Medication Safety : An Ounce of Prevention - PowerPoint Presentation

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Medication Safety:An Ounce of Prevention

H. Gwen Bartlett, BS Pharmacy, PharmD, BCPS, BCCCPAssistant Professor of Pharmacy PracticeCardiology SpecialtyHusson UniversityBangor, ME

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DisclosureI have no relevant financial or non-financial conflicts of interest to disclose. 2Slide3

3“Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable.”Lepakhin V. Geneva 2005Slide4

Learning ObjectivesDistinguish between a preventable verses a non-preventable adverse drug event.  Describe the role that a latent failure (blunt end) may play in an active failure (sharp end) with respect to medication errors. Evaluate how the recent national initiatives focused on improving medication safety for high-risk patient populations might impact your practice. Summarize the potential impact of low health literacy on medication safety.4Slide5

Patients (our customers, friends, family and….ourselves) Are At Risk! Between 44,000 and 98,000 deaths are attributed to medical errors in U.S. hospitals7,000 deaths annually attributable to medication errorsSerious and PREVENTABLE errors are occurring5

Kohn KT, Corrigan JM, Donaldson MS, To Err Is Human: Building a Safer Health System. National Academies Press; Washington, DC 1999; http://www.nap.edu/openbook.php?record_id=9728 Accessed 9/1/15 Slide6

Why is Medication Safety Important to Pharmacy Practice? 6http://www.nap.edu/catalog/10681/health-professions-education-a-bridge-to-quality

https://www.ptcb.org/about-ptcb/news-room/news-landing/2014/04/21/ptcb-adds-new-patient-safety-ce-requirement-for-recertification#.Ve1k9hHBzRY Accessed 9/1/152014 Pharmacy Technician Certification Board → 1 hr CEU in Patient Safety for recertificationSince 2006, included in Rx school standards9

states currently require Patient Safety CEU for annual pharmacist relicensure (i.e., Delaware, District of Columbia, Florida, Iowa, Maryland, New Mexico, Pennsylvania, New York, and

Ohio effective 1/15/16)Slide7

Medication-Related Errors: Consistently Rank at the Top of Medical ErrorsReiterated significance of medication errors1 medication error per patient per day of hospitalizationNaming (look-alike, sound-alike), labeling, packaging account for:33% medication errors30% fatalities

7Aspden P, et al; Preventing Medication Errors; Washington DC; National Academies Press; Washington, DC 2007 http://www.nap.edu/catalog/11623/preventing-medication-errors-quality-chasm-series Accessed 9/1/15Slide8

The Numbers Speak3 billion prescriptions written annuallyIn 2006, 82% of U.S. adults reported taking at least 1 medication29% take 5 or moreOver age 65: 57-59% take 4-9 and 17-19% take 10 or more1.5 million preventable ADEs/yr → cost ~ $4 billion

8National Action Plan for Adverse Drug Event Prevention U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014); Washington, DC. http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf Accessed 9/1/2015Slide9

Medication Error“Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient, or consumer……..”

9National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP); http://www.nccmerp.org/about-medication-errors Accessed 9/5/15Slide10

Medication Use Process: Error at Any Step = Potential for Harm10

Leape LL, et al; Systems Analysis of Adverse Drug Events; JAMA; 1995;274; 35-43

Prescribing/Transcribing

Selection/Storage

Dispensing

Administering/Adherence

Monitoring

PreparationSlide11

Relationship Between ADE’s and Medication Errors11

Adverse Drug EventPreventable Medication ErrorsPreventable medication errors that result in patient harm

Patient experiences undesired side effect

Patient does not respond as expected to the drugNew allergic responseErrors that have the potential to cause patient harm

Errors that do NOT have the potential to cause patient harm

Note

: **

Includes errors of omission!Slide12

Close Calls Are Wake Up Calls! Near misses are preventable errors that don’t make it to the patientSafety nets workedNear misses should be reported (but seldom are). Those with potential for severe outcomes should be examined: root cause analysisLearn from other’s mistakes → teach others from them12Slide13

Preventable or Non-preventable or Near Miss?Hyperkalemia (serum K+ 5.2 mEq/L) on routine follow-up basic metabolic panel in a 48 y.o. female with an 8 year history of Type II DM initiated on lisinopril 10 mg PO daily 2 weeks ago following a second screening albuminuria

level greater than 300 mg/day.Trimethoprim/sulfamethoxazole ordered for presumed uncomplicated UTI in a 54 y.o. female, admitted for dofetilide loading, which precipitated a pharmacist contacting the prescriber to recommend a change in therapy to nitrofurantoin 100 mg PO BID.A left popliteal proximal DVT identified during bilateral lower extremity ultrasound in a 38 y.o. male with idiopathic dilated cardiomyopathy admitted for an acute exacerbation of heart failure 5 days ago and placed on bed rest without DVT prophylaxis.

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Learning ObjectivesDistinguish between a preventable verses a non-preventable adverse drug event.  Describe the role that a latent failure (blunt end) may play in an active failure (sharp end) with respect to medication errors. Evaluate how the recent national initiatives focused on improving medication safety for high-risk patient populations might impact your practice. Summarize the potential impact of low health literacy on medication safety.

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Active Failure15

Aronson JK; Medication Errors: Definitions and Classification; Br J Clin Pharmacol; June 2009; 67(6):599-604OOPS!!! I didn’t know that…..Oh, I thought that…..KnowledgePerformance

BehaviorSlide16

Each Layer Has the Potential to Avert or Contribute to Error! 16

Reason, J; Human Error; 1990; Cambridge: University Presshttp://patientsafetyed.duhs.duke.edu/module_e/swiss_cheese.html Accessed 9/6/15Slide17

Active or Latent Failure?Phlebotomist fails to identify the patient by 2 distinct identifiers and obtains an INR on the wrong patient. Active (error occurred): mistake → skill-based error or slip (i.e., oops); rule-based (i.e., double identify good rule, but not applied; or risky business? Per-diem pharmacist filling in for an independent Rx in rural Maine notes the shelves are organized by trade name. Brintellix and Brilinta

are stored next to each other on the shelf. Latent (error waiting to occur): FDA advisory re: name confusion between vortioxetine and ticagrelor 7/30/1517Slide18

18U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.

(2014). National Action Plan for Adverse Drug Event Prevention. Washington, DC: Author. http://health.gov/hcq/pdfs/ADE-Action-Plan-508c.pdf Accessed 9/11/15Slide19

Basic Safety PrinciplesAutomateWhen appropriate – include use of forcing functionsStandardizeReduce reliance on memoryUse checklistsReduce the number of steps and handoffsAdd redundancy (double checks) for high risk processes19

http://patientsafetyed.duhs.duke.edu/module_e/basic_safety.htmlSlide20

Following assessment of the patient, development and completion of a formal SOAP note, and determination of an appropriate dosing regimen, the pharmacist forgets to enter the order for vancomycin into the computer which goes unrecognized until the following day. This medication error would BEST be characterized as:An example or an active failure; action-based errorAn example of a latent failure; ineffective trainingAn example of an active failure; rule-based error

An example of a latent failure; uncertainty in role or responsibility20ANSWER A: With the circumstances given, there is not suggestion of any deficiency in training, environment, or equipment etc which are often contributors to latent failure. Therefore, both B and D would be incorrect. So, since is an active error, one must characterize whether there were likely rules in place for this procedure or simply an intended action that wasn’t carried out (i.e., slip). The slip or lapse seems to fit this scenario best. Slide21

21Error is the inevitable downside of having a brain! WHO 2010Slide22

Learning ObjectivesDistinguish between a preventable verses a non-preventable adverse drug event.  Describe the role that a latent failure (blunt end) may play in an active failure (sharp end) with respect to medication errors. Evaluate how the recent national initiatives focused on improving medication safety for high-risk patient populations might impact your practice. Summarize the potential impact of low health literacy on medication safety.

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“Patients’ best source (and often ONLY source) of information regarding the medications they have been prescribed is on the prescription container label.”“Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, nonadherence, and medication errors.” 23

USP 36: General Chapter <17>: Prescription Container Labeling; Slide24

We need to Lose the Spoon!! 24Slide25

White Paper & Policy Statement25

Pediatrics; 135(4); April 2015mLSlide26

All Oral Liquid Dosing Devices Should Use METRIC dosing only! National Alert Network (NAN) Anticipated USP <17> updateGraduations “shall be legible and indelible, and the associated volume markings shall be in metric units and limited to a single measurement scale that corresponds with the dose instructions on the prescription container label”

26http://www.ismp.org/NAN/files/NAN-20150630.pdf

Accessed 9/7/15Slide27

What’s in a label? (Human/Patient-Centered design)27Slide28

The Essential Elements of A Drug Facts Label! 28

http://www.fda.gov/Drugs/ResourcesForYou/ucm133411.htmSlide29

USP <17> Official Standard Universal Approach to Prescription LabelingOrganize → reflect how patients seek out and understand; Minimize!Emphasize instructions Simplify language → clear, concise, familiarExplicit instruction (not implicit or implied)Separate dose from timing2 → not twoAvoid numeracy (no HOURLY times)

29USP General Chapter <17>: Prescription Container Labeling http://www.usp.org/usp-nf/key-issues/usp-nf-general-chapter-prescription-container-labeling/download-usp-nf-general-chapter-prescription-container Accessed 9/1/2015May 1, 2013Slide30

USP <17> Standardized Label: Promoting Patient UnderstandingInclude purpose for use → always ask preferenceLimit auxiliary information Address limited English proficiencyImprove readability high-contrast printsimple, uncondensed fontsentence caselarge font sizehorizontal text only

USP General Chapter <17>: Prescription Container Labeling http://www.usp.org/usp-nf/key-issues/usp-nf-general-chapter-prescription-container-labeling/download-usp-nf-general-chapter-prescription-container Accessed 9/1/2015Slide31

The ProblemDozens of Different Ways to Say“Take 1 tablet a day.”31

Take one tablet orally once every day.Take 1 tablet by mouth every morning.Take one tablet for cholesterol. Take 1 tablet 1 time daily.Take ONE (1) tablet by mouth daily.

Take one pill by mouth at bedtime.

Take one tablet by mouth once daily.Take one pill by mouth once each day.

Take 1 tablet one time each day

.

Bailey, SC et al; Comparison or Handwritten and Electronically Generated Prescription Drug Instructions;

Ann

Pharmacother

; Jan 2009; 43(1):151-2Slide32

A New Design (PCL): User Friendly Interface32

Sahm et al; What’s in a Label? An exploratory study of patient-centered drug instructions; Eur J Clin Pharmacol; Nov 30, 2011 http://www.bumc.bu.edu/healthliteracyconference/files/2009/10/wolf.pdfSlide33

The Problem with “APAP”33Slide34

ISMP Unsafe Drug Name Abbreviations List Updated to Include:APAP (added in 2012)Not recognized as acetaminophenNoAC (added in 2015)No anticoagulant

34https://www.ismp.org/tools/errorproneabbreviations.pdfSlide35

2014 Poison Center Data Snapshot35

https://aapcc.s3.amazonaws.com/pdfs/annual_reports/2014_Annual_Report_Snapshot_FINAL.pdfSlide36

The Vast Majority of Exposures are UNintentional! 36

https://aapcc.s3.amazonaws.com/pdfs/annual_reports/2014_Annual_Report_Snapshot_FINAL.pdfSlide37

Minimizing Unintentional Acute Liver Failure From AcetaminophenAugust 2011 → NCPDP White Paper re: acetaminophen: completely spell out all active ingredientsJanuary 2013 → Standard concomitant use + liver warning label on Rx in harmony w/ OTCPrioritized to print in top 3 warning labels January 2014 → FDA mandated manufacturer

compliance with 325 mg limit per tab/cap for all prescription products Does NOT apply to OTC37NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen; January 2013 1.1; http://ncpdp.org/NCPDP/media/pdf/wp/NCPDPacetaminophen WPv1.1_31jan2013.pdf Accessed 09/5/2015Slide38

Movement In the Right Direction re: OTC Acetaminophen!August 2015, FDA issued guidance document for OTC oral liquid products containing acetaminophenDoes NOT establish legally enforceable responsibilitiesKey recommendations labeled for use in < 12 y.o.:Single-ingredient: “160 mg/5 mL” or “160 mg per 5 mL”Images of child should be appropriately representativeDosing directions only in mLProduct package should include dosage delivery device

Dosage delivery device calibrated units expressed as mL 38http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417568.pdfSlide39

Upcoming Challenges 2014 U.S. Access Board Best

Practices → patient-centered labeling for visually impairedMarket 21 million blind and millions more with low visionLabel → affixed to container, not folded, and not obscure original typed label; font > 1839http://www.accessamed.com/downloads/AccessaMed%20White%20Paper%202013.pdfSlide40

Learning ObjectivesDistinguish between a preventable verses a non-preventable adverse drug event.  Describe the role that a latent failure (blunt end) may play in an active failure (sharp end) with respect to medication errors. Evaluate how the recent national initiatives focused on improving medication safety for high-risk patient populations might impact your practice. Summarize the potential impact of low health literacy on medication safety.

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Scope of Low Health Literacy90 million Americans may be at risk1 out of 5 reads at the 5th grade level or belowAverage American reads at the 8th to 9th grade levelAnnual health care costs are 4 times higher with low literacy skillsOnly 25-50% of all patients take medications as directedMedication misuse has resulted in > 1 million ADE’s annually in the U.S.

41http://c.ymcdn.com/sites/www.npsf.org/resource/collection/9220B314-9666-40DA-89DA-9F46357530F1/AskMe3_Stats_English.pdfSlide42

The Impact of Low Health LiteracyServed to raise awareness of, at the time, an underappreciated challenge2006 formed the Roundtable on Health LiteracyLack of health literacy costs U.S. > $100 BILLION annually42

Neilson-Bohlman L, Panzer A, Kindig D; Health Literacy: A Prescription to End Confusion; National Academies Press; Washington, DC, 2004; https://iom.nationalacademies.org/ Reports/2004/Health-Literacy-A-Prescription-to-End-Confusion.aspx Accessed 9/7/15Slide43

What does Health Literacy Mean?“Degree to which people can obtain, process, and understand the basic health information and services they need to make appropriate health decisions.”http://www.healtheddesign.com/blog/2015/2/3/health-literacy-and-medication-safety43Slide44

Health Literacy Universal Precautions!44Brega AG, et al; AHRQ

Health Literacy Universal Precautions Toolkit, Second Edition. AHRQ Publication No. 15-0023-EF) Rockville, MD. 2015; http://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/index.htmlStructure your care as if EVERY patient/customer may have limited health literacyIt isn’t enough to simply hand individuals easier to read information Slide45

Teach-back: A Powerful Tool 45Slide46

ConclusionBe proactive in identifying opportunities enhanced patient/medication safety, and thus quality of carePay close attention, but report when it fails → share what you’ve learned.Practice health literacy universal precautions unless proven otherwise. 46Slide47

Medication Safety:An Ounce of Prevention

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Post-Assessment Questions 48Slide49

Question # 1: Which of the following case vignettes BEST represents a preventable adverse drug event?A 68 y.o. male discharged 3 months earlier following a new stroke complicated by seizure. Patient was discharged on carbamazepine and now presents with acute mental status changes presumed to be second to serum Na+ 119

mEq/L.A 53 y.o. female is admitted to ICU with severe sepsis. Her husband shares the only past medical history is his wife suffered a MVA 6 years earlier requiring a splenectomy. A review of her hospital and clinic EHR is devoid of any record of vaccinations other than influenza.A 27 y.o. male intubated trauma patient placed on fentanyl and propofol for analgesia and sedation. On day 2 of ICU stay, serum triglycerides were 520 mg/dL. The propofol is discontinued and a midazolam drip is started.A 64 y.o. male with no known allergies has advanced Stage 4 CKD. His progressive anemia is so severe that the decision is made to convert from oral to parenteral iron. He develops an anaphylactic

reaction with the first test dose of InFed.

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Question #2: Which of the following would be most likely to optimize patient safety by identifying sources of latent failures?Lack of independent double checks prior to dispensingIncomplete patient information such as comorbidities

Excess or insignificant computer warnings or alerts Open supportive environment for discussing errors/near misses50Slide51

Question #3: The National Council for Prescription Drug Products (NCPDP) recently published a patient safety white paper that provides best practice guidance to mitigate patient risk associated with dosing of liquid medications. According to this document, what is the preferred unit of measure for all oral liquid formulations? dropstspmL

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Post Assessment Key52Slide53

Post Assessment Question #1: Answer B is correct. Of the options listed, this is the only example of an adverse drug event which was preventable. Note a preventable adverse drug event can involve an error of omission (i.e., an untreated indication). According to the 2016 Adult Immunization schedule this patient should be vaccinated for encapsulated organisms which include: Pneumococcal13-valent pneumococcal conjugate vaccine (PCV13); 23-valent pneumococcal polysaccharide vaccine (PPSV23) at least 8 weeks later. REPEAT 23-valent pneumococcal polysaccharide (PPSV23) in 5 years. Revaccinate 23-valent pneumococcal polysaccharide (PPSV23) at age 65

MeningococcalSerogroup A, C, W, and Y meningococcal vaccine (MenACWY); REPEAT MenACWY at least 8 week later. Revaccinate MenACWY every 5 yearsHaemophilus influenza type BHyponatremia, although a known side effect of carbamazepine, is not predictable and hence not preventable. Likewise, propofol is mixed in 1% lipid emulsion and is associated with hypertriglyceridemia. Anaphylactic reactions to parenteral iron products are very rare. There are some products which large-scale observational studies suggest may be associated with less frequency than dextran containing formulations (i.e., iron sucrose). However, none of the above were prescribed, inappropriately, forseeable, or preventable. Answers A, C, and D are not correct. 53Slide54

Post Assessment Question #2: Answer D is correct. Answers A, B, and C are all examples of latent failures which can predispose active failure or the “sharp end”. Latent failures, also referred to as contributing factors, are weaknesses in structure that support medication processes. They are often subtle and “worked around” or tolerated until a slip or individual failure exposes the failure which often occur in combination (i.e., swiss cheese). An open supportive environment allowing discussion of errors and near misses is one of the best ways to identify the latent failure and correct it. Slide55

Post Assessment Question # 3: Answer C is correct. In March, 2014, NCPDP published a white paper recommending best practice to decrease dosing errors associated with oral liquid medications. Among the recommendations is the standard unit of measure of mL. In addition, it is recommended to AVOID cc, ml, or ML and the term milliliters spelled out. The Institute of Safe Medication Practice (ISMP) suggests a proposed change to United States Pharmacopeia (USP) General Chapter <17>: Prescription Container Labeling which will also endorse provision of a dosing device to accompany oral liquid products that are labeled in metric units ONLY! As such, answers A, B, and D are incorrect.

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