A total number of 200 eligible patients were enrolled in the study. Modified ashworth scale instructions general information derived bohannon and smith, 1987. Who umc probability scale modified schumock and thornton scale modified hartwig and siegel severity scale demographic characteristics commonly used antiepileptic drugs profile of systemic toxicity patterns of adrs severity assessment 020 years2140 years4160 years60 years 7. Particulars frequency % adverse drug reactions 254. This study revealed that an increased risk of adrs is suspected in elderly patients, and that almost 80% of. Pdf preventability and severity assessment in reporting. Preventability was assessed by using the modified schumock and thornton scale which showed that 45. Case report an 85 year old male, exsmoker and ethanolic, nonhypertensive, nondiabetic with good. Thereafter, instillation of atropine as eye drops leads to reappearance of symptoms. Adverse drug reaction profile of oseltamivir in indian. Modified ashworth scale instructions abilitylab home. Since january 1994, each adr has been further categorized as to whether it was potentially preventable with a modification of the criteria published by schumock and thornton. Preventability modified schumock and thornton section a. Figure discussion the current study was planned with an approach to reveal pattern of acdrs with simultaneous.
Causality, severity and preventability assessment of. Predictability was assessed ba sed on the incidence rate of the reported adrs as per product information and relevant literatures. Preventability of adr by using modified schumock and thornton scale preventability, predictability and seriousness of adverse drug reactions amongst medicine inpatients in a teaching hospital. In our study all certainly preventable ades derived from one of the following suspected causes, according to european pharmacovigilance guidelines 32. An analysis of serious adverse drug reactions at a. Assessment of adverse effects of most commonly prescribed. The causality, severity and preventability were assessed using the naranjo, hartwig scale and modified schumock and thornton scales respectively. Predictability was assessed based on previous history on exposure to the drug or literature incidence of adrs, preventability was assessed by using modified schumock and thornton scale, causality was assessed by who probability scale and severity was assessed by using modified hartwig and siegel scale. From the page scaling popup menu, select tile all pages to expose the tile scale % option. Detection, monitoring and assessment of adverse drug. Preventability assessment by modified schumock and thornton scale showed that 56% was probably preventable and 44% was not preventable. A total of 1120 adrs were documented in the study period. Schumock and thorntons criteria have three sections namely.
Characterization and preventability of adverse drug events. After inclusion and exclusion criteria, 147 cases were enrolled in the study. Spss and microsoft excel were used for data analysis. Answering yes to one or more of the following implies that an adr is definitely preventable 1. Identifying significant preventable adverse drug events. The reported adrs on the notification forms, after been confirmed by the physicianincharge, were assessed for causality using naranjos algorithm scale, type of adr using wills and brown classification, preventability using modified schumock and thornton scale and severity using modified hartwig and siegel scale. According to the modified schumock and thornton preventability scale, 20 cases 20% were possibly preventable while 80 cases 80% were not preventable. Comparative survival and safety analysis of cisplatin. A study on assessment of knowledge about adverse drug. Modified schumock and thornton scale and the results revealed that. Adverse drug reactions due to cancer chemotherapy in a. Using modified schumock and thornton preventability assessment scale 21. Preventability of adrs were assessed by using modified schumock and thornton scale which revealed that 3579. Hartwig and siegel scale, and preventability schumock and thornton criteria.
A total of 44 adrs were identified in 3237 general medicine ward admissions. Does the person have difficulty reading or writing, difficulty speaking or finding the right word. Central anticholinergic syndrome induced by single. Suggestions would be considered if appropriate for implementations. The reaction was definite according to naranjos algorithm. Adrs, preventability was assessed by using modified schumock and thornton scale, causality was assessed by who probability scale and severity was assessed by using modified hartwig and siegel scale. Severity of the reaction was assessed using adr severity assessment scale modified hartwig and siegel which classifies adr into mild, moderate and severe.
The clinical pharmacist who was posted in a particular ward, used to take part in the ward rounds. Hence monitoring of adverse drug reactions is the key factor in ensuring patient compliance and safety. Type a reaction accounted for most of adverse drug reaction. Preventability criteria according to schumock and thornton scale. Study on the classification, causality, preventability and.
Pdf preventability and severity assessment in reporting adverse. Out of 2171 adrs reported during study period, 538 were cutaneous adrs 24. Print as image or, for acrobat only, separations or inrip separations. Drug induced macucopapular rash with the commonly used. Who probability assessment scale revealed that out of 60 adrs 4371.
If the tile options are not in the menu, make sure that the following options are not selected in the advanced print dialog box. A retrospective analysis was carried out for clinical presentation, causality as per the whoumc scale and the naranjoa reactions adrs severity hartwig and seigel scale, and preventability schumock and thornton criteria of a said drug. Analysis of cutaneous adverse drug reactions reported at. Pdf on oct 1, 1992, steven c hartwig and others published preventability and.
Preventability and severity of adverse drug reactions assessed by modified schumock and thornton scale, modified hartwig and siegel scale, respectively. A total of 450 adrs were observed from 109 patients. Majority of the patients received 6 cycles of fac therapy 5fluorouracil, adriamycindoxorubicin, cyclophospha. As per whoumc causality assessment scale, 80% were certain with 5fucis. None of the adrs was definitely preventable figure 4. Focusing on the preventability of adverse drug reactions pdf. Evaluation of pattern, predictability, severity and. A study on assessment of knowledge about adverse drug reactions sivanandy palanisamy, kottur sg arul kumaran and aiyalu rajasekaran. Was there a history of allergy or previous reaction to the drug. Causality, severity, and preventability assessments were done by using naranjos scale, modified hartwig and siegels scale, and modified schumock and thornton scale, respectively. Modified schumock and thornton scale, modified hartwigs and siegals scale and naranjos algorithm. The schumock and thornton criteria 37 was established for assessing the preventability of adrs. In recent years, the preventability of adverse drug reactions adrs has downstream of these system errors, and it needs to focus more on the patient and his drug reactions adrs induced by this class of medicinal of adverse reactions induced by cardiovascular drugs in.
An evaluation of adverse drug reactions profile at a tertiary care. A prospective study of incidence and assessment of adverse. Causality and preventability assessment of adverse drug. In 85 cases 85% the suspected drug was withdrawn while in 10 cases 10% no change in dose. Among 51 patients, 48 developed adrs to cisplatin chemotherapy.
Severity assessment scale, it revealed that majority of the suspected adrs were found to. The severity of adrs was assessed by using modified hartwig and siegel scale 19. Data were collected by personal interview after obtaining written informed consent. Research article preventability, predictability and. Incidence rate, relative risk and attributable risk were evaluated among the regimens. Prescribing trends of drugs and assessment of adverse drug. Similarly, in our study, preventability assessment using modified schumock and thornton scale shows 37. Causality and preventability assessment of adverse drug reactions. Who probability scale, severity and preventability modified schumock and thornton scale. Assessment of adverse drug reactions to antiretroviral.
Preventability of adrs was assessed by using modified schumock and thornton criteria 18. Research article effects of chemotherapy in breast cancer. Place the patient in a supine position if testing a muscle that primarily flexes a joint, place the joint in a maximally flexed position and move to a position of maximal extension over one second count one thousand one. Preventability assessment was done by using schumock and thornton scale 9 which classifies the adrs into definitely preventable, probably preventable and not preventable.
It was severe and definitely preventable according to modified hartwig and siegels scale and modified schumock and thornton scale respectively. A study to analyze the pattern, causality, severity. Causality was assessed by the world health organization who causality assessment scale and naranjos algorithm. Naranjo score, modified schumock and thornton scale were used for causality and preventability assessments, respectively. A total of 147 cutaneous eruptions were identified in which. Preventability and severity of adrs were assessed by modified schumock and thornton scale, modified hartwig and siegel scale respectively. Causality, severity and preventability assessment of adverse cutaneous drug reaction. An analysis of seriousness, predictability and preventability of adverse drug. National journal of physiology, pharmacy and pharmacology. Preventability assessment modified schumock and thorntons scale. Modified schumock and thornton scale and the results revealed that 3579. Age group adverse drug reactions total no n % yes n %.
Modified hartwig and siegel scale, 80% of adrs shown by 5fucis were moderately severe. Adverse drug reaction information will be discussed with physicians in internal medicine department to know their opinion regarding utilization of trigger tools in clinical practice. The who and naranjos scales evaluated the suspected adrs for causality assessment, severity by hartwig and siegel scale, and preventability by modified schumock and thornton scale. An adverse drug reaction cannot be avoided especially with drugs like antipsychotics which are the mainstay for the treatment of schizophrenia, a chronic disease, as well for the treatment of psychosis. Modified hartwig and siegel scale showed most reactions 41. Pdf focusing on the preventability of adverse drug reactions. Since pyrazinamide is a commonly used drug in tuberculosis and tuberculosis is a common problem in developing countries, this adr due to pyrazinamide gains importance. Focusing on the preventability of adverse drug reactions. The objective of this study was to analyze the various aspects of serious adverse drug reactions serious adrs such as clinical presentation, causality, severity, and preventability occurring in a hospital setting.
683 890 1245 146 1453 983 124 280 1176 1242 1253 215 1325 723 140 40 1053 358 761 718 401 965 192 131 711 608 1432 1041 1060 141 1139 107 772 744 865 720 1431 638 890 1072 1285 1318 1 1483