From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi

Abstract

Background

Adverse drug reactions (ADRs) pose significant risks to patient safety, particularly in tertiary care settings characterized by polypharmacy and multiple comorbidities. Monitoring and evaluating ADRs is vital to improving therapeutic outcomes and minimizing harm.

Objective

This study aimed to assess the pattern, severity, predictability, seriousness, and causality of ADRs reported in a tertiary care teaching hospital in Belagavi, India.

Methods

A prospective observational study was conducted on 2035 spontaneously reported ADRs collected between January and December 2024 at the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). Data were analyzed using the WHO-UMC causality assessment, Hartwig and Siegel severity scale, and standard classifications for seriousness and predictability.

Results

Adults (60.54%) and elderly (24.67%) were most frequently affected. Gastrointestinal disorders (23.91%) were the most commonly reported System Organ Class (SOC). Most ADRs were predictable (87.81%) and probable in causality (67.91%). Severe ADRs accounted for 15.97%. Vomiting and headache were the most reported adverse events. Antiretroviral were the most commonly implicated drug class.

Conclusion

The majority of ADRs were predictable and involved widely used drug classes. Strengthening pharmacovigilance practices and implementing targeted clinical interventions are essential to prevent avoidable ADRs and improve patient safety.

Keywords

adverse drug reaction pharmacovigilance drug safety causality assessment System Organ Class patient safety

Introduction

Medications are developed to alleviate symptoms, treat diseases, and improve overall patient health. However, they can also lead to unintended and harmful effects known as adverse drug reactions (ADRs). The World Health Organization (WHO) defines an ADR as “a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”¹

In hospital settings, especially tertiary care centers, the occurrence of ADRs is relatively common. This is often attributed to the complexity of underlying conditions, polypharmacy, drug-drug interactions, and occasional clinical oversight.² These reactions not only compromise patient safety but also contribute to morbidity, occasional mortality, and increase the economic burden on healthcare systems and patients.

To address this concern globally, the WHO initiated a pharmacovigilance program, aimed at ensuring medication safety through the detection, assessment, understanding, and prevention of ADRs. The program encourages rational drug use, strengthens public health safety, and supports cost-effective prescribing practices across more than 65 countries.³ In alignment with these goals, our tertiary care teaching hospital has established an Adverse Drug Reaction Monitoring Centre (AMC) which is actively involved in recording and reporting suspected ADRs.

Despite ongoing pharmacovigilance initiatives, underreporting of adverse drug reactions (ADRs) remains a significant barrier to effective drug safety monitoring. Various factors contribute to this, including the prioritization of immediate patient care by physicians, particularly in high-intensity units like intensive care units (ICUs), where the identification of ADRs becomes even more challenging.⁴ In India, adverse drug reaction (ADR) reporting remains below 1%, significantly lower than the global average of 5%, largely due to limited awareness of pharmacovigilance among healthcare professionals and patients. Although the spontaneous reporting system is a widely used tool for post-marketing surveillance and plays a crucial role in detecting ADRs in everyday clinical settings, it is hindered by substantial underreporting and a lack of precise data on patient exposure to suspected medications.⁵

In light of these challenges, there is a pressing need to systematically analyze the adverse drug reactions documented by our AMC. This study aims to evaluate the causality, severity, predictability, and preventability of these events in a tertiary care teaching hospital. The insights gained are expected to strengthen ADR detection strategies, foster a culture of reporting among healthcare professionals, and ultimately enhance patient safety outcomes.

Materials and methods

A prospective observational study was conducted at the AMC of a tertiary care teaching hospital in Belagavi. All spontaneously reported ADRs between January and December 2024 were included. Ethical approval was obtained from Institutional Ethics Committee (Ref. No. KLECOPBGMEC D028-2024). Data access and analysis were approved by the PvPI Coordinator.

The ADR reports were collected by the Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). The reports include detailed patient information such as demographics, medical history, pre-existing conditions, relevant laboratory investigations, and prior drug allergies. Comprehensive drug histories were obtained, encompassing suspected and concomitant medications, dosage, route of administration, indication, and any previous history of drug allergies. Details regarding the management and treatment of the reported ADRs were also documented. Absolute anonymity was maintained throughout the study to protect the identities of both patients and reporters.

ADRs were assessed using the following:

• WHO-UMC criteria for causality.

• Hartwig and Siegel scale for severity.

• Classification into serious/non-serious and Type A/B predictability.

Data analysis was performed using descriptive statistics.

Results

A total of 2035 adverse drug reaction (ADR) reports were analyzed in this study. Age-wise distribution showed that adults (18-59 years) accounted for the highest number of ADRs with 1232 reports (60.54%), while neonates (<1 month) had the lowest, with only nine reports (0.44%). Gender distribution indicated a slight male predominance, with 1056 ADRs (51.91%) reported in males and 979 (48.09%) in females (Table 1).

Table 1.

Demographics details.

Parameters	Category	Number of patients	Percentage
Age	Neonates (<1 month)	9	0.44
	Infants (1 month to <1 year)	21	1.03
	Child (1 year to <12 years)	169	8.30
	Adolescents (12 years to <18 years)	102	5.01
	Adult (18 years to <60 years)	1232	60.54
	Elderly (≥60 years)	502	24.67
Gender	Male	1056	51.89
Gender	Female	979	48.11

In terms of severity, mild ADRs were observed in 914 cases (44.91%), moderate in 796 (39.12%), and severe in 325 (15.97%), based on the Hartwig and Siegel scale. Regarding predictability, the majority were predictable reactions (Type A) accounting for 1787 reports (87.81%), while non-predictable (Type B) ADRs were noted in 248 cases (12.19%). As per the WHO-UMC criteria, 325 ADRs (15.97%) were classified as serious, and 1710 (84.03%) were non-serious (Table 2).

Table 2.

Assessment of ADRs by severity, predictability, seriousness, causality, action taken, and outcomes.

Scales	Types	No. of ADRs (%)	Percentage
Severity assessment by Hartwig and Siegel Scale	Mild	914	44.91
	Moderate	796	39.12
	Severe	325	15.97
Predictability as per types of ADRs	Non predictable-Type B	1787	87.81
Predictability as per types of ADRs	Predictable-Type A	248	12.19
Seriousness as per WHO-UMC Scale	Serious	325	15.97
Seriousness as per WHO-UMC Scale	Non-serious	1710	84.03
Causality assessment as per WHO-UMC scale	Certain	91	4.47
	Probable	1382	67.91
	Possible	562	27.62
Action taken	Drug withdrawn	945	46.44
	Dose of the drug not changed	646	31.74
	Dose of the drug reduced	97	4.77
	Dose of the drug increased	6	0.29
	Not applicable	327	16.07
	Unknown	14	0.69
Outcomes of adverse drug reactions	Recovered	697	34.25
	Not recovered	316	15.53
	Recovering	988	48.55
	Resolved with sequelae	3	0.15
	Unknown	31	1.52

Causality assessment using the WHO-UMC scale indicated that 91 ADRs (4.47%) were certain, 1382 (67.91%) were probable, and 562 (27.62%) were possible. In response to ADRs, 945 drugs (46.44%) were withdrawn, 646 (31.74%) were continued without dose change, 97 (4.77%) had a dose reduction, 6 (0.29%) had a dose increase, and 327 (16.07%) were marked as not applicable. In 14 cases (0.69%), the action taken was unknown. Regarding patient outcomes, 988 cases (48.55%) were recovering at the time of reporting, 697 (34.25%) had fully recovered, 316 (15.53%) had not recovered, 3 (0.15%) resolved with sequelae, and 31 (1.52%) had unknown outcomes.

Among the 2287 individual adverse events classified by System Organ Class (SOC), the gastrointestinal system was the most commonly affected (547 events; 23.91%), followed by nervous system disorders (303 events; 13.25%). Less frequently reported SOCs included psychiatric, renal, cardiovascular, and endocrine disorders (Table 3).

Table 3.

System Organ Class (SOC)–wise distribution of reported ADRs.

System organ class (SOC)	Number of reports	Percentage (%)
Gastrointestinal disorders	547	23.91
Nervous system disorders	303	13.25
Skin and subcutaneous tissue disorders	269	11.76
General disorders and administration site conditions	230	10.06
Metabolism and nutrition disorders	191	8.35
Blood and lymphatic system disorders	113	4.94
Respiratory, thoracic, and mediastinal disorders	97	4.24
Musculoskeletal and connective tissue disorders	87	3.80
Investigations	84	3.67
Vascular disorders	64	2.80
Renal and urinary disorders	56	2.45
Injury, poisoning, and procedural complications	52	2.27
Psychiatric disorders	49	2.14
Eye disorders	29	1.27
Infections and infestations	26	1.14
Immune system disorders	24	1.05
Cardiac disorders	23	1.01
Hepatobiliary disorders	17	0.74
Ear and labyrinth disorders	12	0.52
Endocrine disorders	6	0.26
Reproductive system and breast disorders	6	0.26
Surgical and medical procedures	2	0.09
Total	2287	100

Among the Preferred Terms (PTs), the most commonly reported ADRs were vomiting (138; 6.78%), headache (125; 6.14%), diarrhea (117; 5.75%), constipation (101; 4.96%), rash (81; 3.98%), and pruritus (78; 3.83%). Other frequently encountered ADRs included dizziness (63; 3.10%), peripheral edema (62; 3.05%), abdominal pain (54; 2.65%), dyspnea (48; 2.36%), nausea (46; 2.26%), and somnolence (42; 2.06%). Less common but notable events included asthenia, thrombocytopenia, hyponatremia, hypersensitivity, and acute kidney injury, each comprising less than 2% of reports (Table 4).

Table 4.

Most frequently reported adverse events.

Adverse Event (PT)	Number of reports
Vomiting	138
Headache	125
Diarrhea	117
Constipation	101
Rash	81
Pruritus	78
Dizziness	63
Edema peripheral	62
Abdominal pain	54
Dyspnea	48
Nausea	46
Somnolence	42
Asthenia	40
Post spinal Headache	39
Cough	38
Pyrexia	37
Hypokalemia	36
Hyponatremia	35
Thrombocytopenia	34
Hyperglycemia	33
Insomnia	33
Weight increased	33
Swelling face	31
Anemia	30
Decreased appetite	28
Arthralgia	26
Hypotension	26
Hypoglycemia	25
Myalgia	23
Acute kidney injury	23
Hypersensitivity	18
Dyspepsia	16
Hypertension	15

The drugs most frequently implicated in ADRs were the fixed-dose combination of Dolutegravir + Lamivudine + Tenofovir Disoproxil Fumarate, accounting for 189 reports (9.29%), followed by Ceftriaxone (56; 2.75%), Furosemide (55; 2.70%), Dexamethasone (50; 2.46%), and Prednisolone (50; 2.46%). Other commonly associated agents included Tramadol (47; 2.31%), Piperacillin + Tazobactam (39; 1.92%), Bupivacaine (37; 1.82%), and Meropenem (25; 1.23%). Anticancer drugs such as Paclitaxel, Methotrexate, Vincristine, and Cytarabine also featured prominently, as did anticoagulants (Heparin, Warfarin) and antiepileptic’s (Levetiracetam) (Table 5).

Table 5.

Suspected drugs associated with reported ADRs.

Product	Number of reports
Dolutegravir + Lamivudine + Tenofovir Disoproxil Fumarate	189
Ceftriaxone	56
Furosemide	55
Dexamethasone	50
Prednisolone	50
Tramadol Hydrochloride	47
Piperacillin + Tazobactam	39
Bupivacaine	37
Meropenem	25
Paclitaxel	23
Isosorbide Mononitrate	22
Amoxicillin + Clavulanic Acid	20
Ticagrelor	20
Methotrexate	20
Heparin Sodium	19
Risperidone	18
Vincristine	18
Abacavir+Lamivudine	17
Levetiracetam	15
Amlodipine Besylate	14
Diclofenac	14
Sulfamethoxazole + Trimethoprim	13
Cytarabine	13
Amikacin Sulfate	12
Warfarin Sodium	12

A focused analysis indicated that antiretrovirals were most associated with gastrointestinal ADRs, particularly vomiting and diarrhea. Antibiotics were linked to dermatological reactions such as rash and pruritus, while corticosteroids and CNS agents showed associations with metabolic and neurological ADRs, respectively. Such associations can guide pre-emptive patient counseling, monitoring and adding a supportive therapy to treat the reactions accordingly. Although, not every reaction may require further pharmacovigilance action unless serious or unexpected.

Discussion

In the present study, a slight male predominance was observed, with 51.91% of ADRs reported in males compared to 48.09% in females, reflecting a male-to-female ratio of approximately 1.08. This finding is consistent with the study by Bhattacharjee et al., who also reported a higher percentage of ADRs in males (65.96%) than in females (34.04%), with a male-to-female ratio of 1.94, indicating a general trend of increased ADR reporting in males.⁶

Age-wise distribution in our study revealed that adults constituted the majority of ADR reports (60.54%), followed by elderly patients aged above 60 years (24.67%). These findings are broadly consistent with those of Amita Jindal et al., who reported a higher proportion of ADRs in adults aged 31–60 years (63%), while infants and those above 75 years constituted a smaller percentage. This similarity supports the notion that ADR prevalence increases with age, particularly in adults and the elderly, possibly due to polypharmacy and comorbidities.⁷

In the present study, causality assessment using the WHO-UMC scale revealed that the majority of ADRs were classified as probable (67.93%), followed by possible (27.61%) and certain (4.47%). These findings are consistent with those of Jayanthi et al., who reported a similar trend with probable ADRs accounting for 61.0% and possible for 39.0%. In contrast, Leena Anthony et al. observed a higher proportion of possible ADRs (60.0%) and a lower percentage of probable cases (35.0%), reflecting variability in causality assessment outcomes across different study settings and populations.^8,9

With respect to predictability, 87.85% of the ADRs in the present study were classified as predictable (Type A), aligning with findings by Kishore Babu et al., who reported that Type A reactions constituted 76.6% of the total ADRs. These results suggest that the majority of adverse reactions are dose-related and potentially preventable through appropriate monitoring and dosage adjustments.¹⁰ When comparing the severity distribution, our study found mild ADRs in 44.91%, moderate in 39.12%, and severe in 15.97% of cases. In comparison, the study by Meda Venkatasubbaiah et al. reported a higher proportion of mild ADRs (55.12%), similar moderate ADRs (39.76%), but significantly fewer severe ADRs (5.12%), possibly reflecting differences in patient comorbidities or drug utilization patterns.¹¹

Regarding seriousness, our study reported that 15.97% of ADRs were classified as serious based on WHO-UMC criteria. This is lower than the combined serious outcomes reported by Meda Venkatasubbaiah et al., where 27.95% required hospitalization, 1.57% were life-threatening, 31.89% required intervention to prevent permanent damage, and 0.39% resulted in death. This indicates that while the incidence of serious ADRs in our cohort is notable, it may still be relatively lower than in some other studies.¹¹

In the present study, gastrointestinal disorders emerged as the most commonly affected System Organ Class (SOC), accounting for 23.91% of adverse drug reactions (ADRs), followed by nervous system disorders (13.25%), skin and subcutaneous tissue disorders (11.76%), and general disorders and administration site conditions (10.06%). These findings are consistent with those of Gomathi et al., who also identified gastrointestinal disorders as the predominant SOC. Similarly, Menglin He et al., in their analysis of the FAERS (FDA Adverse Event Reporting System) database, reported gastrointestinal disorders as the most frequent SOC (30.63%). However, in contrast to our study, their findings showed a markedly lower incidence of nervous system disorders (1.25%). This variation may be attributed to differences in drug utilization patterns, demographic profiles, or the robustness of ADR reporting systems across populations.^12,13

In our study, anti-infective agents were the most commonly implicated class, particularly antiretrovirals and antibiotics, followed by corticosteroids (e.g., Dexamethasone and Prednisolone), cardiovascular drugs (e.g., Furosemide and Ticagrelor), and CNS agents (e.g., tramadol and risperidone). These findings are consistent with those of M.I. Geer et al., who reported anti-infectives (40.92%), steroids (14.03%), anticoagulants (8.77%), and NSAIDs (7.89%) as leading causes of ADR-related admissions.¹⁴

In our study, the most frequently reported adverse events included vomiting (138), headache (125), diarrhea (117), constipation (101), and rash (81). These findings highlight the predominance of gastrointestinal and neurological symptoms, which are commonly associated with a wide range of medications. Notably, dermatological reactions such as rash and pruritus were also frequent, aligning with the observations by Santhosh Kumar Raju et al., who reported itching, rashes, and erythematous eruptions as the most common presentations, primarily associated with antibiotics and NSAIDs. The overlap in skin-related ADRs across both studies reinforces the need for careful monitoring of hypersensitivity reactions, particularly with commonly prescribed antimicrobials and analgesics.¹⁵

While underreporting remains a critical issue in pharmacovigilance in India, Worakunphanich et al. observed that countries with higher patient ADR reporting rates often implement supportive measures such as feedback mechanisms, collaboration with patient organizations, and public awareness campaigns. These strategies not only encourage patient participation but also strengthen the overall national pharmacovigilance systems.¹⁶

Similarly Menang et al. highlighted that education should be embedded within a broader, system-oriented framework that includes capacity building for advanced Pharmacovigilance functions include signal detection, risk communication, and active surveillance mechanisms. Interventions combining education with mobile-based reporting tools, national safety committees, electronic data systems, and institutional policies have shown greater sustainability and impact on ADR reporting rates and data quality.¹⁷

To conclude, our study offers valuable insights into the patterns, severity, and causality of adverse drug reactions within a tertiary care hospital setting. The findings underscore the importance of active pharmacovigilance, particularly in adult and elderly populations who are more susceptible to ADRs due to polypharmacy and comorbid conditions. The predominance of predictable and preventable Type A reactions highlights the critical role of healthcare professionals, especially clinical pharmacists, in early detection, risk mitigation, and patient education, as highlighted by Menang et al.¹⁷The identification of high-risk drug classes-such as anti-infectives, corticosteroids, and CNS agents provides actionable data to guide safer prescribing practices. This study contributes to enhancing patient safety, optimizing therapeutic outcomes, and promoting the rational use of medicines in clinical practice by highlighting the most commonly affected system organ classes and the nature of frequently reported ADRs.

Conclusion

This study underscores the critical role of systematic pharmacovigilance in enhancing medication safety within a tertiary care hospital. By documenting and analyzing adverse drug reactions (ADRs), the findings contribute to a better understanding of drug-related risks in clinical practice and highlight the importance of monitoring programs in routine healthcare settings. The results provide a practical reference for clinicians to identify patterns of ADRs and adopt preventive strategies to improve patient outcomes.

Future directions

Future research should focus on the integration of multicenter studies involving diverse populations to improve the external validity of results and identify geographical variations in ADR profiles and should encourage the differentiation of labeled versus novel ADRs. Additionally, periodic training and capacity-building initiatives for healthcare providers-especially targeting early detection and reporting-can further strengthen the pharmacovigilance infrastructure.

Economic analyses evaluating the cost burden of ADR-related hospitalizations and interventions would also be valuable to inform hospital policies and national drug safety strategies. Overall, sustained efforts toward strengthening pharmacovigilance at the institutional and policy levels are essential to ensure safer prescribing practices and to uphold patient safety as a cornerstone of healthcare delivery.

Supplemental Material

Supplemental Material - From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi

Supplemental Material for From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi by Pratiksha Kini, Mandati Santhosh Reddy, and MS Ganachari in International Journal of Risk & Safety in Medicine

Footnotes

Acknowledgments

We extend our sincere gratitude to the Principals of KLE College of Pharmacy, Belagavi and J N Medical college, Belagavi, Head of the Department and all faculty members of Pharmacy Practice, Superintendent of KLE’s Dr Prabhakar Kore Charitable Hospital, Belagavi; and Medical Director of KLE’s Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi, for their continuous support and encouragement throughout the course of this study. We also thank the Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, and the Ministry of Health & Family Welfare, Government of India, for their valuable guidance and support in facilitating this research.

ORCID iDs

Pratiksha Kini

Mandati Santhosh Reddy

MS Ganachari

Ethical considerations

Prior Institutional Ethics Committee approval was obtained (KLECOPBGMEC D028-2024) before initiating the study.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Supplemental Material

Supplemental material for this article is available online.

Appendix

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World Health Organization . The importance of pharmacovigilance. Geneva: WHO, 2002. [cited 2025 May 10]. Available from. https://apps.who.int/iris/handle/10665/424932

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