What are essential medicines and how can I avoid counterfeit medicines?

Essential Medicines and Avoiding Counterfeit Medications

Essential medicines are those that satisfy priority health care needs based on disease prevalence, clinical efficacy, safety, and cost-effectiveness, while counterfeit medicines—which account for 6-20% of drug sales globally—can be avoided through purchasing from WHO-certified suppliers, verifying proper storage conditions, and ensuring medications come from regulated supply chains. 1

What Are Essential Medicines?

Essential medicines represent a curated list of medications selected to address the most critical health needs of populations. 2, 3

• The WHO Essential Medicines List (EML), first published in 1977 and updated biennially, identifies medicines with proven efficacy, safety, and cost-effectiveness for conditions of significant public health relevance. 1, 2, 3

• Selection criteria include disease prevalence, public health relevance, evidence of clinical efficacy and safety, and comparative cost-effectiveness. 2, 3

• The EML serves as a guide for countries to develop national essential medicines lists, ensuring consistent availability within functioning health systems at affordable prices. 1

• Examples include basic medications like ibuprofen and paracetamol for pain management, as well as disease-specific treatments like methotrexate, hydroxychloroquine, and biologics (adalimumab, etanercept, infliximab) for chronic conditions. 1

The Counterfeit Medicine Problem

Counterfeit medications represent a critical threat to patient safety, with a median prevalence of 28.5% in low- and middle-income countries, and 93% of these containing inadequate amounts of active ingredients. 1

Types of Substandard Medications

• Counterfeit drugs are deliberately falsified products that may contain wrong ingredients, no active ingredients, or incorrect amounts of active ingredients—antibiotics are the most commonly counterfeited medication class. 1

• Expired medications that remain accessible to patients fall under the counterfeit/substandard category. 1

• Inadvertently substandard products result from improper manufacturing processes without deliberate intent to deceive. 1

• Degraded medications occur when heat- and moisture-labile drugs (many antibiotics) deteriorate in tropical conditions due to improper storage. 1

Clinical Consequences

• Lower-than-stated doses in antibiotics lead to selection of drug-resistant strains and therapeutic failure. 1

• Quality issues with generic production create a double-edged sword: while generics lower prices, diffused production complicates drug origination assessments and quality assurances. 1

• Weak pharmacovigilance systems in many low- and middle-income countries further compromise quality assurances. 1

How to Avoid Counterfeit Medicines

For Healthcare Providers and Institutions

Purchase only from WHO-certified suppliers using databases of reputable drug suppliers and formulations to guide procurement. 1

• Verify supplier credentials through WHO-certified lists of reputable drug suppliers that should be developed and maintained for national procurement. 1

• Implement robust supply chain mechanisms at the state level to ensure proper distribution from verified sources to communities. 1

• Establish strong regulatory oversight to ensure proper quality of medications and monitor availability and accessibility. 1

• Utilize interinstitutional knowledge sharing on drug quality through mobile technology platforms to facilitate improved post-marketing quality surveillance. 1

Storage and Handling Safeguards

• Ensure appropriate storage conditions since many medications are heat and moisture labile and deteriorate in ambient tropical conditions—this requires proper infrastructure and training. 1

• Verify proper storage throughout the supply chain from manufacturer to point of dispensing, as improper storage can render medications partly or totally inactive. 1

• Train pharmacists and bedside providers in safe and accurate preparation and administration of medications, particularly for injectable formulations. 1

Regulatory and Policy Approaches

• Support WHO-led harmonization of national regulatory regimes through regional collaboration to facilitate pooled procurement from verified sources. 1

• Advocate for policies that encourage use of quality-assured generic medications rather than unregulated alternatives. 1

• Implement point-of-care quality diagnostics using new, cost-effective methods to verify medication quality at the point of use. 1

• Establish regional partnerships with trusted producers to ensure reliable production processes and minimize introduction of harmful excipients. 1

Patient-Level Precautions

• Avoid purchasing medications from unregulated over-the-counter sources, as two-thirds of antibiotics are sold without written prescriptions in many settings. 1

• Use regulated healthcare facilities rather than alternative (non-medical) sellers who are often the first point of call but lack quality oversight. 1

• Verify medication packaging for proper labeling, batch numbers, and expiration dates before use. 1

Common Pitfalls to Avoid

• Do not assume lower price equals better value—paradoxically, reducing prices may disincentivize stocking of low-priced generics in favor of higher-priced branded products at point of purchase. 1

• Recognize that generic availability does not guarantee quality—the capacity for generic production diffuses manufacturing, complicating quality assurances. 1

• Understand that inadequate regulation of antimicrobial supplies has important consequences for antimicrobial resistance, especially where antibiotic choices are limited. 1

• Be aware that cultural and religious factors may affect medication acceptability and use, requiring additional patient education and engagement. 1