Pediatric Annals

Feature Article 

Refusal of Vitamin K Injection: Survey of the Current Literature and Practical Tips for Pediatricians

Rebecca Levin, MD; Josephine Misun Jung, MD; Lindsay Forrey, LCSW; Jill Glick, MD

Abstract

Vitamin K refusal and associated sequelae of vitamin K deficiency bleed (VKDB) in the newborn period is becoming a more common occurrence. We present six recent cases from a 4-month period in 2017 of parent refusal of vitamin K and describe the reasons for refusal and the clinical outcomes of these infants. There have been a number of case reports citing the rising incidence of VKDB and the reasons why parents refuse. However, there is a gap in the literature and clinical practice guidelines describing how a physician should approach a refusal in the hospital and in the office, and the need to report a refusal to child welfare. In addition, we describe a scenario in which the caregivers provide a religious reason for refusal of vitamin K that, to the best of our knowledge, has yet to be cited in the literature. [Pediatr Ann. 2018;47(8):e334–e338.]

Abstract

Vitamin K refusal and associated sequelae of vitamin K deficiency bleed (VKDB) in the newborn period is becoming a more common occurrence. We present six recent cases from a 4-month period in 2017 of parent refusal of vitamin K and describe the reasons for refusal and the clinical outcomes of these infants. There have been a number of case reports citing the rising incidence of VKDB and the reasons why parents refuse. However, there is a gap in the literature and clinical practice guidelines describing how a physician should approach a refusal in the hospital and in the office, and the need to report a refusal to child welfare. In addition, we describe a scenario in which the caregivers provide a religious reason for refusal of vitamin K that, to the best of our knowledge, has yet to be cited in the literature. [Pediatr Ann. 2018;47(8):e334–e338.]

Newborns are born vitamin K deficient, and without replacement via intramuscular (IM) injection at birth the infant is at risk for vitamin K deficiency bleeding (VKDB).1 The neonate is vitamin K deficient for the following reasons: inability to effectively use vitamin K due to immature liver function, low stores, poor placental transfer, and low vitamin K content in breast milk.2 Since the development of the IM vitamin K injection in 1961, there has been robust evidence citing its efficacy and reduction of VKDB to a level so low that it is no longer under surveillance.3 However, in recent times there has been an increase in vitamin K refusal at birth, resulting in an increase of case reports of VKDB in the literature. The goal of this article is to spread awareness of the increase in vitamin K refusal, to explore the varied reasons for refusal in the newborn, and to attempt to provide practical guidance to navigate this growing population.

Illustrative Case

The infant was full-term and born via normal spontaneous vaginal delivery to a 26-year-old mother. The pregnancy was managed by the obstetrical high-risk service due to maternal desire for vaginal trial of labor after previous caesarean delivery. Otherwise, all serologies were normal, ultrasound anatomy survey was unremarkable, and the pregnancy was uncomplicated. The baby's Apgar scores were 9 of 9 at 1 and 5 minutes, respectively, and he was born crying and vigorous.

A pediatrician from the general care nursery was called to the delivery room because of parental refusal of vitamin K injection and erythromycin ointment administration. Risks of refusal were reviewed but both parents firmly refused on the following grounds: fear of the side effects, which they believed specifically targeted black male infants; strong mistrust of the medical community grounded in historical precedent; and their religious and philosophical beliefs about adverse medical treatments targeting the black community. After an intense conversation with the parents, the pediatrician was asked to leave the room.

The baby was moved to the newborn nursery, where pediatric providers continued to meet resistance when it came to conversations about vitamin K as well as for the general care of the baby. Social work (SW) and the Child Advocacy and Protective Services (CAPS) team were consulted for further guidance. CAPS and SW informed the pediatric team that refusal of vitamin K is recognized by the state child welfare system as medically negligent and is grounds to report this refusal to the Department of Child and Family Services (DCFS). A dialogue was crafted giving the parents two options: (1) either come to an agreement with the medical team and administer the vitamin K or (2) involve DCFS. When these two options were posited, the parents were not persuaded, and furthermore physically barred the medical providers access to the baby.

Because there was no immediate threat to life and limb, the CAPS team did not advocate for taking protective custody but instead recommended reporting the family for medical neglect. After involving a number of different teams (eg, social work, CAPS, legal services, and the nursery team), it was decided to discharge the baby without vitamin K and make a report to DCFS. It was hoped that acquiescing to the family would prevent the parents from feeling more alienated from the medical community and increase the likelihood of them going to a pediatrician or emergency department with concerns in the future.

Refusal of vitamin K administration had previously been a rare and isolated phenomenon at our hospital, but recently, within a 4-month period, a total of six newborns' caretakers refused administration of vitamin K, including a case of twins in which one of the twins presented a few days later with hypoglycemia and concern for sepsis. Because the child had not received vitamin K, a lumbar puncture had to be delayed until vitamin K was administered. The second twin was admitted to the pediatric intensive care unit approximately 2 months later with late-onset VKDB in the form of a gastrointestinal bleed. The infant had an International Normalized Ratio of >17, which rapidly corrected with administration of vitamin K.

Each of the six cases of vitamin K refusal we encountered within this 4-month period in 2017 is listed in chronological order in Table 1. Also included in the table are refusals of other newborn screening and interventions.

Six Cases of Vitamin K Refusal

Table 1:

Six Cases of Vitamin K Refusal

Discussion

Importance of Vitamin K

Neonates are born deficient of vitamin K,1 an essential component in the coagulation cascade, making this population vulnerable to VKDB. With the advent of IM injection of vitamin K in 1961, VKDB has reached an all-time low and has nearly been eradicated.3 Early-onset VKDB occurs within 24 hours of birth, classical within age 2 to 14 days, and late onset between ages 2 and 12 weeks. Although the current incidence of VKDB is difficult to determine due to near elimination of the condition, an estimate of classical VKDB is 1.7% of live births and late-onset VKDB of 4 to 80 per 100,000 live births.2–4 Bleeding can range from mild mucocutaneous bleeding to intracranial hemorrhage. It is important to note that more severe bleeding and increased morbidity and mortality are associated with late-onset VKDB, with a large proportion of intracranial hemorrhages occurring after 2 weeks of postnatal life.

Although the likelihood of VKDB occurring in cases of vitamin K rejection is low, the highly preventable morbidity and mortality of a late-onset bleed can be life-altering and even life-threatening. It is particularly worrisome that the most severe manifestations of VKDB are likely to occur at home after discharge from the hospital. In this case, there was also concern that the family would not readily seek medical care in the future, even in an emergency, given their deep distrust of medical providers.

Adverse Events

With the recent rise in vitamin K refusal, there has been a rise in hospitals seeing manifestations of vitamin K deficiency in infants.3–5 One article by Schulte et al.4 describes seven infants in an 8-month period who were found to have vitamin K deficiency after failing to receive vitamin K at birth. All were found to have a coagulopathy, and four had intracranial hemorrhage.

Demographics of Refusal

The most commonly cited population for vitamin K refusal for their newborn infant is the older (>30 years), white, and highly educated (college graduate) parent demographic.5,6 The incidence of refusal is much higher at birthing centers (up to one-third of births) compared to hospital births (cited at 3%).5,6 Reasons for refusal are varied, but the most commonly cited in the literature include fear of adverse side effects (high dose or toxic properties of injection), poor understanding of indication, and belief that the injection is unnecessary.3,5,6 Other reasons are elaborated in Table 2. Unsurprisingly, vitamin K refusal has been associated with refusal of other neonatal preventive services such as the hepatitis B vaccine and erythromycin eye ointment, as well as later vaccine hesitancy and refusal.5 All parents in one study reported their intention to exclusively breast-feed, which is an additional risk factor for VKDB in neonates who do not receive IM vitamin K at birth, as studies have shown relatively low levels of vitamin K content in breast milk.6

Parental Reasons for Refusal of Vitamin K Injection

Table 2:

Parental Reasons for Refusal of Vitamin K Injection

Most families used the Internet to find supporting evidence for refusal, but a major concern was the high percentage of families who consulted and were incorrectly counseled by a health care provider. The list of health care providers was broad, including medical doctors (obstetricians and pediatricians) as well as chiropractors, doulas, and midwives.5 Most of the resources that were cited endorsed an alternative or natural childbirth. In an article by Hamrick et al.,6 although 83% of parents were aware of the risks of vitamin K deficiency, only a fraction of this percentage reported an awareness of intracranial bleed and death (17% and 9%, respectively).6

The parents in our case did not match the demographic cited in the literature. They were black and younger (mother and father were age 26 and 24 years, respectively), with unknown educational background. They initially desired a circumcision for their child but decided against it when they learned the vitamin K injection would be required. Although they cited the potential harms to the child the medical team was worried about, the parents were convinced of the underlying motives of the medical establishment.

Legality of Refusal

The legality of refusing vitamin K was discussed throughout the family's stay. Vitamin K must be available shortly after birth in hospitals in the state of Illinois to meet licensure requirements. There are administrative codes that state each facility must “adopt, implement, and enforce” newborn care practices, including vitamin K administration.7,8 That said, the code seems targeted at maintaining a minimum standard for birthing facilities and does not explicitly provide instruction for situations involving parental refusal. Illinois DCFS investigational protocols cite that DCFS recognizes vitamin K and ophthalmic solution administration as considered legally necessary, and that calls to the hotline due to refusal are to be taken as reports of medical neglect.9

Navigating Refusal

The literature cites a variety of ways to navigate a vitamin K refusal by parents.3 Tactics include educational intervention, requirement of vitamin K for certain procedures (frenulotomy or circumcision), unique state health mandates and reports to child protective services. Some centers even offer an alternative regimen of oral vitamin K. Notably, most of these methods did not persuade parents and the option of oral vitamin K, an alternative that has no evidence for efficacy, may even encourage further refusal. Although some studies report an increase in parents acquiescing to vitamin K after receiving teaching about VKDB,6 teaching was not successful with this family.

Our hospital's legal counsel and medical providers examined the available literature and evaluated the wording from the various state bodies. In the event that a similar case should arise in the future, it was decided to develop a clear policy. At our hospital, a multipronged approach will be developed in the next few months to decrease initial parental refusal, provide earlier recognition of families that are planning to refuse vitamin K, and have strategies in place if families do not consent after education and discussion. The obstetrics department will help to more explicitly educate families about VKDB during pregnancy and after delivery. They will be responsible for educating mothers throughout pregnancy about expectations for newborn care and clearly stating that all neonates will be given vitamin K. The CAPS team and the pediatrics team are discussing whether to enforce vitamin K administration for all infants, regardless of parents' wishes. The Illinois Committee on Child Abuse and Neglect (COCAN) recently reached a consensus that refusal of vitamin K should be viewed as medical neglect by providers and DCFS (COCAN, written communication, October 2017). One argument they have is that newborns are, by definition, deficient in vitamin K,1 so we are providing a treatment; it is not simply prevention of disease and a public health issue like vaccination. In addition, no major religions currently oppose vaccination,10 which could be extrapolated to include vitamin K injection.

Conclusion and Future Directions

Further investigation into the incidence and scope of vitamin K refusal is needed to better characterize how to help this population. Currently there is no surveillance system by the Illinois Department of Public Health to assess the incidence of refusal and/or track the incidence of VKDB, so there is a need for case-based reports in the literature. Pediatric providers must be informed of patients who did not receive vitamin K at birth to be prepared to monitor for signs of bleeding for months after birth and be aware of procedures and maneuvers that should be avoided or approached with caution, such as circumcisions and lumbar punctures. Inquiring about the administration of vitamin K injection as a standard question on the newborn history and physical examination may be prudent for primary care practitioners. In addition, emergency department physicians will need to review past medical history specifically for refusal of vitamin K for infants until around age 6 months at the minimum. One of our twins in this case report initially was assessed by the emergency department to have colic, but because of the development of bloody stools in the emergency department the child was reassessed and was later found to have late onset gastrointestinal bleeding and was severely coagulopathic. Although this cannot be stated with any level of certainty, there is also cause for concern in our patient population that refusal of vitamin K might be a red flag, as three of the six patients continue to be observed by DCFS after finding their home environments to be unsafe for other reasons.

Each of the articles reviewed here recommended early and extensive education (starting in the prenatal period) for parents refusing vitamin K. It will be important to tailor educational materials to the specific patient population in question. For example, the patient population we described would not be swayed by materials designed for the different demographic classically described in the literature. There must also be a decision made at each institution about what to do in the event of persistent refusal despite education. Although some states have implemented policies to ensure the administration of vitamin K, a standardized methodology to navigate refusal has not yet been developed in most states or at most hospitals, including our own.

At this point, we are left with a host of unanswered and difficult questions:

  1. What is the incidence of refusal in our community and at what rate is this increasing?

  2. Are there effective early educational initiatives during pregnancy that may reduce the incidence of vitamin K refusal?

  3. Should providers intervene by taking protective custody and administering vitamin K against the parents' wishes, potentially preventing a rare and life-threatening condition and risk damaging the relationship with the family and the potential liability risks for the hospital with regard to civil law suits? Or should we have them observed closely with a primary care provider in the medical community?

  4. As a primary care physician taking care of such children, what particular signs and symptoms should be monitored carefully?

  5. How do we reintroduce screening for refusal of vitamin K into the routine care of children?

References

  1. Shearer M. Vitamin K metabolism and nutriture. Blood Rev. 1992;6(2):92–104. doi:. doi:10.1016/0268-960X(92)90011-E [CrossRef]
  2. Sankar M, Chandrasekaran A, Kumar P, Thukral A, Agarwal R, Paul V. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol. 2016;36(suppl 1):S29–S35. doi:. doi:10.1038/jp.2016.30 [CrossRef]
  3. Loyal J, Taylor J, Phillipi C, et al. Refusal of vitamin K by parents of newborns: a survey of the better outcomes through Research for Newborns Network. Acad Pediatr. 2017;17(4):368–373. doi:. doi:10.1016/j.acap.2016.10.012 [CrossRef]
  4. Schulte R, Jordan L, Morad A, Naftel R, Wellons J, Sidonio R. Rise in late onset vitamin K deficiency bleeding in young infants because of omission or refusal of prophylaxis at birth. Pediatr Neurol. 2014;50(6):564–568. doi:. doi:10.1016/j.pediatrneurol.2014.02.013 [CrossRef]
  5. Marcewicz L, Clayton J, Maenner M, et al. Parental refusal of vitamin K and neonatal preventive services: a need for surveillance. Matern Child Health J. 2017;21(5):1079–1084. doi:. doi:10.1007/s10995-016-2205-8 [CrossRef]
  6. Hamrick H, Gable E, Freeman E, et al. Reasons for refusal of newborn vitamin K prophylaxis: implications for management and education. Hosp Pediatr. 2016;6(1):15–21. doi:. doi:10.1542/hpeds.2015-0095 [CrossRef]
  7. Joint Committee on Administrative Rules. Section 265.1900 Newborn infant care. http://www.ilga.gov/commission/jcar/admincode/077/077002650A19000R.html. Accessed July 8, 2018.
  8. Joint Committee on Administrative Rules. Section 250.1830 General requirements for all obstetric departments. http://www.ilga.gov/commission/jcar/admincode/077/077002500O18300R.html. Accessed July 8, 2018.
  9. Illinois Department of Children and Family Services. Reports of Child Abuse and Neglect. https://www.illinois.gov/dcfs/aboutus/notices/Documents/Procedures_300_Appendix_B.pdf. Updated October 9, 2015. Accessed July 8, 2018.
  10. Peclic G, Karacic S, Mikirtichan GL, et al. Religious exception for vaccination or religious excuses for avoiding vaccination. Croat Med J. 2016;57(5):516–521. doi:. doi:10.3325/cmj.2016.57.516 [CrossRef]

Six Cases of Vitamin K Refusal

Case Other Refusalsb Reason for Refusal Had Primary Care After Birth? Outcome Post-Discharge
HBV NBS EO
1a X X X Lifestyle No Presented to emergency department at age 3 days with hypoglycemia and concern for sepsis. Lumbar puncture delayed until vitamin K was given. Also, with failure to thrive due to lack of adequate nutrition, DCFS is now involved.
2a X X X Lifestyle No Presented to emergency department at age 2 months with GI bleed and INR >17. Reversed with vitamin K injection. Failure to thrive due to lack of adequate nutrition. DCFS now involved.
3 X X Religion Yes Unable to receive circumcision. Continued refusal as outpatient.
4 X X Mother is a doctor and didn't want “toxic ingredients” in injection Yes Continued refusal as outpatient.
5 X X Natural birth No DCFS indicated the case for medical neglect and closed it with no services.
6 X X Desire to delay shots until age 7 months Scant Unable to receive circumcision. Admitted at age 3 months for rib fractures. Mother consented to vitamin K injection. DCFS involved due to child physical abuse.

Parental Reasons for Refusal of Vitamin K Injection

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Lack of understanding of the indication for the injection

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Belief that injection is unnecessary

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Desire for natural birthing process

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Concern about harm to the baby (including preservatives/toxins, adverse reactions, pain, increased risk of leukemia/cancer)

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Belief that mother's intake of vitamin K is sufficient

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Religious reasons

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Mistrust of medical community

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Personal factors

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Authors

Rebecca Levin, MD, is a Resident in Pediatrics, Comer Children's Hospital. Josephine Misun Jung, MD, is a Resident in Pediatrics, Comer Children's Hospital. Lindsay Forrey, LCSW, is a Child Advocacy and Protective Services Clinical Coordinator, Comer Children's Hospital. Jill Glick, MD, is a Professor of Pediatrics, the Medical Director of Child Advocacy and Protective Services, and a Child Abuse Pediatrician. All authors are affiliated with The University of Chicago Medicine.

Address correspondence to Rebecca Levin, MD, Comer Children's Hospital, 5721 S. Maryland Avenue, Chicago, IL 60637; email: rebecca.levin@uchospitals.edu.

Disclosure: The authors have no relevant financial relationships to disclose.

10.3928/19382359-20180709-02

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