Evidence-Based Medicine Overview

Evidence-Based Medicine & Rational Use of Drugs

• Evidence-based medicine (EBM) is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients and improving the health of populations.
• EBM uses a hierarchy of evidence to weigh up the relative importance of different types of evidence.
• Expert opinion can be biased and may not be evidence-based.
• Different groups of experts may produce different guidelines, which may reflect cultural attitudes and financial incentives to patient management.
• Randomized trials are considered to be more reliable than clinical experience.
• Meta-analysis is the systematic collation and synthesis of data across multiple studies.
• The hierarchy of evidence only applies if evidence comes from well-conducted studies; otherwise, poorly conducted clinical trials may be less valid than high-quality cohort studies.
• EBM practitioners should use quantitative data to assist in decision-making.
• EBM considers average effects, but variation (heterogeneity) should also be taken into account.
• EBM may recommend the same drug treatment, but EBM doctors are more likely to explain harms and benefits using numbers needed to treat or the probability or risk of an event.
• Examples of EBM stages include formulating a clear question, searching and critically appraising the evidence, applying it to individual patients, and considering preferences.
• PICO (Patient, Intervention, Comparator, Outcome) is an acronym used for formulating clinical questions.
• Evidence must be appraised to some degree.

Learning Objectives

• Understanding the importance of STGs, EMLs (Essential Medicines List), and ZNF (Zambia national formulary) in the treatment of diseases.
• Understanding the role of STGs, EMLs, and ZNF in rational use of medicines.
• Excluding Wikipedia as a source
• Databases for medical literature reviews include Medline, WHO site, and the Cochrane Collaboration.

Levels of Evidence

• Study designs should be evaluated according to the hierarchy of evidence.

Role of Clinical Trials on EBM

• The hierarchy of evidence only applies to well-conducted studies and poorly conducted trials may not be valid.

How Does EBM Affect Clinical Practice?

• EBM may lead to recommending the same drug treatment, but provide information on harm and benefits.
• EBM considers variations in patients' experiences.

Stages Undertaking EBM

• Formulating a clear clinical question.
• Searching for the relevant evidence.
• Critically appraising the evidence found.
• Applying the evidence to the unique patient's situation.
• Considering patient preferences and evidence generalizability.

Applying EBM in Practice

• Differentiate asthma from other causes of breathlessness in children.
• Evaluate long-term asthma symptoms and functional limitations.
• Evaluate role of allergens/chemicals in asthma development.

EBM Practice Continued

• Evaluate if maintenance of inhaled steroids is effective and cost-effective.

Finding Evidence

• Use validated scientific sources.
• Databases like Medline, WHO, UNICEF, and Cochrane Collaboration should be used.
• Utilize NHS Evidence website for EBM guidelines.
• Access data from scholar.google.com.

Standardization of Methodology

• Methodological checklists are useful tools to remind key aspects when reviewing study designs, analyses and interpretations.

Key Learning Points of EBM

• Study designs are appraised according to hierarchies of the study design and evidence.
• The number needed to treat to express EBM concepts is used.
• Domains of EBM include diagnosis, prognosis, etiology, treatment, and cost-effectiveness.
• Utilize the PICO framework to generate well-structured clinical questions.

Issue of Generalizability

• The relevance of the evidence to the specific patient considered is crucial.
• Subjectivity plays a role in deciding if evidence applies to a specific patient.
• Therapeutic trials may not include diverse populations.

Essential Medicines List & Formularies

• Essential medicines are chosen to meet priority health needs.
• Essential medicine selections are based on public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.
• Adequate amounts and quality of essential medicines are important to ensure that systems function well, and medicines are appropriately priced.

Why Promote Rational Use of Drugs

• Rational use of medicines is characterized by patients receiving the appropriate medication in an adequate dose for the appropriate amount of time, and at the minimum cost to both the patient and community.
• Incorrect use of drugs generates waste of resources and undermines quality of care.

Common Patterns of Inappropriate Drug Use

• Using too many medications.
• Incorrect use of antimicrobials.
• Overuse of injections
• Failure to prescribe based on clinical guidelines.
• Inappropriate self-medication.
• Improper drug prescription.
• Lack of access to medicines.
• Inappropriate use of interventions

Efforts to Improve the Use of Medicines

• Development of national medicine policies.
• Strengthening of drug regulation.
• Ensuring access to essential drugs.
• Improvement for rational use of medicines by providers and consumers.

Initial Shortfalls to RDU

• Health policymakers focused on the supply and regulation of medicines rather than on the consumer aspect of utilization.
• Evaluation of interventions for promoting rational drug use of consumers was insufficient.

1987 WHO Survey Findings

• Development of the PRDUC course.
• Enhanced understanding of medicine use in communities.
• Identification of effective community interventions to improve medicine use.
• Essential medicines are cost-effective.
• Essential medicines constitute a large part of health budgets in developing countries.

Challenges to Rational Drug Use

• Despite increased medicine costs, medicines are often inefficiently and irrationally managed.
• Inadequate training of health staff and lack of continuing education and supervision.
• Lack of updated, reliable, unbiased drug information.

Areas of Inefficiency and Drug Use Problem

• Poor selection of medicines based on efficacy , cost-effectiveness, and availability.
• Inefficient procurement practices, for non-availability, poor quality, wastage and unnecessary expenses.
• Prescribing inconsistent with standard protocols.
• Poor dispensing practices (resulting in errors) and patients' lack of knowledge about dosage schedules.
• Inconsistent patient adherence to treatment and dosage advice.

Consequences of Using Medicines to Meet Definition of RDU

• Undesirable health and economic outcomes.
• Insufficient therapeutic effect.
• Adverse drug reactions.
• Preventable side-effects and interactions.
• Resistance of microorganisms to antimicrobials and increased hospital admissions.
• Additional costs of medicine utilization.

Collective Action March 2004

• Essential medicines RDU can save lives and improve health when:
  • Available.
  • Affordable.
  • Assured quality.
  • Properly used.

Essential Medicines List and Formularies

• Essential medicines are those that address the priority health care needs of the population.
• Criteria for selection include public health relevance, efficacy and safety, and comparative cost-effectiveness.

Essential Medicines Availability

• Availability of essential medicines within functional health systems at all times is a priority.
• Sufficient quantities, appropriate dosage forms, assured quality, adequate information, and affordability are crucial.

Implementation of Concept of Essential Medicines

• The essential medicines concept should be flexible and adapt to different situations and remain a national responsibility.
• Total access to essential medicines has increased
• Medicine financing in developed countries covers significant parts of pharmaceuticals, whereas low and middle-income countries are unable to meet the basic medicine needs of a significant part of the population.

Challenges of Essential Drugs in Low and Middle-Income Countries (LMIC)

• High costs of treatment.
• Globalization and trade agreements may threaten access to newer essential medicines in LMIC.

Advantages of Essential Drug Lists, Treatment Guidelines, and National Formularies

• Access to medicines is supported by the concept of essential medicines.
• Common health problems can be addressed by few medicines.
• Training and experience can be tailored to focus on the most relevant medications to improve usage.
• Essential medicines procurement, distribution, and supply can be carried out efficiently by focusing on a limited number of medicines.
• Patients can better understand the use of effective medicines to improve healthcare.
• Equitable access to healthcare and essential medicines is a fundamental right.

Necessity for Essential Drug List Implementation

• Evolving suitable policies and action plans to improve access to essential medicines is a necessary step.
• Challenges of a complex nature exist in ensuring access to essential medicines for the public and private sectors involved.

Goals of National Treatment Guidelines

• Improve access to essential medicines.
• Rational selection and use of essential medicines based on best-available evidence(regarding efficacy, safety, quality, and cost-effectiveness).
• Develop a national list of essential medicines.
• Guidelines are used by stakeholders to make informed decisions (for procurement, reimbursement, and training).
• Encouraging local production of essential medicines of assured quality (when appropriate and feasible).

National Lists of Essential Medicines

• Rational use of essential medicines is a critical activity for health workers and patients.
• Essential medicine selection is the first step to ensure access.
• Standard treatment guidelines for common diseases are necessary at each level of healthcare.
• Safe and effective treatments and minimizing wastage are needed.
• Motivated health workforce and appropriate diagnostic equipment are necessary.