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         Clinical intelligence for supply chain leadership

 
 
 

DAILY UPDATE

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September 30, 2014   Download print version

Best practices in contract communications to be unveiled at Streamlining Healthcare Conference

Life-saving drugs and deadly delays

Citizen hackers tinker with medical devices

The magic number that could end the Ebola epidemic

Ebola: 'Magic Bullets' or Current Tools?

NIH and FDA win top award for intellectual property licensing of meningitis vaccine

Roche breast cancer drug 'unprecedented' in extending lives

Enterovirus: CDC investigates Colorado Children for link between ED-68 and paralysis

Don’t miss the annual UDI Conference!

 
 

Daily Update Archives

 

 

 

Self Study Series:
October 2014

Assessing staff competencies in Central Service

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Read HPN's Exclusive  
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News in Brief

Standing Tall in
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Dominica:
Straightening Spines


Hospital Guidelines
 for Protecting Patients and Healthcare Workers from
Ebola Virus

with Wava Truscott


Best practices in contract communications to be unveiled at Streamlining Healthcare Conference

The Health Industry Distributors Association (HIDA) will release a new white paper, Improving Pricing Accuracy: Best Practices in Contract Communications, during a special session at its Streamlining Healthcare Conference in Chicago, IL, on October 2. The paper offers detailed procedures for automation of contract management processes, including price authorization acknowledgements, chargeback reconciliations, and manufacturer price/sales catalogs. 

“More than 45 companies came together to develop these guidelines for manufacturers and distributors,” said Elizabeth Hilla, Senior Vice President, HIDA. “This is a huge initiative that we will continue in 2015 and beyond, and is the first of many steps aimed at making our supply chain leaner and less costly.” 

The recommendations resulted from a two-year effort to streamline healthcare contracting processes among distributors, manufacturers, group purchasing organizations, and providers. HIDA expects support for this initiative to continue to grow as participating companies and trading partners put the guidelines into action. 

HIDA is the trade association representing medical products distribution with members primarily serving the nation’s hospital, long term care, and physician/alternative care markets. For more information, visit www.HIDA.org. For more information on HIDA’s Streamlining Healthcare initiative, visit www.streamlininghealthcare.org.

 

 

Life-saving drugs and deadly delays

The Food and Drug Administration just granted permission for “expanded access” to an experimental medicine for Ebola. It’s OK as far as it goes, but it’s an exception to the FDA’s reluctance to approve the use of life-saving products.

Safety and efficacy testing of the drug, designated TKM-Ebola, has barely begun, and quantities are extremely limited. It will be given to patients with confirmed or suspected Ebola infections, but not as part of a clinical trial.

To put it less charitably, FDA routinely drags its feet on the approval of products critical for the prevention or treatment of fatal diseases that are far more common in this country than Ebola.

Consider the saga of Bexsero, a vaccine for meningitis B. Since the first vaccine for bacterial meningitis was approved in 1974, immunization has significantly reduced the threat — but a vaccine for MenB took much longer to develop. Bexsero was approved last year by the European Union, Australia and Canada — but it still hasn’t gotten an FDA OK, though outbreaks continue to occur on US campuses. (The most recent one killed a Georgetown University student this month.)

And the mother of a woman who died in Michigan has organized bus trips for dozens of people, mostly college-age kids, to Windsor, Ontario, where she arranged for the group to be seen by a doctor and vaccinated.

Another example: pirfenidone, a drug meant to treat a pulmonary disorder called idiopathic pulmonary fibrosis, or IPF, which kills tens of thousands of Americans each year. The disease’s cause is unknown, and there are no FDA-approved therapies. But pirfenidone is marketed in Europe (since 2011), Japan (2008), Canada (2012) and China. The drug won EU approval on the basis of three randomized, double-blind, placebo-controlled studies — one done in Japan and the other two in Europe and the United States.

Why is the FDA waiting? In 2010, an advisory committee of outside experts recommended approval, but agency officials demanded another major clinical study. The results, published last May, were impressive. Pirfenidone markedly improved several laboratory and clinical measures of lung function and, most importantly, reduced the probability of death from IPF. The FDA will probably OK the drug by year’s end. But in four years of delay, IPF will have killed more than 150,000 US patients.

Economist Diana Furchtgott-Roth has described similar delays in the approval of drugs to treat Duchenne muscular dystrophy, multiple sclerosis and diabetes.

The FDA bases priorities on factors other than data and the nation’s medical needs. Africa’s Ebola outbreak is front-page news, so the FDA grants expanded access for an Ebola drug. Similarly, the FDA last spring brokered the creation of a clinical trial specifically to get an experimental anti-viral drug to a young cancer patient suffering from an adenovirus infection after a bone marrow transplant.

Again, fine on the merits - except that this effort was expended for a single patient and only after the agency was subjected to “intense pressure” from the public on Facebook and Twitter

Visit the New York Post for the opinion.

 

 

Citizen hackers tinker with medical devices

Jason Adams, a business-development executive by day and a molecular biologist by training, had never considered himself a hacker. That changed when he discovered an off-label way to monitor his 8-year-old daughter's blood-sugar levels from afar.

His daughter Ella has Type 1 diabetes and wears a glucose monitor made by DexcomInc. The device measures her blood sugar every five minutes and displays it on a nearby receiver the size of a pager, a huge advantage in helping monitor her blood sugar for spikes and potentially fatal drops. But it can't transmit the data to the Internet, which meant Mr. Adams never sent Ella to sleepovers for fear she could slip into a coma during the night.

Then Adams found NightScout, a system cobbled together by a constellation of software engineers, many with diabetic children, who were frustrated by the limitations of current technology. The open-source system they developed essentially hacks the Dexcom device and uploads its data to the Internet, which lets Adams see his daughter’s blood-sugar levels on his Pebble smartwatch wherever she is. It isn't perfect. It drains cell phone batteries, can cut out at times and hasn't been approved by the FDA. But for many, it has filled a gap.

The home-built setup is part of a shift in the way Americans relate to the medical industry and their own healthcare. Technologically savvy patients are starting to tinker under the hoods of medical contraptions, seeking more influence over devices like blood-sugar monitors, insulin pumps and defibrillators that record and control bodily functions. Their goal is greater access to data and faster invention than is possible under the formal regulatory process.

Patients have been tweaking hearing aids so they play music, using 3-D printers to make their own prosthetics and fiddling with a device used to measure acidity levels in the esophagus. The Massachusetts Institute of Technology has been hosting "hackathons" where engineers and students try to improve medical products and work out new solutions to common diseases. The latest one, held last weekend, was aimed at improving breast pumps.

The tinkering is raising concern at the FDA, medical-device companies and among some academics and clinicians that modifications are being used before they are fully tested and safe for a broad audience. Continuous glucose monitors such as the one Adams daughter uses are Class III medical devices, meaning they get the highest level of regulatory scrutiny, and even new support software must clear a battery of approvals.

The rigorous approval process is there for a reason. A diabetes patient can come to rely on an alarm that prompts him or her to address dangerously high or low blood sugar, so devices need to work predictably and be comprehensible to patients who aren't schooled in technology.

Dexcom, the maker of the glucose monitor, is aware of NightScout, as is the FDA, and neither is taking issue with it for now. While not completely comfortable with the software, the FDA takes a risk-based approach to enforcement and is concerned about its distribution and how it affects patient safety.

Representatives of the FDA have encouraged NightScout's backers to consult formally with the agency. The NightScout team said it filed an application in August, and a formal meeting has been scheduled for next month.

Other do-it-yourself developments in diabetes control—in particular efforts to come up with software to govern dosages of insulin, where errors could be fatal—have prompted more serious concerns. Such efforts are spreading anyway. A nonprofit group started by a former Amazon.com Inc. engineer, called Tidepool, is teaming up with makers of diabetes devices to create better data displays for patients and their doctors.

The homegrown efforts are springing up, in part, because approvals through formal channels can take a long time. A new Medtronic pump that communicates with a glucose monitor and suspends insulin delivery when blood sugars are low wasn't approved in the U.S. until 2013, after being used in Europe since 2009. Johnson & Johnson submitted a new version of its Animas insulin pump that uses the Dexcom monitor in April 2013 and is still waiting for approval. The device was approved in Europe in 2011.

The FDA acknowledges the frustration and doesn't want to be seen as standing in the way of innovation. The FDA notes there are different requirements in Europe for device approvals and that approvals depend on when manufacturers submit their applications to U.S. regulators.

Dexcom plans to seek FDA approval for a software system similar to NightScout by early next year with hopes of getting it on the market by year-end.

Chronic diseases such as diabetes, asthma and heart conditions—where cross referencing data can help improve health—have been an early focus of hacking.

"This grass-roots initiative and drive is very important in accelerating the development of these technologies," said Howard Wolpert, who runs a technology institute at the Harvard-affiliated Joslin Diabetes Center. "It is also important that the processes for approval can be accelerated so that this can be done in a way that there is an element of regulatory oversight." The institute has received funding from Dexcom.

Medical do-it-yourselfers—including some of the people behind NightScout—are now pushing to develop systems that combine the blood-sugar data from glucose monitors with insulin dosing to even out spikes and troughs in blood sugar.

Some do-it-yourselfers are taking steps to commercialize their inventions. Former Wall Street trader Bryan Mazlish has launched a startup—Smartloop LLC—that has filed patents on computer-assisted technology to help manage blood-sugar levels. Mr. Mazlish, whose son and wife have Type 1 diabetes, has built a smartphone app that runs an algorithm to optimize blood-glucose levels by advising on insulin dosing using data from glucose monitors.

Mr. Mazlish said he thinks the current system for developing new medical devices could be improved upon, but figures he can have the most impact going the commercial route.

Visit the Wall Street Journal for the story

 

 

The magic number that could end the Ebola epidemic

There are a lot of scary numbers floating around about Ebola. Take 1.4 million: the U.S. Centers for Disease Control and Prevention’s (CDC’s) worst-case scenario for Ebola cases in Western Africa by the end of January. Or two: the approximate number of healthy people infected by each new Ebola patient.

But perhaps the most important Ebola number right now is 70 percent. That’s the proportion of patients who need to be isolated, in treatment centers or at least in their homes, in order to put a quick end to the Ebola outbreak, according to the CDC.

“Once 70 percent of patients are effectively isolated, the outbreak decreases at a rate nearly equal to the initial rate of increase,” researchers wrote in the CDC’s Morbidity and Mortality Weekly Report. If 70 percent of the current outbreak was achieved by late December, the epidemic “would be almost ended by January 20.”

Seventy percent is a number full of hope and dread. Hope, because it’s a goal that feels attainable; a developed country would be able to handle 70 percent isolation on its own soil in short order. Dread, because in Ebola-swept regions like Liberia and Sierra Leone, we are nowhere near achieving it. Right now, only about 18 percent of Ebola patients in Liberia are being isolated.

Each day the epidemic persists makes 70 percent more difficult to reach. More doctors, hospital beds and treatment centers will be needed, and more people must be educated about the disease. For every 30-day delay, the peak number of new daily cases triples, according to a model of the disease created by the CDC.

Despite its reputation as a killer, Ebola isn’t very good at reproducing itself. The virus is spread through body fluids, not air, and it often kills patients before they have a chance to spread the disease widely. When 70 percent of patients are isolated, the disease no longer spreads fast enough to replace dying or recovering patients. It burns itself out.

All it takes to break the epidemic is to reach that magic number. What makes the current outbreak so difficult is that it’s happening in war-impoverished countries that have no prior experience with Ebola and very few doctors and hospitals to start with. The size of the outbreak also puts it in uncharted territory.

The 1.4 million worst-case projection by the CDC, the agency's own estimation, is “very unlikely.” It doesn’t account for major health interventions, which are already underway. For example, U.S. soldiers have started arriving in Liberia after President Barack Obama pledged to help build as many as 20 treatment centers, train 500 healthcare providers and send 3,000 troops to assist. The Pentagon may spend as much as $1 billion fighting the disease. That’s a lot of numbers. Let’s hope they add up to 70.

Visit Bloomberg for the story.

 

 

Ebola: 'Magic Bullets' or Current Tools?

European health authorities want to compile an overview of all the available data on experimental medications for Ebola. The World Health Organization (WHO) is planning to issue guidance on the potential therapeutic use of serum from Ebola survivors.

But the emphasis on "magic bullets" misses the point that basic care already available in West Africa could markedly cut the fatality rate, according to an international group of physicians experienced in treating Ebola patients in the current epidemic.

"Intravenous catheters, fluids, and electrolyte replacement are readily available but thus far are being used much too sparingly," according to François Lamontagne, MD, of the Centre Hospitalier Universitaire de Sherbrooke in Sherbrooke, Quebec, and colleagues. Such "simple interventions" can prevent deaths from hypovolemia and metabolic abnormalities, they argued online in the New England Journal of Medicine.

The epidemic has now led to 6,553 infections and 3,083 deaths, numbers that the WHO says are almost certainly a vast underestimate.

But many of the deaths are preventable and "reflect the natural history of the illness, not an inability to alter its course," Lamontagne and colleagues argued. Many patients, no longer able to drink, are left without adequate intravenous fluid resuscitation, they reported, and when biochemistry measurements have been available "we have commonly found extreme serum sodium and potassium abnormalities."

One barrier to correcting such abnormalities is the lack of trained clinicians, Lamontagne and colleagues said, but specialist care isn't needed, just "fundamental acute care skills" and supplies that are already available in the region. "We are convinced that it's possible to save many more patients," the clinicians argued.

The commentary comes as the European Medicines Agency begins to review what's known about various Ebola treatments currently under development. The goal, the agency said in a statement, is to create an overview of the various experimental medicines to "support decision-making" by health authorities.

In Guinea, WHO said, the situation "appears to have stabilized" with between 75 and 100 new confirmed cases in each of the past 5 weeks. Transmission in the capital, Conakry, is relatively moderate. The cumulative total of confirmed, probable, and suspected cases in Guinea stands at 1,074, with 648 deaths, according to a situation report issued Friday.

Liberia, on the other hand, has seen an anomalous decline in new confirmed cases, the agency said, mainly because no confirmed cases were reported from the capital, Monrovia, from Sept. 14 to 21. But that is probably because of delays in reporting, the WHO said, since responders in the country -- and especially in Monrovia -- continue to report deterioration in the situation.

Liberia has been especially hard-hit, with a cumulative total of 3,458 confirmed, probable, and suspected cases and 1,830 deaths.

And in Sierra Leone, the WHO situation report said, the number of new confirmed cases reported has increased in each of the past five weeks, driven primarily by newly reported cases in the capital, Freetown. The country has a cumulative total of 2,021 confirmed, probable, and suspected cases and 605 deaths.

The Friday report suggests that the disease continues to spread, with cases seen in the Guinean province of Kindia and the district of Grand Kru in Liberia.

The WHO continues to warn that the case totals are moving targets and very likely underestimate the total disease burden.

Source reference: Lamontagne F, et al "Doing today's work superbly well - treating Ebola with current tools" N Engl J Med 2014; DOI: 10.1056/NEJMp1411310.

Visit MedPage Today for the study

 

 

NIH and FDA win top award for intellectual property licensing of meningitis vaccine

The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society External Web Site Policy at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.

NIH and the FDA teamed with PATH External Web Site Policy, a Seattle-based non-profit leader in global health innovation, and the Serum Institute of India (SII) to develop MenAfriVac. The vaccine has a low production cost and does not require constant refrigeration, making it ideal for use in remote locations. A critical part of the manufacturing process for the vaccine is based upon a patent license granted from the NIH Office of Technology Transfer (NIH OTT) to PATH.

The technology was invented by FDA scientists and subsequently sublicensed by PATH to SII under the Meningitis Vaccine Project, a partnership of PATH and the World Health Organization (WHO). The vaccine targets the most common form of bacterial meningitis, known as serogroup A, found in sub-Saharan Africa. According to WHO, 80 to 85 percent of all meningitis infections in the region are from group A.

Meningococcal meningitis, a deadly bacterial infection of the brain, can be prevented with vaccination, but the production technology is complex and generally beyond the capacity of infrastructures in most developing countries. The patent license agreement involving the FDA-developed technology and the expertise of the NIH technology transfer officers was critical to developing and transferring the technology needed to manufacture MenAfriVac at an affordable cost for the 26 African countries where serogroup A meningitis is most common.

Through a partnership organized by PATH, NIH OTT licensed the technology needed to make the new vaccine, which was developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of the FDA’s Center for Biologics Evaluation and Research. PATH worked with SII, which agreed to scale up the technology in exchange for technical know-how and produce the vaccine at a cost that African countries could afford, thus providing stable and sustainable access to MenAfriVac.

MenAfriVac was launched in a vaccination campaign in Burkina Faso in December 2010. To date, more than 150 million people in 12 African countries have been vaccinated with no reported cases of serogroup A meningitis in vaccinated populations.

Visit NIH for the story.

 

 

Roche breast cancer drug 'unprecedented' in extending lives

A new breast cancer drug from Roche has shown "unprecedented" benefits in extending lives in a clinical trial and experts urged its widespread use for women with an aggressive form of the disease.

Patients with a type of breast cancer known as HER2 positive, which makes up about a quarter of all breast cancers, who were given Perjeta on top of older medicine Herceptin and chemotherapy lived 15.7 months longer than those on Herceptin and chemotherapy alone.

That is the longest extension to survival ever seen for a drug studied in metastatic breast cancer and also an unusually good result for any type of metastatic cancer, where disease has spread to other parts of the body.

Both Herceptin and Perjeta are antibodies designed to block the function of HER2, a protein produced by a cancer-linked gene. Perjeta, also known as pertuzumab, binds to a different part of the same protein, which makes combining the two drugs extra effective.

Perjeta, which was approved by regulators two years ago, was tested in the Roche-backed study involving more than 800 women.

Researchers had previously reported the Perjeta drug regimen significantly extended progression-free survival, or the period of time patients live without their disease worsening, but the final overall survival data has taken longer to collect.

The median overall survival time was 56.5 months for those given Perjeta against the already impressive 40.8 months for patients taking only the older drugs. Looking at the study results a different way, the risk of dying was reduced by 32 percent for women who received the Perjeta regimen compared to those who got Herceptin and chemotherapy.

While both Perjeta and Herceptin have side effects, including rash, diarrhea and a potentially adverse impact on heart function, using the two drugs together did not make these issues any worse.

Swain and Javier Cortes, another researcher on the study from the Vall D’Hebron Institute of Oncology in Barcelona, said the results suggested using Perjeta should now be the standard of care for HER2 positive breast cancer patients.

A favorable reaction from oncologists will underpin expectations of strong sales for Perjeta, which analysts currently expect to sell $3.1 billion a year by 2018, according to consensus forecasts compiled by Thomson Reuters Cortellis. But it poses a challenge for healthcare providers, since Perjeta and Herceptin are costly injectable drugs and the multiple-drug regimen promises to strain budgets.

In the United States, the monthly price of Perjeta is approximately $5,900, while Herceptin costs around $5,300, a Roche spokeswoman said. Prices in Europe are lower.

For Roche, Perjeta is an important new product that should help defend its position in breast cancer, following the success of Herceptin, which was first approved in 1998.

The company said the latest data would be submitted to regulatory authorities around the world for inclusion in the prescribing information for Perjeta.

The Swiss drugmaker also has another related drug called Kadcyla, which is also being tested in combination with Perjeta. Some analysts believe Kadcyla's prospects could be curbed if results from that combination are not better than the impressive findings reported this weekend.  

Visit Reuters for the study.

 

 

Enterovirus: CDC investigates Colorado Children for link between ED-68 and paralysis

Health researchers are investigating whether the enterovirus-68 respiratory disease that’s been seen in especially high rates this year is related to a neurological condition that causes limb weakness and paralysis. In a Friday statement, the CDC said it planned to work with the state health department to “investigate these cases among children in Colorado who had respiratory illness and later developed neurologic illness.”

Of the eight children tested, four were found to have cases of enterovirus-68, ABC News reported Saturday.

“It is a spectrum of arm or leg weakness that can be as mild as weakness or as severe as paralysis,” Dr. Larry Wolk, chief medical officer for the Colorado Department of Public Health and Environment, told ABC News. “What ties them all together though are findings of spots or lesions in the grey matter of the spinal cord on MRI scans.” He also said the children were between the ages of 1 and 18.

Enteroviruses are relatively common usually cause between 10 million and 15 million cases a year. Symptoms usually present like a bad cold, with cough and body aches. But this year, children have been experiencing wheezing and other breathing problems. The CDC said enterovirus-68 “appears to be the predominant type of enterovirus this year, and may be contributing to the increases in severe respiratory illnesses.”

Some 277 confirmed cases have been reported in 40 states from mid-August to Sept. 26. But the CDC said a spike during these months is normal. “We’re currently in the middle of the enterovirus season,” it said in the public statement, adding it’s likely the incidents will decline in the fall.

Visit the IB Times for the article.

 

 

Don’t miss the annual UDI Conference!

As an educational authority on UDI, the 6th industry stakeholders, together with the FDA UDI Team, will meet to ensure accurate UDI implementation and continued adoption momentum. The annual UDI conference will take place October 28-29, 2014, in Baltimore, MD.

HPN is proud to sponsor the UDI Conference, an important industry gathering for medical device manufacturers, distributors, and hospitals to learn about the UDI Regulation and the Global UDI Database (GUDID). Teams encouraged to attend this significant conference include those from medical device manufacturers, healthcare distributors, group purchasing organizations, hospitals and healthcare providers and healthcare industry professionals.

What to expect if you attend the UDI conference:  

  • Learn technical details about the UDI Regulation from the FDA Team

  • See how to best utilize the Global UDI Database (GUDID) to harness the data

  • Understand the requirements for your automatic identification systems

  • Create a plan for implementation

  • Gain the knowledge and establish resources needed to guide your organization

** NEW this year – A special “Provider Track” will be offered as part of the Conference Program, which is hosted by the Association for Healthcare Resource & Materials Management (AHRMM).

The UDI Regulation requires new/improved systems and processes to efficiently mark/tag equipment, scan device information at various points in its life cycle, and transmit that data to the GUDID and other software systems. The UDI Conference allows attendees to interact directly with the FDA UDI team, investigate UDI technology in the exhibit hall, plan a migration path, and network with peers in the healthcare industry in one place, at one time.

To secure a seat at the best price, when registering, enter "HPN" in the promotional code field and automatically save $100. Team registrations are encouraged. If 2 or more from the same company are planning to attend, contact nicole@clariongroupinc.com to receive a discount code. Register today at http://udiconference.com/register.html.

For additional conference details and the most up-to-date information, please visit www.UDIconference.com.