Every year on 17 September, the global health community comes together to commemorate World Patient Safety Day (WPSD). This pivotal initiative was established by the World Health Assembly to galvanize worldwide action in advancing the safety of health care. The day is not merely symbolic; it serves as a rallying call to patients, families, health workers, policymakers, researchers, and civil society to unite under a common purpose: to eliminate preventable harm in healthcare and safeguard the lives and well-being of patients.
For 2025, the theme, “Safe care for every newborn and every child”, places a spotlight on the most vulnerable among us: newborns and children who face disproportionately high risks of harm in healthcare settings. This theme emphasizes the urgency of addressing safety lapses in paediatric and neonatal care, strengthening systems, and building a culture of vigilance, learning, and accountability.
In this commemorative article, we explore the role of pharmacovigilance (PV), which refers to the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other medicine-related problems, in protecting patient safety, especially for newborns and children.
Why World Patient Safety Day Matters
Patient safety is the foundation of quality healthcare. Yet, the World Health Organization (WHO) estimates that one in every ten patients worldwide suffers harm while receiving care, and at least 50% of this harm is preventable. In low- and middle-income countries, unsafe care results in 2.6 million deaths annually, most of which are avoidable.
Children, especially newborns, are at heightened risk:
- Up to 97% of adverse events in neonatal intensive care units are preventable
- Rates of adverse events reach 91.6% in paediatric intensive care settings and 53.8% in general paediatric wards
- Many harms arise from medication errors, unsafe childbirth practices, infections, diagnostic delays, and lack of safety protocols.
WPSD 2025 sets out four key objectives:
- Raise global awareness of the safety challenges in paediatric and newborn care.
- Mobilize stakeholders to implement policies, training, and systems to reduce preventable harm.
- Empower families and children to participate in care decisions and safety education.
- Promote research and innovation in child and newborn safety practices.
This theme aligns perfectly with the mission of pharmacovigilance: to prevent harm caused by medicines, promote safe and effective medication use, and protect the health of patients across all ages.
Pharmacovigilance as a Pillar of Patient Safety
Pharmacovigilance (PV) is a critical health system function that aims to detect, assess, understand, and prevent adverse effects or other medicine-related problems. It acts as the early warning system for unsafe medicines and practices, helping to prevent harm before it spreads widely.
In the context of patient safety, pharmacovigilance contributes in three major ways:
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Detecting and evaluating risks early
PV systems collect and analyze reports of adverse drug reactions (ADRs) from healthcare providers, patients, and pharmaceutical companies. This allows early identification of safety signals, such as unexpected side effects or medication errors, especially in vulnerable groups like children. -
Implementing risk minimization actions
Once a risk is detected, PV authorities and companies can update product labels, issue safety alerts, restrict use, or withdraw unsafe medicines from the market to prevent further harm. -
Fostering a culture of safety and learning
PV promotes continuous learning among healthcare professionals by disseminating safety information, conducting training, and encouraging transparent reporting without blame.
In short, pharmacovigilance helps ensure that the benefits of medicines always outweigh their risks. This is a cornerstone of patient safety.
Why Pharmacovigilance Is Vital for Newborns and Children
While all patients deserve safe care, newborns and children face unique risks that make strong pharmacovigilance systems especially critical:
1. Developmental Vulnerability
Children’s organs and metabolic systems are still developing. They may respond differently to medicines than adults, with higher susceptibility to toxicity or altered drug metabolism.
2. Limited Clinical Trial Data
Most medicines used in children were originally tested in adults, meaning safety data for paediatric use is often limited. PV systems help fill this knowledge gap through post-marketing surveillance and real-world data.
3. High-Alert Medication Environments
Neonatal intensive care units (NICUs) and paediatric wards involve complex dosing, multiple medicines, and fragile patients. Even small errors in dosing or preparation can have life-threatening consequences.
4. Off-label and Unlicensed Use
Due to the lack of paediatric formulations, healthcare providers often use adult medicines in unlicensed or off-label ways for children. PV systems help track and evaluate safety outcomes in these contexts.
5. Early Detection to Prevent Lifelong Harm
An ADR in a newborn can cause lifelong disability or developmental issues. Pharmacovigilance allows for early detection and intervention, reducing the risk of long-term harm.
How Pharmacovigilance Improves Patient Safety Systems
Pharmacovigilance strengthens patient safety through system-wide actions that extend beyond detecting ADRs:
1. Building Robust ADR Reporting Systems
- Establishing national reporting centres (like NAFDAC in Nigeria) and hospital-level PV units.
- Creating digital ADR reporting tools and patient-friendly reporting channels.
- Training health workers and parents to recognize and report suspected adverse reactions.
2. Analyzing and Acting on Safety Data
- Using signal detection and risk assessment algorithms to identify safety issues quickly.
- Collaborating with regulatory authorities, hospitals, and pharmaceutical companies to take timely corrective measures.
3. Disseminating Safety Communications
- Issuing Drug Safety Alerts, Dear Healthcare Professional Letters, and public advisories.
- Updating product labelling, dosage recommendations, and contraindications based on new data.
4. Training Health Workers in Safe Use of Medicines
- Integrating PV and medication safety into medical, nursing, and pharmacy curricula.
- Conducting continuous professional development (CPD) workshops on safe prescribing, administration, and monitoring.
5. Engaging Families and Patients
- Educating parents and caregivers about safe medicine use, warning signs of ADRs, and the importance of active participation in safety reporting.
- Empowering them to ask questions, double-check medicines, and speak up if something seems wrong.
6. Driving Research and Innovation
- Supporting paediatric pharmacovigilance research to develop safer formulations, dosing tools, and error-prevention technologies.
- Encouraging collaborations between academia, industry, and regulators to close knowledge gaps.
These strategies transform PV from a passive reporting system into a proactive, integrated safety ecosystem that protects patients of all ages.
Case Example: Strengthening Pharmacovigilance in Nigeria
Countries like Nigeria have made significant strides in strengthening pharmacovigilance to protect patients. The National Agency for Food and Drug Administration and Control (NAFDAC) runs the National Pharmacovigilance Centre, which coordinates ADR reporting nationwide and aligns with the WHO Programme for International Drug Monitoring.
In recent years, Nigeria has:
- Deployed electronic reporting tools like VigiFlow and MedSafety App to capture ADRs from healthcare workers and patients.
- Conducted nationwide training of health professionals on PV and medication safety.
- Established hospital PV committees to monitor and respond to local safety incidents.
- Promoted paediatric ADR reporting in immunization and HIV treatment programmes.
These efforts demonstrate how robust pharmacovigilance infrastructure directly improves patient safety, especially for vulnerable populations like newborns and children.
Building a Culture of Safety: Everyone Has a Role
Pharmacovigilance is most effective when all stakeholders actively participate. Protecting children from harm requires a whole-of-society approach:
- Healthcare Professionals: Accurately prescribe, administer, and monitor medicines; report suspected ADRs promptly.
- Pharmaceutical Companies: Conduct rigorous safety monitoring of their products and share data transparently.
- Regulators: Enforce safety standards, act on safety signals, and educate the public.
- Academia and Researchers: Study ADR patterns, identify risk factors, and innovate safer practices.
- Parents and Caregivers: Stay informed, observe their child’s reactions to medicines, and report concerns.
- Children and Youth (where appropriate): Be engaged in their own care and safety education.
Call to Action: Making Every Dose Safer for Every Child
On this World Patient Safety Day 2025, let us reaffirm our collective commitment to “Safe care for every newborn and every child.” We can:
- Strengthen pharmacovigilance systems to detect and prevent harm early.
- Invest in training health workers on safe medication practices and ADR recognition.
- Promote family and patient engagement in medicine safety.
- Encourage reporting of all suspected ADRs, no matter how minor they seem.
- Support policies and funding that prioritize medication safety in paediatric care.
By doing so, we can turn the vision of patient safety into a daily reality, not just for some, but for every child, everywhere.
Final Thoughts
World Patient Safety Day is more than a date on the calendar. It is a movement to protect lives. Pharmacovigilance stands at the heart of this movement, serving as the watchful guardian of medicine safety.
As we celebrate this year’s theme, let us remember: every report matters, every action counts, and every child deserves safe care. Together, through strong pharmacovigilance and a culture of safety, we can build a future where no child is harmed by the medicines meant to heal them.
References
- WHO. Patient Safety. Key facts. 2023. https://www.who.int/news-room/fact-sheets/detail/patient-safety
- WHO. Global Patient Safety Action Plan 2021–2030. 2021.
- WHO. Newborn and Child Safety: World Patient Safety Day 2025 campaign materials (Preliminary data). 2024.
- Stockwell DC, Landrigan CP, Toomey SL et al. Adverse Events in Pediatric Inpatients: A Systematic Review and Meta-analysis. JAMA Pediatrics. 2018;172(12):1107–1115.
