Oct 19 2016 webinar COMBINED PRESENTATION …s3.proce.com/res/pdf/CHS2016Oct19Handout.pdfCHS...

Improving the Safety of Compounded Sterile Preparations ‐ Practical Strategies:USP <797> & <800> Compliance in Everyday PracticeCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2016 Pharmacy Education Series

October 19, 2016Improving the Safety of Compounded Sterile Preparations ‐ Practical Strategies:

USP <797> & <800> Compliance in Everyday Practice

Featured Speakers:

Lou Diorio, RPh, FAPhA Lacy B. Crawford, PharmD, BCPS, BCNSP, MBAPrincipal Corporate Pharmacy Standards SpecialistLDT Health Solutions, Inc. Community Health Systems Professional Services Corporation

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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/CHSRx 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: November 18, 2016 CPE Monitor (applicable to pharmacists and pharmacy technicians)

– 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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2016 Pharmacy Education Series

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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. Mr. Diorio is an employee and stockholder of LDT Health Solutions, Inc. Dr. Crawford has no relevant commercial and/or financial relationships to disclose.

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.

October 19, 2016Improving the Safety of Compounded Sterile Preparations ‐ Practical Strategies:

USP <797> & <800> Compliance in Everyday Practice

Featured Speakers:

Lou Diorio, RPh, FAPhA Lacy B. Crawford, PharmD, BCPS, BCNSP, MBAPrincipal Corporate Pharmacy Standards SpecialistLDT Health Solutions, Inc. Community Health Systems Professional Services Corporation

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist CE)

– 2.0 contact hours

6

Funding:This activity is self‐funded through CHSPSC.



Improving the Safety of Compounded Preparations ‐USP <797> & <800> ‐ Assessing Gaps and Preparing for the Future

Lou Diorio, RPh, FAPhAPrincipal

LDT Health Solutions, Inc.October 19, 2016 – CHS Webinar

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The speaker would like to disclose the following relationships with commercial interests regarding the content of this presentation: Consultant to ‐

Grifols USA (Hospital Division)

West‐Pharma

Actelion Pharmaceuticals US Inc.

(c) 2016 LDT Health Solutions, Inc.

Disclosures

8



The presenter would like to thank the following colleagues for their help and support in the development of this program:

Patricia Kienle, RPh, MPA, FASHP

Eric Kastango, RPh, MBA, FASHP

Arthur Chaput, RPh, PharmD

David Thomas, RPh, MBA


Acknowledgements ‐

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Discuss the current & future status and of both USP <797> & <800>

Describe the professional responsibility of compounders in meeting the standards described USP General Chapters <797> & <800>.

Outline parameters to consider in assessing deficiency gaps in your institution.

Describe potential compliance strategies individualized for the size and resources of your facility.

Outline practical compliance strategies for the short and long term planning.


Session Objectives‐

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How did we get here?

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The short answer is that there are NO Guarantees! Constant vigilance is in order!

Know the limits of your Pharmacy Practice Act.

Be familiar with all the moving parts: USP <795>

USP <797>

USP <71>

USP <85>

USP <800>

DQSA

NIOSH & OSHA regulation


Can tragedies like NECC be prevented in the future?

12



USP 797

USP 795

USP 71 USP 85

USP 800

DQSA

State Regulation TJC / ACHC

Centers for Medicare &

Medicaid Services


Are you comfortable knowing how all the pieces fit together?

13

Observation

6 Procedures designed to preventmicrobiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

7 Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications andidentity and strength of each active ingredient prior to release.

8 There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not thebatch has been already distributed.

9 Each batch of drug product purporting to be sterile and pyrogen‐free is not laboratory tested to determine conformance to such requirements.

10 Separate or defined areas to prevent contamination or mix‐ups are deficient regarding operations related to aseptic processing of drug products.

11 Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

12 Aseptic processing areas are deficient regarding air supply that is filtered through high‐efficiency particulate air filters under positive pressure.

13 Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety,identity, strength, quality or purity of the drug product.

14 Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

15 Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

16 Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug productsconform to appropriate standards of identity, strength, quality and purity.

17 Batch production and control records do not include complete information relating to the production and control of each batch.

18 Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

19 There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purportor are represented to possess.

20 Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning,maintenance, and proper operations.

21 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaningand maintenance.

22 Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

23 Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

Occurances Percentage

187 68.8%

174 64.0%

161 59.2%

143 52.6%

117 43.0%

115 42.3%

108 39.7%

93 34.2%

91 33.5%

60 22.1%

54 19.9%

45 16.5%

44 16.2%

44 16.2%

39 14.3%

34 12.5%

31 11.4%

25 9.2%

24 8.8%

23 8.5%

21 7.7%

20 7.4%

20 7.4%

19 7.0%

19 7.0%

FDA 503A Top 25 Observations 205d

1 Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

2 Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perform.

3 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

4 Procedures designed to preventmicrobiological contamination of drug products purporting to be sterile are not established, written, and followed.

5 There is no written testing program designed to assess the stability characteristics of drug products.

24 The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

25 An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

LDT Health Solutions, Inc. www.LDTRx.com Thursday, September 22, 2016 Top 25 Observations14



1. The drug compounded is for an identified patient based upon the receipt of valid prescription order.

2. The compounding is performed by:1. A licensed Pharmacist, or

2. licensed Physician authorized by State law to prescribe drugs.

3. Within the Limits on “Anticipatory Compounding”

3. The drug is in compliance with USP guidance on the use of Bulk Drug substances.

4. The drug is manufactured by an FDA registered establishment.

5. The drug product used for compounding is accompanied by a valid Certificate‐of‐Analysis.

6. The Drug products compounded conforms to applicable USP/NF monographs & the USP chapters on compounding.

7. The Drugs compounded have been NOT withdrawn from the market for safety reasons

8. The Compounded drugs that are NOT essentially copies of commercially available FDA approved drug products.

9. The Compounding of this drug that has NOT been identified by FDA as presenting any demonstrable difficulties for compounding.

10. You are NOT compounding drugs in a State that has entered into a memo of understanding (MOU) with FDA that addresses the distribution of inordinate amounts of compounded drug products interstate (5% rule).


“FDA’s TEN commandments”(the compounded drug qualifies for exemptions if…)

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The Objective of USP <797>…

“…is to describe conditions and practices to prevent harm, including death, to patients…”*


* Introduction: USP <797> Pharmaceutical Compounding‐ Sterile Preparations © USP

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USP Chapter <797> Sections:

Definitions Responsibilities of compounding personnel CSP microbial contamination risk levels Personnel training and evaluation in aseptic manipulation skills Immediate use CSPs Single‐dose and Multiple‐dose containers Hazardous drugs as CSPs Radiopharmaceuticals as CSPs Allergen Extracts as CSPs Verification of Compounding Accuracy and Sterility Environmental Quality and Control Suggested Standard Operating Procedures (SOPs) Elements of Quality Control Verification of Automated Compounding Devices (ACDs) for Parenteral Nutrition Compounding Finished preparation release checks and tests Storage and beyond‐use‐dating Maintaining Sterility, Purity, and stability of Dispensed and Distributed CSPs Patient or Caregiver training Patient monitoring and adverse event reporting The Quality Assurance (QA) Program Abbreviations and Acronyms Appendices I‐V


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USP General Chapter <797> ‐

Is about three things…

CONTROL ! CONTROL !

CONTROL ! Control of the compounding personnel.

Control of the compounding environment.

Control of the compounding processes.


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Responsibilities of Compounding Personnel

Personnel are adequately educated, instructed, and skilled to perform their functions

Ingredients have correct identity, quantity, amount

Open/partial containers are properly stored

Minimize bacterial endotoxins

Proper and adequate sterilization is used

Equipment is clean, accurate, appropriate

Potential harm from added substances considered Packaging is appropriate for sterility, stability Compounding environment maintains the sterility of pre‐sterilized items Labels are appropriate and complete Beyond‐use‐dates are appropriate and based on valid scientific criteria Correct compounding procedures are used Deficiencies in compounding can be rapidly identified and corrected Separate compounding from quality evaluation


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Risk Levels of USP <797>

“NO” Risk[Low‐Low Risk]

•RTU, Pre‐mixed, or UOU Commercial Doses

Low Risk•“Simple,” single dose compounding

Medium Risk•Using multiple sterile components (i.e. Batch compounding)

High Risk•Beginning from non‐sterile components ORrendering sterile components non‐sterile during manipulations

Are you sure how to categorize any compounded, outsourced or contract compounded CSPs you provide to your patients?


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Personal Training and Evaluation in Aseptic Manipulation Skills‐

“Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through audio‐video instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations and in achieving ISO Class 5 environmental conditions before they begin to prepare CSPs.”


1‐USP<797> Pharmaceutical Compounding‐Sterile Preparations Revision Bulletin © USP

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Personal Training and Evaluation in Aseptic Manipulation Skills‐

Aseptic training in pharmacy schools is inadequate or non‐existent.

Most training occurs “OJT” and by “verbal tradition”

Training must include through didactic instruction in theory and practice of sterile preparation before starting compounding and annually/semi‐annually thereafter.

Evaluations should include a formal written exam, motor‐skills assessment and practical evaluation of aseptic technique using growth media.


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Quality Assurance Program‐

Requires formalized policies, controlled processes and clear procedures used in preparing CSPs

One element of quality that is not routinely performed in pharmacies is documentation, or “written proof” that compounding is occurring properly.


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Cleanroom Cleaning & Disinfecting‐for non‐HD CSPs

SWFI 70% Sterile IPAQuat Ammonium

CleanerSporicidal Agent2% Sterile Bleach

Per <797> when dissolution of messy spills is in order

Per <797> this is the primary disinfect agent in your cleanroom

Needed when a “soap” is indicated. Sticky spills etc.

FDA is advocating the regular use of a sporicidal agent, regardless of ENV monitoring. POINTS to REMEMBER‐dilution strength & contact time. [as well as residues]

A good economical disinfectant, especially if a large volume of solution is needed. Can be used to remove Sporicidal residues. OSHA‐Corrosive , S Steel could have issues

(c) LDT Health Solutions Inc.

<797> ‐ Primary concern is Maintaining Sterility

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Proposed Major Changes ‐

3 Risk levels changed to 2 categories distinguished by conditions under which they are made and time within which used

Removal of HD handling section and cross‐reference to USP <800>

Quarterly requirement for Personnel Monitoring (visual observation of hand hygiene and garbing, MFT and on‐going GFS

Monthly requirement for Viable Air sampling & Surfacesampling

BUD and Storage times changes with a maximum BUD of 45 days regardless of sterility testing

Introduction of “In‐Use‐time” (time before which conventionally manufactured product or compounded dilution bag must be used after it is punctured)

Master formulation and compounding recordswill be required for all batch and non‐sterile compounding

New guidance for sterility testing of CSP prepared in batch sizes of less than 40. (10% rule)

New placement requirements on use of isolators Requirement for sterile gloves and sterile sleeves, sterile wipers and cleaning tools that need to be re‐sterilized but not sterile disinfectants


Proposed USP <797> Changes ‐

CHART © 1999‐2016 Clinical IQ, LLC – All rights reserved – used by permission25

“This chapter describes practice and quality standards for handling of hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.”

© United States Pharmacopeial Convention ‐USP Chapter <800> – First Supplement to USP 39 – NF 34


USP <800> Hazardous Drugs –Handling in Healthcare Settings

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USP General Chapter <800> will be come official on July 1, 2018.

HOWEVER, the body of information around these drugs is long‐standing, substantial, and well known.

Since an HD Handling Compliance Program is multi‐faceted, implementation timelines will complex. Delaying any efforts until 2018 will be problematic.


USP <800> ‐ A word about dates…

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Based upon existing documents:

NIOSH Alerts

List of Antineoplastic and other Hazardous Drugs in Healthcare Settings 2016

ASHP Guidelines

Other Regulatory & Professional Guidance


USP <800> Hazardous Drugs –Handling In Healthcare Settings

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TRUE or FALSE : Compliance to USP General Chapter <800> exempts a Pharmacy from the rigors of complying with USP <797>?


Question 1 ‐

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“This chapter applies to all healthcare personnel who handle HD preparations and all entities which store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals, and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices.”

© United States Pharmacopeial Convention ‐USP Chapter <800> – First Supplement to USP 39 – NF 34


USP <800> Hazardous Drugs ‐ Scope

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Eliminates current allowance for “low volume” providers in a “non‐negative” space.

All Hazardous drug compounding shall be done in a separate area specifically designed for that purpose.

Addition of a allowance for low/medium HD compounding in a “Containment Segregated Compounding Area” (C‐SCA) with at least 12 ACPH with a BUD not to exceed 12 hours.

© United States Pharmacopeial Convention ‐USP Chapter <800> Briefing – First Supplement to USP 39 – NF 34


USP <800> Hazardous Drugs –Significant Changes

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List of Hazardous Drugs‐

Must be maintained which include items on the current NIOSH list. [currently the 2016 edition]

PLUS –

HDs that enter the market after the most recent version of the list has been published.

Investigational drugs‐

If the information available on any drug is deemed insufficient to make an informed decision, consider the drug hazardous until more information is available.


USP <800> Hazardous Drugs –

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Cleanroom Cleaning & Disinfecting‐for HD Compounded Preps

Deactivation Decontamination Cleaning Disinfection

(for CSPs)

Rendering a compound inert or

inactive

EPA‐Oxidizers:• BLEACH

• H2O2

Removal of HD Residues

Validated materials:• IPA• H2O• H2O2

• BLEACH

Removal of Organic and Inorganic Material

• Germicidal Detergents

Destroy Micro‐Organisms

• EPA‐registered disinfectant and/or

Sterile IPA

(c) LDT Health Solutions Inc.

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Dosage forms of drugs defined as hazardous may not pose a significant risk of direct occupational expose because of their dosage formulation.

Solid Tablets or Capsules If administered intact without modification!

Follow the manufacturer's instructions / recommendations

Mind the “dust!”

Consider alternative containment strategies / work practices.



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Personnel Training for HDs – Training must occur before the employee independently handles

HDs Annual re‐assessment, when new of significant practice changes occur.

Each employee training must be return demonstrated.

The Training Program must include the following: Overview of the entity's list of HDs & their Risks

Review of the entity’s SOPs related to the handling of HDs

Proper use of PPE

Spill Management

Response to known or suspected HD exposures



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When considering cleaning of an HD compounding area (for sterile or non‐sterile operations), which of the following is FALSE:

(a) all personnel must be properly trained to do so.

(b) all personnel must wear all appropriate PPE.

(c) all supplies and PPE must be disposed of properly.

(d) all cleaners must have separate spray bottles for use.


Question 2 ‐

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Compounding of HDs‐

Engineering Controls are required to protect the preparation from cross‐contamination & microbial contamination (if a CSP)

Primary – Ventilated device or “Hood.”

Secondary – The room where the device is placed.

Supplemental – Adjunct controls offering additional levels of protection [CSTDs]


USP <800> Hazardous Drugs – Key Design Elements‐

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Engineering Controls ‐

* PEC examples NOT endorsements

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Engineering Controls for HDs‐

MUST‐

Always be a C‐PEC inside a C‐SEC

Run continuously

Be externally vented through HEPA filtration

Be physically separated (a different room)

Be run at NEGATIVE pressure between 0.01” – 0.03” water column

Have a sink & eye wash available



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Example: C‐PEC within a C‐SEC

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Hazardous Drugs (HDs) can only be compounded;

(a) in a separate area designed for that purpose.

(b) under “negative pressure” in some type of containment room / area.

(c) both a & b

(d) neither a nor b


Question 3 ‐

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Containment Supplemental Engineering controls for HDs‐

Closed System Transfer Devices (CSTDs) ‐

Provide adjunct controls & offer additional protection especially in eliminating the potential of generating aerosols during compounding.

There are no published universal performance standards

CSTDs are NOT a substitute for C‐PECs.

CSTDs “should” be used for compounding…

CSTDs “must” be used for administration…



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Personal Protective Equipment –

Gloves [ASTM standard D6978]

Gowns [Polyethylene, coated or laminates]

Head, Hair Shoe, and Sleeve Covers

Eye and Face Protection – [Goggles]

Respiratory Protection – [Surgical N95 Respirator]

Disposal of PPE

Spill Control

Training of Personnel



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When considering an HD drug compounding program, which of the following is TRUE? [for both sterile or non‐sterile]

(a) PPE used in compounding cannot be put into the regular trash.

(b) Training of all staff, including janitorial staff is required.

(c)Two pairs of gloves are required in both the compounding & administration of HDs

(d) ALL are TRUE


Question 4 ‐

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Environmental Quality and Control‐

ENV wipe sampling should be performed routinely ‐

Initially as a Baseline

Minimum of semi‐annually to verify containment

KEY Locations –

Interiors of C‐PECs and equipment contained within

Staging area(s) near C‐PECs

Patient administration area(s)



45

When unpacking HD drugs at the Pharmacy, Practice, or Facility; which of following is FALSE:

(a) Only a negative pressure area is suitable.

(b) Employees must wear appropriate PPE, including gloves & eye protection.

(c) Drug packaging should be wiped down before placing into inventory.

(d) A spill kit & eye wash must be readily available.


Question 5 ‐

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Self‐Assessment tools (SAT) or “GAP” Analysis‐

Use a SAT or GAP Analysis to identify organizational points of compliance and operational gaps. High level situational analysis of current state of readiness.

Should address‐ USP <71> <85> <795> <797> <800>

FDA CPGs 503A & Hospital and Health System Compounding

State and Local Regulation

SAT or GAP Analysis will serve as a placeholder for regulatory and accreditation agencies. It is only a starting point!

But the best place to start is at the beginning!


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Developing an Action Plan‐

Focus should be on: “Changing the culture” ‐Controlled processes and documentation

Competency Based Training and Education

Compliance to Local, State, and Federal Regulations

Patient Safety is always your goal!


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There is no substitute for constant vigilance on the part of any professional, compounder, or healthcare provider of CSPs.

All professionals must be aware of ALL best practices & prevailing regulation!


Summary / Conclusions ‐

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Thank You [email protected]

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Personnel are capable and qualified to perform their assigned duties.

Ingredients used in compounding have their expected identity, quality, and purity .

Critical processes are validated to ensure that procedures, when used, will consistently result in the expected qualities in the finished preparation.

The engineering controls and production environment is suitable for its intended purpose (addressing such matters as environmental cleanliness, control, monitoring, staff attire, and the setting of action limits, as appropriate).

There is assurance that processes are always carried out as intended or specified and are under control.

Appropriate stability evaluation is performed or determined from the literature for establishing reliable expiration dating to ensure that finished preparations have the expected potency, purity, quality and characteristics at least until the labeled expiration date.

Appropriate release checks or testing procedures are performed to ensure that finished CSPs have their expected potency, purity, quality and characteristics at least until the labeled beyond use date.

Preparation conditions and procedures are adequate for preventing mix‐ups.

There are adequate procedures and records for investigating the product, correcting failures or problems in preparation, testing, or in the preparation itself.


Quality Process‐

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• General Chapter USP <795> <797> <800> ‐ www.usp.org• Controlled Environmental Testing Association (CETA) – www.CETAinternational.org• Centers for Disease Control & Prevention www.cdc.gov• Pharmacy Purchasing and Products Magazine‐www.pppmag.com• FDA Website – www.FDA.gov

• NECC FDA form 483 ‐http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf

• Drug Quality & Safety Act ‐• http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm376732.htm

• Guidance – Pharmacy Compounding ‐• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf

• Guidance – Hospital & Health System Compounding‐• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf

• OSHA / NIOSH Resources –• HD Drug list ‐ http://www.cdc.gov/niosh/docs/2016‐161/default.html• NIOSH Drug Alert‐ http://www.cdc.gov/niosh/docs/2004‐165/default.html• Workplace Solutions – PPEs‐ http://www.cdc.gov/niosh/docs/wp‐solutions/2009‐106/pdfs/2009‐

106.pdf• DONNING & DOFFING – (videos) http://www.cdc.gov/vhf/ebola/hcp/ppe‐training/• CSTD‐ (Draft for comment) ‐ http://www.cdc.gov/niosh/docket/review/docket288/default.html


Bibliography‐

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Action Planning –Implement your plan for <797> & <800>

Compliance

Lacy Blackwell Crawford, PharmD, BCPS, BCNSP, MBA

Corporate Pharmacy Standards

Community Health Systems Professional Services Corporation

53

Disclosures

I have no financial interest in and/or affiliation with any external organizations in

relation to this CE program.

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• www.usp.org – FAQ Hazardous Drug (HD) Handling in HC Settings

• Critical Point, LLC: <797> & <800> Compliance Studies

www.797gaptool.com & www.800gaptool.com

• Joint Commission Resources(JCR)/BD: https://HazMedSafety.com

• www.jcrinc.com – search USP 800 (3 free webinars)

• ASHP’s “Preparing for USP Chapter <800> Now is the Time to Get Ready” CE

• Improving Safe Handling Practices for HD Toolkit – free book coming soon from JCR/BD

• Pharmacy Purchasing & Products Magazine www.pppmag.com

Gap Analysis Tools & Education

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Facility‐specific Hazardous

Drug (HD) List

NIOSH List (all Tables)

Meds and dosage forms

Assessment of Risk

Facilities

Environmental controls

Signage

Monitoring

Personnel (SOP)

Designated Person

Training

Personal Protective Equipment

Competency

Monitoring

Cleaning (SOP)

Deactivation

Decontamination

Handling (SOP)

Receiving

Storage

Compounding

Dispensing/Transport

Administration

Disposal

Adapted from (c) 2016 LDT Health Solutions, Inc.

Compliance with USP <800>

* Source – USP Education Library 2016

56



• “No attempt has been made to perform risk assessments on each drug or to propose exposure limits.”

• Goal – protect EVERYONE from ANY inadvertent exposure

• Table 1 – Antineoplastics = handle with environmental controls (ECs) and Personal Protective Equipment (PPE)

• Table 2 – Non‐antineoplastics meeting >/=1 NIOSH criteria

• Table 3 – Non‐antineoplastics primarily having adverse reproductive effects

• Table 5 – PPE and ECs

Hazardous Drug List

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• Personal Protective Equipment (PPE)

• Head, Hair (facial too) , & Shoe Covers (1‐2 pair)

• Gowns (1‐2 pair) [polyethylene, coated or laminates]

• Gloves (1‐2 pair) [ASTM std D6978‐05]

• Sterile Sleeves* ‐ new proposed 797

• Eye & Face –[goggles, face shields]

• Respiratory – [N95 mask, PAPR]

• Spill Kit

HD Personal Protection

58



• Receiving • NON‐POSITIVE pressure area

• “equipped” for process (PPE, cleaning,

spill kit, etc.)

• Receipt verification techniques

• Storage• Active Pharmaceutical Ingredients (APIs) and antineoplastics

requiring manipulation • negative pressure, external venting, > 12 ACHP, antineoplastics in dedicated fridge in negative room (preferably near exhaust)

• HD buffer, C‐SCA acceptable

• Other HDs = per Assessment of Risk

HD Receiving & Storage

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HD Containment Secondary Engineering Control

• “All Hazardous drug compounding shall be done in a separate area specifically designed for that purpose.”

• Low volume exemption for antineoplastics prepared in BSC/CACI in positive pressure room ENDS 7.1.2018

• Fixed walls, negative 0.01‐0.03” w.c. pressure differential, HEPA supply air, external venting

• C‐SEC/buffer room, >30 ACPH (15 from HVAC) • C‐SCA/storage/non‐sterile, >12ACPH

• Positive Ante (ISO 7 if serves HD buffer)• Sink with eyewash station• Proposed <797>

• < 68oF• < 60% humidity

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Primary Engineering Control (PEC)

• Not a “magic” place• Operate continuously• Sterile gloves required in ALL• Proper technique essential

• First air depends on type of unidirectional flow

• HDs ‐ Negative pressure technique

• HDs ‐ Appropriate alarms for exhaust system performance or canopy for malfunction and loss of power precautions

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“Optimal” SEC/PEC

Non‐sterile Sterile

Adapted from USP <800> Appendix B62



“Limitations” SEC/PEC

Sterile

Sterile & Non‐sterile12hr BUD

HD thru non‐HD

12hr BUD LAFW

Non‐simultaneous, 1 meter apart, maintain ISO 7

12hr BUD

12hr BUD

63

Cleaning & Disinfecting

Area Frequency Product

PEC & other work surfaces

daily germicidal cleaner disinfectant (*sporicidal weekly), sterile 70% IPA

HD PEC additional > weekly (or after spill)

sporicidal cleaner disinfectant, sterile 70% IPA

SEC Floor daily germicidal cleaner(*sporicidal weekly)

SEC ceiling/wall/ shelves, outside surfaces of PEC

monthly germicidal (+/‐) sporicidal cleaner disinfectant

64



HD Deactivating and Decontaminating

Deactivation Decontamination Cleaning Disinfection

(Sterile Produts)

Renders compound inert or inactive(weekly or spill)

EPA‐Oxidizers:• Sodium hypochlorite (BLEACH)

• Sodium peroxide (H2O2)

Physical Removal of HD Residues to Disposable

(daily or spill)

• Sterile 70% IPA• Sterile Water

• H2O2• BLEACH (followed by

sodium thiosulfate or sterile water)

• Commercial products

Mechanical Removal of Organic and Inorganic Material (daily or spill)

Detergents:Germicidal or

Sporicidal (weekly) and Sterile Water

Destroy Micro‐Organisms (during compounding)

• Sterile 70% IPA• EPA‐registered

product

Adapted from (c) LDT Health Solutions Inc. 65

Certification & Monitoring

AreaISO

Class/ACPH

Non‐viable Particles 0.5 micron or larger/m3

air (q6 mo)

Viable Sampling Action Level

Environmental:Air cfu/m3

(initial,interruption,

q 6mo)

Environmental(& practices):

Surfacecfu/plate(periodic)

Personnel:Fingertip (GFS)

cfu/plate & media‐fill(MFT), (annual/semi, after initial 3 consecutive w/

zero cfu/plate)

DCA 5 < 3,520 1 3 3

Buffer 7/30 < 352,000 10 5 na

Ante 8/20 < 3,520,000 100 100 na

• Know what to do with results i.e. alter operations, shut down , re‐test etc.• Proposed 797

• viable frequency to q3 mo, monthly and quarterly, respectively • ANY failed personnel monitoring repeated 3x prior to compounding 66



• Independent double checks of components• <800>

• Non‐sterile HDs• Monoclonal antibodies• Environmental Monitoring• Medical Surveillance• BCG

• <797> (proposed)• Master formulation and compounding records• In‐Use Time (new)• Urgent‐Use• Hand dryers?• Cell phones, ear buds, glasses, etc

“Other” Practice Issues

67

Chapters USP <797> <800> ‐ www.usp.org

Controlled Environmental Testing Association (CETA) –www.CETAinternational.org

CriticalPoint, LLC – Sterile Compounding Boot Camp, Hands‐On Training for Practical Compliance with USP <797>

LDT Health Solutions Inc.

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings http://www.cdc.gov/niosh/docs/2016‐161/pdfs/2016‐161.pdf

References

68



69

71

Jerry H. Reed, MS, RPh, FASCP, FASHP

Senior Director, Pharmacy Services

Community Health Systems

Update on Current Pharmacy Initiatives and Strategies



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