsen addiction. And lawmakers seemed reluctant to support it, postponing a committee vote...The bill from Democratic Assemblywoman Susan Talamantes Eggman would make it legal for local and state health departments to allow the use of controlled substances in clinics that would offer medical intervention...Supporters say the facilities would reduce deaths and transmissions of HIV and hepatitis C...

ASHP created a Women in Pharmacy Leadership Steering Committee to help guide ASHP’s efforts in providing services and support for women pharmacists as they seek leadership positions...Professional opportunities to conduct direct patient care combined with flexible scheduling and six-figure salaries have drawn more...women into the profession...ASHP is preparing for the future of the pharmacy workforce by identifying and addressing barriers to female leadership...To jumpstart the process of building a new generation of female pharmacy leaders, ASHP held several live networking events at both its 2015 Conference for Pharmacy Leaders...and its 2015 Midyear Clinical Meeting & Exhibition...The moderators...shared their own professional experiences and provided insights into ways to grow into leadership. The events served to connect younger women in the early stages of their careers with positive role models...gender shifts and generational changes have a real potential to change the profession...We need to cultivate a new generation of leaders at every level—clinical, administrative, academic pharmacy, and more. And to do that, we need a candid and thorough assessment of the needs that women pharmacists have and the opportunities for advancement…

Rare disease drug specialist Shire has been on a buying streak lately, culminating with its $32 billion deal for Baxalta. Now the company says it is time to build something...The...company intends to invest $400 million to erect a biologics plant in Ireland, its first manufacturing facility in its adopted home country. Shire's only other manufacturing is in the U.S...Construction is expected to begin this summer in Piercetown...it will add 400 jobs when the project is completed in 2019...Shire says it needs the new plant to meet growing demand for its products. It saw good growth last year, underpinned by its ADHD and binge eating treatment Vyvanse (lisdexamfetamine), as well as strong sales from hereditary angioedema products, Cinryze (complement C1 esterase inhibitor) and Firazyr (icatibant). With Baxalta, Shire gets products for treating hemophilia. Some analysts are unsure why Shire is so hot for Baxalta, given the competitive hemophilia market where new drugs could decimate the business going forward...

The old process is slow and prone to errors...The process of biopharmaceutical drug manufacturing is stuck in the past. And the Food and Drug Administration is now openly calling for drugmakers to spring it forward into the 21st century..."batch" manufacturing technique used by the industry to an archaic relic...batch manufacturing in pharma involves regular breaks between spurts of production. Continuous manufacturing is usually a persistent, unbroken process wherein production plants keep humming... continuous manufacturing is more reliable...the (FDA) agency’s pioneering decision last week to approve Johnson & Johnson biotech arm Janssen’s request to switch over from batch to continuous manufacturing for the production of the HIV drug Prezista. And now, regulators are declaring outright that other biopharma players should "consider similar efforts."

The Australian consumer watchdog says manufacturer Reckitt Benckiser profited substantially and should be fined accordingly...Nurofen’s manufacturer Reckitt Benckiser should be fined $6m for misleading consumers over a range of “targeted” pain products that cost twice as much as its standard painkillers despite all products in the range having the same active ingredient and effect, the Australian Competition and Consumer Commission has found...the federal court found the British company...had engaged in “misleading conduct” by representing that its Nurofen Specific Pain products targeted a type or area of pain despite being identical, and ordered they be removed from supermarket shelves...There needs to be some serious taking away of profit...Targeted painkillers zero in on one vital organ – the wallet...Nurofen did not set out to mislead consumers. Nurofen has cooperated with the ACCC in relation to these proceedings and will fully comply with the court order….

Today’s Pharmacy Podcast Show guest is Dr. Jeffrey Fudin. We’re talking about the March 30th 2016 article from Pain News Network: How Opioid Prescribing Guidelines Use Pseudoscience, By Michael Schatman and Jeffrey Fudin..., we address the issue of how governmental and managed care opioid guideline prescribing committees use the flawed concept of morphine-equivalent daily dose to arbitrarily place limits on the amount of opioids that a clinician "should" prescribe to any patient with chronic pain (podcast 20 min).

...IMS Health disclosed that total spending on prescription drugs in 2015 rose 12.2% to almost $425 billion. Since drug pricing continues to be a major topic of discussion...What is striking about the newly released data are the drugs Americans spend the most on... cholesterol-lowering drug Crestor, with sales of $6.3 billion...this will soon become moot as Crestor will lose patent protection and become a generic drug, an event that will likely drive down its cost by as much as 90%...rheumatoid arthritis drug, Amgen’s Enbrel, with U.S. sales of $6.6 billion last year. The FDA is now reviewing a biosimilar version of Enbrel which was filed by...Sandoz...Given that Zarxio was launched at a 15% discount to Neupogen, a similar discount could be anticipated for a biosimilar Enbrel...rheumatoid arthritis, Humira (adalimumab) from AbbVie . Many analysts believe that Humira’s $10.6 billion in 2015 revenue will be severely impacted by biosimilars being developed by Merck, Amgen, Pfizer and others...one might expect even larger discounts than 15%...the top drug with respect to spending in the, the hepatitis C drug Harvoni from Gilead, weighing in at $14.3 billion. It is unlikely that the sales of this drug will decrease any time soon. However, the use of hepatitis C drugs to cure this infection will reduce the incidence of liver cancer, thereby lowering overall costs to the healthcare system over the coming years...there will be new–and expensive–breakthrough drugs emerging from the pipelines of the biopharmaceutical industry. But let’s not lose sight of the fact that these same drugs that save lives or alleviate the suffering of millions, eventually will become a lot cheaper.