INTRODUCTION:

Any adverse drug reaction (ADR) is described by the WHO as "Any response to a medication which is noxious, unanticipated, and occurs at levels typically employed in man for prevention, diagnosis, or therapy of illness, or for the alteration of physiologic function."^1-4 Adverse drug reactions (ADRs) are one of the major global causes of morbidity and death and may continue to pose a serious threat to public health and represent a massive economic burden in terms of care prices, which
contributes to a major proportion of hospital admissions.⁵

ADRs to be nearly 2% to 3% among hospitalized patients. A recent systematic review estimated the median incidence of ADRs that led to hospitalization and those that developed during hospitalization as 2.85% and 6.34% respectively.⁶ Therefore, this definition does not include drug misuse, accidental or purposeful overdoses, failed treatments, or mistakes in the administration of medications.^7-10

When it comes to rational drug therapy, safety and efficacy are the primary concerns for healthcare professionals, they should consider using the most effective and safe medicine according to an individual patient in order to avoid such unintended consequences of drug therapy.¹¹

Due to their expertise in medication information, clinical pharmacists play a crucial part in the treatment and reporting of ADRs. They have in-depth knowledge of the way medications work and act in the human body, which will be helpful in assuming any possible adverse drug reactions. As a result, contribute to ADR prevention and medication safety monitoring.^12-13

AIM:

An ambispective study on adverse drug reactions in a tertiary care teaching hospital.

OBJECTIVE:

· To identify and report the ADR’s occurring in hospital.

· To find the incidence rate of adverse drug reactions in various departments hospital.

· To evaluate the causality using WHO, severity, preventibility. predictibility causality assessment scale.

METHODOLOGY:

The study was conducted at “Parul Sevashram Hospital” in Vadodara, Gujarat over a period of 6 months. The chosen study design was an Ambispective study. The proposed sample size was 150 patients. The data was collected from the hospital itself and ADRs were identified by patient’s daily case records, physician’s notes, and patient interviews. The ADRs were also confirmed with the help of the clinical guide. Materials used were the CDSCO form, Informed Consent form, Patient Profile Form, and ADR reporting scales. This project involved multiple potential benefits including providing an indirect measure of the quality of pharmaceutical care through identification of preventable ADRs and anticipatory surveillance for high- risk drugs or patients. Complementing organizational risk-management activities and efforts to minimize liability and also measuring ADR incidence.

Inclusion Criteria:

1 Patients of any age or either sex.

2 Patients of only Parul Sevashram hospital.

Exclusion Criteria:

1) Patients not willing to participate in the study.

Data Analysis:

The data’s statistically analysis was done using Graphpad prism version 9.1.5.

RESULT:

After reviewing and assessing files in the hospital as well as the medical records department, 8.92% prevalence was observed during the study with a total of 125 ADRs reported.

Table 1 Gender-wise distribution

Gender	No. of patients	Percentage
Male	66	58.40%
Female	47	41.59%

Through the study conducted, results were categorized on the basis of gender. It claims that male population were highly affected by the ADRs which was 58.40% as compared to female population which was 41.59%.

Table 2: Age-wise distribution

Age	No. of patients	Percentage
Infants (0-2)	1	0.88%
Children (3-16)	3	2.65%
Young adults (17-30)	16	14.15%
Middle aged adults (31-60)	78	69.02%
Elderly (above 60)	15	13.27%

The study result was classified based on their age. According to the report, the highest number of ADRs were found in middle-aged adults accounting for 69.02%, followed by young adults 14.15%, and the elderly 13.27%. The children and infants were least affected by the ADRs which was 2.65% and 0.88% respectively.

Table 3 Department-wise distribution

Wards	No. of patients	Percentage
Pediatrics	2	1.6%
Surgery	25	20%
Medicine	63	50.4%
Emergency	3	2.4%
Medicine ICU	2	1.6%
Psychiatry	17	13.6%
Orthopedics	7	5.6%
GYN and OBG	1	0.8%
Cardiology	2	1.6%
Emergency ICU	1	0.88%
Respiratory	2	1.6%

The study results have been classified based on various hospital departments. According to the study, majority of ADRs were found in medicine and surgery department contributing 50.4% and 20%. Emergency and GYN & OBG departments contributed for the least number of ADRs which was 0.8%.

Table 4 Distribution based on Organ System Involved

Organ system involved	No. of patients	Percentage
Gastrointestinal	75	60%
Dermatological	9	7.2%
Nervous	16	12.8%
Respiratory	11	8.8%
Renal	1	0.8%
```Others	6	4.8%
Cardiovascular	5	4%
Haematological	2	1.6%

The results have been divided into categories based on the different organ systems involved. According to the observations, 60% of ADRs involved gastrointestinal system, 12.8% involved nervous system and 8.8% involved respiratory system. Renal and hematological ADRs were found to be least common accounting 0.8% and 1.6% respectively.

Table 5 Reaction-wise distribution

Reactions	No. of patients	Percentage
Constipation	56	44.8%
Vomiting	3	2.4%
Nausea	1	0.8%
Abdominal pain	1	0.8%
Abdominal discomfort	1	0.8%
Diarrhea	5	4%
Xerostomia	6	4.8%
Flautence	2	1.6%
Hb decreased	1	0.8%
Neutrophils dec	1	0.8%
Dizziness	3	2.4%
Tremors	1	0.8%
Headache	8	6.4%
Delirium	1	0.8%
Vertigo	1	0.8%
Somnolance	2	1.6%
Rash	2	1.6%
Blisters	1	0.8%
Xeroderma	1	0.8%
Maculopapular	1	0.8%
Urticaria	1	0.8%
Itching	3	2.4%
Dyspnea	2	1.6%
Cough	2	1.6%
Rhinnitis	1	0.8%
Nasal congestion	2	1.6%
Breathlessness	2	1.6%
Nasal bleeding	1	0.8%
Pedal edema	5	4%
Limb pain	1	0.8%
Ulcers	1	0.8%
Rigors	1	0.8%
Fever	2	1.6%
Hemoptysis	1	0.8%
Haematuria	1	0.8%
Dry cough	1	0.8%

The data has been categorized based on the different types of reactions. Out of 125 ADRs, the major ADRs occurred were constipation contributing 44.8%, headaches contributing 6.8% and xerostomia contributing 4.8%. Some of the least occurring ADRs were found to be xeroderma, nasal bleeding, urticaria, dry cough, etc. contributing for 0.8.

Table 6 Distribution based on dechallenging of drugs

dechallenge	No. of patients	percentage
Yes	18	14.4%
No	60	48%
Not known	47	37.6%

The study findings show that 48% of the drugs that caused ADRs were not de-challenged, 37.6% of drugs were classified as unknown, and 14.4% of drugs were classified as dechallenged.

Table 7 Based on WHO Causality Assessment

Causality assessment	No. of patients	Percentage
Probable	30	24%
Possible	95	76%

The data has been categorized using the WHO Causality Assessment of ADRs. According to the study's conclusion, 24% of ADRs were considered to be probable, while 76% were considered to be possible.

Table 8 Based on Severity Assessment

Severity	No. of patients	Percentage
Mild	115	92%
Moderate	10	8%

Based on the level of severity of ADRs, 92% of the ADRs that were found to be in mild group, and the remaining 8% into the moderate category, according to the report.

Table 9 Distribution based on Predictability Assessment

Predictability	No. of patients	Percentage
Yes	110	88%
No	15	12%

The research showed that 88% of the discovered ADRs fell into the predictable category, whereas 12% of the ADRs fell into the not predictable category.

Table 10 Distribution based on Management of ADR

Management of adr	No. of patients	Percentage
Yes	41	32.8%
No	84	67.2%

Depending on ADR management, 33% of the population is classified as managed, and 67% of the population as not managed.

Table 11 Distribution based on Fate of Suspected Drug

Fate of suspected drug	No. of patients	Percentage
Dose altered	1	0.8%
No change	107	85.6%
Drug withdrawn	17	13.6%

Following the discovery of adverse drug reactions (ADRs) associated with particular drugs, the research states that 85.6% of patients experienced no change, 13.6% had their medication removed, and 0.8% had their dose adjusted.

Table 12 Distribution based on Treatment given for ADR

Treatmen given	No. of patients	Percentage
Specific	39	31.2%
Symptomatic	3	2.4%
Nil	83	66.4%

The study found that 2.4% of patients simply received symptomatic treatment, 31.2% of patients received specific therapies, and 66.4% of patients received no therapy at all.

Table 13 Distribution based on Preventability Assessment

Preventability	No. of patients	Percentage
Definitely preventable	5	4%
Probably preventable	52	41.6%
Not preventable	68	54.4%

Based on the Modified Schumock and Thornton preventability scale, the identified data have been categorized, 54.4% of ADRs were classified as not preventable, 41.6% as probably preventable, and 4% as definitely preventable.

Table 14 Distribution based on Outcomes of ADRs

Outcomes	No. of patients	Percentage
Recovered	79	63.2%
Unknown	30	24%
Recovering	16	12.8%

Out of the 125 ADRs that were recorded, 63.2% of the patients were classified as recovered, 12.8% as recovering, and 24% had responses for which the outcomes were unknown.

Table 15 Distribution based on Type of reactions

Types of reaction	No. of patients	Percentage
Augmented	93	74.4%
Bizzare	11	8.8%
Delayed	9	7.2%
Hypersensitivity	3	2.4%
Unclassified	9	7.2%

When 125 ADRs were examined, the research found that 74.4% of them were of the augmented type, 8.8% were of the bizarre type, 7.2% were of the delayed type and unclassified type. With 2.4%, hypersensitivity type was the least common.

DISCUSSION:

The average life expectancy in India is around 70.8 years.¹⁴ Studies done in various parts of India have estimated that around 5-10% of patients experience ADRs during hospitalization.¹⁵ After reviewing and assessing a total of 1400 files in the hospital and the medical records department, an 8.92% prevalence was observed during the study with a total of 125 ADRs reported. This is similar to a study done by Meda Venkatasubbaiah et al., who carried this study in a tertiary care teaching hospital in Andhra Pradesh.¹⁶Male patients were found to be more prone to ADRs as compared to females, with middle aged patients (31-60 years) being the most affected group. The results of similar studies¹⁷ revealed that the elderly were more prone to ADRs. The incidence rate of ADRs in children ranges from 0.2% and 22% according to the study conducted by Hailye Birhane et.¹⁸ Causality assessment was conducted using the WHO-UMC scale in which the findings were 24% classified as probable and 76% as possible causalities, whereas the study conducted by Rayees N M et al.,¹⁹suggested majority were probable 38(69.09%) and 11 (22%) reactions were possible. Most of the ADRs are categorized as possible causalities which is also supported by other evident studies.²⁰ The Modified Schumock and Thornton scale was used for preventability, with 54.4% listed as non-preventability and 41.6% as probably preventability. Our study is supported by a similar study done by Keche et.al.²¹ The severity of the ADRs was determined using a modified Hartwig and Siegel scale, which categorizes ADRs as "mild," "moderate," or "severe" with various levels based on characteristics such as the necessity of a change in treatment, the duration of hospitalization, and the impairment caused by the ADR.²²So, the results of study conducted were 92% categorize as mild and 8% as moderate ADRs. A similar pattern was observed in a study done by Bhargavi J. Patel et.al., which supports are results.²³ The GI and neurological systems exhibited the most frequent reactions, with constipation (44.8%) and headaches (6.4%) being the most common conditions. This was observed in another study conducted by Fosnes GS et al.²⁴, where it was discovered that, of the 11078 participants who were invited, 4622 completed the questionnaires, and 640(13.8%) experienced constipation. Augmented reactions were the most common, followed by bizarre, delayed, and unclassified. 66.4% of the subjects received no treatment at all, 31.2% received specific treatments based on the reaction observed, and 2.4% received symptomatic treatment. A compilation of the ADRs was conducted based on the outcome of the ADRs, and it was discovered that 63.2% of the patients had recovered from the ADR, 12.8% were in the process of recovering, and the other 24% had unknown results. Comparative statistical analysis was done by using GraphPad prism version 9.5.1 which was based on gender and age groups, showing differences in causality, predictability, preventability, and outcomes between males and females. By comparing the data on the basis of causality assessment, females (26.41%) were more probable than males (22.22%). Whereas, males (77.77%) were having more possible ADRs than females (73.58%). The severity assessment showed that females were more vulnerable towards mild ADRs (96.22%). The males showed more moderate ADRs (11.11%) than females. The result could be compared with a study done by Sarah Watson et.al., where females were less prone to serious reactions. The predictability assessment showed that predictable ADRs were more in females (90.56%) compared to males (86.11%). Whereas, the non-predictable ADRs were more in males (13.88%) than in females (9.40%). The preventability assessment gives a result that the definitely preventable ADRs were more in males (4.16%), whereas the females had more ADRs which were probably preventable. There was a higher prevalence of not preventable reactions in males (63.88%). Comparing the results based on outcomes, male patients (68.05%) were recovered in higher numbers and females (16.98%) showed higher rates of continuing. Research conducted by Rashed et al.²⁵ in five countries (Australia, Germany, Hong Kong, Malaysia, and the United Kingdom) identified 1253 cases and recorded 328 ADRs. The findings of this study revealed a non-significant relationship between gender and ADRs in a specific age range. The comparison of type of reaction according to gender and was found that out of 125 ADRs found, augmented ADRs were more in males (45.6%) than in females (28.8%). The hypersensitivity ADRs were more in males (1.6%) than in females (0.8%). The second set of comparative data was between the different age categories and other parameters. Middle-aged adults and young adults showed the highest number of ADRs which could be justified by the hospitalization flow of patients. As stated by Balamurugan Tangiisuran et.al.²⁶, the elderly are more vulnerable to adverse drug reactions (ADR), which are mostly caused by polypharmacy and physiological changes that alter the pharmacokinetics and pharmacodynamics of several medicines, as well as poor compliance due to cognitive impairment or depression. Young and middles-aged adults had the highest ADR incidence, while elderly patients experienced majorly mild ADRs. In summary, this study provides insights into ADRs in India, highlighting the need for tailored prevention and management strategies.

CONCLUSION:

ADRs negatively impact a patient's physical, financial, and overall quality of life and are a clinical and time-consuming burden for hospital staff. Our study concludes that a fraction of the population experienced ADRs while being hospitalized. Antiemetics, analgesics, antibiotics, and antipsychotics caused the greatest number of adverse drug reactions (ADRs). Systems like the gastrointestinal, nervous, and respiratory systems were the ones with the most ADRs. The ADRs encountered were mostly more likely to be possible than probable. Medicine, surgery, and psychiatry wards were those with the highest suspicion of having ADRs. In general, men were more severely impacted by ADR than women, particularly middle-aged adults. Constipation, xerostomia, and diarrhea were the three most common ADRs seen. Throughout the stay in the hospital, patients received advice on how to report any symptoms or side effects they may have had after taking a medication. Health Care Professionals (HCPs) received a summary of the data collected. Details on the main medications and every other factor contributing to the development of an ADR are included in the information that was supplied. Suspected Adverse Drug Reaction Reporting Forms including the specifics of all 125 ADRs were completed and delivered to the Pharmacovigilance department of Parul Sevashram Hospital in Vadodara, the regional ADR reporting center, and CDSCO. This study's findings suggest that adequate identification, assessment, monitoring, and management of ADRs are needed in healthcare settings to improve patient care and satisfaction during hospital stays.

SOURCES OF FUNDING:

The study was a non-funded study.

ETHICS APPROVAL:

The study was conducted after obtaining approval from Parul University -Institutional Ethics Committee on Human Research (PU-IECHR). Approval Number: PUIECHR/PIMSR/00/081734/5209

DECLARATION OF INTEREST:

The work described has not been published previously. It is not under consideration for publication elsewhere, its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and if accepted, it will not be published elsewhere in the same form.

ACKNOWLEDGEMENTS:

We express our heartfelt appreciation to Dr. Jitendra Vaghasiya and Dr. Mital Patel for their exceptional guidance, as well as our gratitude to Hospital Parul Sevashram and the Parul Ethics Committee for their support in facilitating our research endeavors.

AUTHORSHIP:

All corresponding authors have made substantial contributions to all the following:

1 The conception and design of the study, or acquisition of data, or analysis and interpretation of data.

2 Drafting the article or revising it critically for important intellectual content.

3 Final approval of the version to be submitted.

ABBREVIATIONS:

ADR – Adverse Drug Reaction,

CDSCO – Central Drug Standard Control Organization.

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Received on 13.03.2024 Revised on 08.10.2024

Accepted on 05.02.2025 Published on 18.04.2025

Available online from April 22, 2025

Asian J. Res. Pharm. Sci. 2025; 15(2):107-112.

DOI: 10.52711/2231-5659.2025.00016

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.