Clinical Pharmacology · MU Sofia

1. Sources of unbiased medical information - Evidence Based Medicine (EBM): Definition, Class recommendation and Levels of evidence. Application in clinical practice.

Explains evidence-based medicine as the use of the best current evidence alongside clinical expertise and patient values, and sets out the WHO P-drug concept with its four comparative criteria of efficacy, safety, suitability and cost. Includes a table of levels of evidence A to D, a table of classes of recommendation I to III, and the steps for applying EBM through five stages, from asking a PICO question to assessing the outcome.

Inside: 3 sections · 3 tables · 16 flashcards · 3 min

Topic 1 of 30 in the MU Sofia syllabus for Clinical Pharmacology (Medicine, Year 5). The free AceMed note covers it in 3 sections, about 329 words (3 min of reading), with 16 flashcards.

In this note

  1. Introduction
  2. Rational pharmacotherapy and the WHO P-drug concept
  3. Evidence-based medicine (EBM)

Introduction

Clinical pharmacology and therapy is the clinical specialty of using drugs well in real patients: individualised, effective, efficient and safe treatment based on evidence. It differs from pharmacology, which studies drugs mostly in preclinical (animal) settings.

Rational pharmacotherapy and the WHO P-drug concept

Rational pharmacotherapy means the right drug, in the right dose and regimen, at a reasonable cost, matched to the needs of the individual patient. It needs a correct diagnosis, knowledge of the patient (co-morbidities, other drugs, preferences), knowledge of the drug's pharmacokinetics and pharmacodynamics, and monitoring of efficacy and safety.

WHO's P-drug (personal drug) is the doctor's own drug of first choice for a common condition, with its formulation, dosing regimen and duration. It is chosen by four comparative criteria:

The P-drug steps

  1. Define the problem and the treatment objective.
  2. Choose a drug group, then a drug within it, by efficacy, safety, suitability and cost (each can be scored and weighted).
  3. Check the P-drug suits this patient; start treatment.
  4. Inform and warn the patient: why, how and how long to take it, missed doses, expected benefit, adverse reactions, interactions with alcohol and other drugs.
  5. Monitor efficacy and safety.

P-drugs differ between countries and doctors (availability, cost, guidelines). Because no treatment is risk-free, every prescription is a benefit–risk decision. Objective drug information comes from the SmPC (Summary of Product Characteristics).

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