Some industry critics have railed that any contact between physician and drug makers is akin to a mortal sin; the very thought sullies the purity of medical practice. We think extremism, in any form, shows poor judgment and lack of logical thought. Transparency is excellent, but contact between industry and physician is still necessary for medical advancement.
So we loved the piece we read in Pharmaceutical and Medical Packaging News about the pharmaceutical consulting firm that set up booths at a rheumatology conference which allowed physicians to experience what their RA patients deal with every day. The point: education for all stakeholders, and that includes the use of biologics. A Web-designed program also stresses the need for exercise and the importance of medication adherence.
The booths were equipped with a working faucet and sink; a laundry detergent container; and working taxi cab door. A pharma sales rep guided each physician through the booth, who was asked to turn on the faucet, and so on. The physician, who was measured on how difficult it was to perform the tasks, generally had no problem doing so.
Then the HCP put on specially made gloves (made by folks at George Tech University) that simulated the challenges the RA patient goes through; the physicians' decline in functionality was significant.
The doctors who went through the booth loved it; 92% said they would go through it again – 98% said the demonstration helped them understand what their patients dealt with every day.
Just think: Maybe the consulting firm that developed this tool, OneWorld, can design similar booths for neurologists, so they can appreciate what migraineurs live with, and for pulmonologists, so they can understand what it’s like to live with emphysema.
Showing posts with label REMS. Show all posts
Showing posts with label REMS. Show all posts
Monday, April 18, 2011
Thursday, April 7, 2011
$4 Generics and Medication Non-Adherence
Let’s face it – the business of healthcare is enough to make anybody nuts.
Take the recent study, conducted in 2007, showing only a handful of people, relatively speaking, who took advantage of their healthcare insurance provision to buy $4 generic drugs. If all the people who could buy $4 generics did so at that time, society would have saved nearly $6 billion. A lot of money, no question. The study included 31,000 people; fewer than 6% bought $4 drugs.
It’s tough to imagine that 93% of these people hated society, so maybe there’s something else going on here. They didn’t know? Perhaps. They don’t like generics? Unlikely. According to the Kaiser Family Foundation, 72% of all scripts written in 2008 were generics, and sales of generics grew 8% from 2005 to 2006. The percentages wouldn’t have changed that much from 2007.
In that same study, “Over half of physicians say they frequently talk with patients about the out of-pocket costs of medicines they prescribe, 62% say they switch patients to less expensive drugs, and 58% say they give patients office samples.”
It's anybody guess why those patients chose to spend more money. But, none of the above is the good-grief part. The following is.
Back in November, the New England Journal of Medicine ran a piece about the possible damage that these $4 generic sales can do to long-term improvements in healthcare.
Normally, when a patient purchases a prescription with insurance, that purchase generates a claims record. The pharmacy sends the claim to the pharmacy benefit manager. These claims can be used for healthcare management, including medication safety, verifying clinical trial results, and ensuring medication adherence.
But, with the $4 generics, patients often pay in cash. The authors say the pharmacies often do not submit the claim information “since they have no incentive to do so.” The result: patients are classified as non-adherent or non-users. And, because these drugs are often prescribed for chronic diseases, “the consequences of these missing claims are not insignificant.” This is also important to the topic of medication adherence because it already suffers from a lack of awareness. With almost 80% of the prescriptions today being dispensed as generic, medication non-adherence will become more of a silent disease.
The authors, Niteesh K. Choudhry, M.D., Ph.D., and William H. Shrank, M.D., M.S.H.S., aren’t labeling the pharmacies as bad guys – their actions are unintentional, they say. But, as they point out, new systems need to be devised to make sure the claims are filed.
Take the recent study, conducted in 2007, showing only a handful of people, relatively speaking, who took advantage of their healthcare insurance provision to buy $4 generic drugs. If all the people who could buy $4 generics did so at that time, society would have saved nearly $6 billion. A lot of money, no question. The study included 31,000 people; fewer than 6% bought $4 drugs.
It’s tough to imagine that 93% of these people hated society, so maybe there’s something else going on here. They didn’t know? Perhaps. They don’t like generics? Unlikely. According to the Kaiser Family Foundation, 72% of all scripts written in 2008 were generics, and sales of generics grew 8% from 2005 to 2006. The percentages wouldn’t have changed that much from 2007.
In that same study, “Over half of physicians say they frequently talk with patients about the out of-pocket costs of medicines they prescribe, 62% say they switch patients to less expensive drugs, and 58% say they give patients office samples.”
It's anybody guess why those patients chose to spend more money. But, none of the above is the good-grief part. The following is.
Back in November, the New England Journal of Medicine ran a piece about the possible damage that these $4 generic sales can do to long-term improvements in healthcare.
Normally, when a patient purchases a prescription with insurance, that purchase generates a claims record. The pharmacy sends the claim to the pharmacy benefit manager. These claims can be used for healthcare management, including medication safety, verifying clinical trial results, and ensuring medication adherence.
But, with the $4 generics, patients often pay in cash. The authors say the pharmacies often do not submit the claim information “since they have no incentive to do so.” The result: patients are classified as non-adherent or non-users. And, because these drugs are often prescribed for chronic diseases, “the consequences of these missing claims are not insignificant.” This is also important to the topic of medication adherence because it already suffers from a lack of awareness. With almost 80% of the prescriptions today being dispensed as generic, medication non-adherence will become more of a silent disease.
The authors, Niteesh K. Choudhry, M.D., Ph.D., and William H. Shrank, M.D., M.S.H.S., aren’t labeling the pharmacies as bad guys – their actions are unintentional, they say. But, as they point out, new systems need to be devised to make sure the claims are filed.
Saturday, March 19, 2011
The VA Shouldn't Hold Its BREATH
What a mess. In 2009, the Department of Veterans Affairs abruptly halted a study called the BREATH study, designed to help 413 veterans manage their advanced COPD, because of unspecified safety concerns.
Apparently the deadly type of safety concerns.
The VA, keeping mum about what happened until it publishes in a peer-reviewed journal, had all the right intentions. It wanted to help the sick vets cope with this chronic lung illness by teaching them how to manage it–-with the hope of then keeping them out of the hospital.
But apparently the trial backfired. While the study’s researchers wouldn’t give details, one told the Pittsburgh Tribune-Review, “If someone were to start a disease management program, I would suggest they probably not do it just yet, until the information is available," said Dennis Niewoehner, a pulmonary doctor in Minneapolis, a co-chair for the trial.
Forgive us, Dr. Niewoehner, but we disagree. One, the VA should tell healthcare providers now what happened. There may be a clinical trial going on that could benefit from your knowledge. And two, stalling the start of a disease management program until a paper is published is not right. For those with chronic diseases, every minute has got to be torture.
What is ironic is that maybe the VA should have waited to start its study. Just recently, a review was published in Current Opinion in Pulmonary Medicine on COPD and older adults. The researchers looked at various areas, including comorbidities and disease management.
Older adults with this disease have an average of nine other comorbidities, including depression, cardiovascular diseases and chronic renal failure. What they found was that research suggests that “aging is a determinant of the progression of disease and that management of this population requires different metrics and strategies.” According to the summary information of the VA study, the study group received an education program, an “action manager," plus care. They also received telephone calls. The control group received standardized care.
Since we have no clue as to what went wrong with the study, we can only speculate, but the take-away message is that patient monitoring and management could have potentially signaled these problems sooner. While we think publishing what goes wrong is as important as publishing what goes right, we also believe the use of monitoring technologies like MedAdherence can help providers manage patients with many comorbitities remotely, and possibly better.
Let us know what you think.
Apparently the deadly type of safety concerns.
The VA, keeping mum about what happened until it publishes in a peer-reviewed journal, had all the right intentions. It wanted to help the sick vets cope with this chronic lung illness by teaching them how to manage it–-with the hope of then keeping them out of the hospital.
But apparently the trial backfired. While the study’s researchers wouldn’t give details, one told the Pittsburgh Tribune-Review, “If someone were to start a disease management program, I would suggest they probably not do it just yet, until the information is available," said Dennis Niewoehner, a pulmonary doctor in Minneapolis, a co-chair for the trial.
Forgive us, Dr. Niewoehner, but we disagree. One, the VA should tell healthcare providers now what happened. There may be a clinical trial going on that could benefit from your knowledge. And two, stalling the start of a disease management program until a paper is published is not right. For those with chronic diseases, every minute has got to be torture.
What is ironic is that maybe the VA should have waited to start its study. Just recently, a review was published in Current Opinion in Pulmonary Medicine on COPD and older adults. The researchers looked at various areas, including comorbidities and disease management.
Older adults with this disease have an average of nine other comorbidities, including depression, cardiovascular diseases and chronic renal failure. What they found was that research suggests that “aging is a determinant of the progression of disease and that management of this population requires different metrics and strategies.” According to the summary information of the VA study, the study group received an education program, an “action manager," plus care. They also received telephone calls. The control group received standardized care.
Since we have no clue as to what went wrong with the study, we can only speculate, but the take-away message is that patient monitoring and management could have potentially signaled these problems sooner. While we think publishing what goes wrong is as important as publishing what goes right, we also believe the use of monitoring technologies like MedAdherence can help providers manage patients with many comorbitities remotely, and possibly better.
Let us know what you think.
Thursday, January 20, 2011
The FDA and Social Media: The Industry Needs Guidelines
If you love irony, you’ll love the following.
Respondents to a Deloitte study said social media likely could improve clinical trial efficacy in two ways: one, by supplying data to quicken reporting results, and two, to determine the correct patient reported outcomes.
But of course, these respondents aren’t likely to investigate whether these presumed efficiencies would actually work, because the FDA has put off, yet again, its guidelines on how industry can use social media.
Social media is already proving some success, says FierceBiotech, in recruiting and retaining clinical trial subjects.
It’s a head-scratcher. Facebook has more than 500 million users; half of them log on every day. The average user has 130 friends. As for Twitter – and these are older stats – it has more than 105 million Tweeters, yours truly included.
Do we need to list the problems that clinical trial researchers have had over the years in conducting quality trials, in trying to meet all the rigorous criteria? Remember the media attention the FDA’s report received last year regarding the lack of monitoring of overseas trial sites? That report showed that “between 40 percent and 65 percent of clinical trials investigating FDA-regulated products are conducted outside the United States.”
We can take an educated guess as to why the agency is putting off publishing its guidelines – the unknowns are enormous. More than half of the 208 Deloitte study respondents say there will be confusion – in interpreting the guidelines, in administering the guidelines -- after the FDA publishes them.
We say, that’s okay. At least we’ll have something on paper and a place to start. The agency can redact as we move forward or modify moving forward. But just like the internet in general, the world is moving to more adaptable, amorphous content built by communities. The FDA and other regulators around the world need to appreciate that fact.
As things are now, many industry members are willing to take risks, and spend money on social media innovations, but, as Deloitte points out, innovation is developing slowly, as members wait for the agency’s lead. We think there needs to be another approach. Again: The agency should develop regulations that are progressive, adaptable, and modifiable.
But industry members could get restless, and venture into unchartered areas, as Novartis did last year – and got its wrist slapped for it. Is that fair? No, it isn’t. The technology is here, possible solutions to major problems are here, and the agency, in our opinion, should pick up the pace.
Monday, September 13, 2010
Mobile Health Tech Study: Get Linked
A new PricewaterhouseCoopers' Health Research Institute survey says that physicians recognize that mobile health technologies can help with patience adherence issues, physician shortages and other long-standing healthcare problems.
The results of the Healthcare unwired survey, which involved 1,000 physicians and 2,000 consumers, suggest that physicians and the public alike are ready for mobile health technologies. But PWC says various stakeholders, including some in industry, are essentially ignoring this news. The primary reason: The way the U.S. health care system makes its money. Because only in-person consults are reimbursed, the system is dependent on volume to make its money, so it is not likely to embrace the idea of reducing that volume or transferring that model to lower-cost care -- Americans feel they are entitled to the best healthcare.
According to the survey results, most physicians said they would like to receive healthcare data from their patients’ smart phones or cell phones. (Three out of 10 consumers surveyed were good with tracking it that way.) While these might not seem like big numbers, this is the start of the innovators' curve and this country will reach the tipping point. Our goal is to make our readers aware this "IS" coming and like many other changes, try not to let these opportunities slip by.
We believe that receiving such data could help with patient adherence, 88% of the physicians polled said they would want their patients to monitor certain numbers at home, especially blood sugar levels, blood pressure, and weight. Moreover, 57% of the physicians said they’d like to receive similar data from discharged patients under their care -- this lack of data is one of the biggest issues in medicine today and causes millions of dollars in inefficient care.
A few years ago, physicians, as a group, were not technologically in tune. But that has changed. In this survey, 63% said they are using personal devices to help their patients – and these devices aren’t connected to hospitals or their practices. Of those using smart phones and cell phones, 56% said the technology quickens the decision-making process, and 40% said these tools shave time spent on administration.
And time is what it’s all about: 45% of the doctors said Internet visits would allow more patient access, and 43% said mobile health technologies like e-mail and texting could reduce actual office visits. The gains, PWC says, would be huge. They could:
• help with physician shortages;
• reduce costs of hospital readmissions; and
• increase access for those patients who put off care because they won’t wait for an appointment.
The actual study (you'll need to register to get it) points out two (pharma and retail pharma) members that are tapping into this market: Bayer and CVS Caremark. Bayer has integrated its digital glucose monitor, DIDGET, into the Nintendo game console. And CVS has an iPhone app that allows members to get information on refills and other pertinent information.
Our point is that the industry needs to embrace change, especially technological change like the ubiquitous use of mobile phone technology.
The results of the Healthcare unwired survey, which involved 1,000 physicians and 2,000 consumers, suggest that physicians and the public alike are ready for mobile health technologies. But PWC says various stakeholders, including some in industry, are essentially ignoring this news. The primary reason: The way the U.S. health care system makes its money. Because only in-person consults are reimbursed, the system is dependent on volume to make its money, so it is not likely to embrace the idea of reducing that volume or transferring that model to lower-cost care -- Americans feel they are entitled to the best healthcare.
According to the survey results, most physicians said they would like to receive healthcare data from their patients’ smart phones or cell phones. (Three out of 10 consumers surveyed were good with tracking it that way.) While these might not seem like big numbers, this is the start of the innovators' curve and this country will reach the tipping point. Our goal is to make our readers aware this "IS" coming and like many other changes, try not to let these opportunities slip by.
We believe that receiving such data could help with patient adherence, 88% of the physicians polled said they would want their patients to monitor certain numbers at home, especially blood sugar levels, blood pressure, and weight. Moreover, 57% of the physicians said they’d like to receive similar data from discharged patients under their care -- this lack of data is one of the biggest issues in medicine today and causes millions of dollars in inefficient care.
A few years ago, physicians, as a group, were not technologically in tune. But that has changed. In this survey, 63% said they are using personal devices to help their patients – and these devices aren’t connected to hospitals or their practices. Of those using smart phones and cell phones, 56% said the technology quickens the decision-making process, and 40% said these tools shave time spent on administration.
And time is what it’s all about: 45% of the doctors said Internet visits would allow more patient access, and 43% said mobile health technologies like e-mail and texting could reduce actual office visits. The gains, PWC says, would be huge. They could:
• help with physician shortages;
• reduce costs of hospital readmissions; and
• increase access for those patients who put off care because they won’t wait for an appointment.
The actual study (you'll need to register to get it) points out two (pharma and retail pharma) members that are tapping into this market: Bayer and CVS Caremark. Bayer has integrated its digital glucose monitor, DIDGET, into the Nintendo game console. And CVS has an iPhone app that allows members to get information on refills and other pertinent information.
Our point is that the industry needs to embrace change, especially technological change like the ubiquitous use of mobile phone technology.
Wednesday, July 7, 2010
The Case for REMS
FiercePharma Manufacturing's special report on planning for REMS was spot-on in our opinion. But we'd like to stretch the concept just a bit: What if the industry acted as if every product needed a REMS program?
Yes, we understand what a drag industry considers REMS to be on sales potential--there is no question about that. Also, having a REMS plan means the product's life cycle would be under more heavy scrutiny, which means there will be less room for error. (Actually, we think that's okay.) But if industry could get beyond that - get beyond that REMS is a regulatory tool - and consider what a boost REMS could be to sales potential, then we'd be getting some place.
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