Essential Medicines and Counterfeit Medicines: Definitions and Global Health Impact
Essential Medicines
Essential medicines are those deemed necessary for a basic health care system to function effectively, addressing the most important health care needs while being cost-effective, safe, and readily available. 1
WHO Model List of Essential Medicines
The WHO Model List of Essential Medicines (EML) prioritizes medicines with significant global public health value and serves as a guide for countries to develop or update national essential medicines lists. 1
The EML aims to address priority health-care needs by identifying the most effective, safe, and cost-efficient medicines for conditions of significant public health relevance. 1
Essential medicines should be consistently available within functioning health systems in appropriate dosage forms, with assured quality, and at prices affordable for both individuals and health-care systems. 1
Examples Across Disease Categories
For paediatric rheumatic diseases: ibuprofen, paracetamol (pain management), hydroxychloroquine, methotrexate, acetylsalicylic acid, triamcinolone, and biologics like adalimumab, etanercept, or infliximab (including biosimilars) are classified as essential. 1
For antibiotics: The WHO AWaRe classification categorizes 41 essential antibiotics for over 30 clinical infections, providing empirical guidance for both primary health care and hospital settings. 1
Critical Access Challenges
Access to essential medicines is vital to achieving health equity and the UN Sustainable Development Goal 3 target of reducing premature mortality from noncommunicable diseases by one-third by 2030. 1
In low- and lower-middle-income countries (LMICs), only 31% of respondents reported reasonable access to essential medications in community settings, compared to 80% in tertiary health care settings. 1
Up to 90% of the population in LMICs purchase medicines through out-of-pocket payments, making medicines the largest family expenditure item after food. 1
Financial pressures often mean patients purchase medicines on a daily basis, so treatment courses are frequently not completed or never started. 1
Counterfeit Medicines
Counterfeit medicines are those deliberately and fraudulently mislabeled regarding their identity and/or source, representing an unpredictable risk to public health and leading to loss of confidence in medicines, healthcare providers, and health systems. 2, 3
Defining Characteristics
Counterfeit medicines may include products with correct or wrong ingredients; without active ingredients; with insufficient or excessive active ingredients; or with fake packaging. 2
All kinds of medicines have been counterfeited, both branded and generic products, including drugs, vaccines, excipients, active substances, medical supplies, and devices. 2, 3
Counterfeits are always inferior in quality, safety, and efficacy compared to original pharmaceuticals. 3
Global Prevalence
The WHO estimates that up to 1% of medicines in developed countries are counterfeit, rising to 10% globally, and reaching 50% in some developing countries. 2
The WHO estimates that 50% of medicines available via the internet are counterfeit. 2
It is estimated that 5% of all world trade in branded goods is counterfeit, leading to massive financial losses for the pharmaceutical industry. 4
Health Risks and Consequences
The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. 4
Adverse health effects, including death, have resulted from using counterfeit medications. 5
Consumers who self-medicate without appropriate healthcare system interactions rarely receive adequate healthcare. 5
Counterfeit products often lack the purported drug compound, have variable concentrations of active ingredients, and sometimes contain dangerous toxins. 5
Distribution Channels
The Internet provides a large, convenient route for counterfeiters to reach potential buyers with unregulated, often dangerous products. 5
The majority of medicines purchased via unverified Internet sites are counterfeit. 5
Although many consumers acknowledge some degree of risk with purchasing medications via the Internet, speed, convenience, and cost often prompt these purchases. 5
Counterfeit medications have also been detected in the legitimate supply chain, but represent a significantly smaller proportion of sales than those purchased via the Internet. 5
COVID-19 Pandemic Impact
The COVID-19 pandemic created a combination of public health emergency, economic distress, and misinformation-driven panic that made access to high-quality essential medicines problematic and pushed consumers and vendors even more towards counterfeit pharmaceuticals. 3
Before the pandemic, a constant trend of increased trafficking was already reported, which accelerated during COVID-19. 3
Prevention and Detection
The crucial step in prevention is to obtain supplies from reliable sources, specifically licensed pharmacies. 2
Healthcare professionals are the most important players in campaigns against counterfeit medicines and should stay vigilant, report suspicious products, and consider counterfeits as a possible cause of adverse reactions or therapeutic failure. 2
Patients should inform their pharmacists and doctors if they suspect any irregularity concerning their medication, experience side effects, or notice a decrease in beneficial effect. 2
Strong regulatory agencies are essential, and initiatives can only be successful if all parties concerned actively cooperate. 4
Pilot programmes in Europe have demonstrated that product verification systems prevent penetration of counterfeit products into the legitimate supply chain. 5