Evidence-Based Medicine & Rational Drug Use PDF

1 Evidence Based Medicine & Rational use of Drugs Standard Treatment Guidelines (STG), Essential Medicines List and Formularies & Role in Rational use of Medicine DR. T. N CHIDUMAYO  2 Evidence Based Medicine & Rational use of Drugs LEARNING OBJECTIVES EBM...

1 Evidence Based Medicine & Rational use of Drugs Standard Treatment Guidelines (STG), Essential Medicines List and Formularies & Role in Rational use of Medicine DR. T. N CHIDUMAYO  2 Evidence Based Medicine & Rational use of Drugs LEARNING OBJECTIVES EBM 3 Explain concept of Explain need for Describe elements evidence-based- evidence-based of evidence- medicine clinical practice based medicine Describe various List examples of Describe benefits types of medical databases & challenges of literature articles available for evidence-based- used in evidence- medical literature medicine based-medicine review  4 ‘The conscientious, explicit and judicious use of current best evidence in making What is decisions about the care of individual evidence- patients and improving the health of populations’ (David Sackett et al.) based medicine? Uses hierarchy of evidence to help weigh up relative importance of different types of evidence Levels Of Evidence 5  6 Evidence must be appraised it to some degree. Much ‘evidence’ is based on expert or consensus opinion Expert May not be evidence-based opinion The evidence can be biased. Different groups of experts may produce different guidelines. May reflect cultural attitudes, and financial incentives to patient management.  7 Consider clinical experience in absence of good-quality trials Levels of Evidence from more than one study by Evidence systematically collating and synthesizing data across all studies is called meta- analysis Randomized trials are placed above clinical experience  8 Role of Clinical trials on EBM Hierarchy of evidence ordering only applies if evidence from each type of study design comes from well-conducted studies. Otherwise, this may be misleading Poorly conducted clinical trial may be less valid than data from a high-quality cohort study EBM compared to non-EBM practitioners should use quantitative data to help them and patients decide on management options  9 Practitioners may recommend same drug treatment; the EBM doctor more likely to explain harms & benefits by using information on the number needed to treat or the probability or risk of an event How does Describes an average effect which may not reflect the experience of the patient in front of them. Variation EBM affect (heterogeneity) takes this into account to some degree. clinical practice? E.G, after a myocardial infarction, the benefits of aspirin in preventing future cardiovascular events outweigh harm from bleeding Recent research suggests that aspirin may now also reduce the risk of cancer and metastatic spread.  10 Stages Undertaking of EBM There are several steps in being an EBM practitioner Formulate a clear question. Search for the evidence. Critically appraise the evidence. Apply the evidence (or not) to the individual patient or population as appropriate. Generalizability of evidence & considering patients‘ preferences is important in applying evidence to individuals. Sackett coined the acronym PICO (Patient, Intervention, Comparator, Outcome) as a helpful tool in formulating EBM questions.  11 Applying EBM in practice A pediatrician encounters a child who has recently been admitted with their first episode of shortness of breath which was subsequently diagnosed as asthma. Consider the following questions: What is the most useful diagnostic test (or set of tests) to differentiate asthma in a child from other causes of shortness of breath? Will this child have persistent asthma symptoms in adulthood, and will this have any long-term functional limitations? Did exposure to allergens or chemicals in childhood have a role in their development of asthma?  12 Will maintenance of inhaled steroids reduce the likelihood of future admissions and are they cost-effective? EBM practice What is the evidence that EBM changes the way we practice? cont. Most assessed knowledge and found that some form of teaching (workshop, journal club, seminars, etc) improved understanding and knowledge and critical appraisal skills.  13 Use scientific validated sources of information, google and Wikipedia are not validated sources Database search (e.g., Medline, https://www.who.int/, https://www.cdc.gov/index.htm ) Finding Databases such as the Cochrane collaboration Evidence (http://www.cochrane.org/) In the United Kingdom, the NHS evidence website (https://www.evidence.nhs.uk/) provides a portal to other sources of evidence including EBM guidelines https://scholar.google.com/  14 There are several methodological checklists: Standardization of Checklists are a useful reminders of key aspects of study design, analysis and interpretation that Methodology can go wrong. When applied blindly there is a danger of rejecting evidence based on some methodological problem. (see http://www.unisa.edu.au/cahe/CAHECATS/ such as CONSORT (single trials), STROBE (observational studies), PRISMA (systematic review and meta-analysis of trials) MOOSE (meta-analysis of observational studies), STREGA (genetic association studies)  15 Study designs should be evaluated according to the hierarchy of evidence. Key EBM tries to use evidence in an explicit fashion Learning by quantifying benefits and harms using concepts such as the numbers need to treat. Points of EBM The five EBM domains are diagnosis, prognosis, etiology, treatment and cost-effectiveness. PICO is a useful acronym to formulate clear EBM questions.  16 Is the evidence relevant to the patient that generated the question in the first place? Issue of There will always be an element of subjectivity in such a decision. generalizability Apply external knowledge such as pharmacology to decide whether the findings in one population should or should not apply to another Many therapeutic trials do not include many ethnic minority patients so a benefit seen in a Caucasian population may or may not apply to South Asian patients.  17 Essential Medicines List and Formularies & Role in Rational use of Medicine  18 Learning Objectives  Understand the importance of the STG, essential medicines list(EML) and the Zambia national formulary (ZNF) in the treatment of disease.  Understand the role of STGs, EMLs and ZNF in the rational use of medicines.  19 Since the 1980s the essential drugs concept has become one of the cornerstones of international and national Why health policy. Promote WHO defined rational use of drugs as the situation in Rational Use which ‘Patients receive medications appropriate to their clinical needs, in doses that meet their own individual of Drugs requirements, for an adequate period of time, and at the lowest cost to them and their community’ (WHO, 1985). Inappropriate use of medicines wastes resources and seriously undermines quality of patient care.  20 Common Patterns of Inappropriate/ Irrational Drug Use Using too many medicines per patient. Inappropriate use of antimicrobials. Over‐use of injections. Failure to prescribe according to clinical guidelines. Inappropriate self‐medication (WHO, 2002; Hardon, Hodgkin and Fresle, 2004). Improper prescription. Inappropriate use of interventions. lack of access to medicines. Efforts to improve the use of medicines 21 Development of national medicines policies. Strengthening of drug regulation. Ensuring access to essential medicines. Efforts to improve the rational use of medicines by providers and consumers. Creation of: Zambian National treatment guidelines (HIV, Malaria, TB). Zambian National Formulary by Ministry of Health and BNF (British National Formulary). Zambian Essential Drugs List.  22 Health policy‐makers tended to focus more on the provision, regulation of medicines and improve health workers’ prescribing habits, rather than on Initial efforts to ensure rational use of medicines by consumers. Shortfalls to RDU A 1997 global survey of consumer‐oriented interventions aimed at improving the rational use of medicines, revealed few interventions had been designed appropriately, most were non‐sustainable, and there had been very little monitoring and evaluation of interventions (WHO, 1997).  23 1987 WHO survey findings prompted  Essential Drugs and Medicines Policy Department of WHO, the Medical Anthropology Unit of the University of Amsterdam and KIT to design the PRDUC course.  Develop a better understanding of medicine use in community  Design, implement and evaluate effective interventions that improve medicine use in the community.  Essential medicines are one of the most cost-effective ways of saving lives and improving health.  EM constitute 20–40% of health budgets in many developing countries.  Increasing costs and lack of resources result in public health systems unable to procure sufficient medicines to meet patient demand.  24 Challenges to Rational Drug Use  Despite increased costs, medicines are often managed and used inefficiently and irrationally: 1. Inadequate training of health staff. 2. lack of continuing education and supervision. 3. lack of updated, reliable, unbiased drug information.  25 Poor selection of medicines, without consideration for relative efficacy, cost-effectiveness or local availability. Areas of Inefficient procurement practices, resulting in non- availability, inadequate quality, wastage, or use of Inefficiency unnecessarily expensive medicines. and Drug Prescribing not in accordance with standard treatment protocols. Use Problems Poor dispensing practices resulting in medication errors, and patients’ lack of knowledge about dosing schedules. Patients not adhering to dosing schedules and treatment advice. Consequences of Using Medicines to Meet 26 Definition of RDU  Undesirable health and/or economic outcomes: 1. Insufficient therapeutic effect 2. Adverse drug reactions 3. Preventable side-effects and interactions from medicines 4. Increasing resistance of bacterial pathogens to antimicrobial medicines; result in increased or prolonged hospital admissions. Expensive Collective action March 2004 27  World Health Organization Geneva Essential medicines RDU can save lives and improve health when:  Available  Affordable  Assured quality  Properly used  28 Essential Medicines List and Formularies  29 “Essential medicines are those Role that satisfy the priority health Zambian care needs of the population” Essential Drug List and They are selected with due Treatment regard to: guidelines Public health relevance. Evidence on efficacy and safety. Comparative cost-effectiveness.  30 Essential Medicines Availability  Within the context of functioning health systems at all times:  Adequate amounts  Appropriate dosage forms  Assured quality  Adequate information  At a price the individual and the community can afford.  31 Should be flexible and adaptable to many different situations “Which medicines are regarded as essential remains a national responsibility.” Implementation Total number of people with access to essential of Concept of medicines has increased. Essential Medicines Medicine financing in many high-income countries, cover 70% of pharmaceuticals. Low & middle-income countries public medicine expenditure does not cover the basic medicine needs of the majority of the population.  32 50% to 90% of medicines are paid for by Challenges patients of Essential drugs in Low & Middle- Treatment costs are high Income Countries Globalization -global trade agreements can (LMIC) threaten access to newer essential medicines in low-and middle-income countries  33 Advantages of Essential drug lists, Treatment guidelines and National Formularies Access to medicines is supported by the principles of the essential medicines concept. Common health problems for the majority of the population can be treated with a small number of carefully selected medicines. Individual health professionals routinely use fewer than 50 different medicines. WHO Model List of Essential Medicines contains about 300 active substances. Training and clinical experience should focus on the proper use of those few medicines (National Drug Formulary, National treatment guidelines). Procurement, distribution and other supply activities can be carried out most efficiently for a limited number of pharmaceutical products.  34 Patients better informed about the effective use of medicines by health professionals. Advantages of EDL, STG, Access to health care and essential & National medicines is part fundamental right to Formularies health. cont. All countries have to work towards the equitable access to health services and commodities, necessary for the prevention and treatment of prevalent diseases.  35 Appropriate policies and action plans. Necessity for Essential Drug List The Access Framework Implementation Improving access to essential medicines. Most complex challenge for public, private and NGO sectors involved in the field of medicines supply. Goals of National Treatment Guidelines 36 Improve Improve access to essential medicines. Checklist for policy makers: Rational selection and Check use of essential medicines. Based on the best available evidence concerning Based efficacy, safety, quality, and cost-effectiveness. Develop Develop a national list of essential medicines.  37 Use for procurement, reimbursement, & training. Goals of National Encourage local production of essential medicines of assured quality when appropriate and feasible. Treatment Guidelines Defined by WHO as systematically developed, evidence- based statements to assist providers, patients and other cont. stakeholders make informed decisions about appropriate health interventions. Mostly been used to advise practitioners on which interventions to use in their interactions with patients.  38 Rational use of essential medicines is one of the core activities of health workers and patients (Drug Therapeutics Committee). National lists Careful selection of essential medicines is the first step in ensuring access. of essential Should be developed for different levels of care as medicines standard treatment guidelines for common conditions treated at each level. Ensure safe and effective treatments, minimizing the risks and waste linked to irrational prescribing and use of medicines. Trained and motivated health staff Necessary diagnostic equipment