USP 800: Now What Do We Have To Do?!

Transcription

1 SCSHP 2014 Fall Meeting USP 800: Now What Do We Have To Do?! Natasha Nicol, Pharm D, FASHP Director, Medication Safety Cardinal Health Objectives Explain the reasoning behind USP 800 and how it expands the requirements of USP 797. List the criteria for a containment segregated compounding area as required in USP 800. Detail where chemotherapy drugs must be stored. Describe when closed system transfer devices are to be used. Disclosure I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation Pharmacopeial Forum PF is the bimonthly online journal in which USP publishes proposed revisions to USP NF for public review and comment. Free, onlineonly resource One time registration is required to access PF nf/pharmacopeial forum General Chapter <800> is posted online at notice The REAL Disclosure I am only the messenger Why (oh why!)? Chapter <800> builds on the standards established by existing compounding chapters <795> Pharmaceutical Compounding Nonsterile Preparations <797> Pharmaceutical Compounding Sterile Preparations Adds in the elements of containment of hazardous drugs (HDs) 1

2 Purpose There is no acceptable level of personnel exposure to HDs The processes listed in this chapter are intended to provide containment of HDs to as low a limit as reasonably achievable (ALARA) HDs shall be compounded in proper engineering controls, as defined in this chapter Chapter Sections, cont Receiving Transporting Dispensing HD Dosage Forms Not Requiring Alteration Compounding HD Dosage Forms Protection When Administering HDs Cleaning: Deactivation, Decontamination, Cleaning, and Disinfection Existing References NIOSH Alert new list came out September 2014: ASHP Guidelines on Handling Hazardous Drugs and the last Spill Control Disposal Environmental Quality and Control Documentation Medical Surveillance Incorporates principles of medication safety and worker protection Chapter Sections: List of Hazardous Drugs Types of Exposure Responsibilities of Personnel Handling Hazardous Drugs Facility Design and Engineering Controls Personal Protective Equipment OSHA Hazard Communication Program Training for Compounding Personnel Objective of USP 800 Protect personnel and the environment Includes, but not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs Includes both nonsterile and sterile products and preparations Standards apply to all personnel who compound HDs preparations and all places where HDs are prepared, stored, transported, and administered 2

3 Entity Requirements Comprehensive approach to prevent worker and environmental exposure Engineering controls (including primary, secondary and supplemental) Competent personnel Robust work practices Availability of appropriate Personal Protective Equipment (PPE) Medical surveillance program Risk Mitigation Not all drugs on the NIOSH list are cytotoxic agents Some dosage forms defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation Compounding Supervisor Designated individual Develops and implements appropriate procedures Oversees facility compliance with this chapter and other applicable laws, regulations, and standards Ensures competency of personnel Assures environmental control of the compounding areas Facility Design Restricted access Unpacking Storage Nonsterile HD compounding Sterile HD compounding Hazardous Drug Any drug identified by at least one of the following six criteria: Carcinogenicity Teratogenicity or developmental toxicity Reproductive toxicity in humans Organ toxicity at low doses in humans or animals Genotoxicity New drugs that mimic existing hazardous drugs in structure or toxicity No Positive Pressure Areas HDs shall not be stored, unpacked, compounded or otherwise manipulated in an area that is positive pressure relative to the surrounding areas A laminar air flow workbench (LAFW) or compounding aseptic isolator (CAI) shall not be used for the compounding of a HD 3

4 Receiving To allow for safety in the receiving and internal transfer process HDs should be received from the supplier sealed in impervious plastic to segregate them from other drugs HDs should be immediately delivered to the Containment Secondary Engineering Control (C SEC) Spill kits shall be accessible in the receiving area Storage Storage of antineoplastic HDs shall be separate from storage of non HDs Refrigerator in negative pressure room Storage of non antineoplastic HDs shall be separate from non HDs unless only coated, final manufactured dosage forms are clearly labeled as HDs, AND safety strategies are included in the entity s policies and procedures Receiving Storage of Injectable and Other HDs HDs shall not be stored, unpacked, compounded, or otherwise manipulated in an area that is positive pressure relative to the surrounding areas This DOES NOT mean that you have to receive all HDs in a negative pressure room not positive means either negative or normal pressure Storage of sterile and nonsterile HDs may be intermingled HD storage in a sterile compounding buffer area shall be limited to those used for sterile compounding Why Not? PEC = Primary Engineering Control PEC Positive Pressure CPEC = Containment Primary Engineering Control CPEC Negative Pressure Dispensing HDs Not Requiring Alteration Unless required by the manufacturer No further requirements for containment for unit dose or unit of use packaging No further requirements for containment for transfer of non antineoplastic HDs to prescription containers Counting of HDs Dedicated equipment No automated counting or filling machines 21 4

5 Containment Requirements Non sterile Compounding Containment Primary Engineering Control (C PEC) This is the thing you re mixing in! Externally vented Containment Secondary Engineering Control (C SEC) Separate room Externally vented Negative pressure Appropriate air changes per hour A C PEC is not required if manipulations are limited to handling of intact final manufactured products (e.g. coated tablets or capsules) that do not produce aerosols or gasses or involve manipulation of powders A C PEC for nonsterile compounding can be placed in a room that does not need to be ISO 7 nor have HEPA filtered air BUT Must be separate room, negative pressure, vented to the outside C PEC for Non Sterile Compounding C PEC for Sterile Compounding Containment Ventilated Enclosure (CVE) Class I Biological Safety Cabinet (BSC) Class II BSCs or Compounding Aseptic Containment Isolators (s) may be used for nonsterile compounding if they are dedicated for nonsterile compounding If they are used for occasional nonsterile compounding, Class II BSCs or s must undergo thorough cleaning and disinfection before being used for sterile compounding Class II BSC Biological Safety Cabinet Compounding Aseptic Containment Isolator Containment Ventilated Enclosure Powder Hood Elimination of Low Volume Exemption Elimination of the current allowance in <797> for facilities that prepare a low volume of hazardous drugs that permits placement of a Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator () in a non negative pressure room All hazardous drug compounding shall be done in a separate area designated for hazardous drug compounding 5

6 Segregated Compounding Area USP <797> currently does not allow a Segregated Compounding Area for HDs Containment Segregated Compounding Area Low and medium risk CSPs C PEC in a separate negative pressure room At least 12 air changes per hour Maximum beyond use time of 12 hours Nonsterile and Sterile HD Compounding For entities that compound both nonsterile and sterile HDs, the respective C-PECs shall be placed in segregated rooms separate from each other, unless those C-PECs used for nonsterile compounding are sufficiently effective that the room can continuously maintain ISO 7 classification throughout the nonsterile compounding activity BSC or CPEC for nonsterile Buffer ISO 7 Negative Ante ISO 7 positive OR CPEC for nonsterile Negative 34 Sterile HD Compounding Supplemental Controls Function C PEC C SEC Airflow Maximum BUD Compounding sterile HD in a cleanroom Compounding sterile HD in a that meets the requirements listed in <797> Compounding low or medium risk sterile HDs in a BSC BSC or BSC ISO 7 Cleanroom C SCA C SCA BSC = Biological Safety Cabinet = Compounding Aseptic Containment Islolator ACPH = Air Changes Per Hour C-SCA = Containment Segregated Compounding Area 30 ACPH (HEPA supply) 12 ACPH (exhaust) 12 ACPH (exhaust) As listed in <797> As listed in <797> 12 hours Closed System Drug Transfer Devices (CSTDs) CSTDs should be used when compounding HDs when the dosage form allows CSTDs shall be used when administering HDs when the dosage form allows EQUASHIELD BD PhaSeal Separate HD and Non HD Compounding Personal Protective Equipment A C PEC used for the preparation of HDs shall not be used for the preparation of a non HD unless the non HD preparation is placed into a protective outer wrapper before removal from the C PEC and is labeled to require PPE handling precautions Gloves ASTM tested chemotherapy gloves Sterile gloves for sterile HD preparations Gowns Impervious Head, hair, and sleeve covers Eye and face protection Respiratory protection 6

7 Personnel Training OSHA Hazard Communication Program All personnel who handle HDs Requirements for compounding personnel in <795> and <797> Monitoring Spill control Disposal Environmental quality and control Documentation Medical surveillance Intact HD Dosage Forms HDs in unit dose or unit of use packaging that do not require any further alteration before delivery to the patient or the patient s caregiver may be dispensed without any further requirements for containment unless required by the manufacturer USP 800 Chapter nf/notices/compounding notice Cleaning Deactivation Decontamination Cleaning Disinfection Next Steps Comment period closed July 31 st, 2014 SCSHP submitted comments May be 6+ months before requirements go into effect It IS coming.whether you like it or not! 7