pharmacists and patient safety: ismp medication error ......•practitioner testing •published fda...

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Pharmacists and Patient Safety: ISMP Medication Error Reports and Self-Assessment Tools

Wednesday, November 18, 2020

Financial Disclosures

Michael Cohen declares that neither he nor any of his immediate family members have a current affiliation or financial arrangement with any organization that may have a direct interest in the subject matter of this CPE activity within the past 12 months.

Michael Gaunt discloses the following financial relationship: Spouse is employed by/receives a salary from Janssen Research & Development, a Johnson & Johnson company.

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Pharmacists and Patient Safety: ISMP Medication Error Reports and Self-Assessment Tools NABP CPE Webinar - November 18, 2020

Perspectives in Medication Safety © 2020 ISMP

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ISMP Confidential ©2020 ISMP | www.ismp.org | 3

Michael R. Cohen, MS, ScD (hon), DPS (hon), RPh, FASHPPresident and FounderInstitute for Safe Medication Practices

How Pharmacists Can Benefit Patient Safety Through Proactive Use of ISMP Medication Error Reports and Self-Assessment Tools

©2020 ISMP | www.ismp.org | 4ISMP Confidential

Institute for Safe Medication Practices— 501(c)(3) nonprofit organization founded in 1994— Mission: to advance patient safety worldwide by empowering the health care

community, including consumers, to prevent medication errors— Along with ECRI, we are certified as a Patient Safety Organization by the

Agency for Healthcare Research and Quality — Advocacy efforts focus solely on preventing medication errors— Multidisciplinary staff and board of trustees

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Institute for Safe Medication Practices— Hear directly from and interact with practitioners and consumers— Impacts both product and practice issues, safety culture, etc— Recommendations are respected and acted upon by health care

practitioners and organizations— Directly impacts the work of Food and Drug Administration (FDA)


Where Does ISMP Get Its Information?

Consumer MERP

Practitioners

ISMP MERP/VERP

FDA MedWatch

Other sources

Practitioners

Organizations

Consumers

Regulatory

Industry

ISMP CanadaISMP SpainISMP Brazil

IMSN

MERP: National Medication Errors Reporting ProgramVERP: National Vaccine Errors Reporting ProgramIMSN: International Medication Safety Network

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Medication Error Case Reports

— FDA has a memorandum of understanding agreement with ISMP to share publicly available medication error information.

— FDA and ISMP hold regular monthly meetings to discuss regulated product issues. We meet in person twice annually.

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Provider Error Reporting Programs— Narrative information driven by provider and/or consumer altruism

— A key to success globally

— Always confidential; can be legally shielded from discovery if requested

— Interact with regulators, standards organizations, accreditors, professional organizations, pharmacovigilance agencies


ISMP National Medication Errors Reporting Program (MERP)

https://ismp.org/report-medication-error

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National Medication Errors Reporting System— Early Warning System

• Issue nationwide hazard alerts andpress 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


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ISMP Relationship With United States FDA— Discuss regulated product issues

• Nomenclature• Labeling, packaging• Relationship between medication and medical device

— FDA Advise-ERR publications

— ISMP and FDA share fellowship program

— FDA guidance statements based in part on ISMP reporting program findings


Wrong Patient’s Medication Dispensed to PatientReport Submitted Date: 10/22/2020Age: 46 Years, 0 Days, 10 MonthsPlease describe the error or potential error: This is the 2nd time that my husband has received another person’s medications from our pharmacy.

When and how was the error discovered: Name on the bag was correct; name on the medicine bottles inside belonged to someone else.

Reporter’s Recommendations: Some kind of follow-up to ensure that medication reconciliation is being done.

Additional Information: XXXXXX Pharmacy, located at XXXXX

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Targeted Medication Safety Best Practices (Acute Care)

Primary target areas:• IV vincristine• Oral methotrexate• Patient weights in metric units• Neuromuscular blocking agents• High-alert drug via smart pumps• Availability of antidotes and rescue

agents• Use of oral syringes

Purpose: inspire widespread adoption of consensus-based best practices on specific error-related issues that continue to harm patients and/or cause death

• Oral liquid dosing devices• Glacial acetic acid• Eliminate liter bags of sterile water• Use of technology for IV admixture

compounding• Being proactive by using

information about errors happeningelsewhere

• Eliminate promethazine


ISMP Websites

www.ismp.org www.medsafetyofficer.org www.consumermedsafety.org

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Medication Safety Board

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Tools for Practitioners


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ISMP Medication Safety Self Assessment® for High-Alert Medications

— Over 850 participants

— Collaborative data

— Findings


Harmonizing Safe Medication Container Labeling and PackagingCreate a minimum set of best practices for labeling and packaging aimed at reducing medication errors

— On June 19 and 20, 2018, at the FDA campus in Maryland, summit created a minimum set of best practices for labeling and packaging aimed at reducing medication errors

— Participants agreed that guidelines are needed regarding the presentation of critical label information to deal with look-alike labels, noting that logos and highly stylized graphics detract from readability of the label

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Are We Making Progress? — Elimination of handwritten prescriptions

• New York state rule• More than 90% of US hospitals e-prescribe• More than 90% of pharmacies accept e-prescribing• More than 80% doctors’ offices have available e-prescribing

— Adoption of safety technologies• Bedside bar code scanning (drug and patient)• Community pharmacy bar coding, screen imaging, drug use review, adjudication of

prescriptions, etc• “Smart” infusion pumps in hospitals• Automated dispensing cabinets for drug distribution• IV workflow systems (imaging, scanning, weighing of compounded sterile products, etc)


Are We Making Progress? — Drug name development

• Practitioner testing• Published FDA guidance for industry• POCA• FDA review• Use of “Tall Man” letters (metroNIDAZOLE vs metFORMIN)• Indication-based prescribing

— Role of trademark testing firms and premarket testing of labeling and packaging

— Improvements in container labeling and packaging• Published FDA guidance for industry• US Pharmacopeia <7> Labeling and Nomenclature

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Are We Making Progress? — Problems now addressed as “system issues” vs “people issues”

— Increased reporting of medication errors and focus on safety

— Ongoing ISMP efforts with industry, regulators, and standards organizations• Product and practice issues must be addressed


Are We Making Progress? — Emphasis on safety in health care

• Safety committees in hospitals• Medication safety officers• Accreditation standards (Centers for Medicare & Medicaid Services, The Joint

Commission, etc)

— Biologicals presenting new issues with nomenclature:• Unlike with INN/USAN, it’s hard to “place” drugs

◦ Drug class and indication◦ Potential adverse effects

• Biosimilar name suffix use in practice

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Self-Assessment Questions (Choose Best Response)1. The ISMP consumer medication safety website includes all of the following

except:a. Consumer medication error reporting programb. Complaints about pharmacies where consumers experienced a dispensing errorc. An insulin safety centerd. An over-the-counter safety center


Self-Assessment Questions (Choose Best Response)2. Which of the following statements is correct about the ISMP Community

Pharmacy Online Assessment?a. The assessment includes a list of 100 ways that consumers make medication errorsb. The assessment promises to share all data with state pharmacy boardsc. The assessment allows pharmacy staff to confidentially compare dispensing errors with

other pharmaciesd. The assessment allows an assessment of evidence-based and collaboratively developed

safe practices

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Self-Assessment Questions (Choose Best Response)3. Which of the following statements are correct about the ISMP Targeted

Medication Safety Best Practices?a. The Best Practices are intended to spotlight the most important pharmacy dispensing

improvementsb. The Best Practices are intended to spotlight serious medication errors along with error

prevention strategiesc. The Best Practices were developed by ISMP with input from four major national

professional pharmacy organizationsd. None of the above

ISMP Confidential ©2020 ISMP | www.ismp.org | 34

Michael J. Gaunt, PharmDMedication Safety AnalystEditor, ISMP Medication Safety Alert! Community/Ambulatory CareInstitute for Safe Medication Practices

Risk Assessment forCommunity Pharmacy

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Risk Identification in Health Care— The detection of a potential or actual problem associated with patient care

— Recognizing variations in process or expected outcomes that may or may not involve patient harm


Methods of Proactive Risk Assessment — Self Assessments

— Failure Mode and Effects Analysis (FMEA)

— External Sources of Data

— WalkRounds ™

— Staff Meetings, Safety Briefs

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Assessment Value— Assessment of evidence-based and collaboratively developed safe practices

— Heighten health care providers’ awareness of critical safe medication systems and practices

— Assist health care providers with identifying and prioritizing opportunities for reducing patient harm • Prioritize and focus resources to reduce errors and prevent losses


www.ismp.org/assessments/high-alert-medications Coming early 2021!

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Risk Assessment –Medication Safety in Community/Ambulatory Pharmacy

Not Implemented

Coming Soon!

Community Pharmacy Risk AssessmentsAvailable Now!

Community Pharmacy Survey on Patient Safety CultureDeveloped by the Agency for Healthcare Research and Quality

Sample Questions and Areas of Evaluation

Partially Implemented

Fully Implemented


Web-Based Platform— Each active pharmacy staff member completes the assessment

• Questions curated by role type

— Assessments are accessible with an internet connection• Participants access the assessment using the provided URL• Anonymous responses promote increased participation

— Does not need to be completed in one sitting

— Online dashboard displays are available for designated report viewers

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Online Assessment Tool Value— Collects data uniformly and confidentially— Improves efficiency— Generates reports/data analysis in near-real time

• Includes benchmarking/comparative analysis• Provides current best practice guidance to address identified opportunities for

improvement— Monitors participation and trends progress over time


Sample Items— Key Element I: Patient Information

• The pharmacy computer system incorporates special prompts for selected high-alertmedications to obtain or verify critical information about the patient (eg, past opioid usefor patients receiving transdermal fentaNYL patches, concentrated morphine solutions,long-acting opioids) necessary to confirm the appropriateness of the prescribedmedication, dose, dosage form, and directions for use.

• Technological enhancements are employed at the point of sale to require pharmacy staffto verify the patient’s identity using at least the patient’s name and date of birth.

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Sample Items— Key Element II: Drug Information

• The pharmacy computer system is periodically evaluated for clinically insignificant andfalse-positive alerts, and action is taken to minimize alert fatigue.

• The pharmacy computer system defaults to a weekly dosage regimen for oralmethotrexate and if the default is overridden to allow daily dosing, a hard stopverification of an appropriate oncologic indication is required.

• The pharmacist ascertains the clinical purpose of each prescription before the medicationis dispensed to ensure that the prescribed therapy is appropriate for the patient’scondition.


Sample Items— Key Element III: Communication of Drug Orders and Other Drug Information

• When telephone orders must be taken, the order is read back to the prescriber orauthorized agent for confirmation. Scoring guideline: Choose Not Applicable only iftelephone prescription orders are never accepted.

— Key Element IV: Drug Labeling, Packaging, and Nomenclature• A minimum of the first five letters of a drug name is required during product searches to

limit similar names from appearing together on the same screen.• Milliliter (mL) is the standard unit of measure used on prescription container labels for

oral liquid medications (apothecary system designations or symbols [eg, grains, drams,ounces] or household measurements [eg, teaspoons] are never used).

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Sample Items— Key Element V: Drug Standardization, Storage, and Distribution

• Electronic systems that document temperature ranges around the clock and provideproblem notification are used for refrigerators and freezers that store temperature-sensitive medications and vaccines, and written procedures regarding how to handle anybreach of a safe temperature range have been developed and are followed.

• A process is in place to keep two-component (ie, two-vial) vaccines together and to keepdiluents and their corresponding vaccines together if storage requirements do not differ.Scoring guideline: Choose Not Applicable only if vaccines are never stored in the pharmacy.


Sample Items— Key Element VI: Use of Devices

• If bar code scanning is employed during production, a team reviews data from the system,including the percentage of medications with a readable bar code, scanning compliancerates, and bypassed or acknowledged alerts, and any barriers to using the technologysafely and effectively are addressed.

— Key Element VII: Environmental Factors, Workflow, and Staffing Patterns• Prescription labels for multiple patients cannot be printed at the same time (ie, batch

printing) from the pharmacy computer system.• The pharmacy does not ask pharmacists to meet specific quotas for prescription

dispensing, including vaccine administrations if provided.

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Sample Items— Key Element VIII: Staff Competency and Education

• Management and frontline staff receive training in identifying risks within the system andincorporating high-leverage error reduction strategies to help eliminate the risks.

— Key Element IX: Patient Education• Electronic hard stops are in place at the point of sale to restrict completion of the sale

until patient education has occurred for selected high-alert medications or high-riskpatient populations.

• The patient’s prescription container is opened with, or the sealed manufacturer package isshown to, the patient and/or caregiver to verify the medication.


Sample Items— Key Element X: Quality Processes and Risk Management

• Pharmacy staff openly discuss errors without embarrassment or fear of reprisal fromimmediate supervisors, store owners, or regional/district administrators.

• All medication errors that reach the patient, regardless of the level of harm that results,are honestly disclosed to patients, caregivers, and/or families in a timely manner.

• Management and pharmacy staff routinely read and use published error experiences fromother organizations to proactively target improvements in the dispensing process.

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©2020 ISMP | www.ismp.org |49ISMP Confidential

Thank You

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ACPE Universal Activity Numbers:0205‐0000‐20‐060‐L05‐P 0205‐0000‐20‐060‐L05‐T

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pharmacists and patient safety: ismp medication error ......•practitioner testing •published fda...

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