Rational Prescription of Medicines
Objectives
PRM is meant to train future clinicians in the selection and practical use of medicines. Besides the practical aspects linked to the pharmacological treatment of common diseases, the patient perspective will also take into account factors such as co-morbidities, drug interactions and use of medications in the context of systemic diseases.
Specific objectives:
-Basic notions of pharmacoeconomy, pharmacoepidemiology and pharmacosurveillance.
-Critical appraisal of the concept of Evidence Based Medicine (EBM). Practical integration of EBM in the treatment of patients with chronic diseases and multiple pathologies.
-Therapeutic implications and research into pharmacological treatment compared to conventional treatment.
-Practical applications of treatment knowledge into the most common disorders of a systemic nature.
-Understanding of the factors that bias the treatment of the chronic patient with particular regard to polypharmacy, and analysis of its risks and of its clinical, economical and social implications.
General characterization
Code
11210
Credits
3
Responsible teacher
Prof. Doutor José Delgado Alves
Hours
Weekly - Available soon
Total - Available soon
Teaching language
Portuguese
Prerequisites
Bibliography
Após cada aula teórica serão disponibilizados no Moodle os diapositivos principais utilizados na aula e as referências bibliográficas específicas.
1 Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology. A Basic Science for Clinical Medicine. Second Edition. Little, Brown and Company; 1991.
2 Piantadosi S. Clinical Trials. A Methodological Perspective. Third Edition. Wiley - Interscience; 2017.
3 Brunton L, Chabner B, Knollman B. Goodman and Gilmans The Pharmacological Basis of Therapeutics, 13th Edition, McGraw- Hill, 2017.
4 Strom BL, Stephen EK. Textbook of Pharmacoepidemiology. Fourth edition, eletronic edition. John Wiley & Sons, LTD; 2013.
5 Katzung BG, Masters SB, Trevor AJ. Basic and Clinical Pharmacology, 14th Edition.McGraw Hill Companies, Inc. 2017.
6 Rothman KJ, Greenland S, Lash TL. Modern Epidemiology, 3rd Edition 2008 Lippincott Williams & Wilkins
7 Textbook of Pharmacoepidemiology. Eds, Brian L Strom, Stephen E Kimmel. 4th ed, 2013. John Wiley and Sons Ltd.
8 Note for guidance on Statistical Principles for Clinical Trials. CPMP/ICH/363/96. European Medicines Agency (1998).
9 Points to consider on switching between superiority and non-inferiority. CPMP/EWP/482/99. European Medicines Agency (2000).
10 Choice of Control Group in Clinical Trials. CPMP/ICH/364/96. European Medicines Agency (2001).
11 Guideline on the choice of the non-inferiority margin. EMEA/CPMP/EWP/2158/99. European Medicines Agency (2005).
12 Guideline on clinical trials in small populations. CHMP/EWP/83561/2005. European Medicines Agency (2006).
13 Guideline on adjustment for baseline covariates in clinical trials. EMA/CHMP/295050/2013. European Medicines Agency (2015).
14 Monteiro C et al. Interacções medicamentosas como causa de iatrogenia evitável. Rev Port Clin Geral 2007;23:63-73
15 Valor Terapêutico Acrescentado. CF Ribeiro. Rev Port Clin Geral 2008; 24:723-8
16 Avaliação Económica de programas de saúde. Lourenço O, Silva V. Rev Port Clin Geral 2008;24:729-52
17 Plano Nacional de Saúde 2011-2016. Política do medicamento, dispositivos médicos e avaliação de tecnologias em saúde. Alto comissariado da Saúde.
18 Guyatt, Oxman et al. GRADE guidelines: A new series of articles in the Journal of Clinical Epidemiology. Journal of Clinical Epidemiology; 64 (2011) 380-382
19 Guyatt, Oxman et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. Journal of Clinical Epidemiology; 64 (2011) 395-400
20 GRADE guidelines: 7. Rating the quality of evidenced inconsistency. Journal of Clinical Epidemiology; 64 (2011) 1294-1302
21 GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. Journal of Clinical Epidemiology; 66 (2013) 151-157
22 GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. Journal of Clinical Epidemiology; 66 (2013) 719-725
23 Glenny AM, Altman DG et al. Indirect comparisons of competing interventions. Health Technology Assessment 2005; 9(26)
24 Guideline Comparators and Comparisons: direct and indirect comparisons. EunetHTA. Adapted version (2015)
Teaching method
The curricular unit of Rational Prescribing of Drugs runs over a semester. It has 3ECTs that correspond to two hours of theoretical teaching per week of 110 minutes duration.
Because of the nature of the topics discussed, some of teaching sessions may be delivered as seminars with all students present at the same time.
Evaluation method
The evaluation will be carried out by a written exam of 40 multiple choice questions with 5 options and with 1 correct answer.
Students that obtain a score of 9.5 or higher will pass.
Improvement of the pass score can be done by repeating the exam after a defined time. The final score will be the highest score achieved in any attempt.
Subject matter
-Adverse effects and drug interaction: pharmacovigilance.
-Basic notions of pahrmacoeconomy and of the type of studies required to validate the concepts
-Concepts of pharmacoepidemiology and its fundamental principles
-Concept of Evidence Based Medicine: protocols, clinical guidance and levels of reccommendations.
-Therapeutic implications and research into pharmacological treatment compared to conventional treatments
-Knowledge and application of common treatments according to the most common disorders of a systemic nature: cardiometabolic diseases (arterial hypertension, heart failure, diabetes mellitus), inflammation and pain management and antimicrobial treatment.
New therapeutic approaches com a predictable future impact: immunossupression, gene therapy and stem cells.
-Therapeutic management of the chronic patient and the elderly patient.
- Polypharmacy: current status, risks and clinical, economical and social implications.