Rational Use of Drugs and Evidence based Medicine

Department of PharmacologyNEIGRIHMS, Shillong

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 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. 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 ?

Drug explosion Efforts to prevent the development of

resistance Growing awareness Increased cost of the treatment Consumer protection Act. (CPA)

What to Give ?

Rationality

REASONS FOR IRRATIONAL USE OF DRUGS 1. Lack of information – Nimesulide, enteroquinol2. Faulty & inadequate training & education of medical

graduates3. Role models – Teachers or seniors4. Lack of diagnostic facilities/Uncertainty of diagnosis –

medicine for all possible causes 5. Demand from the patient – prompt and quick action6. Patient load7. Promotional activities of pharmaceutical industries8. Poor communication between health professional &

patient9. Drug promotion and exaggerated claim by companies10. Defective drug supply system & ineffective drug

regulation

Hazards of Irrational Use1. Ineffective & unsafe treatment

over-treatment of mild illness inadequate treatment of serious illness

2. Exacerbation or prolongation of illness3. Distress & harm to patient4. Increase the cost of treatment5. Increased drug resistance - misuse of anti-

infective drugs 6. Increased Adverse Drug Events7. Increased morbidity and mortality8. Loss of patients confidence to doctor

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

AbsolutelyIrrational1. Injudicious use of antimicrobials: Antibiotics

in Viral fever and diarrhea2. Unnecessary combinations: Nimesulide and

paracetamol, Tinidazole and ciprofloxacin3. Use of drugs not related to diagnosis4. Incorrect route5. Incorrect dosing – under or overdose6. Incorrect duration – prolong or short term

use7. Unnecessary use of expensive medicines8. Unsafe use of corticosteroids9. Polypharmacy

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. 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

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 !

The bacterial DNA-dependent RNA polymerase is inhibited by Rifampicin

EVIDENCE BASED MEDICINE

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 ?

Clinical trials Cohort studies Case Control Studies

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

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 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. 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: 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

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 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 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

Thank you

Important - Exams

Questions on Rational Use of Drugs Short questions on Clinical Trials Short question on EBM