Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A Regulatory and Pharmacovigilance-Led Solution

Product shortages involving essential medicines can create significant clinical and regulatory challenges, particularly when vulnerable patient populations depend on uninterrupted access to treatment. Maintaining continuity of care while adhering to strict regulatory requirements requires close collaboration across regulatory affairs, medical information, pharmacovigilance, and healthcare providers.

A manufacturer experienced a prolonged shortage of a vitamin K formulation indicated for neonatal prophylaxis in Serbia, raising urgent concerns about maintaining care for newborns at risk of vitamin K deficiency bleeding (VKDB). Although an alternative formulation contained the same active ingredient and was scientifically suitable for substitution, local regulations prohibited any promotional communication supporting off-label use. As the Marketing Authorization Holder, ProPharma developed a compliant, regulatory-led solution that enabled healthcare institutions to obtain standardized scientific information through formal medical inquiry channels while reinforcing pharmacovigilance reporting and patient safety measures.