Nature Of Adverse Drug Reactions Research Articles

ADVERSE DRUG REACTIONS AMONG PATIENTS IN DEPARTMENT OF MEDICINE IN A TERTIARY CARE TEACHING HOSPITAL, KOLLAM

Objectives: Pharmacovigilance practices are still in the infancy in India, more so in South India. adverse drug reactions (ADRs) are often underreported and the risks are higher in adults and elderly due to the association of comorbidities, self-medication, combination of indigenous systems of medicines and modern medicine, and so on. The present study was done with the objective to analyze the ADRs among patients in the general medicine department, Government Medical College, Kollam. The primary objective is to determine the prevalence and nature of ADRs and secondary objective to assess the causality, severity, and preventability of the ADRs. Methods: In this cross-sectional study done in the Department of Medicine, Government Medical College, Kollam, 1000 patients of either sex were analyzed using CDSCO ADR reporting forms and the approved scales for causality, severity, and preventability. Results: Among 1000 patients studied, the prevalence of ADRs was 7.6%. The most common system involved were dermatological (41%) followed by cardiovascular (18%) and gastrointestinal and neurology (16% each). Majority of the ADRs came under probable (48.7%) with a Naranjo score of 5 (40.8%), of moderate severity (65.8%) and not preventable (71.1%). Conclusion: ADRs pose a major problem needing hospital stay or prolonging the duration of stay. Developing an ongoing ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspected ADRs will help to continue reporting and improving the patient safety. Improved communication of health-care professionals with the pharmacovigilance centers should be promoted for better patient healthcare.

Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

ABSTRACT Background We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Background: Diabetes is characterized by hyperglycemia, a metabolic disorder resulting from defects in insulin secretion, action, or both. The traditional treatment choices available for diabetes include medications that are oral hypoglycemic agents and insulin. Due to the introduction of several medications during the past 20 years, the identification of adverse drug reactions has gained importance. Aim: The aim of this study was to evaluate the adverse drug reactions among diabetic patients and patients’ variables that were linked to the adverse drug reactions. Study Design: Cross-sectional study Place and Duration of Study: This research was done at private clinics in Hyderabad, Pakistan, from August 2021 to January 2022. Methodology: Three hundred and seventy seven participants and the data regarding baseline characteristics of participants, adverse drug reactions reported were analyzed together with the assessment of causality and severity of unwanted reactions. Results: Two hundred and forty one (63.9%) were males and 136 (36.1%) were females. Only 19 (5%) reported adverse drugs reactions. Hypoglycemia was the most commonly reported adverse drug reaction i.e.11 ((57.9%). On causality assessment, most of the adverse drug reactions fell under the category of probable adverse drug reaction i.e.15 (78.9%). Four (21.1%) of them had the doubtful relation with the medications. The majority of the adverse drug reactions that were reported by the participants were found to be moderately severe 13 (68.4%), when analyzed through severity assessment scale. Six (31.6%) were belonged to mildly severe category. Conclusion: The upper age group, male gender, and diabetes duration of more than 5 years were associated with a higher incidence of adverse drug reactions. This study gave in depth analysis of adverse drugs reactions reported in the patients of diabetes mellitus together with the nature of adverse drug reactions reported. A better patient outcome would result from the clinical pharmacist's active participation in adverse drug resistance. Keywords: Adverse drug resistance (ADR), Diabetes mellitus, Hypoglycemia, Severity

Agreement between a regional pharmacovigilance centre and an adjudication committee regarding adverse drug reactions on a cohort of hospitalised children

The EREMI project was set up to collect data on adverse drug reactions (ADRs) occurring due to off-label and/or unlicensed drugs prescribed to hospitalised children in France. These events were evaluated by a regional pharmacovigilance centre (RPC) and an adjudication committee (AC). The aim of this study was to assess the agreement between these two different entities on their evaluation of ADRs. The RPC first validated the ADRs and assessed their causality using the Naranjo scale. The AC assessed then ADRs using all available information, including the RPC evaluation. The agreement on severity and nature of ADRs, role of treatment (suspect or concomitant) and drug causality was calculated using Cohen's nonparametric kappa coefficient (k). Three hundred and eighty-six events were reported in 219 children. The RPC excluded 65 events and validated 321 ADRs. Agreement was very good on nature of ADRs (k=0.85) and role of treatment (k=0.81), moderate on severity of ADRs (k=0.60) and very poor on drug causality (k=0.05). Agreement between the RPC and the AC was not constant throughout this evaluation. They troubled to agree on severe ADRs and on drug causality.

P-MD019. Gabapentin as add-on therapy to trihexyphenidyl in children with dyskinetic cerebral palsy: A randomized controlled trial

Introduction . Mangement of hypertonia in dyskinetic cerebral palsy is challenging. The present study was designed to compare the efficacy and safety of gabapentin as add-on therapy to trihexyphenidyl in the treatment of children with dyskinetic CP. Methods . An open labelled, randomized controlled trial was conducted among 60 children aged 3–9 years with dyskinetic CP (GMFCS 4-5). The participants were randomized into two groups: Gabapentin group receiving gabapentin with trihexyphenidyl (n = 30) and Trihexyphenidyl group receiving trihexyphenidyl alone (n = 30). Primary outcome measures include total Dyskinesia Impairment Scale (DIS), Dystonia Severity Assessment Plan (DSAP) and International Classification of Functioning Disability, and Health-Children and Youth Version (ICF-CY) assessed at four weeks and twelve weeks. Secondary outcome measure include frequency and nature of adverse drug reaction observed after initiation of drug therapy. Results . Out of 60 children, five children in gabapentin group and two children in trihexyphenidyl group were lost to follow up at twelve weeks. There was significant reduction in severity of dystonia in both the groups at four weeks as well as at twelve weeks (DIS: P < 0.001, DSAP: P = 0.007, ICF-CY: P < 0.001) but when the data were compared between the groups, there was no significant reduction in severity of dystonia at four weeks and at twelve weeks (DIS: P = 0.09, DSAP: P = 0.49, ICF-CY: P = 0.25). Constipation (11.5% in gabapentin group and 14.3% in trihexyphenidyl group) was the commonest side effect observed in both groups and both gabapentin as well as trihexyphenidyl were well tolerated without any serious side effect. Conclusion . Trihexyphenidyl alone is as effective as combination of gabapentin with trihexyphenidyl in reducing the severity of dystonia at twelve weeks. Hence, there is no added benefit of gabapentin in management of dystonia in children with dyskinetic CP.

Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic.

Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70-13.32; p < 0.001]. Along with the increasing utilization of direct oral anticoagulants, the reporting rate gradually declined over time, especially for rivaroxaban and apixaban. Fatal outcomes were reported in 7%, mostly for dabigatran. Hemorrhagic reactions were the most frequently reported adverse drug reactions (37% associated with dabigatran, 28% with apixaban, 24% with warfarin, and 23% with rivaroxaban), and compared to warfarin, they were significantly more often associated with direct oral anticoagulants (ROR: 14.36; CI: 9.57-21.54; p < 0.001). Conclusion The number of adverse drug reaction reports related to oral anticoagulants in the Czech Republic was relatively low, compared to other studies, but 96% of the cases were serious. Data from spontaneous adverse drug reactions reporting should be further analyzed in order to obtain additional information on the safety profile of oral anticoagulants.

Monitoring of adverse drug reactions in psychiatry outpatient department of a tertiary care hospital in Central India

Background: Adverse drug reactions (ADRs) are prevalent in patients taking psychotropic medications and can occur even at the normal doses used in the management of acute and maintenance phases of psychiatric disorders. Pharmacovigilance have cardinal role in alerting the healthcare providers from the possible ADRs and thus protecting the patients who are using psychotropic medications. To Monitor and estimate the incidence and nature of ADRs in psychiatry OPD of tertiary care hospital in central India and assess the causality, preventability and severity of documented ADRs.Methods: A prospective observational study was conducted in psychiatry out-patient department (OPD). Patients diagnosed with any psychiatric disorder and receiving psychotropic medications was included in the study. The recorded data were filled in the ADR form obtained from pharmacovigilance program of India (PvPI). Causality assessment was done using Naranjo scale and severity was assessed using Hartwig scale and preventability assessment using modified Schumock and Thornton’s scale.Results: The incidence rate of ADR was found to be 15.8%. A total of 61 ADRs were documented. Weight gain 14 (18.1%) followed by nausea 11 (14.2%) was the most commonly reported ADR. Atypical antipsychotics were the most common class of psychotropic drugs implicated in ADRs. Clonazepam 21 (27.2%) followed by amitriptyline 20 (25.9%) were associated with a maximum number of ADRs. Majority of the suspected ADRs were probable in nature (40.9%) followed by possible type (31%).Conclusions: Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and definitely preventable type.

A pattern of serious adverse drug reactions reported in a tertiary care hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh

Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.

Adverse Drug Reactions Across the Age Continuum: Epidemiology, Diagnostic Challenges, Prevention, and Treatments.

Adverse drug reactions (ADRs) are common and important complications of drug therapy for children. The risk for ADRs changes over childhood, as do the nature and types of ADRs. Importantly, the risk and nature of ADRs in children are markedly different from those of adults, and adult data cannot be relied on to guide safe drug therapy in children. There are groups of children, notably those with complex and chronic diseases, who are at substantial risk for ADRs. The evaluation of an undesired effect during therapy is ideally accomplished by an organized approach that is a skill that clinicians who care for children-especially those children at high risk for ADRs must have. Additionally, clinicians as well as drug regulatory agencies and industry need to be both vigilant and astute as well as aware that ADRs in children are often different in nature and frequency from those in adults. The increasing use of pharmacogenomics to guide drug dosing and the increasing number of biological agents will provide new sets of challenges to clinicians over the next decade.

Developmental Pharmacotherapy: The Interface Between Ontogeny and Drug Effect.

Developmental Pharmacotherapy: The Interface Between Ontogeny and Drug Effect.

Rare disease prevention and treatment: the need for a level playing field.

Pharmacogenetic tests are being used increasingly to prevent rare and potentially life-threatening adverse drug reactions. For many tests, however, cost-effectiveness is hard to demonstrate, and with the exception of a few cases, widespread implementation remains a distant prospect. Many orphan drugs for rare diseases are also not cost effective but are nonetheless normally reimbursed. In this article, we argue that the health technology assessment of pharmacogenetic tests aimed to prevent rare but severe adverse drug reactions should be on a level playing field with orphan drugs. This is supported by a number of arguments, concerning the severity, rarity and iatrogenic nature of adverse drug reactions, the distribution of benefits and costs and societal preference towards prevention over treatment.

Intensive monitoring of adverse drug reactions to antipsychotic medications in the inpatient psychiatry department of a secondary care hospital of UAE

Background: Antipsychotics are a class of medications used primarily for the treatment of psychotic disorders. However, these medications are associated with potential adverse drug reactions (ADRs). Aim: To monitor the incidence and nature of ADRs in the psychiatric inpatient department of a secondary care hospital of Ras Al Khaimah, UAE. Materials and Methods: This was an observational, prospective, noninterventional study, conducted in the psychiatric inpatient setting of a secondary care hospital. Psychiatric inpatients of all age groups and both the gender, diagnosed with any psychotic disorder, and hospitalized in the psychiatry ward and managed with at least one antipsychotic medication were included in the study. The causality, severity, and preventability of ADRs were assessed using different assessment scales. Results: Out of 170 patients, 38 patients reported at least one ADR with an incidence rate of 22.3%. The most common ADRs were weight gain 15 (29.4%) due to olanzapine, followed by pseudo‑parkinsonism 11 (21.6%) due to parenteral haloperidol. Schizophrenia (18, 35.3%), followed by bipolar I disorder (10, 19.6%) was the most common condition associated with ADRs. Female gender and duration of hospital stay were found to be significant (P < 0.05) predictors of occurrence of ADRs. Conclusion: A high incidence of ADRs was observed in the inpatients of psychiatry department, especially of mild nature and probably preventable types. The study highlights the importance of intensive monitoring by pharmacists to identify high ADR risk psychiatric inpatients. To reduce the ADR risk, specific and frequent monitoring for antipsychotics is recommended such as weight and extrapyramidal symptoms.

Pharmacovigilance study in psychiatry out-patient department of a tertiary care teaching hospital

Background: Adverse drug reactions are important in psychiatry practice like any other branch of medicine. Adverse drug reactions associated with psychotropic drugs causes either noncompliance or at times discontinuation of therapy. The objective of the study was to evaluate the incidence and nature of adverse drug reactions in psychiatry outpatient department and to assess the causality and severity of the documented adverse drug reactions.Methods: Prospective observational study was done in the psychiatry outpatient department. All the patients were interviewed for basic details, history of medications and relevant history for adverse drug reactions. The causality, severity and modes of management assessment of the documented adverse drug reactions were done.Results: 2,727 patients attended psychiatry outpatient department, of which 582 patients developed at least one adverse drug reaction. The incidence of adverse drug reaction observed to psychotropic drugs was 21.34%. Majority of adverse drug reactions were seen with antidepressants 298 (10.93%) followed by antipsychotics 187 (6.86%), sedative hypnotics, anticonvulsants and antimanics. The most common adverse drug reactions were sedation 3.44%, weight gain 3.04%, and extrapyramidal symptoms 2.79%. Reported adverse drug reactions were assessed for causality and maximum belonged to probable (15.6 9%). The severity assessment of the reported adverse drug reactions revealed that most of the adverse drug reactions were mild (16.83%) in nature and majority of patients were made to continue the same treatment.Conclusions: Active monitoring of adverse drug reactions in psychiatry outpatient department can help in early detection and management of adverse drug reactions.

Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

Studies that evaluate the safety of non-prescription drugs in children remain scarce. The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test. We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p=0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p=0.0006 and p<0.0001, respectively). The frequency of "serious" ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p=0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n=37; 4.2%), tuberculosis vaccine (n=23; 2.6%), aspirin (n=20, 2.3%), and paracetamol (n=17; 1.9%). ADRs from prescription drugs involved asparaginase (n=27; 3.1%), immunoglobulins (n=25; 2.9%), and amoxicillin (n=23; 2.4%). Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen.

Adverse drug reactions of antihypertensive agents at tertiary care hospital in central Nepal

Background &amp; Objectives: Acute Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately. The study was conducted with the objective to examine the incidence of different types of adverse drug reactions in drug treated hypertensive patients.Materials &amp; Methods: Patients (n=382) who received antihypertensive agents were selected and interviewed using a standardized questionnaire. The Naranjo Algorithm, which categorizes the causality relationship into definite, probable, possible and doubtful, was used for the assessment of the exact nature of Adverse drug reaction (ADR).Results: Calcium channel blockers (CCBs) were the drug class with highest number (22 or 32.84%) of ADRs followed by Angiotensin-converting enzyme Inhibitors (ACEI) in 17 (25.38%), Angiotensin Receptor Blockers (ARB) in 12 (17.91%), diuretics in 10 (14.92%) and beta adrenergic antagonist in six (8.95%). Cardiovascular system (40 or 59.70%) was the most affected followed by central nervous system (16 or 23.88%) and respiratory and dermatological system each in 11 (16.42%) cases. On Naranjo’s probability scale, nine (13.4%) of the ADRs were definite, 39 (58.2%) possible, 16 (23.9%) probable and three (4.5%) doubtful. Conclusion: Calcium channel blockers were mostly associated with ADRs while Cardiovascular system was the most frequently affected.

ANALYSIS OF ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL: A RETROSPECTIVE STUDY

ABSTRACTObjectives: Adverse drug reaction (ADR) is an important cause of morbidity, mortality, and prolonged hospitalization. The objective of this study is tomeasure the incidence, types, and nature of ADR in a tertiary care hospital located in Silchar, Assam.Methods: A retrospective noninterventional analysis of all ADRs reported by ADR Monitoring Centre, Department of Pharmacology, Silchar MedicalCollege, from March 2014 to February 2015 was performed. A total of 162 predesigned forms were used for collection of data. All forms were dulychecked for completeness, if not, they were rejected.Results: A total of 162 forms were assessed of which 96 (59%) were females and 66 (41%) were males. The distribution of ADRs in different age groupswere found to be 3 (1.85%) in 0-15 years, 71 (43.82%) in 16-30 years, 65 (40.12%) in 31-45 years, 8 (4.93%) in 46-60 years, and 15 (9.25%) in agegroup &gt;60 years. 150 (92.6%) of the ADRs were serious and 12 (7.4%) were not serious. As per the World Health Organization causality assessmentscale, 120 (74.07%) were probable and 42 (25.92%) were possible. The most common ADR was anaphylactic reaction (AR) in 69 (42.59%) patients.The drugs which commonly caused ADR were iron sucrose infusions, nevirapine, cephalosporins, antiprotozoals, nonsteroidal anti-inflammatorydrugs, and quinolones followed by others.Conclusion: The majority of ADRs were probable. The most common ADR was AR caused by iron sucrose infusion. Different drugs caused differentADRs. ADRs thereby increase morbidity and mortality in patients as well as socioeconomic burden.Keywords: Adverse drug reaction, Anaphylactic reaction, Iron sucrose infusion, Noninterventional, Retrospective analysis.

Monitoring of adverse drug reactions in psychiatry outpatient department of a Secondary Care Hospital of Ras Al Khaimah, UAE.

Background:Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, resulting in increased healthcare cost. Association of psychotropic medications with ADRs is common. Pharmacovigilance can play a vital role in alerting the healthcare providers from the possible ADRs and thus protecting the patients receiving psychotropic medications.Aim:To monitor and report the incidence and nature of ADRs in psychiatry outpatient department (OPD).Materials and Methods:A prospective observational study was carried out in the psychiatry OPD. All the patients attending psychiatry outpatient and satisfying the inclusion criteria were monitored for ADRs. The causality, severity and preventability assessment of documented ADRs was done. Chi-square test was done to identify the association between ADRs and sociodemographic, disease and treatment-related variables. Paired Student's t-test was carried out to compare the significance difference in the weight of the patients who reported weight gain to psychotropic medications.Results:The incidence rate of ADR was found to be 10.2%. A total of 112 ADRs were documented. Weight gain 18 (16.07%) followed by somnolence 8 (7.14%) was the most commonly reported ADR. Atypical antipsychotics 37 (33.0%) were the most common class of psychotropic drugs implicated in ADRs. Escitalopram 16 (14.28%) followed by quetiapine 14 (12.5%) were associated with a maximum number of ADRs. No significant association (P > 0.05) documented between demographic and treatment-related variables with number of ADRs.Conclusion:Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and not preventable type.

Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study From Ethiopia

In Ethiopia, the use of antiretroviral therapy (ART) has been scaled up for HIV/AIDS over the past decade. Adverse drug reactions (ADRs) associated with ART pose a unique challenge in the treatment of the infection in this resource-limited setting. The aims of this study were to examine the incidence and nature of ADRs, identify the risk factors associated with the development of ADRs, and assess their impact on treatment outcomes. A prospective cohort study was conducted in adult patients (≥18 years of age) with HIV/AIDS who commenced ART. All ADRs in the first 12 months of therapy were recorded, and the severity, causality, and preventability assessed. The impact of severe ADRs on self-reported adherence, immunological, and body mass index (BMI) outcomes were assessed. Of the 211 patients included in the analysis, 181 (85.7 %) experienced at least one ADR and 66 (31.3 %) experienced at least one severe ADR within 12 months of commencing ART (incidence rates for any ADR and severe ADR of 14.8 and 3.2 per 100 person-months, respectively). Logistic regression analysis indicated that taking zidovudine-containing regimens (odds ratio [OR] 4.2, 95 % confidence interval [CI] 2.1-8.4) or being unemployed (OR 2.2, 95 % CI 1.1-4.3) were independent predictors of experiencing severe ADRs. Patients who experienced a severe ADR were less likely (OR 0.4, 95 % CI 0.2-0.9) to be ≥90 % adherent to ART. The mean gain in BMI was significantly lower in patients with severe ADRs after 3 and 12 months of therapy. ADRs were common within the first 3 months in patients initiated on ART. Severe ADRs were negatively associated with self-reported adherence and gain in BMI. Measures need to be implemented to routinely monitor for severe ADRs to improve ART adherence and treatment outcomes.

Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India.

Purpose:Studies regarding pattern of adverse drug reactions (ADRs) in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions.Materials and Methods:This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO) causality assessment scale and Naranjo's algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively.Results:Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%), nausea/vomiting (21.6%) and febrile neutropenia (13%). Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be “probable” and 35% to be “possible”, while Naranjo's algorithm indicated that 65.6% of ADRs were “probable” and 34.4% were “possible”. Modified Hartwig and Siegel scale showed most reactions (41.4%) to be of “moderate level 4(a)” severity, while 30.6% of reactions were of “mild level 1” severity. About 30.8% of the ADRs were “definitely preventable” according to the modified Schumock and Thornton scale.Conclusion:ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.

Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center

BackgroundIn France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrénées Regional Pharmacovigilance Center (RPVC) set up in July, 2010a Web-based ADR reporting tool in order to improve ADR reporting rate. ObjectivesTo assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports. MethodsIn a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, “seriousness” and nature of ADRs) of online notifications reported to the RPVC between July 7th, 2010 (first online notification) and December 31th, 2011. We performed comparisons to a random sample of “conventional” notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period. ResultsThe total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26days) earlier than “conventional” ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19days with the new tool). In comparison to “conventional” notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for “seriousness” of ADRs. ConclusionsIt is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting period and file processing, which is essential to generate early safety signals.