Compliance software for USP 340B TJC & More …...Depends on state • USP (2014) and USP (2008) Official • USP did not agree to appeal, USP expected

Enterprise Pharmacy Quality Management System

Cover photo: Garbed pharmacist documenting in Compounding360

Pharmacy Stars, LLC1111 Guinness StreetWaunakee, WI [email protected]://pharmacystars.com800-351-2664

BE THE ONE ALWAYS

IN COMPLIANCE

Compliance software forUSP 340B TJC & More

This webinar has been sponsored by Pharmacy Stars, makers of Compounding360.

Enterprise Pharmacy Quality Management System

Check all the boxes...and more

Checks all the boxes

Best Choice!

Quality ControlDaily, weekly & monthly cleaningTemperature, pressure & humidityAir & surface sampling/Envir. monitoringHood & room certificationEyewash station, MDV/SDV, Outdates, OOL...CompetenciesNew hire and ongoing didiactic trainingGloved Fingertip Test - initial and ongoingMedia Fill ChallengeAseptic techniquePharmacy mathBatchMaster formulation recordsAuto-populate labelsAuto-assign lot #Multi-step approval processSterile & NonsterileStandard Operating ProceduresUSP Chapter 795USP Chapter 797USP Chapter 800Hazardous drug handling for nursesContinuously updated by expertsHD / NIOSH Formulary tool/outputReporting & Records & AlertsTrended measurement reportsQuality control, batch & competency reportsQuality control & competency alertsAutomated monthly compliance scorecardDelivery modelSecure, cloud-based software as a service

Screenshot of the Pharmacy Stars QMS worklist. Note the Quality control Tasks, Competencies and Batch sections to fully support Compounding compliance programs.

For more info visit HTTPS://Pharmacystars.com

Staying the Course to USP <800> Compliance

Current Status and New Hazards

Fred Massoomi, Pharm.D., BCSCP, FASHPSenior Director

Visante, Inc.

August 20, 2020

• USP <800> informational………Depends on state • USP <795> (2014) and USP <797> (2008) Official• USP did not agree to appeal, USP <825> expected compliance• USP agreed to move USP <795> & USP <797> to the Expert Committee for review

Source: https://www.usp.org/compounding

3rd Annual Survey-315 respondents-Time Period: 2nd Quarter 2020

*Fred Massoomi is on the editorialBoard of Pharmacy Purchasing and Products

Halverson D. Hazardous Drug Handling 3rd annual USP <800> Survey Results. Pharmacy Purchasing Products July 2020

USP <800> is currently a compendial ‘information’ chapter……..But is it?

Depends on your state

HD Compliance Delayed Due to Appeals


Trends In USP <800> Compliance

24% reporting FULL Compliance

49 % reporting MET MOST Compliance


First Sign of Compliance with StandardsDesigned Person(s)

• Create Job Description, or,

• Add to Job Description


Indicator of ComplianceSOP Development

SOPs must be reviewed at least every 12 months by the designated personthe review must be documented…USP <800>


Decontaminant for Engineering Controls

“There is no one proven method for deactivating all compounds”…..USP <800>


Closed System Transfer Drug Devices (CSTD)Adoption for use in Compounding Hazardous Drugs

“CSTDs should be used when compounding HDs when the dosage form allows”…..USP <800>


Closed System Transfer Drug Devices (CSTD)Adoption for use for Administering Hazardous Drugs

“CSTDs must be used when administering antineoplastic HDs when the dosage form allows”…..USP <800>


Closed System Transfer Drug Devices (CSTD)A Discrepancy In Safety

16%


Safety for HD Administration Still a Concern

Source: Friese CR, et.al. Hazardous Drug Exposure. CLINICAL JOURNAL OF ONCOLOGY NURSING, JUNE 2020, VOL. 24, NO. 3

Drug Exposure Feedback and Education for Nurses’ Safety(DEFENS) study was launched in March 2015

Source: Friese CR, et.al. Hazardous Drug Exposure. CLINICAL JOURNAL OF ONCOLOGY NURSING, JUNE 2020, VOL. 24, NO. 3

Drug Exposure Feedback and Education for Nurses’ Safety(DEFENS) study was launched in March 2015

Considerations for CSTD UseDefining When NOT to Use a CSTD

Source: Stevens JS, Martinez L, Trace C. Pharmacy Purchasing and Products December 2019

Joe DiMaggio Children’s Hospital; Hollywood, FL

Will a CSTD Work for These Routes?

Addressing HD Spills

“Spill kits containing all of the materials needed to clean HD spills must be readily available in all areas where HDs are routinely handled”……USP <800>


Uptake of Wipe Analysis


Reported Frequency of Wipe Analysis

“initially as a benchmark and at least every 6 months, or more often as needed”


Reported Wipe Analysis Locations


Source: Pharmacy Practice News; July 2020

2020 NIOSH New Documentsreleased May 1, 2020 – Comment Period Closed

Source: https://www.regulations.gov/docket?D=CDC-2020-0046. Accessed August 19, 2020

https://www.regulations.gov/docket?D=CDC-2020-0046

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• CAUTION: Drugs purchased and used by a facility may have entered the marketplace after the list below was assembled. Therefore, this list may not be all-inclusive and employers should consider creating a facility-specific hazardous drug list.

• NIOSH Hazard Definition• Carcinogenicity;• Developmental toxicity (including teratogenicity);• Reproductive toxicity;• Genotoxicity;• Organ toxicity at low doses; or• Structure and toxicity profile that mimics existing

drugs determined hazardous by exhibiting any one of the previous five toxicity types

20042020 NIOSH Hazardous Drug Lists

• Build on your current hazardous drug list• 2020 NIOSH Hazardous Drug List Table 1 Drugs

• Changes to the placement of drugs on the list• FDA’s CBER: Vaccines; Blood Products; Allergenics; Cellular/Gene Therapy

• FDA’s Purple Book for Biological Products

• USP <800> Guidance on Risk Assessment• “If an assessment of risk is not performed, all HDs must be

handled with all containment strategies defined in this chapter.”• Type of Hazardous Drug • Dosage form• Risk of exposure• Packaging• Manipulation• Investigational drugs with limited information

Developing Your Sight Specific Hazardous Drug Lists

Source: https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare

Developing Your Sight Specific Hazardous Drug Lists

Source: https://www.cardinalhealth.com/en/cmp/ext/med/gen-med/usp800-assessment-of-risk-video.html?cid=EML-PT-MED-MG-usp-110719

Investigational Drugs as Hazards

Source: Prime Healthcare

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• CAUTION: Drugs purchased and used by a facility may have entered the marketplace after the list below was assembled. Therefore, this list may not be all-inclusive and employers should consider creating a facility-specific hazardous drug list.

• NIOSH Hazard Definition• Carcinogenicity;• Developmental toxicity (including teratogenicity);• Reproductive toxicity;

•Genotoxicity;• Organ toxicity at low doses; or• Structure and toxicity profile that mimics existing drugs

determined hazardous by exhibiting any one of the previous five toxicity types

20042020 NIOSH Hazardous Drug Lists

Source: JAMA Published online July 29, 2019

Source: N Engl J Med 2019;381:455-64.

- Imlygic: Talimogene Iaherparepvec- Zolgensma (onasemnogene abeparvovec-xloi)- Luxturna (voretigene neparvovec-rzyl)- GDNF Glial Cell Line-Derived Neurotrophic

Factor Gene Transfer (AAV2-GDNF)

-Kymriah (tisgenleclecucel) -Yescarta (axicabtagene ciloleucel) -Tecartus (bexucabtagene autoleucel)

Is the Promise Too Much?

Source: https://www.statnews.com/2020/08/19/fda-rejects-biomarin-hemophilia-gene-therapy/

Source https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF

Preparing for the Change

Source: https://bakerco.com/images/uploads/assets/3ABSA_2017_poster.pdf

Refer to the Package Inserts!

BLACK BOX WARNING TheraCys®, BCG Live (Intravesical) contains live, attenuated mycobacteria.

• Handled and disposed of as a biohazard material. • BCG infections have been reported in health care workers,

primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration

• To avoid cross-contamination, parenteral drugs SHOULD NOT be prepared in areas where BCG has been prepared.

• A separate area for the preparation of the TheraCys suspension is strongly recommended.


Imlygic: (Talimogene Iaherparepvec)

Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients

Accidental exposure may lead to transmission of IMLYGIC and herpetic infection

• Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC


Luxturna (voretigene neparvovec-rzyl)Adeno-associated virus vector-based therapy

Prepare Luxturna within 4 hours of administration using sterile technique under aseptic conditions in a Class II vertical laminar flow biological safety cabinet (BSC).

If there is a completepackage insert!

• Best Practice #1• Dispense vinCRIStine and other vinca alkaloids in a minibag of a

compatible solution and NOT a syringe

• Best Practice #2• Use a weekly dosage regimen default for oral methotrexate in electronic

systems when medication orders are entered• Require Hard Stop verification of an appropriate oncologic indication for all daily oral

methotrexate orders• Provide specific patient and /or family education for ALL oral methotrexate discharge orders

• Best Practice #4 (Revised)• Ensure that all oral liquid medications that are not commercially available

in unit dose packaging are dispensed by the pharmacy in an oral syringe or an enteral syringe that meets the ISO 80369 standard such as ENFit

• Best Practice #6• Eliminate glacial acetic acid from ALL areas of the hospital*

• Pharmacy areas, Clinic areas, physician office practices; *EXCLUDES Laboratories

• Best Practice #11 (Revised)• When compounding sterile preparations, perform an independent

verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of EACH ingredient PRIOR to its addition to the final container.

Source: ISMP.org

Source: McMahon Publishing Group; Pharmacy Practice News Supplement 2020

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ASHP Guidelines on Handling Hazardous DrugsAM J HEALTH-SYST PHARM | VOLUME 75 | 2018

New ASHP References For USP Chapters

Source: https://store.ashp.org/default.aspx

Staying the Course to USP <800> Compliance

Current Status and New Hazards

Fred Massoomi, Pharm.D., BCSCP, FASHPSenior Director

Visante, Inc.