Learning Objectives

Preventing Errors Related to Drug Delivery Devices and Using Technology to Prevent Medication Errors

Learning Objectives • Describe types of technology available for reducing the potential for medication errors • Explain the potential errors in drug administration created by implementing technology • Discuss the role of multidisciplinary teams in choosing and implementing technologies to prevent medication errors

Preventing Medication Errors Related to Drug Delivery Devices • Misuse of infusion pumps and other parenteral device systems is the second most frequent cause of medication errors during drug administration • When using failure mode and effects analysis (FMEA) to assess these devices, both safety features and intuitive use should be as important as price and service in the evaluation Purchasing Infusion Pumps • An interdisciplinary team should use FMEA to predict possible errors and identify other failures and their potential harmful effects before purchasing new pumps • See page 276 in the textbook for FMEA questions for evaluating potential new purchases or the safety of the current pumps in use

Infusion Pumps Preventing Programming Errors • Administration errors involving the IV route are the most likely to cause patient harm • IV pumps deliver a more accurate flow rate than a gravity-flow drip, however they are prone to programming errors • IV pumps can be difficult to use: multiple functions, small screens, confusing or disorderly menus • 2006 Institute of Medicine (IOM) report calls for the Agency for Healthcare Research and Quality and the medical device industry to promote and apply user interface designs based on the cognitive and human factors principles • Errors will continue if programming functions are illogically placed or the keys do not function • A nurse set an infant’s total parenteral nutrition (TPN) solution at 130 mL/hour when she meant to set it at 13.0 mL/hour, but the decimal point key failed

Infusion Pumps Preventing Programming Errors (continued) • Some pumps automatically calculate an infusion rate, which should reduce potential errors • However, the process of programming is error-prone • Calculations are only as accurate as the information entered • Nurse may need to enter patient weight, concentration of drug, rate desired • All data entry must be accurate to be effective • Independent checking should accompany the infusion of high-alert medications • One nurse should prepare the solution and program the pump • Another nurse should verify the drug, dose concentration, line connection, patient identification, and pump setting • Both practitioners should observe the pump’s final infusion rate when using pumps that automatically calculate the rate

Infusion Pumps Preventing Programming Errors (continued) • Use a single standard concentration for drug solutions • Particularly important for high-alert medications • Affix auxiliary labels that list the data to be entered into the pump • Pharmacists can affix labels with dose/infusion rate tables for commonly used drug infusions • Nurses can verify final infusion rate calculated by the pump is correct

Infusion Pumps Protection From Free-Flow • Free-flow is accidental, uncontrolled gravity flow of IV fluids and drugs after an IV administration set is removed from the pump • Free-flow happens when an IV without a mechanism to prevent the flow is not clamped by the operator • Newer pumps have a fail-safe mechanism • Free-flow errors can result in patient death • The Joint Committee (TJC) requires hospitals to guarantee that free-flow protection is in place for all patient-controlled analgesia (PCA) pumps and general-use infusion pumps used in their organization

Infusion Pumps Preventing Line Mix-Ups • Multiple-channel pumps allow several solutions to be infused into a patient, thus having space around the patient for providing care • Lines can be confused when more than one line or more than one pump is used • Nurses should handle only one line at a time, tracing the line from the solution, through the pump, and to the insertion site • An independent check system should be used with high-alert medications • One nurse should hang the solution and ready it for infusion • Another nurse should validate the original order, the patient’s identification, the dose and concentration, the route, and the pump setting • Drug names may be affixed to each IV line at the end closest to the patient and at the point where the line enters the pump

Infusion Pumps Preventing Line Mix-Ups (continued) • The label must be removed when the drug is discontinued; the nurse should not depend upon the label alone to select the correct channel • All IV solutions should be checked by the nurse more than once each shift, tracing the individual lines from solution to channel and verifying the correct channel is selected • Never use one multiple-channel pump to infuse two patients • Evaluate the risk of line mix-up when purchasing multiple-channel pumps • Be aware that two single-channel pumps on the same pole could potentially cause errors • Bar coding could verify the solution being hung, but will not find an error if the tubing is switched during set up

Infusion Pumps Protecting Epidural Lines • Special tubing with a yellow line running along the lumen and containing no side ports is available for epidural infusion • May prevent epidural administration of drugs or solutions not intended to be administered by this route • A distinctive infusion pump is used in some organizations to prevent IV solutions from being given epidurally Removing Lines • Remove tubes and catheters that are no longer needed as soon as possible • A patient suffered intense pain because a nurse administered an IV dose of pain medication into an intra-arterial line that was not in use

Smart Infusion Pumps • Smart infusion pumps that warn nurses about programming errors before the infusion has started have been available since 2002 • A traditional IV infusion pump becomes smarter with the addition of medication safety software (a drug library to cross-check for programming that is not within high or low preset limits) • The computerized pump can be programmed with standard concentrations • Dose limits for adults and children can be set • Pumps can be set for each treatment area (e.g., oncology, critical care) • Pumps are loaded with the dose information and terminology by each individual hospital

Smart Infusion Pumps • An alert will appear in a smart pump if the rates do not fall within the dose limits • Pump programmed for 7 units/kg/hour; ordered dose was 7 units/hour • Patient was 70 kg; dose was set for 490 units/hour • Programmed dose was outside the normal limits and alerted nurse • To reach their full potential, smart pumps should be used as part of an integrated system • Developing and applying a standard terminology to ensure better communication among smart pumps and other clinical information systems is recommended in the 2006 IOM report • Smart pumps do not detect line mix-ups

Smart Infusion Pumps • Transaction data are retrievable from the pumps • Data may be stored on the pumps (1 to 2 days’ worth or months’ worth on a server) • Multidisciplinary teams are crucial • Must determine who is responsible for updates and maintenance of drug libraries • Team must determine maximum and minimum limits and approve them through Pharmacy and Therapeutics (P&T) Committee • Smart pump technology is available for standard IVs and PCAs, and may integrate with electronic medication administration records (eMAR), computerized prescriber order entry (CPOE), and bar code medication administration (BCMA) technologies

PCA Devices • PCAs allow the patient, rather than the nurse, to administer analgesics, thus reducing the risk of oversedation when used correctly • PCAs used incorrectly can cause errors that are sometimes serious • Table 12-1 lists safety strategies to reduce these errors, such as: • Improving access to information • Limiting access • Using reminders • Carefully monitoring • Standardizing and simplifying • Differentiating • Requiring redundancies • Including forcing functions and fail-safes • Employing FMEA

PCA Devices PCA by Proxy • Only patients should administer the alagesics • “PCA by proxy” is when health care personnel or family members push the pump to try to keep the patient comfortable • PCA by proxy can lead to death due to respiratory depression Improper Patient Selection • Candidates for PCA should be physically and psychologically able to manage their own pain • PCAs have been given to children and those in confused mental states thus leading to PCA by proxy or undertreatment because of inability to communicate pain • Oversedation may result when PCAs are given to patients with conditions such as asthma or obesity, and patients at risk for respiratory depression receiving drugs that potentiate the action of opioids

PCA Devices Appropriate Monitoring • Frequent patient monitoring, especially during the first 24 hours and at night • Even a patient with opioid toxicity can be aroused and assessed • Patients can be easily stimulated to a higher level of consciousness and an increased respiratory rate • Patient may return to the oversedated state once the stimulus is removed • Pulse oximetry readings can offer a false sense of security because oxygen saturation is usually maintained, especially if oxygen is being administered

PCA Devices Improper Patient Use • Inadequate patient education contributes to improper PCA use • Most patients can be educated about PCA use • Not immediately after the postoperative period when they are groggy • Directions can be misunderstood even by patients who are fully alert; e.g., thought the pump had to be pushed every 6 minutes even though their pain was under control • PCA button resembles a call button • Some pumps have no feedback mechanism (visual or auditory) so the patient does not know whether the button was successfully pressed

PCA Devices • Misprogramming • Complex programming sequences • Pump design flaws • Requirement of multiple steps • Device design is not intuitive • Common pump design flaws • Users may not know the manufacturer default settings • Verification of some program settings is difficult • Some do not require users to review all settings before the start of infusion • Some programs require dosing in milliliters, not milligrams • Defaults may be hidden and thus unknown to the user

PCA Devices Misprogramming (continued) • A nurse programmed a PCA at 50 mcg/mL as prescribed for fentanyl • Model defaulted to 1 mcg/mL when the enter key was not pressed within a specified amount of time, causing the delivery to be 50 mL • Persons programming the PCAs can have mix-ups or mental slips Mechanical Problems • Examples of mechanical problems leading to PCA failures • Siphoning of air from broken syringes or cassettes • Short circuits • Insufficient batteries • View of the label on the syringe or cassette can be obstructed once they are in the pump

PCA Devices Staff Education • Train nurses adequately • PCA programming, potential adverse events, and monitoring • Nurses may not be proficient if multiple types of PCAs are used or if PCAs are used infrequently • Prescribers have made errors because: • There is no requirement to demonstrate proficiency in areas such as conversion of dosages of oral drugs to IVs dosages • Incorrectly prescribing for morbidly obese, elderly, or opioid-naïve patients • Concurrent orders can result in therapy duplication and overdose Drug Mix-Ups • Name similarities (e.g., morphine and hydromorphone) • Packaging is similar for multiple concentrations • Opioids are typically unit stock • PCA orders have been misheard and misread

Oral Syringes • Failure to identify the correct tubing has led liquid medications meant for gastric or nasogastric tubes to be given intravenously • Small-bore polyurethane nasogastric feeding tubes or percutaneously inserted gastric tubing connections fit IV line connection tubing • Cardiac arrest was caused when nimodipine in a parenteral syringe was given through an IV rather than through the nasogastric tube • Oral syringes should be clearly labeled “oral only” in red attached to the plunger • Making the connections between IV lines and nasogastric tubes incompatible would help eliminate some errors

Enteral Feedings • Some containers can be spiked at the main entry point with an IV administration set • Container looks like a three-in-one parenteral nutrition admixture • Many ready-to-hang containers allow formula to flow through a standard IV infusion set despite the use of an inline filter, which can quickly become occluded • A patient given 200 mL of an enteral feeding by IV infusion over 1 to 2 hours instead of receiving TPN later died • Warnings on enteral feeding containers are not sufficient to stop errors • The proper enteral administration set should be attached to the enteral product container before stocking or dispensing

EnteralFeedings • Discontinued products should immediately be removed from patient care areas and returned to their source • Some nurses purposely use IV pumps to administer enteral feedings or solutions when enteral administration sets are not available • A child was started on GoLytely (PEG-3350 and electrolytes) at 400 mL/hour via IV tubing attached to a nasogastric tube, but 1 hour later the nurse found it was actually being administered through an IV access line • A safer solution: use an adapter to connect two enteral feeding pumps, with each delivering half the desired volume of the product simultaneously • Some nasogastric tubes have a dual port for this type of connection • Some enteral pumps can administer a higher dose than usual volumes

Other Tubing Misconnections • Tubing used on a blood pressure (BP) device connected to an IV port • Patient went to radiology; BP device was disconnected before the MRI and presumably reconnected afterward • Family member discovered that the BP monitor tubing was really attached to a needleless Y injection port on the patient’s IV line • Oxygen tubing was mistakenly attached to a total joint drainage system instead of the suction tubing • Patient died from a gas embolism • Oxygen tubing connected to a nebulizer became disconnected and mistakenly reconnected to IV line, killing a child • Figures 12-1, 12-2, and 12-3 in the textbook show potential for misconnections

Using Technology to Prevent Medication Errors

Getting Started • Technology for error prevention—organizations call for widespread use • IOM recommendations • Enhanced point-of-care electronic references • Full electronic prescribing by 2010 • Widespread computerized patient monitoring • Improved consumer drug information via Internet • Institute for Safe Medication Practices recommendations • Elimination of handwritten prescriptions • Call for manufacturers to include bar codes on all medications • Advocate for point-of-care BCMA

Medication Management Process With Specific Technologies • Wireless devices for medication history capture, etc. History-Taking Obtain Medication-related History Document Medication History Medication Inventory Management Formulary, purchasing decisions Inventory management Ordering Diagnostic/ Therapeutic Decisions Made Medication Ordered Order verified and submitted • Physicianorder entry • Robotic dispensingsystems Pharmacy Management Surveillance Evaluate order Select medication Prepare medication Dispense/ distribute medication Incident/adverse event surveillance and reporting • Automatedsurveillance • Pharmacy informationsystems Administration Management Monitor/Evaluate Response Document Administer Medication Education Intervene as indicated for adverse reaction/error Assess and document patient response to medication according to defined parameters Document administration and associated information Select the correct drug for the correct patient Educate patient regarding medication Educate staff regarding medications Administer according to order and standards for drug • Bar coding administration

Pharmacy Computer Systems • Maximize system capabilities • Incorporate alerts and clinical decision support • Alerts and upgrades should be easily added • See Chapter 15 Appendix of textbook for Draft Guidelines for the Electronic Presentation of Information About Prescribed Medications • Drug information database should include: • Allergy alerts • Drug-drug, drug-disease, drug-food interactions • Duplication warnings • Minimum and maximum doses • Contraindications

Pharmacy Computer Systems • Maximize system capabilities (continued) • Interface with laboratory information systems • Table 15-4 discusses Ways Lab and Pharmacy Can Be Linked to Improve Care • Require allergies, patient weight, and height to be entered prior to medication orders • Font should be easily changed for TALL-Man format • Require pharmacist verification for all orders • Implement hard stops (forcing functions) for unsafe orders • Default to review of current orders before new orders are entered • Generate customized MARs

Alerts and Warnings • Alerts and warnings work only if the information is entered into the system • A patient allergy must be coded correctly for the computer to recognize it • Heights and weights must be updated each time a patient is admitted • Systems should include a verification step when data are from a prior admission

Presentation of Information • MARs and labels must be clear to nurses • Allow for prospective review of labels prior to implementation • Allow for the use of commas in the strength field • Ensure proper spacing between the drug dose and strength • Mnemonics for drug selection has led to order entry errors • ACTO could be ACTOS (pioglitazone) or ACTONEL (risedronate) • Use of both brand and generic names may decrease potential for errors

System Maintenance and Support • Systems must be continually maintained and upgraded • Budgets must include continued support • Hardware and software upgrades • Internal personnel responsible for testing and maintaining the system • Orientation for new employees • Customized enhancements as needed

Automated Dispensing Cabinets (ADCs)

ADCs • Designed to control storage and documentation of medications in patient care areas • Replacing cart exchange systems • Expanded software capabilities • May be used for floor stock, narcotics, or complete drug storage on patient care units • Benefits of ADCs • Improved productivity within the pharmacy • Improved nursing and pharmacy productivity • Cost reduction • Improved charge capture • Decreased errors

ADC-Related Errors • Errors may be related to: • Stocking errors • Overrides or “work-arounds” • Available safety functions being turned off • Look-alike, sound-alike medications stored near each other • Removing medications for multiple patients at one time • Nurses returning medications to the ADC with no double check

ADC Safety Steps • Purchase: • Adequate number of cabinets per patient area • Systems that allow for patient profiling (pharmacist review) • Systems that are BCMA compatible • Carefully select drugs and quantities to be stocked • Separate look-alike, sound-alike medications and different strengths of the same medication • Use separate cabinets for pediatric and adult medications, if possible • Periodically reassess drugs stocked in each cabinet • Remove only a single dose of the medication ordered • Nurses should not return unused doses to the ADC

ADC Safety Steps • Require a double check after cabinet restocking • Incorporate screen alerts for certain medications • Do not make up doses of medications when the ordered strength is available • Do not ask nurses to split doses in half; the device cannot account for half doses • Incorporate a system of documenting the reason for overrides • Routinely run and analyze override reports • Develop and test downtime procedures

CPOE • CPOE is an electronic system for entry of medication orders by prescribers • Prescriber system is linked to: • Patient history • Alerts of allergies and interactions, duplicate therapy, contraindications based on diagnosis, and unsafe or subtherapeutic doses • CPOE systems significantly impact prescribers • Identify physician champions in early stages

CPOE • Integrate or Interface? • CPOE and pharmacy systems must be integrated or seamlessly interfaced • If not, electronically entered orders will print in the pharmacy and need to be reentered into the pharmacy computer system (PCS) • Creates potential for transcription errors • Interfacing systems from multiple vendors requires maintenance of multiple drug databases • Interfacing versus one vendor = “best of breed” • CPOE and PCS must support the MAR • MAR information should closely match labels • Administration instructions should flow from pharmacy to nursing

CPOE • Staff Involvement • In addition to physician champions: • Identify a multidisciplinary team to investigate, analyze, “sell” benefits to others, and implement • Prospectively identify team leaders and departments responsible for maintenance and education • P&T Committee should be actively involved • Drug Versus Lab Orders • Lab and drug orders must be distinctive to identify drug order versus lab studies • Drug levels should not just be the drug name • Digoxin versus digoxin level or digoxin assay

Clinical Decision Support (CDS) • CDS is a set of rules, alerts, and information that orders are checked against for safety • These rules are often written by each facility • CDS should be checked carefully prior to implementation • CDS databases must be updated regularly • Caution should be used to avoid excessive trigger alerts • Effects of excessive “noise” leads to bypassing of alerts

Point-of-Care BCMA • Ensures 5 “rights” of administration using bar codes • 3-way match at bedside • Wireless real-time medication tracking • Discrepancy alerts • Online profile/MAR • Administration planning • Data for patient monitoring activities • Charting and charge capture at the time of administration, not dispensing Jane Doe, RN

BCMA • 38% of medication errors occur at the bedside, with only 2% being caught • BCMA focuses on the administration phase of drug delivery • Rapidly evolving area of technology • Newer models can interface with CPOE, eMAR, and smart infusion pumps

BCMA • Workflow Changes • Implementation of BCMA must be done with input from nursing • Many of the pitfalls of implementation can be overcome by modifications to the system • Difficult to document deviations from scheduled administration times • Leads to work-arounds • Nurses would scan medications and then put them in their pocket so they would show as “on time” in the computer

BCMA • Alerts and Overrides • Overrides should be used only for urgently needed medications • Number of alerts must not be overwhelming • Bar Codes on All Doses • FDA requires bar codes on all medications • Does not require all medications be available in unit dose package • Bar code format has not been standardized • Organizations will likely need to repackage many doses • May be done in-house or outsourced

BCMA • Considerations for preparing medications for repackaging • Orientation of bar code on the product • Bar codes on curved areas (vials and bags) are difficult to scan • Verify that manufacturer bar code matches pharmacy database • Pharmacy computer system should print readable bar codes for multiproduct IVs • Must match the components in the IV • Dispense patient-specific doses with bar codes • Label equipment (printers) must be checked often for accuracy

Conclusion • Technology can reduce the potential for adverse drug events • Stakeholders must commit both budget and manpower for planning, implementation, continuous education, and monitoring • Technology implementation has the potential to introduce new errors

References Grissinger M, Cohen H, Vaida AJ. Using technology to prevent medication errors. In: Cohn MR, ed. Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association; 2007. Smetzer JL, Cohen MR. Preventing medication errors related to drug delivery devices. In: Cohen MR, ed. Medication Errors. 2nd ed. Washington, DC: American Pharmacists Association; 2007.

Learning Objectives