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Providing Care Where Potential Benefit Outweighs Potential Risk

Maynard, Roy 2Roy C. Maynard, M.D., is the Medical Director for PHS. He serves as PHS’s clinical leader, working with the team to provide consultation and advice to ensure quality and effective care to children and their families in their own homes. He also leads implementation of clinical policies, procedures and programs to further enhance the best possible care for each child. He is a Neonatologist and Pediatric Pulmonologist, and serves as a staff physician at Children’s Hospitals and Clinics in Minneapolis, Minn. 

Evidence-based medicine provides important information on the potential benefit or lack of efficacy of therapies in the treatment of disease. Health care providers are tasked with continuing medical education to provide state of the art care where the potential benefit of an intervention outweighs the potential risk. The American Academy of Pediatrics (AAP) and the Food and Drug Administration (FDA) are important organizations updating those providing care for children on practice guidelines.

Reducing Antibiotic Intake

During the first 2 years of life, the average child will have 8 – 10 colds. Exposure to a crowded daycare center in the winter may almost double the frequency of viral respiratory infections, some with significant morbidity such as influenza or RSV. Sorting out how much of a child’s symptoms can be attributed to a viral upper respiratory tract infection versus a secondary or co-existing bacterial infection can be difficult.

There is a worldwide initiative to curb the overzealous prescribing of antibiotics which has contributed to the development of drug resistant “superbugs” such as MRSA (methicillin resistant staph aureus) and VRE (vancomycin- resistant enterococcus).

The Minnesota Department of Health reported on antibiotic resistance in invasive streptococcus pneumonia isolates from patients in this state during 2012 and found 17% of pneumococcal isolates were resistant to two or more antibiotic classes and 9% were resistant to three or more antibiotic when using meningitis breakpoints.

Guidelines for Prescription

To address concerns over possible over-prescribing of antibiotics, The AAP has released guidelines addressing principles for antibiotic prescriptions for upper respiratory tract infections.

This recent update focuses on the following 3 principles:

  • Accurate diagnosis of a bacterial infection
  • Consideration of the risks vs. benefits of antibiotic treatment
  • Implementation of sensible prescribing strategies – including selection of the most effective antibiotic, prescription of an appropriate dose, and treating for the shortest possible duration.

Adherence to these recommendations will help decrease unwarranted antibiotic prescriptions in the pediatric community.

FDA on Acid-Suppression Therapy

Another category of prescription drugs often over-prescribed in infants includes acid-suppressants like proton pump inhibitors (PPI). Recently, after reviewing clinical studies, the FDA has issued a statement supported by a pediatric gastroenterology panel that PPIs should not be administered to treat symptoms of reflux in otherwise healthy infants without evidence of acid-induced disease.

In placebo controlled studies of fussy and spitty healthy babies, when placebo controlled and blinded, there is no measurable benefit between the 2 groups in symptoms. The FDA convictions were strong enough to recommend no further placebo-controlled studies of acid-suppression therapy in infants.

Undoubtedly there is a small subset of infants with gastrointestinal disorders where the benefit of acid-suppression therapy outweighs associated risks of this therapy.

Cold and Cough Medication Risks

Pediatric providers are well aware of the AAP position on over-the-counter cold and cough medicine.  The AAP has stated that these “medications do not work for children under age 6 and, in some cases, may pose a health risk.”

The FDA has been instrumental in decreasing the availability of these drugs on store shelves for children under age 2. Until these cough and cold medicines are appropriately studied in children to look at safety and efficacy, it is incumbent for all of us taking care of the child, to educate parents on the potential risk of over-the-counter cough and cold medicine in their children.

Originally published: January 24, 2014