Cause Of Adverse Drug Reactions Research Articles

Correction to: Adverse drug reaction causality assessment tools for drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: room for improvement.

The correct name of the 9th Author is David J. Margolis. The original article was corrected.

Opioid analgesics are the leading cause of adverse drug reactions in the obstetric population in South Korea.

Medication use during pregnancy is gradually increasing; however, the safety of this practice remains largely unknown.We investigated medications with the most adverse drug reactions (ADRs) among pregnant women and the clinical features of those medications.Reports of ADRs among pregnant women were extracted from the Korea Adverse Events Reporting System (January 2012-December 2015). We analyzed the data of drugs frequently reported to cause ADRs and their clinical features among 3 age groups.A total of 5642 ADRs among 3428 patients were analyzed. The number of ADR reports increased annually. The most common drug categories causing ADRs were analgesics, followed by gynecologic, uterotocolytic, anti-infective, antidiabetic, analgesic, and antihypertensive drugs. Analgesics comprised 6 opioids (morphine, fentanyl, hydromorphone, oxycodone, tramadol, pethidine) and an anti-pyretics (nefopam and ketorolac). As an individual drug, ritodrine (24.4%) was the most frequently reported, followed by morphine, 5-HT3 serotonin antagonist, nefopam, fentanyl, magnesium sulfate, insulin lispro, cefazedone, sodium chloride, hydromorphone, oxycodone, cefotetan, nifedipine, human insulin, tramadol, ketorolac, pethidine, methylergometrine, metoclopramide, and misoprostol (in that order). ADRs most frequently occurred in women aged 25 to 34 years, and the trend of ADR with the 20 most commonly reported medications significantly differed among the age groups (P = .011). In addition, the kind of common causative drugs was different among the age groups.Knowledge of medications and clinical conditions resulting in the highest ADR rates among pregnant women is necessary for medical practitioners to administer proper care.

Prospective monitoring of cutaneous adverse drug reactions in a secondary care hospital, UAE

<p class="abstract"><strong>Background:</strong> Adverse drug reactions (ADRs) are one of the most important causes of morbidity, hospitalization, increased healthcare cost and even mortality. Cutaneous adverse reactions are most commonly documented for drugs. The aim of the study was to monitor the incidence and nature of cutaneous adverse drug reactions (CADRs) in the dermatology outpatients and identify the causative drugs.</p><p class="abstract"><strong>Methods:</strong> A prospective observational study was conducted at the dermatology outpatient department of a secondary care hospital, UAE. All the patients attending dermatology outpatient and satisfying the inclusion criteria were monitored for ADRs. The required data were collected from the patients, their case files, and caretakers and entered in a suitably designed ADR reporting and documentation form. The causality, severity, and preventability of cutaneous ADRs were assessed using Naranjo, WHO, Hartwig and modified Schumock and Thornton scale.<strong></strong></p><p class="abstract"><strong>Results:</strong> The prevalence of cutaneous ADRs was found to be 2.6%. Majority (43.4%) of the cutaneous ADRs were caused by nonsteroidal anti-inflammatory drugs. Majority (56.5%) of the study population reported itching as the most common cutaneous ADR. Also, 60.8% of the reported ADRs were “probable” in nature according to World Health Organization scale, whereas 56.5% reports were “probable” according to Naranjo’s algorithm. Majority (97%) of the ADRs were not preventable.</p><p class="abstract"><strong>Conclusions:</strong> Nonsteroidal anti-inflammatory drugs were the common causes of cutaneous ADRs in the study. Majority of the adverse reactions were mild in nature. The type and nature of cutaneous adverse drug reaction profile documented in this study is almost similar in many ways to other ADRs monitoring studies conducted in dermatology outpatient clinics.</p>

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 comparative evaluation of diclofenac and tramadol as post-operative analgesics along with causality and severity assessment of ADRs

Background: Diclofenac and Tramadol are well established analgesics for post-operative pain management, yet some adverse effects are associated with their use which govern their tolerability. The objective of the study was to evaluate the comparative efficacy of the two drugs and to assess the causality and severity of documented Adverse Drug Reactions (ADRs).Methods: An open labelled, prospective, interventional, simple randomized clinical study to compare efficacy and safety of diclofenac and tramadol was conducted by the Department of Pharmacology in collaboration with the Department of Surgery. Post-operative pain intensity was measured on Visual Analogue Scale (VAS). Causality and severity assessment of the recorded ADRs was done using WHO-UMC scale and modified Hartwig and Seigel Scale respectively.Results: A total of 211 patients underwent different surgeries. The most common surgery performed was mesh hernioplasty 78 (36.96%). VAS score was used as data to determine the analgesic efficacy of two drugs. Wilcoxon Signed Rank test showed significant reduction in pain on all days for each group individually while Mann Whitney U test compared both the groups and revealed that both the drugs i.e. diclofenac and tramadol were equally efficacious in reducing post-operative pain. Causality assessment showed that all the documented ADRs fall in POSSIBLE category while severity assessment revealed that all the ADRs were MILD in nature.Conclusions: Diclofenac and tramadol proved to be equi-effective in reducing post-operative pain . The study also emphasized that active surveillance of ADRs can lead to timely intervention and provide maximum benefit to the patient.

A scrutiny of circulating microRNA biomarkers for drug-induced tubular and glomerular injury in rats

Drug-induced acute kidney injury (AKI) is a frequent cause of adverse drug reaction. Serum creatinine (CRE) and blood urea nitrogen (BUN) are widely used as standard biomarkers for kidney injury; however, the sensitivity and specificity are considered to be low. In recent years, circulating microRNA (miRNAs) have been attracting considerable attention as novel biomarkers for organ injury, but there are currently no established miRNA biomarkers for drug-induced AKI. The present study aimed to identify plasma miRNAs that may enable early and specific detection of drug-induced tubular and glomerular injury through next-generation sequencing analysis. Six-week old male Sprague-Dawley (SD) rats were intravenously administered cisplatin (CSP, 6 mg/kg) and gentamicin (GEN, 120 mg/kg) to induce tubular injury. To create glomerular injury models, puromycin (PUR, 120 mg/kg) and doxorubicin (DOX, 7.5 mg/kg) were intravenously administered, and these models were always accompanied by tubular damage. Small RNA-sequencing was performed to analyze time-dependent changes in the plasma miRNA profiles. The cluster analyses showed that there were distinct plasma miRNA profiles according to the types of injury, and the changes reflected the progress of renal damages. In the differential analysis, miR-3473 was specifically up-regulated in the glomerular injury models. miR-143-3p and miR-122-5p were commonly down-regulated in all models, and the changes were earlier than the traditional biomarkers, such as plasma CRE and BUN. These data indicated that changes in the specific miRNAs in plasma may enable the early and sensitive detection of tubular and glomerular injuries. The present study suggests the potential utility of plasma miRNAs in the early and type-specific detection of drug-induced AKI.

Reported Adverse Drug Reactions During the Use of Corticosteroids in a Tertiary Care Hospital.

Corticosteroids have been used in numerous medical conditions. Studying the pattern and causality of adverse drug reactions (ADRs) helps us gain greater insight into their prevention, detection, assessment, and treatment. This reduces cost of health care and increases compliance. The study aimed to evaluate the ADRs reported in patients receiving corticosteroids for age, type of reaction, duration of steroid therapy, treatment prescribed for the ADR, and causal relationship of the ADR with the prescribed steroid. ADRs observed in the patients admitted to the hospital wards and reported from October 1, 2015, to January 1, 2016, were studied for age, type of reaction, seriousness of the reaction, duration of steroid therapy, and treatment prescribed for the ADR. Causality assessment was done using the WHO-UMC scale. A total of 59 ADRs were reported. More than three-fourths (76.6%) were adults. The gastrointestinal system was the most common organ system affected (45.8%), followed by the cardiovascular system (18.6%). The other ADRs affected the psychiatric, dermatologic, musculoskeletal, endocrine, metabolic, and nervous systems. In addition, 3.4% of the ADRs were serious causing disability and prolongation of hospitalization respectively. More than half (57.4%) of the patients were on long-term steroids. Most (91.5%) of the ADRs showed a possible causal relationship, whereas 6.8% showed a probable causal relationship with the prescribed steroid. The causal relationship of one ADR with the prescribed steroid seemed unlikely. The decision to initiate corticosteroids requires careful consideration of relative risks and benefits in each patient. Strategies such as low-dose and alternate day therapy may reduce the incidence of adverse effects.

Clinical pharmacist assessment in monitoring and resolving the adverse drug reaction in bipolar disorder patients: A prospective, observational study at tertiary care teaching hospital

BACKGROUND: Adverse drug reaction (ADR) is a noxious, unintended effect of the drug which may occur due to pharmacotherapy of the disease. Bipolar disorder is a chronic mental illness represented by mania, depression and cyclic episode. The treatment of Bipolar disorder is lifelong. Hence, there are increased chances of ADRs. METHODOLOGY: An observational, prospective study was performed on 286 patients, to identify, monitor, and resolve the ADR with bipolar disorder patients. The patients aged 18–65 years of either gender or diagnosed with bipolar disorder were enrolled in the study. Patient-related data had been collected from the patient record; probability of ADR was measured by Naranjo scale and severity by Hartwig scale. Descriptive statistics had been used for study data interpretation. RESULTS: A total of 286 patients were enrolled in the study, of which 27 patients suspected with ADR. Among all the ADR, nonallergic side effect suffered ADR were 88.1%. Of which, the most common ADR were hand tremor and hypothyroidism, which were associated with lithium (81.4%) followed by valproate (11.1%). On causality assessment, 44.4% cases were probable and possible. In most cases, severity of ADR was founded at Level III with 74.7% and Level II with 25.9%. The rate of acceptance of pharmacist intervention by a psychiatrist has been found to be 74.7%. The major cause of ADR was a drug/dose selection (74.07%). CONCLUSION: ADRs occur most frequently in bipolar disorder. The incidence of drug-related noxious effect can be minimized by the prior identification, monitoring, and reporting. Thus, the clinical pharmacist can play a key role in pharmacovigilance of ADR.

The Basics of Antithrombotic Medications

Drugs used to treat or prevent thromboembolic disease are a common cause of adverse drug reactions in older adults. The purpose of this review is to provide rehabilitation professionals working with older adults with an understanding of the basics of antithrombotic drug therapy. By gaining familiarity with hemostasis and mechanisms of action of common drugs, therapists can more easily understand the adverse effects of these medications, how patients are monitored, and how drugs are reversed. Most importantly, this review provides readers with insight into the impact of these drugs on clinical decision-making in the rehabilitation of older adults.

A prospective study on causality assessment rating, mortality rate, and case fatality rate for adverse drug reactions among medical inpatients at the University of Benin Teaching Hospital, Nigeria

Background: An adverse drug reaction (ADR) is a special form of adverse drug event (ADE) in which a causative relationship can be shown or established and is attributable to the offending/precipitating medication. ADR causality assessment is used to determine the likelihood that a particular drug caused a suspected ADR. Causality assessment rating evaluates the relationship between drug treatment and the occurrence of an ADE. It is also used to evaluate, check, confirm, and ascertain that the particular treatment is the cause of an observed adverse event or not. Aim: This study was designed to evaluate the causality assessment rating, mortality rate, and case fatality rate for ADRs among adult medical inpatients in clinical practice setting with the goal of preventing them and improving their treatment outcome. Methods: The patients admitted to the adult medical wards of a Nigerian University Teaching Hospital over 9 months from December 2013 to August 2014 were prospectively recruited for the study and followed up till discharge. Results: Five hundred and seven patients were evaluated during the study, of which 269 (53.1%) of them were male and 238 (46.9%) were female. The mean age of the study population was 48.9 ± 17.8 years (median of 46 years). In this study, the causality assessment rating for the observed ADRs was evaluated using both the World Health Organization (WHO) causality rating criteria and the Naranjo algorithm. Using the WHO causality rating criteria, certain cases were 10 (19.6%), probable cases were 17 (33.3%), and possible cases were 24 (47.1%). Using the Naranjo algorithm, definite cases were 9 (17.6%), probable cases were 19 (37.3%), and possible cases were 23 (45.1%). The number of patients admitted solely because of ADRs (ADR-out) was 18 (3.6%) patients, whereas those that experienced ADRs during admission (ADR-in) stood at 33 (6.5%) patients. Furthermore, the case fatality rate for ADRs was 7.8% (4/51), while the ADR-associated overall mortality rate was 0.8% (4/507). Conclusion: In this study, the two methods used to ascertain causality rate for ADRs caused by a suspected drug; both the WHO causality rating criteria and Naranjo algorithm, showed similar causality ratings, which strengthening the ascribed ADR causality rating. In addition, the mortality rate and case fatality rate for ADRs were significantly high among these adult medical inpatients.

Evaluation of adverse drug reactions in dermatology department of a charitable hospital in India

Background: Adverse drug reactions (ADRs) can be confined to either skin or be a part of systemic reaction such as drug hypersensitivity syndrome or toxic epidermal necrolysis. Objective: The objective is to evaluate the incidence, causality, severity, preventability, and risk factors of ADRs in the dermatology department of a charitable hospital in India. Patients and Methods: A prospective observational study was carried out over a period of 8 months in the dermatology department. The WHO and Naranjo's scales evaluated the suspected ADRs for causality assessment, severity by Hartwig and Siegel Scale, and preventability by modified Schumock and Thornton Scale. Results: A total number of 200 eligible patients were enrolled in the study. Out of 200, 18 patients developed ADRs. The incidence of dermatological ADRs in the study was 9%. The most commonly manifested ADRs were Stevens–Johnson syndrome (SJS) (22.2%) followed by skin rashes (16.7%) and others. The maximum number of ADRs were observed with antibiotics (33.5%), followed by antiepileptic drugs (16.7%) and nonsteroidal anti-inflammatory drugs (NSAIDs) (16.7%). According to the WHO and Naranjo's scales, most of the reactions were probable with 61.1% and 55.6%, respectively. Most of the ADRs were moderately severe (66.6%) and were not preventable (55.6%). Conclusions: SJS and rashes were the most commonly observed clinical pattern of ADRs. The most common drug class responsible for ADRs was antibiotics, followed by antiepileptic drug and NSAID's. Dermatological ADRs varied in their causality, severity, and preventability.

Anaphylaxis to Ceftriaxone – Evaluation of Two Cases

Allergic reactions to beta-lactamase antibiotics are the most common cause of adverse drug reactions mediated by specific immunological mechanism. Anaphylaxis is diagnosed clinically. In two of our cases, patients developed acute respiratory distress syndrome (ARDS) secondary to anaphylaxis, which was however managed successfully without residual deficits.

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

Background: Treatment of tuberculosis involves giving multiple drugs to the patient which is done to prevent development of resistance besides targeting all bacterial sub-populations. The objective of the present study was to find out the adverse drug reactions (ADRs) of the first line anti-tubercular drugs and to calculate prevalence and causality of these drugs.Methods: The study was conducted by the Department of Pharmacology, Government Medical College, Srinagar in association with the department of Chest medicine. All patients of tuberculosis on directly observed treatment-short course (DOTS) of either sex or age group were enrolled. An assessment of the causality and allocation of ADRs was done using Naranjo’s monitoring scale and WHO-UMC scale.Results: A total of 57 ADRs with 13 different types were observed in 164 patients, with an overall prevalence of about 34.7%. Thirty seven (64.9%) ADRs were categorized as having a ‘probable’ causal relationship while 17 (29.8%) was categorized as ‘possible’ as per the Naranjo’s scale. As per the WHO-UMC monitoring scale fifty two (91.2%) were categorized as ‘possible’ while three (5.3%) were categorized as ‘certain’.Conclusions: Occurrence of ADRs generally results in non-adherance. Timely detection of ADRs through an effective pharmacovigilance programme is the need of hour. The establishment of an active pharmacovigilance centre which was set up in our institution has paved the way to improve the quality of patient care by ensuring safer use of drugs and has helped us to identify and report the various ADR’s encountered.

A pharmacovigilance study of antiretroviral therapy in HIV positive out patients at a tertiary care teaching hospital

Background: Anti-Retroviral Therapy regimen (ART) is the only treatment option for treating the HIV positive patients for improving the immune system by increasing the CD4 cells. But eventually these medications lead to development of some Adverse Drug Reactions (ADRs) in seropositive patients under treatment.Methods: A prospective observational study was conducted for 6 months from March to August 2018 at ART Centre, Sri Venkateswara Ramnarayan Ruya Government General Hospital (SVRRGGH), Tirupati.Results: Out of 216 ADRs identified, majority where identified in females (54.35%). Most common regimen caused ADR was tenofovir+ lamivudine+ efavirenz (TLE) (55.55%). Data were analysed using the chi-square test were P-value was found to be 0.0024. Majority of ADRs were found in patients of age group between 31-35years was found to be 45 (20.83%) followed by age group between 41-45years was found to be 40 (18.51%). Most of the ADRs were related to central nervous system (27.31%) followed by metabolic disorders (26.38%), hematologic system (23.14%), gastrointestinal system (12.96%), dermatologic system (9.25%), renal system (0.46%) and musculoskeletal system (0.46%). On evaluation of WHO-UMC causality of ADRs, majority were found to be possible (78.7%). The Hartwig and Siegel’s severity assessment scale showed that most of the ADRs were mild (64.42%). The Schumock and Thornton preventability scale showed that 50.92% patients ADRs were probably preventable.Conclusions: As most of the ADRs were observed in patients receiving TLE regimen. So, patients receiving TLE regimen need intensive monitoring. Doctors, nurses, pharmacist must focus on early detection and prevention of ADRs, based on their severity.

HYPERSENSITIVITY REACTION TO AMOXICILLIN-CLAVULANATE: EENY, MEENY, MINY, MOE, CATCH A REACTION BY THE SS-LACTAMASE INHIBIT…OH!

Introduction β -lactams remain the most frequently reported cause of adverse drug reactions. Isolated adverse drug reactions to Clavulanate, a β -lactamase inhibitor added to Amoxicillin to form amoxicillin-clavulanate, remain rarer. Case Description A 62-year-old male heart transplant candidate due to complicated coronary artery disease presented with a previous anaphylactic reaction secondary to amoxicillin-clavulanate for a sinus infection. Skin testing to penicillin G, penicilloate, benzylpenicilloyl polylysine and amoxicillin was negative, followed by a negative oral provocation test to amoxicillin. At a subsequent visit, the patient had negative skin testing to non-irritant concentrations of amoxicillin-clavulanate (20 mg/ml) and ampicillin-sulbactam (20 mg/ml). Clavulanate without amoxicillin was not available for testing. However, upon oral challenge with full-dose amoxicillin-clavulanate, he developed urticaria on his upper back, left upper extremity (Figure 1) and chest and experienced bilateral hand flushing that resolved over the course of two hours with the administration of IM diphenhydramine, fexofenadine and montelukast. The patient was counseled to avoid all forms of β -lactamase inhibitors and use equally efficacious alternatives. Discussion While IgE-mediated hypersensitivity reactions to penicillin are more common, IgE-mediated hypersensitivity reactions to β-lactamase inhibitors, including clavulanate, sulbactam, and tazobactam in isolation, have been reported. This case depicts an isolated β-lactamase inhibitor IgE-mediated reaction in the setting of previously negative skin testing. β -lactams remain the most frequently reported cause of adverse drug reactions. Isolated adverse drug reactions to Clavulanate, a β -lactamase inhibitor added to Amoxicillin to form amoxicillin-clavulanate, remain rarer. A 62-year-old male heart transplant candidate due to complicated coronary artery disease presented with a previous anaphylactic reaction secondary to amoxicillin-clavulanate for a sinus infection. Skin testing to penicillin G, penicilloate, benzylpenicilloyl polylysine and amoxicillin was negative, followed by a negative oral provocation test to amoxicillin. At a subsequent visit, the patient had negative skin testing to non-irritant concentrations of amoxicillin-clavulanate (20 mg/ml) and ampicillin-sulbactam (20 mg/ml). Clavulanate without amoxicillin was not available for testing. However, upon oral challenge with full-dose amoxicillin-clavulanate, he developed urticaria on his upper back, left upper extremity (Figure 1) and chest and experienced bilateral hand flushing that resolved over the course of two hours with the administration of IM diphenhydramine, fexofenadine and montelukast. The patient was counseled to avoid all forms of β -lactamase inhibitors and use equally efficacious alternatives. While IgE-mediated hypersensitivity reactions to penicillin are more common, IgE-mediated hypersensitivity reactions to β-lactamase inhibitors, including clavulanate, sulbactam, and tazobactam in isolation, have been reported. This case depicts an isolated β-lactamase inhibitor IgE-mediated reaction in the setting of previously negative skin testing.

THE STUDY OF PREVALENCE OF HYPERSENSITIVITY TO Β-LACTAM ANTIBIOTICS AMONG THE POPULATION OF UKRAINE

This article is a part of research project of Ukrainian Medical Stomatological Academy “The Study of the Prevalence of Hypersensitivity to β-Lactam Antibiotics among the Ukrainian Population”, state registration No. 0116U004377.
 Allergic reactions to β-lactam antibiotics are the most common cause of adverse drug reactions, mediated by specific immunological mechanisms. The aim of this research was to determine the prevalence of hypersensitivity to β-lactam antibiotics among the population, by examining anamnestic data and conducting allergological examination to increase the safety of antibiotic therapy and improve the pharmacoeconomic profile of treatment.

Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients.

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries.

Prospective identification versus administrative coding of adverse drug reaction‐related hospitalizations in the elderly: A comparative analysis

To compare prospective identification of adverse drug reaction (ADR)-related hospital admissions in the elderly with administrative coding using the International Classification of Diseases 10th Revision Australian Modification (ICD-10-AM) coding system. We linked the records of 768 enrolled patients from an earlier study, where clinical pharmacists identified ADRs using prospective data collection, to hospital administrative data. We identified patients in the study whose admissions were coded as ADRs using ICD-10-AM codes. We then compared the prevalence and characteristics of ADR-related hospital admissions identified by the two approaches. According to ICD-10-AM coding, 2.7% of patients were admitted due to ADRs, while 15.0% of patients were deemed to have been admitted due to ADRs based on prospective identification by clinical pharmacists. Most (85.7%) patients coded as having an ADR-related hospital admission were also identified as such prospectively. Hematological (23.1%) and metabolic reactions (23.1%) were frequent causes of ADRs identified by coding, whereas cardiovascular ADRs (27.8%) were more common causes of ADRs identified prospectively by pharmacists. Antidepressants (16.7%) and cardiac glycosides (16.7%) were the most commonly implicated drug groups in ADRs identified by coding, whereas diuretics (28.8%) and renin-angiotensin system inhibitors (17.0%) were frequently implicated as causes of ADRs identified prospectively by pharmacists. Reliance on administrative coding potentially underestimates the extent of the problem of ADRs as a cause of hospitalization in the elderly, and more detailed prospective analysis of admissions provides additional targets for strategies to prevent ADRs. The types of ADRs identified also differ between the two approaches.

Analysis of drug related electrolyte disturbances in emergency medicine department

Background: Electrolytes play an important role in various physiological functions of the body. Electrolyte disturbances are one of the most common problems encountered in critically ill patients. Drugs are also known to cause adverse electrolyte consequences. These drugs could be anti-hypertensive agents, hormones, antipsychotics or steroids. There is paucity of published literature on electrolyte disturbances caused by drugs. The purpose of our study was to evaluate the electrolyte disturbances caused by various drugs in critically ill patients.Methods: Following approval of the Institutional Ethics Committee, data collection was started. Adverse Drug Reactions (ADRs) presenting as an electrolyte disturbance in emergency medicine department or occurring in hospitalized patients in the Intensive care unit (ICU) of our hospital was be collected. ADRs resulting into electrolyte disturbances were identified and analysed in detail for demographic details, types of electrolyte disturbances, seriousness, severity, causality and preventability of ADRs. Fisher's exact test was done to find out the statistical difference between the electrolyte disturbances and different drugs.Results: Total 58 ADRs were reported as an electrolyte disturbance. Mean age of the patients affected was 52.48 years. Highest number of ADRs were observed in the age group of 61 to 70 years. Hypokalemia constituted 32 cases (55.2%) followed by hyponatremia (25.9%), hyperkalemia (6.9%), hypernatremia (6.9%), hypocalcemia (1.7%), hypomagnesemia (1.7%) and hypophosphatemia (1.7%). Insulin was associated with maximum cases of ADRs (27.6%).Conclusions: Electrolyte disturbances constitutes a major chunk of ADRs especially in critically ill patients. The physicians must be well-versed with the dynamics of fluid-electrolyte balance.

Study of Adverse Drug Effects of Direct-Acting Antivirals for Chronic HCV Infection at Fayoum Governorate, Egypt - A Pharmacovigilance Study.

Different combinations of Direct Antiviral Agents (DAAs) have been used against different Hepatitis C Virus (HCV) genotypes and in different types of patients. Despite being effective and characterized by a very low rate of adverse effects in clinical trials, few data are available on adverse events in real life studies. The aim of this study was to identify the incidence and pattern of Adverse Drug Reactions (ADRs) caused by DAAs; daclatasvir and sofosbuvir and their combination with ribavirin and to assess the causality and the severity of the reported ADRs. A prospective observational study was conducted over six months at treatment HCV center of Health Insurance Hospital in Fayoum Governorate, Egypt. A pre-tested, interviewed structured questionnaire was used by authors to gather required data from 345 enrolled patients regarding demographics, co-morbidity and ADRs. Causality and severity of ADRs were assessed. According to our data. we have found that 75.7% (261out of 345) patients reported 36 different ADRs involving different systems, of these 1.2% experienced Serious Adverse Events (SAEs), including three deaths (0.9%). A majority of ADRs were more significantly reported with ribavirin-containing regimen. Out of 345 patients, 23.5% have comorbidities. Among them, 92.6% reported ADRs. Causality assessment of ADRs by WHO-UMC criteria revealed that 38.89% were probable while 61.11% were possible. New antiviral drugs require careful follow-up of any significant adverse event that may occur and can affect adherence. Special population as the elderly and those with comorbidities should always be managed with caution to avoid development of serious side effects.