Nutrition and Dietetic Product Shortages are A Neglected Issue in Alerting Systems and in Registries

Context: Medicines shortages have become a global phenomenon and are recognized to affect all health systems. It is a problem that has grown to become a crisis in terms of delivering patient care. Over 1400 products were reported to be in shortage in the Netherlands between 2004 and 2011. In Switzerland, in April 2016 as much as 221 products were on shortage. 44 alerts were noticed within the latest 7 days. Shortages induce individuals’ suffering, bad clinical outcomes and additional costs for public health. Objective: The aim of this review is to evaluate whether nutrition and dietetic products are a neglected issue in shortages research. Method: Eight medicines shortages reporting systems, ten batch recall registries, and homepages of manufacturers were evaluated. Categories such as food for special medical purposes and dietary use, supplements, and infant formula were included. Results: Among the products in shortage, infant formula, micronutrient additives for parenteral nutrition, vitamin and trace elements products were most frequently affected. Infant formula and potassium chloride injection concentrates are repeatedly affected by shortages as well, mainly in Germany, since 2008. Only products for parenteral nutrition, vitamins, and trace elements for oral use are registered in medicines shortage registries. Conclusion: It is highly desirable to include clinically used nutrition and dietetic products in registries. Artificial legal delimitation between food and medicines not reflecting natural commonalities impairs inclusion of nutritional products in reporting systems. It is likely that dietitians are not accus-tomed to report incidences to contribute to improved patient safety and to prevent further incidences of shortages. A rigid regulation revealed to be one of the driving forces for threat to shortage. The milder impact of the less rigid regulatory frame in food industry as compared to pharma industry is likely to facilitate an undisrupted supply chain.