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1 Medication Errors We're Looking Down the Tunnel and Seeing Light (10+ years since IOM) Michael R. Cohen, RPh, MS, ScD Institute for Safe Medication Practices 1
2 Disclosure Information Michael R. Cohen, RPh, MS, ScD has no financial relationships to disclose and will not discuss off label use and/or investigational use in this presentation. 2
3 Medication Safety Issues Culture of safety (blame and shame) Error reporting programs Quality issues Patient safety technology Product related issues
4 Heparin issues Recent high-profile reports of injury
5 Error Reporting Programs and Resulting Improvement Efforts B+
6 Patient Safety Act and Quality Improvement Act of 2005 Patient Safety Organizations
7 ISMP Medication Errors Reporting Program Operated by the Institute for Safe Medication Practices ISMP is a federally certified patient safety organization (PSO) Pennsylvania Patient Safety Reporting Program
8 Other reporting programs Maryland Patient Safety Center PSO Pennsylvania Patient Safety Authority VHA Center for Patient Safety/NASA New York Patient Occurrence and Tracking System (NYPORTS) Oregon Patient Safety Center MedMARx (medication errors)
9 Other government funded programs FDA MedWatch Web M and M (allows sharing of cases via Internet)
10 Medication Error Reporting System Early warning system Issue nationwide hazard alerts and press releases Learning Dissemination of information and tools Change Product nomenclature, labeling, and packaging changes, device design, practice issues Standards and Guidelines Advocates for national standards and guidelines
11 National Quality Forum Serious Reportable Events (SREs) Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Examples: surgery on the wrong body part; foreign body left in a patient after surgery; mismatched blood transfusion; major medication error; severe pressure ulcer acquired in the hospital
12 National Quality Forum Serious Reportable Events (SREs) Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Problem in the safety and credibility of a health care facility Examples: surgery on the wrong body part; foreign body left in a patient after surgery; mismatched blood transfusion; major medication error; severe pressure ulcer acquired in the hospital
13 The Joint Commission (TJC) Sentinel Event Reporting Program You can get much further with a kind word and a gun than you can with a kind word alone. Al Capone National Patient Safety Goals
14 JCAHO
15 NQF Safe Practices
16 Culture of safety C+
17 The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes. Lucian Leape
18 Safety Culture sins Focus on individuals Hindsight bias Reacting to emotional component of patient harm Failure to move beyond proximate causes Believing there is a single root cause Response confused with proactive risk management when actually reactive Tunnel vision (both causes and actions) Weak error reduction strategies
19 Culture of Safety Errors not a measure of competency Management style promote safety and Just Culture Value complainers Reward patient safety and reporting Encourage story telling Visible leadership (walk arounds) medication safety officer
20 ISMP top things to do to improve safety Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team. Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.) Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-rx, etc.) Standardize drug concentrations, units of measure, etc. Encourage error reporting internal and external (see ISMP Med Safety Alert! Pump up the volume tips for increasing reporting. Feb 9,
21 Just Culture - The Three Behaviors Human Error Product of our current system design Manage through changes in: Processes Procedures Training Design Environment At-Risk Behavior Unintentional Risk-Taking Manage through: Removing incentives for At- Risk Behaviors Creating incentives for healthy behaviors Increasing situational awareness Reckless Behavior Intentional Risk-Taking Manage through: Remedial action Disciplinary action Console Coach Punish
22 Two Disconnected Conversations No Blame Accountability
23 Criminal Charges for Medication Errors
24 ISMP top things to do to improve safety Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team. Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.) Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-rx, etc.) Standardize drug concentrations, units of measure, etc. Encourage error reporting internal and external (see ISMP Med Safety Alert! Pump up the volume tips for increasing reporting. Feb 9,
25 Quality Issues B+
26
27 Hand Washing Typical hand hygiene rates circa 1999: 20-30% Public reporting of / no pay for/?lawsuits for HAIs: tremendous push to improve Many organizations now at 40-70%, and stuck It s a Systems Problem : Education, dispensers every 3 feet A systems problem? Really? Wachter, Pronovost. NEJM 10/1/09
28 Patient safety technology B
29
30 High Impact Do First Constraints on high alert drugs Limiting abbreviations Pocket drug reference Dedicated ICU Pharmacist Med Safety Officer Intervention database Unit dose dispensing Automated dispensing cabinets Smart pumps Investment Automated ADE monitoring CPOE Bar-coding Robotic dispensing Preprinted order forms Medication training Drug-food interactions Don t Bother Low Cost (Courtesy David Bates) High
31 Product safety B
32 Examples of the Impact Medication Error Reporting
33 US Food and Drug Administration PDUFA IV Nomenclature testing Package label requirements Device safety Patient safety news FDA-ISMP Fellowship Etc. Division of Medication Error Prevention and Analysis (DMEPA)
34 Look-alike and Sound-alike Drug Names
35
36
37 Leading Products in Harmful Medication Errors Generic Name n % Insulin* Morphine* Heparin* Fentanyl* Hydromorphone* Warfarin* Potassium Chloride* Vancomycin Enoxaparin* Metoprolol Tartrate Furosemide Methylprednisolone Meperidine* From MedMarx 2007 * = high alert
38 Problems associated with PCA Patient selection, assessment and monitoring Drug product mix-ups Human factors/design flaws Staff training, and competency assessment Order communication errors PCA by proxy Device-related issues
39 Risk Evaluation and Mitigation Strategies (REMS) 39
40
41
42 Look-alike product labeling
43 Slide 43
44
45
46
47 47 Current labeling
48
49 49 TALLman LETTering
50 Considerations with color on labels Potential for mix-ups within the class must be considered
51
52
53
54 Availability of medicines D-
55 Drug Shortages Clinical effects Adversely affect drug therapy Compromise or delay medical treatment/procedures Result in failure to treat and progression of disease Result in medication errors and adverse patient outcomes
56 Drug Shortages Financial effects of shortages Costly alternative medications for provider and patient Significant time spent on addressing shortages Additional costs associated with treatment of adverse outcomes Emotional effects of shortages Frustration, anger, mistrust Strain professional relationships
57 Adverse patient effects due to drug shortage
58 Tubing Misconnections
59 Forthcoming ISO standards for small bore connectors ISO General Requirements ISO Breathing Gas Systems ISO Enteral Feeding ISO Urological ISO Limb Cuffs ISO Neuraxial ISO Vascular/Luer fittings (formerly ISO 594)
60 This is not the end. It is not even the beginning of the end. But it is perhaps, the end of the beginning.
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