Skip to main content
NCBI home page
European Journal of Midwifery logoLink to European Journal of Midwifery
editorial
. 2022 Nov 24;6:65. doi: 10.18332/ejm/156439

The value of midwifery counseling during lactation as a key factor of pharmacovigilance

Maria Tigka 1,2,✉, Victoria Vivilaki 1, Dimitra Metallinou 1, Christina Nanou 1, Aikaterini Lykeridou 1
PMCID: PMC9686434  PMID: 36474672

Breastfeeding has proven benefits for infants, including reduced morbidity and mortality, reduced acquired infections and a positive impact on cognitive functions1. At present, the reported initiation of breastfeeding reaches a rate of 90% in some European countries, but exposure to pharmaceuticals in the postpartum period varies widely from 34% to 100%2. Multiple conditions (chronic or acute) requiring pharmacological treatment may arise during breastfeeding. Decisions about pharmaceutical therapy require consideration regarding the effect on the mother and her child3. Unfortunately, the need for pharmaceutical therapy during lactation has led many women to discontinue breastfeeding either due to unclear counseling by healthcare professionals (HPs) or fear of harming their child2-4.

Currently, the quality of information on the safety of certain pharmaceutical products during lactation varies and recommendations for the use of medicines during lactation are inconsistent. This may affect the ability of HPs to convey information on drug safety to breastfeeding women and may lead to inappropriate advice for breastfeeding cessation and complexity in the decision-making process5. Previous studies on physicians’ knowledge about medication safety during lactation have disappointingly shown that approximately 53% of the participants were unaware that antiepileptic drugs are acceptable during lactation and mothers can breastfeed safely6. Additionally, the 39% of them believed that breastfeeding is contraindicated in women with prescribed antidepressant drug therapy7. Conflicting information about pharmaceutical products safety during lactation and lack of counseling skills are important barriers for the initiation and duration of breastfeeding and, therefore, emphasis should be given on the promotion of pharmacovigilance in pregnant and lactating mothers.

There are limited data to support clinical decisions in the perinatal period due to the fact that it is difficult to recruit breastfeeding women and their infants in clinical trials as they are considered vulnerable8,9. The ethical considerations that may arise in such cases are whether a breastfeeding mother should use a medication for which data are lacking and expose her infant to potential risk, or discontinue breastfeeding for the duration of the study so that the infant is not exposed to the investigational medicine10,11. Furthermore, pharmaceutical industries are discouraged from involving breastfeeding mothers in clinical trials due to possible litigation and relatively little benefit compared to the investment; their inclusion requires long-term follow-up in order to assess infant outcomes10. To enable the safe use of pharmaceuticals during lactation, alternative methods have been developed to overcome the derived barriers. Population pharmacokinetic (pop PK) modeling, for example, provides evaluations on infant drug exposure via breast milk through simulation. Preliminary results obtained from studies using pop PK modeling enhance the validity of the model-based simulations12-14.

Pharmacovigilance procedures in the European Union regarding the use of medicines during lactation is also an area that needs further guidance. Once a pharmaceutical product is placed on the market, it is important that data are collected to better understand the risks associated with its use. Pharmacokinetic data in an infant after exposure to a medicine through breast milk provide important information on the potential risks for a nursing child, and when an adverse effect is suspected, it may be valuable to obtain a blood sample from the child for further analysis. Spontaneous reports during the post-authorization phase are a critical source of information on adverse effects occurring during lactation9. There is an advancing interest on pharmacovigilance during perinatal period by midwives and other HPs15-17. However, to our knowledge, only one study has been conducted on pharmacovigilance in the postnatal period18 which describes spontaneous reports of adverse drug reactions (ADRs) of drugs transmitted via breast milk based on data included in the French pharmacovigilance database. The ADRs were reported by HPs in 88.7% of the cases and the rest by individuals. The most commonly reported ADRs were neurological and gastrointestinal, and suspected medicines included antiepileptics, opioid analgesics and benzodiazepines.

Community midwifery could contribute to pharmacovigilance systems and detect safety signals from the use of medicines during the perinatal period19. European legislation on the safety of medicines should lead to regulatory turning points and provide an additional level of public health protection from potential harm to breastfeeding mothers and their infants, caused by maternal medication intake20. Therefore, midwives could play an active role in the detection, evaluation, understanding, and prevention of ADRs or any other drug-related health problem during lactation9. This important action research should focus on reporting information on a possible causal relationship between an adverse event and a drug deriving from a variety of sources rather than individual case reports of mother-child dyads, where causality can be ambiguous20. Risk–benefit analysis during lactation mainly refers to the systematic collection of information in order to clarify suspicious events while using a pharmaceutical product and also to identify medicine’s risks and benefits. Increased and adequate data collection and their timely evaluation will allow mothers and midwives to have relevant information to make informed decisions about the use of medicines during lactation and will provide the scientific committee and regulatory authorities with essential information to update healthcare databases11. Neither continuation nor discontinuation of medicines is without risk, but harm can be minimized by effective pharmacovigilance21.

CONFLICTS OF INTEREST

The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported.

FUNDING

There was no source of funding for this research.

ETHICAL APPROVAL AND INFORMED CONSENT

Ethical approval and informed consent were not required for this study.

DATA AVAILABILITY

Data sharing is not applicable to this article as no new data were created.

PROVENANCE AND PEER REVIEW

Not commissioned; internally peer reviewed.

DISCLAIMER

The views and opinions expressed in this article are those of the authors.

REFERENCES

  • 1.Breastfeeding Overview American Academy of Pediatrics. Accessed September, 2022. https://www.aap.org/en/patient-care/breastfeeding/breastfeeding-overview/
  • 2.Saha MR, Ryan K, Amir LH. Postpartum women's use of medicines and breastfeeding practices: a systematic review. Int Breastfeed J. 2015;10:28. doi: 10.1186/s13006-015-0053-6. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3.Tigka M, Metallinou D, Pardali L, Lykeridou K. Shared decision-making about medication intake during lactation: A prospective longitudinal study in Greece. Eur J Midwifery. 2022;6(August):1–12. doi: 10.18332/ejm/149830. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for Earlier Than Desired Cessation of Breastfeeding. Pediatrics. 2013;131(3):e726–e732. doi: 10.1542/peds.2012-1295. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.McClatchey AK, Shield A, Cheong LH, Ferguson SL, Cooper GM, Kyle GJ. Why does the need for medication become a barrier to breastfeeding? A narrative review. Women Birth. 2018;31(5):362–366. doi: 10.1016/j.wombi.2017.12.004. [DOI] [PubMed] [Google Scholar]
  • 6.Long L, Montouris G. Knowledge of women's issues and epilepsy (KOWIE-II): a survey of health care professionals. EpilepsyBehav. 2005;6(1):90–93. doi: 10.1016/j.yebeh.2004.11.006. [DOI] [PubMed] [Google Scholar]
  • 7.Leavitt G, Martínez S, Ortiz N, García L. Knowledge About Breastfeeding Among a Group of Primary Care Physicians and Residents in Puerto Rico. J Community Health. 2009;34(1):1–5. doi: 10.1007/s10900-008-9122-8. [DOI] [PubMed] [Google Scholar]
  • 8.Verstegen RHJ, Anderson PO, Ito S. Infant drug exposure via breast milk. Br J Clin Pharmacol. 2022;88(10):4311–4327. doi: 10.1111/bcp.14538. [DOI] [PubMed] [Google Scholar]
  • 9.European Medicines Agency, Heads of Medicines Agencies . Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations III: Pregnant and breastfeeding women. EMA/653036/2019. European Medicines Agency, Heads of Medicines Agencies; 2019. December, 2019. Accessed September, 2022. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-product-population-specific-considerations-iii_en.pdf . [Google Scholar]
  • 10.Illamola SM, Bucci-Rechtweg C, Costantine MM, Tsilou E, Sherwin CM, Zajicek A. Inclusion of pregnant and breastfeeding women in research–efforts and initiatives. Br J Clin Pharmacol. 2018;84(2):215–222. doi: 10.1111/bcp.13438. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11.Wang J, Johnson T, Sahin L, et al. Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. Clin Pharmacol Ther. 2017;101(6):736–744. doi: 10.1002/cpt.676. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Weisskopf E, Guidi M, Fischer CJ, et al. A population pharmacokinetic model for escitalopram and its major metabolite in depressive patients during the perinatal period: Prediction of infant drug exposure through breast milk. Br J Clin Pharmacol. 2020;86(8):1642–1653. doi: 10.1111/bcp.14278. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Wald J, Henningsson A, Hanze E, et al. Allopregnanolone Concentrations in Breast Milk and Plasma from Healthy Volunteers Receiving Brexanolone Injection, With Population Pharmacokinetic Modeling of Potential Relative Infant Dose. Clin Pharmacokinet. 2022;61(9):1307–1319. doi: 10.1007/s40262-022-01155-w. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Tanoshima R, Bournissen FG, Tanigawara Y, et al. Population PK modelling and simulation based on fluoxetine and norfluoxetine concentrations in milk: a milk concentration-based prediction model. Br J Clin Pharmacol. 2014;78(4):918–928. doi: 10.1111/bcp.12409. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Barlow-Mosha L, Serunjogi R, Kalibbala D, et al. Prevalence of neural tube defects, maternal HIV status, and antiretroviral therapy from a hospital-based birth defect surveillance in Kampala, Uganda. Birth Defects Res. 2022;114(3-4):95–104. doi: 10.1002/bdr2.1964. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Noseda R, Bedussi F, Gobbi C, Zecca C, Ceschi A. Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. Cephalalgia. 2021;41(7):789–798. doi: 10.1177/0333102420983292. [DOI] [PubMed] [Google Scholar]
  • 17.Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol. 2013;45(6):616–618. doi: 10.4103/0253-7613.121375. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Soussan C, Gouraud A, Portolan G, et al. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;70(11):1361–1366. doi: 10.1007/s00228-014-1738-2. [DOI] [PubMed] [Google Scholar]
  • 19.European Medicines Agency . Screening for adverse reactions in EudraVigilance. EMA/849944/2016. European Medicines Agency; 2016. December 19, 2016. Accessed November, 2022. https://www.ema.europa.eu/en/documents/other/screening-adverse-reactions-eudravigilance_en.pdf . [Google Scholar]
  • 20.Warren J. Pharmacovigilance. In: Feldschreiber P, editor. The Law and Regulation of Medicines and Medical Devices. 2nd ed. 2021. pp. 87–C4.P223. [DOI] [Google Scholar]
  • 21.Jordan S, Bromley R, Damase-Michel C, et al. Breast feeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert. Int Breastfeed J. 2022;17(1):55. doi: 10.1186/s13006-022-00494-5. [DOI] [PMC free article] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

Data sharing is not applicable to this article as no new data were created.

Articles from European Journal of Midwifery are provided here courtesy of EUEP European Publishing

RESOURCES