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What Will Opioid Users Treating Mesh Pain Do If CARA Becomes Law?
May 31, 2016 | Mesh Medical Device Newsdesk
I have periodically tried to update you on what is being done in Congress to impact how opioid and opioid-type prescriptions are dispensed, so here is a quick look at HR. (House of Representatives) 953 and S. (Senate) 524 bills. The official title of the act is the Comprehensive Addiction and Recovery Act (CARA). -
Suffering in silence: Many embarrassed to talk about incontinence, but treatments exist
May 31, 2016 | The Gazette
By Jen Mulson
About a year ago Sharon Pikul sat on a park bench and felt like she was sitting on a water balloon. She later learned her bladder had fallen and was hanging about an inch outside of her vaginal cavity, making life rather difficult. -
California, Washington Sue J&J Over Vaginal Mesh
May 31, 2016 | Politico
By Brett Norman
Two states last week piled onto tens of thousands of private suits filed by individuals claiming injury from vaginal mesh products, with California and Washington, bringing actions against Johnson & Johnson.
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What Will Opioid Users Treating Mesh Pain Do If CARA Becomes Law?
May 31, 2016 | Mesh Medical Device Newsdesk
Update on Opioid Prescription Legislation which will affect users experiencing mesh pain!
I have periodically tried to update you on what is being done in Congress to impact how opioid and opioid-type prescriptions are dispensed, so here is a quick look at HR. (House of Representatives) 953 and S. (Senate) 524 bills. The official title of the act is the Comprehensive Addiction and Recovery Act (CARA).
Still Standing graphic
The Act was just passed out of a House committee with some amendments, but this is significant because if the Senate passes a bill, the House has to provide the funding and there is plenty of approved spending in this bill. This bill stands a good chance of being enacted because there is bipartisan support and it is an election year. The name of the bill sounds harmless enough and one that most people would say “sure, we need this program.” Who would say they are against preventing opioid addiction?
However, unfortunately, all people who use opioids for chronic pain management have been swept into this over-reaching bill.
It was introduced to address the high rate of heroin, prescription drug and opioid addiction, which has sharply increased in the past five years. New Hampshire has been particularly hit hard. They do need help, no doubt. However, if you go the govtrack.us website and read the summary of the bill, there is NO place in the summary that talks about how this will impact people who have chronic pain conditions and who have good pain management using opioids.
Here are the summary points:Allow naloxone to be prescribed with opioid prescriptionsImprove prescription drug tracking programs in each stateTreating people with addiction who are incarceratedProhibit the department of education from asking about the conviction from possession or sale of illegal drugs on the Federal Student Aid (FASFA) form
However, there are many things written in the 128-page document that are significant to people with chronic pain. So, here are the take-away highlights from the 128-page funding bill passed in the House committee that will have significant impact on physicians who prescribe even appropriate levels of pain medication to manage pain and what options will be best practice for treating patients.
Many of these regulations seem to group those with chronic pain with those who have addictions. An interesting new label in this act is the term “opioid use disorder.”
Opioids, FDA
This applies to people who are opioid dependent and pertains to any drug that is opioid, opioid-like or potentially addictive. I have read the bill multiple times and still can’t figure out how they will determine if someone who uses opioids for chronic pain will be classified as having an opioid use disorder. It is loosely defined as a person who has developed a dependency or addiction to opioid prescriptions based on the brain chemistry that occurs with these drugs. But, basically, if you have taken opioids for pain, you do have an altered brain chemistry. Physicians who treat people with opioid dependency must go through at least 8 hours of training on opioid use disorder in order to be a qualifying practitioner under this act. They will also be required to obtain a written agreement from each patient, signed by the patient, that the patient will receive and initial assessment and treatment plan, will be monitored for medication adherence and substance use, is informed of all treatment options, and they understand that regular counseling services is critical to “recovery.”
While this still sounds like a good plan, treating people with chronic pain seems to be only a peripheral concern. The American Academy of Family Physicians (AAFP) sent a letter to Congress on March 1, 2016 with the following concern:
“The CARA (Comprehensive Addiction and Recovery Act) provision to require the Pain Management Best Practices Inter-Agency Task Force (created by this ACT) to impose so-called ‘best practices’ on receiving and renewing registrations for prescribing medications regulated under the Controlled Substances Act raises very serious concerns. The AAFP opposes action that limits patients’ access to pharmaceuticals prescribed by a physician using appropriate clinical training and knowledge. Family physicians and other primary care clinicians play a vital role in effective pain management, which could include the prescribing of opioid analgesics. The creation of additional prescribing barriers for primary care physicians would limit patient access when there is a legitimate need for pain relief.”
The link to the full text of this letter is here. The Academy supports all of the other sections of the bill. The Task Force will be made up of many government agency appointees and must include one person who has chronic pain. Wow.
One funding part of the bill is that states can apply for funding to put in place a surveillance system that can be accessed by physicians and other medical providers that will track your opioid use. Physicians will be required to access this system before they prescribe opioid or other habit forming drugs.
Insurance companies are also jumping on the opioid bandwagon. Cigna has already introduced an initiative that “flags” customers who are determined by them to be high risk. These are patients who take large quantities of pain medications or those who are filling pain medication through several different doctors.
The article, available here , says that the insurance carrier will consider refusing to pay for opioid medications for patients who fall under this high risk category. A big concern just from thinking this through is what medical credentials will the insurance company employees have when they decide that a customer is high risk? What recourse will patients have to become “un-flagged” as high risk if they feel that they have been unfairly labeled?
CARA does mention alternative pain management methods such as cognitive behavior therapy and complementary and alternative medical alternatives. However, it is important to understand that these interventions don’t provide immediate relief nor total relief. It takes time to learn to apply the skills needed for Cognitive Behavior Therapy to help you. Other interventions such as yoga, physical therapy, mindfulness can certainly help reduce the experience of pain. So, what should women with mesh do to insure that they are not a victim of the fallout of this bill?
Talk to your physician NOW! Ask him or her if you would be considered as high risk under this bill and if so, how will that impact your pain management plan? It is vitally important that you have this conversation before the heavy hand of the government comes down squarely on your very personal pain experience. This will become law. Be educated. Be prepared.
http://www.meshmedicaldevicenewsdesk.com/will-opioid-users-treating-mesh-pain-cara-becomes-law/
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Suffering in silence: Many embarrassed to talk about incontinence, but treatments exist
May 31, 2016 | The Gazette
By Jen Mulson
About a year ago Sharon Pikul sat on a park bench and felt like she was sitting on a water balloon.
She later learned her bladder had fallen and was hanging about an inch outside of her vaginal cavity, making life rather difficult.
For the past year she used a therapeutic pessary, a medical device inserted vaginally that helps with pelvic organ prolapse, and numerous Poise pads - enough that she jokingly wishes she'd bought stock. But in April, after Medicare insurance came through, she met with a urologist and received a bladder sling.
"I'm a new woman," said Pikul, 65, who's birthed three babies. "I don't even need a Poise pad. I'm such a happy camper. It's a miracle especially after dealing with it for so long."
Hers is not an unusual story - incontinence is a big issue that affects millions. About 1 in 3 adults has bladder control issues, according to the Urology Care Foundation. A February article on the business and markets news website Bloomberg.com noted that growth in the adult diaper market is outpacing that of every other paper-based household staple in the U.S.
"Nobody talks about it because it's embarrassing," said Mary Hollenbeck, a physical therapy assistant at Orthopedic Rehabilitation Associates who works with folks having incontinence issues.Related:Live Well: What is mudita? How can it help you feel joy for others?
Anything that affects the brain, such as strokes, Parkinson's disease, Alzheimer's disease or trauma, can bring on incontinence issues because the brain and spinal cord have a calming effect on the bladder, said Dr. Gary Bong, a urologist at Pikes Peak Urology and chief of Robotic Urologic Surgery at St. Francis Medical Center.
Women are the main sufferers due to childbirth, menopause and even high impact sports. Men can experience problems, too, though in much lower numbers, and mostly due to prostate issues, including prostate cancer, or pelvic surgery.
"A lot of people suffer silently because it's embarrassing," said Dr. Benjamin Coons, a urologist at Urological Associates, "but there are very easy and well-tolerated treatments that can cure a vast majority of patients."
Urge incontinence
Several different types of incontinence exist along with different methods of treatment. Urge incontinence is the feeling of suddenly needing to urinate. It's typically treated first with daily medication that can calm the bladder down, dietary changes or pelvic floor physical therapy, Coons said. If those don't work doctors consider InterStim, an implantable device that quiets down bladder activity, acupuncture done through an electrode placed on an ankle nerve, or Botox. Though best known for its use fighting facial wrinkles, injecting Botox into the bladder can help curtail activity by suppressing nerves.
"It can be done in the office and is well tolerated," said Coons. "The biggest downside is it wears off over six to 12 months."
Surgery is available if medicines fail. A bladder sling can be used for both stress and urge incontinence, said Bong. The procedure involves putting a small piece of material underneath the urethra. The sling material can be made from a synthetic material or muscle, ligament or tendon tissue taken from the patient or an animal.
The controversial sling has come under fire, but both Bong and Coons endorse it.
"A lot of people are under the impression that it's (the sling) been recalled," Bong said. "It's FDA approved. It's been around for decades. We reassure women it's a safe option despite the advertisements."
Stress incontinence
Stress incontinence, mostly found in women, is the involuntary leakage of urine, often when a patient coughs, sneezes, jumps, runs or lifts something heavy. Treatment can include kegels (an exercise to contract and relax the pelvic floor), using bulking agents to add weight to the transurethral area and slings.
Bong is also excited about MonaLisa Touch, a new vaginal rejuvenation laser his office started using in October. While the intended use of the laser is for menopause symptoms, including vaginal itching and dryness and pain with intercourse, Bong has noticed the carbon dioxide-based laser also helps with stress incontinence.
Natural ways to improve
Urologists recommend losing the caffeine, chocolate, spicy foods and acidic fruits and beverages. Too much acidity can irritate the bladder while caffeine and chocolate can have a diuretic effect, prompting the kidneys to create more urine.
Staying hydrated is also important.
"The bladder gets used to what you put in it," said Hollenbeck. "Concentrated urine is toxic to the body and can lead to infection. It can also lead to an overactive bladder. It sounds like a contradiction, but we suggest they slowly increase the amount of fluid and we want them to be on water."
Patients can also try behavioral modification, including relearning the best way to sit on the toilet so the bladder is fully emptied, timed voiding - trying to urinate on a timeline independent of urge - and double voiding, which is going to the bathroom once and then sitting back down to make sure the bladder is properly emptied.
Preventive measures
Hollenbeck strongly recommends patients improve the health of the pelvic floor with kegels, especially women who want to get pregnant, are pregnant or have just given birth. Men and children also can do them. "People say I've done those and that never worked," Hollenbeck said. "The problem is you were never taught how to do them correctly. It's like cake. If you don't put in the right ingredients, you're not going to get the right results. You need an individual treatment program for the best outcome."
Maintaining a healthy weight can also stop incontinence in its tracks.
"Weight is definitely associated with incontinence - both stress and urge," said Bong. "Both tend to be prevalent in obese situations."
Most importantly, open up to your health care provider about any involuntary leakage unless you're nine months pregnant.
"If we can catch it early on and get therapy and treatment maybe we can prevent a problem from coming later," said Hollenbeck.
http://gazette.com/suffering-in-silence-many-embarrassed-to-talk-about-incontinence-but-treatments-exist/article/1577202
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California, Washington Sue J&J Over Vaginal Mesh
May 31, 2016 | Politico
By Brett Norman
Two states last week piled onto tens of thousands of private suits filed by individuals claiming injury from vaginal mesh products, with California and Washington, bringing actions against Johnson & Johnson. Both states say the company misrepresented the risks for years. The California suit: http://bit.ly/20KsjQn Washington’s: http://bit.ly/1UanbjU
http://www.politico.com/tipsheets/prescription-pulse/2016/05/mat-caps-surface-as-top-cara-priority-upton-pitts-push-on-off-label-marketing-unwelcome-superbug-arrives-in-us-214565
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