1Associate Professor, KMCT College of Pharmaceutical Sciences, Kalanthode , Kozhikode, Kerala, India, 673601
2Student, VIII semester B Pharm, KMCT College of Pharmaceutical Sciences, Kalanthode , Kozhikode, Kerala, India, 673601
Background : Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. Objective: The study was conducted to evaluate the monitoring and reporting of adverse drug reactions in a tertiary care hospital Methods: Spontaneous ADR reporting method was followed for the study. Most of the ADRs reported by the health care professionals, or the patients were confirmed with the physician in charge. The drugs causing ADRs were identified, and different signs and symptoms of ADR were evaluated. Results: A total of 30 patients were reported having ADRs in a period of 6 month. We found that the incidence of ADRs was more in females (60%) when compared to males (40%). Adults showed more incidences of ADRs when compared to paediatrics and adolescents. More number of ADRs was associated with antibiotics and NSAID than other category of drugs. Conclusion: We can say that adverse drug reaction is a significant limitation to the success of therapeutics.The study was useful in finding which category of drugs were more prone to ADRs . During the study period, we have encouraged all the health care professionals in the monitoring and reporting of ADRs, with continuous awareness and motivation, reporting culture can be improved; this can be achieved pharmacovigilance system running by a clinical pharmacist.
In the last decades there is a remarkable growth in drug development. It has brought astounding benefits for the patients. At the same time the incidence of Adverse Drug Reaction (ADR) has also raised. ADR is defined by World Health Organization (WHO) as ‘‘a response to a medicinal product which is noxious, unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function”.[1] Adverse drug reactions (ADRs) in hospitalised patients can be divided into two broad categories: those that cause admission to hospital, and those that occur in in-patients after hospital admission.[2] Postmarketing surveillance on the effects of drugs as well as spontaneous reporting of Adverse Drug Reactions (ADRs) is important in clinical practice because it increases drugs effectiveness and safety knowledge. In several countries, pharmacovigilance is based on the spontaneous reporting aimed at ADR detection after commercialization.[3] However, a major limitation of this model is that only a small part of all ADRs are reported [4]. A previous reports showed that several factors were associated with under-reporting such as ignorance (only severe ADRs need to be reported), diffidence (fear of appearing ridiculous for reporting merely a suspected ADR), lethargy (e.g., lack of interest or time), indifference (one case from an individual practitioner does not contribute to medical knowledge), insecurity (causality between a drug and an adverse event is hard to determine) and complacency (only safe drugs are allowed on the market)[5] In India, in the year 2010 the Ministry of Health and Family Welfare (MoHFW), launched the nationwide Pharmacovigilance Programme of India (PvPI). Indian Pharmacopoeia Commission (IPC) under the MoHFW has been functioning as the National Coordination Centre (NCC) for PvPI since April 2011, this leads in the rapid progress in reporting of ADRs by the healthcare professionals. PvPI stated that during the period of April 2011 to March 2016, a total of 181,656 reports have been received through various reporting modalities.[6] In 2020, a total of 30525 reports have been received through various reporting modalities.[7] Through this data PvPI regularly recommends the drug regulatory authorities and suggests the Healthcare professionals (HCPs) in improving the safe use of drugs. However, there is a significant need to create and enhance awareness in community and healthcare professionals about the importance of close monitoring of drug outcomes especially newer ones. Awareness regarding the detection, management, prevention, and reporting of ADR is utmost important in improving patient care and to reduce cost.[1] Present study was conducted to evaluate the monitoring and reporting of adverse drug reactions in a tertiary care hospital so as to alert health professionals, regulatory authorities and patients on the importance of reporting ADRs.
MATERIALS AND METHODS
An observational study based on the reports collected from different departments of Govt. Taluk hospital - Thamarassery, Kozhikode, Kerala. The study was conducted for a period of 6 months, Starting from November 2023 to May 2024.Permission/consent from the institutional ethics committee was taken before the study. Direct interview of patient, their caretakers and medical professionals were conducted. All the patients from both sex and of any age who developed an ADR during the above mentioned time period were included in the study and the exclusion criteria were the outpatient cases, patients who developed an ADR due to intentional or accidental poisoning, ADRs due to the fresh blood/blood products, drug overdose and patients with drug abuse and intoxication. On daily basis, HCPs were informed regarding the importance of monitoring and reporting of ADRs. At the time of admission, all the patients were assessed for the previous allergies, ADRs, and past medical history and were noted in the case sheets. The symptoms/signs observed through the clinical review process were assessed for their relation with the drug(s), were suspected as drug-induced and then analyzed it. If the reaction is not related to the underlying disease and if the causal relation is more with the drug then it will be suspected as an ADR and was confirmed with the support of literature (if any). The suspected ADRs whichever meet PvPI reporting criteria were separated, reported and documented in PvPI suspected ADR reporting form.14 We have also encouraged the patients and their caretakers to report all ADRs using reporting modalities like directly reporting, either to the treating physician or any other health care professionals.
Evaluation of data
On the basis of patient demographics (age and gender) and ADR characteristics (the type of ADRs, drug characteristics, system organ class, outcome and management) the reactions were categorized .
Patient demographics characteristics
The ADRs were summarized based on the patients’ age and gender. Patients were divided into three age groups such as paediatrics (0–12 years), adults (18–60), and geriatrics > 60.
Adverse drug reaction characteristics
The ADRs were analyzed for their seriousness, severity, preventability and organ system affected. The criteria for serious ADR have been specified by WHO and US Food and drug administration (FDA) and are adopted by CDSCO in suspected ADR reporting form - PvPI criteria. (9) It includes any untoward medical occurrence at any dose that,
The severity of the reaction was determined and categorized as mild, moderate or severe according to the classification system of Hartwig and Siegel Severity Assessment Scale (Hartwig: Hartwig’s Severity Assessment Scale: mild (1–2), moderate (3–4), and severe (5–7). [8]. Preventability was assessed using the classification system of modified Schumock and Thornton scale.[9] Data analysis was carried out with simple descriptive statistics like percentage.
RESULTS
A total 90 patients were involved in the study and in that of the 30 reported/notified suspected ADRs from different departments were analyzed and reported to PvPI.
Data evaluation based on demographics of the patient .
Of the 30 ADRs 18 were experienced by females and 12 by males patients. The incidence of ADRs among males and female was similar. The majority of ADRs were reported in adults (53.30%) then the geriatric (30%) paediatric (16.66%) patients which was shown in Table 1.
Table 1: Distribution based on demographics.
Analysis of ADRs
Severity
Assessment of severity is essential to take necessary action against the drug continuation, in our study most of the ADRs were moderate (56%) and only few were severe (3.3%) The severity distribution of ADRs was represented in Table 2.
Preventability
Preventability assessment helps in improving drug use, out of 30 ADRs, most were probably preventable (53.3%) followed by definitely preventable (40%) and only a few (13.3%) were not preventable and this was clearly showed in Table 2.
Seriousness
Seriousness was assessed by using standard criteria given by the PvPI and found the majority of them were not serious (40%). All the criteria were clearly showed in table:2
Table 2: Analysis of ADR
*Hartwig: Hartwig’s Severity Assessment Scale: mild (1–2), moderate (3–4), and severe(5–7).
# Modified schumock and thornton preventability scale
$ As per PvPI criteria
System affected
We observed that 16 (53.3%) ADRs were related to skin followed by 7 (23.3%) in Central Nervous System and for Gastrointestinal system is 3 (10.0%), and the involvement of other systems is illustrated in Table 3.
Table.3 Characterization of system affected with ADRs
Management of ADRs
Out of 30, 16 (53.47%) patients have received treatment with at least one additional drug for the reported ADR with or without dechallenge, and in 5 (16.6%) patients substituted with another drug and for 4 (13.33%) drug has withdrawed only. Table 4 illustrate clearly the management of ADRs.
Table 4. Management of ADRs
DISCUSSION
The study shows that incidence rate of ADRs was found to be more for females when compared to males in the selected time periods (November2023- May 2024). The incidence rate of ADR for adults to be higher than geriatrics and paediatrics. This could be due to the increased hospital admissions of adult's patients. These findings were consistent with the study carried out by Shamna et al. [10] and Prudhivi Ramakrishna et al. [11] ADRs in paediatric patients were less compared to other and their ADR was also mild. We found that antibiotics and NSAIDS were the classes of drugs were more prone to ADRs. One possible reason could be the wide usage of these drugs for most case. Assessment of severity is also essential to take necessary action against the drug continuation, in our study most of the ADRs were moderate, and fortunately, the incidence of severe ADRs is low, as in the case of similar studies conducted by H. Singh et al (12) and TM Vijayakumar et al (13). Preventability assessment helps in improving rational drug use; in our study, the majority of ADRs were of probably preventable, which shows that by medication history interview and and individualized drug therapy can minimize these ADRs. Most of the patients were not able to maintain their medical records properly and also they were unaware of their previous ADR occurrence. These findings were like the study findings of G Sneha et al (14). The seriousness was assessed by using PvPI criteria and found the majority of ADRs were no serious reactions, others required intervention to prevent permanent damage and increased hospitalization. In an Indian study conducted by Sneha et al (14) also reported that few were life threatening (13.3%) Hospitalization/Prolonged (30%) and required intervention (16.6%). Even though the pharmacovigilance system is well established, under-reporting is a major problem even in western countries also. In India the major problem is a lack of proper system of pharmacovigilance. PvPI gathers the ADRs from all healthcare setups and from the public and communicates the significant data to drug regulatory authorities for necessary action on the drugs; it also communicates the healthcare professionals and the public regarding the risk of ADRs, by this it improves the patient safety and welfare, and it is the responsibility of all healthcare professionals to support the PvPI in promoting safe use of medicine, in this view we have reported a total of 30 ADRs to the PvPI through AMCs according to the standard criteria given by National Coordinating Centre (NCC) for monitoring ADR..(1) A clear limitation of our study is that it was conducted in one hospital and there is likely to be variation between different hospitals because of differences in the local population characteristics and the specialties within the hospitals.
CONCLUSION
In conclusion, we can say that adverse drug reaction is a significant limitation to the success of therapeutics. In order to deal with this problem Pharmacovigilance program was initiated. It is essential to improve the quality and quantity of ADR reports and to promote surveillance programs in health care facilities. our study shows that ADRs are a significant problem in hospital inpatients, contributing to morbidity and mortality and resulting in considerable financial burden. Over half are definitely or potentially avoidable, and steps should be taken to introduce strategies to reduce their impact. Present study depicted an overview of the different types of ADRs encountered in a tertiary care hospital. It highlighted that ADR is mostly prevalent among the elder individuals. Antibiotics were the most commonly causing ADR and mainly from skin problems. The study concluded that the spontaneous reporting of ADRs is fairly good in this hospital. Although the ADRs in the present study were serious and preventable, monitoring and management of such ADRs through therapeutic interventions would be beneficial in better patient care. Pharmacists and other health care providers should join hands together to improve the scenario. During the study period, we have encouraged all the health care professionals in the monitoring and reporting of ADRs. With continuous awareness and motivation, reporting culture can be improved; this can be achieved through pharmacovigilance system running by a clinical pharmacist.
CONFLICT OF INTERESTS
Authors have no conflict of interests.
ACKNOWLEDGMENTS
The authors wish to thank all healthcare professionals at the Govt. Taluk Hospital Thamarassery, Kozhikode, Kerala who helped with the study, and all the patients.
REFERENCES
Manju K Mathew , Noora Nazarin , Mohamed Asil TK , Harsha Ratheesh E. C. , Sreejisha S. R. , Mohammed Mufeed P. , Monitoring And Reporting Of Adverse Drug Reaction In A Tertiary Care Hospital- An Observational Study In Kozhikode District Kerala, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 9, 1223-1229. https://doi.org/10.5281/zenodo.13834145
10.5281/zenodo.13834145
