Compliance with USP 800 - Amazon S3...Compliance with USP 800 Patricia C. Kienle, RPh, MPA, FASHP...

Compliance with USP 800

Patricia C. Kienle, RPh, MPA, FASHPSaad Dinno, BSPharm, RPh, FIACP, FACA

International SeminarHouston, TX

November 10 ‐12, 2016

© 2016. All Rights Reserved. 1

Disclosure• Patricia Kienle is an employee and stockholder of Cardinal

Health• She is an elected member and Vice Chair of the USP

Compounding Expert Committee, but this talk is not endorsed by or affiliated with USP

• She authored the ASHP upcoming publication The 800 Answer Book and is a contributor to Competence Assessment Tools for Health‐System Pharmacies


DisclosureProfessional Education Services Group staff have no financial interest or relationships to disclose.


DisclosureThis continuing education activity is managed and accredited by Professional Education Services Group. Neither PESG nor any accrediting organization supports or endorses any product or service mentioned in this activity.


Educational Grant SupportThis continuing education activity is supported by an educational grant from PCCA.


Learning Objectives• At the conclusion of this activity, the participant will be able to:– Discuss the three categories of hazardous drugs – Describe elements of an Assessment of Risk – Review facility design options for compounding hazardous drugs

– Discuss the garbing requirements and cleaning process when compounding hazardous drugs


Compliance with USP <800>

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


Patti’s Wish

• Identify three things that you can improve the next day you are at work


What’s all the fuss?


Preventing Occupational Exposure

* NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 2004

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


Evidence: Health Effects

1960s• Link between alkylating agents and leukemias

1970s• Occupational exposure safety

1980s• Antineoplastics and adverse reproductive effects

1990s• Link of cancer in healthcare workers to exposure to antineoplastics


Occupational Hazard Characteristics• Genotoxicity (mutagenicity)• Carcinogenicity in animal models

• Teratogenicity or fertility impairment

• Evidence of serious organ or other toxicity at low doses


Hazardous Drug Dangers

IngestionIngestion

Skin ContactSkin

Contact

InhalationInhalation


Evolution of the Definition

ASHP OSHA NIOSH


Current List of HD CriteriaTypes of HDs

Carcinogens

Structure or toxicity similar to other drugs classified as hazardous

GenotoxinsTeratogensReproductive toxinsOrgan toxicity at low doses


NIOSH Alert, 2004• Background• Potential for worker exposure• Conditions for exposure• Exposure routes• Evidence for worker exposure• Evidence for health effects in workers• Current standards and recommendations

* www.cdc.gov/niosh/docs/2004‐165/pdfs/2004‐165.pdf


ASHP Guidelines• Environment• Ventilation control• Personal Protective Equipment (PPE)

• Work practices• Containment and disposal

* www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx


OSHA Hazardous Drug Information

* https://www.osha.gov/SLTC/hazardousdrugs/


NIOSH Hazardous Drug Information

* www.cdc.gov/niosh/topics/hazdrug/


Why <800>?• Recognition that there is no federal standard that

protects workers from hazardous drug exposure• Professional organizational guidance documents

are not regulations• USP is recognized in the federal Food, Drug,

and Cosmetic Act • USP chapters numbered under <1000> are

federally‐enforceable standards* Courtesy of United States Pharmacopeial Convention


Development of USP <800>• USP Compounding Expert Committee

– Subcommittee on Hazardous Drugs• USP Expert Panel on Hazardous Drugs

– Pharmacy– Nursing– Medicine– Engineering– Industrial hygiene– Certification


USP <800> Handling Hazardous Drugs

• To promote patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs)

• Addresses, but is not limited to– Receipt– Storage– Compounding

– Dispensing– Administration– Disposal


USP <800> Handling Hazardous Drugs (cont’d)

• Applies to all healthcare personnel who handle hazardous drugs

• Applies to all healthcare entities that store, prepare, transport, or administer hazardous drugs

• Becomes federally enforceable on July 1, 2018


How Close to Compliant is Your Pharmacy?

100%50% 75%25%


Hazardous Drugs in Your Pharmacy

Finished dosage forms

Finished dosage forms

MixingMixingStoringStoringReceivingReceiving


Major Components of USP <800>• Facilities• Assessment of risk• Other elements

• Personnel acknowledgement

• Medical surveillance• Education and training• Personal Protective

Equipment• Use of closed‐system drug

transfer devices (CSTDs)• Environmental monitoring


NIOSH List of Hazardous Drugs• Antineoplastic• Non‐antineoplastic• Reproductive hazards• Hazardous to personnel

– Different from EPA hazards* www.cdc.gov/niosh/docs/2016‐161/pdfs/2016‐161.pdf


NIOSH List Disclaimer• Some drugs defined as hazardous may not pose a significant risk of

direct occupational exposure because of their dosage formulation (for example, intact medications such as coated tablets or capsules that are administered to patients without modifying the formulation).

• However, they may pose a risk if solid drug formulations are altered outside a ventilated cabinet (for example, if tablets are crushed or dissolved, or if capsules are pierced or opened).


Your Hazardous Drug List

• Review the NIOSH list of hazardous drugs

• Identify the drugs and dosage forms you handle

• Document review of this list annually


Your Handling Options

Treat all Hazardous Drugs with all containment strategies in <800>

Perform an Assessment of Risk


Your List

All containment strategies in <800> Alternative containment strategies

API of any hazardous drugs on the list Antineoplastics you only need to count or package

Antineoplastics you have to manipulate Non‐antineoplastics

Items that don’t fit your Assessment of Risk approach Reproductive hazards


Receipt of Hazardous Drugs• Supplier should mark containers• Can be received in either a neutral / normal

or negative pressure area (NOT in positive pressure)

• Receiving personnel need to assess the integrity of the container

• You must provide:– Chemotherapy gloves – Chemotherapy spill kit


Engineering Controls• Primary (PEC)

– Containment Ventilated Enclosure (CVE)– Biological Safety Cabinet (BSC)– Compounding Aseptic Containment Isolator (CACI)

• Secondary (SEC)– The room in which the PEC is placed

• Supplemental– Closed system drug‐transfer devices


Hazardous Drug Storage and Compounding

• Contain the hazard– Separate room with fixed walls– Negative pressure

• Remove and dilute the hazard– Vented to the outside– Appropriate number of air changes per hour (ACPH)

These are the minimum requirements


Design for Non‐sterile Compounding• Primary Engineering Control

– Containment ventilated enclosure (“powder hood”)

• Secondary Engineering Control– Room that is separate from non‐hazardous drugs, and is under negative pressure, vented to the outside, and has at least 12 air changes per hour (ACPH)

Occasional nonsterile compounding can be done in the sterile compounding area; details are in USP <800>


Two Options for Sterile Compounding

• Cleanroom suite– Positive pressure ISO 7 anteroom opening into externally vented, negative pressure ISO 7 buffer room with at least 30 ACPH and an externally vented PEC [either a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI)]


Two Options for Sterile Compounding (cont’d)

• Containment Segregated Compounding Area– Room that is separate from non‐hazardous drugs, under negative pressure, vented to the outside, with at least 12 air changes per hour (ACPH) and an externally vented PEC [either a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI)]

– Limited to 12 hour beyond‐use time (BUD)– NOTE: Not currently allowed by <797>

Low volume exemption is no longer allowed


Equipment Requirements• Clean equipment should be dedicated for use with HDs and should be decontaminated after every use.

• Tablet and capsule forms of antineoplastic HDs must not be placed in automated counting or packaging machines, which subject them to stress and may create powdered contaminants.


Equipment Requirements (cont’d)• Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs.

• All areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned. Additionally, sterile compounding areas and devices must be subsequently disinfected.


Personnel• Acknowledgement of risk of handling hazardous drugs• Training

– USP <795> for nonsterile compounding– USP <797> for sterile compounding– State Board regulations– Proper use of equipment and devices

• Monitoring for sterile compounding– Media fill test– Gloved fingertip test* Acknowledgement form available at www.pppmag.com/HDRiskForm


Personal Protective Equipment Requirements in <800>

• Gloves ‐ tested to ASTM D6978• Gowns ‐ impervious• Hair covers• Shoe covers• Face protection• Respirators


PPPMag – January 2015


Other Garb Issues• Eye protection

– BSC / CACI provide eye protection– Use goggles when working outside a PEC

• Respirators– Use when outside a PEC

All garb is required when using a CACI


Closed System Drug ‐ Transfer Devices

• CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system

• NIOSH has published a proposed performance protocol

Photo courtesy of BD


Cleaning ProcessesStep Agent

DeactivateDecontaminate

Properly‐diluted EPA‐approved oxidizer intended for use with hazardous drugs

Clean Germicidal detergentDisinfect Sterile isopropyl alcohol


Monitoring

Personnel EnvironmentSafe

Workplace


Medical Surveillance• Recommended by <800>• Requirement to follow organizational

policies• Consider

– Health questionnaire– History of exposure to HDs– Record of acute exposure (spills)– CBC with diff* www.cdc.gov/niosh/docs/wp‐solutions/2013‐103/pdfs/2013‐103.pdf


Environmental Monitoring

• <797> requires EM to detect microbial contamination

• <800> recommends wipe samples to detect rogue hazardous drug contamination

Screenshot courtesy of ChemoGlo


How <800> Differs from <795>• Requirement of Primary Engineering Control• Requirement of negative pressure Secondary Engineering Control– Can be a containment segregated compounding area

• PEC may be either externally vented (preferred) or have redundant HEPA filters

• SEC must be externally vented


How <800> Differs from <797>• All compounding must be performed in negative pressure– No exemption for low volume of CSPs mixed

• Requirement for Supplemental Engineering Controls for administration of hazardous drugs– When the dosage form allows


How Close to Compliant is Your Facility?

100%50% 75%25%


Where do I start?


Resources• Gap analysis

– Critical point– Joint Commission Resources

• Assessment of Risk• Facility changes• Policies and Procedures


Acton Pharmacy Lab: Room 800

Saad Dinno, BSPharm, RPh, FIACP, FACAPresident, Co‐Owner


Each Room• Has its own designation of tasks• Room 300:

– Any research materials, formulation development, MD calls, etc. is done here

– Rx checking is done here– Most of paperwork is kept out of the lab and stored / done here

to create a clutter‐free environment & decrease dust / detritus in lab

• Room 400– Gowning, garbing as well as de‐garbing from non‐NIOSH

compounding


Each Room• Room 600

– Boxes of incoming chemicals are opened & invoiced here– Boxes are broken down and disposed of in appropriate trash

containers here (NIOSH, non‐NIOSH) immediately after invoicing is done

– Inventory is invoiced in The Compounder, barcodes are generated, and quarantine happens here, as well as unopened bulk‐chemical storage and expired raw ingredients / compounds bins

– Vented to outside after air passes through a HEPA filter• Room 700

– Non‐NIOSH open bottle storage and compounding


Room 800


Room 800• Separated from Room 700 by a medical‐grade sliding glass door

– Seals perfectly all‐around– Non‐touch (motion sensor pad for hand motion) to open– Emergency open by pushing door out if in 800 room to escape

• More negative than 700 room– When door opens, nothing gets out, air from 700 room will be

sucked into 800 room– All air is vented out after passing through HEPA filter


Room 800 (HVAC System for Lab)


Room 800 (Hood Vent)


Room 800• Contains duplicate filler ingredients

– Microcrystalline cellulose, capsules, bases, etc. that are used only in compounding with NIOSH‐listed medications

• All open containers of NIOSH‐listed chemicals are stored in this room– Any solid‐dosage forms (tablets) that are NIOSH‐rated and used in compounding are stored in this room


Room 800 (cont’d)• All equipment is duplicated and specifically marked for utilization only in this room– Mortars, pestles, spatulas, etc. are marked with red electrical tape or some red marking that is as permanent as possible and not impacting compounding (this included chemicals / drugs)

– EMP, hoods, balances, etc. are dedicated to this room ‐ they are not used for any other compounding, nor are they moved between rooms for use (maintenance is acceptable)


Room 800• Cleaning

– All equipment that is used is sprayed down with 70% IPA prior to being removed from hood, and excess material is wiped off

– Equipment is then placed in a bleach / water mixture (no defined ratio per USP, but is a required decontamination step ‐ bleach or peroxide) in black tubs


Room 800• Cleaning (cont’d)

– Tubs are removed from Room 800 at the end of the day and cleaned in a sink with separate sponge / cleaning materials

• Not washed at the same time as non‐NIOSH related items• Washed after non‐NIOSH related items have been cleaned

• Dishwasher is NOT utilized for NIOSH‐related item cleaning


Room 800• Cleaning (cont’d)

– Room 800 is cleaned stem‐to‐stern once a month with sanitizing agents, as is the rest of the lab (Cidecon® & acidified bleach rotated each month)

• Weekly cleaning ‐ all vertical surfaces, trash bins, etc. are cleaned with 70% IPA ‐ all areas of lab


Room 800• Garbing

– Dressing for primary garb (Room 700 standard garb) is done in Room 400

• Booties, hair net, disposable gown, N‐95 (R‐95 is optional) facemask, long‐cuff gloves worn over gown cuff, goggles when applicable


Room 800• Garbing (cont’d)

– Upon entering Room 800, a second layer is donned• Step onto dedicated floor space marked by green electrical tape, closest to cabinets

• Second gown, non‐absorbent, chemo‐rated, rear fastening is donned on top of primary gown

• 2nd set of booties placed on feet• Second set of gloves placed on hands, chemo‐rated, over cuffs of second gown


Room 800


Room 800

• Gowning– While someone is compounding in Room 800, they are to be disturbed as least as possible, whether over the phone system or by entering the room

– Before leaving the room, outer garb (potentially contaminated) is removed and disposed of in NIOSH trash


Room 800 (cont’d)

• Trash– Is in dedicated bins, lined with biohazard trash bags, which are goose‐necked prior to removal from the room, and stored in cardboard containers in the basement (clearly marked, dedicated by the removal company) and picked up by a hazardous waste company which generates an EPA‐required form for disposal of boxed trash


Obtaining CE

If you would like to receive continuing education credit for this activity, please visit:http://pcca.cds.pesgce.com


Compliance with USP 800 - Amazon S3...Compliance with USP 800 Patricia C. Kienle, RPh, MPA, FASHP...

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