Outcome of Dangerous_Medication_Events.ppt

Medication errors and its outcome

1. Kirk Lalwani, MD, FRCA, MCR
Professor of Anesthesiology and Pediatrics,
Oregon Health and Science University,
Portland, Oregon, U.S.A.
‘To err is human; to fail to learn is inexcusable’
Susan Sheridan, Vice President, Consumers
Advancing Patient Safety, 2004.
Updated 5/2017

2. Disclosure
The author has no conflict of interest or disclosures.

3. Objectives
List the different types of dangerous medication
events.
Distinguish between adverse drug events (ADEs),
adverse drug reactions (ADRs) and medication errors
(MEs).
Describe current models for analyzing errors in
clinical medicine
Assess the scope of the problem of medication errors
(MEs), especially in pediatric populations.
List strategies to minimize medication errors in
anesthesia practice.

4. Dangerous Medication Events

5. Adverse Drug Events-Classification
Adverse
Drug
Events
(ADE’s)

6. Adverse Drug Reactions

7. Adverse Drug Reactions in Pediatrics
Overall incidence in hospitalized children was 9%
12% of these were severe
2% of ADRs resulted in hospital admission
39% of these reactions were life-threatening
Overall incidence of ADRs in outpatient children was
1.4%
Impicciatore et al. Incidence of adverse drug reactions in pediatric in/out-patients: a systematic
review and meta-analysis of prospective studies. Br J Clin Pharmacol. 2001;52(1)::77-83.

8. Models of Human Error
Reason’s Swiss Cheese Model of Accident Causation
Complex systems have barriers to protect against human error
(alarms, protocols for double-checking, checklists, etc.)
Each barrier is like a slice of Swiss cheese (with holes in it)
Each barrier has defects (holes in the cheese) often called ‘latent
errors’ that are continually shifting
Latent errors provide a route for active errors to penetrate the
system’s defenses or barriers
An active failure or error combined with latent errors allow a hazard
to result in an accident
Accidents typically occur as a result of the convergence of several
latent and active errors as successive layers of barriers are breached
A ‘near-miss’ event then converts to an ‘accident’ or ‘adverse event’
Reason et al. Diagnosing ‘vulnerable system syndrome': an essential prerequisite to
effective risk management. Qual Health Care 2001;10(Suppl II):ii21-5.

9. Models of Human Error
The ‘Human Factors’ Approach
Modern approach
Less focus on the individual who made the error
More on the pre-existing organizational factors
Active failures
Actions-picking up the wrong syringe, mislabeling a syringe etc
Cognitive factors-memory lapses
Violations-deviations from safe practice or protocols
Latent failures
Heavy workload
Stressful environment
Inadequate communication
Inadequate maintenance of equipment
Rapid organizational change
Inadequate knowledge or experience
Inadequate supervision
Vincent et al. Framework for analysing risk and safety in clinical medicine. BMJ 1998:316;1154-7.

10. Medication Errors-Scope
Institute of Medicine, 1999
1
:
44,000-98,000 patients die annually as a result of
medication errors
~1.5 million preventable medication errors cause harm
in the USA each year.
Most serious consequences occur in operating rooms,
ICUs and emergency rooms.
UK Department of Health
2
:
850,000 adverse events annually
>$3 billion in direct costs alone for hospital days
Up to half of these events may be avoidable
1. Kohn et al. To err is human: building a safer health system. IOM, 1999.
2.Dept. of Health. An organization with a memory. London, 2000.

11. Medication Error-Definition
Any preventableevent that may cause, or lead to,
inappropriate medication use or patient harm, while
the medication is in the control of the healthcare
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.
National Coordinating Council for Medication Error Reporting and Prevention, 1996
(NCC MERP)

12. Medication Errors –Types
70.1 Dose Omission
70.2 Improper Dose: Over dosage, under dosage, extra dose
70.3 Wrong Strength/Concentration
70.4 Wrong Drug
70.5 Wrong Dosage Form
70.6 Wrong Technique (includes inappropriate crushing of tablets)
70.7 Wrong Route of Administration
70.8 Wrong Rate: Too fast, too slow
70.9 Wrong Duration
70.10 Wrong Time: Administration outside the defined interval for that drug, for that
facility
70.11 Wrong Patient
70.12 Monitoring Error: Contraindicated drugs, Drug-Drug Interaction, Drug-
Food/Nutrient interaction, documented allergy, Drug-Disease Interaction, Clinical
Monitoring error (i.e. prothrombin time with warfarin P
x )
70.13 Deteriorated Drug Error (administration of expired drug)
70.14 Other: Any medication error that does not fall into one of the above
National Coordinating Council for Medication Error Reporting and Prevention, 1996
(NCC MERP)

13. Medication Errors: Taxonomy by
Patient Outcome
*Harm is defined as impairment of physical, emotional, or psychological function or
structure of the body and/or pain resulting therefrom
National Coordinating Council for Medication Error Reporting and Prevention, 1996
(NCC MERP)
Category A Potential for error
Categories B, C, D Actual error without harm*
Categories E, F, G, H Actual error with harm
Category I Actual error that may have
contributed to, or resulted in
a patient’s death

14. Medication Errors: Reporting
United States Pharmacopeia (USP)-Non-profit entity
Medication Errors Reporting (MER)-In collaboration
with the Institute for Safe Medication Practices accepts
reports from any healthcare provider
MEDMARX-Internet-accessible database designed as
internal performance improvement tool for health
systems to compare their data with all other MEDMARX
participants.
•Food and Drug Administration(FDA)
•MedWatchAdverse Event Reporting Systemfor serious
reactions, product quality problems, therapeutic failure, and
product use errors for drugs and medical devices.

15. Medication Errors in Pediatrics
Weight or surface area-based calculations
Pharmacokinetic variations amongst different age groups
Availability of multiple concentrations of medications
Confusion may occur between dosing by volume (ml) or quantity (mg)
Dangerous decimal point misplacement (10-fold or more dosing error)
is more likely in pediatric dosing
Many IV medications not available in pediatric unit doses, so nurses
need to calculate dilutions from adult unit-dose packages
Pediatric elixirs must often be reconstituted
For most drug classes, almost no information on use in patients <2 yrs
Children cannot talk about side effects, or advocate for themselves
(wrong drug color, quantity, route, interval, etc.)
Maternal administration of drugs can easily affect the fetus and cause
adverse events in neonates
How to avoid pediatric medication errors: a user’s guide to the literature.
Walsh KE et al, Arch Dis Child 2005;90:698-702.

16. Medication Errors in Anesthesia
Delivery of multiple potent drugs, often in rapid
succession during high acuity situations
1
Providers have the unique responsibility of being
responsible for the direct preparation, dosing, and
delivery of medications to patients
In contrast to inpatient prescribing, this scenario lacks
safety mechanisms like pharmacist reviews of
prescriptions, check by second provider etc.
A survey of 687 anesthesiologists revealed 85% had a
drug error or near-miss in clinical practice
2
.
1. Hanna et al: Medication safety in the perioperative setting. Anesth Clin (2011) 135-144.
2. Orser et al: Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth 2001:48:139-46.

17. Types of Medication Errors in Anesthesia
ASA Closed-Claims Project
1
205 claims for drug errors (4% of all Closed Claims in 2003 report)
31%-incorrect dose
24% substitution
17% insertion
24% miscellaneous
Webster et al, 2001
2
~ 8000 anesthetics found 1 medication error in 133 anesthetics (0.75%)
20% incorrect dosing
20% accidental substitutions
63% of all errors involved intravenous boluses
These errors caused additional interventions and/or escalation of care
No deaths or permanent morbidity
1.Bowdle TA. Drug administration errors from the ASA closed claims project. ASA Newslet 2003; 67:11-13.
2.Webster et al. The frequency and nature of drug administration error during anaesthesia. Anaesth Inten Care.2001;29494-500

18. Common Drugs Implicated and Errors
Anti-infective agents
Electrolytes and fluids
Analgesics and sedatives
Insulin
4.2% of reviewed reports were harmful (Categories E-I)*
Commonest errors
Improper dose/quantity
Omission errors
Prescribing errors
Weight vs. volume errors (mg vs. ml)
Infusion pump misprogramming (mg/kg/min instead of mg/kg/hr)
Patient weight confusion (pounds instead of kilograms)
Kaushalet al Medication errors and adverse drug events in pediatric inpatients. JAMA 285, 2114-20.
*Hicks et al. Harmful medication errors in children: A 5 year analysis of the MEDMARX program. J Ped
Nursing. 2006;21:290-8

19. Heparin
3
rd
most common implicated drug
1
Several high-profile heparin overdoses in babies.
Indiana, 2006: 5 infants received heparin 10,000U/ml instead of
10U/ml -3 infants died
2
California, 2007: 3 infants received heparin 10,000U/ml instead of
10U/ml, including the twins of a Hollywood celebrity –no lasting
adverse effects
3
Pharmacy technicians had mistakenly restocked the clinical care
areas with 1000x more concentrated heparin
Both concentrations of heparin had similar labels.
Baxter has since repackaged them with different labels
1.Hicks et al. Harmful medication errors in children: A 5 year analysis of the MEDMARX program. J Ped Nursing. 2006;21:290-8.
2.Supporting Staff Recovery and Reintegration After a Critical Incident Resulting in Infant Death. Roesler, R, Ward D, Short M.Adv. Neonatal Care.
2009:9(4);163–171.
3. Another heparin error: Learning from mistakes so we don't repeat them.
Institute for Safe Medication Practices Medication Safety Alert, 2007:Nov.29.
http://www.ismp.org/Newsletters/acutecare/articles/20071129.asp(accessed 4/27/11).

20. ADEs in Pediatric Sedation
In a landmark study of adverse events in pediatric
sedation settings, the conclusions were:
Frequent drug overdoses and interactions, especially when 3 or more drugs
were used
ADEs associated with all routes of administration
Patients receiving drugs with long half-lives may benefit from a prolonged
period of observation
ADEs occurred when sedation was administered outside the safety net of
medical supervision
Uniform monitoring and training standards required regardless of
subspecialty or venue
Standards of care, scope of practice, resource management, and
reimbursement should be based on depth of sedation achieved (vigilance
and resuscitation skills required)
Cote et al. Adverse sedation events in pediatrics: analysis of medications sued for sedation. Pediatrics. 2000
Oct;106(4):633-44

21. Safety Goals and Recommendations
The Joint Commission For Accreditation of Healthcare
Organizations (TJC)
1
Instructs providers to ‘label all medications, medication
containers, or other solutions on and off the sterile field’
Frequent cause of citations on JCAHO surveys
Anesthesia Patient Safety Foundation (APSF, 2010)
2
New paradigm based on label formatting and careful
reading of labels
STPCParadigm-Standardization, Technology,
Pharmacy, and Culture
1.Suyderhoud JP. JCAHO requirements and syringe labeling systems Anesth Analg 2007; 104: 242
2. Eichhorn JH. APSF hosts medication safety conference: APSF newsletter 2010; 25: 1-20.

22. APSF: STPC Standardization
Standardization
High alert drugs should be made by pharmacy
Ready-to-use form appropriate for adults and/or kids
Infusion pumps with drug libraries must be used
Standardized fully compliant labels
Technology
Every location should have bar code readers to identify medications and a
way to provide feedback, documentation and computerized decision
support, i.e. anesthesia information systems
Pharmacy
Provider prepared medications should be discontinued in favor of pre-
prepared kits.
Clinical pharmacists should be part of the perioperative team
Culture
Establish a culture of education, accountability and error reporting with
discussion of lessons learned.

23. American Academy of Pediatrics: Committee on
Drugs and Committee on Hospital Care
Policy Statement: ‘Prevention of Medication Errors
in the Pediatric Inpatient Setting’
Detailed evidence-based recommendations to prevent
medication errors, and education about medication
errors for:
Hospitals and organizations
Prescribers
Pharmacy staff
Nursing staff
Patients and families
Stucky ER. Pediatrics 2003;112(2): 431-436.

24. Prevention of Medication Errors
Presence of Clinical Pharmacists to Monitor
Medication Orders (Ordering, Transcribing, and
Administering)
Ordering alone-Error rate reduction of 58%
Transcribing and administering-additional 25%
reduction
Monitoring of all 3 functions-81% error rate reduction
Fortescue et al. Prioritizing strategies for preventing medication errors and adverse
drug events in pediatric inpatients. Pediatrics 2003;111:722-729.

25. Prevention of Medication Errors
Computerized Provider Order Entry (CPOE) with
Clinical Decision Support Systems (CDSS)
Basic CPOE (ensures legibility and complete orders)
prevented 65% of errors
When CDSS added to CPOE, error reduction rate was
72%
Fortescue et al. Prioritizing strategies for preventing medication errors and adverse
drug events in pediatric inpatients. Pediatrics 2003;111:722-729.

26. Prevention of Medication Errors
Improved Communication Between Healthcare
Practitioners
Specifically, physician-pharmacist communication could
have prevented 47% of all medication errors
Physician-nurse communication (i.e. nursing
involvement in physician rounds) –17% error reduction
Fortescue et al. Prioritizing strategies for preventing medication errors and adverse
drug events in pediatric inpatients. Pediatrics 2003;111:722-729

27. Prevention of Medication Errors
3 Strategies Combined (Presence of Clinical
Pharmacists, CPOE with CDSS, and Improved
Communication)
Prevention of 98.5% of medication errors
Potentially harmful medication errors-3 strategies
combined could have prevented 96.7% of errors
Fortescue et al. Prioritizing strategies for preventing medication errors and adverse
drug events in pediatric inpatients. Pediatrics 2003;111:722-729

28. Prevention of Medication Errors in
Anesthesia
The label on any ampule or syringe should be read carefully before
drawing it up.
Legibility and contents of labels should be optimized according to
agreed standards.
Syringes should always be labeled
Formal organization of drug drawers and workspaces should be used
Labels should be checked with a second person or device (e.g. barcode
reader) before drug is drawn up or administered
Avoidance of similar packaging and presentation of drugs
Errors should be reported and reviewed for continuous quality
improvement purposes
Hanna et al: Medication safety in the perioperative setting. Anesth Clin (2011) 135-144.
Jensen et al. Evidence-based strategies for preventing drug administration errors during anaesthesia.
Anaesthesia 2004;59:493-504

29. Prevention of Medication Errors in
Anesthesia: The Role of Technology
Automated Anesthesia Information Management Systems (AIMS)
CPOE with CDSS
Prefilled, automated medication syringes (IntelliFill IV System, FHT
Inc, USA)
Automated ampule opening and syringe-labeling device (SAFERamp,
Cambridge Enterprise, Ltd., UK)
Bar-coded labels with drug information, visual and auditory
confirmation, and automated recording on the electronic record
(SAFERsleep system, Safer Sleep Inc. , USA)
DocuSys-Computerized interface for medication management and
narcotic tracking with decision support (DocuSys Inc, Georgia, USA)
Safe Label System (Codonics Inc., Ohio, USA)-Barcode identification
and labeling with safety checks, confirmation and label printing
Hanna et al: Medication safety in the perioperative setting. Anesth Clin (2011) 135-144.

30. Communication with the Family
Patients unanimously desire to be told about any error that
caused them harm
Present results of how the incident occurred
Thorough apology
Information on how these events will be prevented in future
No evidence to suggest full disclosure results in increased
liability payments
Disclosure by professionals more likely if they feel
supported by organization
Dissemination of findings to family and wider audience,
i.e. other institutions/units nationally and internationally
Stebbing et al. The role of communication in paediatric drug safety. Arch Dis Child 2007;92:440-45.

31. Summary
ADEs can be classified as preventable or non-preventable
Children are at increased risk for medication errors as a result of several
factors
Anesthesia practice is a high-risk setting for medication errors
Providers can utilize simple strategies to minimize the potential for
medication errors.
Adoption of technologies that decrease medication error is essential to
make hospitals safer for patients
Organizational culture must support and encourage the reporting of
errors as a quality improvement tool
A policy of full disclosure of errors to patients and family must occur at
an organizational level
Despite adoption of all measures, it is likely that we are a long way from
achieving a zero-incidence of medication errors in clinical care