Abstract
Introduction
In pregnancy, drug treatment presents a special concern. The physiological changes in the mother affecting pharmacokinetics of drugs, coupled with the threat of potential teratogenic effects determine the choice of drugs.1-3 Drugs prescribed during the intranatal period also warrant special concern as they directly impose risks on breast-feeding. Drugs used during normal delivery include analgesics, anesthetics, antacids, intravenous fluids, oxytocin, prostaglandin analogs, antibiotics, iron, folic acid, calcium, and so on.
The transfer of drugs into human milk is similar to the transfer of drugs across the placental barrier. It occurs mainly by passive diffusion. Certain properties of some drugs may cause them to be sequestered or actively excreted into breast milk. The most important factors involved in exposure of infants to drugs in breast milk are the amount of drug in the mother’s serum and intrinsic properties of the drugs and the body such as bioavailability, molecular weight, protein binding, pKa, and lipid solubility. Milk to plasma ratio is a useful description of how much drug passes into milk and may be available as part of the drug literature supplied by drug companies.4,5 It is thus essential to monitor rational drug administration during the intranatal period.
There are very few kinds of treatment during which breast-feeding is absolutely contraindicated. However, there are some drugs that a mother has to take despite harmful effects to the baby (such as antiepileptics, immunosuppressants, etc). Several studies have confirmed that one of the factors that leads to early weaning is an infant’s exposure to maternal drugs.6,7 Information and bibliographic references on drugs and breast milk have been available, but the information contained in drug package inserts and the scientific evidence regarding drug use during breast-feeding is often inconsistent. 8
There are numerous studies looking into the drug prescribing pattern during pregnancy and/or lactation, but there is a dearth of articles exploring the drug prescribing pattern during delivery (ie, intranatal period). This is of paramount importance as drugs administered during delivery may influence the duration of hospital stay and also have an impact on lactation, thus affecting both the mother and the newborn. 2
Pharmacoepidemiological studies can help minimize the use of potentially dangerous drugs in pregnancy by establishing a profile of drug consumption, by monitoring the health services, and by investigating interventional measures. 9 This is especially relevant for rural, primary and secondary care hospitals in a developing country where resources are limited.
With this background, the present study was conducted with the following objective: to evaluate the drug prescribing pattern during the intranatal period retrospectively among all the mothers undergoing normal delivery for 3 months in the Community Health and Development Hospital, Christian Medical College, Vellore, a secondary care hospital. This hospital belongs to the second tier of health system, in which patients from primary health care are referred to specialists in district hospitals and community health center at the block level. 10
Materials and Methods
This study was started after obtaining approval from the Institutional Review Board, Christian Medical College, Vellore.
Study design: Descriptive.
Study type: Cross-sectional survey.
Study tools: Preformatted forms and patients’ charts obtained from the Medical Records Department.
Inclusion criteria: All the women who delivered (including episiotomy) normally from October 1, 2014 to December 31, 2014.
Exclusion criteria: Drug histories of the women who delivered by Cesarean section.
Data analysis: Microsoft Excel 2010 was used.
Results
A total of 313 antenatal record charts were surveyed during the study period; 0.65% mothers were younger than 18 years, 91.23% were from 18 to 30 years old, and 8.12% were older than 30 years. Episiotomy was required for 190 (60.70%) mothers. All the mothers started breast-feeding immediately after delivery. A total of 2222 drugs, comprising 51 different drug types were administered. Some of the drugs were continued throughout the pregnancy in patients with chronic diseases.
The distribution of drugs with lactation risks11,12 has been itemized in Table 1. Of all the 51 types of drugs, most are safe. However, some prescribed drugs were not recommended for use during lactation including tramadol, cetirizine, pheno-barbitone, metoclopramide, betamethasone, nifedipine, frusemide, amlodipine, metronidazole and doxycycline due to potential risk of adverse reactions.
Distribution of Drugs Administered During Delivery With Their Lactation Risks (n = 313).
Discussion
This study was undertaken to find out the drug prescribing patterns during normal delivery and screen for possible drug errors. The most common indications for drug prescription included stabilization of vital signs, pain during delivery, to promote uterine contraction and stop postpartum hemorrhage, hypertension, urinary infections, respiratory infections, vaginal infections, Rh isoimmunization, vomiting, hypothyroidism, diabetes, gastritis, constipation, asthma, diarrhea, epilepsy, and cough. Along with these, routine supplementation of iron, folic acid, and calcium was continued. Some of the mothers were already on concomitant medications for chronic diseases like diabetes, hypothyroidism, and asthma.
The World Health Organization 11 has classified drugs into different categories based on safety during lactation:
Compatible with breast-feeding: no monitoring required
Compatible with breast-feeding: monitor infant for side effects
Avoid if possible: monitor infant for side effects
Avoid if possible: may inhibit lactation
Avoid
No data available
The safety of certain drugs also depends on the age of the infant. Premature babies and neonates have a different capacity to absorb and excrete drugs than older infants. Thus, in general, extra caution is needed for these infants. 12
In our study, most of the prescribed drugs are safe. Although some drugs are best avoided, their limited use only during delivery might not affect the breast-feeding infant. For some drugs, the lactation status is not available. Tramadol can increase prolactin levels, but discontinuation of breast-feeding following a single dose is not necessary. 12 Cetirizine is excreted into human milk and the manufacturer does not recommend it’s use in nursing mothers. 12 Diazepam is excreted into human milk because of which sedation, lethargy, and weight loss have been reported in nursing infants. 12 With phenobarbitone, sedation and lethargy have been also reported in breast-fed infants. Some investigators have recommended close therapeutic drug monitoring of infant blood concentrations if a nursing mother takes phenobarbital. 12 Metoclopramide is best avoided during lactation, although there is insufficient data on long-term adverse reactions (possible defects in neural development in newborn animals and increased breast milk production). 11
Mothers should not breast-feed during treatment with methergine for at least 12 hours after administration of the last dose and milk secreted during this period should be discarded. 12 The manufacturer recommends that because betamethasone has the potential for serious adverse reactions in breast-fed infants, it should be used with caution. 12 Nifedipine is excreted into human milk and although there is insufficient data on long-term adverse reactions, the manufacturer warns it could cause serious adverse reactions in nursing infants.11,12 Use of amlodipine is not recommended during lactation. 12 Although compatible with breast-feeding, ranitidine should be used with caution. 12 Frusemide inhibits lactation and is also best avoided. 11 Insulin is compatible with breast-feeding but dose adjustment may be required.11,12 With gentamicin, the neonate needs to be monitored for thrush and diarrhea. 11 Animal data suggest that metronidazole may be carcinogenic and if given in a single dose of 2 g, breast-feeding should be discontinued for 12 hours and the baby should feed on expressed breast milk ejected in advance. 11 With doxycycline, there is a possibility of staining the infant’s teeth, although a single dose is probably safe. 11
Thus, in our study, most of the various drugs prescribed during delivery appear safe in lactation. So also were the concomitant medications. Although some of the drugs would have been best avoided, they did not cause any harm possibly due to their limited use only during the time of delivery. In a study done previously, drug prescribing pattern in pregnancy to antenatal mothers in the same secondary care hospital was also very safe and rational. 13 The limitation of our study was that detailed demographic data of all mothers were not available at the time of data collection.
Conclusion
This study reflects a good, safe, and rational medication practice during normal delivery for various common indications in a secondary care hospital and can be cited as an example for similar primary and secondary care hospitals in India.
Footnotes
Acknowledgements
The authors are grateful to the Medical Records Department, Christian Medical College, Vellore for helping in data collection and Dr. Jacob Peedicayil, Professor, Department of Pharmacology, Christian Medical College, Vellore, India for giving valuable feedback during manuscript preparation.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.