E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital

Jayanthi C R, Bhavya Darshini M.

Abstract
Background: Adverse drug reactions (ADRs) in women demand a special care due to altered physiology. Despite lingering safety questions, studies on vulnerable groups such as pregnancy, lactation, peri- and post-menopausal women are lacking. Hence, the assessment of ADRs is essential for early risk detection and its management.

Aims and Objectives: To analyze the pattern, causality, severity, predictability and preventability of occurrence of ADRs in the Obstetrics and Gynecology (OBG) Department.

Materials and Methods: An observational study was conducted from June 2012 to 2016 to analyze the ADRs reported spontaneously from the Department of OBG to ADR Monitoring Center, Bangalore Medical College and Research Institute. Causality of each ADR was assessed by the WHO-ADR scale, severity by Hartwig and Siegel scale and preventability by modified Schumock and Thornton scale.

Results: A total of 100 ADRs were reported over 48 months; a maximum number of ADRs were observed in the age group of 21–40 years (81%) and majority of them during pregnancy (62%). The highest number of ADRs was associated with iron therapy (42%) followed by antimicrobials (31%). Gastrointestinal system (51%) was affected predominantly. Gastritis (25%) followed by allergic reactions (18%) was most commonly observed ADRs. The WHO-UMC criteria showed that 61% were “probable” and 57% were “mild” in nature. Preventability assessment showed that 56% were “probably preventable” ADRs. Furthermore, 72% of the ADRs were predictable in nature. 43% of the ADRs required additional medical treatment, while causative drug was withdrawn in 44% of cases.

Conclusion: This study provides a database of ADRs in the OBG Department and most of the ADRs were predictable and probably preventable with no severe ADRs, which highlights the appropriate management of ADRs at our center.

Key words: Adverse drug reactions; Causality; Severity; Predictability; Preventability


 
ARTICLE TOOLS
Abstract
PDF Fulltext
How to cite this articleHow to cite this article
Citation Tools
Related Records
 Articles by Jayanthi C R
Articles by Bhavya Darshini M
on Google
on Google Scholar


REFERENCES
1. Weinberg LA. Atlas of tooth and implant supported prosthodontics. Chicago, IL: Quintessence Publishing, 2003: 47-84.
2. Branemark P-I. Osseointegration and its experimental background. J Prosthet Dent 1983; 50: 399-410. [DOI via Crossref]   
3. Misch CE. Contemporary Implant Dentistry. St.Louis: Mosby Inc, 1993: 187-189.
4. Belser UC, Bernard JP, Buser D. Implant-supported restorations in the anterior region: prosthetic considerations. Pract Periodontics Aesthet Dent 1996; 875-83. [Pubmed]   
5. Briggs P, Ray-Chaudhuri A, Shah K. Avoiding and managing the failure of conventional crown and bridges. Dent Update 2012; 39: 78-80. [Pubmed]   
6. Cordioli GP, Brugnolo E, Mazzocco C, Rossi PC: Esthetic considerations with implant-supported prostheses, in Albrektsson T, Zarb GA (eds); The Branemark Osseointegrated Implant. Chicago: Quintessence Pub.Co.,Inc., 1989: 221-228. [Pubmed]   
7. Kim Y, Oh TJ, Misch CE, Wang HL. Occlusal considerations in implant therapy: clinical guidelines with biomechanical rationale. Clin Oral Implants Res. 2005: 16: 26-35. [DOI via Crossref]    [Pubmed]   
8. Van Steenberghe D. A retrospective multicenter evaluation of the survival rate of osseointegrated fixtures supporting fixed partial prostheses in the treatment of partial edentulism. J Prosthet Dent 1989; 61: 217-223. [DOI via Crossref]   
9. Albrektsson T, Zarb G, Worthington P, Erikson AR. The long term efficiacy of currently used dental implants. A review and proposed criteria of success. Int J Oral Maxillofac Ýmplants 1986; 1: 11-15.
10. Sahin S, Çehreli MC, Yalçin E. The influence of functional forces on the biomechanics of implant-supported prostheses-a review. J Dent 2002; 30: 842-845. [DOI via Crossref]   
11. Saba S. Occlusal stability in implant prosthodontic-clinical factors to consider before implant placement. J Can Dent Assoc 2001; 67: 522-6. [Pubmed]   
12. Sahin S, Cehreli M, Yalcin E. The influence of functional forces on the biomechanics of implant supported prostheses-a review. J Dent 2002; 30: 271-282. [DOI via Crossref]   

How to Cite this Article
Pubmed Style

R JC, M BD. A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. Natl J Physiol Pharm Pharmacol. 2019; 9(2): 172-177. doi:10.5455/njppp.2019.9.1236921122018


Web Style

R JC, M BD. A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. https://www.njppp.com/?mno=21942 [Access: June 01, 2022]. doi:10.5455/njppp.2019.9.1236921122018


AMA (American Medical Association) Style

R JC, M BD. A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. Natl J Physiol Pharm Pharmacol. 2019; 9(2): 172-177. doi:10.5455/njppp.2019.9.1236921122018



Vancouver/ICMJE Style

R JC, M BD. A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. Natl J Physiol Pharm Pharmacol. (2019), [cited June 01, 2022]; 9(2): 172-177. doi:10.5455/njppp.2019.9.1236921122018



Harvard Style

R, J. C. & M, . B. D. (2019) A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. Natl J Physiol Pharm Pharmacol, 9 (2), 172-177. doi:10.5455/njppp.2019.9.1236921122018



Turabian Style

R, Jayanthi C, and Bhavya Darshini M. 2019. A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. National Journal of Physiology, Pharmacy and Pharmacology, 9 (2), 172-177. doi:10.5455/njppp.2019.9.1236921122018



Chicago Style

R, Jayanthi C, and Bhavya Darshini M. "A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital." National Journal of Physiology, Pharmacy and Pharmacology 9 (2019), 172-177. doi:10.5455/njppp.2019.9.1236921122018



MLA (The Modern Language Association) Style

R, Jayanthi C, and Bhavya Darshini M. "A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital." National Journal of Physiology, Pharmacy and Pharmacology 9.2 (2019), 172-177. Print. doi:10.5455/njppp.2019.9.1236921122018



APA (American Psychological Association) Style

R, J. C. & M, . B. D. (2019) A study to analyze the pattern, causality, severity, predictability and preventability of adverse drug reactions among patients attending department of obstetrics and gynecology at a tertiary care hospital. National Journal of Physiology, Pharmacy and Pharmacology, 9 (2), 172-177. doi:10.5455/njppp.2019.9.1236921122018