Department of Pharmacy Updates and Future DevelopmentsMajid Tanas, PharmD, MHA, MSChief, Department of Pharmacy

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Unlike most other pharmacies, the pharmacy enterprise spans the entire spectrum of medication development and use. This causes us to have unique problems and become

somewhat different than any other department.

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Clinical Center Medication Use

Process

Sourcing

Development and Procurement

Research/Study Design

Prescribing/Ordering

Transcribing/Reviewing

Preparing/Dispensing

Distribution

Administration

Clinical Review/Monitoring

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OrganizationalChart

Chief

Service Chief, Operations

IV Room Central Operations Outpatient Procurement Informatics

Service Chief, Clinical & Research

ClinicalInvestigational

Drug Mgmt. Research Section

Investigational Drug Control Unit Analytical Unit Outsourcing Unit

Clinical Pharmacokinetics

Research Unit

Medication Safety Officer

Quality Assurance/Regulatory Affairs

Drug Information Educator

Process Improvement

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Our Leadership Team

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A Shift in Course

May 2015 FDA Visit

June 2015 Pharmaceutical Development

Section Shut Down

April 2016 Red Team Report

June 2016 Proposed Entry

into I-IVAU

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A Shift in Course

August 2016 New Chief

October 2016

Construction Delays

October and November 2016 FDA Meetings

January 2017 Room

Qualification Remediation

April 2017 Enter I-IVAU

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Closing the Gap Between Care Models

Patient CarecGMP

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Road Map to Improved Care

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Road Map to Improved Care

Plant

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Road Map to Improved Care

• Plant• Change in mentality to a more pharmaceutical

grade operations• Pass through into critical spaces• Separation of classified areas by doors• Room have adequate monitoring controls to

ensure differential pressure• Facility has been separated between hazardous

preparation and non-hazardous preparation

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12

Hazardous Q1 2017 CY Average Time in Hood vs Capacity Wednesday

0

50

100

150

200

250

300

350

400

450

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Min

utes

Hour of Day

Non-NCI Demand NCI Demand Capacity Max Hood Capacity

NCI Demand

Capacity

Non-NCI Demand

Max Hood Capacity

Capacity

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Phases for cGMP spaces

Interim-IVAU

Expansion-IVAU

Permanent-IVAU

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Road Map to Improved Care

Process

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Road Map to Improved Care

• Process• Policies and SOPs have been developed and implemented

• Continual development with more experience in our facility.• Data trends and observations are helping solidify our processes• We have had several external audits to check our progress• Establishment of Quality Management System• Moving from an oral to written to electronic tradition

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Road Map to Improved Care

Personnel

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Road Map to Improved Care

• Personnel• Work on hiring and developing strategies

with our HR partners to fill openings• Development of a committed workforce that

is changing the culture to a more GMP functioning hospital pharmacy

• Empowering staff to stop production if there are any issues

• Embracing a culture of safety• Establishment of standardized work• Improved FEVS scores

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Road Map to Improved Care

Patient

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Road Map to Improved Care

• Covering the continuum of care and increasing the relationships between investigators and nurses

• Providing increased flexibility for researchers in our systems

• Increasing our accountability and process improvement

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Returning to basics

• New leadership team and structure• Training and competency• Systems of checks and balances• Questioning the historical practices• Striving towards becoming a High Reliability Organization• Strengthening relationships with researchers, care providers, and

nursing

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Completed Items

• FDA remediation of original 483 items• Formulary resource development• Implementation of wireless pump in the treatment of patients to

utilize guardrails• Automated Dispensing Cabinet roll out in the Operating Room and

patient care areas• Ambulatory care Automated Dispensing Cabinet

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Completed Items

• Institute of Safe Medication Practice and establishment of a Medication Safety Committee

• Joint Commission visit• Proposals for 8 major system installation/upgrades• Numerous journal publications

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Becoming more reliant on technology

• Current processes are heavy manual (e.g., cart exchange, work cards) -moving towards creating a fully automated core

• Increasing inventory on the floors with our Automated Dispensing Cabinets

• Increasing utilization of technologies such as barcode medication administration on the floor (right patient, medication, and time)

• Increase patient safety and quality of care

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Targeted approach to improve systems

• IDMS replacement• Pursuing home grown solution replacement• Ensure ongoing compliance with national standards• Enhanced record keeping

• Automated Inventory Controls• Improve access to medications to patient care areas• Central inventory management solutions• Tracking of medication and diversion

• IV Workflow• Removing paper process• Barcoding and imaging • Enhance safety and quality

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Ongoing opportunities

• At the direction of the FDA, we are working towards a higher level of care

• Expanding aseptic area to meet patient care demands• Meeting new standards for hazardous medications• Maintaining the facility in light of the rigorous cleaning schedule• Improvement of the Quality Management System• Improving patient education of their medications

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Medication Safety TrendsDachelle Johnson, PharmD, BCPS

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Overview

• Medication safety issues span the entire spectrum of the medication use process

• Every physical move adds a new layer of medication safety challenges • Clinically significant needs to customize makes standardization and

simplification difficult• Continuing to establish controls within our system to manage the

safety portfolio of our unique medication use process

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Institute for Safe Medication Practices (ISMP)

• February 20 – 23, 2018 interdisciplinary team of consultants performed a system review of medication use

• Provided us with a comprehensive list of recommendations to work through as an institution

• An interdisciplinary team of CC Departmental Leadership reviewed the recommendations and identified project leads for the observations from the report

• Progress updates are made quarterly to CC executive leadership• The goal is to complete all projects over the next 3-5 years and invite

ISMP back for reassessment

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Major Themes from ISMP Report

• Culture of safety• Staff competency and education • Environment, staffing, and workflow• Drug storage, stock, standardization, and distribution• Automation, clinical decision support, software enhancements,

device acquisition, and monitoring

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Dispensing Errors Trends

0

5

10

15

20

25

04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12

2017 2018

Mild HarmNear MissNo HarmService Quality IssueUnsafe ConditionModerate Harm

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CC Medication Related Event Trends, Q1FY19

020406080

100

OtherMed Unavailable/Delayed

Total 205

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Pharmacy Related Event Trends, Q1FY19

0

10

20

30

40

50

60

IV Area CentralPharmacy

Informatics OutpatientPharmacy

Other

MedUnavailable/Delayed

Total 130

• IV Area• Delays, limited beyond use dating, manual

expiration dating, delivery issues

• Central• Delays, incorrect diluent, cart exchange, timing

and volume of nonsterile compounding

• Informatics• Barcoding, Automated Dispensing Cabinets,

PCA pump issues (use of manual mode), EMR (clinical decision support)

• Outpatient • Lack of orders, shipment, order verification

• Investigational Drug Section• Sponsor labeling, onsite labeling, expiration

dating, drug accountability 33

Knowledge Based Medication AdministrationMedications Administered and Medication Barcode Usage (%)

3NE Inpatient UnitOctober 2016 - December 2017

9

9

9

9

9

9

9

9

1

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17

Num

ber o

f Med

icat

ions

Adm

inis

tere

d

Medication Administration via KBMA Medication Administration via Worklist % KMBA Used Goal

2%

3%

4%

5%

6%

7%

8%

9%

00%

Med

icat

ion

Barc

ode

Usa

ge (%

)

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Future Direction

• Increased automation to enhance safety• Increase capacity to improve patient experience and support research• Solidify process to improve across the pharmacy enterprise• Elevate staff to the new standards and direction

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Majid Tanas, PharmD, MHA, MSChiefDepartment of Pharmacy

Dachelle Johnson, PharmD, BCPSMedication Safety Officer Department of Pharmacy

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