Presentations from a panel at Health Journalism 2013:

From compounders to drug shortages: Covering pharmacies and pharmacists
• Michael R. Cohen, R.Ph., M.S., president, Institute for Safe Medication Practices
• William Churchill, M.S., R.P.H., chief of pharmacy services, Brigham and Women’s Hospital
• John Walczyk, pharmacy manager, Johnson Compounding and Wellness Center

Keldy Ortiz wrote about the panel for Covering Health: Growing challenges to safety, adequacy of drug supply

Previous coverage

The Boston Globe‘s coverage of a fungal meningitis outbreak tied to contaminated drugs won first place in the public health category of the 2012 Excellence in Health Care Journalism Awards. See the coverage as well as a questionnaire about how they reported on the topic.

FDA regulation

In her tip sheet on the anti-aging movement, Arlene Weintraub touches on compounding pharmacies. She notes that the U.S. Food & Drug Administration has tried unsuccessfully to put a halt to improper marketing claims by compounding pharmacists and its continuing efforts in this area are well worth following. In the aftermath of the earlier meningitis outbreak traced to a compounding pharmacy, at least two legislators said they will draft legislation to give the FDA more oversight of compounding pharmacies.

On April 26, senators introduced a draft bill to make clear oversight responsibilities for pharmaceutical compounding.

Budget Victim: Inspections For Compounding Pharmacies, WBUR, May 20

The FDA has a section of its website devoted to compounding pharmacies.

Transparency

This also might be a good time to remind public officials that there is now guidance on what information should be made public when someone dies or falls ill during a public health emergency. The document – developed by leaders in public health and health-care journalism – provides a framework for releasing such information as the age and location of private individuals who have been affected by an epidemic or other public-health event.

Pharmacy industry groups

• Senate draft proposal would clarify FDA authority over high-risk compounding, American Pharmacists Association
• Independent community pharmacist testifies at U.S. House hearing on pharmacy compounding, National Community Pharmacists Association
• National Alliance of State Pharmacy Associations
• American Association of Colleges of Pharmacy
• National Association of Boards of Pharmacy
• International Academy of Compounding Pharmacists
• Pharmacy Compounding Accreditation Board
• Professional Compounding Centers of America

… As we gather more resources, we will add them to this post …

The Center, based at the University of Southern California, partners with local news organizations to produce in-depth coverage of health issues.

For nearly 25 years, Kipling was an editor at the Los Angeles Times. From the announcement:

In 2008 Kipling was tapped by USC Professor Michael Parks to lead a pilot project aimed at assessing the feasibility of a California health-reporting organization. When the center was officially launched in 2009, Kipling became its managing editor, and he since has edited most of the center’s projects.

Read the full announcement …

Photo by State Farm.

As the residents of Moore, Okla., begin the cleanup and recovery process from the super-tornado that destroyed the town and claimed at least two dozen lives, the physical and mental health of the older population requires special handling. This is especially true for those over age 75 and the frail elderly, who are considered vulnerable and high-risk populations, according to the Substance Abuse and Mental Health Administration (SAMHSA).

Many older adults suffer from multiple chronic conditions – including diabetes, heart disease, arthritis, and dementia – and juggle multiple medications. Access to prescriptions may suddenly be cut off when someone is moved to a shelter or temporary housing. Adherence becomes an issue. Missing medical records, lack of a person’s ability to recall all prescribed medications, delays in refilling prescriptions, and stress contribute to compliance challenges.

Other physical and environmental conditions, ranging from struggles with activities of daily living (ADLs) and instrumental activities of daily living (IADLs), to poor sensory perception, to loss of electricity and water, add to an increased sense of vulnerability, according to researchers. Temporary living conditions may exacerbate these conditions – appetite may be affected and access to some foods may be limited, which impact chronic disease management. Sleep is disrupted, mental and emotional stresses take a toll on the body and mind.

The Geriatric Mental Health Foundation advises that mental health support is as vital as meeting physical needs. Even before disaster occurs, mental issues need attention. Diminished cognitive capacity makes it more difficult for some elderly people to understand and follow instructions. Decision-making skills may be in decline. Language, cultural, educational, and socio-economic barriers can increase confusion and misunderstanding. According to FEMA, it’s not uncommon for elderly survivors of natural disasters to be withdrawn, confused, anxious, or depressed. Anger, grief, insomnia, and even thoughts of suicide may also manifest among this population post-disaster.

The American Red Cross teaches psychological first aid to many relief workers to assist in minimizing stress and improving coping skills. While that may provide short-term help, mental health issues linger for years following a natural disaster. Post-traumatic stress disorder is not uncommon among older adults in these situations. Ongoing counseling is necessary, yet access may be a real problem. One solution is telephone counseling, like the national Disaster Distress Helpline, established by the Mental Health Association of New York City and SAMHSA following Hurricane Katrina. It’s a permanent, free, 24/7 line that provides confidential disaster crisis counseling in several languages.

Ironically, this is Older Americans Mental Health Awareness Week. There are many possible tie-ins for reporters to cover:

• What is the availability of services in your community to address the mental health needs of older adults in general and/or during a disaster?
• Signs and symptoms of mental illness in older adults – and why they are often mistaken for “normal” signs of aging
• Help for caregivers of older adults with mental illness – things they should know
• Obtain a copy of the state, county, or city health department’s disaster preparedness plan; see whether physical and mental health needs of older adults are addressed in detail, including pre, during, and post event.
• Check with local teaching hospitals on whether any studies or reviews on PTSD and seniors are underway. This may be especially useful in areas hit by other large-scale disasters, including hurricanes, earthquakes, smaller-scale tornadoes.

Shannon Muchmore

As many of you know, it can be hard following an ongoing story – keeping up with the latest developments, looking ahead and staying ahead of the competition, finding the larger stories and putting it all into context.

Shannon Muchmore of The Tulsa World has been doing just that since the end of March, reporting on an investigation into a dentist whose clinics have been cited for multiple violations, many related to unsanitary practices. Hundreds of patients are being tested for HIV and hepatitis and officials say as many as 7,000 patients may have been exposed since 2007.

Amid a steady stream of stories, she took the time to share some of her insights into the complexities of the unfolding drama, including how her daily work life has changed, the level of risk faced by patients and some tips for other reporters.

The debate, and the fight for the documents, are detailed by Mary Beth Pfeiffer in the Poughkeepsie (N.Y.) Journal and by documentary film maker Kris Newby on IRE’s Transparency Watch blog.

In 2007, in doing research for a film, Newby requested emails and resumes pertaining to three employees at the Center for Disease Control and Prevention. She writes that “For five years the agency strung me along with frivolous denials, mysterious delays, shifting explanations and false promises. In essence, the delays became an illegal, off-the-books FOIA denial.” Her account of how the CDC handled – or didn’t handle – her request is alarming.

Newby, whose film had been completed, provided the 3,000 pages of documents to Pfeiffer.

The documents show close connections between the government officials who set disease policy and researchers who have received government funds and written treatment guidelines. “As a result, physicians and scientists with opposing views on Lyme disease believe they have been marginalized in the debate.” This graphic provides a good overview of the connections and issues.

The list of problems with primary care today is long and long-standing. P

All this as the nation prepares for a spike in demand for primary care providers – fueled by millions of patients newly-insured through the Affordable Care Act – and a drop in supply due to retirements in the aging physician workforce and the unpopularity of the specialty, according to four panelists at Health Journalism 2013.

“I hate to be a downer,” said Andrew Morris-Singer, M.D., president and principal founder of Primary Care Progress. “We do have profound problems in the primary care pipeline.”

Solving the problem boils down to making essential changes to the way primary care providers do business, the panelists agreed.

These practices of the future – some of which already are operating – emphasize engaging patients, using technology, and distributing patient care across a primary care team.

Jane Maffie-Lee, a nurse practitioner, is the clinical program director at the Ambulatory Practice of the Future at Massachusetts General Hospital. The program treats hospital employees and is meant to reduce costs while increasing the satisfaction of patients and providers.

Features of the practice include sharing patients’ medical records with them, and maintaining a team environment where everyone from front-desk clerks to health coaches run staff meetings.

“It’s important for us to have a culture of collaboration with our patients,” Maffie-Lee said.

G. Alan Kurose, M.D.,’s Rhode Island practice, Coastal Medical Inc., operates under similar principles. A provider is available to patients every day of the year, and the practice uses its data to analyze costs of care through comparisons of insurance claims and clinical information.

For the new approach to work, future primary care doctors need to master skills not previously associated with medical training.

Morris-Singer started his national nonprofit, Primary Care Progress, to promote the curriculum changes and to spotlight innovations.

Harvard Medical School started focusing on such changes about two years ago, with its new center for primary care.

Primary care doctors of tomorrow need to be excellent clinicians, but also to be effective communicators and leaders who know how organizations work and how to work on a team, said Andrew Ellner, M.D., M.Sc., a co-director of the Harvard Center for Primary Care and a practicing internist at Brigham and Women’s Hospital.

“For us to succeed in health care reform, the transition is really from a system that’s built completely around doctors to ideally a system that’s built around people – I would even say patients,” Ellner said. “And that’s a pretty dramatic and profound, not just system transformation, but cultural transformation.”

Related

• Covering primary care in the 21st century
• Changes coming to health care workforce ripe for coverage
• Primary Care Physician Shortage Requires System Overhaul, Panel Says

Photo by planetc1

If you follow me on Twitter, you may have noticed several 140-character conniptions I had last week over coverage of a Danish study that used antibiotics to treat low back pain.

I generally feel pretty protective of health reporters. I’m in the trenches with you. I have good days and bad days, too. Deadline reporting on medical studies is tough and sometimes undervalued for the work serious, balanced coverage requires. I’m with you.

Even so, I was dismayed by most of the stories I was reading.

Reporters were trumpeting the results of two studies published in the European Spine Journal, a less influential medical journal.

The first study tested tissue samples from patients who had suffered from bulging, or herniated discs in their spines. Nearly 40 percent of those patients tested positive for bacteria. And the presence of bacteria was associated with a certain kind of bone swelling, called Modic type 1 changes, near the ruptured disc.

For the second study, researchers recruited 162 patients with Modic type 1 changes and chronic low back pain. They randomly assigned half to take a 14-week course of antibiotics, while the other half took placebo pills. After one year, the placebo group saw little change in their back pain, while the group that got antibiotics saw significant improvements in measures of pain and disability.

Taken together, the studies suggest that antibiotics could dispatch as many as 40 percent of all cases of chronic low back pain.

Lower back pain is notoriously tough to treat. Pain relievers and muscle relaxants often don’t touch it. It usually gets better over time on its own, but it also commonly comes back time and time again. Surgery is almost always considered a last resort for most patients because it makes the problem worse nearly as often as it helps. So a 40 percent “cure” rate, if it were true, would be a big deal.

The British press widely quoted a neurologist and spinal surgeon, Dr. Peter Hamblyn: “Make no mistake this is a turning point, a point where we will have to re-write the textbooks,” he said in a quote for this cringe-worthy story in The Daily Telegraph. “It is the stuff of Nobel prizes.”

Wait now. What was that? Nobel Prizes? For a study of 162 patients?

Small studies like this one don’t even warrant a change in practice, says Richard Deyo, M.D., M.P.H., a back pain specialist and a professor of evidence-based medicine at Oregon Health and Sciences University, in Portland. Deyo called the study “innovative and provocative,” but said he’d also like to see some serious attempts to replicate the results before it was tried on patients.

But it gets worse; those weren’t the only ones that picked up on that Nobel quote.

The Guardian wrote a slightly more responsible story but still saw fit to paraphrase the over-the-top quote, as did The Times of London.

Who was this guy, Peter Hamblyn, and why was he suddenly passing out Nobel prizes? As it turns out, he was the guy who helped organize a press conference to publish the study. He’s also a doctor who stands to make money off the treatment, through a website he set up with the study’s author to promote the therapy, which has been dubbed MAST, for Modic Antibiotic Spinal Therapy.

Only one story, from the Independent, included that information. That story also reached out to independent reviewers to get a more balanced take on the study.

By far, the best story of the bunch came from Canada’s Globe and Mail.  There was no mention of Nobel prizes, just balanced comments from two independent back pain experts. O Canada!

(Apparently I wasn’t the only one who thought the coverage of these studies needed a closer look. Dr. Margaret McCartney, a general practitioner from Glasgow, did a great roundup of the whole debacle for the BMJ’s Medicine in the Media column.)

Here’s what’s really troubling about this whole mess. The antibiotic therapy these two doctors are pushing is easy to get. Doctors could try it now just by writing off-label prescriptions for the treatment.

Stories that failed to note the serious conflicts of interest behind the push to promote the study did a great disservice to back pain patients, many of whom are desperate for help.

A long course of antibiotics isn’t likely to be harmless. And the study notes that 21 percent of patients experienced serious side effects, though the authors didn’t detail what they were.

“Cases of C. difficile colitis seem inevitable if this is widely implemented,” Deyo said. What’s more, “Prolonged [more than three months] broad spectrum antibiotic therapy in substantial numbers of people will undoubtedly contribute to antibiotic resistance,” he said. “There are big stakes in being right about this.”

Photo by um.dentistry via Flickr

Advocates for the poor and uninsured have worked long and hard to bring attention to the shortage of dental care for millions of Americans.  On Wednesday, the American Dental Association weighed in on the problem too, announcing a nationwide campaign designed to respond to address what leaders called the nation’s “dental crisis.”

“We’ve made great progress with each generation enjoying better dental health than the one before,” ADA President Robert Faiella, D.M.D., noted. “But there is still a dangerous divide in America between those with good dental health and those without. Our mission is to close that divide. Good oral health isn’t a luxury – it’s essential.”

Yet many go without that care.

While a vast majority of middle- and upper-income Americans reported good access to dental services, nearly half of lower-income adults said they had not seen a dentist in a year or more, according to a Harris poll released by the ADA as part of the campaign’s launch. The poll also found that poor Americans are more than two times as likely to be toothless than their wealthier counterparts and that low-income adults were far more likely to seek last-resort care in emergency rooms than their better-off counterparts.

Nearly 1 in 5 low-income adults said they or a household member had sought treatment for dental pain in an emergency room.  Yet only 6 percent of the poor who went to ERs for help with dental emergencies said their needs were met, the poll found.

The Action for Dental Health campaign includes a number of strategies intended to address the problems faced by different populations. One initiative would divert patients with dental emergencies from hospital ERs to local dentists and clinics where their needs might be appropriately addressed. Others would focus on delivering preventive care and basic treatments by getting more private practice dentists to contract with federally qualified health centers (FQHCs), increasing the free care dentists offer at Give Kids a Smile events and expanding care to nursing home patents through a long-term care initiative.

The campaign also seeks to streamline Medicaid credentialing processes and increase reimbursement rates as a way of getting more dentists to treat the poor.

Some of the advocates who have been working for broader changes in the system said they were glad to hear the ADA acknowledging the lack of care experienced by millions of Americans.

“I think it’s an important step they took in calling attention to the access crisis,” said Jane Koppelman, research director for the Children’s Dental Campaign at the Pew Charitable Trusts.

But she and others said the ADA campaign stops short of getting to the heart of the dental crisis. They point to the lack of providers in poor and isolated places such as the thousands of federally-designated dental health provider shortage areas.

“To me it seems like they are talking about referral mechanisms. But what do you do when there is no dentist to refer to?” asked Sarah Wovcha, executive director of Children’s Dental Services, a Minneapolis, based nonprofit which operates scores of clinics treating poor children. “We need more affordable dentists or another type of provider.”

Recently the work at Wovcha’s clinics has been done with the help of dental therapists, midlevel dental auxiliaries trained to do such things as fill cavities, place crowns, give local anesthesia and, in some cases, pull teeth.

Wovcha says the therapists, who work under a dentist’s supervision, provide high quality care at a low cost, allowing her to reach more patients in need. She believes the model, now used only in Alaska and Minnesota could help answer needs across the country. With support from organizations including Pew, Kellogg and Community Catalyst, grassroots efforts aimed at giving the model a try are pressing forward But they are meeting with fierce resistance from the ADA.

What is going on in your state to address the nation’s dental crisis? Now might be a good time to ask.

“… officials at the Centers for Medicare and Medicaid Services say the job of monitoring prescribing falls to the private health plans that administer the program, not the government.”

CMS officials say Congress never intended for the agency to monitor prescriptions and never gave it authority to do so, though they could not cite the provision in the law that limits its oversight ability.

In fact, “the Office of the Inspector General of the Department of Health and Human Services has repeatedly criticized CMS for its failure to police the [prescrition] program, known as Part D.”

The story, also published in The Washington Post, was done using data obtained under the Freedom of Information Act and “makes public for the first time the prescribing practices and identities of doctors and other health-care providers.”

A sidebar explains the data the reporters received from CMS and how they analyzed it.

The Part D records detail 1.1 billion claims in 2010 alone, including prescriptions and refills dispensed. ProPublica has created an online tool, Prescriber Checkup, to allow anyone to search for individual providers and see which drugs they prescribe.

For reporters interested in localizing the story, ProPublica will host a reporters’ conference call on Tuesday, May 14 at 2 p.m. ET to walk journalists through the app and how best to utilize it for their own reporting. Participants should sign up in advance.

• Kimberly Alleyne, independent journalist, Sterling, Va.
• Joyce Flory, independent journalist, Chicago
• Katharine Gammon, independent journalist, Santa Monica, Calif. (@kategammon)
• Rose Pike, executive editor, Everydayhealth.com, Brooklyn, N.Y.  (@rosepike0)
• Amy Trent, health reporter, News & Advance, Lynchburg, Va.  (@amylynnetrent)
• Moria Byrne Zaaloff, student, New York University, Bronx, N.Y.  (@globalgeek4good)

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