A study on prescription drug use during pregnancy in a secondary care hospital a retrospective population based study

1. Prescription drug use during pregnancy
in a secondary care hospital:
A retrospective population based study
By :
Mahdy Ali
Sangram Das
Alex N. George
Yasir Mustafa
5th Pharm. D
2015 - 16
Under the Guidance of:
Ms.Roopa B.S. ,
M.Pharm,Lecture
Department Of Pharmacy Practice
JSS College Of Pharmacy,Ooty

2. Introduction
 Drugs play an important role in improving human health and
promoting well-being.
 Pregnancy is an important period in many women's lives and it
is important to consider not only the health of pregnant women
but also the health of foetus .
 Therefore judicious use of drugs, adequate knowledge,
positive approach and awareness towards the drug use are
mandatory prerequisites for good maternal and child health.
 More than 50% of pregnant women take prescription or non-
prescription drugs (over-the-counter drugs (OTC) at some time
during their pregnancy.

3. Aim and Objective
 Aim: The aim of the study is to determine the prescription
pattern of medications during pregnancy in the town of Ooty
population who had been hospitalised at Government Head
Quarters Hospital, Ooty.
 Objective: To examine the frequency, timing, and the pattern
of pregnancy exposure to FDA category A,B,C ,D and X
during pregnancy using medical records of a secondary care
hospitalized patients of Government Head Quarters Hospital,
Ooty.

4. Methodology
Study type : Observational
Study Design: Retrospective
Time perspective: Cohort
Sampling Size: 505.
Eligibility criteria:
Age: ≥ 18 years and up to 40 years
Gender eligibility for study:- Female
Accept health volunteers: No
Study population: Pregnant women

5. Inclusion Criteria:
• Pregnant women came for ANC and those who were
already enrolled in routine ANC program,
• Pregnant women who were treated for illness at in-
patient set up and prescribed with at least one drug.
Exclusion Criteria:
• pregnant women in whom the drug information is not
available.

6. Data management :
The data will be collected retrospectively from their respective
medical records attending OBG GYN unit at District
Government Head Quarters Hospital Ooty in-patient
department with confirmed pregnancy during the period Jan 2013
to Jan 2016.
A specially designed Performa (Annexure I) will be used to
collect the data of patient’s such as demographics: age,
Pregnancy trimester, the patient admission date, the patient IP
number, past medical history, past medication history, the
allotted subject number, the eligibility criteria. The details of the
diagnostic condition, the current prescribed use regarding its
duration and frequency and the details of prescription of risk
category agent will be collected.

7. Prescription drugs from categories A,B, C, D, or X of
the United States Food and Drug Administration risk
classification system will be considered. International
Classification of Diseases, Tenth Revision (ICD-10)
diagnostic codes indicating delivery on the maternal
hospital record will be collected. Drug name will be
categorised as per ATC classification and codes.
 Ethical considerations:
• Institutional Ethics Committee:
The study will be started upon obtaining the approval
from the ethical committee of hospital.

8. Expected Outcome:
 To build capacity to obtain reliable information on obstetric,
medical, and drug history during pregnancy.
 To quantify the risk of major congenital malformations
associated with exposure to medicines during the course of
pregnancy.

9. Work Progressed till date:
 IRB Approval was obtained from JSS College of Pharmacy,
Ooty, Institutional Review Board on Nov 2015.
 Prepared Data Collection Form.
 Prepared Excel Sheet for data coding.
 Introduction and review of literature review written completed.
 Data Analyzed
 Got Result of our study
 Arrived on the conclusion.

10. Future work
 Printing of the thesis

11. Analysis
 The collected data was clearly categorized, entered
in to computer, edited, cleaned, and analyzed by
using using the Standard Statistical Software in M.S
Excel sheet.
 Percentage of the drug prescribed for pregnant
women was Analyzed with GPAs.
 Percentage of the risk category with different GPAs
was evaluated.

12. Result
Category Characteristics 1st 2nd 3rd Mean±SD
Age
<20 2(1%) 4(2%) 44(17%) 16.6±23.6
20-35 14(5%) 15(6%) 168(66%) 65.6±88.6
>35 0 31(%) 5(2%) 2.6±2.5
Table. 1: Socio-demographic description of the
pregnant women (n=255) Govt Head Quarters Hospital, Ooty.

13. Category Characteristics 1st 2nd 3rd Mean±SD
Gravida
1 12(3%) 5(2%) 67(26%) 28±33.9
2 3(1%) 8(3%) 117(46%) 42.6±64.4
3 0 6(2%) 15(6%) 7±8%
4 0 2(1%) 2(1%) 1.3±1%
5 0 1(0.39%) 0 0.3±0.5
Parity
0 12(5%) 1(0%) 34(13%) 15.6±16.8
1 3(1%) 18(7%) 3(1%) 8±8.6
2 0 3(1%) 0 1±2%
Live
0 1(0.39%) 6(2%) 114(45%) 40±63.8
1 2(1%) 12(5%) 17(7%) 10±7.6
2 3(1%) 4(2%) 4(2%) 3±0.5
Duration of
Pregnancy 270 258 256 261.3
Trimester 16(6%) 22(9%) 217(85%)
Delivery in study 0 1(0.39%) 153(60%)
patient Prescribed
with
1.Multivitamin 20(8%) 58(23%) 189(74%) 89
2.Iron Suppliment 84(19%) 35(14%) 456(179%) 179.6
Mode Of Delivery
1.Caesarean 0 0 53(21%)
2.Normal delivery 0 0 84(33%)
Abortion 7(2.74%) 2(0.78%) 0
Table. 2: Pregnancy Related Information of
Pregnant Women (n=255) Govt Head Quarters Hospital, Ooty.

14. 1
6%
2
9%
3
85%
TRIMESTER
1 2 3 4
1
0%
2
1%
3
99%
Numberof delivery during study period
0
500
1000
1500
2000
2500
1 2 3
Total number of drug
prescribed in pregnancy/
trimester

15. Table. 3: Drug Risk category and Dosage Related Information of
Total Drug (n=255) Govt Head Quarters Hospital, Ooty.
Category Characteristics 1st 2nd 3rd Avg
Drugs categories
A. 53(1.12%) 75(1.59%) 334(7.06%) 154
B. 45(0.95%) 441(9.32%) 530(11.2%) 338.6
C. 857(18.11%) 1121(23.69%) 1124(23.76%) 1034
D. 14(0.3%) 7(0.15%) 111(2.35%) 44
X. 3(0.06%) 8(0.17%) 8(0.17%) 6.3
USFDA D&X category
1.D 14(0.30%) 7(0.15%) 111(2.035%) 44
2.X 3(0.06%) 8(0.17%) 8(0.17%) 6.3
Dosage form
1.Tab 356(7.52%) 489(10.34%) 1355(28.64%) 733.3
2.Cap 42(0.89%) 125(2.64%) 188(3.97%) 118.3
3.syp 0.00% 3(0.06%) 1(0.02%) 1.3
4.Gel 0 0 0 0
5.Vigina cream 0 0 0 0
Route of administrtion
1.P.O 398(8.41%) 617(13.04%) 1658(35.05%) 891
2.Parentral 322(6.81%) 521(11.01%) 1212(25.62%) 685
3.Top 2(0.04%) 1(0.02%) 0 1

16. 0
20
40
60
80
100
120
1 2 3 4
D
0
1
2
3
4
5
6
7
8
1 2 3
3
8 8
X

17. Category Characteristics 1st 2nd 3rd Avg
Chronic disease YES/NO No No Yes
Diagnosis Disease
Em.LSCS-O82.1 0 0 53(20.78%) 17.6
False Pain-O4700 3(1.18%) 4(1.57%) 9(3.53%) 5.3
Labour pain-O0281 0% 1(0.39%) 84(32.94%) 28.3
Abortion-O021 7(2.75%) 3(1.18%) 1(0.39%) 3.6
Anaemia-O99013 1(0.39%) 6(2.35%) 21(8.24%) 9.3
Polyhydromnios-O403XX0 1(0.39%) 0% 3(1.18%) 1.3
Oligohydramnios-O4102X0
0
1(0.39%) 11(4.31%) 4
HIV-Z717 0 0 0 0
PIH-O163 0 3(1.18%) 12(4.71%) 5
UTI-O0883 1(0.39%) 2(0.78%) 3(1.18%) 2
Early Labour-O0281 0 0 3(1.18%) 1
AGE-O82.1 1(0.39%) 0 3(1.18%) 1.3
Hyperemisis-021-1 1(0.39%) 1(0.39%) 1(0.39%) 1
Rh Negative/GDN- Z67.41 1(0.39%) 0% 0% 0.3
Seizures-F445 0 0 0 0
Cervical Incompetence-O3430
0
2(0.78%) 2(0.78%) 1.3
Hypothyroidism-E03-3 0 0 2(0.78%) 0.6
Abdominal PainF/E-K27.3
0 0
1(0.39%) 0.3
LN with Episiotomy-O82.2
0 0
2(0.78%) 0.6
Persistant Natural Tachycardia
0 0
1(0.39%) 0.3
Post Delivery-O480 0 0 1(0.39%) 0.3
Fever for Evaluation-R50-82
0 0
1(0.39%) 0.3
Asthma-J45.5 0 0 1(0.39%) 0.3
Table. 4: Disease Related Information of Pregnant Women (n=255) GH, Ooty.

18. Medications use among pregnant women in
Ethiopia: A cross sectional
Study , Jimma University, Ethiopia.
our study
A total of 339 pregnant women included
in the study. Majority 224 (66.1%) of the
women were in the age group of 21–30
years .
About half of the patients hospitalized in
second trimester.
Majority (57.2%) of the women who
received these medications were in
their third trimester of pregnancy.
Out of 255 pregnant women, about 66%
were between 20-35 years .
About 85% of the patients hospitalized in
third trimester.
Majority (45.%) of the women who
received these medications were in
their third trimester of pregnancy.
Discussion

19. Higher proportion of category-D
medications use was observed in the
third (18.6%) and first (16.1%) trimesters
compared second (13.5%) trimester of
pregnancy. Similarly, category-X
medications use was higher in the third
(7.2%) and first (7.1%) trimesters than
second (6.7%) trimester of pregnancy.
Majority 191(56.3%) of medications
used were from category-C followed by
category-B 165(48.7%) and category-A
(35.4%). Of the total medications used
during pregnancy.
57(16.8%) and 24(7.1%) were from
category D and X.
 Higher proportion of category-D
medications use was observed in the
third (2.35%) and first (0.30%)
trimesters compared second (0.15%)
trimester of pregnancy. Similarly,
category-X medications use was
higher in the third (0.17%) and second
(0.17%) trimester than first (0.06%)
trimesters of pregnancy.
Majority 3102 (23.76%) of medications
used were from category-C followed by
category-B 1016(11.20%) and category-
A 462(7.06%). Of the total medications
used during pregnancy.
132(2.35%) and 19(0.17%) were from
category D and X.

20. Conclusion
 The age between 20 to 35 are the most common women are in 3rd trimester .
 The average of total duration in Pregnancy of all study population is 261.3
days.
 857 (18.11%) of drug from “C” risk category were prescribed more in 1st
trimester.
 1121(23.69%) of drug from “C” risk category were prescribed more in 2nd
trimester.
 1124(23.76%) of drug from “C” risk category were prescribed more in 3rd
trimester.
 The average shows the less amount of drug prescribed is from risk category
“X” (6.3).
 According to study the average shows (733.3)Tablet is more often used in
over all patient.
 Oral route of administration is more preferred in 1st (8.41%),2nd (13.04%),3rd
(35.05%) trimester than Parenteral and Topical route of administration.

21.  This type of study can help in evaluating the existing
drug use during pregnancy.
 It is essential for healthcare providers to acquire the
latest evidence regarding the potential benefits or
harm associated with.
 medications use during pregnancy to recommend or
prescribe any medications only after carefully
considering evidences supporting the use during
pregnancy.

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24. THANK YOU