Abstract
Background
In pregnancy drug treatment presents a special concern due potential teratogenic effects and physiologic alterations in mother. This retrospective study was performed to evaluate the drug prescribing pattern in pregnancy among pregnant women in a secondary care hospital in India.
Materials and methods
This cross-sectional retrospective study was done for 3 months using pre-formatted forms and patient’s records.
Results
A total of 326 drugs, including 46 different types of drugs, were prescribed to 606 gravid women. Eight different types of medications were started before being seen at the antenatal clinic. Most of these drugs fall under US FDA pregnancy categories B and C and few under categories A, X and N.
Conclusion
This study reflects a good, safe and rational medication practice during pregnancy in various common disorders in a secondary care hospital and can be cited as an example to similar primary and secondary care hospitals.
Introduction
In pregnancy drug treatment presents a special concern due to the threat of potential teratogenic effects of the drug and physiologic alterations in the mother affecting her responses to medication. The pharmacokinetics of certain drugs is altered by the physiological changes and certain drugs can cross the placenta to cause harm to the fetus. Also, there is increase in the volume of distribution of some soluble drugs. Placental transfer is a key factor in the potential teratogenicity of a drug. Teratogenic drugs may act directly on the fetus causing damage or abnormal development, or can also alter the physiological function of the placenta affecting fetal growth.1–3
Some historical catastrophes have occurred using teratogenic drugs such as the thalidomide and diethylstilbestrol tragedies. Therefore, the rationale for medication during pregnancy needs to be extra strong. In other words, benefits to the mother and risks to the fetus need to be continuously monitored. It is pertinent here to mention that the US FDA had laid strict regulations regarding drug labelling, use of medications in pregnancy, requiring proper demonstrations of safety and efficacy of any drug before it comes to the market. 4
Food supplements like iron, folic acid, calcium and vitamins are prescribed almost routinely in pregnancy potentially to improve the nutritional and health status of mother and fetus, and prevent complications such as neural tube defects. In addition, various drugs may also be prescribed for frequent diagnoses requiring treatment in pregnancy such as fever, nausea and vomiting, trauma, respiratory infections, constipation, sleep disturbances, depression, headache, urogenital infections, diabetes, hypothyroidism, hypertension, acquired immune deficiency syndrome, epilepsy, chronic obstructive pulmonary disease, etc. 5
A study in 2001 found that there was not enough information about the risk or safety in pregnancy of more than 90% of the medications approved by the FDA between 1980 and 2000. 6 In countries like India, most pregnant women are ignorant of the harmful effects of several drugs when used in pregnancy. Also, many women take medications in the early weeks of pregnancy before realising that they are pregnant. Moreover, due to easy availability of drugs coupled with inadequate health services, increased proportions of irrational drugs (allopathic, homeopathic or herbal) are used as self-medication (‘over the counter’ drugs). ‘Social drugs’ in the form of smoking, alcohol, ‘bidi’, addictive substances and others may also cause deleterious effects to the growing fetus. Often physicians themselves inadvertently prescribe teratogenic drugs in pregnancy. 7
Pharmaco-epidemiological studies can help to minimise 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. 8 This is especially relevant for rural, primary and secondary care hospitals in India where resources are limited. With this background, the present study was carried out with the following objective: to evaluate the drug prescribing pattern in pregnancy retrospectively among all the pregnant women attending the antenatal clinic (ANC), irrespective of the duration of pregnancy, for 3 months in Community Health and Development Hospital, Christian Medical College, Vellore, a secondary care hospital.
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: Pre-formatted forms and patients’ charts obtained from Medical Records Department.
Inclusion criteria: All the pregnant women who attended our ANC from 1 October 2014 to 31 December 2014, irrespective of the duration of pregnancy.
Exclusion criteria: Drug histories of the admitted gravid women who were prescribed medications from the inpatient department (and not from the ANC) were not counted.
Data analysis: Microsoft Excel® 2010 was used. US FDA pregnancy safety categories of each of the concerned drugs were verified using an online checker. 9
Results
A total of 606 antenatal record charts were surveyed for a period of 3 months.
Trimester-wise distribution, frequency and US FDA pregnancy categories of different drugs prescribed during pregnancy (total 606 ANC attendants).
Frequency and US FDA pregnancy categories of the medications started before being seen at our ANC (total 606 ANC attendants).
At the time of data collection, documentation of iron, calcium and folic acid prescriptions was not available in the antenatal records of 21, 21 and 17 gravid women, respectively. However, no history of any addiction or intake of ‘over the counter’ medication was recorded.
Discussion
This study was undertaken to find drug prescribing patterns in pregnancy and screen for possible medication errors. The women presented mostly with common ailments such as vomiting, white vaginal discharge, abdominal pain, urinary tract infections, cough and cold, fever, worm infestations, gastritis, acidity, minor trauma, diabetes, pregnancy-induced hypertension and ear discharge. The different drugs prescribed were antibiotics (amoxicillin, azithromycin, ciprofloxacin, metronidazole, nitrofurantoin), anti-emetics (doxylamine, metoclopramide), anti-histaminics (chlorpheniramine, diphenhydramine, cetirizine), anti-fungals (fluconazole, clotrimazole), anti-helminthics (albendazole, levamisole, pyrantel), steroids (beclomethasone, betamethasone, prednisolone), analgesics and anti-pyretics (paracetamol, diclofenac, ibuprofen, pentazocine), drugs for acid-peptic disorder (antacids, ranitidine, famotidine), astringents and soothing agents (turpentine oil, calamine lotion, pramoxine lotion), and miscellaneous drugs (aspirin, aminophylline, hydroxyprogesterone, labetalol, metformin, pseudoephedrine, vitamins and alkali like disodium hydrogen sulfate). Drugs were prescribed as tablets, syrups, pessaries, injectables, topical drops and lotions.
Paracetamol is widely used in pregnancy but might be grossly over prescribed for fever management and its value is more perceived than real. Interestingly, animal studies have shown reduced production of testosterone, cryptorchidism and diminished weight of seminal vesicles in male offspring after prolonged use of analgesics, including paracetamol in pregnancy. Human studies have also shown cryptorchidism, low plasma testosterone, hypospadias, low sperm count and increased chance of testicular germ cell cancer with overuse of paracetamol in pregnancy. It is therefore better to avoid excessive use paracetamol in pregnancy, particularly in the first trimester when testes are developing.10,11
Some of the pregnant women were already on some chronic medications before attending the ANC and they were continuing those during their gestation. Those drugs were L-thyroxine for hypothyroidism, metformin for diabetes, methylcobalamin for neuropathic pain, progesterone for history of previous unexplained abortions, 12 penicillin for rheumatic fever, imipramine for chronic depression, domperidone for chronic gastritis and vomiting, and multivitamins as dietary supplement.
In 1979, US FDA introduced a classification of fetal risks due to pharmaceuticals as follows:
13
Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential substantial benefits may warrant use of the drug in pregnant women despite potential risks. Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential substantial benefits may warrant use of the drug in pregnant women despite potential risks. Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Category N: FDA has not classified the drug.
In our study, most of the various drugs prescribed (categories B and C) in the ANC appear safe in pregnancy. Few drugs prescribed are generally contraindicated during pregnancy and falls under category D. Of these, aspirin has been used in patients with pregnancy-induced hypertension, previous history of pre-eclampsia and miscarriage, which are justified uses.14–16 One tablet of fluconazole was prescribed in a pregnant mother with severe white discharge although it would have been better avoided and two tablets of ibuprofen were prescribed to a lady with traumatic injury in the ankle, although it is contraindicated in the third trimester of pregnancy. However, the nominal dose and frequency in which fluconazole and ibuprofen were prescribed was unlikely to cause any teratogenic harm. None of the drugs prescribed fall under category X.
Also, the drugs which were used as concomitant medications were under categories A, B and C, and may be considered safe in pregnancy.
Thus, overall it can be said that the drug prescribing pattern in pregnancy in our ANC is safe and rational.
Conclusion
This study reflects a good, safe and rational medication practice during pregnancy for various common disorders in a secondary care hospital and can be cited as an example to similar primary and secondary care hospitals in India.
Footnotes
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.