Chapter <797>: There Goes the Budget

Brooke L. Richards, CphT Pharmacy Business Specialist H.D Goodall Hospital Sanford, Maine

Program Objectives

 Outline variables to consider in achieving optimal compliance to USP 797 regulations  Discuss the Pharmacy Buyer’s role in the financial considerations of compliance to USP 797

What is the United States Pharmacopeia?

 Non-Profit public health organization founded in 1820  Created a system of standards, quality control, and a national formulary  First version of USP text published in 1830 with revisions every 10 years, then ever 5 years in 1942, and now annually as of 2002

 Became a state board requirement  when state boards formed in 1880 1890’s In early 1900’s recognized by Federal Food and Drug Act as official standards  USP standards can be used as evidence of national standards in law suits

What is USP Chapter <797>?

 The first set of enforceable standards for compounding sterile products.  Enforceable by FDA and state boards of  pharmacy Liability lawyers can and will use these standards in cases

 The Joint Commission for Accreditation of Healthcare Organizations adopted the standards from USP as guidelines, but not requirements for accreditation  Initially published in the United States Pharmacopeia in 2004.

 Revised in 2008  Currently under review for further revision

 Details procedures, training, and quality assurance measures for all healthcare facilities in which sterile products are compounded  Requirement for all healthcare professionals including pharmacists, pharmacy technicians, physicians, and nurses who prepare sterile products

What are some of the specific standards set forth in Chapter <797>?

 Objective is prevent harm to patients in regards to Compounded Sterile Preparations (CSP’s)

 Acknowledges that direct or physical contact with critical sites poses greatest risk for CSP contamination  Education, aseptic technique, and compliance to polices are keys to preventing patient harm

Risk Categories

 Defines risk categories for the preparation and beyond use dating of CSP’s  Risk categories include Immediate use, Low with 12-hour or less BUD (Beyond use date), Low, Medium, and High risk

Immediate Use CSP

Immediate-use CSPs are exempt from the requirements described for low-risk level CSPs only when all of the following criteria are met:  Exempt from all requirements in <797>    Only simple aseptic measuring and transfer are needed Not more than three manipulations and no hazardous drugs No delays/interruptions

Immediate Use CSP

     No contact contamination of ingredients or critical sites Dose must be labeled if not administered by the preparer Administration must begin within one hour after the start of preparation Dose must be discarded if administration has not begun within one hour after the start of preparation (No storing. No recycling.) Examples: Ambulance, ER, Bedside *Pharmacy Purchasing & Products April 2011 - Vol. 8 No. 4 - Page #10

Low-risk CSP

    Aseptic technique in an ISO Class 5 environment 3 or fewer sterile manipulations utilized Not more than 2 entries into any one container Beyond use dating of 48 hours controlled room temperature, 14 days refrigerated, 45 days frozen

Low-risk with 12 hour or less BUD

     Administration must begin within 12 hours unless stated less by package insert Compounded in a non USP complaint clean room or self-contained isolator No hazardous drugs All cleansing and garbing requirements apply Primarily follows low risk level requirements

Medium Risk CSP

     Complex aseptic technique in ISO Class 5 environment More than 3 sterile manipulations utilized Greater than 3 entries into containers Pooling of sterile products to prepare multiple CSP’s Beyond use dating of 30 hours room temperature, 9 days refrigerated, 45 days frozen

High risk CSP

    Complex aseptic manipulations in ISO Class 5 environment Use of non-sterile ingredient and/or non sterile device Final sterilization by filtration, steam, or dry heat In the absence of passing sterility, beyond use dating of 24 hours room temperature, 3 days refrigerated, and 45 days frozen

Beyond Use Dating

   

Important to note

Beyond use dates are based on sterility and not stability When drug stability differs from sterility use whichever is shorter Example is Phenytoin Requires 4 hour dating due to drug

stability

 Outlines the responsibilities of personnel involved including their training and documentation procedures when compounding  Defines the facility design of the clean room and ante room as well as the cleaning procedures for these areas

Personnel Responsibilities

 Aseptic hand washing

Personnel Responsibilities

     Proper garbing Proper aseptic technique Proper cleaning of IV hoods and IV rooms Adherence to policies Correct documentation

Personnel Responsibilities

  Didactic training, written exam, media fill testing, and surface sampling Media fill tests done annually for low to medium risk and semi-annually for high risk facilities

Facility Design

 Optimal design depends on risk level Low, Medium, High risk Low with 12 hour Beyond use dating

**Figures 1 & 2 USP Chapter <797> Revised 2008**

Facility Design

      Optimal design also includes: HEPA filtration Proper temperature Proper room pressure Humidity Controlled Smooth non-porous floors, ceilings, and work surfaces

Cleaning and Disinfecting

     

ISO Class 5 environment

Beginning of each shift Start of each batch At least every 30 minutes Whenever contamination is either known or suspected Use of sterile water to remove residue followed by residue-free disinfecting agent e.g. sterile 70% alcohol

Cleaning and Disinfecting

  

ISO Class 7 and 8 areas

Floors, counters, and work surfaces cleaned daily Walls, ceilings, and shelving cleaned monthly

Steps to achieving optimal compliance

 Learn it!  Know it!  Train yourself and your staff! 

You can not see where to go without knowing where you are already

.

 Become familiar with your state’s regulations regarding <797>. Not all states are the same therefore it is important to know how your state’s board of pharmacy is “enforcing” the standards

797 Survey Compliance Results

  Conducted by Clinical IQ, LLC Consulting company; Eric Kastango, RPh and Peter Cantor Covers U.S Boards of pharmacy, Sterile Compounding Laws, Regulations, and CE Requirements

   Examples of states with direct 797 requirements are Texas and Florida States with indirect 797 (not 797, but other compliance requirements for sterile compounding) are Maine and Nevada Michigan and Connecticut are examples of places with no reference to 797 

http://clinicaliq.com/text-version

Where to begin?

    Define your facilities risk category Perform a gap analysis- Can be found online, Helps show areas which are not in full compliance with <797> Form committees with members of Pharmacy, Risk Management, and Infection Control Meet with facility management: How far from the defined ante and clean room is your existing space? Is there a way to get there without a complete renovation?



Policy & Procedures

 Update facilities polices and procedures on sterile product preparation to coincide with that of <797>



Document!

 Hand written or computerized, documentation of facility cleaning, personnel training and competency, certification of IV hoods, clean room monitoring, and CSP preparation is a major key to compliance.

What is the buyer’s role in <797> compliance?

Cost Analysis



CSP preparation

 Define risk level  Utilizing pre made IV bags Versus technician batch preparation  Examples: Galaxy, Duplex, Mini-Bag Plus, or, Advantage

Cost Analysis



Outsourcing

 Define risk level  Purchasing from facilities dedicated to higher risk preparations  High cost of end product sterilization and testing for High Risk CSP’s  Examples: PCA syringes, TPN bags, epidurals

Cost Analysis

     

Cleaning supplies

Non-shedding wipes Sterile Alcohol (bottles, prep pads) Alternate disinfecting products Mops Tacky mats

Cost Analysis

  

Personal Protective Equipment Etc

Waterless alcohol-based surgical hand cleanser Garbing supplies: gloves, gowns, masks, shoe covers, and hair covers

Cost Analysis

       

Environmental Monitoring

Define risk level Media fill testing kits Surface Sampling Temperature/humidity monitoring Room Pressure monitoring Air sampling Endotoxin and pyrogen testing

Cost Analysis

    

Room Design

Open room Closed room Use of an isolator hood Design affects cleaning, maintenance, and usage costs

Staff Education

 

Essential to patient care

Creating the “perfect” clean room environment means nothing if staff does not know proper aseptic technique, cleaning procedures, and documentation

Staff Education

     Improperly made CSP’s are to be discarded $$$ Multiple doses vials that are not dated are to be discarded $$$ Misuse of cleaning products $$$ Media fill testing/Surface Sampling (retesting upon failed test) $$$ Misdated/Mislabeled/Improperly stored CSP’s $$$

Summary

    Chapter <797> is here to stay Enforceable!!

Staff education has a huge affect on compliance Pharmacy Buyers/Purchasers can have a tremendous impact on the financial side of compliance

References

             United States Pharmacopeia Chapter <797>, Copyright 2008 USP Chapter <797> Update on Recent Revisions, Claudia C. Okeke, Ph.D. R.PH, NABP Annual Meeting May 20, 2008 http://www.ivinsights.com/cost-effective-usp-compliance.php

The ASHP Discussion Guide on USP Chapter <797> for Compounding Sterile Preparations www.ashp.org

:ASHP Compounding Resource Center: Q & A with Clyde Buchanan http://www.usp.org

www.baxa.com

: Overview of USP General Chapter 797 Pharmaceutical Compounding Sterile Preparations http://www.jcrinc.com

:Joint Commission Resources: Compliance with New USP-NF Chapter on Compounding Sterile Preparations http://www.pppmag.com

MBA, RPh, FASHP : USP <797>: The First Step to Compliance By Eric S. Kastango, www.pharmacyonesource.com

Simplifi797 http://www.pppmag.com

: The Top 10 Gaps in USP Chapter <797> Compliance www.eclydebuchanan.com

http://www.clinicaliq.com

: 797 State compliance survey results