Joining Forces for Medication Safety: The Crucial Role of WHO and PAHO

By Latin American Federation of the Pharmaceutical Industry (FIFARMA)

At the heart of global public health, medication safety is a priority. The World Health Organization (WHO) and the Pan American Health Organization (PAHO) play an essential role in this area, especially in strengthening National Pharmacovigilance Systems. This blog explores how these authorities are working to ensure that the medications we use are safe and effective through the strengthening of national pharmacovigilance networks responsible for these processes.

The Importance of Pharmacovigilance

Pharmacovigilance is not just a technical term; it is a vital safeguard in the world of medicine. This discipline focuses on creating systems that constantly monitor the effects of the medications we take, ensuring they are safe and effective. Its work is essential because medications, while beneficial, can have side effects and risks. Pharmacovigilance helps identify and evaluate these risks, ensuring that the benefits of a medication outweigh its potential harm. This is essential not only for patients but also for healthcare professionals, as it provides vital information for making informed decisions about treatments. 

What Are WHO and PAHO Doing to Support the Strengthening of Medication Surveillance?

These two organizations have various initiatives and sources of support for national pharmacovigilance networks that allow for constant exploration of alternatives and options resulting in more robust surveillance and safety systems for the welfare of all patients. Among the different actions/initiatives carried out by these organizations, the following stand out:

1. Focus on Policy CSP30/11 - Policy for Strengthening National Regulatory Systems for Medicines and Other Health Technologies

Policy CSP30/11, adopted by PAHO, represents a milestone in strengthening regulatory systems for medicines and health technologies. This policy is not just a set of guidelines; it is a comprehensive action plan designed to address critical challenges and improve the safety and efficacy of medications in the Americas.

CSP30/11 focuses on several situations: 

• Quality and Safety of Medicines: Ensures that medicines and health technologies meet the highest standards of quality and safety throughout their lifecycle.
• Subregional and Multinational Regulatory Initiatives: Promotes collaboration among national regulatory authorities (NRAs) to improve efficiency and complement the development of regulatory functions, especially in contexts of limited resources.
• Equitable Access to Essential Medicines: Seeks to increase access to medicines and health technologies that are safe, affordable, clinically effective, and of guaranteed quality.

Additionally, this policy aims to address deficiencies in national systems by focusing on three areas. First, it strengthens regulatory systems to close gaps in the regulation and supervision of medicines, ensuring their quality and safety. Second, it actively works to reduce inequalities in access to safe and effective medicines, an essential step toward health equity. Finally, it promotes regulatory harmonization, facilitating the exchange of information and best practices among countries, resulting in more efficient and consistent management of medicines at the international level.

Finally, CSP30/11 stands out for its critical importance in three fundamental aspects. First, it establishes high standards of quality and safety for medicines and health technologies in the market, thus ensuring the protection of public health. Second, it promotes health equity by ensuring universal access to essential medicines, regardless of people's economic or geographic differences. Lastly, it significantly improves the responsiveness of health systems to health emergencies, as demonstrated during the COVID-19 pandemic, by reinforcing preparedness and response capacity in critical health situations.

2. Establishment of the PARF Network (The Pan American Network for Harmonization of Pharmaceutical Regulation)

This network is a shining example of how collaboration can lead to significant advances in public health. The PARF network brings together countries from across the Americas in a common effort to harmonize pharmaceutical regulation. Why is this important? Because by working together, countries can share best practices, learn from each other, and establish common standards. This not only improves the quality of medicines throughout the region but also facilitates access to safe and effective medicines for all, regardless of where they live.

3. As a practical example, WHO/PAHO support for the National Pharmacovigilance Strategy in Mexico

The National Pharmacovigilance Strategy in Mexico, with crucial support from PAHO to COFEPRIS, is an outstanding example of how pharmacovigilance systems can be improved at the national level. This strategy encompasses a comprehensive approach that monitors medicines from manufacturing to final dispensing to the patient, ensuring their quality and safety at each stage, prioritizing key aspects such as: 

• Comprehensive Monitoring: The strategy not only focuses on the final product but also monitors the entire manufacturing process. This includes verifying the quality of active ingredients, production processes, and manufacturing standards.
• Distribution and Storage: Special attention is paid to storage and distribution practices to ensure that medicines do not degrade or become contaminated during transportation and storage.
• Measures against Counterfeiting: The strategy implements rigorous measures to combat the counterfeiting of medicines, a serious problem that can endanger patients' health. This includes verifying the authenticity of products and traceability from manufacturer to consumer.
• Collaboration with Healthcare Professionals: The strategy actively involves healthcare professionals in the pharmacovigilance process, encouraging the reporting of any adverse effects or issues related to medicines.
• Education and Awareness: Part of the strategy includes education and awareness programs for healthcare professionals and the general public about the importance of pharmacovigilance and the safe use of medicines.

4. Collaboration with Strategic Partners in Public Health and Pharmacovigilance

Collaboration in pharmacovigilance with strategic partners such as the Brighton Collaboration, PAHO/WHO Collaborating Centers, the Epistemonikos Foundation, and The Uppsala Monitoring Centre is essential for strengthening research and development of vaccines and medicines. Each of these partners brings unique skills and knowledge crucial for improving the safety and efficacy of medical treatments.

Brighton Collaboration, with its focus on vaccine safety, helps standardize the assessment and reporting of adverse events, maintaining confidence in immunization programs. PAHO/WHO Collaborating Centers, including academic and research institutions, support training and policy development in health. The Epistemonikos Foundation provides access to vital scientific information, while The Uppsala Monitoring Centre Centre plays a key role in global monitoring of medication safety. This collective collaboration is essential to ensure that medicines and vaccines are safe and effective, benefiting patients worldwide.

In conclusion, the work carried out by WHO and PAHO in the field of pharmacovigilance is of great importance, profoundly and directly impacting our daily health. By ensuring the safety and efficacy of medications, these organizations play a crucial role in preventing adverse effects, leading to safer and more reliable treatments. This work not only alleviates patient concerns but also increases confidence in the medical treatments they receive. The ability to identify and manage risks associated with medications before they become major issues is a fundamental aspect of modern healthcare, contributing to a better quality of life for patients.

Furthermore, pharmacovigilance has a significant impact on the efficiency of healthcare systems. By preventing adverse side effects and better managing risks associated with medications, additional costs related to the treatment of unwanted complications are avoided. This not only saves valuable resources but also improves the sustainability of healthcare systems. Ultimately, pharmacovigilance is an essential tool to ensure that advances in medicine and pharmacology translate into tangible and safe benefits for public health, reinforcing WHO and PAHO's commitment to continuous improvement of healthcare worldwide.

Sources: 

• https://www.paho.org/es/temas/farmacovigilancia
• https://www.paho.org/es/temas/farmacovigilancia#:~:text=Respuesta%20de%20la%20OPS,la%20farmacovigilancia%20en%20los%20pa%C3%ADses.
• https://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0301-696X2018000100047
• https://www.paho.org/es/sistemas-servicios-salud/farmacovigilancia-activa
• /https://www.mspbs.gov.py/dependencias/dnvs/adjunto/9eea04-4.DocumentoTcnicoN5REDPARF.pdf
• https://www.paho.org/es/documentos/csp3011-politica-para-fortalecimiento-sistemas-regulatorios-nacionales-medicamentos