A Prospective Study on Adverse Drug Reaction- Monitoring, Reporting, Patient Counselling on Safe Medication Practice in A Tertiary Care Hospital

Assessment of Adverse Drug Reactions (ADRs) in Geriatric patients was carried out in a south Indian tertiary care teaching hospital. Our study focused on the greater susceptibility of geriatric patients to ADRs, which are an important health issues and a leading cause of morbidity.  A single-centre prospective observational study was conducted with a total of 227 patients to investigate the occurrence and characteristics of ADRs. Males (58.62%,) were affected more than females (41.38%,). Age, polypharmacy, and Co-morbid diseases were the primary risk factors, accounting for 100%, 100%, and 94.82% respectively. The most significant risk factors identified were hypertension (51.72%), and type II diabetes mellitus (44.82%). The prevalence of ADRs was determined as 25.5% (n=58) with an incidence rate of 6.82%, Odds ratio (0.34, p=0.059) and Relative risk (142.65, p=0.0005). Oral administration of drugs (72.41%) lead to the most ADRs. Antibiotics and Antiplatelets (20.69%) caused the most ADRs such as Constipation (20.68%) by Clopidogrel, Various Reactions from Antibiotics (>17%) followed by Oedema (13.8%) by Prednisolone. Skin and Appendages (32.76%) were implicated by the majority of reactions.  Most of the reactions were possible (WHO-UMC Scale - 53.45%), Moderate (Hartwig and Siegel Scale – 31%) and possible (Liverpool Causality Assessment Tool – 60.34%). Clinical pharmacists reported the highest (82.76%) ADRs. Our study contributes to the pharmacovigilance programme of the nation. There is a pressing need of reporting the ADRs and to develop tools to empower healthcare professionals that would significantly decrease the time required for initial assessment of ADRs and related harm.

Background: Antidepressant drugs, though of great benefit in a range of psychiatric disorders, are associated with a wide range of potential adverse effects. There is growing concern among the healthcare personnel to assess these adverse drug reactions (ADRs) of newer psychotropic drugs, which have an impact on long-term compliance and achieving successful treatment. The present study was thus designed to monitor and analyze the pattern of occurrence of ADRs to antidepressant medications in Outpatient Department (OPD) of a tertiary-care hospital. Materials and Methods: A cross-sectional observational clinical study was carried out in the OPD of Psychiatry in Medical College, Kolkata. A total of 190 patients who received antidepressants were studied. 5-8 consecutive previously diagnosed depression patients attending follow-up per day, were screened for suspected ADRs, 2 days (one male OPD and one female OPD) in a week, over 6 months (October 2013 to March 2014). Adverse event history, medication history and other relevant details were captured in a format as adopted in the Pharmacovigilance Programme of India (PvPI). Causality of ADR was assessed by Naranjo's ADR probability scale. The severity of each reported ADR was assessed using Hartwig and Siegel Scale. All the statistical analysis was done by using SPSS-version 20 (SPSS Inc). Results: A total of 190 patients were screened for the study of which males and females represented 43.68% and 56.31% of the cases respectively. The age-group presenting with maximum depressive problems was found to be 30-39 years. A total of 481 ADRs were noted of which dry mouth was the commonest, closely followed by nausea and tremor. Out of 130 ADRs assessed for causality, 89.23% of the ADR cases, were found to be 'probable', while 10.77% were found to be 'possible'. According to Hartwig and Siegel's Scale 83.99% of the cases were found to be mild, 14.97% moderate and 1.04% severe. Conclusion: The study enables to obtain information on the incidence and pattern of adverse drug reactions associated with antidepressants in the local population thereby reducing its occurrence and protecting the user population from avoidable harm.

Sir, Adverse drug reactions (ADRs) have been reported to be among leading causes of morbidity and mortality1,2,3,4. The spontaneous reporting of ADRs is considered as the foundation of post marketing surveillance of drug safety5,6,7. The main function of spontaneous reporting is the early detection of signals of new, rare and serious ADRs8. It is also one of the cheapest methods of monitoring the safety of medicines as utilized by many drug regulatory agencies worldwide9,10. Therefore, pharmacovigilance programme plays a vital role in ensuring the drugs’ safety. In many countries (including India) a pharmacovigilance system is operational; however, under-reporting is a major problem11,12,13,14. An increase has been observed in the current reporting culture of ADRs under Pharmacovigilance Programme of India (PvPI) after conducting regular training and awareness programme and circulating the ‘PvPI Drug Safety Newsletter’. Healthcare professionals (HCPs) reports ADRs to nearest ADR Monitoring Centres (AMCs) under PvPI and the same is collected and collated by the Indian Pharmacopoeia Commission (IPC), National Coordination Centre (NCC)15. The objective of this study was to ascertain the contribution of different stakeholders in reporting of ADRs, reporting status of government medical institutions (GMI), non government medical institutions (NGMI) and corporate hospitals (CH) under the fold of PvPI. All Individual Case Safety Reports (ICSRs) received by the NCC between July 1, 2011 and December 31, 2012, were taken into account for analysis. The data were entered manually into VigiFlow along with the mandatory field of ‘Information on Primary Source’ where a reporter has to specify his/her name, contact details and qualification. Analysis of a total number of 23,975 ICSRs revealed that the majority of ADRs were reported by physicians (n=15440, 64.4%). Relatively lower reporting was done by the pharmacists (n=3620, 15.1%). Other HCPs (nurses, physiotherapists etc.) contributed to (n=4891, 20.4%) reports; while reporting by non HCPs was found to be (n=24, 0.016%) only. The highest reporting rate was observed in GMI (74.4%) as compared to NGMI (24.5%) and CHs (1.0%). This study also revealed the rate of reporting of ADRs month-wise and it was found that the reporting rates were consistently increased after disseminating the information through PvPI Newsletter, awareness programme, sending circulars to the ADRs monitoring centre, etc. The ADRs reporting percentage of physicians in the Programme (n=15440, 64.4%) was higher as compared to pharmacists (n=3620, 15.1%) and other HCPs (n=4891, 20.4%). The reporting rate of pharmacists was low as compared to physicians because in India, the system of distribution does not leave much scope for the pharmacists to be a significant source of ADRs reporting. Similarly, even though nurses are in closer contact with the patients for a longer duration, in the event of ADRs observed by the nursing staff, it would be reported to the treating physician, who in turn if deemed appropriate, communicates the information to the relevant higher authorities. In some of the European countries only those authorized to prescribe medication are allowed to report ADRs16. Therefore, co-ordination among clinician, pharmacist and nurse appears to be of vital importance to contribute each of their respective expertise and experience to promote the rational and safe use of medicines. Lack of knowledge of where, what and how ADRs should be reported also affects reporting. The reason for poor reporting may also include financial incentives, legal aspects, apprehension that the serious ADRs are already documented when a drug is introduced in the market, and that a single report would make no difference, ignorance (that only serious ADRs are to be reported) and lack of time or over load17. NCC has taken steps to tackle this by addressing this issue in various forum and conferences, circulating questionnaire form, writing to professional bodies, scientific journals, etc. In the next step, NCC may recommend Medical, Pharmacy and Nursing Councils of India to include pharmacovigilance in their respective education curriculum. These measures could improve the quantity and quality of the reports. Pharmacovigilance Programme of India can only be vibrant if utilized effectively with active participation of HCPs. This preliminary study may be useful in devising strategies to create awareness in ADRs reporting among health care professionals under PvPI. Further, awareness programmes to sensitize healthcare professionals are necessary to improve pharmacovigilance.

Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. This is an observational, retrospectiveand non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

Drugs used for the treatment of cardiovascular disorders are frequently reported to cause adverse drug reactions (ADRs), second only to antimicrobials. ADRs strain the patients' health and finances further and could prove fatal too. Pharmacovigilance programs aim to detect, monitor and understand ADRs in order to prevent them. Pharmacovigilance provides vital input to drug regulatory agencies to monitor safety of new as well as old drugs. Spontaneous reporting of suspected ADRs by healthcare professionals forms the backbone of pharmacovigilance programs worldwide including the Pharmacovigilance Program of India (PvPI) launched in 2010. The PvPI has significantly contributed to strengthening pharmacovigilance in India but suffers from under-reporting of ADRs like similar programs worldwide. Consumer-initiated reporting of ADRs incorporated in pharmacovigilance programs of several countries has been found to decrease under-reporting rates besides supplementing traditional pharmacovigilance information. The PvPI has recently introduced the facility for consumers to report ADRs by contacting a hotline (1800-180-3024), through e-mail (pvpi.compat@gmail.com) or by filling specifically designed ADR reporting forms, either in English language or vernacular translations, and submitting them to the nearest ADR monitoring centre. This is a welcome step in empowering patients as consumers of drugs with the mechanism to monitor their safety. It could potentially fill the huge gap in spontaneous ADR reporting and supplement the indigenous drug safety database with patients' perspectives regarding ADRs e.g. effect on their quality of life. Whether it encourages rational prescription practices by doctors or enhances transparency regarding safety of investigational drugs in clinical trials needs to be seen.

Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital

Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital. 
 Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug.
 Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %).
 Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.

Pharmacovigilance is monitoring the effects of drugs after they have been licensed for use to identify and evaluate previously unreported adverse drug reactions (ADRs). In totality, it deals with the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.[1] We often say that the eye is a window to the body. The myriad ophthalmic manifestations of systemic diseases encountered in clinical practice are a testament to that statement. Therefore, it is only logical that the various pharmacological agents used to treat systemic diseases, through diverse mechanisms – intended or otherwise can similarly have an effect on the eye as well. Conversely, it is equally plausible that a drug intended for ocular use can get absorbed into systemic circulation and result in deleterious adverse effects elsewhere in the body. The question is – how vigilant are we at detecting, treating, and reporting them?[1] For example, sildenafil – a phosphodiesterase-5 inhibitor – was initially developed as a drug to treat angina. Soon, it evolved into the drug of choice for the treatment of erectile dysfunction. Over time, the drug was noted to selectively reduce pulmonary pressure and pulmonary vascular resistance in patients with pulmonary arterial hypertension.[2] Today, the drug is Food and Drug Administration (FDA) approved for the use in the treatment of pulmonary hypertension. Recently, there have been many reports linking the use of sildenafil and nonarteritic anterior ischemic optic neuropathy (NA-AION).[3] While subsequent studies have not yet established a clear causal relationship, FDA now requires all prescribing physicians to explain to their patients the low but possible risk of NA-AION.[4,5] Furthermore, it mentions that loss or decreased vision, whether painful or painless, demands urgent patient assessment and immediate cessation of phosphodiesterase type 5 inhibitor use.[6] This cascade of events occurred only through the efforts of clinicians engaged in diligent pharmacovigilance and proper reporting. Similarly, topiramate – a drug used to treat migraine – has been reported to cause angle closure, whereas aripiprazole, an antipsychotic drug, has been known to cause transient myopia and even diplopia.[7,8] While informing peers in the form of case reports or other published material is important – it is equally important to intimate the drug regulatory authorities about such ADRs such that the issue can be investigated objectively. Once the causality is established, and the occurrence is established as a known ADR, it could help in other similar cases where the patient can avoid the trouble of going through detailed and exhaustive examinations and investigations.[1] However, pharmacovigilance does not end there at reporting – pharmacovigilance is a continuing process that goes beyond the documentation of ADRs. Many drugs may perhaps be wrongly implicated or get a label of being a “dangerous” drug simply because of one reported an adverse event. Intravitreal use of antivascular endothelial growth factor (VEGF) was, at a point in time, considered to be directly responsible for thromboembolic events in patients who received these injections.[9] However, subsequent, large-scale studies have established that the incidence of vascular events in such patients was associated with older age rather than therapy received. Furthermore, the incidence rate of myocardial infarction, stroke, and death among patients treated with anti-VEGF was not significantly higher than the age-adjusted incidence rate of these events among the general population.[10,11] To support the efforts of the medical fraternity to participate effectively, the Ministry of Health and Family Welfare via the Indian Pharmacopoeia Commission, has reached out and created a “Suspected Adverse Drug Reaction Form” which lays down the prescribed format for all clinicians to report ADRs to The National Coordination Centre - Pharmacovigilance Program of India. Often times, despite having observed unusual or rare ADRs, there seems to be inertia on the clinicians' part. In India, given the population, the amount of drugs prescribed and consumed by patients, it is evident that there is underreporting of ADRs primarily due to lack of knowledge and awareness about Pharmacovigilance Programme of India; lethargy, indifference, insecurity, and complacency among other things.[12] As elaborated by Kalasiselvan et al. in this issue, submission of an ADR report does not have any legal implication on the reporter and reporter details are maintained confidentially. This move facilitates smooth, standardized, and transparent reporting and enables the clinician to report ADRs in a systematic format without hassles. Ophthalmology has changed drastically over the past two decades – intravitreal anti-VEGFs are now the first line of treatment in diabetic macular edema, and topical prostaglandin analogs are now routinely used as the front-line drugs in glaucoma. If we have upped our game in pharmacotherapy, why should our pharmacovigilance lag behind?

Adverse Drug Reactions (ADR) are one of the common causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Centre) scale, the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

Background: The Pharmacovigilance Programme of India (PvPI) aims at sensitizing the health-care providers toward strengthening the spontaneous reporting of adverse drug reactions (ADRs) which are a significant cause of morbidity and mortality and to protect the lives of millions of people living in a vast country like India. Aims and Objectives: This study aims to analyze the knowledge and attitude regarding PvPI among interns in a tertiary care hospital. Materials and Methods: This cross-sectional model was approved by Scientific Research and Institutional Ethics Committee. All the 120 internees of Sri Venkateshwaraa Medical College Hospital and Research Centre were evaluated for their knowledge and attitude regarding PvPI with the help of pre-validated structured questionnaire. This study was conducted for a period of 3 months after obtaining written informed consent from each participant. The data were analyzed using descriptive statistics. Results: Findings of this study showed that 81% were aware of PvPI, whereas 75% had very good knowledge about Naranjo’s causality assessment. 43% of the entrants were willing to report ADR. 65% of the participants agreed the mandatory reporting of ADR with 35% of uncertainty and 14% accepted that collection boxes at all departments are helpful for ADR reporting. Conclusion: This study has demonstrated that knowledge and attitude toward PvPI are gradually improving among interns. The ADR reporting could be made mandatory in a tertiary care hospital as an integral part of clinical activities, which is the only solution, wherein PvPI can be implemented effectively.

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale.
 Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail.
 Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole.
 Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.

The World Health Organization (WHO) declared Coronavirus disease-19 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) a pandemic on March 11, 2020. On 16th January 2021, India began its vaccination programme using two COVID-19 vaccines (Covishield and Covaxin). Precautionary dose (booster shots) was administered to health and front-line workers in the beginning and then to all eligible populations. This was a descriptive observational study conducted in the COVID-19 vaccination centres of Karnal district and the ADR monitoring centre, KCGMC, Karnal. During the visits to vaccination centres, all beneficiaries of the precautionary third dose of COVID-19 vaccines as well as healthcare workers were sensitized to report in case of any adverse event following vaccination as part of the policy of the vaccination programme run by the government and Pharmacovigilance Programme of India. The data were collected in suspected adverse drug reaction (ADR) reporting form version 1.4, and causality assessment was done as per the WHO-UMC scale. The data were analysed as simple proportions and percentages. The booster dose was administered to 72,853 individuals, while the 1st dose and 2nd dose were given to 13,30,042 and 10,73,050, respectively. Only three ADRs were reported with the booster dose in 34 vaccination centres in the Karnal district. These three ADRs were classified as unlikely on causality assessment and hence not included in the analysis. The booster dose administered for the prevention of COVID-19 has been found to be reasonably safe. The population who received COVID-19 booster doses was significantly less than the populations who received the first and second doses, which suggests a low acceptance rate.

Background: As a part of pharmacovigilance program of India (PvPI) adverse drug reactions (ADRs) are cause of mortality and morbidity in patients unnoticed, which is a part of WHO program for International Drug Safety Monitoring across world. ADRs are considered to be among top 10 causes for mortality. The reason for sex difference in medication response is multi factorial with wide range of aspects like steroid hormones, organ physiology to psychology and socio-cultural factors. The aim was to study on gender related differences in adverse drug reactions in patients attending tertiary care teaching hospital at Nandyal.Methods: ADR cases were collected from multicenter health care units from tertiary care teaching hospital. ADRs were reported in ADR notification forms or yellow form, CDSCO forms are used to report ADR to Regional pharmacovigilance center. Causality assessment of the ADRs was done based on WHO-UMC causality assessment scale using modified Hartwig and Seigel scale.Results: In the 30 ADR reports collected 21 reports (70%) are of female patients and 9 reports (30%) are of male patients. According to WHO-UMC scale 20 (70%) of Adverse drug reactions were falling into PROBABLE, while 10 (30%) ADR’s are CERTAIN. In 21 females, ADR reports were due to 15(76.43%) Antibiotics, 2 (9.52%) NSAID’s, 2 (9.52%) proton pump inhibitors, 2 (9.52%) anti-convulsants. In 9 males, ADR reports were due to 5 (55.5%) Antibiotics, 2 (22.22%) NSAID’s, 2 (22.22%) anti-convulsants.Conclusions: ADRs are the common occurrences but ADR monitoring helps in prevention of morbidity and mortality in patients. The most commonly affected gender is among female patients, as they are more exposed to drugs starting their journey right from the childhood, pregnancy till their adult menopausal stage.

Background: The burden of dermatological Adverse Drug Reactions (ADRs) is resulting into switching or discontinuation of drug as well as medication non-adherence. Active search is essential for evaluating, managing, reporting ADRs and strengthening the activity of pharmacovigilance of the country. The purpose of the study was to evaluate causality, severity and preventability of Dermatological ADRs. Method: A prospective, observational study was carriedout over a period of six months at Out Patient Department of Dermatology, Sheth V.S. hospital, Ahmedabad with diagnosed dermatological ADRs. The suspected ADRs were evaluated for causality by WHO-UMC causality and Naranjo’s scale, severity by Hartwig and Siegel scale, and preventability by Schumock and Thornton criteria. The agreement between causality scales was obtained by Cohen’s Kappa test. Result: Total of 51 patients were enrolled with 74 suspected ADRs. The incidence of dermatological ADR was 3.78%. Most commonly manifested ADR was rash (26.67%). Total 97 drugs were suspected. Maximum incidence of dermatological ADRs were observed with antimicrobial agents (43.30%) followed by non-steroidal antiinflammatory drugs (26.80%), possible (54.64%) and 35 (36.08%) probable ADRs by WHO-UMC scale. Naranjo’s scale showed most cases of probable (74.23%). ADRs were of moderate severity (98.97%) and definitely preventable (72.16%). The causality scales showed ‘slight agreement’ with kappa value 0.012. Conclusion: Dermatological adverse drug reactions were a common occurrence and awareness about them was found to be essential for early detection and prevention. The healthcare system can promote the spontaneous reporting of dermatological ADR top Pharmacovigilance centre’s for ensuring safe drug use and patient care.

Introduction: Cutaneous Adverse Drug Reactions (CADRs) share significantly to Adverse Drug Reactions (ADRs) comprising 10%-30% of all ADR reporting in India. Multi Drug Therapy for Leprosy (MDT-L) and antimicrobials contribute remarkably to the overall CADRs burden. Aim: To show distinctive pictures of CADRs profile and to assess inter-rater agreement of assessment scales among study populations. Materials and Methods: A retrospective analysis was done for 245 CADRs reported from March 2018 to March 2020. Cohen kappa statistics was applied for inter-rater agreement study for causality (World Health Organisation-Uppsala Monitoring Cente {WHO-UMC} Scale and Naranjo’s Algorithm), severity (Hartwig and Siegel scale) and preventability assessment (Modified Schumock and Thornton scale). Results: CADRs contribute 45.54% of total ADRs reported during study period. Male (60.41%) and age group 21-40 years (22.45%) were predominant sex and age group, respectively. Multidrug therapy for leprosy (51.83%) was the most common offending agent and hyperpigmentation (20.82%), dryness (13.1%), and both (11%) were the most prevalent CADRs. Causality of WHO–UMC Scale was higher with ‘Possible’ than ‘Probable’. Whereas, ‘Probable’ was maximally found with Naranjo’s Algorithm. Severity assessment showed maximum ‘mild’ cases i.e., 66.53% (manual) and 69.8%% (app). Preventability assessment depicted mostly ‘Definite’, 66.53% (manual) and 85.71% (app). Inter-rater agreement study showed ‘Substantial agreement’ for WHO-UMC Scale (K=0.678) and Naranjo’s algorithm (K=0.820), when manual vs app ratings were compared. ‘Almost perfect’ for severity assessment (K=0.893) and ‘Moderate’ for preventability assessment (K=0.434) were noticed. ‘Fair’ agreement was observed when manual (WHO-UMC scale) vs manual (Naranjo’s algorithm) were compared with K=0.290 and also, in app (WHO-UMC scale) vs app (Naranjo’s algorithm) with K=0.319. Conclusion: CADRs were most prevalent among ADRs which have a distinctive picture in eastern India. WHO- UMC scale and Naranjo’s algorithm concluded significant differences in causality with only ‘fair’ agreement between them. Severity and preventability assessment done by manually little varied in their results with pharmvigill app and is still more reliable and popular.