Largescale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs mei liu,1 yonghui wu,1 yukun chen,1 jingchun sun,1 zhongming zhao,1 xuewen chen,2,3 michael edwin matheny,1,4,5,6 hua xu1 abstract objective adverse drug reaction adr is one of the. Department of pharmacology temple university school of medicine philad elphia, pa physicians were interviewed to assess their willingness to risk adverse drug. Materials and methods this was a retrospective study, which was carried out in the department of pharmacology, pharmacovigilance unit of adverse drug monitoring centre amc, rims, ranchi. The patient was administered a drug known to cause such symptoms. Unexpected and severe adverse drug reactions are frequent. Largescale prediction of adverse drug reactions using. They are easily confused but can not be used interchangeably, requiring care in usage. A grading severity scale is provided for each ae term. Certain a clinical event, including a laboratory test abnormality, that occurs in a plausible time relation to drug coun 100% chi administration, and which cannot be explained by concurrent disease or other drugs or chemicals. Hence it is essential to recognise adrs and to establish a causal relationship between the drug and the adverse event. A scale for assessing the severity of diseases and adverse.
Although some adrs present as minor symptoms, others are serious and cause death. Who headquarters is responsible for policy issues while the operational responsibility for the programme rests with the who collaborating centre for international drug. The basics on adverse event monitoring, assessment and. For the various treatment modalities in psychiatry e. These interventions ranged from stopping the causative medicines to substituting the therapy by another drug or simply reducing the dose of suspected causative agent. Since the majority of since the majority of these adverse reactions are predictable and often preventable, there is a need for a greater awareness among the healthcare professionals. Severity of adverse drug reactions drugs msd manual. The world health organization who defines an adverse drug reaction adr as a response to a medicine that is noxious and unintended and occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease.
Pdf preventability and severity assessment in reporting. Neonates are vulnerable to adverse drug reactions adr in clinical care, but these events are underreported. The modified hartwigs and siegel scale defines the severity of adr as mild, moderate. The terms severe and serious, when applied to adverse events, are technically very different. To direct prevention efforts at highrisk residents, information is needed on residentlevel risk factors. Hospitalbased adverse drug reaction adr monitoring and reporting programs intend to. Causality, severity and preventability assessment of adverse. Adverse drug reaction and causality assessment scales. Adverse drug reaction and causality assessment scales medind. The severity of each reported adr was assessed using the criterion developed by modified hartwig et al. There is no universal scale for describing or measuring the severity of an adverse.
The drug class most commonly implicated with adrs was cardiovascular 18. Objectives define adverse drug reactions discuss epidemiology, classification and causes of adrs describe basic methods to detect, assess, manage and document adrs in the clinical setting describe postmarketing drug safety surveillance, the fda medwatch program, and fda adverse event reporting system faers. Adverse drug reactions adverse effects are any unwanted effects of a drug. Little is known about the adverse drug reactions for chronic obstructive pulmonary disease therapy. The adverse drug reactions were analyzed by naranjos algorithm scale and hartwig severity assessment scale and the outcomes were studied. Assessment of the expectancy, seriousness and severity of adverse. Adverse drug reactions monitoring an international system for monitoring adverse reactions to drugs adrs using information derived from member states was established in 1971.
Preventability and severity assessment in reporting adverse drug reactions. It was expected that the present study will furnish baseline data regarding the type, frequency and severity of adverse drug reactions among kashmiri population, particularly those presenting to the study hospital. Rating scales for adverse drug reactions springerlink. This was a prospective, spontaneous reporting study conducted over a period of 7 months by clinical pharmacists.
Causality assessment of suspected adverse drug reaction. Of the 86 trials that mentioned severity of adverse drug reactions, only 42 49% stated how severity had been defined. Common terminology criteria for adverse events ctcae. The basics on adverse event monitoring, assessment and reporting. Asian journal of research in biological and pharmaceutical sciences. Economic impact and severity of adverse drug reactions in. Subset of suspected adverse reactions any adverse event caused by a drug. Asian journal of research in biological and pharmaceutical.
Adverse drug reaction is a leading cause of hospitalization in many sri lankan hospitals. These untoward reactions were ranked according to severity and weighted against the primary illness being treated. Other causes of the symptomatology are effectively excluded. Dec 15, 20 causality, severity and preventability assessments. Pdf casualty assessment and the severity of the adverse. Classification severity of event minor moderate serious serious lifethreatening serious lethal fotis m, budris w. Causality assessment of suspected adverse drug reactions 1. Risk factors for adverse drug events among nursing home. Pdf on oct 1, 1992, steven c hartwig and others published preventability and. The severity level of assessment of the adverse drug reactions observed in the study showed that most of them were moderate in nature as per the hart wig et al. Severity of the reaction was assessed using adr severity assessment scale modified hartwig and siegel. Severity of adverse drug reactions msd manual consumer version.
We conducted survey on adverse reactions in all patients admitted to the tertiary care hospital in galle. January march 4 other drug groups macrolide by 25% and glibaicamide by. Adrs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. A retrospective analysis of received incident reports of potential and preventable adverse drug events over a 22month period was conducted at a 1,300bed, universityaffiliated, tertiary care hospital. The causality assessment by using naranjos and who scale showed majority of the adverse drug reactions had a probable. Causality assessment of suspected adverse drug reaction with. Preventability and severity assessment in reporting adverse drug reactions article pdf available in american journal of hospital pharmacy 499. Largescale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs mei liu,1 yonghui wu,1 yukun chen,1 jingchun sun,1 zhongming zhao,1 xuewen chen,2,3 michael edwin matheny,1,4,5,6 hua xu1 abstract objective adverse drug reaction adr is one of the major causes of failure in drug development. The meaning of this term differs from the term side effect because side effects can be beneficial as well as detrimental. Study design case reports of adr to glucosamine and chondroitin sent to the therapeutic goods administration between 2000 and 2011 were. Study design case reports of adr to glucosamine and chondroitin sent to the therapeutic goods administration between 2000 and 2011 were obtained and analysed. The world health organization defines adrs as any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or. Adverse drug reactions occur almost daily in health care institutions and can adversely affect a patients quality of life, often causing considerable morbidity and mortality. A study to analyze the pattern, causality, severity.
Adverse drug reactions may cause patients to lose confi dence in or have. Ashp guidelines on adverse drug reaction monitoring and reporting pharmacists in organized health care systems should develop comprehensive, ongoing programs for monitoring and reporting adverse drug reactions adrs. Hypersensitive adverse drug reactions to glucosamine and. Each reported adr was assessed for its causality by using various scales, namely the who probability scale, naranjos scale. There is no universal scale for describing or measuring the severity of an adverse drug reaction. National journal of physiology, pharmacy and pharmacology. An adverse drug reaction adr is an injury caused by taking medication. To overcome the limitations of rawlins and thompson classification, adverse reactions are classified into nine categories based on their mechanism. A study on assessment of adverse drug reactions in. Adverse drug reactions in a south indian hospitaltheir. To examine the causality, preventability and severity of adr in a hospital setting.
Adverse drug reaction an overview sciencedirect topics. Adverse drug reactions adrs are a major cause of morbidity, hospital admission, and even death. Classification of reported adrs according to severity scale. Methods casecontrol study nested within a prospective study of ades among residents in 18 nursing homes. Preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital. Approximately 22% of reported adverse drug reactions affect peoples everyday life to a greater extent and require additional therapy which might further increase the risk. Common terminology criteria for adverse events ctcae v5. The nci common terminology criteria for adverse events is a descriptive terminology which can be utilized for adverse event ae reporting. Physicians were interviewed to assess their willingness to risk adverse drug reactions among patients.
A study on assessment of adverse drug reactions in patients. Severity was divided into seven classes denoted by progressively increasing numerical scores. Majority of adverse drug reactions are classified in levels 1 32. Severity was divided into seven classes denoted by progressively increasing numerical scores, w1 to w7, whose.
There are various published definitions for adverse drug reactions adrs currently being used in practice and published in the literature. The study was also aimed at determining the economic burden of adrs from a hospital perspective. Background in a prospective study of nursing home residents, we found adverse drug events ades to be common, serious, and often preventable. Hutchinson taflegel kmkramer msleduc dgkong hhp frequency, severity and risk factors for adverse drug reactions in adult outpatients. Adverse drug reactions adrs related hospital admissions are a significant problem in the health care system. Purpose of the study this study investigates spontaneous adverse drug reactions adrs to glucosamine and chondroitin in the australian population between 2000 and 2011, with a primary focus on hypersensitivity reactions. Probability is assigned via a score termed definite, probable, possible or doubtful. Adverse drug reactions in paediatric inpatients in a. Common terminology criteria for adverse events ctcae used for oncology drugs, generally not appropriate for otherwise healthy subjects.
Clinical analysis of adverse drug reactions in principles of clinical pharmacology, 3rd ed. A specially designed questionnaire in the form of a matrix was used. It is desirable that adrs should be objectively assessed and presented based on an acceptable probability scale. Study on the classification, causality, preventability and. Department of pharmacology, temple university school of medicine, philadelphia, pa. The study was aimed to assess the pattern of occurrence of adverse drug reactions adrs in the local population, severity of reported adrs and additional financial resource utilisation associated with adrs. The naranjo algorithm, naranjo scale, or naranjo nomogram is a questionnaire designed by naranjo et al. An adverse drug reaction adr is an unwanted, unde sirable effect of a medication that occurs during usual clinical use. August 9, 2006 quick reference the nci common terminology criteria for adverse events v3.
The temporal sequence of drug administration and appearance of symptoms is consistent with a drug reaction. Descriptive statistics of the reported adverse drug reactions was performed and the relative risk of developing an adverse drug reaction with all international nonproprietary names included in the analysis was calculated. Adverse drug reactions, hartwigs scale, hospital pharmacovigilance running title assessment of actively screened adr in tertiary care hospital word count. Assessment of the expectancy, seriousness and severity of. Adverse drug reactions in an oncological population. Hospitalbased adverse drug reaction adr monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. An analysis of reported adverse drug reactions advisory.
A scale for assessing the severity of diseases and adverse drug reactions. Severity of adverse drug reactions drugs merck manuals. Frequency, types, severity, preventability and costs of. The causality was assessed with the help of naranjo adr probability scale,11 and whoumc causality. This observational and crosssectional study was conducted for 6months from november 2016may 2017 in an inpatient setting of a tertiary care hospital of pune. Severity is a point on an arbitrary scale of intensity of the adverse event in question. Pdf preventability and severity assessment in reporting adverse. In order to improve the accuracy of our assessments, individual causality assessments were undertaken using the naranjos causality assessment scale which classifies drug reactions into definite, probable, possible and doubtful adr. Majority 47% of the reactions were moderate in severity. Approximately three quarters of adverse drug reactions were scored at level 3 and 4 on the hartwig scale and by definition required intervention. Coberts manual of drug safety and pharmacovigilance, 2nd ed. Severity of the reaction was assessed using adr severity. Values obtained from this algorithm are often used in.
Uppsala monitoring centre criteria, whereby the likelihood of a drug causing the ae is certain, probable, possible, unlikely, or unrelated 35 table 2. An international system for monitoring adverse reactions to drugs adrs using information derived from member states was established in 1971. Pdf adverse drug reaction and causality assessment scales. January march 4 other drug groups macrolide by 25% and glibaicamide by 20% but the reactions caused by. Adverse drug reactions adrs have been reported with significant impact on morbidity, mortality, quality of life, and healthcare cost. Causality, severity and preventability assessment of. Development of a neonatal adverse event severity scale. Classification severity type 7 classification severity of event minor moderate serious serious lifethreatening serious lethal fotis m, budris w. The goal of this study is to assess the expectedness, seriousness and severity of adverse drug reactions during chronic obstructive pulmonary disease therapy based on their reporting in the national pharmacovigilance system.