Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Friday, February 13, 2015

Non-Pharmacologic Treatment of Functional Abdominal Pain: What Works?

By: Lewis First, MD, MS; Editor-in-Chief

          If you read our journal or others, you are bound to run into a variety of studies trying to identify the best therapeutic approach to functional abdominal pain.  Ideally the goal is to avoid prescription pharmacologic intervention and focus on non-pharmacologic strategies like changes in diet, lifestyle, cognitive behavioral therapy, pre- and probiotics, or alternative or integrative medical approaches. 
So what works best?  Rutten et al. (doi: 10.1542/peds.2014-2123) have performed a systematic review of this topic that we are releasing this week online identifying all randomized controlled trials done in children with functional abdominal pain.  While the quality of evidence was “very low-moderate” overall, the authors did find some studies showing efficacy of some of the modalities mentioned above and a few others not yet mentioned in this blog. 
Given how common this problem is with our patients, reading this review article should not hurt at all and may result in trying some options you have not tried before, and giving up on others where the evidence is poor.  What have you found to be successful in treating your patients with functional abdominal pain?  We’d love to hear your solutions to this problem and “what works” by responding to this blog, sending us an e-letter, or commenting on our Facebook or Twitter sites.
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Saturday, August 2, 2014

More Pediatric Drug Trials & Fewer “Off Label” Prescriptions?

Pediatrics Editorial Board Member Joann Schulte, DO, MPH, shares her expert perspective on a new article from our August issue. To learn more about Dr. Schulte and her work in general pediatrics and preventive medicine, check out her bio on our Contributors page.

By: Joann Schulte, DO, MPH
Photo by Kathea Pinto via Flickr

One of my nieces has just graduated from college, a feat that seemed unlikely when she was 16 years old and admitted to a pediatric ICU. She had serious injuries after a school bus crash, and during the graduation ceremony her mother recalled those months of hospital stay and rehab. "Thank God--or maybe the doctors--that she had the right drugs and good doctors," my sister-in-said. I didn't add to her anxiety by telling her that many of the drugs were used off label because the clinical trials to establish dose, safety and efficacy in children hadn't been done.

New research published in the August issue of Pediatrics chronicles some progress in the area of clinical research to benefit children.  Wharton et al. from the Food and Drug Administration (FDA) and Duke University (doi: 10.1542/peds.2013-2987) examined the outcome of 401 requests made by the FDA between 1998 and 2012 under the Pediatric Exclusivity (PE) Program.

PE was established by Congress in 1997 and offers six months of additional market exclusivity in exchange for conducting specific pediatric studies requested by the FDA. Pharmaceutical companies must adhere to a trial protocol that comes from the FDA.

The pharmaceutical company responded to fewer than half (189, 47 percent) of the FDA requests. Of the 189 drugs for which studies were done, 173 (92 percent) resulted in new pediatric labeling and 108 (57percent) received a new or expanded pediatric indication.

The PE program focuses on drugs that are still under patent. A related commentary by Drs. Matthew Laughon and Daniel Benjamin (doi: 10.1542/peds.2014-1585) notes that the program does not deal with off patent drugs, which also often are lacking in pediatric labeling. The Pediatric Trials Network oversees protocols for those drugs, and six applications have been submitted to the FDA.

Pediatric drug research still needs more trials and funding. Children and the illnesses that impact them deserve better labeling and more research.

Wednesday, July 16, 2014

Dosing Out Some Concerning Information on Parent Errors in Administering Medications to Children

By: Lewis First, MD, MS; Editor-in-Chief 

Illustration by Nemo via Pixabay
If you have ever looked at instructions for medications to be administered to children, you will find dosage amounts listed in every unit from milliliters to teaspoon or tablespoons or droppers-full. Sadly, when one varies the dosing measurement scale, errors are prone to happen, especially if well-meaning parents use non-standardized kitchen spoons instead of the recommended spoon size on a package.

To determine just how serious the frequency of dosing errors might be, Yin et al. (doi: 10.1542/ peds.2014-0395) did a cross-sectional analysis of almost 300 parents whose children were prescribed liquid medications in two different emergency departments and identified a high percentage (39.4 percent) of errors in measuring the correct dose, either by not understanding the amount in the prescribed dose or using a nonstandard instrument to measure out what they thought was the correct dose.

When milliliters were used instead of spoon size, the rate of errors decreased. The authors identify subgroups of parents and types of measurements that increased the chance of dosing errors, and my prescription is to read the article in detail so you might be better able to recognize risk factors for doing errors before they actually occur.

This article is a bitter pill to swallow—especially when we hope parents are giving their children just what the doctor ordered and in a number of cases—are not.

Do you have any tips you use to reduce dosing errors in your patients? Why not share them with us by commenting below, via an eLetter or by posting on Facebook or Twitter.

Related Reading:

Wednesday, June 18, 2014

A Pediatric Learning Health System & the Search for an Effective IBD Treatment

By: Lewis First, MD, MS

TNF α, (Public Domain)
Children with inflammatory bowel disease (IBD) are commonly seen by both primary care providers and gastrointestinal specialists but never with high enough numbers to really know if a specific approach to IBD is better than others—that is until the arrival of ImproveCareNow (ICN), a network of practices linked together as a pediatric learning health system, which allows standardized data-gathering across sites at multiple children’s hospitals in real time to best determine methods to improve the quality of outcomes in these chronically ill children, teens, and young adults.

This week, Forrest et al. (doi: 10.1542/peds.2013-4103) share with us the result of how the ICN network can be used for high-quality clinical research by looking at data across 35 pediatric gastrointestinal practices as a sequence of non-randomized trials. The study question was whether anti-TNFα therapy was effective at achieving clinical and steroid-free remission rates when compared to children not getting this treatment. The results involve more than 1,800 of 4,130 patients with Crohn’s disease getting this therapy who were then compared to those not receiving TNFα. The results will bowel (I mean bowl) you over and herald this type of network as a valuable research tool for improvement.

To help further highlight the value of learning health systems like ICN, read the accompanying commentary by Abernethy (doi: 10.1542/peds.2014-1182), which further explores the what learning health systems are, how they are put into practice (or not) and the kinds of research opportunities they present.

Both study and commentary will make your helping families with inflammatory bowel disease far less painful than you might imagine dealing with this illness might be, so read on and learn more!

Friday, May 30, 2014

High-Dose Methylprednisolone & Caustic Esophageal Burns: A Hot Topic

By: Lewis First, MD, MS

Photo via Wikimedia Commons
Whether or not to use corticosteroids to prevent strictures in esophageal caustic burns has been controversial over the years, but Usta et al. (doi: 10.1542/peds. 2013-3331) attempted to look at this issue by randomizing children with corrosive burns to either receive high-dose methylprednisolone or not along with cases and controls also receiving ranitidine, ceftriaxone, and total parenteral nutrition. The outcome was the development of strictures after treatment with or without the steroids as well as any side effects recorded in both groups with the therapeutic treatments received.

If you are a supporter of steroids, you’ll like what you read, and if not, then share your thoughts as to why the findings here will or will not change your decision to treat with steroids the next time you encounter a caustic bleed by responding to our blog, writing an eLetter or sharing a comment via Facebook or Twitter.

Of course the best way to deal with a caustic burn is not to let one happen—so no matter what you decide to do regarding treatment, it never hurts to talk poison prevention with your patients and families to ensure that caustic substances are locked away and secured from young children so esophageal burns as described in this study cannot happen.

Tuesday, April 22, 2014

Codeine Use Despite Two National Guidelines That Say No

Public Domain Photo via Wikimedia Commons
Since 2006, there have been two national guidelines recommending avoidance of codeine in children for cough or upper respiratory symptoms—so how effective have those guidelines been in curtailing use of this drug for this purpose?

Kaiser et al. (doi: 10.1542/peds. 2013-3171) did a cross-sectional ten year look at codeine prescriptions written in emergency facilities as part of the National Ambulatory Care Survey both before and after the guidelines were published. The results may surprise or more likely disappoint those of you who are not using codeine for common cough and cold symptoms. Many still are. Why?

Both the authors and an accompanying commentary by pediatric toxicologists Drs. Alan Woolf and Christine Greco (doi: 10.1542/peds.2013-4057) shed some light on this issue and are worth your consideration. Hopefully publishing this article and commentary will make more of a dent in curtailing codeine usage than efforts have to date—but read both and learn more.

Related Reading:

Thursday, March 27, 2014

Ceftriaxone and Acute Renal Failure: A Rare but Real Complication

Ceftriaxone, Public Domain Image
We certainly use ceftriaxone for a number of common bacterial diseases and usually with minimal, if any, complication.

This week, however, Li et al. (doi: 10.1542/peds.2031-2103) share 31 cases of postrenal acute renal
failure in children who recently received ceftriaxone. How these children presented, what their renal findings were, and how they were treated makes for an interesting article.

If you did not know about this possible adverse effect of this very commonly used antibiotic, this article is for you. Head over to the Pediatrics site and learn more.

Tuesday, March 18, 2014

Weighing the Ups and Downs of ADHD and Stimulant Use on BMI Trajectory

Photo by Nemo via Pixabay
Prior studies in our journal and others have suggested that attention deficit/hyperactivity disorder (ADHD) in the absence of stimulant use is associated with an increased risk of childhood and adult obesity. But what happens when stimulants are started, and does the duration of their use influence BMI trajectory?

Schwartz et al. (doi: 10.1542/ peds.2013-3427) release their findings this week gathered from longitudinal electronic health record data on more than 164,000 children aged 3-18 years. The role that stimulants play during childhood and how the BMI trajectory can change during adolescence is a study you should pay attention to if you follow patients with ADHD—and there are few pediatricians practicing primary care who do not. Read this study and learn more.

Related Reading:

Friday, February 28, 2014

Case Report: Posterior Reversible Cerebral Edema Syndrome

Our Case Report Editor, Dr. Jeffery Malatack shares a case report we early released this month from our upcoming March issue:

Posterior reversible cerebral edema syndrome, often referred to as posterior reversible encephalopathy syndrome (PRES), has been recognized more and more frequently since its original description by Hinchey in 1996 as a complication of systemic hypertension.

MRI image of PRES patient by Stevenfruitsmaak
via Wikimedia Commons
PRES is a potentially reversible clinico-radiological entity characterized by the insidious onset of headache, confusion, visual disturbances and seizures associated with brain edema, which predominates in the posterior cerebral areas and in the white matter on imaging. Some believe loss of autonomic control of the posterior cerebral circulation is at the basis of the clinical presentation. Many varied medical conditions as well as multiple drugs have now been associated causally with its presentation. Common to all of these conditions and drugs is the development of significant systemic hypertension.

Dr. Milani and colleagues writing out of Milan, Italy (doi: 10.1542/peds.2013-1301), report yet another drug implicated as potentially causative. Risperidone, a second generation antipsychotic agent, caused PRES in a thin 12-year-old female who did not suffer from pre-treatment hypertension but developed hypertension once the drug was used and resolved when the drug was discontinued. A validated drug reaction scale suggested that the relationship between risperidone and PRES was in the probable range.

Mindful of the increasing use of risperidone outside of the setting of psychosis for all manner of behavioral problems in children as well as adults, Milani brings to our attention an important observation—an observation pediatricians should file away in the back of their minds (as long as they doesn’t suffer from PRES) as they go about a busy practice day.

Wednesday, February 19, 2014

Recurrent Viral Wheezing and Beclomethasone: Should You or Your Patients Breathe a Sigh of Relief?

Photo by Amanda Mills, via the CDC
Many studies have been published looking at the role of steroids in the setting of a viral lower respiratory infection and this week we add to those with a well-done randomized double blind placebo-controlled trial of nebulized beclomethasone as a treatment for recurrent viral wheezing that was conducted by Clavenna et al. (doi: 10.1542/peds.2013-2404).

More than 500 children who had had prior viral wheezing and subsequently presented with upper respiratory symptoms were entered in a 10 day trial of the inhaled steroid with follow-up 10 days later to see if viral wheezing was still present in both the drug and placebo groups.

The results may delight some and irritate others, but are certainly worth your attention. Are you using inhaled steroids for viral wheezing in your young patients? Is it working? Do you agree with the results of this study—and if not, why not? Share your comments and concerns with us via eLetter, in the comment space below on this blog, Facebook or Twitter.

Related Reading:

Monday, February 10, 2014

Dexamethasone versus Prednisone for Acute Asthma: Does It Work?

We are so used to using a 5-day course of prednisone for acute asthma exacerbations—but what about giving just one or two doses of dexamethasone?

Photo by Cea via Flickr
Keeney et al. (doi: 10.1542/peds.2013-2273) decided to gather the evidence for or against this therapeutic strategy and share their findings in a meta-analysis being early released this week. While the numbers of randomized controlled trials in the emergency department used for this meta-analysis are smaller than some might hope, the effectiveness of this medication compared to prednisone or prednisolone appears to be quite comparable.

Have you ever tried dexamethasone instead of a 5-day course of prednisone? Does it work? Would you try it after reading this article? Share your comments and thoughts by responding to this blog or on Facebook or Twitter. You may also consider leaving an eLetter on our journal site so you can share some inspiring thoughts on this topic. Take a deep breath and read this study that may change how you handle acute asthma management.

Related Reading:

Friday, February 7, 2014

Chemotherapy Drug Shortages: A Critical Issue for Children & Not Just Specific to Cancer

Photo by TheNickster via Flickr
Every so often we read or hear about drug shortages such as a vaccine or antibiotic. Perhaps we have paid less attention to the drugs needed for children with chronic illness such as children with cancer, but fortunately our fellow oncologists have been quite focused on this issue and the ethical and practical ramifications of not having the appropriate drug to treat the appropriate tumor or cancer.

DeCamp et al. (doi: 10.1542/peds.2013-2946) share the results of a Working Group on Chemotherapy Drug Shortages in Pediatric Oncology with six suggested steps to remedying the drug shortage issues in for children with cancer.

Accompanying this article is a terrific commentary by Dr. Dianne Murphy and colleagues (doi: 10.1542/peds.2013-4018) to show the relevancy of the cancer drug shortage situation to other potential pediatric drug shortage situations.

This is an important issue to think about—and the two articles will give you plenty to then talk about with your specialists as well as your fellow primary care practitioners who coordinate the care and therapies for your patients with chronic illness.

Related Reading:

Thursday, February 6, 2014

Acute Procedural Pain Guidelines: A Systematic Review to Ease the Discomfort

Photo by Enockson via Flickr
Many of our patients undergo procedures at one time or another. Some of these—despite their benefits of yielding diagnostic information or even being therapeutic— can be painful, requiring techniques or medications to reduce the pain. So what is the best approach to reducing the pain of a procedure?

Lee et al. (doi: 10.1542/peds.2013-2744) systematically reviewed existing practice guidelines in an interesting article being released this week. Not only did they find a published guideline for acute procedural pain reduction, they found 18 of them, some applicable to outpatient, others to inpatient or emergency settings.

So how good are these guidelines? For a painless takeaway of their findings, read this review and learn more in terms of common themes as well as what is needed to make such existing guidelines even better quality than they currently are.

Tuesday, February 4, 2014

Dosing Out Trends in Outpatient Antibiotic Use: A Tough Pill to Swallow

Photo by Ano Lobb via Flickr
Over the past decade, we and other journals have published studies on antibiotic overuse and the complications of doing so. Yet has the message sunk in? Are pediatricians reducing their usage of antibiotics or at least limiting the spectrum of the drug used in simple respiratory illnesses that are likely to be viral?

Vaz et al. (doi: 10.1542/peds.2013-2903) examined the use of antibiotics over a decade by studying dispensing rates in three geographically different health plans. The results show that early declines in usage at the start of the past decade have not stayed that way, and in fact are starting to trend upward in some of the plans studied. In addition, broad-spectrum antibiotic usage for conditions such as otitis that should not warrant such broad coverage is also heading in the wrong direction.

Why this might be and what we can do about it are discussed both in the study and in an accompanying commentary by Dr. Ateev Mehrotra (doi: 10.1542/peds.2013-4016).

I would certainly prescribe reading both early release articles and then reflecting on your own practice. What are your trends in antibiotic use like? Do you disagree with the trends reflected in this study? Share your thoughts on outpatient antibiotic usage by leaving a comment below, or via an eLetter, Facebook, or reach me through Twitter.

Thursday, January 30, 2014

Case Report: Treating Generalized Lymphangiectasia With Propranolol in a Preterm Infant

Our Case Report Editor, Dr. Jeffery Malatack shares a case report we early released this month from our upcoming February issue:

Generalized lymphangiectasia is a rare congenital disorder characterized by diffuse or multi-centric proliferation of dilated lymphatic vessels. When there is involvement of intra-thoracic structures the course may be fatal. Propranolol has become a mainstay of treatment of medically threatening congenital hemangioma, another proliferating endothelial structure.

Propranolol, image by Benjah-bmm27 via Wikimedia Commons
In the February case report section of Pediatrics, Dr. Poralla and colleagues at Bonn University (doi: 10.1542/peds.2012-2087) report on an infant with generalized lymphangiectasia critically ill with hydrops at birth treated with propranolol. The patient appeared to respond with reduction of lymphangectases and overall clinical improvement. The case is presented as a possible therapy for this condition in a desperate setting.

Whether the improvement is cause and effect or unrelated to propranolol therapy remains in question. Some, if not most, lymphangiectasia is likely secondary phenomena of lymphatic obstruction, and the effectiveness of propranolol, (if it truly is effective), is likely based on the underlying cause. A well-controlled study of this treatment is necessary before we can consider propranolol a therapeutic option. Also, if it is shown to be effective in one setting, as it appeared to be in this case, painting all lymphangiectasia with the same wide brush may be an error. Not only do we need research to decide if this drug is useful for lymphangiectasia, but we need to better understand whether the exact setting and phenotype might make a difference as well.

Propranolol is a relatively benign drug when potential untoward effects are monitored for and managed expectantly. Use of this drug would be a significant therapeutic advance from the limited treatment approaches currently available for this condition.

Friday, January 10, 2014

Good News in Regard to Antidepressant Usage in Teens and Its Association with Increased Suicide Risk

With a flurry of news activity surrounding the possible risk of suicide in depressed teens using fluoxetine and a resultant need to always discuss this risk when starting the drug in one of our patients, concerns certainly can also arise in regard to the use of other antidepressant SSRI medications.

Photo by Brandon Giesbrecht via Flickr
Cooper et al. (doi: 10.1542/peds.2013-0923) looked at almost 865 depressed children age 6-18 years enrolled in Tennessee Medicaid from 1995 to 2006 who were prescribed an SSRI antidepressant to determine if they were at an increased risk of suicide compared to new users of fluoxetine.

The results will hopefully reassure you that newer SSRIs are not putting our patients at any more risk than fluoxetine, small though that drug’s risk may be. To get the details, give this study your attention—certainly before you prescribe any form of SSRI in your depressed teenage patients—since it may reassure them and you that the benefits of these medications will hopefully outweigh the risks.

Related Reading:

Wednesday, January 8, 2014

Over-the-Counter Medications for Fever, Cough, Cold and Allergy: Are They Adhering to Federal Recommendations for Dosing Directions and Devices?

We have all experienced parents making dosing mistakes despite our most valiant efforts to educate them on how to administer an over-the-counter (OTC) medication, purchased at the drug store without a prescription, to their young child.
Photo by crazytales562 via Flickr

In fact, this was such a big problem nationally, that in 2011, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) made a series of voluntary recommendations so dosing directions and devices could be improved. So how well has the OTC product world responded? Budnitz et al. (doi: 10.1542/peds.2013-2362) share the results of their investigation of 68 OTC products. You are likely to be pleased by the results if you are an optimist, and see room for improvement based on the study results if you “view the cup as half-empty”.

While on the subject of OTC medications, Jensen et al. (doi: 10.1542/peds.2013-1107) offer another perspective on this issue. The authors chose to determine whether self-medication with OTC analgesics by children ages 6-11 years is influenced by a mother’s self-reported health and use of similar OTC pain medications. Even adjusting for the level of pain the child was experiencing, a strong association occurs. Are you asking parents about their OTC medication use in front of their children and in turn monitoring what your school-age and teen patients are using? After reading this study, you may find not inquiring about this topic may be a bitter pill to swallow.

There’s a good dose of information in both of these studies, so if your patients are using OTC medications, check them both out and learn more.

Related Readings:

Thursday, December 19, 2013

Empiric Antibiotics for Community Acquired Pneumonia: Which Ones Work Best?

When you hospitalize a child with a community-acquired pneumonia, which antibiotic do you like to use? A narrow-spectrum one or a broad-spectrum agent?

Photo by BigBlockBobber via Pixabay
Queen et al. (doi: 10.1542/peds.2013-1773) decided to see how the two approaches stack up in a comparative effectiveness study we are early-releasing this week. Length of stay, readmission rates, daily costs, duration of fever, and duration of supplemental oxygen served as outcome measures of effectiveness of narrow- versus broad-spectrum therapy.

So which is better? The authors cough up some interesting results that may or may not change your current antimicrobial approach to treating community-acquired pneumonia. Take a good dose of what this study has to offer and then apply it to your own patients to see if you agree with the findings.

Related Readings:

Monday, December 2, 2013

Neuraminidase Inhibitors: Are They as Effective for Children with Influenza as They are for Adults?

There is some good data published in adult medical journals regarding the efficacy of neuraminidase usage in improving survival of adults critically ill with influenza. Can the same be said when these medications are used for sick children with influenza?

Louie et al. (doi: peds.10.1542/2013-2149) studied medical records of children with influenza requiring intensive care from 2009 through 2012 and compared outcomes of children treated and not treated with a neuraminidase inhibitor. The results don’t just depend on whether or not these medications are used, but how soon they are started.

To better understand just how much benefit one might derive from using this medication on critically ill children with influenza, give this study your best shot to see what is and is not beneficial about their use.

Monday, November 11, 2013

Adverse Reactions to Cough and Cold Medicines After Withdrawal of Infant and Toddler Products from the US Market

We are all aware that in 2007, there was voluntary withdrawal by manufacturers of infant cough and cold medications followed a year later by warnings against their usage in children less than 4 years of age. So did these changes result in fewer adverse reactions?

Photo by MarkBuckawicki via Wikimedia Commons
Hampton et al. (doi: peds.10.1542/2013-2236) provide an answer to that question using data from the National Electronic Injury Surveillance System—Cooperative Adverse Drug Event (ADE) Surveys issued from 2004 to 2011.  There is good news and bad news in the results reported in this study. While the number of ADEs for infants and toddlers are on the decline, a good number are still occurring and this study explains why. Labels on products and market withdrawals are all good things—but not enough.

A tougher dose of prevention is needed—and that is preventive medicine that must be swallowed by all of us if adverse events are to be eradicated from these still easy-to-access common cough and cold medications.