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Edit Comment Close Premium member Presentation Transcript Rational Use of Drugs and Evidence based Medicine : Rational Use of Drugs and Evidence based Medicine Department of Pharmacology NEIGRIHMS, Shillong Objectives : Objectives Definition of rational Use of Medicines Rationale behind rational use of medicines Reasons of irrational use of drugs Dangers of irrational drug use Steps to be taken for rational use of drugs Definition : Definition In simplest words rational use means “prescribing right drug, in adequate dose for the sufficient duration & appropriate to the clinical needs of the patient at lowest cost WHO: The rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community … contd. : … contd. Correct drug Appropriate indication Appropriate drug considering efficacy, safety, suitability for the patient, and cost Appropriate dosage, administration, duration No contraindications Correct dispensing, including appropriate information for patients Patient adherence to treatment Why Rational Use ? : Why Rational Use ? Drug explosion Efforts to prevent the development of resistance Growing awareness Increased cost of the treatment Consumer protection Act. (CPA) Slide 6: What to Give ? Rationality : Rationality REASONS FOR IRRATIONAL USE OF DRUGS : REASONS FOR IRRATIONAL USE OF DRUGS Lack of information – Nimesulide, enteroquinol Faulty & inadequate training & education of medical graduates Role models – Teachers or seniors Lack of diagnostic facilities/Uncertainty of diagnosis – medicine for all possible causes Demand from the patient – prompt and quick action Patient load Promotional activities of pharmaceutical industries Poor communication between health professional & patient Drug promotion and exaggerated claim by companies Defective drug supply system & ineffective drug regulation Hazards of Irrational Use : Hazards of Irrational Use Ineffective & unsafe treatment over-treatment of mild illness inadequate treatment of serious illness Exacerbation or prolongation of illness Distress & harm to patient Increase the cost of treatment Increased drug resistance - misuse of anti-infective drugs Increased Adverse Drug Events Increased morbidity and mortality Loss of patients confidence to doctor Overuse and misuse of AMAs - antimicrobial resistance : Overuse and misuse of AMAs - antimicrobial resistance Malaria choroquine resistance Tuberculosis primary multi-drug resistance Gonorrhea penicillin resistance in N. gonorrhea Pneumonia and bacterial meningitis penicillin resistance in S. pneumonia Diarrhea: shigellosis resistance AbsolutelyIrrational : AbsolutelyIrrational Injudicious use of antimicrobials: Antibiotics in Viral fever and diarrhea Unnecessary combinations: Nimesulide and paracetamol, Tinidazole and ciprofloxacin Use of drugs not related to diagnosis Incorrect route Incorrect dosing – under or overdose Incorrect duration – prolong or short term use Unnecessary use of expensive medicines Unsafe use of corticosteroids Polypharmacy Steps of rational drug use : Steps of rational drug use Step:- I Identify the patient’s problem based on symptoms & recognize the need for action Step:- II Diagnosis of the disease – define the diagnosis Step:- III List possible intervention or treatment (drug or no drug) – Identify the drug Step:- IV Start the treatment by writing an accurate & complete prescription e.g. name of drugs with dosage forms, dosage schedule & total duration of the treatment … contd. : … contd. Step:-V Given proper information instruction & warning regarding the treatment given e.g. side effects (ADR), dosage schedule & dangers/risk of stopping the therapy suddenly Step:-VI Monitor the treatment to check, if the particular treatment has solved the patient’s problem. Passive monitoring – done by the patient himself. Explain him what to do if the treatment is not effective or if too many side effect occurs Active monitoring - done by physician and he make an appointment to check the response of the treatment Instruction to the patients : Instruction to the patients Effects of the Drug Adverse effects Instructions Precautions to be taken Warning (Disulfiram Reaction): Symptoms: flushing of the skin accelerated heart rate shortness of breathe nausea, vomiting, throbbing headache visual disturbance mental confusion, postural fainting and circulatory collapse If we loose Rifampicin ???? Beware ! : If we loose Rifampicin ???? Beware ! The bacterial DNA-dependent RNA polymerase is inhibited by Rifampicin EVIDENCE BASED MEDICINE : EVIDENCE BASED MEDICINE What is EBM ? : What is EBM ? Definition: Process of systematically finding, evaluating and using contemporary research findings as the clinical basis of clinical decisions Evidence-based medicine (EBM) or Evidence-based practice (EBP) aims to apply the best available evidence gained from the scientific methods or studies in clinical decision making Therapeutic evaluation of a drug on the basis of available evidence in terms of Benefits, dosage, duration and patient selection Comparison with available drugs ADRs What are the sources of Evidence ? : What are the sources of Evidence ? Clinical trials Cohort studies Case Control Studies Clinical trials : Clinical trials Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols) on human subjects These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place Clinical trial : Clinical trial Initially pilot study is carried out followed by larger studies Human subject: Healthy volunteers or patients Healthy volunteers – for Pharmacokinetic properties (new drugs) Patients - Existing drug evaluation The Study Design : The Study Design Subject selection - Exclusion and inclusion criteria Predetermined by investigators Inclusion-exclusion mainly based on age (over 18), sex, date of diagnosis, stage of disease etc. Informed consent form - signed Allocation of groups Randomization: Each study subject is randomly assigned to receive either the study treatment or a placebo Blind: The subjects involved in the study do not know which study treatment they receive Single Blind and Double Blind Clinical trial – contd. : Clinical trial – contd. Control Group (C) and Test Group (T) Control group (C) – Placebo or an existing drug Test group (T) – Test drug Parallel group design – C and T runs simultaneously Cross over design – same subject as C and T End Point and sample size : End Point and sample size End point: Measure of the goal of the trial - predetermined cure, degree of improvement, symptom relief, survival or death etc. Sample size: The number of subjects are predetermined The larger the sample size or number of participants in the trial, the greater the statistical power Meta Analysis : Meta Analysis The application of statistical procedures to examine tests of a common hypothesis from more than one study. “The analysis of analyses” Size of the population of study is more Power of conclusion is more Cohort Study : Cohort Study Cohort is a group of individuals having some common features People taking same drug Occurrence of events – beneficial or adverse among users and non-users Primarily used for discovery of rare adverse events Retrospective or Prospective Case Control Study : Case Control Study Observational study To study the association of a suspected rare adverse event with use of particular drug Cases of suspected adverse events and a control group similar in other aspects (taking the drug) but without adverse events Case Control Study : Case Control Study Thank you : Thank you Important - Exams : Important - Exams Questions on Rational Use of Drugs Short questions on Clinical Trials Short question on EBM You do not have the permission to view this presentation. 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Rational Use of Drugs - drdhriti brahma Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 1332 Category: Science & Tech.. License: All Rights Reserved Like it (3) Dislike it (0) Added: November 11, 2010 This Presentation is Public Favorites: 1 Presentation Description A Power point presentation for understanding basics of Rational Use of Drugs by UG Medical Students. Comments Posting comment... By: brahma (16 month(s) ago) Thank you and nice to know that it was very helpful to you. You can send request to me for the ppt. presentation form your email id. Saving..... Post Reply Close Saving..... Edit Comment Close By: kedh (16 month(s) ago) kind regards. this presentation is very educative and it has been of tremendous help to me.please email me a copy of the presentation to enable me disseminate this very important information.thank you. Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Rational Use of Drugs and Evidence based Medicine : Rational Use of Drugs and Evidence based Medicine Department of Pharmacology NEIGRIHMS, Shillong Objectives : Objectives Definition of rational Use of Medicines Rationale behind rational use of medicines Reasons of irrational use of drugs Dangers of irrational drug use Steps to be taken for rational use of drugs Definition : Definition In simplest words rational use means “prescribing right drug, in adequate dose for the sufficient duration & appropriate to the clinical needs of the patient at lowest cost WHO: The rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community … contd. : … contd. Correct drug Appropriate indication Appropriate drug considering efficacy, safety, suitability for the patient, and cost Appropriate dosage, administration, duration No contraindications Correct dispensing, including appropriate information for patients Patient adherence to treatment Why Rational Use ? : Why Rational Use ? Drug explosion Efforts to prevent the development of resistance Growing awareness Increased cost of the treatment Consumer protection Act. (CPA) Slide 6: What to Give ? Rationality : Rationality REASONS FOR IRRATIONAL USE OF DRUGS : REASONS FOR IRRATIONAL USE OF DRUGS Lack of information – Nimesulide, enteroquinol Faulty & inadequate training & education of medical graduates Role models – Teachers or seniors Lack of diagnostic facilities/Uncertainty of diagnosis – medicine for all possible causes Demand from the patient – prompt and quick action Patient load Promotional activities of pharmaceutical industries Poor communication between health professional & patient Drug promotion and exaggerated claim by companies Defective drug supply system & ineffective drug regulation Hazards of Irrational Use : Hazards of Irrational Use Ineffective & unsafe treatment over-treatment of mild illness inadequate treatment of serious illness Exacerbation or prolongation of illness Distress & harm to patient Increase the cost of treatment Increased drug resistance - misuse of anti-infective drugs Increased Adverse Drug Events Increased morbidity and mortality Loss of patients confidence to doctor Overuse and misuse of AMAs - antimicrobial resistance : Overuse and misuse of AMAs - antimicrobial resistance Malaria choroquine resistance Tuberculosis primary multi-drug resistance Gonorrhea penicillin resistance in N. gonorrhea Pneumonia and bacterial meningitis penicillin resistance in S. pneumonia Diarrhea: shigellosis resistance AbsolutelyIrrational : AbsolutelyIrrational Injudicious use of antimicrobials: Antibiotics in Viral fever and diarrhea Unnecessary combinations: Nimesulide and paracetamol, Tinidazole and ciprofloxacin Use of drugs not related to diagnosis Incorrect route Incorrect dosing – under or overdose Incorrect duration – prolong or short term use Unnecessary use of expensive medicines Unsafe use of corticosteroids Polypharmacy Steps of rational drug use : Steps of rational drug use Step:- I Identify the patient’s problem based on symptoms & recognize the need for action Step:- II Diagnosis of the disease – define the diagnosis Step:- III List possible intervention or treatment (drug or no drug) – Identify the drug Step:- IV Start the treatment by writing an accurate & complete prescription e.g. name of drugs with dosage forms, dosage schedule & total duration of the treatment … contd. : … contd. Step:-V Given proper information instruction & warning regarding the treatment given e.g. side effects (ADR), dosage schedule & dangers/risk of stopping the therapy suddenly Step:-VI Monitor the treatment to check, if the particular treatment has solved the patient’s problem. Passive monitoring – done by the patient himself. Explain him what to do if the treatment is not effective or if too many side effect occurs Active monitoring - done by physician and he make an appointment to check the response of the treatment Instruction to the patients : Instruction to the patients Effects of the Drug Adverse effects Instructions Precautions to be taken Warning (Disulfiram Reaction): Symptoms: flushing of the skin accelerated heart rate shortness of breathe nausea, vomiting, throbbing headache visual disturbance mental confusion, postural fainting and circulatory collapse If we loose Rifampicin ???? Beware ! : If we loose Rifampicin ???? Beware ! The bacterial DNA-dependent RNA polymerase is inhibited by Rifampicin EVIDENCE BASED MEDICINE : EVIDENCE BASED MEDICINE What is EBM ? : What is EBM ? Definition: Process of systematically finding, evaluating and using contemporary research findings as the clinical basis of clinical decisions Evidence-based medicine (EBM) or Evidence-based practice (EBP) aims to apply the best available evidence gained from the scientific methods or studies in clinical decision making Therapeutic evaluation of a drug on the basis of available evidence in terms of Benefits, dosage, duration and patient selection Comparison with available drugs ADRs What are the sources of Evidence ? : What are the sources of Evidence ? Clinical trials Cohort studies Case Control Studies Clinical trials : Clinical trials Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols) on human subjects These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place Clinical trial : Clinical trial Initially pilot study is carried out followed by larger studies Human subject: Healthy volunteers or patients Healthy volunteers – for Pharmacokinetic properties (new drugs) Patients - Existing drug evaluation The Study Design : The Study Design Subject selection - Exclusion and inclusion criteria Predetermined by investigators Inclusion-exclusion mainly based on age (over 18), sex, date of diagnosis, stage of disease etc. Informed consent form - signed Allocation of groups Randomization: Each study subject is randomly assigned to receive either the study treatment or a placebo Blind: The subjects involved in the study do not know which study treatment they receive Single Blind and Double Blind Clinical trial – contd. : Clinical trial – contd. Control Group (C) and Test Group (T) Control group (C) – Placebo or an existing drug Test group (T) – Test drug Parallel group design – C and T runs simultaneously Cross over design – same subject as C and T End Point and sample size : End Point and sample size End point: Measure of the goal of the trial - predetermined cure, degree of improvement, symptom relief, survival or death etc. Sample size: The number of subjects are predetermined The larger the sample size or number of participants in the trial, the greater the statistical power Meta Analysis : Meta Analysis The application of statistical procedures to examine tests of a common hypothesis from more than one study. “The analysis of analyses” Size of the population of study is more Power of conclusion is more Cohort Study : Cohort Study Cohort is a group of individuals having some common features People taking same drug Occurrence of events – beneficial or adverse among users and non-users Primarily used for discovery of rare adverse events Retrospective or Prospective Case Control Study : Case Control Study Observational study To study the association of a suspected rare adverse event with use of particular drug Cases of suspected adverse events and a control group similar in other aspects (taking the drug) but without adverse events Case Control Study : Case Control Study Thank you : Thank you Important - Exams : Important - Exams Questions on Rational Use of Drugs Short questions on Clinical Trials Short question on EBM