2015 pharmacotherapy specialty examination review course: medication...

2015 Pharmacotherapy Specialty Examination Review Course: Medication Safety

Leigh Briscoe-Dwyer, Pharm.D., BCPS, FASHP Chief Pharmacy and Medication Safety Officer

North Shore Long Island Jewish Health Care System Lake Success, New York

Medication Safety Learning Objectives:

At the conclusion of the session the participant should be able to discuss national regulations and local (but universally adopted) practices related to

• Adverse drug reaction reporting • Medication safety • Formulary management • Drug development and approval processes • Ethical issues, such as appropriate interactions with industry, conflict of interest disclosures, and

research-related ethical issues. Format: This session will use a series of case studies and audience response questions to engage the audience and to prepare participants to answer similar questions on a board certification examination. The facilitator will discuss national regulatory and population health issues pertinent to pharmacy practice. Local practices will also be discussed that have been universally adopted. Premise: Participants in this course are pharmacists who practice in a health system. This session will serve as a review and help you identify areas you may want to study more in preparation for the board exam.

______________________________________________________________________________________________ ©2015 American Society of Health-System Pharmacists, Inc. All rights reserved.

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Presentation Questions

1. A 69-year-old white female was referred to the emergency department by her vascular surgeon for the second time in 2 months after her routine INR was 18. She has a past medical history of type 2 diabetes, hypertension, peripheral vascular disease (severe/arterial), peptic ulcer disease, above the knee amputation (right, 2001), left leg stent placement, and perforated gastric ulcer repair. She is allergic to penicillin and clopidogrel but the nature of the reactions are not noted. Her current home medications include:

Alendronate sodium 70 mg po once weekly Atenolol 25 mg po twice daily Rabeprazole 20 mg po daily Enalapril 10 mg po twice daily Warfarin 2 mg po daily Lovastatin 40 mg po daily Sitagliptin 100 mg po daily

Which of the following is the most likely cause of the increased INR seen in this patient? a. Changes in diet b. Drug interactions c. Compliance issues d. Some other confounding issue

2. Which of the following best describes the relative incidence of adverse drug events (ADE), adverse drug reactions (ADR), and medication errors (ME)? a. ME > ADR > ADE b. ME > ADE > ADR c. ADE > ADR > ME d. ADR > ME > ADE

3. A 58-year-old man with a past history of coronary artery disease, hypertension, hyperlipidemia,

and type 2 diabetes was admitted to the medicine service with cellulitis of the left lower extremity. Admission medications included:

• Continuation of home medications for coronary artery disease, hyperlipidemia, and hypertension

• Antibiotics • Sliding scale insulin • Insulin glargine 20 units SQ at bedtime • NovoLog Mix 70/30: 10 units SQ three times daily before meals

On day 2 of hospitalization, a rapid response was called for altered mental status. Upon evaluation, a finger stick blood glucose was 35 mg/dL. One (1) ampule of 50% dextrose was given via IV push and the patient recovered normal mental status. How would you classify this medication error using the NCC MERP classification system? a. Category C b. Category D c. Category E d. Category G


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4. Which of the following methodologies is used to identify medication-related events that cause harm to patients, measure the level of harm from each adverse drug event, and identify areas for improvement in the organization?

a. Iceberg Method Near Miss Reporting b. Voluntary Reporting by Clinical Pharmacists c. AHRQ Patient Safety Indicator Tool d. Institute for Healthcare Improvement Trigger Tool

5. Which of the following characteristics best differentiates the just culture from a non-punitive

culture in patient safety models? a. Human error b. System error c. Reckless behavior d. Anonymous reporting

6. Peramivir is a parenteral antiviral agent indicated for the treatment of acute uncomplicated

influenza in patients 18 years and older who have been symptomatic for no more than 2 days. It was approved by the FDA in December 2014 and approved under expedited review by your hospital P&T committee in February of 2015. Which of the following recommendations will provide the P&T committee with the most appropriate data to meet the monitoring standards of a hospital formulary required by The Joint Commission and CMS?

a. Development of guidelines for appropriate use of the agent b. Performing a prospective MUE on all use of this agent for 6 months c. Presentation of reported ADRs entered into the pharmacy electronic database at the next

P&T meeting d. Development of restrictions in the computerized prescriber order entry system

7. A pharmacy is compounding a new patient-controlled analgesia solution for epidural

administration that contains preservative-free hydromorphone, ropivacaine, and clonidine. Assuming that the pharmacy is in full compliance with all United States Pharmacopeia chapter <797> standards, which of the following beyond-use dates and storage temperatures should be used without product-specific testing for this epidural solution? a. 24 hours at controlled cold temperature b. 30 hours at controlled room temperature c. 48 hours at controlled room temperature d. 72 hours at controlled cold temperature


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8. The Joint Commission arrives at your health system to conduct an on-site survey. The surveyor selects a 56-year-old female patient who has just undergone a total hip replacement and uses this patient’s medical record as a roadmap to evaluate organizational compliance with selected standards and organizational systems for providing care, including patient counseling on anticoagulation. This approach is best described as: a. Tracer methodology b. Quality check c. Core measures d. Pay for performance

9. The Durham-Humphrey Amendment of 1951 included which of the following statutory changes?

a. Required informed consent from research subjects b. Established incentives to develop drugs targeted to a patient population of less than

200,000 c. Differentiated prescription and nonprescription drugs d. Required manufacturers to pay fees for product applications

10. Which of the following would most likely NOT be perceived as a conflict of interest? a. Accepting a gift from a pharmaceutical vendor while working as a pharmacy purchasing

officer at a health system b. Participating in institutional purchasing decisions about products made by a company in

which you hold stock c. Performing clinical research on a medication while serving as a member of the P&T

committee d. Involving students or residents in work that could directly benefit a company in which the

faculty member supervising the students has a personal financial interest

11. A formulary request is received for extended-release tapentadol. The requesting physician is a pain specialist who has signed a conflict of interest form prior to attending the P&T meeting to consider the request. You are asked to verify that this physician has not received payments from the pharmaceutical manufacturer under what legislation? a. Kefauver-Harris Amendments b. Physician Payments Sunshine Act c. Food and Drug Administration Safety and Innovation Act d. Patient Protection and Affordable Care Act


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References and Recommended Readings Adverse Drug Events, Adverse Drug Reactions, and Medication Errors 1. American Society of Health-System Pharmacists. ASHP guidelines on adverse drug reaction

monitoring and reporting. Am J Health-Syst Pharm. 1995; 52:417-9. http://www.ashp.org/s_ashp/docs/files/MedMis_Gdl_ADR.pdf

2. American Society of Hospital Pharmacists. ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993; 50:305-14. http://www.ashp.org/DocLibrary/BestPractices/MedMisGdlHosp.aspx

3. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med. 2004; 140:795-801. http://handover.cmj.org.pl/upload/library/fgjexh4it1cyuuz3762qe.pdf

4. National Coordinating Council on Medication Error Reporting and Prevention a. Home page

http://www.nccmerp.org/ b. Index for categorizing medication errors

http://www.nccmerp.org/pdf/indexColor2001-06-12.pdf c. Index for categorizing medication errors

algorithm http://www.nccmerp.org/pdf/algorColor2001-06-12.pdf

5. Bates DW, Boyle DL, Vander Vliet MB et al. Relationship between medication errors and adverse drug events. J Gen Intern Med. 1995; 10:199-205. http://www.ncbi.nlm.nih.gov/pubmed/7790981

6. Classen DE, Resar R, Griffin F et al. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011; 30:581-9. http://content.healthaffairs.org/content/30/4/581.long

7. Larson CM, Saine D. Medication safety officer’s handbook. Bethesda, MD: American Society of

Health-System Pharmacists; 2013.

8. Morimoto T, Gandhi TK, Seger AC et al. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care. 2004; 13:306-14. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1743868/

9. Institute of Medicine. To err is human: building a safer health system (1999).

http://www.iom.edu/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx


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http://www.ashp.org/s_ashp/docs/files/MedMis_Gdl_ADR.pdf

http://www.ashp.org/DocLibrary/BestPractices/MedMisGdlHosp.aspx

http://www.ncbi.nlm.nih.gov/pubmed?term=clarifying%20adverse%20nebeker

http://handover.cmj.org.pl/upload/library/fgjexh4it1cyuuz3762qe.pdf

http://www.nccmerp.org/

http://www.nccmerp.org/pdf/indexColor2001-06-12.pdf

http://www.nccmerp.org/pdf/algorColor2001-06-12.pdf

http://www.ncbi.nlm.nih.gov/pubmed/7790981

http://content.healthaffairs.org/content/30/4/581.long

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1743868/

http://www.iom.edu/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx

Formulary Management 1. American Society of Health-System Pharmacists. ASHP guidelines on the pharmacy and therapeutics

committee and the formulary system. Am J Health-Syst Pharm. 2008; 65:1272-83. http://www.ashp.org/DocLibrary/BestPractices/FormGdlPTCommFormSyst.pdf

2. American Society of Health-System Pharmacists policy positions on formulary management http://www.ashp.org/DocLibrary/BestPractices/FormularyPositions.aspx

3. American Society of Health-System Pharmacists. ASHP statement on the pharmacy and therapeutics committee and the formulary system. Am J Health-Syst Pharm. 2008; 65:2384-6. http://www.ashp.org/DocLibrary/BestPractices/FormStPTCommFormSyst.pdf

4. American Society of Health-System Pharmacists. ASHP principles of a sound drug formulary system. 2011. http://www.ashp.org/DocLibrary/BestPractices/FormEndPrinciples.aspx (accessed 2014 Apr 15).

5. American Society of Health-System Pharmacists. ASHP guidelines on medication-use evaluation. Am

J Health-Syst Pharm. 1996; 53:1953-5. http://www.ashp.org/DocLibrary/BestPractices/FormGdlMedUseEval.aspx

6. Weaver SJ, Lubomiski LH, Wilson RF, Pfoh ER, Martinez KA Dy SM. Promoting a culture of safety as a patient safety strategy. Ann Intern Med. 2013; 158(5 Pt 2):369-374.

7. Schiff GD, Galanter WL, Duhig J, Koronkowski MJ, Lodolce AE, Pontikes P, Busker J, Toucherre D, Walton S, Lambert B. A prescription for improving drug formulary decision making. PLoS Med. 2012; 9(5):e1001220. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001220.

The Joint Commission (TJC) and Centers for Medicare and Medicaid Services (CMS) Conditions of Participation 1. The Joint Commission. Facts about the tracer methodology. December 2013.

http://www.jointcommission.org/assets/1/6/Facts_Tracer_Methodology.pdf

2. Centers for Medicare and Medicaid Services. CMS conditions for coverage (CfCs) and conditions for participation (CoPs). November 6, 2013. http://www.cms.hhs.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs/

3. The Joint Commission. 2015 national patient safety goals. http://www.jointcommission.org/standards_information/npsgs.aspx

Medical Safety Standards and Federal Regulations 1. United States Pharmacopeial Convention. General chapter <797> Pharmaceutical compounding sterile preparations http://www.doh.wa.gov/Portals/1/Documents/2300/USP797GC.pdf 2. United States Pharmacopeial Convention. General chapter <795> Pharmaceutical compounding non-sterile preparations http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf


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http://www.ashp.org/DocLibrary/BestPractices/FormGdlPTCommFormSyst.pdf

http://www.ashp.org/DocLibrary/BestPractices/FormularyPositions.aspx

http://www.ashp.org/DocLibrary/BestPractices/FormStPTCommFormSyst.pdf

http://www.ashp.org/DocLibrary/BestPractices/FormEndPrinciples.aspx

http://www.ashp.org/DocLibrary/BestPractices/FormGdlMedUseEval.aspx

http://www.jointcommission.org/assets/1/6/Facts_Tracer_Methodology.pdf

http://www.cms.hhs.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs/

http://www.cms.hhs.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs/

http://www.jointcommission.org/standards_information/npsgs.aspx

http://www.doh.wa.gov/Portals/1/Documents/2300/USP797GC.pdf

http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf

Hazardous Drugs 1. United States Pharmacopeial Convention. Briefing: <800> hazardous drugs—handling in healthcare

settings. December 1, 2014. http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf (accessed 2015 Apr 15).

Ethical Issues 1. Institute of Medicine. Conflict of interest in medical research, education, and practice. April 21,

2009. http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx

2. American Society of Hospital Pharmacists. ASHP guidelines for pharmacists on the activities of vendors’ representatives in organized health care systems. Am J Hosp Pharm. 1994; 51:520-1. http://www.ashp.org/DocLibrary/BestPractices/MarketingGdlVendors.aspx

3. American Pharmacists Association. APhA potential conflicts of interest in pharmacy practice. March 25-28, 2011. http://www.pharmacist.com/sites/default/files/files/2011ActionsoftheAPhAHoD-Public.pdf

Just Culture 1. California Hospital Patient Safety Organization. Becoming a safer organization: just culture.

http://www.chpso.org/just/index.php

2. Marx D. Patient safety and the “just culture.” 2007. http://www.health.ny.gov/professionals/patients/patient_safety/conference/2007/docs/patient_safety_and_the_just_culture.pdf

3. ASHP Council on Pharmacy Practice. Policy statement 1115 on just culture. http://www.ashp.org/DocLibrary/BestPractices/MedMisPositions.aspx 4. The Joint Commission. Leadership committed to safety. Sentinel Event Alert. 2009 Aug

27;(43):1-3. http://www.jointcommission.org/assets/1/18/SEA_43.PDF Drug Development and Approval Process

1. U.S. Food and Drug Administration. Novel new drugs 2014 summary. January 2015. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm430299.pdf.

2. U.S. Food and Drug Administration. How drugs are developed and approved. November 10, 2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm


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http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf

http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf

http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx

http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx

http://www.ashp.org/DocLibrary/BestPractices/MarketingGdlVendors.aspx

http://www.pharmacist.com/sites/default/files/files/2011ActionsoftheAPhAHoD-Public.pdf

http://www.pharmacist.com/sites/default/files/files/2011ActionsoftheAPhAHoD-Public.pdf

http://www.chpso.org/just/index.php

http://www.health.ny.gov/professionals/patients/patient_safety/conference/2007/docs/patient_safety_and_the_just_culture.pdf

http://www.health.ny.gov/professionals/patients/patient_safety/conference/2007/docs/patient_safety_and_the_just_culture.pdf

http://www.ashp.org/DocLibrary/BestPractices/MedMisPositions.aspx

http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm430299.pdf

http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm430299.pdf

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm

3. U.S. Food and Drug Administration. FDA's drug review process: continued. Drug approval process infographic November 6, 2014. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

4. The Independent Institute. History of federal regulation: 1902-present. http://www.fdareview.org/history.shtml (accessed 2015 Apr 15).


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http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

http://www.fdareview.org/history.shtml

Leigh Briscoe‐Dwyer, Pharm.D., BCPS, FASHP

Chief Pharmacy and Medication Safety Officer

North Shore Long Island Jewish Health Care System

Lake Success, New York

Medication Safety Disclosure

• I have nothing to disclose related to the content of this presentation.

Learning Objectives

• At the conclusion of the session the participant should be able to discuss national regulations and local (but universally adopted) practices related to – Adverse drug reaction reporting – Medication safety – Formulary management – Drug development and approval processes – Ethical issues, such as appropriate interactions with industry, conflict of interest disclosures and research‐related ethical issues.

Case

A 69 year white female was referred to ER by her vascular surgeon for the second time in 2 months after her routine INR returned at 18.

She has a past medical history of diabetes, hypertension, peripheral vascular disease (severe/arterial), peptic ulcer disease, above the knee amputation (right, 2001), left leg stent placement, and perforated gastric ulcer repair

Case

• Medication History • Allergies: PCN / clopidogrel (reactions not noted)• Home Meds:

– Alendronate sodium 70mg po once weekly– Atenolol 25mg po twice daily– Rabeprazole 20mg po daily– Enalapril 10mg po twice daily– Warfarin 2mg po daily– Lovastatin 40mg po daily– Sitagliptin 100mg po daily

Question 1: Which of the following is the most likely cause of the increased INR seen in this patient?

A. Changes in diet

B. Drug interactions

C. Compliance issues

D. Some other confounding issue


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The Other Issue Identified:

• Upon meeting with the family to perform comprehensive medication review and reconciliation, it was discovered that the patient was originally prescribed warfarin 1 mg tablets and told to take 2 tablets daily for a total daily dose of 2 mg

• A new prescription was subsequently written for 2 mg warfarin tablets with the instructions to take 1 tablet daily but the patient continued taking 2 tablets daily

Institute of Medicine ‐ 1999• 98,000 deaths per year

from preventable medical errors

• Cost $29 billion/year

• Medical errors are caused by faulty systems that lead people to make mistakes or fail to prevent them – not reckless individuals

• Health care organizations develop a “culture of safety”

Still Crossing the Quality Chasm

April 2011

Adverse Drug Reaction and Event Reporting

Definitions

• Adverse Drug Event (ADE)– An injury resulting from medical intervention related to a drug

• Adverse Drug Reaction (ADR)– A response to a drug or medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or treatment of disease or for the restoration, correction, or modification of physiological or psychological function.

Definitions

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

– A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

Bates DW et al. J Gen Intern Med. 1995; 10:199‐205.


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Question 2:Which of the following best describes the relative incidence of adverse drug events (ADE), adverse drug reactions (ADR), and medication errors (ME)?

A. ME > ADR > ADE

B. ME > ADE > ADR

C. ADE > ADR > ME

D. ADR > ME > ADE

Detection and Classification of Adverse Drug Events

Morimoto T et al. Qual Saf Health Care. 2004; 13:306-14.

Copyright © BMJ Publishing Group Ltd and the Health Foundation. All rights reserved.

ADE vs. ADR vs. Med Error

• Medication Errors– Much more common than ADEs– Result in harm less than 1% of the time– Preventable

• ADR– Not preventable

• ADE– Could be either an ADR or Med Error as long as itresults in an injury from a medication

– 75% from ADRs and 25% from Med Errors

Nebeker JR, Barach P, Samore MH. Ann Intern Med. 2004 May 18; 140(10):795-801.

Reporting ADRs

• Requires discontinuing the drug (therapeutic or diagnostic)

• Requires changing the drugtherapy

• Requires modifying the dose (except for minor dose adjustments)

• Necessitates admission to ahospital

• Prolongs stay in a healthcare facility

• Necessitates supportivetreatment

• Significantly complicates diagnosis

• Negatively affects prognosis or

• Results in temporary orpermanent harm, disability, or

• death

Medication Error Categorization ADE/ADR/Medication Error Reporting

• FDA Adverse Event Reporting System (AERS)

• FDA MedWatch

• Institute for Safe Medication Practices NationalMedication Errors Reporting Program

• Clinical investigations conducted under aninvestigational new drug application

• The Joint Commission

• Centers for Medicare and Medicaid Services(CMS) Conditions of Participation

Enlarged slide at back of handout.

______________________________________________________________________________________________©2015 American Society of Health-System Pharmacists, Inc. All rights reserved.

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Patient Case

58 year old man with a past history of CAD, HTN, hyperlipidemia, Type 2 DM was admitted to the medicine service with cellulitis of the left lower extremity.

Admission medications included:

• Continuation of home medications for coronary artery disease, hyperlipidemia, HTN

• Antibiotics

• Sliding scale insulin

• Insulin glargine 20 units SQ at bedtime

• NovoLog Mix 70/30: 10 Units SQ three times daily before meals

Patient Case (continued)

• On day 2 of hospitalization, a rapid response was called for altered mental status.

• A finger stick blood glucose was 35 mg/dl.• 1 ampule 50% Dextrose was given via IV push and the

patient recovered normal mental status

Question 3: How would you classify this Medication Error using the NCC MERP classification system?

A. Category C

B. Category D

C. Category E

D. Category G

Question 4: Which of the following methodologies is used to identify medication‐related events that cause harm to patients, measure the level of harm from each adverse drug event, and identify areas for improvement in the organization?

A. Iceberg Method Near Miss Reporting

B. Voluntary Reporting by Clinical Pharmacists

C. AHRQ Patient Safety Indicator Tool

D. IHI Trigger Tool

“Trigger” Tools

• Institute for Healthcare Improvement

• Small percentage of adverse events (AE) voluntarily reported

• Use of "triggers," or clues, to identify AE in an organization captures larger percentage

– Reporting increased by 10 times when a Global Trigger Tool was utilized

Classen DC et al. Journal of Patient Safety. 2008 Sep; 4(3):169-177.

Adler L et al. Journal of Patient Safety. 2008 Dec; 4(4):245-9.

Classen DE et al. Health Aff. 2011 April; 30(4):581-9.

Use of Global Trigger Tools

Classen DE et al. Health Aff. 2011 April; 30(4):581-9.

Type of Adverse Event

E F G H I Total

Medication ‐related 100 46 2 2 0 150

Procedure‐related 67 26 5 7 4 109

Nosocomial Infection 30 37 2 2 1 72

Pulmonary/VTE 8 5 2 0 1 16

Pressure Ulcers 10 1 0 0 0 11

Device Failures 0 6 0 0 0 6

Patient Falls 2 1 0 0 0 3

Other 10 11 0 3 2 26

Total 227 133 11 14 8 393

Severity Level

Adverse Events Detected by All Methods, By Severity Level


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50% Dextrose as a Trigger Tool

Site Doses Dispensed

Children’s Hospital 9

Community Site 1 699


Teaching Site 1 2433

Teaching Site 2 1849


Teaching Site 3 462

Community Site 4 40

Psychiatric Hospital 1

Total 6438

Doses dispensed over a 12 month period

Iceberg model

Heinreich HW. Industrial Accident Prevention. New York and London, 1941

Events that cause harm

Events that do not cause harm and/or near‐misses

Swiss cheese model

• Active errors

• Latent errors

• Skill‐based

• Rule‐based

• Knowledge‐based

Reason J. Human Error. Cambridge MA: Cambridge University Press; 1990.

Question 5: Which of the following characteristics best differentiates the just culture from a non‐punitive culture in patient safety models?

A. Human error

B. System error

C. Reckless behavior

D. Anonymous reporting

Just Culture Definition

• A just culture is one that has a clear and transparent process for evaluating errors and separating events arising from flawed system design or inadvertent human error from those caused by reckless behavior, defined as a behavioral choice to consciously disregard what is known to be a substantial or unjustifiable risk.

ASHP Council on Pharmacy Practice. Policy statement 1115 on just culture. URL in handout.

Evolution of Patient Safety

• Punitive Culture (Person approach)– Places blame on person and ignores the system

– Discourages reporting

• Non‐punitive Culture (System approach)– Perceived as too lax

– Inconsistent or lack of consequences

– Often misunderstood

• Just Culture (Combined, balanced approach)– Includes a focus on behavioral choices

– Now the best practice

– Challenging to implement and maintain


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California Hospital Patient Safety Organization. URL in handout.

Patient education and counseling by EXCERPTA MEDICA (FIRM) Reproduced with permission of ELSEVIER IRELAND LTD in the format Journal via Copyright Clearance Center.

Formulary Management

What A Formulary Is Not… Formulary Definition

• Continually updated list of medications and related information, representing the clinical judgment of pharmacists, physicians, and other experts in the diagnosis and treatment of disease and promotion of health– Medication‐use policies

– Ancillary drug information

– Decision‐support tools

– Organizational guidelines

ASHP Principles of a sound drug formulary system. URL in ref list.

Formulary Standards

• TJC Medication Management Standard MM.02.01.01

• CMS Conditions of Participation

• Interdisciplinary

• Dynamic Process

• Written policies and procedures for selection, utilization and monitoring medications on the formulary

• Reviewed on a regular basis

Formulary Review – Peramivir

• Peramivir is a parenteral antiviral agent indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. It was approved by the FDA in December 2014 and approved under expedited review by your hospital in February.

Formulary Review – Peramivir

Enlarged slide at back of handout.


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Question 6: Which of the following recommendations will provide the P&T Committee with the most appropriate data to meet the monitoring standards of a hospital formulary required by The Joint Commission and CMS?

A. Development of guidelines for appropriate use of the agent

B. Performing a prospective MUE on all use of this agent for 6 months

C. Presentation of reported ADRs entered into the pharmacy electronic database at the next P&T Meeting

D. Development of restrictions in the CPOE system

• Medical staff must establish a formulary system• Formulary lists medications for dispensing or administration that the hospital maintains or that are readily available

• Include written criteria for determining what medications are available for dispensing or administration. At a minimum, include the– indication for use– effectiveness– risks (including propensity for medication errors, abuse potential, and sentinel events)

– costs

Formulary – CMS Conditions of Participation

• Need to monitor patient responses to a newly added medication before the medication is made available for dispensing or administration

• Ensure that medications designated as available for dispensing or administration are reviewed periodically based on emerging safety and efficacy information

• Develop processes to approve, procure, and monitor medications that are not on formulary


• Develop processes to address medication shortages and outages, including the following:– Communicating with appropriate prescribers and staff;

– Developing approved substitution protocols;

– Educating appropriate LIPs*, appropriate health care professionals, and staff about these protocols; and

– Obtaining medications in the event of a disaster.*LIP = licensed independent practitioners


Medical Safety Standards and Federal Regulations

Question 7: A pharmacy is compounding a new patient‐controlled analgesia solution for epidural administration that contains hydromorphone, ropivacaine, and clonidine. Assuming that the pharmacy is in full compliance with all United States Pharmacopeia chapter <797> standards, which of the following beyond‐use dates and storage temperatures should be used without product specific testing for this epidural solution?

A. 24 hours at controlled cold temperature

B. 30 hours at controlled room temperature

C. 48 hours at controlled room temperature

D. 72 hours at controlled cold temperature


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United States Pharmacopeia (USP)

• USP Chapter <797> – Definitions

– Responsibility of compounding personnel

– Microbial contamination risks

– Personnel training and evaluation of aseptic technique

– Storage and beyond‐use dating

– Patient monitoring and adverse event reporting

– And others…

Dating in absence of direct sterility testing results

Risk category Room Temperature

Refrigeration/Cold Frozen

Immediate‐use 1 hour 1 hour N/A

Low‐risk 48 hours 14 days 45 days

Medium – risk 30 hours 9 days 45 days

High‐risk 24 hours 3 days 45 days

USP Chapter <797> Sterile Compounding

Type of formulation Beyond‐use date*

Nonaqueous Formulations not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever is earlier

Water‐Containing Oral Formulations

not later than 14 days when stored at controlled cold temperatures

Water‐Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations

not later than 30 days

*These maximum BUDs are recommended for nonsterile compounded drug preparations in the absence of stability information that is applicable to a specific drug or preparation. The BUD shall not be later than the expiration date on the container of any component.

USP Chapter <795> Non‐sterile Compounding

• In the absence of stability data for the drug product in the repackaged container, the beyond‐use dating period is one year or the time remaining of the expiration date, whichever is shorter

• Records must be kept of the temperature of the facility where the dosage forms are stored

USP Chapter <1146> Repackaging Oral Unit Doses

Question 8: The Joint Commission arrives at your health system to conduct an on‐site survey. The surveyor selects a 56‐year‐old female patient who has just undergone a total hip replacement and uses this patient’s medical record as a roadmap to evaluate organizational compliance with selected standards and organizational systems for providing care, including patient counseling on anticoagulation. This approach is best described as:

A. Tracer methodology

B. Quality check

C. Core measures

D. Pay for performance

The Joint Commission

• Tracer methodology

– Surveyor selects an active patient

– Patient’s record serves as roadmap to move through the organization

– Surveyor traces specific care processes via direct observation and patient/staff interviews


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The Joint Commission

• Hospital: National Patient Safety Goals – Identify patients correctly

—Use at least two unique patient identifiers (not physical location or room number)

– Improve effectiveness of caregiver communication—Reporting critical results on a timely basis

– Use medications safely—Label all medications

—Manage patients on anticoagulants

—Communicate information on medications and perform medication reconciliation for all patients

Question 9: The Durham‐Humphrey Amendment of 1951 included which of the following statutory changes?

A. Required informed consent from research subjects

B. Established incentives to develop drugs targeted to a patient population of less than 200,000

C. Differentiated prescription and nonprescription drugs

D. Required manufacturers to pay fees for product applications

Key Drug Legislation • Pure Food and Drug Act of 1906

– Required labeling of selected dangerous and addictive substances– Identified United States Pharmacopoeia and the National Formulary as

official standard for drugs

• Food, Drug, and Cosmetic Act of 1938– Required that firms provide evidence of safety to the FDA before

marketing; Placed drug advertising under the jurisdiction of the Federal Trade Commission

• Durham‐Humphrey Amendment of 1951– Statutorily differentiated prescription and nonprescription drugs

• Kefauver‐Harris Amendments of 1962– Established the requirement for drug firms to demonstrate efficacy as

well as safety– Authorized the FDA to regulate advertising of prescription drugs and

establish good manufacturing practices

Key Drug Legislation (cont.)

• Prescription Drug User Fee Act (PDUFA)– Requires drug, biologics, and medical device (MDUFA) manufacturers to pay fees for product applications, supplements, and other services

– Renewed every 5 years 1992, ‘97, ‘02, ’07, ‘12

• Food and Drug Administration Safety and Innovation Act (FDASIA) or PDUFA 2012– Manufacturer notification at least 6 months prior to discontinuation or interruption of certain medications or as soon as practicable

FDA Drug Approval• Center for Drug Evaluation and Research (CDER)

– Regulates prescription and nonprescription drugs

• New Drug Application (NDA)

– Vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing

• Abbreviated New Drug Application (ANDA)

– Contains data for the review and approval of a generic drug product

• Investigational New Drug (IND)

– Three IND types: Investigator, Emergency Use, Treatment

• Biologics License Application (BLA)

– Submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of a biologic product (monoclonal antibodies, enzymes, immunomodulators, growth factors, and cytokines) seeking approval to market

FDA Drug Approval Process

Developed by FDA's Center for Drug Evaluation and Research


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FDA Drug Approval Process

Developed by FDA's Center for Drug Evaluation and Research

Hazardous drugs

• Regulatory oversight and best practices– Occupational Safety and Health Administration (OSHA)

– National Institute for Occupational Health and Safety (NIOSH)

– American Society of Health‐System Pharmacists

– University Health System Consortium Pharmacy Council

– New: USP proposed general chapter <800> hazardous drugs—handling in healthcare settings

Hazardous drugs

• Characteristics

– Genotoxicity

– Carcinogenicity

– Teratogenicity or fertility impairment

– Serious organ or other toxic manifestation at low doses in experimental animals or treated patients

• Prevention of employee exposure

– Handling, storage, transportation

– Preparation

– Administration

– Disposal

– Personal protective equipment

Ethical Issues

Conflict of Interest (COI)

• Institute of Medicine:– A conflict of interest is a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.

• In general COI exists when outside financial or other interests may inappropriately influence the way in which an individual carries out his or her responsibilities– The PERCEPTION of COI is just as significant

Conflict of Interest (COI)

• Incorporate policies for COI into your processes for all meetings where decisions are being made

– Ask for potential COI at the beginning of every meeting– Annual signature to acknowledge acceptance of policy

The Case of the NQF and Dr. Charles Denham


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Question 10: Which of the following would most likely NOT be perceived as a conflict of interest?

A. Accepting a gift from a pharmaceutical vendor while working as a pharmacy purchasing officer at a health system

B. Participating in purchasing decisions about products made by a company in which you hold stock

C. Performing clinical research on a medication while a member of the P&T Committee

D. Involving students or residents in work that could directly benefit a company in which the faculty member supervising the students has a personal financial interest

Question 11: A formulary request is received for extended‐release tapentadol. The requesting physician is a pain specialist who has signed a conflict of interest form prior to attending the P&T meeting to consider the request. You are asked to verify that this physician has not received payments from the pharmaceutical manufacturer under what legislation?

A. Kefauver‐Harris Amendment

B. Sunshine ActC. Food and Drug

Administration Safety and Innovation Act

D. Affordable Care Act

The Physician Payments Sunshine Act

• Designed to bring transparency to financial relationships between physicians, teaching hospitals, and the pharmaceutical industry.

• Requires manufacturers of pharmaceutical drugs and devices, as well as Group Purchasing Organizations (GPOs), to report payments or transfers of value (such as meals, honoraria, or travel reimbursements) made to U.S. physicians and teaching hospitals.

• Reports are made to the Centers for Medicare and Medicaid Services (CMS), a government agency.


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Medication Error Categorization

California Hospital Patient Safety Organization. URL in handout.

Patient education and counseling by EXCERPTA MEDICA (FIRM) Reproduced with permission of ELSEVIER IRELAND LTD in the format Journal via Copyright Clearance Center.


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