ICAHN Targeted Focus Area: Medication Devices and Technology

Transcription

1 ICAHN Targeted Focus Area: Medication Devices and Technology Matthew Fricker, RPh, MS, FASHP Program Director, ISMP Rebecca Lamis, PharmD, FISMP Medication Safety Analyst, ISMP April 24,

2 Objectives Describe the benefits and challenges associated with the implementation of various technology, as well as errors that have occurred with the use of medication-related technology and devices Review the ICAHN aggregate self-assessment results for these areas Provide strategies that can be implemented to mitigate the risk and optimize the use of these technologies and devices 2

3 Key Elements Key Element Mean % VI Drug Device Acquisition, Use, Monitoring 51% VIII Staff Competency and Education 55% I Patient Information 56% II Drug Information 56% IX Patient Education 63% X Quality Processes and Risk Management 63% IV Drug Labeling, Packaging, Nomenclature 65% III Communication of Drug Orders and Other Drug Info. 70% V Drug Standardization, Storage, Distribution 73% VII Environmental Factors, Workflow, Staffing Patterns 81% Total 63% 3

4 Demographics: Technology CPOE Barcoding (Pharmacy) emar ADCs Barcoding (Bedside) Smart Infusion Pumps * *Ten (10) hospitals have profiled ADCs 4

5 5 Medication Crushing/Splitting Devices

6 Technology and Devices for Drug Delivery Syringes Parenteral syringes used for oral liquid medications Tubing Misconnections Elastomeric pumps (ON-Q pump) No pharmacy involvement / often filled in the O.R. Unlabeled medication Pen devices Potential misuse leading to infection control risk 6

7 Technology and Devices for Drug Delivery Infusion pumps Failure to limit the variety of pumps used Using the same pump for different routes Not utilizing the drug library Multiple concentrations / dosing units in pumps Patient-controlled analgesia (PCA) devices Improper patient selection PCA by proxy Inadequate monitoring 7

8 8 Advances in Technology

9 Risk Assessment Performed for New/Replacement Medication Devices # Item None (A+B) Partial (C+D) Full (E) 130 Error potential for all new and replacement medication devices is identified through a literature search and a failure mode and effects analysis (FMEA); and potentially harmful error potential is documented and addressed before a decision is made to purchase and use the device. 71% 14% 14% 9

10 10 Pen Devices

11 Challenges with Insulin Pen Use Nurses using the pen as a vial due to unfamiliarity or encountering problems when trying to use the pen Use of a pen as a vial can damage the integrity of the pen due to alteration of pressure dynamics with introduction of air into the cartridge Large pockets of air have been observed in cartridges of insulin pen injectors after aspirating some of the drug with a needle Unlabeled syringes can result when insulin is withdrawn from pens used as vials 11

12 Cross Contamination with Insulin Pens Misperception that an insulin pen can be used to deliver a dose of insulin to multiple patients as long as a new disposable needle is attached Air bubbles and pathogenic contaminants can enter the cartridge after injection while the needle is still attached to the pen More than 700 patients at a NY hospital may have been exposed between to HIV, hepatitis B, or hepatitis C Another NY hospital had to notify 1,915 patients of possible exposure to bloodborne pathogens between Between , 2,114 patients were exposed to disease transmission risk at a TX hospital In 2011, more than 2,000 patients were exposed to this risk at a WI hospital and clinic 12 ISMP. ISMP Medication Safety Alert! February 7, 2013;18(3):1-2. Available at:

13 Cross Contamination with Insulin Pens Hemoglobin was detected in 6 out of 146 cartridges (4.1%) used by diabetic patients in one study 1 In another study of 120 patients, non-inert material, including squamous and/or epithelial cells, was found in 58% of the cartridges 2 Seven (5.6%) of 125 insulin pens tested positive for hemoglobin or cells in another study 3 1 Sonoki K, et al. Diabetes Care. 2001; 24: Le Floch JP, et al. Diabetes Care. 1998; 21: Herdman ML, et al. AJHP. 2013; 70:

14 Pens/Syringes Used for Individual Patients # Item None (A+B) Partial (C+D) Full (E) 269 A single syringe is never used for multiple patients, even if the needle is changed in between patients. 0% 0% 100% 270 Pen devices that contain multiple doses of medication (e.g., insulin pens) are dispensed for individual patients and are never used as unit stock for multiple patients, even if the needle is changed between patients or the medication is withdrawn from the pen cartridge with a sterile syringe. 0% 0% 100% 14

15 15 Smart Pump Technology

16 Benefits Drug library allows organizations to enter upper and lower dosing limits Warns clinicians of doses programmed outside the dosing range (programming errors or miscalculated doses) through the use of a soft or hard stop Examples of intercepted programming errors Pump programmed as DOPamine 22 mcg/kg/min; intended rate was 2 mcg/kg/min Pump programmed as IV fluid 155 ml/hr; intended rate was 15 ml/hr Pump programmed as magnesium 10 grams/hr; intended rate was 1 gram/hr Availability of captured data Allows the organization to evaluate smart pump use, identify opportunities to enhance safe use, and take action to correct problems 16

17 Errors with Smart Pumps Wrong drug selected from library Wrong drug concentration selected from library Wrong dosing units mg/hr versus mg/min mcg/kg/hr versus mcg/kg/min units/hour versus units/kg/hour 17

18 Errors with Smart Pumps Wrong dose related to incorrect patient weight Wrong channel programmed Overriding the drug library Bypassing the drug library 18

19 Smart Pump Technology: General Infusion Pumps # Item None (A+B) Partial (C+D) Full (E) 143 General infusion pumps with smart pump technology are in use in all hospital areas (including the ED, pediatrics, oncology, operating room). 29% 29% 43% - 4 hospitals are not utilizing smart pumps - 4 hospitals have partially implemented smart pump technology - 6 hospitals have fully implemented smart pump technology 19

20 Smart Pump Technology: PCA and Syringe Infusion Pumps # Item None* (A+B) Partial* (C+D) Full* (E) 144 PCA and syringe infusion pumps with smart pump technology are in use in all hospital areas (including the ED, pediatrics, oncology, operating room). 42% 17% 42% - 5 hospitals have not implemented smart pump technology - 2 hospitals have partially implemented smart pump technology - 5 hospitals have fully implemented smart pump technology - 2 hospitals do not have PCA or syringe infusion pumps *Based on the number of hospitals that have PCA and syringe infusion pumps (n=12) 20

21 Pumps Use Wireless Technology # Item None* (A+B) Partial* (C+D) Full* (E) 148 The drug library is updated via wireless technology. 80% 0% 20% *Based on the number of hospitals that have smart pump technology (n=10) 21

22 Drug Library: Development/Testing # Item None* (A+B) Partial* (C+D) Full* (E) 147 An interdisciplinary team, develops and tests the drug library, and reviews and updates the library at least quarterly. 60% 40% 0% *Based on the number of hospitals that have smart pump technology (n=10) 22

23 Dose Limits for Titrated Drugs # Item 40 Minimum and maximum dose limits have been established for parenteral medications titrated to effect (e.g., insulin infusions, DOPamine, DOBUTamine), which when approached (fall below minimum doses or exceed maximum doses), require notification of the prescriber for further instructions. None (A+B) Partial (C+D) Full (E) 29% 43% 29% 23

24 Use of Smart Pump Data # Item None* (A+B) Partial* (C+D) Full* (E) 145 The percent of infusions with medications that are administered using full functionality of the safety software is monitored, and the findings are used to increase compliance. 60% 30% 10% 146 An interdisciplinary team reviews data for soft and hard dose and volume limits that have been bypassed, and the findings are used to take action to reduce the number of bypassed warnings or to modify dosing limits. 90% 0% 10% *Based on the number of hospitals that have smart pump technology (n=10) 24

25 25 Tubing, Catheters, Administration Sets

26 Tubing Misconnections Monitor BP Cuff IV 26

27 Reports of Misconnections IV infusions connected to epidural lines, and epidural solutions connected to IV lines Syringe containing IV medication given via an intrathecal catheter IV tubing connected to inflation balloon port of endotracheal tube or tracheostomy tube Sequential compression device tubing or pneumatic blood pressure cuff tubing attached to port of IV administration set Oxygen tubing connected to port of IV administration set Breast milk intravenously infused into neonates Bladder irrigation solutions given IV, or TPN solutions administered via foley catheter port IV administration set spiked into enteral nutrition container, resulting in enteral nutrition administered IV 27

28 Risk Factors for Tubing Misconnections Unsecured or loose line connections Tubing incorporates Luer connectors which allows functionally dissimilar tubes/catheters to be unintentionally connected Multiple tubing lines and dissimilar tubes/tubing in close proximity ( spaghetti syndrome ) Use of tubes, catheters, syringes, and connectors for unintended purposes Transfer of the patient from one setting or service to another Look-alike and unlabeled connectors 28

29 Strategies to Reduce Risk of Misconnections Forcing functions Oral syringes Differentiate Different pumps for IV, enteral, and epidural delivery Verify Trace lines Education/awareness Personnel authorized to connect/disconnect Reminders For oral use only Place labels on distal ports of tubing Redundancies Recheck connections during handoffs 29

30 New ISMP Targeted Medication Safety Best Practices for Hospitals Best Practice 4: Ensure that all oral liquids that are not commercially available as unit dose are dispensed by the pharmacy in an oral syringe Goal: To prevent the unintended administration of oral products by the intravenous route 30

31 Different Pumps for Different Routes # Item None (A+B) Partial (C+D) Full (E) 136 The types of enteral infusion pumps used in the hospital are limited to two or less (adult and pediatric/neonatal pumps) and are different from other infusion devices used in the organization. 0% 0% 100% 138 Only one type of epidural infusion pump is used and is different from general infusion devices used in the organization. 43% 0% 57% 31

32 Epidural Administration Sets # Item None (A+B) Partial (C+D) Full (E) 139 The administration set used for epidural infusion pumps does not contain any access ports (Y connectors), can be distinguished from all other administration sets and medical tubing (e.g., a yellow stripe running the length of the tubing), and is not used for anything other than epidural infusions. 50% 0% 50% 32

33 Oral Syringes and Enteral Tubes # Item None (A+B) Partial (C+D) Full (E) Specially designed oral syringes, which cannot be connected to parenteral tubing, are available in the pharmacy and all patient care units, and are used for dispensing/administering oral/enteral liquid medications that are not available in commercially prepared unit-dose cups. Enteral feeding tubes have ports that only connect to oral syringes and catheter tip connectors; they do not have female Luer connectors. 7% 29% 64% 0% 0% 100% 33

34 Tubing Labels # Item None (A+B) Partial (C+D) Full (E) 131 The distal ends of all tubing are clearly labeled on patients who are receiving multiple solutions via various routes of administration (e.g., labeling of the distal end of bladder installations, IV, central venous, arterial, epidural, umbilical, and enteral tubing properly identifies relevant access sites). 50% 36% 14% 34

35 Risk Assessment: Medical Tubing, Catheters, Fittings # Item None (A+B) Partial (C+D) Full (E) 134 An initial risk assessment has been performed to determine the various types of medical tubing, catheters, and fittings in use, identify the possibility for misconnections, assess the potential severity of misconnections, and address process changes that need to be made, and this assessment is updated prior to the purchase of any new medical tubing, catheters, and fittings. 71% 29% 0% 35

36 36

37 New Connectors are Coming ISO standards Will ensure non-interconnectability with the intravascular Luer small-bore connectors and with the new connector designs of other delivery systems Includes connectors for: Enteral feedings Respiratory systems and driving gases Limb cuff inflation applications Neuraxial applications Urethral and urinary applications 37 AAMI. Stay connected: FAQs about small-bore connectors and tubing misconnections. Available at:

38 New Connectors are Coming Phased approach, starting with enteral devices - expected to reach the market as early as 4 th Quarter of 2014 Resources Stay Connected 2014 initiative (GEDSA) AAMI 38

39 Automated Dispensing Cabinets (ADC) 39

40 Automated Dispensing Cabinets Automated dispensing cabinets (ADCs) Cabinets that aren t profiled Excessive use of matrix drawers Removal of medications for multiple patients at the same time or for more than one administration time for a single patient Inadequate number of cabinets Cabinets in busy areas (hallways, nursing station versus placement in medication rooms) 40

41 Sufficient Numbers of ADCs # Item None* (A+B) Partial* (C+D) Full* (E) 103 Sufficient numbers of ADCs, depending on their intended use (e.g., limited narcotic and unit stock versus total drug distribution), are installed in areas that are easily accessible to staff and in close proximity to patients to ensure access without unreasonable wait times and to reduce workarounds. 0% 0% 100% *Based on the number of hospitals that have ADCs (n=12) 41

42 ADC Override Reports # Item None* (A+B) Partial* (C+D) Full* (E) 119 If ADCs are used, override reports are routinely reviewed for those cabinets that are profiled, and a process (e.g., adjust stock, educate staff) is in place to decrease the frequency of inappropriate overrides. 10% 10% 80% *Based on the number of hospitals that have profiled ADCs (n=8) 42

43 ADC Resources Institute for Safe Medication Practices (ISMP) Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets ISMP Medication Safety Self Assessment for Automated Dispensing Cabinets (ADC) 43

44 Barcode Medication Administration (BCMA) 44

45 Bar Coding # Item None (A+B) Partial (C+D) Full (E) 259 Machine-readable coding (e.g., bar coding) is used to verify drug selection prior to dispensing drugs (includes robotic dispensing). 50% 43% 7% 260 Machine-readable coding (e.g., bar coding) is used at the point of care to verify drug selection prior to administering medications. 21% 50% 29% 45

46 Barcode Verification at Administration Increasing utilization Traditional strategy is vigilance: Just be more careful Bar coding provides an additional validation prior to administration Typically more medication administration errors are captured post implementation than thought existed 46

47 47 Barcode Challenges

48 Failure Points with a BCMA System Medication taken from an automated dispensing cabinet that generates a task Failure to pair to order once entered Smudged, torn, missing barcodes Connectivity issues Hardware issues If it beeps, it must be correct 48

49 Patient ID bands should be attached to the patient BCMA At Risk Behaviors 49

50 BCMA At Risk Behaviors Printing multiple patient ID bands and storing them in the patient s cassette or chart and scanning the medications and the patient ID band in the medication room Having a stash of medication barcodes that are not easy to scan Just scanning one package/vial multiple times rather than the individual packages when more than one is required for a dose 50

51 BCMA - Process Measures Bedside Scan Rate maximize the benefits Identify barriers to scanning Identify staff who have difficulty consistently scanning Wrong Patient Wrong Drug Identify and trend which medications are involved (e.g., insulin) Percent of medications bar coded Identify barriers to bar coding medications 51

52 Metrics Reviewed for BCMA # Item None (A+B) Partial (C+D) Full (E) 261 If bar coding at the point-of-care is used for drug administration, an interdisciplinary team reviews metrics from the system, including the percent of medications with a readable barcode, scanning compliance rates, and bypassed or acknowledged alerts, and any barriers associated with using the technology are addressed to maximize the safe use of the system. 20% 60% 20% *Based on the number of hospitals that have bar coding (n=10) 52

53 53

54 General Technology Issues Does technology improve the quality and safety of the medication use process? Yes No 54

55 General Technology Issues Yes, IF: - Well designed - Thoughtfully implemented - Appropriately used No, IF: - Users do not participate in the design phase - Layered on dysfunctional, manual systems - Ambiguous content is developed that cannot be utilized by frontline staff 55

56 General Technology Issues What gaps are there in your technology? Are all patient populations covered? Consider what technology may miss: Wrong patient Look-alike/sound-alike drugs Overdoses, specifically catastrophic doses 56

57 General Technology Issues Timelines and milestones for improving utilization Measure utilization of BPOC, CPOE, smart pumps Implementation and optimization NEVER end Feedback loop to retrain users Optimize the technology Observe for barriers and workarounds 57

58 General Technology Issues Does medication error analysis probe why the technology did not prevent the error? Technology does not replace independent double-checks 58

59 Reports General Technology Issues What reports are available? Degree of usefulness/value Structured review process 59

60 Questions? Upcoming Webinar: Staff Competency and Education (Key Element VIII) May 22 nd at 1:30 p.m. 60