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HEALTHy 2015!

Happy and healthy new year to all.

Looking forward, looking back, resolutions, predictions. There’s so much of that as the old year winds down and the new year comes in, and I decided to take my pick.

I’m looking forward to more collaborations in 2015 – both in the sense of projects to work on, but also, in the larger sense of increased collaboration health research cutting across sectors of the health community. I’ve been noticing a tendency for initiatives to involve more and more stakeholders and sectors, to create larger databases, to increase enrollment in studies, to obtain patient input, and for all the other good reasons out there.

An example is the Optum Labs collaboration to pool health care data, and translate research findings into improvments in patient care. Some partners include AARP, Harvard Medical School, the Mayo Clinic, Pfizer – you get the picture. What a welcome change from only a few years ago, when these organizations worked in isolation from each other!

Another massive collaborative health research effort is the Observational Medical Outcomes Partnership (OMOP), a public-private partnership to develop methods for using observational healthcare databases to study medical products. Partners include PhRMA, FDA, and the Foundation for the National Institutes of Health. The effort has led to another collaborative, Observational Health Data Sciences and Informatics (OHDSI, pronounced “Odyssey”), a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics.

Collaborative health research is definitely in the air, and that is a fantastic change in the way we do things.

The UCSF blog put together its “Top Trends in Health and Science for 2015”, and second on their list is “Breakthroughs in Teamwork” with this quotation from Matthew State, MD, PhD, chair of Psychiatry,

One of the major drivers of recent progress has been a wholesale shift in culture. Investigators who were once fierce competitors are now finding ways to collaborate with one another in large-scale, multi-site genomic studies.

If someone else besides me is saying it, it must definitely be true! UCSF began an initiative in 2013 to promote team science, and they are taking serious measures to alter the academic climate and foster team approaches,

While scientific research is collaborative in its core, the traditional academic model rewards investigators who get primary credit for their research successes, including first or last authorship in published articles.

Here’s to more teamwork and collaboration in 2015, and lots of high quality science.

Deciding which meds are best for each child

“One Drug or 2? Parents See Risk but Also Hope”, a recent article in the NYTimes, caught my attention because of its focus on pediatric medication use.

The article portrays the issues around the decision to add an antipsychotic medication, Risperdal, to a daily regime of Adderall for attention deficit hyperactivity disorder, and begins with a story about Matthias, 6 years old.

The article describes the mother’s dilemma,

Her dilemma is shared by a steadily rising number of American families who are using multiple psychotropic drugs — stimulants, antipsychotics, antidepressants and others — to temper their children’s troublesome behavior, even though many doctors who mix such medications acknowledge that little is known about the overall benefits and risks for children.

It describes a family with a child who has not responded to the guideline recommended treatment of methylphenidate combined with behavioral therapy, and interviews physicians to find out their opinions about the treatment options. One psychiatrist interviewed, underscored the lack of evidence and and anecdotal nature of decision making when there is no evidence, saying, “When I prescribe multiple psychotropics, there’s a good reason — even if I don’t know the exact interactions or efficacy, there’s a clinical reason to give it a shot,” said Dr. J. Wesley Boyd, a psychiatrist at the Cambridge Health Alliance in Massachusetts. “But saying, ‘The last time I gave x, y and z to someone they did fine,’ that’s not science.” Another physician is quoted as cautioning the mother, “We’re really feeling around in the dark with this stuff.” He followed up by saying that he had never prescribed both medications to a child so young.

Questions are raised by this story

First of all, the glaring lack of evidence to inform clinical decisions and support evidence-based medicine.

Evidence based medicine means just that – a treatment or other medical procedure is studied, the evidence is weighed, and guidelines are developed to help providers decide on the best course for each patient. Unfortunately, we are without an evidence base for many medications used in children. Children have historically been excluded from clinical trials to protect them from research risks. This policy has been reversed in the past 10 or 20 years after realizing that children have not been served by this policy and that children are being treated with medications without an evidence base or guidelines to inform practice.

To clarify what this means, the pediatric labeling for Adderall (the first drug used to treat Matthias) is based on one study of 584 children with ADHD (age 6-12) for three weeks and on a second study of 51 patients (age and duration of the study not specified). Risperidone (the second drug being considered to treat Matthias) has been study in children age 13-17 with schizophrenia, age 10-17 with bipolar disorder, in combination with lithium or valproate for acute manic or mixed episodes associated with bipolar disorder, and in children age 5-17 with autistic disorder.

Second, the wide-spread off-label use of medications

One clinician quoted in the article says, “You cannot tell the family, ‘Come back in five years and we’ll treat you with this medication’ until the F.D.A.’s going to approve it.” The physician is referring to the lack of FDA labeling or approval to use the medication in children. When there is a lack of evidence for an indication or specific age group, FDA cannot approve the medication for that use. When clinicians believe that the drug should be used, despite the lack of evidence, this is termed “off-label” use. As the AAP notes in their press release along with the release of their policy statement, “Off-Label Use of Drugs in Children”,

“Pediatricians must prescribe drugs off-label, simply because an overwhelming number of critical drugs still have no information on the label for use in children”

AAP statement on off-label prescribing

The AAP policy statement proceeds to address ethical and legal concerns practitioners may have about off-label use of medications. The policy statement begins by saying, “The use of a drug, whether off or on label, should be based on sound scientific evidence, expert medical judgment, or published literature whenever possible.” For the reader, lack of evidence and lack of FDA approval are not identical, although evidence should lead to labeling, and lack of labeling suggests a lack of evidence. It is not clear what types of off-label use might meet the AAP criteria of sound scientific evidence, expert medical judgment and published literature in the absence of enough evidence to support practice.

If there is no evidence, is off-label use research? AAP policy states,

In most situations, off-label use of medications is neither experimentation nor research. The administration of an approved drug for a use that is not approved by the FDA is not considered research and does not warrant special consent or review if it is deemed to be in the individual patient’s best interest. In general, if existing evidence supports the use of a drug for a specific indication in a particular patient, the usual informed-consent conversations should be conducted, including anticipated risks, benefits, and alternatives. If the off-label use is based on sound medical evidence, no additional informed consent beyond that routinely used in therapeutic decision-making is needed. However, if the off-label use is experimental, then the patient (or parent) should be informed of its experimental status.

Again, it would be very helpful to have clarification on when the off-label use is considered to be experimental, and perhaps some examples or guidelines.

 What about the legal issues? AAP policy recommends,

… because the use of drugs in an off-label capacity can increase the liability risk for a practitioner should an adverse event or poor outcome ensue, it is essential that practitioners document the decision-making process to use a drug off label in the patient’s medical record.

The level of detail and type of documentation is not specified.

 So, what about the evidence?

Anti-psychotic medication children

FDA approvals for anti-psychotics in children

Neither the journalist nor the physicians interviewed mentioned any of evidence regarding the treatment decision, and while the evidence base is inadequate some evidence exists. Several reports have emerged in the literature describing the use of respiridone in addition to stimulants (methylphenidate) to manage ADHD, and the Agency for Healthcare Research and Quality published an extensive review, “First- and Second-Generation Antipsychotics for Children and Young Adults” summarizing the evidence around pediatric use of anti-psychotics. With over 156 pages plus appendices and state-of-the art systematic review methodology, the authors’ search strategy identified 10,745 citations, of which, 140 articles met the inclusion criteria, and 81 were unique studies. They reported low to moderate evidence that second generation anti-psychotics had beneficial effect on ADHD and disruptive behavior disorder (Table B). They also reported information about adverse events showing low to moderate quality evidence that placebo and anti-psychotic produce no differences for some adverse events, and favor placebo for others. The review excluded studies of combination treatments and does not directly inform the decision whether to add an anti-psychotic to the adderal regimen.

Resources

ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Subcommittee on Attention-Deficit/Hyperactivity Disorder, Steering Committee on Quality Improvement and Management, Wolraich M, Brown L, Brown RT, DuPaul G, Earls M, Feldman HM, Ganiats TG, Kaplanek B, Meyer B, Perrin J, Pierce K, Reiff M, Stein MT, Visser S. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011 Nov;128(5):1007-22.

Aman et al, Journal of the American Academy of Child and Adolescent Psychiatry, January 2014 “What Does Risperidone Add to Parent Training and Stimulant for Severe Aggression in Child Attention-Deficit/Hyperactivity Disorder?”

Atypical Antipsychotic Medications: Use in Pediatric Patients CMS Fact Sheet 2013

Gadow et al, Journal of the American Academy of Child and Adolescent Psychiatry, September 2014 “Risperidone Added to Parent Training and Stimulant Medication: Effects on Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder, and Peer Aggression”

 

Seida JC, Schouten JR, Mousavi SS, Hamm M, Beaith A, Vandermeer B, Dryden DM, Boylan K, Newton AS, Carrey N. First- and Second-Generation Antipsychotics for Children and Young Adults. Comparative Effectiveness Review No. 39. (Prepared by the University of Alberta Evidence-based Practice Center under Contract No. 290-2007-10021.) AHRQ Publication No. 11(12)-EHC077-EF. Rockville, MD. Agency for Healthcare Research and Quality. February 2012.

Now available on iBooks!

“What Pharmacists Need to Know About Racial and Ethnic Health Disparities”, available on iBooks

Available on iBooks - What Pharmacists Need to Know About Racial and Ethnic Health Disparities

 

 

 

 

 


iBooks lets you browse books and download them directly to your Mac®, iPad®, iPhone®, or iPod® touch.

The same content as the print book with the added convenience of

  • Interactive Images with callouts, pan-and-zoom, and pop-overs.
  • Scrolling Sidebars to cover relevant asides and tangential topics.
  • Highlighting and study cards – Use your finger as a highlighter when you’re reading a book on your iOS device or Mac. Just swipe over the selected text (using the trackpad on your Mac), and it’s highlighted. Notes and highlights automatically appear on study cards.
  • iBooks supports updates – that means if a book you purchased is republished with new or additional content, iBooks lets you know. You can download the updated version free, and it automatically replaces the older copy in your library.

A text for use in public health, health disparities, health services research, and related courses

for pharmacy students in their second, third, and fourth years of training. Discusses the concepts of race and ethnicity and the constructs used to classify and categorize them and provides an overview of the data collected regarding disparities in mortality, morbidity, provision of health care, and other health indicators and epidemiologic studies of mechanisms and pathways. Addresses racial and ethnic health disparities that can occur in real-world pharmacy care, such as differences in disease conditions, response to medication, access to care, health literacy, and understanding of health and medications.

As reviewed in the American Journal of Pharmaceutical Education

Print version available on Amazon.com

How much does your doctor’s visit/lab test/MRI/whatever, cost?

I don’t usually comment on health care costs – there are so many other people who have the economics and business background to address this important issue. I’m making an exception to highlight fellow Grinnellian, Jeanne Pinder, and her start-up, Clear Health Costs.

First, the bragging.

Jeanne is a Grinnell alum (like me!), and Grinnellians like to give each other a pat on the back. Grinnell is a small liberal arts college in the Midwest, and I always give it credit for instilling a great mix of academic excellence, creativity, independence, and integrity in its students and in me.

Clear Health Costs

Clear Health Costs

Jeanne Pinder left a career as a journalist at the NYTimes to found Clear Health Costs, a company that gathers information about health care costs and provides the information to the consumer. So, if you go to their website, you can specify the market (currently in NYC, SF, LA, Dallas-Fort Worth, Houston, San Antonio, and Austin) and look up prices for a walk-in clinic visit, mammogram, vasectomy, teeth filling, and much more. You can then CHOOSE where you want to go!!

This is clearly great for the consumer, but also very interesting for health geeks. Just why is there so much variation in costs?

Their work is getting good press from some important folks.

A JAMA Internal Medicine article,  “Variation in Prices for Common Medical Tests and Procedures” in November, reported on their initiative, PriceCheck, launched by KQED, KPCC and ClearHealthCosts to crowdsource health costs. PriceCheck found enormous variation,

“We next asked people to submit prices for lower back MRI. There was variation in prices paid by commercial insurers, government insurers, and cash prices. For CPT code 72148, we found that commercial insurers paid from $467 to $1567. But we found even greater variation when also reviewing additional types of payers not listed in the Table. Here, variation ranged from $255 to a self-pay price of $6221 at an academic medical center. The $255 price was for a patient covered by Medicare; the federal program’s payment was just a fraction of the facility’s charge of $2450.”

Following on the heels of the JAMA coverage, an article by Jeanne in the Harvard Business Review, and much more. I am most excited by the convergence of conversations across domains – from crowd sourced data to an editorial in JAMA. This is the way to address problems, and is a refreshing contrast to the days of yore when conversations in newspapers, television and academia did not overlap or cross-fertilize. Great to see the barriers breaking down, and a vigorous discussion emerge. Also great to see consumers meet and engage with health policy makers on common ground to address our irrational health cost structure, and, most inspiring, to see the profound value of information to shed light on areas needing transformation.

Very exciting!

Pharmacy Deserts – An Emerging Concept

What are pharmacy deserts?

You’ve heard the term “food deserts” – defined by USDA as, “urban neighborhoods and rural towns without ready access to fresh, healthy, and affordable food”. Pharmacy or medication deserts are analogous. The researchers who coined the phrase note they are defined by

“the low availability of the most commonly dispensed prescription medications in these areas.” (Amstislavski et al, 2012).

The concept builds on earlier geographic work examining not only the location of pharmacies, but variations in how pharmacies are stocked in neighborhoods of lower socio-economic status, or neighborhoods with large African-American or Hispanic populations. Researchers (and pharmacy student research assistants) mapped pharmacies in neighborhoods throughout New York City, and obtained information about pricing and stock availability for 13 frequently prescribed medications. They found variability in pricing as well as the pharmacy’s stocking of the prescriptions, and concluded,

“In extreme cases, entire communities could be deemed ‘medication deserts’ because geographic access to pharmacies and the availability of the most prescribed medications within them were very poor.”

Pharmacy deserts

 

Awareness of the role of pharmacies in access to care is growing.

The journal, Health Affairs, just published an article on Pharmacy Deserts in Chicago, “‘Pharmacy Deserts’ Are Prevalent In Chicago’s Predominantly Minority Communities, Raising Medication Access Concerns” (Qato et al, 2014), and the National Community Pharmacists Association (NCPA) picked up on this issue in a commendable way, noting that,

“About 32 percent of Chicago’s 802 communities were “pharmacy deserts,” meaning their residents met the researchers’ criteria for both low pharmacy access and low income.”

They also noted that,

“Between 2000 and 2012, pharmacy disparities worsened. While the number of pharmacies (particularly chains) in majority-white communities increased 20 percent during that time period, there was no such expansion in minority communities.”

These recent studies underscore the importance of taking a broad approach when considering access to care and treatments. Patients with insurance coverage may have limited access to care if they live in neighborhoods without pharmacies, or if the pharmacies in their neighborhood don’t stock needed medications.

If you’re interested in the issue of access to pharmacies take a look at these earlier publications:

  1. Bernstein et al., Disparities in access to over-the-counter nicotine replacement products in New York City pharmacies. Am J Public Health. 2009 Sep;99(9):1699-704.
  2. Cooper H, Bossak B, Tempalski B, Friedman S, Des Jariais D. Temporal trends in spatial access to pharmacies that sell over-the-counter syringes in New York City health districts: relationship to local racial/ethnic composition and need. J Urban Health. 2009;86(6):929-945.
  3. Morrison RS, Wallenstein S, Natale DK, Senzel RS, Huang LL. “We don’t carry that”–failure of pharmacies in predominantly nonwhite neighborhoods to stock opioid analgesics. N Engl J Med. 2000;342(14):1023-1026.

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