Recommended system for surveillance and reporting of problems with large-volume parenterals in hospitals.
Recommendations regarding the detection, confirmation and notification of problems associated with the use of large-volume parenterals at the hospital level are presented. The recommendations are given in a stepwise manner, and include graphic outlines of the evaluation and reporting processes for both product- and patient-signaled problems associated with large-volume parenterals. It is recommended that each hospital appoint a product control officer who would coordinate the hospital's reporting of large-volume parenteral problems.
D004340:Drug Contamination / Q000517:prevention & control*; D006801:Humans; D007263:Infusions, Parenteral; D008722:Methods; D010361:Patients; D010605:Pharmacy Administration; D010607:Pharmacy Service, Hospital; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration