Category Archives: pharmaceuticals
GHX Testing its “Track & Trace” Solutions in Pharma Applications
Is doing the right thing its own reward? GHX has been on a mission to improve transparency and efficiency in the healthcare supply chain. And as we’ve reported here numerous times, not just GHX, but all of the industry’s thought leadership and most all of the industry’s major supply chain “players” want the same thing. Along with the term “transparency,” we throw around the enabling concepts like “track and trace,” which leads to discussion about UDI and the various implementation standards being debated. And most recently, those conversations question the FDA’s lack of urgency, especially when considering that virtually no [...]
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SAP & Molecular Health to Shape Personalized Medicine (PMx) Market
The concept of personalized medicine (PMx) is less than 20 years old, and it does not have a perfect track record. But where it has been proven successful, it has been a game-changer –for providers, payors and especially patients, who can finally participate, meaningfully, in their own care. When physicians and patients can efficiently integrate genetic and biological data into the diagnostic process, personalized therapy will become the norm –there will be no turning back. Yesterday, SAP AG (NYSE: SAP) and MolecularHealth, a leader in clinico-molecular informatics™, announced that they have joined forces to create a clinical decision-making system designed [...]
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Meningitis Outbreak Leading to Second Condition –Epidural Abscesses
People recovering from a meningitis outbreak caused by a contaminated steroid drug have been struck by a second illness, officials say. The new problem, called an epidural abscess, was caused by the same steroid, methylprednisolone acetate, which was injected into patients to treat back or neck pain. Epidural abscesses are a localized infection affecting the membranes covering the brain and spinal cord. They are forming in patients who received the contaminated injections, putting them back in the hospital for more treatment, often requiring surgery. “We’re hearing about it in Michigan and other locations as well,” said Dr. Tom M. Chiller, [...]
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The WHO Drug Certification Scheme: Pharmaceutical Quality Assurance
While it may now be safe to assume that the lack of FDA regulatory control over compounding pharmacies is a problem that will soon be corrected –especially given recent events– keep in mind it will be over the stripped carcass of NECC. If you tend to agree with me, then it is likely you will also agree that one of the downstream problems (i.e. qualifying good pharmaceutical suppliers/procurement) is also bound to get more than its usual dose of attention. Qualifying suppliers is a quality assurance process. Here are three required components of a system for selecting reliable suppliers of [...]
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Regulating Compounding Pharmacies: Sometimes it Takes a Disaster
Can you envision the supply chain? Grinding medicine into specialized doses for individual, special-needs patients; it conjures up an image of a bygone era. But it’s actually not a “thing” of the past. In fact, there is a growing need in the marketplace for “personalized medicines,” so making them is still big business. But for some strange reason it remains unregulated –and scaling what is supposed to be a per-order-based custom manufacturing process turns out to be a very dangerous enterprise. Just ask New England Compounding Center (NECC). By now you’ve probably heard that NECC is at the center of [...]
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Friday Rant: Beware of the “Non-Analytical Positive”
I refuse to criticize Lance Armstrong. Besides, he has enough problems without me adding to them. Just stick him on the growing list of world-class athletes who got caught cheating –right? Let’s look at a few famous and recent offenders: Just about everyone who ever cycled at a high level with Lance Armstrong. The fact that Floyd Landis actually tested positive after winning the 2006 Tour de France distinguishes him. Marion Jones. A highly decorated Olympian who fell from grace faster than Anthony Wiener. A five medal winner in Sydney, she was stripped of all titles although she never tested [...]
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FDA Doesn’t Regulate Compounding Pharmacies?
The meningitis outbreak that has so far killed 15 people and sickened more than 200 others is “nowhere near the end,” a top medical expert said Tuesday, a day after federal authorities warned more tainted drugs may be linked to the health crisis. Dr. William Schaffner, an infectious diseases expert said that he expects a “steady increase” in the number of fungal meningitis infections over the coming weeks. “I think we’re still in the middle,” Schaffner said, when asked about the outbreak’s scope. “We’re nowhere near the end of this problem. And we will see more patients reporting in ill [...]
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Allscripts Loses Major Contract –Cries “Foul”
According to reports circulating in the New York Times, Bloomberg News and others, Allscripts has lodged a formal complaint with the NYC Health & Hospitals procurement review board because it didn’t select Allscripts for a major EHR implementation contract. Rather, the award went to its primary competitor, Epic Systems of Wisconsin. And because public money is involved, Allscripts’ complaint must be resolved before the award can be finalized and Epic’s implementation work can begin. Which, of course, is precisely what’s going to happen. The dispute centers not on the core cost but on the total cost of ownership over 15 [...]
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Baxter Makes $1B Alzheimer’s Bet
Making a bold move to address its capacity constraints, Baxter International is investing more than $1 billion into a plant that will specialize in plasma-derived therapies. The impetus for the investment seems to have a lot to do with the drug Gammagard, which the company is studying as a potential Alzheimer’s treatment. Long known for IV products and regarded as a bit of a one trick pony with its drug Advate (for hemophiliacs), Baxter’s R&D pipeline “will change the personality of the company” according to Bob Parkinson, the company’s CEO. Simply put, while the stakes for Gammagard are high, the [...]
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Compounding Pharmacies –Time for Product Serialization?
Thanks to Thomas Kase of the Spend Matters Advisory Group for the following guest post: By now, most of you have read about the current pharmacy disaster in the U.S. with people getting sick and dying from meningitis caused by tainted spinal steroid injections. The difficulty the CDC had in identifying, tracking and diagnosing the root cause of a problem that is killing people usually means we’re seeing just the tip of an iceberg – as the news is getting worse. Yesterday, the Wall Street Journal (Oct 9) stated that “as many as 13,000 patients may have been exposed to [...]
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FDA Now Collecting User Fees to Improve Access to Important Drugs
Washington, DC. – The Healthcare Supply Chain Association (HSCA) applauds government and industry action to ensure that the U.S. Food and Drug Administration (FDA) will continue to have access to the resources necessary to approve of safe, effective and affordable generic medicines. The FDA made the announcement October 1, 2012 and will begin collecting generic drug user fees (which have been in a bit of limbo) effective to that date. HSCA applauds both government and industry for each doing their part to help protect uninterrupted patient access to important treatments,” said HSCA President Curtis Rooney. “Group purchasing organizations are engines [...]
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About Time: Wharton’s Conference on Supply Chain Optimization
Last Friday, the six-month-old Wharton Supply Chain Organization hosted its inaugural conference, bringing together students, faculty and senior professionals from major companies to talk about managing the journeys of different products from seed to shelf. Senior vice presidents and other leaders from companies such as Google, IBM, Boeing and Amazon.com spoke. With over 700 attendees, the conference marks one of the largest undergraduate-focused Wharton conferences ever. “Until now, supply chains have been taboo in Wharton,” said Wharton and Engineering senior Ridhima Parvathaneni, founding president of the organization. “There was latent interest for operations management, but no way to get involved [...]
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SCM Capabilities Drive Imperial Holdings Move into African Healthcare
Imperial Holdings is a diversified industrial services and retail group with activities spanning logistics; car rental; tourism; financial services; vehicle distribution and retail. The holding company operates primarily in South Africa, Africa, Europe and Australia; it is listed on the Johannesburg stock exchange (JSE); the group is highly decentralized in its management structure and operating principals. And today, this company of 40,000 employees announced that it would buy the pharmaceutical and consumer healthcare supply chain services business of RTT Health Sciences, conducted by RTT Group, for R500-million. It’s a huge step into uncharted territory (healthcare) for a company that started [...]
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Pfizer’s Supply Chain –Now “For the Birds”
Pfizer has spent nearly the last two years completely re-engineering its global supply chain. We’re not just talking about sticking its toe in the water –we’re talking about a wholesale change; a completely new management platform that seems to be delivering on just about everything positive we’ve heard about cloud computing from the Cloud Chamber of Commerce over the last few years. Pfizer and its external providers now share the same supply chain management platform –a cloud based solution that Pfizer describes as a network of “supply neutral devices using an information architecture that includes cloud-based process and information layers [...]
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Big Data Services –File System, DBMS and Analytics Vendors
Big data is being hyped everywhere these days –and for a change, healthcare is looking a lot more like an early adopter than a market laggard. Maybe because social media is considered such a big potential boon for healthcare (?) or is it more about the big new networks of care delivery being formed and the level of analytic “discovery” that is going to need to take place? Of course, the answer is: “All of the above.” Just how big is “big data?” Well, no one has yet proffered a definitive answer, but it’s safe to assume that when scaling [...]
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Novation Raising the Profile of Standardization –Member Awards
I recently did a post on Novation’s private label program –and I discussed it in the context of its standardization efforts. That led to a conversation where I was kindly reminded by Novation execs that driving its private label business and identifying opportunities for its customers to standardize, while complementary activities, is by no means an adequate representation of the breath of its standardization program(s). Fair enough. Driving standardization in healthcare in all its forms, whether we’re talking physician variance, procedural variance, supply utilization variance, product rationalization, supplier rationalization, etc., is happening with renewed vigor for a variety of reasons, [...]
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- Healthcare in the Cloud: Forecast Still Hazy : HIMSS 2013: Top Takeaways Gathering Clouds said: [...] to David McCament’s mind, the future of healthcare cloud is not so clear. In a gue... more
- Time Definite Logistics –MNX Expands Global Network and Adds Track & Trace : Daniel said: Everything is very open with a precise description of the issues. It was definitely inform... more
- Varian Runs a “Clinic” in Effective Lobbying –Harry Reid Rides Shotgun : Thomas Finn said: Thanks for your comment Bo. I do not fully comprehend the differences between the two opti... more
- Varian Runs a “Clinic” in Effective Lobbying –Harry Reid Rides Shotgun : Barton 'Bo' Cooke said: Tom, you nailed it. This rider, put in at the last minute and was rushed into the Congres... more
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