ce activity information & accreditations3.proce.com/res/pdf/427.pdf · • monitoring how well...

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CE Activity Information & Accreditation

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This CE activity is jointly provided by ProCE, Inc. and the Institute for Safe Medication Practices (ISMP). ProCE is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This CE activity is approved for 1.5 contact hours (0.15 CEUs) in states that recognize ACPE providers.

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Disclosure*

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It is the policy of ISMP and 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. The speakers listed below have no relevant commercial and/or financial relationships to disclose.

Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon), FASHP

Christina Michalek, BS, RPh, FASHP

Darryl Rich, PharmD, MBA, FASHPThe speaker listed below disclosed a potential conflict of interest.

Stephen F. Eckel, Pharm.D., M.H.A., BCPS

Stephen Eckel has received grant/research support from BD, Baxter & Carefusionfoundation. He has received financial support as a consultant/speaker for BD.

* Conflicts identified were resolved with a peer review process.

Please note: The opinions expressed in this activity should not be construed as those of the CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

Medication Safety Issues and Recommended Strategies Related to

Sterile Compounding

Christina Michalek, BS, RPh, FASHP

Medication Safety Specialist

Institute for Safe Medication Practices

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Disclosure

Christina Michalek declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned, including grants, employment, gifts, stock holdings, and honoraria.

ISMP is a federally certified patient safety organization and the only nonprofit organization dedicated entirely to medication error prevention and safe medication use. It is not a regulatory agency or accrediting body and has no direct affiliation with these organizations.

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Objectives

• Identify system-based causes of medication errors associated with sterile preparation and compounding activities in hospitals.

• Prioritize selected strategies to prevent harm and improve medication safety with sterile preparation and compounding activities in hospitals.

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Sterile Compounding Errors

• Harmful or fatal errors occurring while compounding sterile preparations in the pharmacy have been making headline news for the past 10 years

• ISMP has compiled and analyzed many sterile compounding errors to determine causes

• Sterile compounding remains a top medication safety issue

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The Issues

Sterility

• 1990-2014: At least 26 incidents of contaminated pharmacy-prepared products were reported nationally, infecting over 900 patients and resulting in 92 deaths

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The Issues

Preparation

• 2006: infant dies from a 1,000-fold zinc overdose (mcg and mg zinc sulfate were confused) added to parenteral nutrition solution

• 2005 and 2006: a neonate and a child each died after compounding errors undetected during final verification led to administration of medications in 23.4% sodium chloride

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The Issues

• 2010: pharmacy staff mistakenly prepared 1000 mg dose of valproate sodium with vecuronium

• 2014: patient ordered to receive intravenous fosphenytoin for seizure control, but instead received rocuronium

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Scope of Opportunity

Are you aware of an error related to sterile compounding that occurred in an organization where you worked?

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Adoption of Standards

• United States Pharmacopoeia (USP) Chapter 797 Pharmaceutical Compounding - Sterile Preparations

• Introduced as enforceable standards in 2004, last revision 2008, current revision open for public comment

• All but one state have laws and regulations related to sterile compounding

• Twenty-six (26) specifically cite USP 797

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Complex System Failure Model

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What Can We Do to Avoid Errors?

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ISMP Model: Key Elements of the Medication Use System™

• Patient Information

• Drug Information

• Communication

• Drug Labeling, Packaging, Nomenclature

• Drug Standardization, Storage, and Distribution

• Medication Device Acquisition, Use and Monitoring

• Environmental Factors, Workflow and Staffing Patterns

• Staff Competency and Education

• Patient Education

• Quality Processes and Risk Management

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ISMP Guidelines

Guidelines for SAFE Preparation of Sterile Compounds

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Rank Order of Error Reduction Strategies

Forcing Functions and Constraints

Automation and Computerization

Standardization and Protocols

Checklists and Double Check Systems

Rules and Policies

Education / Information

“Be more careful”

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Stronger

Weaker

Contributing Factors

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Order EntryOrder

VerificationPreparation Administration

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Staff Competency and Education

• Compounding staff

• Pharmacists charged with verifying compounding activities

• Initial

• Ongoing

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Image courtesy of Stuart Miles at FreeDigitalPhotos.net

Environment

• Lighting

• Overhead

• Refrigerated storage

• Other storage locations

• Temperature

• Noise

• Counters

• Linear counter space

• Counter height

• Stationary versus mobile counters

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Environment

•Storage space and layout

•Compounding space/number of locations

•Number of people and equipment in work space

•Space for checking process

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Environment

• Distractions

• During order review

• During preparation of products

• During validation/verification

• Variable workflow

• Variable production speed (individual based)

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Workflow – Preparation Process

• Movement of compounded sterile preparations (CSPs)

• More than one patient-one product in the compounding area

• Flawed labeling procedures

• Low volume (rarely prepared) solutions

• Lack of clinical expertise for specialty products

• No restrictions on time of day for ordering/production

• Lack of standardized preparation procedures between and among technicians and pharmacists

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• Not using commercially-available products when available

• Maintaining only one strength of a product when multiple strengths are available

• No preparation directions for compounding (preparation from memory)

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Image courtesy clarity at MorgueFile

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• Using manual processes when automation is available

• Lacking or outdated clinical decision support in order verification, drug selection, and production

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Image courtesy of 2nix at FreeDigitalPhotos.net

Quality Processes - Verification

• Education

• Initial competency assessment

• Ongoing competency evaluation

• Pharmacist versus Technician

• Trust/Careful

• Behavior to emulate

• One of the strongest predictors of high-level safety behaviors is observing that behavior in one’s peers

• Culture (reporting; near miss/close call)

• Event investigation

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• Manual versus technology-enhanced

• Lack of technology to test solutions

• Specific gravity

• Photometric analyzers

• Weighing of final solutions

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Image courtesy of Stuart Miles at FreeDigitalPhotos.net


• Variable checks

• Before product is prepared

• When product is prepared but before it is placed in the solution

• After product is prepared using a syringe pull back

• After product is prepared using the vial

• After product is prepared writing the volume on the label

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Staffing/Support

• Weekend/evenings/nights/holidays

• Unexpected staffing issues

• Call outs

• Computer or technology down time

• Areas/functions that require specialty-training

• Shift length (planned/unplanned)

• Breaks

• Avoiding the “hero” syndrome

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Other Items

• Patient Information

• What do we know about the patient (age)

• Communication

• Turnaround time expectations

• Standard versus custom preparation

• Stock, Storage, Standardization

• Storage locations

• Labeling and use of tall man lettering

• Drug Information

• What do we know about how to prepare the product

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Focused Areas for Attention

• Events that can cause attention failures

• Distractions (external and internal)

• Pressure for turn-around

• Workload

• Processes that would lend themselves to a checklist

• Database maintenance

• Processes that would lend themselves to an independent double-check

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Image courtesy of mconnors at MorgueFile

The Power of Observation

• Not to be under estimated

• Take a picture

• Pull in “outside eyes”

• Despite training and standard operating procedures (SOPs), the way processes are executed may vary (by person, time of day, based on external/internal forces)

• Prompt with a checklist

• Gives the opportunity to coach towards what is desired

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Power of Monitoring the Process

• Helps identify a potential problem that needs intervention

• Monitoring how well the process is working can reduce the number of errors that occur

• Increase awareness of potential errors latent in the system

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Image courtesy of pippalou at MorgueFile

Automated Solutions to Reduce Sterile Compounding Errors

Stephen F. Eckel, Pharm.D., M.H.A., BCPSClinical Associate Professor, UNC Eshelman

School of PharmacyAssociate Director, UNC Hospitals

[email protected] @stepheneckel

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Disclosures*• Stephen F. Eckel has received relevant research grants

from the following companies:» Baxter

» BD Carefusion

» Carefusion Foundation

• Stephen F. Eckel has spoken on behalf of the following companies:» BD Carefusion

* Conflicts identified were resolved with a peer review process.

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Objectives

• Discuss the results of a recent study that demonstrated the inaccuracy of the syringe “pull-back” method for checking IV compounded products.

• Explain how automation and technology can reduce errors related to sterile preparation.

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Why do we have errors?

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Another approach to making IVs

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What it takes to get an aspirin …

Used with permission – John Kenagy 39

Benefits of Automation

Used with permission from Intelligent Hospital Systems 40

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Safety Concerns of the Manager

• Streamlined workflow to maximize efficiency and minimize deviations» Use of automation

» Lean six sigma or other processes to minimize variations

• Precision and accuracy in the preparation of all compounded products» Consistently prepare what the physician prescribed

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Assessment of dosing accuracy when using volumetric technique in the

preparation of chemotherapy

Lindsey Poppe, Pharm.D., MS, BCPS

Scott Savage, Pharm.D., MS

Stephen F. Eckel, Pharm.D., MHA, BCPS

Journal of Oncology Pharmacy Practice. 2014 Sep 2. Epub ahead of print

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Objectives• Primary outcome – determine the accuracy of volumetric

measurements in the preparation of chemotherapy by using the gravimetric method

• Secondary outcome – evaluate the accuracy of volumetric measurements based on volumes prepared, syringe size used, patient age, preparations requiring reconstitution, drug prescribed, and technicians preparing the agents

Journal of Oncology Pharmacy Practice. 2014 Sep 2. Epub ahead of print 43

Background• Conducted at the UNC Cancer Hospital

• Approximately 160 chemotherapy doses prepared per day

• 10 different pharmacy technicians are employed there

• All technicians are trained and tested on chemotherapy preparation competencies

• At the time of this study, utilized the syringe pull-back method


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Methodology• Placed an electronic balance in one hood

• All technicians that were scheduled to work there participated in the study

• Data collected between December 15, 2010, and March 30, 2011

• Doses excluded if no specific gravity, agent given via non-i.v. route, or data transcription incorrect


Methodology

Step 4:

Empty syringe weighed (with residual volume) or estimation

Step 3:

Full syringe weighed

Step 2:

Medication Prepared (syringe pull back)

Step 1:

Empty Syringe Weighed

Journal of Oncology Pharmacy Practice. 2014 Sep 2. Epub ahead of print46

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Few Considerations• Concerns with over-dosing and under-dosing of chemotherapy

• Inherent inaccuracies in the current process

» Percent label strength of the parent product

» Issues associated with reconstitution

» Syringe tolerance variability (manufacturing process of syringes)

• Nurse need for and reliance on syringe markings for double check

• What is the desired accuracy and precision of Compounded Sterile Preparations (CSPs)?

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Results – Enrollment


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Journal of Oncology Pharmacy Practice. 2014 Sep 2. Epub ahead of print50

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Lack of precision and accuracy• Factors associated with a percent volume difference:

Pediatric populationPreparations already in solution compared to

reconstituted preparationsSmaller volumes and commonly prescribed

medications Smaller syringe sizes

• Variation was found in all scenarios but was ‘averaged’ out

• Currently validating this data with a 5-hospital study

Journal of Oncology Pharmacy Practice. 2014 Sep 2. Epub ahead of print

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Evaluation of Final Product• One limitation with study is use of syringe pull-back

method

• Classified data on whether dispensed as syringe or i.v. bag

Number Mean % Volume

Difference

Median % Volume

Difference

Range

Total 1,156 -0.53% -1.27%

Bags 915 (79%) -1.80% -1.69% (-28.34% to 76.09%)

Syringes 241 (21%) 4.27% 3.68% (-64.90% to 94.22%)

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Multicenter study to evaluate the benefits of Technology-assisted

workflow on IV Room Efficiency, costs and Safety (TIRES study)

• Eight hospital study» 4 hospitals with no technology in the preparation of IVs

» 4 hospitals that utilize technology assisted workflow (Baxter DoseEdge)

• Research question: Does the implementation of a technology-assisted workflow system, DoseEdge, in an IV room improve the safety, reduce the waste, and enhance the efficiency in preparing compounded sterile products?

• Funded through a grant by Baxter

• Data presentation – single hospital (no technology) 53

Evaluation of Pharmacist Error Detection Rate in Sterile Products Area

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Incidence of error categories (n=547)Error Type Count Percent

Labeling issue 178 32.5%

Incorrect medication volume 111 20.3%

Incorrect medication 94 17.2%

Product container issue 52 9.5%

Incorrect base fluid 43 7.9%

Incorrect base fluid volume 41 7.5%

Compounding method error 25 4.6%

Blank 3 0.5%55


Incidence of errors related to staff and pediatric products

Percent labor Errors Percent of errors

Permanent Staff

91.2% 45182.4%

Students 8.8% 95 17.4%

Total doses made

Errors (% of errors)

Percent of total doses

Adult doses 82,513 325 (59.4%) 0.39%

Pediatric doses

34,173 221 (40.4%) 0.64%

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Technology for IV product preparation

Overview of I.V. Technology• Robotics

» Aesynt (Health Robotics): i.v.STATION, i.v.STATION ONCO

» ARxIUM (Intelligent Hospital Systems): RIVA

» Baxter: INTELLIFILL I.V.

» Loccioni: APOTECAchemo

• I.V. workflow systems» Aesynt (Health Robotics): ivSoft

» Baxter: DoseEdge

» BD: Cato

» Envision Telepharmacy: Pharm-Q ITH

» Healthmark: PHOCUS Rx

» MEDKeeper: PharmacyKeeper Verification

» ScriptPro 58Note: there may be other products available than those listed

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Implementation of chemo robot• Description of the implementation and experience at

Cleveland Clinic

• 7,384 doses over 13 months

• Performance issues categorized» Dose issues: 1.2% were manually modified

» Mechanical issues: 155 documented

» Human error: 12 instances

» Interface / IT issues

• Does not prepare syringes for them

• They did not reduce full-time equivalents (FTEs)

Yaniv AW, et al. Am J Health-Syst Pharm. 2013; 70:2030–7. 59

Impact of Robotics on Chemotherapy Preparation

• Utilized direct observer technique

• Results

Baseline (1,421)

Intervention (972)

P value

Medication errors 9 (0.7%) 7 (0.7%) NS

Staff safety events 73 (5.1%) 28 (2.9%) P=0.007

Unintended consequences --- 45 (4.6%)

Medication accuracy 23 (12.5%) of 184

1 (0.9%) of 110 P=0.002

Workflow – overall 7 min 24 sec 10 min 51 sec P=0.009

Costs – personnel $5.22 $5.10

Costs – ancillary materials $13.36 $6.44 P<0.001

Seger AC, et al. J Oncol Pract. 2012:8; 344–349.60

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Additional Benefits of a Robot• Monoclonal antibodies are difficult to reconstitute

» Foaming hampers drawing correct doses into syringes

» Aggregates associated with immune reactions

» Robotic reconstitution and compounding are similar to manual process

• Manual compounding can cause upper limb disorders (ULD)

» Automated compounding was associated with a lower ULD risk than manual processes

Peters BJM, et al. mAbs 2013:5;162–70; McLeod M. European Journal of Hospital Pharmacy.2012:19;293–298. 61

Technology Associated WorkFlow (TAWF)

• Description of implementation experience » First 8 weeks: 217 errors (1.4% of all doses) intercepted

• 75% of errors intercepted at barcode scan

• 25% of errors detected at pharmacist final verification

» After 2 years: 67% of intercepted errors are RTU (Ready to Use) products, 30% Compounded Sterile Products, and 3% chemotherapy

» Barcode intercepted errors: 60% wrong drug, 28% wrong diluent / fluid, and 12% wrong drug

» Pharmacist rejected errors: 75% incorrect amount of drug or diluent, and 25% improper technique or unclear image

• Return on Investment: 12 month waste avoidance of $30,000

Speth SL, et al. AJHP 2013;70:2076-2080. 62

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TAWF experience at a pediatric hospital

Moniz TT, et al. AJHP 2014;71:1311-1317.

425,683 total doses

422,800 doses accepted 2,883 doses not accepted

1,677 doses rejected1,223 doses re-worked

615 errors detectable

by previous practice

536 new

errors

72 errors not

detectable by

previous practice

734 errors detectable

by previous practice

536 new

errors

375 errors not

detectable by

previous practice

43 no actual error

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3 year experience with chemo robot

Year n Variation ≤5% If variation >5% but <10%

If variation ≥10%

2010 337 (3.8%) 3 (0.9%) 0 0

2011 1,516 (10.8%) 349 (23.0%) 256 (16.9%) 93 (6.1%)

2012 2,993 (13.8%) 460 (15.4%) 354 (11.8%) 106 (3.5%)

• Performance evaluation of a chemotherapy robot• Analyzed data captured by the integrated software

• Referred to the product as a ‘first generation’

Nurgat Z, et al. AJHP 2015;72:1036-1045. 64

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Where do we go from here?

• Demand research before implementing any new piece of technology» Don’t we do this for drugs being reviewed by P&T committee

• Conduct evaluations within your own department to better understand current state of practice» Don’t we believe in evidence-based medicine for pharmacy

operations?

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Conclusions

• There is still little we really know about the preparation of sterile products in regards to accuracy, precision, and overall safety – generally and specifically

• While technology could be an answer, the companies developing them have an obligation to demonstrate their true benefit and pharmacy departments should not implement without this rigorous evaluation

• Pharmacy managers have an obligation to instill a culture of safety within their organizations and continue to improve operations to protect our patients

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Automated Solutions to Reduce Sterile Compounding Errors

Stephen F. Eckel, Pharm.D., M.H.A., BCPSClinical Associate Professor, UNC Eshelman

School of PharmacyAssociate Director, UNC Hospitals

[email protected] @stepheneckel

Update on ISMP Guidelines and Regulatory Requirements

Darryl S. Rich, Pharm.D., MBA, FASHP

Medication Safety Specialist

Institute for Safe Medication Practices

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Disclosure

Darryl S. Rich reports no relevant financial relationships.

The information presented related to Centers for Medicare and Medicaid Services (CMS) and The Joint Commission is the personal opinion of the presenter and is not an official position of CMS, The Joint Commission, or any other accrediting body.

ISMP is a federally certified patient safety organization and the only nonprofit organization dedicated entirely to medication error prevention and safe medication use. It is not a regulatory agency or accrediting body and has no direct affiliation with these organizations.

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Objectives

• Outline current and proposed regulatory and accreditation requirements related to sterile preparation and compounding activities in hospitals, and the role of the pharmacy in ensuring compliance.

• Describe the recent revisions to ISMP’s Guidelines for the Safe Preparation of Sterile Compounds, and new ISMP guidelines for IV push administration of medications (as it relates to pharmacy preparation).

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2013 Guidelines to Reduce IV Compounding Errors

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

Original summit in October 2011

Revised 2015

– Input from a workgroup of the Medication Safety Officers Society (MSOS).

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Why Revise the Guidelines?

• Continued development and enhancement of technology designed to verify that the correct drug product, dose and diluents were used to prepare CSPs

• Reports of error that could have likely been prevented with the use of some form of technology

• Increase regulatory pressure to use existing guidelines and standards of practice in this area– Wanted to ensure they are current and relevant

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ISMP Guidelines for SAFE Preparation of Sterile Compounds

• Policies and Procedures

• Order entry and verification

• Drug storage

• Assembling products and supplies for preparation

• Compounding

• Drug conservation

• Preparation of source/bulk containers

• Technology/Automation

• Quality control/final verification of product

• Product labeling

• Record keeping

• Staff management

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What’s Different

• Eliminated priority ranking of guidelines

• New section with expanded recommendations for compounding done outside the pharmacy

• Stronger recommendations on the implementation of automation and technology

• Minor language changes throughout the document

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What’s Different

• Compounding performed outside of the pharmacy IV admixture service

– The director of pharmacy is responsible for oversight of preparation of CSPs outside the pharmacy. Basic guidelines should be provided that include staff training to assure use of proper aseptic technique, proper preparation of the compounding area prior to mixing, and labeling of all items prepared. Periodic competency assessment should be performed

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What’s Different

• Items of concern related to compounding performed outside of the pharmacy IV admixture service:

– IV fluid bags used as for catheter flushing

– IV fluids with attached administration sets assembled more than an hour before use

– Syringe use practices

– Use of single-dose vials

– Use of prefilled saline flush syringes to reconstitute IV medications

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What’s Different• When using an outsourced pharmacy, only a 503B

registered outsourcing facility is used for the preparation of non-patient specific products.

• Liter bags of sterile water for injection are only stored in the compounding area or within the pharmacy department itself.

• A pharmacist conducts an independent check of the finished preparation/diluted source/bulk container prior to use or further manipulation.

• All orders must be reviewed by a pharmacist before released for compounding. Pharmacy technicians may not override alerts.

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2016-2017 Targeted Best Practices

Best Practice 10– Eliminate all 1,000 mL bags of sterile water (labeled

for “injection,” “irrigation,” and “inhalation”) from all areas outside of the pharmacy. - Consider the use of alternatives to prevent the storage of

sterile water bags in patient care areas (e.g. 2 liter bags)

- Establish a policy that 1,000 mL sterile water bags can onlybe ordered by the pharmacy.

- Work with respiratory therapy and other relevant departments to establish guidelines regarding the safest way to provide large volumes of sterile water when needed for patient care.

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What’s Different• Adopt the use of sterile

processing technology (IV workflow software, robotics, etc.) to augment manual processes.

– At a minimum, bar code scanning linked to the patient’s medical record is used to identify products used in the preparation of CSPs.

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What’s Different

• Proxy methods of verification of ingredients, such as the SYRINGE PULL-BACK METHOD of verification, are never used.

• A quality assurance plan shall include written standards for qualitative and quantitative integrity, potency, quality, and labeled strength analysis of compounded drug products.

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Best Practice 11– When compounding sterile preparations, perform an

independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container.

- Specifically, eliminate the use of proxy methods of verification (e.g., the “syringe pull-back method,” checking a label rather than the actual ingredients).

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Best Practice 11– Except in an emergency, perform this verification in

all locations where compounded sterile products (CSPs) are made, including patient care units.

– At minimum, perform this verification for all high-alert medications (including chemotherapy and parenteral nutrition), pediatric/neonatal preparations, pharmacy-prepared source/bulk containers, drugs administered via high risk routes of administration, and other CSPs that the organization believes are high-risk.

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– Use technology to assist in the verification process (e.g., barcode scanning verification of ingredients, gravimetric verification, robotics, IV workflow software) to augment the manual processes. It is important that processes are in place to ensure the technology is maintained, the software is updated, and that the technology is always used in a manner that maximizes the medication safety features of these systems.

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ASHP Guidelines on Compounding Sterile Preparations (2014)•Physical Facilities, Equipment, & Environment

•Expiration and Beyond-Use Dating

•Risk Level Classification

•Point-of-Care Activiation Systems

•Ampuls, Single-Dose and Multiple-Dose Containers

•Batch Compounding and Sterility Testing

•Outsourced CSPs

•Administration of CSPs

•Personnel

•Packaging & Labeling

•Storage of CSPs

•Control and Oversight of IVs

•Transporting CSPs

•Redispensing CSPs

•Cytotoxic & Specialty Preps

•Competency of Personnel

•Quality Assurance Program

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New IV Push Guidelines

– www.ismp.org/Tools/guidelines/IVSummitPush/ IVPushMedGuidelines.pdf

• 2 day summit held in October 2014• 56 participants –pharmacists

nurses, anesthesiologists, professional organizations, regulatory bodies, and vendors.

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New IV Push Guidelines1. Acquisition & distribution of adult IV push meds

– Most ready-to-administer form

2. Aseptic technique

3. Clinician preparation

4. Labeling

5. Clinician administration

6. Drug information resources

7. Competency assessment

8. Error reporting

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The Joint Commission StandardsCMS Conditions of Participation (CoP) referenced in red

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MM.05.01.07 – Drug Preparation• EP 1 - A pharmacist, or pharmacy staff under the

supervision of a pharmacist, compounds or admixes all compounded sterile preparations except in urgent situations in which a delay could harm the patient or when the product’s stability is short

– Problem areas: OR, cath lab, interventional radiology, nuclear medicine, other procedural areas, PACU, ICU, ED, and outpatient infusion clinics

– Problem products: Irrigations, elastomeric pumps (“pain balls”, On-Q®), heparinized saline (often in non-standard concentrations)

– Glossary definition- admixture: 50 mL or greater bag or bottle– MD presence is not an exception! – If anticipated, it is not urgent

§482.25(b)(1)

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MM.05.01.07 – Drug Preparation• EP 2 - Staff use clean or sterile techniques and maintain clean,

uncluttered, and functionally separate areas for product preparation to avoid contamination of medications.

• EP 3- During preparation, staff visually inspect the medication for particulates, discoloration, or other loss of integrity.

• EP 4- The hospital uses a laminar airflow hood or other ISO Class 5 environment in the pharmacy for preparing intravenous (IV) admixture or any sterile product that will not be used within 24 hours.

• EP 5- Medications are prepared in accordance with the orders of a licensed independent practitioner.

§482.25(b)(1)

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MM.05.01.09 – Labeling• Labeled whenever prepared but not immediately administered.

• Label information displayed in a standardized format in accordance with law, regulations and standards of practice.

• All medications labeled with:– Medication name, strength & amount (if not apparent from container)

– Expiration date

– Expiration time (if less than 24 hours)

– Date prepared and diluent (all compounded IV admixtures/PN)

• If individualized– Patient name

– Location where the medication is to be delivered

– Directions for use and auxiliary labels

§482.25(b)(3)

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ISMP’s Label Guidelines

• Principles of Designing a Medication Label for Intravenous Piggyback Medication for Patient Specific, Inpatient Use

– WWW.ISMP.ORG/TOOLS/GUIDELINES/LABELFORMATS/PIGGYBACK.ASP

• Principles of Designing a Medication Label for Injectable Syringes for Patient Specific, Inpatient Use

– WWW.ISMP.ORG/TOOLS/GUIDELINES/LABELFORMATS/INJECTABLE.ASP

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MM.05.01.11 – Dispensing• EP 2: Dispenses medications and maintains records in

accordance with law and regulation, licensure, and standards of practice.– Compliance with USP 797, when mandated by state

– See also: LD.04.01.01 – hospital complies with law and regulations.

• EP 4: Medications are dispensed in the most ready-to-administer forms commercially available and, if feasible, in doses that have been prepared by the pharmacy or licensed repackager (outsourced)– See also MM.03.01.01, EP 10 (floor stock)

§482.25(b)(1)

§482.25(b)

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USP <797> State Requirements• Direct Compliance: 26

– CO, CT, GA, HI, IN, FL, MA, MD, ME, MI, MN, MT, NC, NE, NM, OH, OK, RI, SD, TN, TX, UT, VA, VT, WV, WY

• Indirect Compliance: 23

– AK, AL, AR, AZ, CA, DC, DE, IA, ID, IL, KS, KY, LA, MO, MS, OR, ND, NH, NV, NY, SC, WA, WI

• No reference (1): PA

www.criticalpoint.info/Statemap/story.html

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Other Standards

• MM.01.01.03, EP 3: Implements process for high-alert and hazardous medications.

• MM.02.01.01, EP 6: Standardizes and limits the number of drug concentrations available.

• MM.03.01.01 – Storage of medications– Safely stores; Labeled with contents, BUD, expired

• MM.04.01.01 – Medication orders (complete)

• MM.08.01.01 – Evaluation of med mgt system– Data collection, analysis and comparison

– Review/implement best practices & technology

§482.25(b)

§482.25(b)(1)

§482.25(a), (b)(3)

§482.25(b)

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Other Standards

• Human Resources– HR.01.02.05 – Qualification for Sterile Compounding

– HR.01.04.01 – Orientation

– HR.01.05.03 – Ongoing education and training

– HR.01.06.01 – Competency

• Infection Control– IC.02.01.01 – Implements infection prevention and

control activities

– IC.02.02.01 – Reduces risk of infections from equipment, devices and supplies.

§482.13(f)(4)

§482.42

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Other Standards• EC.02.04.03 – Inspects, tests and maintains medical

equipment– Safety, operational and functional checks (documented)

– In accordance with manufacturer’s recommendations

- Includes all compounding equipment and software

• LD.04.03.09 – Contracted services (outsourced providers)– Written agreement with performance expectations

– Monitor and evaluate performance based on written expectations

– Take actions to improve

– Maintains continuity of patient care when ends

§482.41(c)(2)

§482.12(3)

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Home Care Survey Tool

June 2014– Environment: Facilities, equipment, equipment calibration and

oversight

– Products: Selection, storage, and labeling; product testing; beyond-use and extended-use dating

– Competency: Assessment of compounding staff

– Infection control: Policies and practices in the compounding facilities

– Leadership: Overall responsibility for and provision of resources

– Performance improvement: Monitoring and evaluation of the compounding process

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TJC Activities

• Hospital surveyors currently underwent training in sterile compounding

• Expansion of survey tool to hospitals in future

• Currently revising MM standards with ?increased emphasis on sterile compounding.

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Regulatory Agencies• FDA regulates outsourcing compounding facilities (503b)

• All state boards of pharmacy regulate patient-specific compounding in their respective states (503a)

– Increased inspector training & regulations re: USP <797>

• CMS new modification to hospital CoPs to address USP <797> (and USP <795> for nonsterile)

– Requires states and deemed accrediting bodies to enforce

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New CMS requirements• Whole new condition level tag for§482.25 Condition of

Participation: Pharmaceutical Services

• In addition to all applicable laws and regulations, hospitals must ensure that they meet all currently accepted standards for safe preparation and administration of medications, which at a minimum includes USP <795> and <797>. Other examples of organization guidelines “include, but are not limited to”:

• American Society of Health-System Pharmacists (ASHP)

• Infusion Nurses Society (INS)

• Institute for Safe Medication Practices (ISMP)

• National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP)

• U.S Pharmacopeia (USP)

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New CMS requirements• Nurse must adhere to USP<797> “immediate use” and labeling

requirements.

• Beyond Use Date (BUD):

• Manufacturer’s BUD;

• If no manufacturer BUD, then USP<797> or other guidelines, if more stringent.

• Can use results of product-specific experimental studies that meets USP<797> examples of testing “considered more appropriate.”

• Pharmacies also need to be aware of external alerts to real or potential pharmacy-related problems in hospitals.

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CMS S&C Memo: 16-01, October 30, 2015. Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications.

Questions

For questions about the interpretation of Joint Commission standards, organizations can either:

– Call the Standards Interpretation Unit at 630-792-5900

– Submit the question in writing by using the following on-line form: www.jointcommission.org/Standards/OnlineQuestionForm/

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Questions?

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Return to the CE activity page and click the Post-Test/Evaluation link to

connect to the ProCE CE Center

Complete the Post-Test and Evaluation

Score of > 70% is required to receive credit

Your CE statement will be available to save or print

To Receive Pharmacist CE Credit

Click HereTo return to CE activity page

Thank You!

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