Online Evaluation, Self-Assessment and CE Credits3.proce.com/res/pdf/Quorum2017MayHandout.pdf · USP Default BUDs Type of Formulation Maximum BUD Non-aqueous 6 months

USP Compounding Chapters: <795>, <797>, <800>Quorum Health Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2017 Pharmacy Education Series

May 25, 2017USP Compounding Chapters: <795>, <797>, <800>

Featured Speaker:

Patricia C. Kienle, RPh, MPA, FASHPDirector, Accreditation & Medication SafetyCardinal Health Innovative Delivery Solutions

Providing Continuing Education For Healthcare Professionals

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Submission of an online post‐test and evaluation is the only way to obtain CE credit for this webinar

Go to www.ProCE.com/QuorumRx

Webinar attendees will also receive an email with a direct link to the web page

Print your CE statement of completion online

– Credit for live or enduring (not both)

Deadline: June 23, 2017

CPE Monitor (applicable to pharmacists)

– CE credit automatically uploaded to NABP/CPE Monitor upon completion of post‐test and evaluation (user must complete the “claim credit” step)

Online Evaluation, Self-Assessmentand CE Credit

Attendance Code

Code will be provided at the end of today’s activity



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May 25, 2017USP Compounding Chapters: <795>, <797>, <800>

Featured Speaker:

Patricia C. Kienle, RPh, MPA, FASHPDirector, Accreditation & Medication SafetyCardinal Health Innovative Delivery Solutions

Providing Continuing Education For Healthcare Professionals

It is the policy of 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. Ms. Kienle is an employee and stockholder of Cardinal Health, and has served as an author for ASHP and a volunteer for USP.

Please note: The opinions expressed in this activity should not be construed as those of the CME/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. 5

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist)

– 2.0 contact hours

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Funding:This activity is self‐funded through Quorum Health.



USP Compounding Chapters: <795>, <797>, <800>PATRICIA C. KIENLE, RPH, MPA, FASHPDIRECTOR, ACCREDITATION AND MEDICATION SAFETYCARDINAL HEALTH INNOVATIVE DELIVERY SOLUTIONS

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Disclosure

Patricia Kienle is an employee of Cardinal Health

She is a member of the USP Compounding Expert Committee, but this presentation is not affiliated with or endorsed by USP

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Objectives

Define the three major USP General Chapters for compounding

Identify the facility requirements for nonsterile, sterile, and hazardous compounding

List the default beyond-use dates for nonsterile and sterile preparations

Cite the document which must be used to develop your hazardous drug list

Describe the steps in the cleaning process

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USP Compounding Chapters

USP <795> Pharmaceutical Compounding – Nonsterile Preparations

USP <797> Pharmaceutical Compounding – Sterile Preparations

USP <800> Hazardous Drugs – Handling in Healthcare Settings

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USP Standards

Federal standards USP

Enforcement of standards U.S. Food and Drug Administration State Boards of Pharmacy State Boards of Health Accreditation Organizations

Photo courtesy of USP

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FDA Guidance Documents

Regulatory Policy Information page www.fda.gov/Drugs/GuidanceComplian

ceRegulatoryInformation/PharmacyCompounding/ucm166743.htm

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Documenting Competency

Orientation & Training Inservicing Remediation Annual review of skills

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NonsterileCompoundingUSP <795>

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<795> Key Elements

Training Component Selection

Facilities and Equipment

Beyond-Use Dates Documentation

Compounding Categories

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Levels of Nonsterile Compounding

Simple

Moderate

Complex

Manufacturer’sInstructions or USP Monograph Stability data for the

specific formulationis not available

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Nonsterile Compounding Facilities

Adequate space that is separate and distinct from other functions

Clean Orderly Sanitary Appropriate equipment of proper

capacity Calibrated if necessary

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Documentation

Master Formulation Record Compounding Record

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USP <795> Beyond Use Dates

Manufacturer’s information USP monograph Peer-reviewed literature

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USP <795> Default BUDs

Type of Formulation Maximum BUDNon-aqueous 6 months

Water-containing oral 14 days, refrigerated

Water-containing topical/dermal and mucosal liquid and semisolids

30 days

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Expiration Date of Bulk Components

Use USP, NF, or FCC components Expiration date on container

If Active Pharmaceutical Ingredient (API) of any component of “non-compedialquality” must be used and there is no expiration date Label with date of receipt Assign a conservative expiration date that does

not exceed three years from date of receipt

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SterileCompoundingUSP <797>

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<797> Key Elements

Training Microbial Contamination Risk Levels

Beyond-Use Dates Environmental monitoring

Documentation

Equipment

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Personnel Training

Didactic Observation Core competencies

Hand hygiene Aseptic technique Personal protective equipment Assigning BUDs Labeling Monitoring

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Physical Tests

Media fill Must reflect the most complex CSP you mix Frequency: initially and annually with no

growth Gloved fingertip test

Initially: three times with zero growth Annually: following media fill, 3 CFUs (total)

permitted

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Mixing CSPs

Cleanroom suite ISO 7 or 8 anteroom + ISO 7 buffer room Primary Engineering Control (PEC)

Segregated Compounding Area (SCA) Separate area

Containment SCA (C-SCA) Separate room NOT currently allowed by USP <797>

Immediate Use26



Non-Hazardous Sterile Compounding

Current USP <797> allows Cleanroom suite: ISO 8 positive pressure

anteroom + ISO 7 positive pressure buffer room

Combined ISO 7 ante/buffer roomUnlikely to be permitted in the future

Segregated Compounding Area (SCA)

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Hazardous Sterile Compounding

Current USP <797> allows Cleanroom suite: ISO 7 positive pressure

anteroom + ISO 7 negative pressure buffer room “Low use exemption”: BSC or CACI in positive

pressure buffer room CACI in neutral room with 12 air changes per

hour, optimally vented USP <800> allows

Cleanroom suite as above Containment SCA

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CSP Risk Levels

Low Risk12 Hour

Low Risk Medium Risk

Controlled room temp(20 to 25°C)

12 hours 48 hours 30 hours

Refrigerated(2 to 8°C) 12 hours 14 days 9 days

Frozen (-25 to -10°C) N/A 45 days 45 days

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Immediate Use

Intended only for emergency or immediate administration Not for convenience Not for scheduled doses or cases

No antineoplastics No more than three sterile components No more than two punctures of any

container30



Environmental Monitoring

Monitoring Function FrequencyCertification Monitors PECs

and SECsEvery six months

Electronic air samples

Monitors for microbial growth from air handling system

Every six months

Surface samples Monitors for microbial growth on surfaces

Periodic

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Action Levels

Area Air Sample(per 1000 liters of air)

Surface(per plate)

ISO 5 > 1 > 3ISO 7 > 10 > 5ISO 8 > 100 > 100

• Document results• Report to Infection Control Committee• Remediate• Retest 32



Work Practices

Policies and procedures PPE Cleaning

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Policies and Procedures

All elements required in USP compounding standards, accreditation organization standards, and additional site-specific requirements

Temperature and pressure/displacement air flow monitoring

Equipment calibration Assessment of Risk for hazardous drugs Acknowledgment of risk when handling

hazardous drugs34



BUDs

Must use the shorter of stability and sterility limits

USP <797> limits In-use times (see proposed revised <797>)

Single-use containers Multiple dose vials Pharmacy bulk packages “Stock bags”

BUDs end when administration of the CSP begins 35

PPE …

Hair covers, masks, and shoe covers Same for non-hazardous and hazardous

compounding Gloves must be sterile for sterile

compounding For handling hazardous drugs, use gloves

tested to ASTM 6978 In Compounding Aseptic Isolators

(CAI)/CACI, sterile gloves must be donned over the gauntlet gloves

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… PPE

Gowns For hazardous drugs, use laminate gown intended

for use with chemo PPE must be worn when working in

CAI/CACI For CAI: the manufacturer may provide

information to exempt some items of garb For CACI: wear the PPE – it’s for your protection

Identify when eye and respiratory protection is required

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Cleaning

Daily cleaning of floors, counters, and high-touch areas

Monthly cleaning of all surfaces in cleanroom suite and SCA

Only compounders may clean Primary Engineering Controls

Proper solutions and dilutions must be used Approved by Infection Control Committee

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Cleaning Includes Multiple Steps

Non-hazardous compounding area Clean with germicidal detergent Disinfect with 70% sterile isopropyl alcohol

Hazardous compounding area Deactivate/decontaminate with properly-diluted

oxidizer intended for use with hazardous drugs Clean with germicidal detergent Disinfect with 70% sterile isopropyl alcohol

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Certification Report

Required every six months

Pass, fail, needs attention

Key elements

Use of Controlled Environment Testing Association (CETA) guides

Tested under dynamic/operating conditions (not “at rest”)

All required components tested

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Environmental Monitoring

Non-Viable Air handling, HEPA filtration and testing,

pressure differentials / displacement air flow, air changes per hour

Viable Microbial contamination

Hazardous Drug HD contamination

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HandlingHazardousDrugsUSP <800>

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What’s All the Fuss?

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Preventing Occupational Exposure

Warning!

Working with or near hazardous drugs in health care settings may

cause skin rashes, infertility, miscarriage, birth defects, and

possibly leukemia or other cancers

Source: NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care

Settings, 2004 44



Hazardous Drug Dangers

Toxicity of the drug Exposure to workers Ingestion

Inhalation

Skin Contact

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Drugs Hazardous to Personnel

Carcinogens Genotoxins Teratogens Reproductive toxins Organ toxicity at low dose in humans or

animals New drugs that mimic existing HDs in

structure or toxicity46



<800> Hazardous Drugs

Published on February 1, 2016 One errata concerning room venting Delayed implementation date until July 1, 2018

Applies to both nonsterile and sterile compounding and all handling Supplements <795> and <797> Wider scope than <795> or <797>

Promotes safety of patients, personnel, and the environment

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Uses NIOSH list of hazardous drugs Different from EPA list of

hazardous materials Facilities may add

other HDs to their list No requirement to do so

www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf 48




Treat all dosage forms of HDs the same•Follow all the containment requirements in

<800>

Perform an Assessment of Risk•Identify and use alternative containment

strategies and/or work practices for specific forms of HDs that are not antineoplastic nor API

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Assessment of Risk Approach

USP <800> establishes the containment strategies and work practices best known to control HD contamination Engineering controls Protective equipment Work practices

https://www.cdc.gov/niosh/topics/hierarchy/ 50



HD Life Cycle in Your Organization

Receive

Transport

Store Mix

Administer

Dispose

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Personnel to Consider

Receiving Transport Pharmacists and pharmacy technicians Nursing Procedural personnel

Surgical Services Emergency Department Obstetrics

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Your Entity’s List

1. Review the NIOSH list of hazardous drugs

2. Identify the drugs and dosage forms you handle

3. Perform an Assessment of Risk4. Document review of the list

annually

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Required Elements to Consider

Drug Dosage form Risk of exposure Packaging Manipulation Documentation of alternative containment

strategies and/or work practices Review annually and document

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Your HD List

Require ALL containment strategies

detailed in <800>

Alternative containment strategies can be

identified and implemented

Active Pharmaceutical Ingredient (API) of any HD on the list

Antineoplastics that only need to be counted orpackaged

Antineoplastics that only need to be counted or packaged

Table 2 drugs

Dosage forms that don’t fityour Assessment of Risk

Table 3 drugs55

Facility Issues

Separate Rooms with Fixed Walls

Vented to the outside

Negative pressure

(0.01-0.03” wcnegative)

Appropriate number of air changes per

hour

Minimum Requirements

Con

tain

s Ha

zard

Removes H

aza

rd

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Closed System Drug-Transfer Devices

CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system Photo courtesy of BD

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CSTDs

Use of a chemo hood outside of a negative pressure room requires use of a CSTD Note that this room configuration is not allowed

by USP <800>

USP <800> requires use of CSTD for administration of hazardous drugs when the dosage form allows Use of a CSTD is recommended for compounding

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Resources

USP Compounding Compendium(www.usp.org)

Critical Point Compliance Studies www.797gaptool.com www.800gaptool.com Summaries in Pharmacy Purchasing & Products

(www.pppmag.com) Joint Commission Resources Hazardous

Drug Toolkit (www.hazmedsafety.com)59

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