according to an update at the virtual Pediatric Hospital Medicine virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance.
“Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up,” reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University.
Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Dr. Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given.
“There is a glaring gap in the way the [California] law was written,” said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws.
Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Dr. Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K.
Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Dr. Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome.
“This is a huge piece of the puzzle for counseling,” Dr. Nguyen said. “The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death.”
Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Dr. Nguyen.
Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Dr. Nguyen reported.
“We do know confidently that oral vitamin K does often result in poor adherence,” she said,
In a recent review article of parental vitamin K refusal, one of the most significant predictors of refusal of any recommended neonatal preventive treatment was refusal of another. According to data in that article, summarized by Dr. Nguyen, 68% of the parents who declined intramuscular vitamin K also declined erythromycin ointment, and more than 90% declined hepatitis B vaccine.
“One reason that many parents refuse the hepatitis B vaccine is that they do not think their child is at risk,” explained Kimberly Horstman, MD, from Stanford University and John Muir Medical Center in Walnut Creek, Calif.
Yet hepatitis B virus (HBV) infection, which is asymptomatic, can be acquired from many sources, including nonfamily contacts, according to Dr. Horstman.
“The AAP supports universal hepatitis B vaccine within 24 hours of birth for all infants over 2,000 g at birth,” Dr. Horstman said. In those weighing less, the vaccine is recommended within the first month of life.
The risk of parental refusal for recommended neonatal preventive medicines is higher among those with more education and higher income relative to those with less, Dr. Nguyen said. Other predictors include older maternal age, private insurance, and delivery by a midwife or at a birthing center.
Many parents who refuse preventive neonatal medications do not fully grasp what risks they are accepting by avoiding a recommended medication, according to both Dr. Nguyen and Dr. Horstman. In some cases, the goal is to protect their child from the pain of a needlestick, even when the health consequences might include far more invasive and painful therapies if the child develops the disease the medication would have prevented.
In the case of intramuscular vitamin K, “we encourage a presumptive approach,” Dr. Nguyen said. Concerns can then be addressed only if the parents refuse.
For another strategy, Dr. Nguyen recommended counseling parents about the need and value of preventive therapies during pregnancy. She cited data suggesting that it is more difficult to change the minds of parents after delivery.
Echoing this approach in regard to HBV vaccine, Dr. Horstman suggested encouraging colleagues, including obstetricians and community pediatricians, to raise and address this topic during prenatal counseling. By preparing parents for the recommended medications in the prenatal period, concerns can be addressed in advance.
The health risks posed by parents who refuse recommended medications is recognized by the Centers for Disease Control and Prevention. Both Dr. Horstman and Dr. Nguyen said there are handouts from the CDC and the AAP to inform parents of the purpose and benefit of recommended preventive therapies, as well as to equip caregivers with facts for effective counseling.