Retrospective study on cutaneous adverse drug reactions in a tertiary care center

Background: Cutaneous adverse drug reactions (CADRs) range from mild-to-severe types and occasionally can become fatal. Hence, these incur additional financial burden both to patients and community. Aim and Objective: The aim of the study was to describe the characteristics of CADRs reported to ADR monitoring center (AMC) of a tertiary care center. Materials and Methods: CADRs reported to the AMC over a period of 2 ½ years were retrospectively studied. This study mainly focused on affected age group, gender, various pattern of CADRs, the group and name of drugs causing CADRs, and severity and causality assessment. Results: CADRs contributed 31.6% of the total ADRs reported to the AMC. Among these, 51.7% were females and 40% were of 51–60 years age group. About 37.9% of CADRs were pruritus. Antibacterial drugs were the most common cause of CADRs and beta-lactam antibiotics were responsible for 30% of CADRs. Stevens Johnson syndrome (SJS) constituted 4.9% of CADRs and 20% of this was due to Paracetamol. Drugs were withdrawn in 89% of cases and 85% cases recovered. On causality assessment, 94% were of probable category. Conclusion: Pruritus was the most commonly observed CADR and antibacterial drugs were the most common cause. Beta lactam antibiotic was the most frequent antibacterial drug to cause CADRs. The most common serious CADR was SJS and Paracetamol was the most frequent culprit drug.

Study of pattern and time-reaction sequence for adverse drug reactions reported to antiretroviral drugs

Background: Adverse drug reactions (ADRs) to antiretroviral drugs have a varied pattern and wide spectrum of severity from mild to very serious. The lack of a pre-established time-reaction sequence hampers the causality assessment of ADRs. Recognition of pattern of ADRs to antiretroviral drugs in a particular setup might sensitize the reporters to report ADRs, especially in setups dependent on spontaneous reporting. Aim and Objectives: The study of pattern and time-reaction sequence for ADRs reported to antiretroviral drugs. Materials and Methods: Retrospective study was conducted at a first-line antiretroviral therapy (ART) center after obtaining approval from the Institutional Ethics Committee. Pattern of ADRs associated with ART was done by analyzing the type of ADRs, severity, and outcome of ADRs reported to antiretroviral drugs. Mean duration of time lapse between administration of drug to onset of adverse drug reaction was calculated. Descriptive statistics was used for data analysis. Results: There were 73 adverse reactions reported. Most common type of adverse reaction was cutaneous (53.42%) followed by anemia (31%). Causality assessment of most ADRs was concluded as possible (60.27%). Most ADRs were of moderate severity and 12% were severe reactions. Reactions such as anemia and neuropsychiatric ADRs often occurred late, while maculopapular rash usually occurred within 30 days of drug administration. Conclusions: ADRs to ART include an array of reactions ranging from mild rash to psychosis or severe anemia. Most of these reactions are of moderate severity and have a favorable outcome. Many of these reactions actually occur almost a month after initiating a drug regime suggesting the need for intensive monitoring around this time.

Interpretation on Consensus on drug-induced liver injury by CIOMS Working Group:liver injury attributed to herbal and dietary supplements / 中国中药杂志

With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.

A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

Objectives: To analyse the adverse drug reactions (ADRs) reported from clinical departments of a tertiary care hospital. Materials and Methods: A prospective, observational study to analyse the reported ADRs to the pharmacovigilance unit, Department of Pharmacology, East Point College of Medical Sciences and Research Centre, between 2019 and 2021. Institutional Ethics Committee approval was taken before doing the study. The data pertaining to various parameters were recorded in the Central Drugs Standard Control Organization (CDSCO) approved ADR reporting form and were analysed with respect to each reported data using descriptive statistics and expressed as numbers and percentages using Microsoft Excel. Results: Overall, 114 ADRs were reported during the study duration, and ADRs were most commonly reported amongst females (69) and 31–45 years (27.2%) age group. Causality assessment was done using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, which showed 75 (66%) probable and 39 (34%) possible ADRs. The highest number of ADRs were reported by Medicine department (48.2%), emergency and intensive care unit (ICU) (16.6%) followed by Dermatology department (9.6%). The majority of them were due to antimicrobial agents (53.5%). The most commonly affected organ system was found to be dermatological (68.4%) followed by the body as a whole (15.7%) and gastrointestinal system (8.7%). The presentations of ADRs were diverse; itching and rashes (34 cases) were most commonly reported. Conclusion: This study gives an overall understanding of the current situation and trends in ADRs and their reporting status by health professionals in a tertiary care hospital, which would help to strengthen the pharmacovigilance activities at all levels of health care.

A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India

Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world. Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India. Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen’s kappa (?) statistics and Spearman’s correlation was used to evaluate the correlation between these two methods. Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen’s kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman’s correlation coefficient was determined to be 0.409. Conclusion: “Probable” was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.

Anaphylactic Reaction Following Injection Cefotaxime Sodium

This is a case study of anaphylactic reaction to cefotaxime sodium in a 23-year-old female who underwent a lower segment cesarean section under spinal anesthesia. Cefotaxime sodium, an antibiotic belonging to the class of cephalosporins, was administered intravenously postoperatively for prevention of infection. The patient complained of breathlessness, swelling around both eyes, and pruritus and urticarial rash over her abdomen, legs, and forehead. The case was successfully managed by withholding the medication and treatment of symptoms. According to the WHO-Uppsala Monitoring Centre causality assessment scale, a probable causal relationship between the suspected drug (cefotaxime sodium) and anaphylactic reaction was made. The severity was found to be moderate (Level 3). Although cefotaxime has well established place in surgical prophylaxis, this case study emphasizes on constant observation and meticulous follow-up of patients receiving it in clinical practice as there is possibility of an adverse drug reaction (ADR) which can be life-threatening. Such happenings can add to challenges faced by the treating physician in the present COVID-19 era. Recognizing ADR helps reduce morbidity and mortality. Reporting ADR helps in documentation and education of healthcare professionals.

Analysis Of Adverse Drug Events Reported At Peripheral Adr Monitoring Centre In Gujarat

Objective: Hospital-based ADR (Adverse drug reaction) monitoring and reporting programmes are useful for identifying and minimizing preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The objective of this study was to evaluate and analyze the spontaneously reported adverse drug events from various departments of Shree Krishna Hospital, Karamsad. Methods: This was a retrospective study and data was analyzed for adverse drug events reported during the period of April 2018 to March 2019 from various departments of Shree Krishna Hospital, Karamsad. Analysis was done on the basis of the demographic profile of patients, health care professionals who have reported and drugs causing ADRs, with their causality assessment using WHO probability scale. Results: Out of 36 patients, 20 (55.55%) were males and 16 (44.44%) were females. Antibiotics were the most common culprit group of drugs for reported ADRs in 21 patients. The number of ADRS related to the skin was 21 (58.33%) followed by GIT 11 (30.55%), cardiovascular 2(5.55%) and neuronal 2(5.55%). According to WHO causality assessment scale 01 (2.77%) of the suspected ADR was certain, 27(75%) were probable and 8 (22.22%) were possible. Conclusion: Our study concluded that the most commonly reported ADRs were dermatological reactions like itching and rashes. Antimicrobials were the most common drug group involved in causing ADRs. Even though there were continuous efforts for adverse drug event reporting awareness, still there is need to sensitize health care professionals to improve reporting.

A pharmacovigilance study of anti-depressant agents in psychiatric patients at a tertiary care teaching hospital

Background: Anti-depressant drugs have great benefit in treating a many psychiatric disorders, including schizophrenia and bipolar disorder, although all these drugs are associated with many potential adverse effects. In this study, the occurrence of adverse effects like weight gain, sleep disturbances, dry mouth were assessed and reported in drug naïve patients Anti-depressant drugs.Methods: It is a prospective observational study of patients attending Psychiatry department in NRI General Hospital of age 10 to 80 years who were prescribed with anti-depressant drugs. The study was conducted for a period of 8 months from June 2018 to February 2018.Results: Among 86 patients prescribed with antidepressants, the occurrence of adverse drug reactions due to antidepressants was 60.78% with Selective serotonin reuptake inhibitors being the most common class of drugs implicated for adverse drug reactions followed by 24.49% with Tricyclic antidepressants. A total of 51 adverse drug reactions were noted of which weight gain was most common, closely followed by sleep disturbances and drowsiness. Out of 52 adverse drug reactions assessed for causality, 88.2% of the adverse drug reactions cases were probable, while 11.7% were possible. According to Hartwig and Siegel’s Scale 84.3% of the cases are found to be mild, 15.68% moderate.Conclusions: The study allows knowing information about the occurrence and pattern of adverse drug reactions associated with Anti-depressant drugs in the population thus reducing its incidence and protecting the user population from available harm.

An Overview Of Various Scales Used In Causality Assessment Of Adverse Drug Reactions

Establishing a relationship of causality between the medications received and the events occurred utilizing causality assessment scale is much needed to reduce the occurrence of Adverse Drug Reactions (ADRs) and to prevent exposure of patients towards additional drug hazards. Causality assessment can be defined as the determination of chance, whether a selected intervention is the root cause of the adverse event observed. The causality assessment is the responsibility of either a single expert or an established committee. As it is a common phenomenon of variable perception of knowledge and experience by each expert, there is a high possibility of disagreement and inter-individual variability on assessment. Many of the causality assessment methods have their advantages and disadvantages. However, no single scale has been adopted as standardized and considered for uniform acceptance.

Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

Background: Adverse drug reactions (ADRs) are among the leading cause of morbidity and mortality in hospital setup. This study was conducted with the aim of understanding the pattern and occurrence of ADRs to minimize their risk and safeguard public health.Methods: This study is a retrospective analysis of pattern of ADRs reported at ADR monitoring centre (AMC) in a tertiary care hospital. A total of 207 spontaneous ADR reports collected over a period of 18 months were analysed for pattern and type of reactions, demographic profile of patients, organ system affected by ADRs, causative drugs, route of drug administration, severity of reaction, their outcome, management and causality assessment.Results: Most common age group affected by ADRs was 41-50 years with almost equal involvement of male and female gender. Cutaneous reactions involving skin like rashes and itching were most common ADRs. The most common causative drug for ADRs were antimicrobials agents like Penicillin and Cephalosporin group of antibiotics. Orally administered drugs were most commonly involved in causing ADRs. Most of the ADRs belonged to Type A category, were non-serious and moderate in severity. Most of the patients recovered from the ADRs on stopping the suspected drug. On assessing the causality, most of the ADRs were probable with the suspected drugs.Conclusions: Most of the patients recover from ADRs with appropriate and timely intervention, but it is important to understand the pattern and occurrence of ADRs for patient safety and this is possible only with an effective and robust pharmacovigilance system.

A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR扴.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo抯, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software抯 are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

Assessment of adverse drug reactions to antituberculosis regimen in a tertiary care hospital

Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.

A pharmacovigilance study of adverse drug reactions in a tertiary care hospital in Haryana

Background: Adverse drug reaction (ADR) is an inevitable risk associated with all the prescribed medicines. They vary in severity & duration in any population. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance programme of India through adverse drug reaction monitoring centres. This study was taken to assess the pattern of ADR reported in a tertiary care hospital in Haryana.Methods: This study was conducted in the Kalpana Chawla Government Medical College, Karnal, Haryana from January 2018 to June 2019. ADRs were collected from different departments and were analysed according to gender, age, department wise distribution, drugs class involved and ADR that was reported.Results: A total of 233 ADRs were reported in the above mentioned period. Females were affected more than males, maximum number reported in the age group of 21-60 years. The maximum number of ADRs reported was from Dermatology department. Antimicrobials were the class of drugs that were responsible for the maximum number of ADRs reported. Skin manifestations of various types were the most reported ADRs.Conclusions: By keeping a careful and timely watch majority of the ADRS can be prevented by early intervention. There is also a need to ensure timely check on the drugs supplied by the various pharmaceutical companies who get the contract for government supply. This will be a step towards improving patient safety.

Study of adverse drug reactions in a tertiary care hospital

Background: The objectives of the study were to evaluate incidence and preventability of adverse drug events (ADEs) and potential ADEs and to analyse preventable events to develop prevention strategies.Methods: The study was retrospective observational study conducted at a rural tertiary care hospital at Maharashtra, for 12 months. Patients of both gender and all age group were included in the study. These entire adverse drug reactions were reported either by the PVPI assistance and/or hospital staff and their severity and causality assessments was performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Data was analyzed by using Microsoft Excel.Results: There were total 256 ADR (adverse drug reactions) were reported in 12 months from January 2018 to December 2018 in various departments of the study center. Most of the adverse drug reactions were reported among age group of 21–40 years patients. Rash and itching (69) were most commonly reported ADR’s. ART (31.25%), antibiotics (28.90%) were reported to induce maximum number of ADRs. Most of the adverse drug reactions were possible (194, 75.78%) and mild (208, 81.25%) in nature.Conclusions: The antibiotics, ART drugs were most common drugs to reported ADRs. The commonly reported reactions were rash and itching.

Medication Therapy Management Services and Pharmacovigilance Studies in Tuberculosis Patients: A Patient Care Aspect in the Pulmonology Department in a Tertiary Care Hospital

Background: Tuberculosis is fundamentally a disease of the lungs, however, it can influence any organ in the body. Objectives: Primary objective was to improve the patient compliance or medication adherence and to identify, detect, monitor ADRs induced by anti-tubercular drugs and report them. A secondary objective was to prevent the emergence of drug resistance and treatment of prolongation/failure in TB patients. Methods: A prospective, observational, cohort study was carried out for 6-months in tertiary care hospital. There were 60 patients included in the study. The data were evaluated for patients’ demographic profile, type of TB, medication adherence and occurrence of ADRs. Adverse drug reactions were observed and recorded. The causality of ADRs was assessed using WHO-causality assessment scale and Naranjo causality assessment scale. The severity of ADRs was determined using Hartwig’s severity assessment scale. Results and Discussion: Total of 60 patients were included in the study. Results showed that among 60 patients included in the study, 44 patients experienced ADRs. Among all age groups, the highest numbers of ADRs were seen in the age group 19-30 (43.1%) years. The occurrence of ADRs was noticed more in females (77.7%). The majority of ADRs occurred in patients was general (28.4%), and gastrointestinal effects (23.8%). Conclusion and Scope of the Study: Adherence to treatment is crucial for the cure of individual patients, controlling the spread of infection, minimizing the development of drug resistance and to reduce the chances of re-infection. Proper therapeutic monitoring of regimen, dose management, and pharmacovigilance activities are necessary. Such approaches will not only improve the treatment outcomes but also minimizes the chances of treatment prolongation/failure. All the health care professionals should interpret their responsibility in this domain of the health care profession.

A study of patterns of adverse drug reactions in a tertiary care hospital of Andhra Pradesh, India

Background: Pharmacovigilance Programme of India (PVPI) is a step towards participation in WHO programme for International Drug Safety Monitoring. Pharmacovigilance (PV) system is an integral part of drug therapy, which helps in detection, monitoring and designing strategies to minimize the occurrence of Adverse Drug Reaction (ADRs). The present study is done to study the patterns of ADRs in a tertiary care government hospital.Methods: A total of 327 suspected ADR reports submitted to the pharmacovigilance unit at department of pharmacology under PVPI were evaluated for a period of two years with respect to age, sex, causative drug, organ system involvement and seriousness of ADRs. The causality assessment was done using WHO assessment method.Results: Female patients experienced more (54.13%) ADRs. The highest percentage (49.24%) of ADRs were seen in age group of 18-44 years, followed by 45-60 years (33.33%). Medicine department reported the maximum number (42.20%) of ADRs. Antimicrobial agents (27.83%) were the commonest group of drugs causing ADRs, followed by anti psychotics (15.90%) and analgesic drugs (10.70%). Skin is the major organ system affected (30.28%). Causality assessment revealed (51.99%) of the ADRs were possible. Majority of the ADRs (79.82%) were nonserious and (20.18%) were serious requiring hospitalization. Death occurred in five patients.Conclusions: The results suggest that there is under reporting and there is a need to create awareness among health care professionals(HCP) about the importance of Pharmacovigilance .The data also helps in designing strategies for framing policies towards safer use of drugs in future.

The study of adverse drug reactions of antihypertensive medicines in essential hypertension patients in Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha, India

Background: Every drug has the potentiality to cause an adverse drug reaction (ADR). ADRs are a major problem in drug therapy .The aim of this study was to assess the incidence and causality of ADRs to antihypertensive agents used for the essential hypertensive patients attending at the general medicine out patients departments of Hi-Tech Medical College and Hospital, Bhubaneswar Odisha, during the time period of November 2016 to October 2018.Methods: This prospective-observational study was carried out in general medicine outpatient department of Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha.Results: Out of 254 patients, 78 (30.71%) patients were developed ADRs to antihypertensive drugs. 51 (65.38%) were female and 27 (34.62%) were male. Calcium channel blockers were the commonest therapeutic class of antihypertensive drugs associated with ADRs (n = 50, 64.10%). According to WHO causality assessment scale most of the ADRs were “probable” 41 (52.56%), followed by “possible” 21 (26.92%), unclassifiable 13 (16.67%) and unlikely 3 (3.85%).Conclusions: The results of this study concluded that antihypertensive drugs able to induce the development of adverse drug reactions, which were significant cause of increase burden on health care system and decrease the quality of life, the health care professionals should take care about the rational use of antihypertensive agents. Thus, to minimize the incidence of adverse drug reaction and to increase the quality of life.

A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of tuberculosis receiving category I and II treatment regimens at tertiary care hospital

Background: First line Anti-TB therapy with rifampicin, isoniazid, pyrazinamide, and ethambutol / streptomycin is very effective. However, major adverse reactions to antituberculous drugs can cause significant morbidity and mortality. One of the main reasons for non?adherence to anti?TB therapy (ATT) is ADRs, even under DOTS. Present study was carried out in tertiary care hospital. The objective of the study was to evaluate types and frequency of ADRs in intensive and continuation phase of category I and II Anti-TB medication.Methods: A prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the TB patients reporting at DOTS Center of institute were enrolled and monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire.Results: Total, n = 241 tuberculosis patients on DOTS therapy were enrolled for the study. Out of 241 patients, 17 were dropouts so 224 patients assessed for ADRs. 127 (56.69%) developed adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40 yrs followed by 21-30 yrs, ADRs were more common in men. Pulmonary TB (73.66%) cases were more common than extra pulmonary TB. Majority of adverse drug reactions were Gastrointestinal (GI) problems (30.92%), followed by Liver dysfunction and Hepatotoxicity (20.39%) and skin problems (17.10%). The causality of ADRs, in majority cases were found to be Probable (56.57%). Around 19 patients require treatment interruption and most of the patients were managed with supportive medication without removing anti tubercular drug from regimen.Conclusions: ADRs are major limiting factor for completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

Adverse drug reaction prevalence pattern among drugs and its correlation with causality assessment in ADR monitoring centre in Kerala over 6 months

Background: Prevalence of adverse drug reactions had been studied extensively in the past to find out the drug pattern distribution of ADR. In this study, authors tried to find out the prevalence pattern and its correlation with the WHO causality assessment over the 6 months.Methods: This study was done in Govt Medical College Palakkad Kerala as an observational study. Without revealing the identity of the patients as is done in ADR reporting in pharmacovigilance program, a retrospective data collection was done by collecting different types of ADR reported in this hospital for the previous six months. Only data of inpatients was collected and tabulated for different group of drugs. Then using the WHO scale of causality assessment, the ADR individually was classified to probable, possible, or certain and tabulated.Results: In this study, the prevalence pattern of drugs causing ADR was evaluated over six months in a tertiary care centre. Out of the 45 cases reported, major ADR were for antibiotics (55.5%) and anticancer agents (18.2%) and the least reported ADR were for vaccines and supplements (2.2%). In causality assessment WHO scale only one case was certain (2.2%). Here the majority Causality assessment was found to be probable (44.45%) and possible (51.2%).Conclusions: From this study it is concluded that the antibiotics has the major ADR pattern. It’s also known that the probable and possible causalities are more common when ADR are reported.

Study of adverse drug reaction and causality assessment of antidiabetic drugs

Background: Study about adverse drug reaction of antidiabetic drugs helps in ensuring maximum benefits of drug therapy.Methods: An observational study was carried out in patients attending tertiary care hospital in Kanyakumari district from August 2013 to August 2014. Adverse drug reactions due to the use of antidiabetic drugs were collected and adverse effects experienced by the patient was assessed using WHO scale, Naranjo scale, Schumock and Thornton scale and Hartwig and Siegel scale.Results: In this prospective study a total of 76 adverse events (41 male and 35 female) were identified. Most frequently observed adverse effect were hypoglycaemia and the less observed were pruritis. Maximum of 14 adverse effect were observed due to use of insulin. Combination of sulphonylurea and biguanides caused 28 adverse effects. Assessment of adverse effect using WHO scale showed 64% as probable, 16% possible, 7% conditional, 5% unclassifiable, 4% certain, and 4% unlikely. Relationship of adverse reaction to antidiabetic drugs using Naranjo scale showed 92% possibly, 5% probably and 3% as definite. Antidiabetic drug adverse effects were not preventable in 63%, definitely preventable in 19% and probably preventable in 18% as per modified Schumock and Thornton scale. Severity assessment of adverse effects were mild in 75%, moderate in 25% and no severe reactions according to modified Hartwig and Siegel scale.Conclusions: Adverse effect most commonly encountered during the study period were predictable, definitely preventable and without serious effects. Majority of the reactions were due to combination of antidiabetic drugs.