Spotlight Case

1. Spotlight Case Total Parenteral Nutrition, Multifarious Errors

2. Source and Credits • This presentation is based on the April 2013AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available • Commentary by: Joseph I. Boullata, PharmD, RPh, BCNSP, University of Pennsylvania, School of Nursing • Editor, AHRQ WebM&M: Robert M. Wachter, MD • Spotlight Editor: Bradley A. Sharpe, MD • Managing Editor: Erin E. Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Define parenteral nutrition (PN) • Describe the PN-use process • Identify potential PN-related medication errors • Describe methods to reduce PN-related errors

4. Case: Errors with PN A 3-year-old boy on chronic total parenteral nutrition (TPN) due to multiple intestinal resections was admitted to an academic medical center for anemia. The boy had multiple recent admissions for anemia and infections. Unable to take anything by mouth, he had been completely dependent on TPN for nutrition and fluid intake for more than a year. The boy had been doing well at home when he began having small amounts of bloody output from his ostomy site. His mother brought him to the hospital and he was admitted for evaluation of the anemia. At the time of admission he was continued on his home TPN regimen.

5. Background: Parenteral Nutrition • Parenteral nutrition (PN) support refers to the provision of calories, amino acids, electrolytes, vitamins, minerals, trace elements, and fluids via an intravenous route  • PN includes total parenteral nutrition (TPN) where patients receive all of their nutritional needs intravenously through a central line • PN also includes partial parenteral nutrition (PPN) and hyperalimentation See Notes for reference.

6. Background: Parenteral Nutrition (2) • Life-sustaining therapy for individuals who cannot maintain or improve their nutrition status through oral or enteral route • Over 350,000 hospitalizations per year include PN, and tens of thousands of patients continue PN use at home • Anticipated adverse effects of PN • Related to intravenous access (e.g., thrombosis, bloodstream infection) • Related to metabolic homeostasis (e.g., hyper- or hypoglycemia, fluid and electrolyte problems) See Notes for references.

7. PN: a High-Alert “Medication” • High-alert medications, by definition, involve risk for significant harm when used in error • PN is characterized as a high-alert medication • Safeguards are required to minimize risk of errors with PN • Errors in PN-use process may be more dangerous than risks with PN ingredients and mixing See Notes for reference.

8. PN-Use Process • PN-use process refers to numerous steps in providing PN therapy including: • Prescribing • Order review • Preparation • Labeling • Dispensing • Administration • Monitoring See Notes for reference.

9. PN and Errors • Although errors are known to occur, limited literature is available • Few organizations capture or share these errors internally • A lone prospective observational study at one institution identified 74 PN-related medication errors (16 per 1000 PN prescriptions) • Most errors occurred during transcription (39%), preparation (24%), and administration (35%) • Nearly 10% of errors identified resulted in or contributed to patient harm See Notes for references.

10. Making PN Use Safer • Ideally the processes should be standardized and experts should be involved • Institutions should manage an adequate volume of PN patients to maintain expertise • Caregivers involved with PN should work within an interdisciplinary setting that includes physicians, nurses, pharmacists, and dietitians, at least one of whom is board certified in nutrition support See Notes for reference.

11. Making PN Use Safer (2) • Despite being a complex and high-alert medication, only 58% of organizations have safeguards to prevent patient harm from errors in PN-use process • To help minimize errors, practice guidelines and recommendations (based on evidence or generally accepted practices) are available from national organizations See Notes for references.

12. PN Guidelines • The American Society for Parenteral & Enteral Nutrition (ASPEN) has published guidelines for safe PN practice guidelines • Unfortunately, adherence to these guidelines has been poor See Notes for references.

13. Transitions in Care and PN • High risk of error with PN during transitions in care • One major factor is lack of prescription uniformity between institutions and across patient care settings • For example, varied units-of-measure can cause significant errors, especially during transitions between hospital and home See Notes for reference.

14. Case: Errors with PN (2) On hospital day 2, the patient’s serum sodium was noted by the team to be low at 130 mEq/L (normal 135−145 mEq/L). The team ordered an increase in sodium in the TPN from 5.2 mEq/kg/day to 5.5 mEq/kg/day, based on a standard formula. The new TPN with increased sodium began infusing at 9:00 PM. Overnight, the boy complained of worsening abdominal pain, which was treated with increased doses of intravenous opiates. He also complained of new headache and was irritable and could not be consoled.

15. Case: Errors with PN (3) In the morning, labs were notable for serum sodium of 158 mEq/L, which was confirmed on recheck. At first, the acute hypernatremia was attributed to dehydration. On rounds, the resident examined the TPN bag and saw a sodium concentration of 55 mEq/kg/day (a 10-fold increase of the intended sodium concentration of 5.5 mEq/kg/day). TPN was immediately stopped and the boy was given free water intravenously to correct severe hypernatremia, which took more than 48 hours. Fortunately, the patient did not experience any adverse consequences from the hypernatremia.

16. Case: Errors with PN (4) On formal case review, multiple errors led to the excess sodium infusion. This academic medical center had a functioning electronic health record (EHR) and computerized provider order entry (CPOE) system. However, due to the complexity of TPN orders, they were completed by hand and then scanned to the pharmacy to be entered by the pharmacist into the CPOE system. The order for the increased sodium was written appropriately on the paper order, which was scanned to the pharmacy.

17. Case: Errors with PN (5) The pharmacist (who was specifically trained to enter TPN orders) inadvertently entered 55 mEq/kg/day into the computer. A second TPN-trained pharmacist reviewed the order by standard protocol and did not catch the dosing error. The order was then sent to the contracted pharmacy to prepare, where an additional two TPN pharmacists did not recognize the error. Automatic warning flags popped up in the system regarding the high sodium dose, but these were ignored and dismissed as this patient had more than 8 warnings each day for his TPN order, even when it was entered correctly.

18. Case: Errors with PN (6) Speaking with the pharmacists revealed that there was not only an error in transcription, but they also had incorrectly perceived 55 mEq/kg/day as 55 mEq/L/day, an appropriate dose for an adult TPN order. Because of this error, the TPN mixture was produced with the high sodium concentration and sent to the hospital. Two nurses verified the TPN order was accurate and appropriate at the bedside and also did not notice the error.

19. Errors with PN • As in this case, most PN errors are due to multiple failures in the process, which can involve: • Order entry and transcription errors • Inappropriate abbreviations, dose designations, or units-of-measure • PN component mix-ups • No warnings for catastrophic dose limits • Ineffective or nonexistent systems of independent double-checks • Catheter misconnections See Notes for reference.

20. Computerized Physician Order Entry and PN • A broad survey of institutions revealed that only 32.7% use a CPOE system for PN • Available electronic health record systems do not perform well with PN; most institutions still use handwritten PN orders • CPOE, if well-built, can have decision support tools to help providers and may require less clarification or intervention compared with written orders See Notes for references.

21. Handwritten Orders and PN • If institutions must use handwritten orders, a standardized order template should be used • The need for calculations or data conversion should be avoided • Institutions should avoid using mixed units in orders to prevent confusion (e.g., mg/L for some contents, mg/kg/d for others) • If there is no active decision support, then pharmacist review becomes essential See Notes for reference.

22. Pharmacists and PN • Pharmacists may not be involved enough—survey found that 23.1% of organizations do not dedicate pharmacist time to review or clarify PN orders • When knowledgeable pharmacists are involved, pediatric PN prescribing errors are identified and resolved at frequencies similar to those with other complex medications See Notes for reference.

23. Other Errors with PN • Depending on preparation method, error rates for complex admixtures (including PN) are 22%−37% • Several case reports of errors from failure to incorporate built-in dosing limits in automated compounding device (the device that prepares the mixture) • Some have argued for using commercially available pre-made PN formulations, but these may not be safer in the absence of a standardized PN-use process See Notes for references.

24. Administration and Monitoring of PN • Nurses administering PN should always independently check the label against the original order • If any ingredients listed on label are out of sequence or have different dose or units than original order, then the process should stop for clarification back up the chain through the pharmacy to the prescriber

25. This Case • Certain safeguards may have prevented this error: • A CPOE system with decision support connected with the pharmacy computer system could have averted the transcription step that led to the wrong sodium concentration being entered into the computer • Without CPOE, requiring that documentation of pharmacist review include comparing dose of each component with an age-appropriate table of accepted values may have made the error less likely • Nurses should have checked the PN label against original order

26. Take-Home Points • PN is a high-alert medication requiring safety-focused policies, procedures, and systems • Institutions should incorporate all appropriate ASPEN clinical guidelines and best practices documents • To enhance safety and reduce PN-related errors, providers should be involved in oversight of PN therapy • Institutions should collect and report all errors associated with PN internally and externally (through ISMP Medication Errors Reporting Program) • Providers should document each step of PN use so that errors can be evaluated and corrective actions taken