Increasing Breastfeeding in Neonates Diagnosed with Neonatal Abstinence Syndrome

Transcription

1 Increasing Breastfeeding in Neonates Diagnosed with Neonatal Abstinence Syndrome Gail A. Bagwell DNP, APRN, CNS 2016 DNP Conference Baltimore, Maryland

2 Disclosure I am on the speaker s bureau for Abbott Laboratories.

3 Objectives Describe the current drug epidemic problem in the United States. Discuss the importance of breastfeeding babies diagnosed with neonatal abstinence syndrome (NAS). Explain the process of increasing breastfeeding in mother s of babies diagnosed with NAS.

4 Addiction Definition A condition that results when a person ingests a substance or engages in an activity that can be pleasurable but the continued use/act of which becomes compulsive and interferes with ordinary life responsibilities, such as work, relationships, or health. Users may not be aware that their behavior is out of control and causing problems for themselves and others. Psychologytoday.com, 2014

5 Addiction Addiction Physical dependence on a street drug or prescribed medication with a psychological component of drug seeking behaviors May not be able to control drug use Can cause intense craving for the drug Dictionary.com, 2014

6 Selected Illicit Drugs Use in Past Month Ages 12 or Older % Using Past Month

7 Heroin Usage in U.S # in Thousands

8 National Overdose Deaths Number of Deaths from Prescription Drugs 30,000 Total Female Male 25,000 20,000 15,000 10,000 5,000 0 h"ps://

9 National Overdose Deaths Number of Deaths from Prescription Opioid Pain Relievers 20,000 Total Female Male 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 h"ps://

10 12,000 National Overdose Deaths Number of Deaths from Heroin Total Female Male 10,000 8,000 6,000 4,000 2,

11 Background Opiate addiction and neonatal abstinence syndrome (NAS) have become major health problems for pregnant women and neonates in the United States. Exact numbers of opiate and drug use in pregnancy are not available, but a recent study reported One out of five women filled a opioid prescription during pregnancy Increased from 18.5% in 2000 to 22.8% in (Desai, Hernandez- Diaz, Bateman, Huybrechts, 2014).

12 Regional variation in the rates of prescription opioid dispensing during pregnancy Medicaid Desai, RJ, Hernandez-Diaz, S, Bateman, B. & Huybreachts, K. 2014

13 Proportion of pregnant women who filled an opioid prescription, Medicaid Desai, RJ, Hernandez-Diaz, S, Bateman, B. & Huybreachts, K. 2014

14 Background In 2012, approximately 21,732 babies were diagnosed with NAS, which is equivalent to one baby born every 25 minutes with NAS. (Patrick, Davis, Lehman & Cooper, 2015). From 2004 to 2013 NICU admissions for NAS increased from 7/1000 admissions to 27/1000 admissions (Tolia et.al., 2015).

15 Incidence of NAS in the United States Patrick, S.W., Davis, M.M., Lehman, C.U., & Cooper, W.O., 2015

16 NICU Admissions

17 Background From 2004 to 2013 NICU admissions for NAS increased from 7/1000 admissions to 27/1000 admissions (Tolia et.al., 2015). In Ohio, between 2004 and 2011the inpatient hospitalization rate grew 6-fold from 14 per 10,000 live births in 2004 to 88 per 10,000 live births in 2011 (Massatti, et al, 2013). Outpatient visits for NAS increased from 170 visits in 2004 to 467 visits in 2011 (Massatti, et al, 2013).

18 Breastfeeding and NAS

19 Breastfeeding Breastfeeding is the ideal nutrition for neonates and considered safe for women in substance abuse treatment programs.

20 Benefits of Breastfeeding Increased attachment between mother and baby Increased maternal compliance to drug treatment programs Decreased NAS symptoms Decreased use of pharmacological treatments Decreased length of stay Abel-Latif, et.al., 2006, Dermer, 2001; Dryden, Young, Hepburn & Mactier, 2009; Isemann, Meinzen-Derr & Akinbi, 2011; McQueen, Murphy-Oikonen, Gerlach & Montelpare, 2011; O Connor, Collette, Alto & O Brien, 2013; Pritham, Paul & Hayes, 2012.

21 Breastfeeding Rates Breastfeeding by mothers of babies diagnosed with NAS is relatively low. One study demonstrated only 24% of mothers, who qualified to breastfeed, breastfed their infants to some extent (Wachman, Byun, & Phillips, 2010). A second study reported 46% reported that 46% of the mothers in their integrated methadone program breastfed their babies (McCarthy, Lehman, Parr & Anania, 2005). At NCH the breastfeeding rate of NAS babies is currently around 11%.

22 Breastfeeding Reasons for the low breastfeeding rates are multifactorial, but one reason is that healthcare providers discourage breastfeeding due to a lack of knowledge on how drugs do or do not cross into breast milk.

23 Barriers to Breastfeeding Healthcare providers fear of large amounts of a drug crossing into the breast milk Staff distrust of mothers (even those in treatment programs) to not be abusing other substances Healthcare provider bias toward mothers with addiction problems Mothers not always being physically available to breastfeed their infant Infant behavior can become barriers (Jansson, Velez, & Harrow, 2004).

24 Current Recommendations The AAP (2001), ACOG (2012), and ABM (2015), all recommend breastfeeding for babies diagnosed with NAS, if the mother is in a treatment program and is HIV negative. Despite these recommendations breastfeeding rates in this population continue to remain low.

25 But what about the drugs in breast milk?

26 Pharmacokinetics of Drugs and Breast Milk There are several factors that affect the transfer of drugs into breast milk. Those factors are: Volume of distribution Molecular Weight Protein binding Lipid solubility Half-life Bioavailability Passive diffusion

27 Volume of Distribution Volume of distribution describes how widely a medication is distributed in the body. Drugs with a high volume of distribution enter different body compartments, resulting in lower concentrations in the blood. Drugs with a high volume of distribution will have lower levels in the mother s milk. Drugs with a volume distribution between 1 to 20 ml/kg are generally compatible with breastfeeding.

28 Molecular Weight Molecular weight helps to determine the entry of a medication into human milk. A higher molecular weight limits a drug s ability to transfer into the breast milk, as it must be actively transported or dissolved in the cell s lipid membrane. Molecular weight > 800 Daltons does not transfer into breast milk.

29 Protein binding Protein binding demonstrates how much of a drug is bound to the plasma albumin and other proteins in the body. Medications circulate in maternal circulation as either bound or unbound to albumin Only unbound drugs get into maternal milk Drugs that are greater than 90% bound are usually compatible with breastfeeding.

30 Lipid Solubility The ability of a substance to enter a cell by dissolving in the lipid portion of the membrane and diffusing through it. The greater the lipid solubility, the more readily a molecule will pass through the membrane. Drugs that are highly lipid soluble penetrate into breast milk in higher concentrations. Drugs that are active in the CNS are drugs with high lipid solubility

31 Half-Life The time required for a drug to lose one half of its effectiveness A shorter half-life leads to shorter peak intervals. An infant s exposure to a drug can be minimized by using drugs with shorter half-lives. A shorter half-life allows the drug to reach lower plasma levels more frequently, allowing the mother to time feedings at trough times. After 5 half-lives, 97% of the drug is eliminated.

32 Bioavailability Bioavailability is amount of drug that is absorbed from the gut into the blood stream Factors that affect bioavailability are: Reduced absorption by the GI tract High uptake by the liver Acidity of drug leading to poor GI stability

33 Diffusion Majority of drugs move in and out of breast milk by passive diffusion Diffusion occurs from high to low, but with Gme the direcgon may shih AcGve transport does occur with certain medicagons such as nitrofurantoin, cimegdine, ranigdine, iodides and acyclovir.

34 One more Factor is Relative Infant Dose (RID) is the portion of the mother s dose that is received by the infant. RID is calculated by dividing the infant s dose via breast milk (mg/kg/day) by the mother s dose (mg/kg/day). The relative infant dose should be less than 10% to be considered suitable and safe for breastfeeding.

35 In General Drugs will transfer into human milk if there is a High concentration in maternal plasma Drug molecules are small Are not protein bound Are highly lipid soluble Once a drug is in the breast milk the absorption of the neonate s gut will determine the amount of drug in the baby s blood and urine. In general babies get < 1% of the maternal drug dose!

36 Breastfeeding and Medications Breastfeeding is considered the ideal nutrition for neonates and the majority of women, even those taking medications, can breastfeed. Contraindications to Breastfeeding in the U.S. are: Human Immunodeficiency Virus Positive Use of illicit drugs by mother Active, untreated TB in mother Active herpes lesion on breast Human T-cell Lymphotrophic Virus positive Galactosemia in baby Certain medications

37 Breastfeeding and Medications All women, rather in a substance abuse program or not should have their medications reviewed if wanting to breastfeed. When reviewing mother s medications, these medications are generally considered not suitable or contraindicated for breastfeeding Antineoplastics Drugs of Abuse Ergot alkaloids Ergonovine Ergotamine Methylergonovine Bromocriptine Radiopharmaceuticals

38 Breastfeeding and Medications Medications to use with caution are: Some Anticonvulsants Phenobarbital Ethosuximide Primidone Lithium Amiodarone Cyclosporins

39 Breastfeeding with Medications Used for Addiction Treatment Methadone has been the gold standard for many years for opiate addiction treatment. More recently buprenorphine, with or without naloxone, is being used as well as Naltrexone and Clonidine. Many studies have been done on these medications to assess the amount of drug that crosses from the mother to the baby and their suitability with breastfeeding.

40 Methadone Considered the gold standard for opiate replacement therapy. Studies have shown that very little methadone is transferred into maternal milk, with minimal amounts measured in neonatal and infant plasma. (Bogen et al., 2010; Geraghty et al., 1997; Jansson, Choo, Velez, Harrow et al., 2008; Jansson, Choo, Velez & Lowe, 2008; Kreek, 1974, 1975, 1979; Pond et al., 1985; Wojnar-Hughes et al., 1997)

41 Methadone Breastfeeding may decrease, but not eliminate, neonatal withdrawal symptoms in infants who were exposed in utero. Some studies have found shorter hospital stay, shorter durations of neonatal abstinence therapy and shorter length of therapy among breastfed infants, although the dosage of opiates used for neonatal abstinence may not be reduced. Abrupt weaning of breastfed infants of women on methadone maintenance might result in precipitation of or an increase in infant withdrawal symptoms, and gradual weaning is advised.

42 Buprenorphine Similar studies to the Methadone studies have been done on mothers and infants receiving buprenorphine. Like Methadone, only small amounts of buprenorphine and norbuprenorphine are transferred into maternal milk, with minimal amounts measured in neonatal and infant plasma. (Gower, Bartu, Ilett, Doherty, McLuarin & Hamilton, 2014; Ilett, Hackett, Gower, Doherty, hamilton & Bartu, 2012; Lindemalm, Nydett, Olov-Svenson, Stahle & Sarman, 2009). Breastfeeding is encouraged, as long as the mother is receiving Buprenorphine in a treatment program and there are no other contraindications to breastfeeding. Like Methadone, when a mother is on Buprenorphine, breastfeeding should not be stopped abruptly, as withdrawal can occur in the infant.

43 Naltrexone A newer drug being used for maintenance treatment of opiate dependence in opiate-detoxified patients. There is little data about this drug and breastfeeding. The data that is available demonstrates that it is minimally excreted into the breast milk. One study showed that a 1 ½ month old infant breastfed by a mother on Naltrexone had no adverse effects and had undetectable levels of the drug in his plasma (Chan CF, Page-Sharp M, Kristensen JH et al., 2004). Current recommendation is if the mother needs the medication it is not a reason to discontinue breastfeeding.

44 Clonidine Has been used for opiate withdrawal treatment in the past. High rate of abuse by substance abusers High serum levels have been found in breastfed infants that were approximately 2/3 of the maternal drug level. Recommendation is for the mother to not breastfeed her newborn or premature infant, if she is receiving clonidine.

45 Drugs and Breastfeeding Reference Sources for Units LactMed Free on-line database from the National Library of Medicine. Designed from healthcare providers and nursing mothers and contains over 450 drug records Can be accessed at Drugs in Pregnancy and Lactation Briggs, Freeman, & Yaffe th Edition Book comes with on-line access to their database. Medication and Mother s Milk Hale & Rowe th Edition - for book or for online information from book DO NOT USE - Physician Desk Reference

46 A Program to Increase Breastfeeding

47 Review of Literature Education to Improve Breastfeeding Rates No studies have found an effective intervention to increase breastfeeding rates in women in treatment programs However breastfeeding education delivered both prenatally and after birth has been shown to increase both breastfeeding and exclusivity in women in general (Mellin, Poplawski, Gole, & Mass, 2011; Rosen, Krueger, Carney, & Graham, 2008). Studies on the effectiveness of healthcare provider education to improve breastfeeding rates was mixed (Cochrane Review, 2003). Education is important to increase knowledge of the healthcare provider, thus remains an important component of a comprehensive program to increase breastfeeding (Shealy, Li, Benton-Davis, & Frummer-Strawn, 2005).

48 Educational Program Educational sessions were developed to: Educate pregnant women in a treatment program about the benefits of breastfeeding were offered at the end of their weekly treatment sessions over 1 month. To educate the nurses of the NICU: Pharmacokinetics of drugs in breast milk Volume of distribution Molecular Weight Half-life Bioavailability Protein binding Passive Diffusion Lipid solubility Relative Infant Dose

49 Educational Program Nursing education also included: Benefits of breastfeeding for women in treatment programs to the neonate were offered during the same time period via hospital learning management system. Pre-and post-tests were given to both pregnant women and nurses to assess knowledge acquisition. Project implementer met with moms after the babies were born to answer questions and assist with breastfeeding

50 Evaluation Outcomes The goal of the project: To increase knowledge of pregnant women and healthcare providers on the importance of breastfeeding as evidenced by an increase of posttest scores and increased rates of breastfeeding.

51 Outcomes Pregnant Women Education (n=6) Age range years 83.3% Caucasian, remainder African American 33.3 % single, 16.3% divorced and 50% living with partner 33.3% did not graduate high school, 16.3% graduated high school, 50% some college education At the end of the project: Four had completed their education Two had delivered their baby

52 Outcomes Iowa Infant Feeding Attitude Scale was used to test pre and post education knowledge.

53 Breastfeeding Rates Outcomes 100% of the women who delivered initiated breastfeeding 50% of the women were breastfeeding on discharge. Breastfed on discharge baby LOS 4 days (mom had C-section) and continues to breastfeed at 2 months of age.

54 Outcomes Healthcare Provider Education (n=19) Age in years Profession 73.6 % RN, 26.3% NNP Years Experience 1-30 years Pre/Posttest evaluation of education done

55 Outcomes Pretest Posttest Overall RN NNP

56 Recommendations to Increase Breastfeeding

57 Recommendations Revise current policy if your current policy is restrictive Counsel all mothers who want to breastfeed their babies about drugs in breastmilk whether baby is admitted for NAS or not

58 NCH Drugs and Breastfeeding Policy Revision The NCH Drugs and Breastfeeding Policy revised December 2014 Policy revisions include: No longer will breast milk be tested for drugs All mothers will be asked about prescription, nonprescription, herbal, and illicit drugs, alcohol and smoking habits, as well as any treatments such as chemotherapy and radiation. Medications and treatments identified will be crosschecked against Drugs and Human Milk or LactMed. All mothers will be counseled on the use of drugs, smoking and alcohol while breastfeeding. If mother is using drugs and agrees to abstain, mother will be allowed to provide breast milk or to direct breastfeed. If mother is using drugs and refuses to abstain, then the breast milk will not be used nor direct breastfeeding allowed.

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60 Rationale for Changes Former policy on testing breast milk was based on profiling of mothers, profiling is considered illegal. We would need to test all breast milk or none. There may be other medications/drugs that are not reported to us by the mother, therefore counseling of all mothers regarding medications, drugs, alcohol and smoking with breastfeeding is of utmost importance. Mothers want the best for their babies, so after counseling and educating them we need to trust them to do the right thing.

61 Recommendations Provide mandatory education to all healthcare providers on this topic Partner drug treatment program to provide prenatal breastfeeding education to pregnant women in drug treatment programs. Mothers in treatment programs should be encouraged and supported to breastfeed

62 Recommendations Be open, honest and non-judgmental with mothers when counseling them Women in substance abuse programs have a natural distrust of healthcare providers due to previous experiences, so developing trust is essential. Working with women before the delivery if possible Keep promises made

63 Conclusion NAS is a growing problem across the country. One method to help improve outcomes of babies diagnosed with NAS, whose mothers are in a treatment program, is to have the mother breastfeed her infant. Initial results are promising that the intervention of providing education to both pregnant women and healthcare providers will lead to increase in breastfeeding in NAS infants. Structured education sessions can be helpful in increasing knowledge levels of healthcare providers and pregnant women

64 Conclusion Initial results for breastfeeding demonstrated that if a baby is breastfed initially and continuously, admission to the NICU may be avoided. The decreased length of stay can lead to saving of healthcare dollars used to care for the NAS babies. Future work should evaluate changes in breastfeeding rates and hospital length of stay as a result of increased knowledge in all settings that care for babies diagnosed with NAS.

65 References Academy of Breastfeeding Medicine, The Academy of Breastfeeding Medicine Board of Directors. (2008). Position Statement on Breastfeeding. Retrieved from American Academy of Pediatrics, Committee on Drugs. (2001). The transfer of drugs and other chemicals into human milk. Pediatrics, 108 (3), American College of Obstetricians and Gynecologists. (2012). Opioid abuse, dependence and addiction in pregnancy. Obstetrics and Gynecology, 119 (5), Desai, R.J., Hernandez-Diaz, S., Bateman, B., Huybrechts, K. (2014). Increase in prescription opioid use during pregnancy among Medicaid-enrolled women. Obstetrics & Gynecology, 123(5); Gower, S., Bartu, A., Ilett, K.F., Doherty, D., McLaurin, R., & Hamilton, D. (2014). The well-being of infants exposed to buprenorphine via breastmilk at 4 weeks of age. Journal of Human Lactation, 30(2), Ilett, K.F., Hacket, L.P., Gower, S., Doherty, D., & Hamilton, D. (2012). Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breast milk during maternal buprenorphine substitution treatment. Breastfeeding Medicine, 7(4), Jansson, L. M., Velez, M., & Harrow, C. (2004). Methadone maintenance and lactation: A review of literature and current management guidelines. Journal of Human Lactation, 20 (1), Jansson, L. M., Choo, R., Velez, M., Harrow, C., Schroeder, J. R., Shakleya, D. M., & Huestis, M. A. (2008). Methadone maintenance and breastfeeding in the neonatal period. Pediatrics, 121 (1), LactMed Retrieved from Nice, F.J., & Luo, A.C. (2012). Medications and breastfeeding: Current concepts. Journal of American Pharmaceutical Association, 52(1), Patrick, SW, Davis, MM, Lehman, CU, Cooper, WO. (2015). Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to Journal of Perinatology, 35; Sachs, H.C. & Committee on Drugs. (2013). The transfer of drugs and therapeutics into human breast milk: An update on selected topics. Pediatrics, 132(3), e796-e809.

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