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Pharmacoepidemiology

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  • 1. PharmacoPharmacoepidemiology??epidemiology?? AvinashAvinash VigiLant
  • 2. ““A desire to take medicine is, perhaps, the greatA desire to take medicine is, perhaps, the great feature which distinguishes man from otherfeature which distinguishes man from other animals”. ---------- Sir William Osler, 1891animals”. ---------- Sir William Osler, 1891
  • 3.  Complex and underperformed task for the manyComplex and underperformed task for the many PhysicianPhysician  Skills in making diagnosis and skills inSkills in making diagnosis and skills in therapeuticstherapeutics  Rapid Introduction of many modern andRapid Introduction of many modern and sophisticated new drugs to the marketsophisticated new drugs to the market VigiLant
  • 4. Risk Benefit Ratio VigiLant
  • 5.  Study of interactions between drugs andStudy of interactions between drugs and populationpopulation  Pharmacoepidemiology is thePharmacoepidemiology is the ‘‘study of the use‘‘study of the use and effects of drugs in large numbers ofand effects of drugs in large numbers of persons.’’persons.’’ VigiLant
  • 6.  Def:Def: ‘‘Pharmacoepidemiology is the‘‘Pharmacoepidemiology is the application of epidemiologic reasoning,application of epidemiologic reasoning, methods, and knowledge to the study of themethods, and knowledge to the study of the uses and effects (beneficial The and adverse) ofuses and effects (beneficial The and adverse) of drugs in human populations”.drugs in human populations”. VigiLant
  • 7. Subdiscipline of Clinical Pharmacology VigiLant
  • 8.  Involves…Involves…  Causality and incidence of ADRsCausality and incidence of ADRs  Effectiveness of new drugs in definesEffectiveness of new drugs in defines populationspopulations  Patterns of and variations in prescribing in aPatterns of and variations in prescribing in a particular health care facility areaparticular health care facility area  Strategies to improve prescribing and so on….Strategies to improve prescribing and so on….  Economic impact of drug useEconomic impact of drug use VigiLant
  • 9. History and evolution ofHistory and evolution of PharmacoepidemiologyPharmacoepidemiology  Empiric medicine- Core of many treatmentsEmpiric medicine- Core of many treatments  Opium and Castor oil have been used sinceOpium and Castor oil have been used since 3500 years ago3500 years ago  Vaccination in India form 550 BCVaccination in India form 550 BC  Compliance ofCompliance of materia medicamateria medica of 500 plantsof 500 plants VigiLant
  • 10.  Isolation of Morphine in 1805Isolation of Morphine in 1805  History of Drug Regulation in US began in theHistory of Drug Regulation in US began in the beginning of the 20beginning of the 20thth CenturyCentury  1906 in US Pure Food and Drug act was passed1906 in US Pure Food and Drug act was passed For adulterated and misbranded drugs toFor adulterated and misbranded drugs to eliminateeliminate VigiLant
  • 11.  No requirement for proof efficacy and safety ofNo requirement for proof efficacy and safety of marketed drugmarketed drug  1937 Sulfanilamide tragedy / 107 died1937 Sulfanilamide tragedy / 107 died  1938 food and drug cosmetic act was passed, requires1938 food and drug cosmetic act was passed, requires manufacturer to submit clinical data about drug safetymanufacturer to submit clinical data about drug safety to the FDA prior to drug marketing, BUT data abt drugto the FDA prior to drug marketing, BUT data abt drug efficacy was not requiredefficacy was not required VigiLant
  • 12.  Most significant event in the History of DrugMost significant event in the History of Drug Regulation “ Thalidomide Disaster”Regulation “ Thalidomide Disaster”  One country get protected form this disasterOne country get protected form this disaster  ????? And How????? And How VigiLant
  • 13. VigiLant
  • 14.  Demonstrate causal relationship of theDemonstrate causal relationship of the in uteroin utero exposure to thalidomide and rare birth defectexposure to thalidomide and rare birth defect  Kefuaver- Harris Amendment in 1962Kefuaver- Harris Amendment in 1962: To: To ensure drug efficacy and drug safety. For theensure drug efficacy and drug safety. For the first time drug manufacturers are required tofirst time drug manufacturers are required to prove FDA the effectiveness of their productsprove FDA the effectiveness of their products before marketing.before marketing.  Requires more extensive NonclinicalRequires more extensive Nonclinical Pharmacology and toxicology testing beforePharmacology and toxicology testing before drug could tested in mandrug could tested in man VigiLant
  • 15.  In addition 3 explicit phases of clinical testingIn addition 3 explicit phases of clinical testing were requiredwere required  ““Three phases” of classical trial becomeThree phases” of classical trial become requirement for drug approval before marketingrequirement for drug approval before marketing  But information is still lacking at the time whenBut information is still lacking at the time when drug enters in marketdrug enters in market VigiLant
  • 16.  In phase III involve relatively small no of patientIn phase III involve relatively small no of patient but possibly serious AE may not be detectedbut possibly serious AE may not be detected  No of patient between 1000 to 3000No of patient between 1000 to 3000  What for rare ADR (1 in 1000)?What for rare ADR (1 in 1000)? VigiLant
  • 17.  Relatively short period of drug administration inRelatively short period of drug administration in Phase III clinical trial last NMT 18 monthsPhase III clinical trial last NMT 18 months which makes longer term effects undetectablewhich makes longer term effects undetectable  Therefore epidemiological technique have beenTherefore epidemiological technique have been widely applied to the discipline of clinicalwidely applied to the discipline of clinical pharmacology known aspharmacology known as PHASE IVPHASE IV Studies orStudies or PMSPMS VigiLant
  • 18.  Eg. In 1970 the Bosten University DrugEg. In 1970 the Bosten University Drug Epidemiology unit was developed, using aEpidemiology unit was developed, using a hospital – based approach of collecting drughospital – based approach of collecting drug exposure history to perform hospital based caseexposure history to perform hospital based case control studiescontrol studies  1976 joint commission on prescription drug use1976 joint commission on prescription drug use was performed to review the status of the fieldwas performed to review the status of the field of Pharmacoepidemiologyof Pharmacoepidemiology VigiLant
  • 19.  In 1980 DSRU was developed in UK toIn 1980 DSRU was developed in UK to conduct Prescription Event Monitoring (PEM)conduct Prescription Event Monitoring (PEM)  All these development are important event inAll these development are important event in the field of Pharmacoepidemiology in developedthe field of Pharmacoepidemiology in developed communitiescommunities VigiLant
  • 20.  Health Expenditure of each nation: 8-10% spentHealth Expenditure of each nation: 8-10% spent on medications in developed countries but thison medications in developed countries but this could be more than 35-40 % in many developingcould be more than 35-40 % in many developing countriescountries VigiLant
  • 21. Pharmacoepidemiology inPharmacoepidemiology in Developing CountriesDeveloping Countries  Poor Regulation of Drug In Developing CountriesPoor Regulation of Drug In Developing Countries  Many prescription drugs as Antibiotics, Anxiolytics canMany prescription drugs as Antibiotics, Anxiolytics can be purchased from any drug Store with no controlbe purchased from any drug Store with no control  Self Medication and Local Remedies ??Self Medication and Local Remedies ??  WHO, FDA, TGA, International Network of ClinicalWHO, FDA, TGA, International Network of Clinical EpidemiologyEpidemiology
  • 22. Study Design inStudy Design in PharmacoepidemiologyPharmacoepidemiology  Randomized Clinical Trial (RCT) [ ExperimentalRandomized Clinical Trial (RCT) [ Experimental Study]Study]  Case Control StudyCase Control Study  Case ReportCase Report  Analysis of Secular trends case seriesAnalysis of Secular trends case series VigiLant
  • 23. Case ReportCase Report  Prior to testing any hypothesis the hypothesisPrior to testing any hypothesis the hypothesis must be generatedmust be generated  How??How??  By collecting case reportBy collecting case report  Most simple form of theMost simple form of the Pharmacoepidemiological StudyPharmacoepidemiological Study VigiLant
  • 24.  Report of single patientReport of single patient  Describe a single patient who was exposed to aDescribe a single patient who was exposed to a drug and experienced a particular adversedrug and experienced a particular adverse outcomeoutcome  Eg. Published case Report about young patientEg. Published case Report about young patient who was taking an antihistamine and developedwho was taking an antihistamine and developed a serious cardiac arrhythmiaa serious cardiac arrhythmia VigiLant
  • 25. Case SeriesCase Series  Collection of the patient with single exposure,Collection of the patient with single exposure, whose clinical outcome are evaluated andwhose clinical outcome are evaluated and describeddescribed  Useful after drug marketing for an easyUseful after drug marketing for an easy quantification of the incidence of an ADRquantification of the incidence of an ADR  Eg. Post marketing studies of the “First- DoseEg. Post marketing studies of the “First- Dose Effect” of Prazosin when drug was firstEffect” of Prazosin when drug was first marketedmarketed VigiLant
  • 26. Case- Control StudyCase- Control Study  Compares cases with a disease to controlsCompares cases with a disease to controls without diseasewithout disease  Eg. GI Bleeding form NSAID including cases ofEg. GI Bleeding form NSAID including cases of patient with GI bleeding and compare them topatient with GI bleeding and compare them to control without diseasecontrol without disease  Difference in prior to exposure to NSAIDs andDifference in prior to exposure to NSAIDs and GI BleedingGI Bleeding VigiLant
  • 27. Case-Cohort StudyCase-Cohort Study  Identifies an exposed group and follows themIdentifies an exposed group and follows them over the timeover the time  Look for the differences in their outcomeLook for the differences in their outcome  Comparison between exposed patient toComparison between exposed patient to unexposed patientunexposed patient VigiLant
  • 28. Approach in EpidemiologicalApproach in Epidemiological StudiesStudies  General Data:General Data:  By Asking QuestionsBy Asking Questions  By Making ComparisonBy Making Comparison  ActionsActions How to solve this problemHow to solve this problem How it can prevented in futureHow it can prevented in future What is the role of community, society, and healthWhat is the role of community, society, and health CareCare VigiLant
  • 29.  Incidence: “ The Number of new cases occurredIncidence: “ The Number of new cases occurred in define population during a specified period ofin define population during a specified period of time”time”  Prevalence: All current and existing cases at aPrevalence: All current and existing cases at a given time over a period in a population”given time over a period in a population” VigiLant
  • 30. Potential AreasPotential Areas  Potential Areas of PharmacoepidemiologicalPotential Areas of Pharmacoepidemiological Study includeStudy include  Identifying and QuantifyingIdentifying and Quantifying  Less common adverse eventsLess common adverse events  Delayed Adverse eventsDelayed Adverse events  Evaluation of safety/efficacy/toxicity in specificEvaluation of safety/efficacy/toxicity in specific patient group in phase IVpatient group in phase IV  Study on Unanticipated AEStudy on Unanticipated AE VigiLant
  • 31. ApplicationApplication  Use of DrugUse of Drug  Drug EfficacyDrug Efficacy  SafetySafety  Cost-effectivenessCost-effectiveness  Drug UtilizationDrug Utilization VigiLant
  • 32. Drug UtilizationDrug Utilization VigiLant
  • 33. STUDY RATIONALESTUDY RATIONALE  To develop a National drug policy and Rational drug use, it isTo develop a National drug policy and Rational drug use, it is necessary to determine drug use patterns and monitor drug usenecessary to determine drug use patterns and monitor drug use profiles over timeprofiles over time  A first step is to describe the utilization in a Quantitative wayA first step is to describe the utilization in a Quantitative way using the anatomical-chemical therapeutic code/daily definedusing the anatomical-chemical therapeutic code/daily defined dose (ATC/DDD) methodologydose (ATC/DDD) methodology  To describe the utilization in a Qualitative way using DU 90To describe the utilization in a Qualitative way using DU 90 methodologymethodology VigiLant
  • 34. STUDY OBJECTIVESSTUDY OBJECTIVES  To evaluate drug utilization in orthopedic population atTo evaluate drug utilization in orthopedic population at civil hospital Nashik with special reference to NSAIDscivil hospital Nashik with special reference to NSAIDs  To monitor prescribing practices at civil hospitalTo monitor prescribing practices at civil hospital Nashik with aim of making medical care rational & costNashik with aim of making medical care rational & cost effectiveeffective VigiLant
  • 35. MATERIALS & METHODSMATERIALS & METHODS  A prospective cross-sectional study was undertaken ,A prospective cross-sectional study was undertaken , prescriptions of the patients who were examined by physician inprescriptions of the patients who were examined by physician in OPD &IPD were collected & copied and the patients wereOPD &IPD were collected & copied and the patients were interviewed.interviewed.  Analysis was done as per WHO indicators & DDD wasAnalysis was done as per WHO indicators & DDD was calculated, and DU 90% was obtainedcalculated, and DU 90% was obtained    *ATC  index with DDDs. Oslo, Norway,WHO Collaborating  *ATC  index with DDDs. Oslo, Norway,WHO Collaborating   Centre for Drug Statistics Methodology,2003.Centre for Drug Statistics Methodology,2003. VigiLant
  • 36. FOR EG: UTILIZATION OF NSAIDSFOR EG: UTILIZATION OF NSAIDS DRUGS IN RIKEKA & STOCKHOLMDRUGS IN RIKEKA & STOCKHOLM
  • 37.  STUDY DESIGN:STUDY DESIGN: Prospective Cross-sectional StudyProspective Cross-sectional Study  Number of sites:Number of sites: oneone  Number of subjects:Number of subjects: Total of 140 PatientsTotal of 140 Patients  Subject type:Subject type: All age groups of either sexAll age groups of either sex  Study duration:Study duration: 2 weeks2 weeks  INCLUSION CRITERIA: Patients who are ready to give informationINCLUSION CRITERIA: Patients who are ready to give information After obtaining ,oral consent, patients fulfilling inclusion and exclusion criteria were included in the study. VigiLant
  • 38. FLOW CHART OF THE STUDY                     PRESCRIPTION STUDY OF THE PATIENT IDENTIFICATION OF THE PATIENT INTERVIEW OF THE PATIENT     DATA COLLECTION & ANALYSIS REPORT VigiLant
  • 39. CORE INDICATORSCORE INDICATORS  Prescribing indicatorsPrescribing indicators  Average number of drugs per encounterAverage number of drugs per encounter  Percentage of drugs prescribed by generic name Percentage of drugs prescribed by generic name   Percentage of encounters with an injection prescribed Percentage of encounters with an injection prescribed   Percentage of drugs prescribed from essential drug listPercentage of drugs prescribed from essential drug list    VigiLant
  • 40. CORE INDICATORSCORE INDICATORS  Patient Care IndicatorsPatient Care Indicators  Average consultation timeAverage consultation time  Average dispensing timeAverage dispensing time  Percentage of drugs actually dispensedPercentage of drugs actually dispensed  Patients' knowledge of correct dosagePatients' knowledge of correct dosage  Complementary indicatorsComplementary indicators  Percentage of patients treated without drugsPercentage of patients treated without drugs  Average drug cost per encounterAverage drug cost per encounter VigiLant
  • 41. THE CONCEPT OF THE DEFINED DAILY DOSE (DDD)  The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.  Drug Classification Systems represents a common language for describing the drug assortment in a country or region. In 1996, WHO established the ATC/DDD system as an international standard in drug utilization studies.  The ATC classification system : the drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties. VigiLant
  • 42. DDD/1000/DayDDD/1000/Day  It is derived by calculating the overall amount of drug being used overIt is derived by calculating the overall amount of drug being used over a specific period of time and dividing this by DDDa specific period of time and dividing this by DDD (ATC)(ATC) multipliedmultiplied by the population and the number of days in the periodby the population and the number of days in the period  DDD/1000/DAYDDD/1000/DAY == Total no of dosage units prescribed * Strength of each dose unit * 1000Total no of dosage units prescribed * Strength of each dose unit * 1000 DDD(ATC) * Duration of the study * Total sample sizeDDD(ATC) * Duration of the study * Total sample size *ATC index with DDDs. Oslo, Norway,WHO Collaborating Centre for Drug*ATC index with DDDs. Oslo, Norway,WHO Collaborating Centre for Drug Statistics Methodology,2003.Statistics Methodology,2003. VigiLant
  • 43. DU 90% FOR EG:DU 90% FOR EG:
  • 44. RESULTSRESULTS  Total no.of patients studied = 140 OPD+IPD (118+22)Total no.of patients studied = 140 OPD+IPD (118+22)  Total no.of prescriptions = 140Total no.of prescriptions = 140  Total no. of drugs dispensed = 489Total no. of drugs dispensed = 489 VigiLant
  • 45. PRESCRIPTION INDICATORSPRESCRIPTION INDICATORS Avg. number of drugs/prescription 489/140 3.49 = 3 Drugs in injectable form 86/489 X 100 17.59% Drugs prescribed by generic name 180/489 X 100 36.81% Drugs from essential drug list 99% VigiLant
  • 46. PATIENT CARE INDICATORS PATIENT CARE INDICATORS  Avg. consultation timeAvg. consultation time 5 min IPD5 min IPD 2 min OPD2 min OPD Avg. dispensing timeAvg. dispensing time 1 min1 min Number of drugs actuallyNumber of drugs actually dispenseddispensed 470 = 96.11%470 = 96.11% Number of drugs actuallyNumber of drugs actually labeledlabeled 100%100% Patient’s knowledge aboutPatient’s knowledge about correct dosecorrect dose 97 were aware =69.29%97 were aware =69.29% 43 were unaware=30.71%43 were unaware=30.71% VigiLant
  • 47. PERCENTAGE OF NSAIDSPERCENTAGE OF NSAIDS PRESCRIBEDPRESCRIBED 0 10 20 30 40 50 60 70 80 90 100 ORAL I V I PD OPD NSAI DS VigiLant
  • 48. DDD IN PERCENTAGEDDD IN PERCENTAGE DDD in Percentage 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% Brufen Voveran DDD in Percentage VigiLant
  • 49. DrugDrug (IV)(IV) PercentagePercentage Inj VoveranInj Voveran 15.7115.71 Inj AmikacinInj Amikacin 7.867.86 Inj RantacInj Rantac 9.299.29 Inj. T.T.Inj. T.T. 55 Inj TaximInj Taxim 10.7910.79 Inj GentaInj Genta 2.862.86 Inj DexaInj Dexa 2.862.86 Drug(Oral)Drug(Oral) PercentagePercentage Tab. BrufenTab. Brufen 55.8655.86 Tab. VoveranTab. Voveran 29.2929.29 Tab. RantacTab. Rantac 71.4371.43 Tab.M.V.B.CTab.M.V.B.C 39.2939.29 Tab.Cal.lactateTab.Cal.lactate 33.533.5 Tab.SeptranTab.Septran 3.53.5 Tab.CetrizineTab.Cetrizine 1.431.43 PERCENTAGE OF DRUGS DISPENSEDPERCENTAGE OF DRUGS DISPENSED
  • 50. COST ANALYSIS Average cost per prescription in IPD = 19142/22 = Rs 870.90 Average cost per prescription in OPD = Rs 38.36 Average cost of tablets per prescription in OPD = Rs 31.81 Average cost of tablets per prescription in IPD = Rs 37.00 Average cost of injectables prescribed in OPD = Rs 4.55 Average cost of injectables prescribed in IPD = Rs 833.90
  • 51. LIMITATIONS OF THE STUDYLIMITATIONS OF THE STUDY  Study durationStudy duration  Number of prescriptions analyzedNumber of prescriptions analyzed  Choice of NSAID available for prescriptionChoice of NSAID available for prescription  Socio-economic class group representationSocio-economic class group representation inadequateinadequate VigiLant
  • 52. ThankThank You…You… VigiLant