Definition Of Adverse Drug Reactions Research Articles

Predictors of hospital-acquired adverse drug reactions: a cohort of Ugandan older adults

BackgroundGlobally, it is estimated that the number of older adults will become 2 billion by 2050. The identification of the predictors of adverse drug reaction (ADR) in hospitalized older patients is crucial to the development of prediction tools and preventive strategies to mitigate the burden of ADRs. This study aimed to determine the predictors of hospital-acquired ADR occurrence among hospitalized older adults in a low-income country.MethodsWe conducted a prospective cohort of older adults admitted to medical, oncology, and surgery wards at Mbarara Regional Referral Hospital (MRRH) for a consecutive 6 months where each patient was followed up daily from admission to discharge. We used Edwards and Aronson’s definition of ADR and the Naranjo ADR Causality Scale. We employed Beer’s criteria and Lexicomp to determine potentially inappropriate medications, and drug interactions, respectively. We conducted univariate and multivariable logistic regression using Statistical Package for the Social Science (SPSS) Version 23.0.ResultsOut of 523 participants with median (Inter Quartile Range) age of 67 (62–76) years, 256 (48.9%) experienced at least one ADR. Independent predictors of occurrence of hospital acquired ADRs included age of 60–75 (Adjusted odds ratio (AOR) = 1.97, 95% C.I: 1.14–3.41; p value = 0.015) compared to > 75 years, previous ADR in 1 year (AOR = 2.43, 95% C.I: 1.42–4.17; p value = 0.001), potentially inappropriate medication (AOR = 4.56, 95% C.I: 2.70–7.70; p value< 0.001), polypharmacy (AOR = 3.29, 95% C.I: 1.98–5.46; p value< 0.001)), having a Charlison Comorbidity Index (CCI) ≥ 6 (AOR = 8.47, 95% C.I: 4.85–14.99; p value< 0.001), having heart failure (AOR = 2.83, 95% C.I: 1.34–6.02; p value = 0.007) or kidney disease (AOR = 1.95, 95% C.I: 1.05–3.61; p value = 0.034) and a hospital stay > 10 days (AOR = 3.53, 95% C.I: 1.89–6.61; p value< 0.001) compared to < 5 days.ConclusionThe current prevalence of ADR is higher than previously reported in high-income countries. Disease-related factors followed by medication-related factors were shown to be the most important predictors of hospital-acquired ADRs. CCI and PIM showed the strongest association with ADR. The predictors of ADRs identified in our study were generally comparable with those reported by previous studies.Plain language titleConditions that predispose older patients to experience harmful effects from their medications while in hospital.Plain language summaryIdentifying the conditions that predispose older adults to incur harmful effects of their medications helps to plan on how best to predict, take precautions and closely follow up on them and thus, to prevent these undesirable outcomes. This study aimed to identify these conditions which determine which older adults are higher risk to incur these harmful undesirable effects of medicines. Everydayduring their hospital stay, we closely followed older patients who were 60 years and above from their entry to the hospital wards until they left the hospital. We interviewed the participants, reviewed their medication files and we also examined them physically to identify any unwanted and harmful outcome from their current medications. Out of 523 participants, almost half of them experienced at least one harmful or undesired effect related to their medicine. Conditions which predisposed them to experience a harmful effect from their medicines included being in age bracket of 60–75 years, having a history of experiencing harmful outcomes from medicines in the previous 1 year, taking a medication which was listed as potentially inappropriate for older adults, taking 5 or more medications concurrently, having a lower 10 years survival chance, having heart or kidney disease and a hospital stay > 10 days.

Prevalence, Incidence, and Characteristics of Adverse Drug Reactions Among Older Adults Hospitalized at Mbarara Regional Referral Hospital, Uganda: A Prospective Cohort Study.

BackgroundAdverse drug reactions (ADRs) are associated with significant clinical and economic effects. Among the elderly population, the risk for ADRs is even higher. Data of ADR prevalence and incidence among the elderly population in Uganda and many low- and middle-income countries are lacking.ObjectiveThis study determined the prevalence, incidence, and characteristics of ADRs among hospitalized elderly patients at Mbarara Regional Referral Hospital (MRRH), Uganda.Methods and MaterialsWe conducted a prospective cohort of older adults admitted to medical, oncology, and surgery wards at MRRH for consecutive 6 months. The primary data were obtained by interviewing patients and caregivers and reviewing patient medication charts, taking vital signs, and physical examinations. We used Edwards and Aronson’s definition of ADR and the Naranjo ADR Causality Scale. We conducted descriptive statistics and the Kolmogorov–Smirnov test using SPSS Version 23.0.ResultsWe studied a total of 523 older adults 60 to 103 years of age. During their hospital stay, 256 (48.9%) of the patients experienced at least one ADR. A total of 365 ADRs were identified during 4702 person-days of follow-up. The incidence of ADRs was 78 ADRs/1000 person-days. ADRs affecting the gastrointestinal tract were the most frequently (40.6%) identified categories. Probable and type A ADRs accounted for 260 (71.2%) and 305 (83.6%) of the total incidents, respectively. Overall, 237 (64.9%) of the ADRs were rated as mild, whereas 10 (2.8%) of them as severe. Lastly, 165 (45.2%) of the ADRs were categorized as preventable.ConclusionAlmost half of the hospitalized patients aged 60 to 103 years experienced at least one ADR during their hospital stay, which is higher than has been previously documented. Almost three-thirds of the ADRs were probable, about 4 out of 5 were type A and almost two-thirds were mild. Nearly half of the ADRs were preventable.

Pharmacovigilance in Ayurveda

Aim: To review the intrinsic tenants available for safe drug usage in Ayurveda and to contextualize the statistical signal detection techniques of current times in terms of Ayurvedic pharmacovigilance program. Materials and methods: Streamlining the information to develop a database that differentiates between known adverse drug reactions (ADRs) from hitherto unknown drug reactions per the standard definition of ADR. To introduce amicable statistical methods viz., Chi-square test, odds ratio (OR), and logistic regression for signal detection. Results and conclusion: The proposed method of developing a known ADR and safe drug usage practices described in Ayurveda that followed the application of standard operating procedures for signal detection as per the pharmacovigilance program by applying statistical methods suggested will ensure pragmatic signal detection.

Highly Active Antiretroviral Therapy Induced Hematological and Dermatological Adverse Drug Reactions in People Living with HIV in India

Introduction: In India, HIV patients are at a high risk of developing hematological and dermatological adverse drug reactions (ADRs) leading to financial burden. Materials and Methods: A prospective observational study was conducted on hematological and dermatological ADRs in a South Indian teaching hospital from October 2011 to October 2012. The definition of ADRs established by the World Health Organization (WHO) was used to assess the causality. Predictability of ADRs was assessed by Micromedex database. Preventability of ADRs was assessed using the Schumock and Thornton criteria. Results: A total of 174 HIV patients were enrolled [133 (76.4%) males and 41 (23.6%) females], who reported 99 ADRs to HAART. Of the total ADRs, 70 (70.7%) were reported in males and 29 (29.3%) in females, indicating significantly higher reporting of ADRs in males. 67 of the 99 ADRs were hematological, while the remaining 32 were dermatological. A high number of hematological [40 (59.6%)] and dermatological [15 (46.8%)] ADRs were reported for zidovudine + lamivudine + nevirapine-based HAART regimen. In most of the reported ADRs, the suspected drug was withdrawn. The reported hematological ADRs were as follows: 1) anemia with zidovudine [35 (52.2%)]; 2) pancytopenia with zidovudine [20 (29.9%)]; 3) neutropenia with lamivudine; and 4) leucopenia, bicytopenia, and eosinophilia with zidovudine. Dermatological ADRs were maculopapular rash [7 (21.8%)] with nevirapine-, tenofovir + emtricitabine + efavirenz. Conclusion: Hematological ADRs was higher than that of dermatological ADRs. Physicians must focus on routine monitoring of all possible risk factors in PLW-HIV for early prevention of hematological and dermatological ADRs to HAART.

Lack of Awareness of Pharmacovigilance among Young Health-care Professionals in India: An Issue Requiring Urgent Intervention.

Background:Young healthcare professionals (HCPs) are the pillar of healthcare system. The objective of the present study was to assess the knowledge, attitude, and practices of young HCPs regarding adverse drug reactions (ADRs) reporting.Methods:This cross-sectional questionnaire-based study was conducted on young HCPs in a tertiary care teaching hospital of North India. The study instrument was semi-structured, prevalidated questionnaire. The responses obtained were compared among doctors and nursing professionals.Results:We obtained response from 84 HCPs (61 doctors and 23 nurses). The mean age of the doctors and nurses was 25.0 ± 2.4 versus 26.3 ± 3.4 years, respectively. No significant difference was observed in questions related to definition of ADR, components of pharmacovigilance (PV), who can report ADRs and medications for which ADRs are to be reported. Only 9.8% doctors and 26.1% nurses were aware of ADR reporting system in India, of which 6 (26%) nurses and none of the doctors were aware of its name. About 16.4% doctors as compared to 61% nurses admitted to have reported an ADR (P < 0.001). The main discouraging factor in ADR reporting was time constraint while lack of knowledge was also highlighted by the HCPs. More nurses as compared to doctors (78.3% vs. 49.2%, P = 0.01) were of the opinion that holding continuing medical education/workshop could encourage reporting.Conclusion:There is an urgent need to increase awareness about PV among young HCPs, and adequate interventions should be instituted to encourage PV practices.

Knowledge, attitude and practice towards pharmacovigilance among postgraduate medical students at a tertiary care hospital: a cross sectional questionnaire based study

Background: Adverse drug reaction (ADR) is major global health problem affecting both children and adults. ADRs are among the leading cause of mortality and morbidity leading to prolonged hospitalization. Hence, spontaneous reporting of ADRs by healthcare professionals forms the backbone of pharmacovigilance. Therefore, there is an urgent need for sensitization about drug safety monitoring among healthcare professionals (HCPs).Methods: A cross sectional questionnaire based study was conducted among 200 postgraduate medical students between April 2016 and May 2016 using a pre-validated questionnaire. Descriptive statistics was used for analysis.Results: Among 200 questionnaires distributed, only 150 provided responses reflecting a response rate of 75%. The postgraduates who understood the definition of adverse drug reaction and pharmacovigilance were 90% and 64% respectively. The most encouraging finding was 97% of postgraduates thought that reporting an ADR was necessary which in turn increases the patient safety. 60% postgraduates were unaware that the nurses and pharmacists also had the responsibility of reporting ADR. The postgraduates who encountered ADRs during clinical practice were 79% whereas reporting was only 2%.Conclusions: This study suggests that even though majority of postgraduates have better knowledge and attitude towards pharmacovigilance and ADR, the practice of reporting ADRs is inadequate. Therefore, there is an urgent need for educational intervention in the form of training programmes and continued medical education (CME) periodically to encourage ADR reporting among the postgraduates.

Attitude, knowledge and experience of hospital pharmacists with pharmacovigilance in a region in Saudi Arabia: a cross-sectional study

Purpose: To assess hospital pharmacists’ knowledge of, attitude to, and experience with pharmacovigilance and adverse drug reactions (ADRs) in Al Madinah Al Munawarah region, Saudi Arabia. Methods: A cross-sectional study was conducted from April – June 2015 among hospital pharmacists using a self-administered questionnaire. All pharmacists working in government hospitals and primary care centers in Al Madinah Al Munawarah region were targeted to participate in the study. A total of 130 pharmacists were included in the study. Data analysis was conducted using the Statistical Package for Social Sciences, version 20. Results: The response rate to the survey was 79 % out of 103 pharmacists. In terms of knowledge about pharmacovigilance, only 56 (54.4 %) correctly identified WHO definition of ADRs, while 53 (51.5 %) of the pharmacists correctly defined pharmacovigilance. Regarding pharmacists’ experience with ADR reporting, less than half (N = 46, 44.7 %) said they have made a suspected ADR report and slightly less than half of the pharmacists (50, 48.5 %) said they are familiar with Saudi Food and Drug Authority (SFDA) system of suspected ADR reporting. The majority of the pharmacists (N = 95, 92.2 %) believed that patient safety is the most important goal of suspected ADR reporting. The most common barrier to ADR reporting was lack of pharmacovigilance training (N = 48, 46.6 %). Conclusion: Pharmacists had insufficient knowledge of, but positive attitude toward pharmacovigilance and ADR reporting. Lack of pharmacovigilance training has been identified as the major barrier to ADR reporting. Keywords: Hospital pharmacists, Pharmacovigilance, Adverse drug reactions (ADRs), Attitude, Knowledge

PHP121 - EVALUATION OF ADVERSE DRUG REACTIONS IN A HOSPITAL IN SOUTHERN TAIWAN

According to the definition of adverse drug reaction (ADR): “An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the produtct.” Data collection and analysis from our hospital, which can provide healthcare professionals as a reference in clinical practice. This study is a retrospective investigation of ADRs enrolled in our hospital in southern Taiwan in 2015. Assessment of ADRs contains that occurring sources, gender and age, Anatomical Therapeutic Chemical (ATC) classification of suspected drugs, types of adverse reactions, Naranjo score calculating by Naranjo Adverse Drug Reaction Probability Scale, and so on. The study included one hundred and eight ADRs. Most of ADRs were occurring in outpatient department (94%). The average age of ADRs was 65.2 years. Less than 65 years of age were in the majority in this study (58%). Majority of all were females (54%). On the basis of ATC classification system, the major categories of suspected drugs were Cardiovascular system (19%). The major type of adverse reactions was Dermatologic Effects (35%). Besides, the major Naranjo scores of all ADRs ranged from 1 to 4 points (98%), a possible correlation between ADRs and suspected drugs. To date the safe use of medicines is still a critical issue for healthcare professionals and the public. The purpose of ADRs reporting, not only to prevent from delivering the same or similar medicines to patients, but also to improve the safety of medication use. Prescribers aim to use medicines that aid patients and do no harm, but no drugs is administered without risk. Therefore, healthcare professionals have a responsibility to their patients, who themselves are becoming more aware of problems associated with drug therapy.

Frequency, types, severity, preventability and costs of Adverse Drug Reactions at a tertiary care hospital

IntroductionHospital-based adverse drug reaction (ADR) monitoring and reporting studies are conducted to identify, quantify and minimize such risks associated with the use of drugs particularly on long-term basis. Kashmir province of Indian state of Jammu and Kashmir presents a huge market for medicines that runs into millions of rupees. Yet there was no provision to monitor these drugs for their adverse effects prior to this study in any of the leading hospitals of the province. As such the present study, which was first of its kind in the valley, was undertaken to assess the frequency, preventability, category, severity, causality, extension of hospital stay and costs of drug-related adverse effects in Kashmiri patients at a Srinagar-based tertiary care hospital. MethodsA prospective, observational, cohort study on 5482 patients was undertaken over a 270day period. Adult patients admitted in Internal Medicine in-patient department (IPD), presenting to the Internal Medicine out-patient department (OPD) and those visiting the Accident and Emergency Department of the study hospital were included in the study. Patients belonging to both the sexes were screened and monitored on a daily basis for the occurrence of any ADRs. Definition of ADR given by the World Health Organization (WHO) was used and causality of suspected ADRs was determined using Naranjo's algorithm whereas severity was assessed using modified Hartwig's scale and preventability was determined using Hallas methodology. Costs of ADRs and extension in hospital stay were calculated as per Lagnaou and Nicholas methodology respectively. ResultsADRs accounted for 6.23% of adult Kashmiri patients visiting the tertiary care hospital under study, either for referral or hospitalization, with the majority (81.57%) of these ADRs being preventable; 23.68% of patients had mild ADRs, 69.29% had ADRs of moderate severity, and 7.01% had severe ADRs. Four classes of drugs most frequently suspected in admissions due to ADRs were anti-infective agents (40.92%) including anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%), and NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9-month period in the internal medicine IPD was found to be USD 22469 at the time of this study. Discussion/conclusionThe present work is the maiden pharmacovigilance study conducted on Kashmiri patients, especially at a tertiary care teaching hospital that has provided baseline information about the prevalence of ADRs and their distribution among different age groups, genders, organ systems affected, and therapeutic classes of medicines. The data collected will be useful for long term and more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies toward the rational use of drugs. This study led to the establishment of a full-fledged pharmacovigilance centre and initiation of pharmaceutical care services in the study hospital.

Causality Assessment of Possible Adverse Drug Reactions in Clinical Trials: An Analysis of Factors Associated with Decision Making by Clinical Investigators in Japan

Introduction Practical difficulties in causality assessment for possible adverse drug reactions (ADRs) are a major source of uncertainty in clinical development, leading to different interpretations and handling procedures of ADRs across regions, in spite of the recent harmonized definition of ADRs. This study focused on how clinical investigators assess causality for adverse events (AEs) observed in clinical trials.

Ophthalmic adverse drug reactions to systemic drugs: a systematic review

To perform a comprehensive and systematic review regarding ophthalmic adverse drug reactions (ADRs) to systemic drugs to: (i) systematically summarize existing evidence, (ii) identify areas, ophthalmic ADRs or drugs that lacked systematization or assessment (namely drugs with original studies characterizing specific ophthalmic ADRs but without causality assessment nor without meta-analysis). Systematic review of several electronic databases (last search 1/7/2012): Medline, SCOPUS, ISI web of knowledge, ISI Conference Proceedings, International Pharmaceutical Abstracts and Google scholar. Search query included: eye, ocular, ophthalmic, ophthalmology, adverse and reaction. Inclusion criteria were: (i) Primary purpose was to assess an ophthalmic ADR to a systemic medication; (ii) Patient evaluation performed by an ophthalmologist; (iii) Studies that specified diagnostic criteria for an ocular ADR. Different types of studies were included and analyzed separately. Two independent reviewers assessed eligibility criteria, extracted data and evaluated risk of bias. From 562 studies found, 32 were included (1 systematic review to sildenafil, 11 narrative reviews, 1 trial, 1 prospective study, 6 transversal studies, 6 spontaneous reports and 6 case series). Drugs frequently involved included amiodarone, sildenafil, hydroxychloroquine and biphosphonates. Frequent ophthalmic ADRs included: keratopathy, dry eye and retinopathy. To increase evidence about ophthalmic ADRs, there is a need for performing specific systematic reviews, applying strictly the World Health Organization's (WHO) definition of ADR and WHO causality assessment of ADRs. Some ophthalmic ADRs may be frequent, but require ophthalmological examination; therefore, ophthalmologists' education and protocols of collaboration between other specialties whenever they prescribe high-risk drugs are suggestions for the future.

A Pharmacovigilance Study Using Tracer Techniques

Objective: To identify adverse drug reactions by using a comprehensive trigger tool method. To categorize the identified adverse drug reactions based upon their Probability, Severity, Harm and Preventability by using different scales. Methods: A single-center, Cross-sectional, observational study based on medication and laboratory trigger tool methodology was conducted over a period of six months. The World Health Organization definition of adverse drug reactions was adopted. A list of 17 triggers were used to trace the adverse drug reactions which were then analyzed to assess the causality by using Naranjo’s scale, severity by Hartwig and Siegel scale, and harm by the National Coordinating Council for Medication Error Reporting and Preventing Index and preventability by Modified Schumock and Thornton scale. Results: A total of 100 suspected ADRs were collected and analyzed. The drug classes most commonly implicated with ADRs were cephalosporins (25%) followed by anti-diabetic agents (19%). According to Naranjo’s scale, the reactions were categorized as probable (80%), possible (10%) and definite (5%). According to the modified Schumock and Thornton preventability scale, 20 cases (20%) were possibly preventable while 80 cases (80%) were not preventable. In 85 cases (85%) the suspected drug was withdrawn while in 10 cases (10%) no change in dose was made and in 5 cases (5%) the dose was altered. Conclusion: Pharmacovigilance using tracer techniques significantly increases the identification and reporting of ADRs. The tracer technique is relatively simple, sensitive, less expensive and largely effective compared to traditional methods. The Trigger tool provides an additional instrument in improving patient safety. This technique leads to an increase in awareness and reporting of ADRs and provide opportunities for the health care system to review drug selection and prescribing practices affecting patient outcomes.

Pattern Of Use Of Highly Active Antiretroviral Therapy Regimens And Pattern Of Occurrence Of Adverse Drug Reactions In An Indian Human Immunodeficiency Virus Positive Patients.

ABSTRACT Background: In India, Human immunodeficiency (HIV) infected patients with highly active antiretroviral therapy (HAART) are at higher risk of developing adverse drug reactions (ADRs). Objectives: The aim of this study was to characterize the pattern of use of HAART, occurrence, incidence, severity and causality of ADRs to HAART in Indian HIV positive patients. Methods: This was a prospective observational study conducted between August 2009 and May 2012. Enrolled HIV positive patients were intensively monitored for ADRs with fixed dose antiretroviral therapy as per National AIDS Control organization (NACO).World Health Organization (WHO) definition of ADR was adopted to detect ADRs to HAART and classified based on WHO adverse reaction terminologies. Naranjo’s scale was used for causality assessment of ADRs. Preventability was assessed using Thornton and Schuman criteria and severity was assessed using the modified Hart wig and Siegel scale. Pattern of ADRs was assessed with patient demographics, ADRs characteristics, and pattern of drug and reaction characteristics. P-value <0.05 was considered as statistically significant. Results: A total of 426 ADRs to HAART were evaluated from 1982 HIV positive patients during the study period. The overall incidence of ADRs to HAART was 21.4%. Significant difference was seen in the incidence of ADRs in the age group of 41-60 years (p <0.001), CD4+T-cell counts of 350-500 cells/μl (p <0.001), females (p <0.001). Three fatal ADRs of with cutaneous drug eruptions of Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) was 1.1%. Anemia (31.7%) accounted for majority of the reports followed by vomiting (15.5%), skin rash (12.9%) and peripheral neuropathy (10.7%). The suspected drug was withdrawn for the management of the ADRs in majority (27.9%) of the reports. Higher incidence rate of ADRs was noted with lamivudine (3TC) + nevirapine (NVP) + stavudine (D4T) (22.9%). In, naranjo's causality assessment, majority of the ADR reports were rated as possible (69%). Symptomatic treatment for ADRs was given in 91.8% of the reports and 86.4% of the reports the patient recovered from the suspected adverse reaction at the time of evaluation. Conclusion: In India, occurrence of ADRs to HAART in HIV infected patients was found to be higher with zidovudine induced anemia (31.7%). The higher percentage of ADRs to HAART was seen with female patients, age 41-60 years; CD4+ T-cell counts 350-500 cells/μl. Physician must focus for monitoring all lab investigations for early detection and prevention of adverse effects associated with HAART.

Adverse Drug Reactions in Ophthalmology - are they a Myth?

Sometimes ocular (and systemic) therapeutics may cause ocular (and systemic) diseases, namely adverse drug reactions (ADRs). The Journal of Ocular Diseases and Therapeutics is therefore doubly adequate for discussion of the theme of ADRs in Ophthalmology. Many terms are utilized as synonyms but the correct definition of ADR (according to the World Health Organization, WHO) is: "any noxious, unintended and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy". Ophthalmology is one of the medical specialties in which there is a high difficulty in continuous diagnosis, assessment and treatment. Additionally, the specific and delicate anatomy and physiology of the eye may easily be disrupted by an ADR, with possible irreversible consequences. Ocular ADRs may be frequent (such as cornea verticillata caused by amiodarone) or specific. On the other hand, systemic ADRs may occur after ocular treatments (such as hypotension after instillation of a beta-blocker drop). The timely detection and recognition of ADRs is therefore critical. Several methods exist for the detection of ADRs, but few are specific or apply to ADRs in Ophthalmology. Spontaneous reporting is a low-resource method for detection of ADRs but has flaws, namely under-detection and risk of bias. The literature can be confusing or incomplete, with several case reports and case series about ocular ADRs lacking a causality assessment (such as Naranjo's or WHO's). In conclusion, ADRs in Ophthalmology are a heterogeneous group of ADRs that lack detection, assessment and systematization. Studies about ADRs should increase their quality for further clarification. Each ophthalmologist should know the specific ocular ADRs to systemic medication, the specific systemic ADRs to ocular medication, and to detect and treat them adequately for good clinical practice.

Community pharmacists' knowledge and perceptions about adverse drug reactions and barriers towards their reporting in Eastern region, Alahsa, Saudi Arabia.

The present study aims to analyze community pharmacists' current knowledge and perceived barriers to adverse drug reaction (ADR) reporting systems in the Eastern region, Alahsa, Saudi Arabia. A cross-sectional study was planned from 1 June 2012 to 15 July 2012 among the community pharmacies in the Eastern region, Alahsa. A total of 70 community pharmacists were approached using a cluster sampling method. A self-administered, 28-item questionnaire was used to attain the objectives of the study. Data analysis was done using Statistical Package for Social Science version 13. Relative index ranking was used to identify the top five barriers to the ADR reporting process. Response to the survey was 71.43%. In terms of knowledge about ADRs, very few (four, 8.0%) pharmacists were unable to differentiate between the right and wrong definition of ADRs. About 42 (84.0%) pharmacists mentioned that patients often report adverse events. However, 45 (90.0%) were not aware of the ADR reporting system in Saudi Arabia. A deficient professional environment was the main barrier to the ADR reporting process. In addition, unavailability of the reporting forms and poor understanding of the reporting process were common barriers to the reporting process. Most of the community pharmacists were unaware of the ADR reporting system in Saudi Arabia. Logistic issues were the main barriers to the ADR reporting process.

Recent Developments in EU and US Pharmacovigilance Legislation

The evolution of EU and US pharmacovigilance legislation highlights two trends. The first is to strengthen the instruments of protection of human health through, inter alia, the continuous monitoring of the risk-benefit ratio of drugs, greater transparency and the power to penalize producers for the failure to meet the pharmacovigilance obligations. The second trend manifests the partial harmonization of the different pharmacovigilance systems. However, this goal is still far away. In order to achieve it would be necessary to establish an identical definition of adverse drug reaction in both the EU and US legislation.

Frequency of adverse drug reactions in hospitalized patients: a systematic review and meta‐analysis

To perform a comprehensive systematic review of prospective studies about frequency of adverse drug reactions (ADRs) occurring during hospitalization (ADR(In) ), including a thorough study quality assessment, meta-analysis and heterogeneity evaluation. Systematic review of several databases: Pubmed, EMBASE, CINAHL, Cochrane, ISI, International Pharmaceutical Abstracts, Scirus, NHS economic, and others, as well as manual search. Inclusion criteria were: prospective studies (assessing all patients before discharge, by a specialized team, at least once a week); with data about ADRs occurring during hospitalization, using WHO's or similar definition of ADR. Two independent reviewers assessed eligibility criteria, extracted data, and evaluated risk of bias. From 4139 studies initially found, 22 were included. Meta-analysis indicate that ADRs may occur in 16.88% (CI95%: 13.56,20.21%) of patients during hospitalization; however, this estimate has to be viewed with caution because there was significant heterogeneity (I² = 99%). The most significant moderators of heterogeneity were risk of bias, population, ward, and methodology for ADR identification. Low risk of bias studies adjusted for population (pediatric versus adult) had I² = 0%. These data are useful as a broad characterization of in-hospital ADRs and their frequency. However, due to heterogeneity, our estimates are crude indicators. The wide variation in methodologies was one of the most important moderators of heterogeneity (even among studies using intensive monitoring). We suggest criteria to standardize methodologies and reduce the risk of bias.

Analysis of awareness on adverse event reporting among physicians and nurses and contribution of pharmacovigilance training

BackgroundPharmacovigilance, derived from the Greek word; ‘pharmakon’, a drug or medicine, and from the Latin ‘vigilans’ watchful or careful, is defined as ‘all methods of assessment and prevention of adverse...

Sex-dimorphic adverse drug reactions to immune suppressive agents in inflammatory bowel disease

To analyze sex differences in adverse drug reactions (ADR) to the immune suppressive medication in inflammatory bowel disease (IBD) patients. All IBD patients attending the IBD outpatient clinic of a referral hospital were identified through the electronic diagnosis registration system. The electronic medical records of IBD patients were reviewed and the files of those patients who have used immune suppressive therapy for IBD, i.e., thiopurines, methotrexate, cyclosporine, tacrolimus and anti-tumor necrosis factor agents (anti-TNF); infliximab (IFX), adalimumab (ADA) and/or certolizumab, were further analyzed. The reported ADR to immune suppressive drugs were noted. The general definition of ADR used in clinical practice comprised the occurrence of the ADR in the temporal relationship with its disappearance upon discontinuation of the medication. Patients for whom the required information on drug use and ADR was not available in the electronic medical record and patients with only one registered contact and no further follow-up at the outpatient clinic were excluded. The difference in the incidence and type of ADR between male and female IBD patients were analyzed statistically by χ(2) test. In total, 1009 IBD patients were identified in the electronic diagnosis registration system. Out of these 1009 patients, 843 patients were eligible for further analysis. There were 386 males (46%), mean age 42 years (range: 16-87 years) with a mean duration of the disease of 14 years (range: 0-54 years); 578 patients with Crohn's disease, 244 with ulcerative colitis and 21 with unclassified colitis. Seventy percent (586 pts) of patients used any kind of immune suppressive agents at a certain point of the disease course, the majority of the patients (546 pts, 65%) used thiopurines, 176 pts (21%) methotrexate, 46 pts (5%) cyclosporine and one patient tacrolimus. One third (240 pts, 28%) of patients were treated with anti-TNF, the majority of patients (227 pts, 27%) used IFX, 99 (12%) used ADA and five patients certolizumab. There were no differences between male and female patients in the use of immune suppressive agents. With regards to ADR, no differences between males and females were observed in the incidence of ADR to thiopurines, methotrexate and cyclosporine. Among 77 pts who developed ADR to one or more anti-TNF agents, significantly more females (54 pts, 39% of all anti-TNF treated women) than males (23 pts, 23% of all anti-TNF treated men) experienced ADR to an anti-TNF agent [P = 0.011; odds ratio (OR) 2.2, 95%CI 1.2-3.8]. The most frequent ADR to both anti-TNF agents, IFX and ADA, were allergic reactions (15% of all IFX users and 7% of all patients treated with ADA) and for both agents a significantly higher rate of allergic reactions in females compared with males was observed. As a result of ADR, 36 patients (15% of all patients using anti-TNF) stopped the treatment, with significantly higher stopping rate among females (27 females, 19% vs 9 males, 9%, P = 0.024). Treatment with anti-TNF antibodies is accompanied by sexual dimorphic profile of ADR with female patients being more at risk for allergic reactions and subsequent discontinuation of the treatment.

Knowledge, attitude and practices associated with adverse drug reaction reporting amongst doctors in a teaching hospital

This study was aimed at investigating the knowledge, attitude and practices associated with adverse drug reaction (ADR) reporting among doctors in a teaching hospital. A total of 100 doctors working in a teaching hospital were evaluated with a questionnaire for their knowledge, attitude and practices related to ADR reporting and pharmacovigilance programmes. Nearly two third (66%) of the doctors knew the definition of ADR. Only one third (38%, 40%) could correctly define pharmacovigilance and adverse drug event (ADE) respectively. Although 100% of the doctors felt the need for a National Pharmacovigilance Programme (NPP) only approximately three fourth (73%) were aware of the existing programme in India and nearly half of the them (47%) actually knew the current status of the NPP at their institute. Surprisingly only one tenth of the doctors (10%) knew what should be reported. The majority (74.4%) felt that reactions to new drug should be reported and also those reactions that are serious and unusual. Only one third (30%) knew whom to report to and less than half (30%) had actually ever reported an ADR. The knowledge of ADRs and how to report them is inadequate among doctors. More awareness should be created regarding the purpose and usefulness of ADR reporting through Continuous Medical Education, training and integration of ADR reporting into the clinical activities of the doctors.