Category Archives: Hospice and Palliative Care

Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Recycle to Reduce Drug Overdoses

Recycling and prescription drug overdoses have something in common.

Recycling has become second nature in many parts of America. Bins and containers to collect excess paper, bottles and cans are ubiquitous. Yet, only a few a few decades ago, recycling seemed foreign, was not convenient, and took some effort and resolve on an individual’s part.

Keith N. Humphreys, Ph.D. (Sherry Boschert/Elsevier Global Medical News)

That same evolution has to happen in the way that we handle leftover medications, Keith N. Humphreys, Ph.D., told physicians at the American Academy of Pain Medicine annual meeting. There’s an epidemic of opioid overdose deaths in the United States, and the most common source of misused opioids is leftover medications obtained from friends and family.

He’s talking about a huge cultural shift – with consumers going from saving and sharing costly medications that can be hard to come by in the current health system to recognizing their potential for harm and routinely returning leftover drugs on “take-back days” organized by law enforcement or even depositing them in specialized “recycling” bins.

The number of opioid prescriptions dispensed by U.S. retail pharmacies increased from 76 million in 1991 to 210 million in 2010, according to a report by the National Institute on Drug Abuse. And since 1990, the rate of drug overdoses has tripled, increasing approximately from 4 per 100,000 people to 12 per 100,000 people, the Centers for Disease Control and Prevention report.

As someone who worked in hospices for a decade, Dr. Humphries knows the valuable role that opioids can play in relieving pain. So, how do we make opioids available but reduce the risk of addiction, abuse and accidental overdose?

There is no policy framework that will eliminate the tension between these two goals, but some policies will help avoid it, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He recently served as senior policy adviser at the White House Office of National Drug Control Policy, and  reports having no financial conflicts of interest on this issue.

Here, he said, are five emerging public policies, codes of practice, and cultural norms that “most people can agree on” while working toward harder-to-implement options like expanding addiction treatment programs:

1) Build prescription monitoring programs (PMPs). The idea is that physicians could check to see if a patient has received another opioid prescription recently before handing over a new prescription, to prevent drug-seeking patients from “doctor-shopping” to get more opioids. Thirty-six states have PMPs, though most are early versions that are slow, clunky and virtually worthless. Fourteen states and the District of Columbia have enacted legislation to create PMPs, and two states have no PMP plans.

PMPs “may be resisted and resented by many professionals, but they’re inevitable” and deserve support to quickly improve, Dr. Humphreys said. Plus, there’s a bonus for prescribers: In some states, checking with the PMP before prescribing an opioid gives physicians presumptive immunity from legal liability.

2) Lock doctor shoppers into one prescriber. Every week, a West Virginian dies of a drug overdose while holding prescriptions from five or more health care providers. Public and private insurers could tell patients who have opioid prescriptions from multiple providers that they must get all prescriptions from a single provider if they want their insurance to cover costs.

Recycling bins at the Palm Springs (Calif.) Convention Center, where the AAPM met. (Sherry Boschert/Elsevier Global Medical News)

3) Make prescription “recycling” a cultural norm. Legally, opioid narcotics can be returned to any Drug Enforcement Agency law enforcer, though some states also allow pharmacies to take back leftover drugs. When sheriffs in one small Arkansas town (population 20,000) organized a drug take-back day, residents brought in 25,000 pills, Dr. Humphreys said. A physician at the meeting from Santa Maria, Calif., said a drug take-back day organized by sheriffs there was so successful that they installed a permanent drop-off box outside the sheriff’s office. Dr. Humphreys urged physicians to promote drug take-back days in their communities.

4) Make abuse-resistant medication approvals easier. Currently, developing an abuse-resistant version of an addictive medication requires a new drug application, engendering a lengthy approval process and potentially hundreds of millions of dollars in costs. Government regulators should find a way to ease this massive disincentive for pharmaceutical companies to develop safer pain medicines, he said.

5) Change opioid-related medical practice. A potpourri of short- and long-term strategies could improve practice, he suggested. Patients should be told that sharing opioids is dangerous and illegal. Both patients and physicians need to learn that opioids are not the only response to pain. Emergency physicians should break their habit of automatically writing prescriptions for 30 days’ worth of a drug, and write for shorter time lengths when appropriate. Health care workers need to get better at recognizing addiction, and more attention should go toward ways of preventing “iatrogenic” addiction caused by the health care system itself.

Physicians need to lead the way in these efforts. “Who else?” he asked.

–Sherry Boschert (@sherryboschert on Twitter)

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

©froglegs/Fotolia.com

“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Could Everybody Just Be Quiet?

The disquieting association between higher-than-recommended levels of nighttime hospital noises and clinically significant sleep loss reported Jan. 9 in the Archives of Internal Medicine  would be an assault to the ears of Dr. Julia  Barnett Rice, the founder of the Society for the Suppression of Unnecessary Noise.

Courtesy Flickr user Swaraie/Creative Commons

Dubbed the “anti-noise queen” for her turn-of-the-century crusade against “preventable” noises such as the night-time whistles of tugboats traversing the Hudson near her New York City home, Dr. Rice (1859-1929) also campaigned tirelessly for the promotion of quiet zones near hospitals, decrying the too-loud and too-frequent environmental noises as murderers of sleep and menaces to health.

Fast-forward 100 years, and it appears that researchers at the University of Chicago have proven her point.

In an effort to confirm previous observations that noisy hospital rooms keep inpatients from getting quality sleep, medical student Jordan C. Yoder and colleagues, under the direction of Dr. Vineet M. Arora of the Sleep, Metabolism, and Health Center at the University of Chicago, sought to objectively measure noise and sleep duration in ambulatory adult hospital patients at the university’s medical center. Toward this end, they collected sleep and/or sound data from 106 consenting patients between April 2010 and May 2011, excluding individuals with  known sleep disorders, those with cognitive impairment, and those under respiratory isolation or who had been admitted for more than 72 hours (Arch. Intern. Med. 2012 Jan. 9 [172]:68-9).

They found that patient room noise levels were significantly higher than the World Health Organization’s (WHO) recommendations for average noise levels. Further, peak noise level “approached that of a chain saw,” according to their research letter. Nighttime sound levels were lower than daytime levels, but all still significantly exceeded recommendations for maximum noise level and 94% exceeded recommendations for average noise level.

More than 40% of the patients reported noise disruptions of sleep, which were associated with higher maximum noise levels.

Sleep actigraphy data demonstrated that ”patients slept significantly less in the hospital than their self reported baseline sleep,” the authors observed, and mean sleep efficiency when hospitalized was low, with more than half of the recorded nights measuring below the normal lower boundary of 80% efficiency for adults.

While roommates, alarms, intercoms, and pagers were all associated with substantial percentages of noise disruption, the most disruptive source of environmental noise, it appears, was chatty staffers, as the percentage of noise disruption attributed to staff conversation was 65%.

Dr. Arora noted that “some amount of sleep loss in the hospital may be expected given the unfamiliar environment.” In fact, she said in an interview, “our next studies are actually looking at this and the component that may be driven by loss of control or stress.” In the current study, however, “patients lost more sleep in the hospital when noise levels were loudest after accounting for baseline sleep characteristics, so at least noise seems like an independent predictor of hospital sleep, highlighting the importance of optimizing the hospital environment.” The magnitude of the difference, she explained, is one hour less sleep, “which is pretty significant,” Further, patients in noisier rooms reported more complaints of noise, indicating that noise is an issue, she said.

Based on their findings, the authors concluded that “hospitals should implement interventions to reduce nighttime noise levels in an effort to improve patient sleep.” One possibility, Dr. Arora suggested, is a device called a Yacker Tracker, which measures noise and provides feedback to the staff about when the noise level exceeds a certain threshold.

And now that patient report of noise is now a reported measure on Medicare’s Hospital Compare, it will be in the best interest of hospitals as well as patients to implement noise-reduction measures, Dr. Arora noted. “Noisy hospitals will want to optimize patient noise to provide the best experience possible,” she stressed.

The Society for the Suppression of Unnecessary Noise, and its founder, would be well pleased.

—Diana Mahoney

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Bundled Dialysis Payments May Leave Some Shortchanged

It’s difficult not to equate the Centers for Medicare and Medicaid Services’ bundled payment system for outpatient hemodialysis with, say, handing a 12-year-old boy a $10 bill to buy lunch and telling him to keep the change.

That the 12 year old might decide to forego the healthful $9.95 veggie wrap with a side of fruit in favor of the $1 Snickers bar so he can pocket the $9 profit is well within the realm of possibility. In the same vein, should we really be surprised to learn that hemodialysis facilities might not be optimizing patient care when they are being paid a flat fee vs. separate payments for each service —  if not to make a buck, to avoid losing one? A study reported during Kidney Week 2011, the annual meeting of the American Society of Nephrology, hints at just such a scenario.

Image courtesy of Image Courtesy Wikimedia Commons/Elembis/Creative Commons

Using data from the nationally representative Dialysis Outcomes and Practice Patterns Study (DOPPS) practice monitor, investigators with the Ann Arbor Research Collaborative for Health in Michigan determined that uncontrolled secondary hyperparathyroidism has been on the rise among black hemodialysis patients since the implementation in January 2011 of the CMS’s prospective payment system for dialysis services. The system bundles payments for dialysis treatments, supplies, drugs, and lab tests. It rewards facilities for meeting or exceeding quality measures in the Medicare fee-for-service system.

Although the revised payment system is intended to “improve patient outcomes and promote efficient delivery of health care services,” in the words of CMS administrator Donald Berwick, the Ann Arbor investigators hypothesized that the increased financial constraints may lead to less use of intravenous vitamin D analogs, and thus poorer control of secondary hyperparathyroidism (SHPT). Black patients would be left especially vulnerable because they require higher vitamin D doses on average than other patients, according to lead investigator Dr. Francesca Tentori.

To test the hypothesis, the investigators examined trends in parathyroid hormone (PTH) values and SHPT in dialysis patients from July 2010-February 2011 and observed a notable increase in PTH levels overall and in severe, uncontrolled SHPT (defined as a PTH level greater than 600 pg/ml) among black patients.

Specifically, the median PTH value rose among blacks from 296 to 379 pg/ml and from 244 to 283 among non-blacks, and the prevalence of SHPT rose significantly from 16-25% among blacks and slightly, from 9-11% among nonblacks,  Dr. Tentori reported.

Based on preliminary analysis, “these changes don’t appear to be related to decreased overall use of [SHPT] treatments, as the percentage of prescribed intravenous vitamin D rose slightly in both groups, or to changes in serum calcium or phosphorous,” Dr. Tentori said. The findings warrant further evaluation to tease out the cause of the trend, particularly because untreated SHPT has been linked to increased mortality risk in dialysis patients, she stressed.

Dr. Tentori disclosed financial relationships with Amgen, Genzyme, KHK, Abbott, and Baxter.

—Diana Mahoney

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TAVI Trek Begins

It took just two days after the Nov. 2 FDA approval of the Edwards SAPIEN transcatheter aortic valve for New York-Presbyterian Hospital/Columbia University Medical Center to claim bragging rights as the first center in the United States to implant the device as an FDA-approved standard of care.

The center will be one of four sites to train U.S. doctors in the procedure, and is promising to lead a live demonstration tomorrow (Nov. 9) at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco for those eager to get a front row view of transcatheter aortic valve implantation (TAVI).

Courtesy Edwards Lifesciences

The FDA approval also put the U.S. in the rare position of following the footsteps of some 40 countries that have already approved the SAPIEN valve including Latvia, Iran, and Russia. This fact elicited a good laugh at the recent Heart Valve Summit 2011 in Chicago, but also prompted much dialogue about some of the thorny ethical and economical consequences that still lay ahead.

“Is anyone at the government talking about rationing of care?” asked Dr. Stephen Strelec, an anesthesiologist at University of Pennsylvania Medical Center, at the summit. It’s not just the 92-year-old who says “I want to live,” but the younger patient facing a valve procedure who decides they don’t want to be on anticoagulants and undergo surgery because they can afford this expensive new transcatheter valve in 2 years. “There’s an economic consequence to that decision as well,” he said.

Dr. Robert Bonow, director of the center for cardiovascular innovation at Northwestern, said the issue is being looked at by federal agencies and insurers, but added that it is “one of the biggest hot-button items about this whole technology because it’s not going to be cheap.”

Dr. David Adams, chair of cardiothoracic surgery at Mount Sinai Medical Center, said they’ve already had their share of 90-year-olds wheeled in from the nursing home by family members who read about TAVI in the newspaper and want mom to stay alive.

The suggestion was made that surgeons and interventional cardiologists will have to hone their skills in making the very specific diagnosis of medical futility, and that a board-certified palliative care physician will be one of the most valuable members of the multidisciplinary teams treating these patients.

“Every PARTNER site looking back over their patients can name patients that they wish they didn’t enroll in the trial and done the valve on,” said Dr. Howard Herrmann, director of interventional cardiology and cardiac catheterization at the Hospital of the University of Pennsylvania. “The question is how to recognize them up front.”

Edwards Lifesciences and the FDA are setting up an intensive training program with simulations, an expert review of cases and a proctoring system. Still, the challenge for Edwards and other companies that will follow will be enormous in terms of launching this technology outside the clinical trial setting, said Dr. Adams, co-principal investigator of Medtronic’s CoreValve trial.

“You can not overestimate the amount of company support you’re going to need to do these things safely,” he said. “This is not a new widget you can pick up in one or two tries like a new ring or new stent…It’s a whole new process.”

The European experience, albeit the initial experience, suggests there’s a distinct learning curve to TAVI. A meta-analysis of 12 TAVI trials presented at this summer’s European Society of Cardiology Congress, reported a flattening of mortality curves 8 years after the first human case in 2002, with procedural mortality decreasing from 16.7% in 2004 to 0.0-0.6% in 2010 and 30-day mortality plummeting from 67% to 11% over the same time period. The authors, led by Dr. Pablo Salinas, University Hospital La Paz, Madrid, credit technical improvements in the devices, better patient selection and on-site case proctoring as helping to shorten the learning curve.

—by Patrice Wendling

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Palliative Care in the Comfort of Home

Meet the Health Buddy, a telehealth technology intervention that significantly improved the symptoms and quality of life for head and neck cancer patients in a randomized trial by delivering symptom management in the comfort of the patient’s home, computer not required.

courtesy of wikimedia commons user Arglos/collected via GNU Free Documentation License

Cynthia Ellis Keeney, RN, MSN, couldn’t contain her excitement as she presented her group’s study findings in a poster session at a palliative care summit in Bethesda, Md. The meeting was sponsored by the National Institute of Nursing Research and partner organizations.

Head and neck cancer patients suffer terribly from a range of symptoms, and they often find it difficult to talk and uncomfortable to leave the house, said Ms. Keeney.

She and her colleagues randomized 80 newly diagnosed head and neck cancer patients to an intervention with a telehealth device or usual care. The telehealth device was connected to a landline phone and featured a small screen with large buttons.

The device allowed patients with limited computer savvy and no internet access to benefit from the convenience of the telehealth intervention, Ms. Keeney emphasized.

Each day, a green light on the Health Buddy would blink, prompting patients to respond to questions about how they were feeling that day. Based on their answers, the system would recommend an intervention, such as asking the doctor for a drug to treat a particular symptom (for example, constipation). Symptom control algorithms had been used to generate questions based on symptoms that are most likely to occur during the active phase of cancer treatment. The phone number of the patient’s doctor had been programmed into the system for immediate access.

After the active phase of their cancer treatments, patients in the Health Buddy group reported significantly higher physical well being than did controls.

Although the doctors and patients weren’t connected visually in real time, the patients felt that being able to define their symptoms through the Health Buddy and receive suggestions for symptom management allowed them to have better conversations with their doctors, Ms. Keeney said. As a result, “the patients in the intervention group thought they got better care,” than if they had not used the Health Buddy, she added.

–Heidi Splete (on twitter @hsplete)

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