May 6, 2016
CDC: 1 in 3 antibiotic prescriptions unnecessary
At least 30 percent of antibiotics prescribed in the United States are unnecessary, according to new data published in the Journal of the American Medical Association (JAMA) by the Centers for Disease Control and Prevention (CDC), in collaboration with Pew Charitable Trusts and other public health and medical experts.
The study analyzed antibiotic use in doctors’ offices and emergency departments throughout the United States. CDC researchers found that most of these unnecessary antibiotics are prescribed for respiratory conditions caused by viruses – including common colds, viral sore throats, bronchitis, and sinus and ear infections – which do not respond to antibiotics. These 47 million excess prescriptions each year put patients at needless risk for allergic reactions or the sometimes deadly diarrhea, Clostridium difficile.
The researchers also estimated the rate of inappropriate antibiotic use in adults and children by age and diagnosis. These data will help inform efforts to improve antibiotic prescribing over the next five years.
In 2015, the White House released The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), which set a goal of reducing inappropriate outpatient antibiotic use by at least half by 2020. This means that 15 percent of antibiotic prescriptions (or half of the 30 percent that are unnecessary) must be eliminated by 2020 to meet the CARB goal.
As part of the effort to achieve the national goal, CDC researchers analyzed the 2010–2011 National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) to determine the number of outpatient visits resulting in antibiotic prescriptions by age, region, and diagnosis in the United States from 2010-2011.
They found that:
· Of the estimated 154 million prescriptions for antibiotics written in doctor’s offices and emergency departments each year, 30 percent are unnecessary. This finding creates a benchmark for improving outpatient antibiotic prescribing and use.
· About 44 percent of outpatient antibiotic prescriptions are written to treat patients with acute respiratory conditions, such as sinus infections, middle ear infections, pharyngitis, viral upper respiratory infections (i.e., the common cold), bronchitis, bronchiolitis, asthma, allergies, influenza, and pneumonia.An estimated half of these outpatient prescriptions are unnecessary.
· Outpatient healthcare providers can evaluate their prescribing habits and implement antibiotic stewardship activities, such as watchful waiting or delayed prescribing, when appropriate, into their practices.
· Health systems can improve antibiotic prescribing in offices and outpatient facilities within their networks by providing communications training, clinical decision support, patient and health care provider education, and feedback to providers on their performance.
· Patients can talk to their healthcare providers about when antibiotics are needed and when they are not. These conversations should include information on patients’ risk for infections by antibiotic-resistant bacteria.
Visit the CDC for the report.
Oxycontin’s 12-hour problem
The drugmaker Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications.
Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors. One OxyContin tablet in the morning and one before bed would provide “smooth and sustained pain control all day and all night.”
On the strength of that promise, OxyContin became America’s bestselling painkiller, and Purdue reaped $31 billion in revenue.
But OxyContin’s stunning success masked a fundamental problem: The drug wears off hours early in many people, a Los Angeles Times investigation found. OxyContin is a chemical cousin of heroin, and when it doesn’t last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.
The problem offers new insight into why so many people have become addicted to OxyContin, one of the most abused pharmaceuticals in U.S. history.
The Times investigation, based on thousands of pages of confidential Purdue documents and other records, found that:
Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
The company has held fast to the claim of 12-hour relief, in part to protect its revenue.
When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing.
Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.
More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.
Over the last 20 years, more than 7 million Americans have abused OxyContin, according to the federal government’s National Survey on Drug Use and Health. The drug is widely blamed for setting off the nation’s prescription opioid epidemic, which has claimed more than 190,000 lives from overdoses involving OxyContin and other painkillers since 1999.
The internal Purdue documents reviewed by The Times come from court cases and government investigations and include many records sealed by the courts. They span three decades, from the conception of OxyContin in the mid-1980s to 2011, and include emails, memos, meeting minutes and sales reports, as well as sworn testimony by executives, sales reps and other employees.
The first patients to use OxyContin were women recuperating from abdominal and gynecological surgery at two hospitals in Puerto Rico in 1989. In the clinical study, designed and overseen by Purdue scientists and paid for by the company, 90 women were given a single dose of the drug while other patients were given short-acting painkillers or placebos. None of the women were regular users of painkillers, so they were more susceptible to the effects of narcotics.
Even so, more than a third of the women given OxyContin started complaining about pain in the first eight hours and about half required more medication before the 12-hour mark, according to an FDA analysis of the study.
The study found that OxyContin was safe, relieved pain and lasted longer than the short-acting painkillers.
Narcotic painkillers work differently in different people. Some drug companies discuss that variability on their product labels and recommend that doctors adjust the frequency with which patients take the drugs, depending on their individual response.
Purdue’s owners, the Sackler family, were already rich — the family name adorns a wing of the Metropolitan Museum of Art and several galleries in the British Museum. The success of OxyContin brought a whole new level of wealth. Forbes magazine last year estimated the Sacklers’ worth at $14 billion, which, the magazine noted, put the family ahead of American dynasties such as the Mellons and Rockefellers.
OxyContin’s impact on the practice of medicine was similarly transformative. Other drug companies began marketing their own narcotic painkillers for routine injuries. By 2010, one out of every five doctor’s visits in the U.S. for pain resulted in a prescription for narcotic painkillers, according to a Johns Hopkins University study.
Rates of addiction and overdose have soared alongside the rise in prescriptions. News coverage of these problems in Appalachia and New England in the late 1990s made OxyContin notorious. Purdue dispatched representatives to Virginia, Maine and elsewhere to defend its drug. They blamed misuse of OxyContin and insisted their pill was a godsend for pain sufferers when taken as directed.
To this day, physicians frequently contact Purdue with questions about dosing. Only 12-hour dosing has been proved safe, the company tells them.
Visit the Los Angeles Times for the full story.
Updates to data initiatives increase transparency of the Medicare Program
As entrepreneurs, investors, data scientists, researchers, policy experts, government employees, and others prepare to gather for the seventh annual Health Datapalooza conference in Washington, D.C., the Centers for Medicare & Medicare Services (CMS) is releasing updated data to increase transparency in the Medicare program. CMS has posted the third annual release of the Physician and Other Supplier Utilization and Payment public use data. In addition, CMS is announcing the availability of more timely data for researchers.
The Physician and Other Supplier Utilization and Payment data contains summarized information on Part B services and procedures provided to Medicare beneficiaries by physicians and other healthcare professionals.The data includes payment and submitted charges, or bills, for services and procedures provided by each physician or supplier. It allows for comparisons by physician, specialty, location, types of medical services and procedures delivered, Medicare payment, and submitted charges.
The updated 2014 dataset has information for over 986,000 distinct healthcare providers (up from 950,000 in 2013) who collectively received $91 billion in Medicare payments (compared to $90 billion in 2013). New in the 2014 data is the Medicare standardized payment amount, which removes geographic differences in payment rates for individual services, such as those that account for local wages or input prices, and makes Medicare payments across geographic areas comparable. CMS protects beneficiaries’ personal information in all its data releases.
CMS is also making more timely extracts of Medicare claims data available to researchers who access this data via Limited Data Sets (LDS). Historically, researchers have only been able to request annual extracts of Medicare data under the LDS request process. With the changes, researchers will be able to request updates to their LDS claims files as frequently as quarterly, making it easier to do the important research that will continue to result in better quality and lower costs in the health care system.
The release of timely, privacy-protected data is especially important as the Medicare increasingly pays providers based on the quality, rather than the quantity, of care they give patients.These initiatives contribute to a wide set of CMS activities focused on achieving better care, smarter spending, and healthier people throughout the healthcare system.
Visit CMS for the article.
Class I Recall: Dialog+ Hemodialysis Systems by B. Braun Medical
B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
The recalled products include: Model numbers: 710200L, 710200K, 710200S, 710200U, 710500L, 710500K; Manufacturing dates: April 1, 2013 to July 3, 2013; Distribution dates: June 25, 2013 to October 7, 2015.
The Dialog+ Hemodialysis System is a machine used in the treatment of chronic kidney disease for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid. These systems are used in hospitals, health centers, and in outpatient dialysis center settings.
Visit FDA for the recall.
Olympus takes plasma vaporization to a new level of efficiency with plasma-OvalButton
Olympus has announced the launch of its FDA cleared Plasma-OvalButton for urologic procedures including minimally invasive surgery to reduce enlarged prostate as well as treatment of bladder cancer. The Plasma-OvalButton uses Olympus' plasma technology in a revolutionary electrode shape designed to maximize O.R. efficiency and enhance clinical outcomes.
With a 25 percent increase in width and 31 percent increase in vaporization area from Olympus' present vaporization device, the Plasma-OvalButton is designed to increase tissue removal rates for enhanced procedural efficiency.
Lab testing has demonstrated a 21% increase in tissue vaporization from Olympus' existing vaporization electrode.
Plasma vaporization therapy with the Plasma-OvalButton is a minimally invasive surgical procedure performed in saline, which has demonstrated reduced risk of TUR syndrome when compared to more traditional monopolar procedures, and is recommended by the National Institute of Health and Clinical Excellence. Other benefits of plasma vaporization therapy over monopolar resection include less bleeding, improved visualization, more precise cutting and coagulation, and shorter catheterization and procedure times.
Enlarged prostate, or benign prostatic hyperplasia (BPH), affects approximately 60 percent of men age 60 or over. The percentage increases to 80-90 percent in men over age 80.
Approximately 150,000 men have transurethral resection of the prostate (TURP) procedures each year in the U.S. During the procedure, the surgeon uses an endoscopic image to guide the electrode through the urethra to the prostate to safely and efficiently remove prostatic tissue to allow the patient to return to normal urinary function. Olympus' plasma portfolio of electrodes can also be used during TURBT – a surgical procedure to remove cancerous tissue from the bladder.
Bladder cancer is the sixth most common cancer in the United States, but 96 percent of patients diagnosed early will survive five years later.
Visit Olympus for more information.
Vision loss linked to increased hospital length of stay, higher readmission rates and increased costs
A national study has found that patients with vision loss who are admitted to the hospital for common disorders, spend more time in the hospital, are more likely to be readmitted and are more likely to use costly emergency department services after discharge than non-visually impaired patients. The findings by lead author Dr. Alan R. Morse, JD, PhD, President and CEO of Lighthouse Guild of New York.
The findings of Dr. Morse and his colleagues point to the importance of understanding the needs of patients with vision loss. “It is essential that hospitals develop plans to assist patients with blindness or low vision as well as their families and caregivers before, during and after hospitalization. Focusing on the needs of patients with vision loss will lower costs and may lead to improved patient outcomes,” said Dr. Morse.
Approximately 3% of Americans over the age of 40 are legally blind and another 23% have low vision. The study found the average cost of a hospital stay for patients without vision loss was $47,289, for those with partial vision loss $48,870, and for those with legal blindness $51,133. Based on these figures, it is estimated that the total excess cost related to hospitalization of Medicare patients with blindness or low vision is $2.7 billion each year.