Reporting Parenteral and Enteral Nutrition Therapy and Device Related Errors
What are PN and EN therapy and device related errors?
According to The National Coordinating Council for Medication Error and Prevention has approved the following as its working definition of medication error:
"... any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."
While Parenteral Nutrition (PN) and Enteral Nutrition (EN) are not traditionally thought of as medications, they are therapies that are prescribed, dispensed, administered, and monitored similar to medications. Administration also involves infusion devices that may be used in error (e.g., type of device, programming of the device). Parenteral nutrition products are drugs according to the FDA. Errors range from “hazardous conditions” (situations that may lead to an error), “close call” type errors that do not reach the patient (e.g., PN bag made incorrectly but never hung), to errors that cause patient harm (EN formulation delivered into an IV line).
Why should you report PN and EN therapy and device related errors?
Error-reporting systems represent one of the primary means by which healthcare providers learn about:
- Hazardous conditions: potential risks hidden in processes
- Actual errors: errors that occur during the delivery of patient care
- Causes and contributing factors of errors: underlying weaknesses in systems and processes that explain why an error happened.
- Error prevention: ways to prevent recurrent events and, ultimately, patient harm.
Error reporting is a fundamental component of a safety culture, but persuading healthcare workers to submit reports is no easy task given the potential disincentives to reporting. For example, people’s reactions to errors are variable, but candid confessions of mistakes are not particularly popular. People may have a natural desire to forget that the incident ever happened. Even if workers are willing to speak up about errors, they may still believe that the extra work is not worth their time if they feel that no changes will take place from reporting. The workforce is also understandably reluctant to report errors if they are worried that the information will get them or their colleagues in trouble, legally or socially, or impact their job.
What is a Medication Error Reporting System that can be used for Reporting PN or EN therapy and device related errors?
We recommend you consider reporting these types of errors to the ISMP Medication Errors Reporting Program (MERP), operated by the Institute for Safe Medication Practices (ISMP), which is a confidential national voluntary reporting program that provides expert analysis of the system causes of medication errors and disseminates recommendations for prevention. Regulatory agencies and manufacturers are notified of needed changes in products when safety is of concern. Professional organizations are notified when changes in practice may assist in preventing errors. Reporter’s identities are held in confidence unless they agree to share their contact information with regulatory agencies or manufactures. Without reporting, such events may go unrecognized or shared only internally within the organization and thus important epidemiological and preventive information would be unavailable to help prevent these errors from occurring with other healthcare professionals on a national and international scale. ISMP is a federally certified patient safety organization (PSO), providing legal protection and confidentiality for submitted patient safety data and error reports.
Errors, close calls, or hazardous conditions may be reported to the program. These include, but are not limited to,
- Errors in prescribing, transcribing, dispensing, and monitoring of medications,
- Unsafe product labeling or storage of medications
- Administering the wrong drug, strength, or dose of medications;
- Confusion over look-alike/sound-alike drugs;
- Incorrect route of administration;
- Calculation or preparation errors; and
- Misuse of medical equipment.
Staff at ISMP will follow-up with every reporter to seek further information on the report to determine the reasons why an error occurred. This information will be forwarded to the Food and Drug Administration (FDA) MedWatch program and to the manufacturer/labeler. You will have the option of including your identity and location on these copies. MERP reporters are encouraged to submit associated materials such as product photographs, containers, labels, prescription order scans, etc, that help support the information being submitted. ISMP guarantees confidentiality of information received and respects reporters' wishes as to the level of detail included in publications.
How can you report PN and EN therapy and device related errors?
Go to ISMP webpage. You will find a list of what types of information you should consider reporting (see below), and a text box to allow you to freely type in a description of the events that took place and then submit your information online to ISMP. Please do not submit any patient identifiable information when forwarding error reports to ISMP.
When reporting errors, please include the following:
- Describe the hazardous condition, error, adverse drug reaction that may have been avoided. What went wrong?
- Was this an actual error (reached the patient) or are you expressing concern about a potential error or writing about an error that was discovered before it reached the patient?
- Patient outcome.
- Type of practice site (hospital, private office, retail pharmacy, pharmaceutical company, long-term care facility, etc).
- The generic name (INN or official name) of all products involved.
- The brand name of all products involved.
- The dosage form, concentration or strength, etc.
- How was the error discovered/intercepted?
Please state your recommendations for error prevention
What is the risk to the clinician for reporting a PN or EN therapy related error?
It wasn’t too long ago that healthcare professionals felt too embarrassed or ashamed to divulge an error. Some were so fearful of legal and personal reprisal that they followed an unwritten, unspoken, but clearly understood rule: silence is golden. But times are changing. Most now realize that the disclosure and open discussion of errors allows us to better analyze a situation, more appropriately predict behavior, and more safely and reliably design systems and processes that are resistant to errors. Organizations can continue to optimize internal reporting systems and their capacity for learning about the human, technical, organizational, and environmental factors that determine the safety of the system as a whole. Reporting externally to national organizations adds the learning and sharing of errors to a much higher level.
Confidentiality is guaranteed for reporters (the healthcare professional reporting the incident), individuals involved in errors, location of events, and patient identity. The information collected during investigation of an error, for the purposes of safety and quality, is protected from legal discovery (when allowed by state or federal statutes). ISMP is certified as a Patient Safety Organization (PSO) by the Agency for Healthcare Research and Quality. Because reporting to a PSO confers both privilege and confidentiality to the information reported, ISMP’s PSO status will afford an even higher level of protection when clinicians and organizations report errors or engage in other types of consulting services with the Institute.
Will I get feedback on my efforts?
After submitting a report to ISMP, you will receive a follow-up email to ask additional questions, including the reasons why the event took place as well as how the event was discovered and the steps your organization put in place to prevent these events from reoccurring. ISMP can then use this information to share with all healthcare practitioners along with members of A.S.P.E.N. so that they can learn about the types of errors, the reasons why the event took place and possible recommendations to prevent similar events from taking place in their organizations.
For this A.S.P.E.N. – ISMP collaboration project, we will jointly be publishing and presenting the findings of these reports and working on product and systems analyses of these errors.
The following represents examples of the types of events that should be reported to ISMP.
- Wrong Route:
- EN misconnection where formulation or oral/enteral medications were delivered into any IV line, trach cuff, abdominal drain, urinary catheter, medical gas tubing, etc.
- Enteral formulation and/or medication infused into an enteral tube with tip in the bronchotracheal system.
- Medication prescribed IV and administered into the enteral feeding tube.
- Enteral formulation administered into wrong port of a multi-port feeding tube.
- Enteral formulation and/or medication infused into an enteral tube with tip in the intraperitoneal cavity.
2. Wrong Patient:
- Patient given EN formulation/ or oral-enteral medications not ordered for them.
- Wrong patient (infant) given another infant’s breast milk.
3. Wrong Dose/Method:
- Patient given wrong dose EN formulation / or oral-enteral medications.
- Patient given EN formulation/ or oral-enteral medications via wrong method (received intermittent instead of continuous).
4. Wrong Drug/Formulation:
- Patient given wrong EN formulation / or oral-enteral medications.
- Patient given wrong additive to EN formulation
5. Wrong Time:
- Patient given EN formulation / or oral-enteral medications at the wrong time.
6. Medications given via tube that should not have been administered by this route (e.g. medications that were crushed and should not have been crushed and given via tube)
7. Tube Placement Errors
- Placement of tube tip into the bronchotracheal system with perforation
- Placement of tube tip into the bronchotracheal system with feeding into lung (do not need to report bronchotracheal system placement if repositioned without incident)
- Placement of tube tip with perforation of GI tract
8. Patient or Staff Removal of Permanent Feeding Tube and inability to Replace without Surgery, Endoscopy, or Radiologic Placement of new tube.
1. Wrong Route:
- Misconnection where PN or IV medications were delivered into any IV line not designated for PN, trach cuff, enteral tube, abdominal drain, urinary catheter, medical gas tubing, etc. In particular, Central PN infused into a peripheral IV line.
- Central PN formulation infused into an IV line with tip that has migrated or been placed outside central vein.Infusing other IV medications that are incompatible with TPN formulation Infusing a TPN through a peripheral line
2. Wrong Patient:
- Patient given PN formulation not ordered for them.
- Patients given a PN formulation based on another patient’s lab values
3. Wrong Dose/Method:
- Patient prescribed wrong dose or formulation of PN solution
- Patient given wrong dose of any component of PN solution.
- Patient given PN formulation at wrong rate.
- Patient given PN formulation via wrong method (received intermittent instead of continuous).
- Wrong PN formulation prepared and delivered to patient care area for patient administration.
- Wrong formula based on wrong patient information (e.g., labs, patient weight)
4. Wrong Formulation: See wrong dose
5. Wrong Time:
- Patient given PN formulation at the wrong time.
6. Medications given via PN IV access that caused interaction / precipitation and required new tube placement. (do not need to report clog if able to aspirate precipitate)
7. Patient or Staff Accidental Removal of Central Venous Catheter in which PN is infusing.