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Drugs, Diluents, Disaster: Medication Error PreventionPharMEDium Lunch and Learn Series

ProCE, Inc.www.ProCE.com 1

Drugs, Diluents, Disaster: Medication Error PreventionJuly 11, 2014

LUNCH AND LEARN

Featured Speaker: Darryl S. Rich, PharmD, MBA, FASHP

Medication Safety SpecialistInstitute for Safe Medication Practices

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CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Tech CE)

1.0 contact hour

Funding: This activity is self‐funded through

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g y gPharMEDium.

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Richhas no relevant commercial or financial relationships to disclose.



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Drugs, Diluents, Disaster:Medication Error Prevention

Darryl Rich, PharmD, MBA, FASHPMedication Safety Specialist

Institute for Safe Medication Practices



Objectives

• List system‐based causes of medication errors associated with preparation of compounded sterile preparations (CSP )(CSPs)

• Identify storage, workflow, labeling, quality control, and documentation best practices that should be standardized and incorporated into the manual preparation of all CSPs

• Discuss hospital regulatory and accreditation requirements l d d drelated to outsourced compounders

• List hospital‐based medication errors associated with the use of outsourced sterile products

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Disclosure

• Darryl Rich declare no conflicts of interest, real t d fi i l i t t ior apparent, and no financial interests in any

company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

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What Is ISMP?

• Federally‐certified patient safety organization– Independent non‐profit; Horsham PA; founded 2004Independent non profit; Horsham, PA; founded 2004– Only PSO dedicated to medication safety – Analysis of medication error reports (ISMP‐MERP, FDA, State)

• Education– newsletters, webinars, guidelines, self‐assessments, tools on‐site consults/root‐cause analysestools, on site consults/root cause analyses, fellowship/training

• Advocacy – FDA, etc.• Med‐ERRS www.ismp.org

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Compounding Sterility Issues

• 1975: “Nationwide epidemic of septicemia caused by contaminated intravenous products”

J Cli Mi bi l 1975 2 436 97• J Clin Microbiol. 1975:2:436‐97.

• 1984: 11 patients received cardioplegia solutions contaminated with Enterobacter cloacae – 5 deaths

• Thorac Cardiovasc Surg. 1986; 91:296‐302.

• FDA: 200 adverse events reported involving 71 compounded sterile products since 1990, some of them with "devastating repercussions”

Th G di O t 10 2012• The Guardian – Oct 10, 2012.

• 1990‐2012: At least 24 incidents of contaminated pharmacy‐prepared products reported nationally infecting over 900 patients resulting in 92 deaths

• ISMP Medication Safety Alert – Oct 8, 2012.

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Incidents Involving Outsourced Sterile Compounders

2001 California 11 infected, 3 deaths (steroids)

h f d ( d )2002 Michigan 2 infected (steroids)

2002 South Carolina 7 infected, 2 deaths (steroids)

2005 Texas 18 infected in 5 states (mag sulfate)

2005 Maryland 10 deaths in 46 facilities (cardioplegia)

2011 Alabama 19 infected; 6 hospitals, 9 deaths (TPN)

2011 Massachusetts 750 infected; 64 deaths (steroids+)2011 Massachusetts 750 infected; 64 deaths (steroids+)

2013 Tennessee 26 infected; 17 states (steroids)

2013 Texas 15 infected (calcium gluconate)

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Sterile Compounding Errors

• 2009: 30% of surveyed hospitals had a patient event involving a compounding error in the prior 5 years

• Pharm Purch Prod. 2009; 6(4):4‐20.

• Five‐hospital study found a mean daily error rate of 9% (highest for complex solutions like TPN – 22‐37%)

• Am J Health‐Syst Pharm. 1997; 54(8):904‐912.

• 2005‐2011: Serious cases of sterile compounding errors involving 15 patients, 8 of whom died, reported due to: – Wrong concentration/strength of the product dispensed– Wrong product or diluent used in compounding– Product mislabeling by the pharmacy

• ISMP Medication Safety Alerts

– 3 cases involved outsourced compounders

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Multiple Fatal Events Related to Sterile Compounding Errors

• Nevada – Death from 1000‐fold zinc sulfate d ( d f d)overdose (mcg and mg confused)

• Illinois – Child died after sodium chloride concentrate used in error during compounding

• Washington Oregon – 3 deaths from 8‐foldWashington, Oregon 3 deaths from 8‐fold measuring error of IV colchicine during compounding

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Multiple Fatal Events Related to Sterile Compounding Errors

• Pennsylvania – 3 neonates die after heparin i i d t tl d i t isyringes inadvertently prepared in potassium

chloride injection concentrate instead of dextrose 5% injection

• Ohio – Child died after compounding error led to administration of chemotherapy in 23.4% pysodium chloride injection instead of 0.9%

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Gaps in Pharmacy Sterile Compounding

• Absence of specific practice guidelines related to product preparation checksproduct preparation checks

• Variability in practices across the country

• Ambiguity in ability to validate compounding

• Lack/Inappropriate use of technology

• Lack of awareness of associated risks

• Lack of formal education & training

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Observations and analysis presented based on data from the ISMP Medication Error Reporting Program (MERP) and on‐site risk assessments across the US.

Risk Points for the Preparation of Sterile Compounds

• Prescribing/Communication

• Technology/Automation

• Product production

• Product checking

• Environment

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ISMP Sterile Preparation Compounding Safety Summit

• October 24‐25, 2011

• Pharmacists, pharmacy technicians, industry, nurses, consumers, medication safety, ASHP, ASPEN, FDA

• Developing core processes for the safe preparation and checking of compoundedpreparation and checking of compounded sterile preparations in the pharmacy setting

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Goals of the Summit

• Identify quality control practices that should b t d di d d i t d i t thbe standardized and incorporated into the preparation of CSPs

• Discuss technologies that assist in the preparation of CSPs

• Identify the minimum safeguards that must beIdentify the minimum safeguards that must be in place

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Consensus Statements Developed for Core Processes

• Policies and Procedures

• Order entry and

• Technology/Automation used for compounding Order entry and

verification

• Drug storage

• Assembling products and supplies for preparation

• Compounding

p gCSPs

• Quality control/final verification of manually prepared product

• Product labeling

• End product testing• Drug conservation

• Preparation of source/bulk containers

• End product testing

• Record keeping

• Staff management

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2012 Guidelines to Reduce IV Compounding Errors

http://www.ismp.org/ Tools/guidelines/ IVSummit/IVCGuidelines.pdf

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From the Guidelines and Other ISMP Recommendations

WHAT ARE SOME STRATEGIES FOR REDUCING ERRORS?

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Highly Reliable Organization

• A “collective mindfulness” in which all workers l k f d t ll bl flook for, and report, small problems or unsafe conditions before they pose a substantial risk to the organization

– Rarely, if ever, have significant accidents

– Prize the identification of errors and close calls for the lessons they can extract from a careful analysis of what occurred before these events

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For more information: Chassin MR, Loeb JM. Milbank Quarterly. 2013;91(3):459–490.



Highly Reliable Organization

• Principles of HROs:

– Preoccupation with failure

• Identification of threats to safety, even if they’ve had no failures

– Sensitivity to operations: Workers always report any deviation from expected performance

l b l kl– Resilience – capability to recognize errors quickly and contain them

• Staff have authority to fix safety issues

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Culture of Safety

• A “Just Culture” – neither punitive nor blame‐ffree

– Focus on behaviors rather than outcomes

• A reporting culture

– Willingness to report, analyze, and communicate errors and near‐misses

• A learning culture

– Willingness to constantly learn ways to improve

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“Culture eats strategy for lunch any day”



Three Behaviors

Human ErrorHuman Error

At‐Risk Behavior (drifting)

Reckless Behavior

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Just Culture Framework

Human Error At‐Risk Behavior Reckless Behavior

Inadvertent action: slip A choice: risk not recognized Conscious disregard ofInadvertent action: slip, lapse, mistake

A choice: risk not recognized or believed justified

Conscious disregard of unreasonable risk

Manage through changes in: Manage through: Manage through:

• Processes• Procedures• Training• Design• Environment

• Removing incentives for at‐risk behaviors

• System changes• Creating incentives for

healthy behaviors

• Remedial action• Disciplinary action

Environment healthy behaviors• Increasing situational

awareness

Console Coach Punish

Learn Learn Learn

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Infrastructure

• Medication safety officer

• Multidisciplinary medication safety committee

– Proactive risk assessments

• Gap analyses, failure modes and effects analysis (FMEA), review of external errors and best practices

– Medication error reporting program (QC)

• Analysis of data, telling stories, robust performance improvement

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Medication Safety Strategies: Basic Premise

• Process for reducing medication errorsF hi h l t d– Focus on high‐alert drugs

• Drugs that present an increased risk for harmful errors

– Actions taken should address as many phases of the medication use process as possible

• Procuring, storing, ordering/prescribing, transcribing, preparing, dispensing, administering, monitoring

– Actions need to be multiple different high‐leverage strategies that enhance safety over normal processes

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Swiss Cheese Model of Errors

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Rank Order of Error‐Reduction Strategies

Strategy

Fail safes and constraints

Power (Leverage)

Fail‐safes and constraints

Forcing functions

Automation and computerization

Standardization

Redundancies

High

Medium

Car won’t start if alcohol is detected

on breath

Reminder signs and checkpoints

Reminders and checklists

Rules and policies

Education and information

Suggestions to “be more vigilant”Low

Rule/Law: It’s illegal to drive if you exceed the allowable blood

alcohol limit

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Human Factors and System Design

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Things That Don’t Work the Way You’d Expect

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Things That Are Hard to Remember

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Things With Too Many Choices

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Strategies: Simplify and standardize



Standardize and Simplify

• Organizations have well‐defined policies and procedures for compounding of sterile productsprocedures for compounding of sterile products

– Fully comply with USP <797> or cGMP

• Organizations identify standardized work flow processes that include quality control, process change control and documentation practices

• Standard Operating Procedures (SOPs) forStandard Operating Procedures (SOPs) for compounding all CSPs are established and sufficiently detailed to prevent variation in practice

– RPh vs. Techs

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• Formulas (ingredients and process to prepare) are established and standardized and are used to guide theestablished and standardized and are used to guide the compounding of CSPs

• Formulas and SOPs are supported by the current literature and revised as new information is available

– Internal as well as external information about medication errors, from sources such as ISMP, should be reviewed and used to

dif ti d d d dmodify practices and procedures as needed

• SOPs are developed and revised based on an FMEA and human‐factors theory, and are simplified to reduce unnecessary steps

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• Organization develop detailed policies for b t h d ti f CSPbatch production of CSPs

– Includes preparation instructions and references

– Are provided for all batch sizes (e.g., production of 50‐mL batch vs. a 250‐mL batch), document theoretical yield vs. actual yield, and account for all waste

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• Pharmacies shall create standard processes to dd th l f b l ti haddress the volume of base solution when compounding CSPs

• Such standard work practices address:

– If and when there is a need to remove base solution in amounts equivalent to drug additive(s)q g ( )

– If and when there is a need to eliminate the manufacturer overfill from the base solution and the method used to accomplish removal

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• Limit and standardize the number of different t ti d t th f d t dconcentrations and strengths of products and

standard base solutions (e.g., dextrose 5%) that are used

• Use of metric system only for measuring devices and software

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Unlimited Access

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Strategies: Restrict access, centralize, segregate



Segregate, Restrict Access

• Minimize drug inventory to avoid intermingling of productsproducts

• Provide sufficient space for drug storage to segregate each drug concentration

• Concentrated electrolytes are isolated from other inventory

• Labeling of bins or bin dividers includes generic drug name and concentration– TALLman lettering, bin locator numbers, and leading zeros are used, and abbreviations and trailing zeros are avoided

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• Drugs, diluents, base solutions, and other supplies are gathered and placed in a separatesupplies are gathered and placed in a separate container (e.g., a basket or bin) for each batch to be prepared

• CSPs that have been compounded and are waiting to be checked are placed in a clearly identified and designated storage locationidentified and designated storage location until the checking process has been completed

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• Only one staff member is permitted to work in th h d h di l CSPthe hood when compounding complex CSPs

• Two staff members are permitted to work in the compounding area simultaneously provided that the hood is at least 6 feet in length and there is a physical dividerg p y

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• Only one CSP should be prepared at a time unless preparing the same dose of the same drug withpreparing the same dose of the same drug with the same route of administration

• Partially‐used multi‐dose vials, bulk containers, or single‐dose containers should not be left in the hood or direct compounding area for future use

– Unless the drug is in short supply (drug shortage)

– Insulin and heparin are never in the hood at the same time

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Segregate

• Computerized label runs for pediatric and t l CSP h ll b t d i t dneonatal CSPs shall be generated or printed

separately from those for adult CSPs, and the preparation of CSPs for each population shall be separated by time or location

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Different Things or Names That Are Too Similar

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Strategies: Differentiate, affix warnings



Differentiate, Affix Warnings

• For look‐alike products, affix color‐coded i l b l t diff ti twarning labels to differentiate

• Purchase products from different sources to prevent look‐alike products

• Use TALLman lettering on all storage labels, documentation and computer screensdocumentation, and computer screens

• Verbal orders: write down and read‐back, sound out individual numerals of the dose

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Conditions That Make Information Hard to Find

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Strategies: Maximize access to information, automation with decision support



Maximize Access to Information

• Current and relevant drug information should b dil il blbe readily available

• All compounding policies and procedures, SOPs, and formulas should be readily available

• All medication‐error, performance‐improvement and quality‐control data shouldimprovement, and quality‐control data should be posted for all staff to see

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A Word About Automation

• Automation holds great promise for error reduction but has generally failed to realize its full reduction but has generally failed to reali e its fullpotential– Irrelevant or outdated databases– Ineffective decision support; alert fatigue– Software companies unwilling to make changes based on patient safety

– Software not written based on human factors• Leads to dangerous workarounds

– Lack of effective back‐up systems, or systems are error‐prone

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Technology/Automation

• Organizations should develop a strategic plan for the continuous evaluation and implementation ofthe continuous evaluation and implementation of new automation and technology, and upgrades

• Technology and automation such as barcode verification or IV robotics should be used as much as possible for preparing and verifying CSPs

• Intravenous workflow software should be used to augment manual processes whenever possible

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Automated IV Compounding Devices

• When an automated IV compounder is used, it should deliver all ingredientsshould deliver all ingredients

• Manual compounding should only be used: – If the volume of an ingredient to be mixed is less than the compounder can accurately deliver

– If there is an interaction between an ingredient and a component of the compounderand a component of the compounder

– If there is a chemical interaction between ingredients that cannot be mitigated by sequencing the addition of ingredients

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• Barcode verification is used to verify product id tit d i t d l t fidentity during set up and replacement of ingredients

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Machines That Do What You Don’t Want Them to Do

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Strategies: Barriers, forcing functions, fail‐safes




• The use of a checklist/sign‐off sheet shall be i d h ki difi ti t threquired when making modifications to the

database

• Organizations shall implement specific soft limits and hard (catastrophic) limits for ingredients that are consistent with the needs gof their patient population

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Single Pathway to Serious Harm

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Strategies: Redundancy, recovery



Recovery and Redundancy

• A detailed standard process shall be in place f i d h ki hfor preparing and checking pharmacy‐compounded SOURCE/BULK CONTAINERS used to prepare multiple doses or batches

– A pharmacist shall INDEPENDENTLY DOUBLE CHECK all diluents and drugs before the preparation of all source/bulk containers

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Recovery: Automated IV Compounder

• If multiple containers of a single additive are d d i th ti f i l CSP llused during the preparation of a single CSP, all

empty containers shall be presented to the pharmacist as part of the final check process prior to dispensing the final CSP

• Customized order‐entry templates created by y p yorganizations should have a documented standard review process

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Recovery: Automated IV Compounder

• Only pharmacists shall be allowed to override l talerts

• A double‐check process for the initial daily setup shall be performed, with two staff members using a printed check list

• Verbal affirmation should take place toVerbal affirmation should take place to validate placement

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Recovery

• Identify CSPs that require visual confirmation of the amount of each ingredient (prior to addition to theamount of each ingredient (prior to addition to the final container)

• At a minimum this list should include: – Chemotherapy

– PN admixtures

– Pediatric and neonatal preparations

Ph d /b lk t i– Pharmacy‐prepared source/bulk containers

– Preparations requiring the use of multi‐dose vials of high‐alert medications

– CSPs administered via high‐risk routes of administration

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Recovery

• Proxy methods of verification such as the SYRINGE PULL BACK th d f ifi tiSYRINGE PULL‐BACK method of verification shall never be used in the preparation of chemotherapeutic, complex, pediatric/‐neonatal, or high‐alert CSPs and shall not be used without the presence of the actual, original source containers (medication and diluent)

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Recovery

• Handwriting the amount of additive is never d th l th d f ifi ti fused as the sole method of verification of any

CSP

• All personnel shall be able to “stop the line” and question any concerns about any order or any sterile preparation to be compoundedy p p p

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Errors from Drug Shortages

• Despite the added costs of dealing with drug h t h d d tshortages, errors have occurred due to unfamiliarity with the substituted product

– Dosing errors with different strength of product

– Clinical errors due to unfamiliarity with dosing of substitute product

– People implementing unsound practices in response to drug shortage

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Guidelines Available

• ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health SystemsShortages in Hospitals and Health Systems

– Am J Health‐Syst Pharm. 2009; 66:1399‐406.

• ISMP: Managing the Drug Shortage Crisis

– ISMP Medication Safety Alert! October 7, 2010.

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What Pharmacies Need to Do

• Develop a drug shortage network to establish sharing and collaborative agreementssharing and collaborative agreements

• Establish a formal process for identification and monitoring, and actions needed in a shortage– Allow actions to be tailored to the circumstances

d f h h kl !• Identify the shortage quickly!– Listservs, websites

• Constantly monitor and maintain inventory

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Drug Shortage

• Organizations should develop a drug ti li th t dd thconservation policy that addresses the

handling and disposition of drugs (while maintaining their integrity and sterility) that may be in short supply due to market conditions, as these shortages can affect work‐flow conditions

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Hospitals Using Outsourced Vendors

• Outsourcing the production of CSPs is considered an alternative to in house compounding whenan alternative to in‐house compounding when:

– The volume of certain CSPs is very low

– The need for certain CSPs is high and staff resources are limited or unavailable to prepare this quantity

– The organization does not possess the technological resourcesresources

– Commercially prepared, premixed product is not available

• www.ashpfoundation.org/sterileproductstool

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Joint Commission Requirements for Outsourced Contracted Providers

• The hospital is responsible for the services id d t it ti t d t tprovided to its patients under contract

• Contracted services must adhere to allapplicable TJC standards

– “The same level of care should be delivered to patients regardless of whether services are p g fprovided directly by the hospital or through contractual agreement”

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LD.04.09.01

• Care, treatment, and services provided through contractual agreement are providedthrough contractual agreement are provided safely and effectively– EP 1: Clinical leaders and medical staff provide advice on sources of contracted services

– EP 2: Hospital describes, in writing, the nature and scope of services provided under contractscope of services provided under contract

– EP 3: Designated leaders approve contracts

– EP 4: Establish performance expectations for the contracted service

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LD.04.09.01

– EP 5: Communicate the expectations in writing to the provider of the contracted servicesthe provider of the contracted services

• Need not be in contract; can be addendum or separate document

– EP 6: Evaluate these services in relation to the established expectations

– EP 7: Take steps to improve these services when th t ti t tthe expectations are not met

– EP 8: Maintains continuity of care/services when contract terminated/renegotiated

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“Change Is Hard”

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We’d like to hear from you!

• Share your medication safety stories and error t i fidreports in confidence:

– Call ISMP (1‐800‐FAILSAFE),

– Via our website (www.ismp.org/MERP)

– By email ([email protected])

Reporter identity and location remain strictly confidential and are never published. Anonymous reports are also accepted.

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