North Carolina – Endocrinology – Concern Raised Over Dosing Of Norditropin For Short Stature

The Board received a complaint regarding the care of a patient.

On 04/03/2013, an 8-year-old boy was referred to an endocrinologist for the evaluation of possible low testosterone.  The boy weighed 20.4 kg and was 46 inches tall.  The endocrinologist examined the patient and noted that he had significant short stature.  He recommended laboratory and radiographic testing in order to develop a definitive plan of care.

On 05/01/2013, the endocrinologist reviewed the patient’s laboratory results with the patient’s parents and explained that the patient’s bone age was approximately 66 months, yet his chronological age was 98 months.  The endocrinologist decided to obtain a growth hormone stimulation test, which was done in June 2013.

On 07/08/2013, the patient presented to the endocrinologist for a follow-up.  The patient weighed 21.1 kg and was 46.5 inches tall.  The endocrinologist reviewed the patient’s laboratory and radiographic results and diagnosed growth hormone deficiency.  The endocrinologist prescribed the growth hormone drug Norditropin (somatropin [rDNA origin] injection).  This treatment involved the patient’s parents injecting the drug Norditropin into the patient’s body.

On 08/16/2013, Norditropin was started on the patient at a dose of 0.6 mg daily (0.23 mg/kg/week).

On 11/27/2013, the patient presented for a follow-up.  The parents mentioned no problems with injecting the Norditropin.  Height was 46.75 inches.  The patient’s Insulin-Like Growth Factor I (“IGF-1”) was 98 ng/ml (normal for this age was 49-351).  The endocrinologist increased the patient’s Norditropin dose to 1.4 mg daily (0.45 mg/kg/week) for one month and then 2 mg daily (0.64 mg/kg/week) until the patient’s next follow-up visit.

On 01/27/2014, the patient presented for a follow-up.  Height was 47.75 inches.  IGF-1 was 146 ng/ml (normal for age was 72-323).  The endocrinologist increased the patient’s Norditropin dose to 3 mg daily (0.9 mg/kg/week).

On 04/07/2014, the patient, now 9 years old, presented for a follow-up.  Height was 48.25 inches and IGF-1 was 210 ng/ml (normal for age was 84-362).  His dose was increased to 4 mg (1.1 mg/kg/week).

On 06/11/2014, the patient presented for a follow-up.  Height was 50 inches and IGF-1 was 203 ng/ml (normal for age was 84-362).  The endocrinologist recommended increasing the Norditropin to 6 mg daily (1.59 mg/kg/week) and wrote prescriptive instructions to that effect.  However, the specialty pharmacy that had been providing the patient’s Norditropin refused to fill the prescription at that dose and the patient never received the 6 mg daily dose.

On 08/06/2014, the patient went to see a pediatric endocrinologist physician who has specialty training and certification in the field of pediatric endocrinology.  This physician lowered the patient’s Norditropin dosage as follows:

“For management of the short stature, I have decreased the growth hormone (Norditropin) to 1.1 mg at night time (0.300 mg/kg/wk as recommended for children with growth hormone deficiency).”

This pediatric endocrinologist treated the patient three months later on 11/3/2014 and noted that he had grown 2 cm (0.79 inches) on the 1.1 mg Norditropin dosage.

The Board obtained the patient’s records and sent them to two qualified independent medical experts for review.  The independent medical experts judged the endocrinologist’s conduct to be below the minimum standard of competence given failure to prescribe the correct Norditropin dosage to the patient.  They did not think the endocrinologist should have increased the dosage based solely on the patient’s IGF-1 levels.  The endocrinologist disagreed with the experts.  The Board notes that the patient was not harmed by the IGF-1, although they acknowledged that there was potential harm if high dose Norditropin therapy is administered in the long term.

The endocrinologist had his care reviewed by three independent medical experts who felt that the care of the endocrinologist was within the standard of care.  One expert wrote that the care of the patient was “evidence-based and follows standard of care.”  One of those experts was the pediatric endocrinologist who lowered the dose of Norditropin from 4 to 1.1 mg.  It is noted that this expert has worked with the endocrinologist over eight years and the endocrinologist referred patients to this expert.  She wrote that her adjustment of the dose “does not imply that [your]dosage was wrong or outside the standard of care” and wrote that the endocrinologist was “a dedicated doctor who provides elite care to his patients.”

The Board issued a public letter of concern, which was reported to the Federation of State Medical Boards.  It was not reported to the National Practitioner Data Bank.

State: North Carolina

Date: August 2016

Specialty: Endocrinology, Pediatrics

Symptom: N/A

Diagnosis: N/A

Medical Error: Improper medication management

Significant Outcome: N/A

Case Rating: 2

Link to Original Case File: Download PDF

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