scholarly journals A prospective pharmacovigilance study in the infectious diseases unit of a tertiary care hospital

2019 ◽  
Vol 13 (07) ◽  
pp. 649-655 ◽  
Author(s):  
Berna Karaismailoglu ◽  
Nese Saltoglu ◽  
Ilker Inanc Balkan ◽  
Bilgul Mete ◽  
Fehmi Tabak ◽  
...  

Introduction: The frequency, causality, severity, preventability and risk factors of ADRs (adverse drug reactions) in infectious disease units are not well defined in the literature. Thus, the aim of this study was to determine the characteristics of the ADRs encountered in an infectious disease unit of a tertiary teaching hospital. Methodology: The patients who were admitted to the infectious disease unit of a tertiary teaching hospital longer than 24 hours between January and December of 2016 were followed prospectively. Patients were observed and questioned for any sign of ADRs. The proportion of ADRs and patient characteristics were investigated. Causality was evaluated by the Naranjo algorithm, severity was determined using the Hartwig classification, and preventability was assessed using the Schumock and Thornton scale. Results: 210 patients were admitted to the unit during the study period, of whom 44 patients (20.9%) experienced 51 ADRs. 5.9% of ADRs were found to be serious according to the Hartwig severity classification. In addition, 88.1% of ADRs were not preventable. The most frequently detected ADR was skin and subcutaneous tissue reactions (33.3%), and systemic antimicrobials were the most common type of drugs that caused an ADR. Prolonged hospitalization (p < 0.001) and usage of an increased number of drugs (p < 0.001) were found to be significant risk factors for ADR development. Conclusions: Prolonged hospital stay and polypharmacy are significant risk factors that increase the incidence of ADRs in infectious disease units. The likelihood of unavoidable ADRs should arouse the attention of clinicians when prescribing antimicrobials.

Author(s):  
V. Meera Rajagopal ◽  
Kalpana Betha ◽  
Satya Priya G.

Background: New global health figures show India to have the highest rates of stillbirth in the world. While maternal and under 5 child mortality rates have halved, stillbirth remains a neglected global endemic. To reduce stillbirths, the prevalence, risk factors and causes must be known. The aim of the present study is to know the prevalence and classify stillbirths by ReCoDe classification system at different trimesters of pregnancy.Methods: This was a retrospective study done between January 2013 to March 2017 at MediCiti Institute of Medical Sciences, a rural tertiary teaching hospital, Telangana, India. A total of 112 cases of stillbirths were included. Data was obtained on demographic variables, risk factors such as preeclampsia, etc. Data regarding mode of delivery, fetal asphyxia, were recorded.Results: Stillbirth rate was 12.1/1000 births. Fifty four percent of the women were unbooked. Preterm stillbirths were a majority (67%). The intra-partum still birth rate was low (15.1%) contrary to what is seen in low middle-income countries. Gestational hypertension/Pre-eclampsia, abruptio placenta, fetal growth restriction and oligohydramnios were the leading causes of stillbirths.Conclusions: Pregnant women from rural background with low socio-economic status are prone for stillbirths. As stillbirths were more among unbooked cases, the study highlights the importance of counselling, creating awareness in the rural areas regarding the importance of regular antenatal checkups. Identifying risk factors like pre-eclampsia, anemia etc., at early weeks will enable us to initiate appropriate strategies to improve pregnancy outcome.


Author(s):  
Ke Manga Reddy ◽  
Lakshmi Sailaja P. ◽  
Sahithi Balmuri ◽  
Avinash Jagarlamudi ◽  
Kalpana Betha

Background: Gestational diabetes mellitus is the commonest medical disorder in pregnancy. Women with GDM are at increased risk for adverse obstetric and perinatal outcome. Prevalence of GDM is known to vary widely depending on region of the country, dietary habits and socio-economic status. This study was undertaken to evaluate the prevalence of GDM and risk factors associated with it among women delivered in a rural tertiary teaching hospital in Telangana and further assess its impact on feto-maternal outcome.Methods: A retrospective study was conducted at Mediciti Institute of Medical Sciences on GDM cases delivered from May 2015 to April 2017. GDM was diagnosed using 2 step procedure of screening with glucose challenge test followed by confirmation with oral glucose tolerance test using Carpenter and Couston criteria. Demographic data and details about perinatal outcome were obtained from medical records and analyzed.Results: The prevalence was low (1.83%) compared to other studies. Majority of the women did not have risk factors. Preeclampsia is the commonest maternal complication seen (18%). Hypothyroidism is more often associated with GDM (15%). Caesarean section rate was high (62%). Though the NICU admission rate was high (76%), neonatal outcome was found to be satisfactory.Conclusions: The low prevalence of GDM seen highlights the importance of carrying out studies in different population groups of India to know the exact prevalence of GDM in the country. Pregnancies in women with GDM continue to be at increased risk of maternal and perinatal complications.


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