Jul-Sep, 2012 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaComparison of days lost due to disability and Karnofsky performance status in burden ofdiclofenac induced adverse drug reactions1 2 3Thomas D* , Mathew M and Mahendra Kumar B.J1Head, Dept of Pharmacy Practice, RIPER, A.P., India2Principal, Malik Deenar College of Pharmacy, Kasaragod, Kerala, India3Prof & Head, Dept of Pharmacy Practice, Director PG Studies, JDT Islam College of Pharmacy, Kozhikode, Kerala, IndiaA B S T R A C TSubmitted: 24/08/2012Accepted: 12/09/2012Basic objective of this study was to find out the benefit of Days Lost due to Disability (DLD) over Karnofsky Performance Status (KPS) in detectingthe burden of Adverse Drug Reactions (ADRs) of diclofenac tablet in clinically recovered male and female groups. This was a cohort study done in1000 prescriptions of diclofenac tablets to find out the burden of its ADRs in a popular pharmacy in Kasaragod District, Kerala, India. Stratifiedrandomized sampling was done to male and female strata to compare DLD and QoL using KPS. DLD considers incidence and duration of ADRs inaddition to the QoL component, disability weight to give a more complete burden of disease score. For cutaneous reaction, female scored 61 DLDover 26 in male. For peptic ulcer female scored 40 over 37 in male, even though males had higher incidence. Female suffered from higher DLD inother ADRs too. DLD was found to be more complete and sensitive tool than KPS QoL tool in calculating the burden of ADRs due to diclofenactablet. Female gender is a contributing factor of increased burden of ADRs.Keywords: peptic ulcer, diclofenac, ADR, femaleINTRODUCTIONBurden of disease or illness could be effectively calculated bydisability adjusted life years (DALY) or quality of life (QoL)tools. DALY has two components i.e., years of life lost (YLL)and years lost due to disability (YLD). YLD assess burden ofdisease or illness in survived casualties. While studyingburden of illness in clinically recovered cases of adverse drugreactions (ADRs), most of the times the suffering of ADRslasts few days. So rather than calculating it for years, as it is inYLD, it could be calculated in days, thus becoming days lostdue to disability (DLD). In this study we plan to assess thesensitivity of DLD by comparing with Karnofskyperformance status (KPS) in gender variation in the burden ofADRs caused by diclofenac tablet.Burden of ADRs were commonly assessed by the decrease inquality of life. Days Lost due to Disability (DLD) which ispart disability adjusted life years is a more advanced tool tocalculate burden of ADRs than Karnofsky PerformanceStatus. DLD is a new tool introduced by the authors. It couldbe calculated for 100 or 1000 population. The key limitation isthat it could be calculated only for clinically recovered ADRs.Address for Correspondence:Dixon Thomas, Associate Professor & Head, Dept of Pharmacy Practice,Raghavendra Institute of Pharmaceutical, Education and Research (RIPER)Chiyyedu Post, Anantapur 515721, AP, IndiaE-mail: dixon.thomas@gmail.comQoL or performance status is one of the commonly usedclinical outcome research tools in many of the illness. Thereare general QoL tools and disease specific tools. Compromisein QoL is used to measure the influence of disease on healthwhen a medical (mainly pharmaceutical) and/or surgicalintervention is used, improvement in QoL could be measuredto study the influence of treatment of disease. At the sametime the medicines also could cause ADR and compromisefurther on QoL. Practically it becomes very difficult toseparate the compromise on health happened due to disease1and ADR on an observational study.DLD is a more complete tool to assess burden of disease orADRs by calculating the incidence, duration and disabilityweight (DW). DLD have a component of QoL in the form of2DW. DW could be measured in a scale between 0 to 1, where30 becomes perfect health and 1 becomes the worst. KPS is awidely used QoL or performance status tool for many decadesin different disease settings. KPS is a very structuredquestionnaire scoring 0 to 100, were 0 becomes death and 1004becomes perfect health. KPS results could be easilyconverted to the scale of 0 to 1 and then 1 - KPS gives DW.DW also could be measured in an analogue scale.While measuring QoL, we had experienced that subjectivemeasures dominate over objective measures. Perception ofthe patients on their health is an important factor of their QoL.Generally females consider ill health more importantly thanmales. They shall be more cautious in prevention andIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 36