Bill Mixon, RPh, MS Senior Associate Gates Healthcare Associates

Transcription

1 Bill Mixon, RPh, MS Senior Associate Gates Healthcare Associates

2 14 pharmacists and 1 epidemiologist make up the committee USP staff FDA and CDC representatives have input but do not vote Call for Candidates for the cycle Deadline for membership applications to the Expert Committee Members are elected in June and begin their work July 1 st. Face to face meetings typically occur twice a year at the USP Headquarters in Rockville, MD

3 PF is an online journal in which USP publishes revisions to USP NF for public review and comment. Free, online-only resource Published every 2 months One-time registration is required to access PF

4 General Chapter <800> is posted online at Submit comments with corresponding line numbers comments to Comments due July 31 st, 2014

5 Chapter 800 adds to compounding standards by: Incorporating information contained in USP <795> and <797> and builds on it Clearly makes OSHA standards a priority Is written to protect the health care worker and the environment we work in Adds the element of containment of Hazardous Drugs The philosophy of the chapter is THERE IS NO ACCEPTABLE LEVEL OF EXPOSURE TO HAZARDOUS DRUGS Exposure should be limited to the lowest possible level by using engineering controls and personal protective equipment

6 NIOSH ALERT: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings ASHP Guidelines on Handling Hazardous Drugs Workplace Solutions: Personal Protective Equipment for Health Care Workers (CDC) Oncology Nursing Society: Safe Handling of Hazardous Drugs

7 List of Hazardous Drugs Types of Exposure Responsibilities of Personnel Handling Hazardous Drugs Facility Design and Engineering Controls Personal Protective Equipment Hazard Communication Program Training for Compounding Personnel

8 Receiving Transporting Dispensing HD Dosage Forms Not Requiring Alteration Compounding HD Dosage Forms Protection When Administering HDs Disinfection Spill Control Disposal Environmental Quality and Control Documentation Medical Surveillance Cleaning: Deactivation, Decontamination, Cleaning, and

9 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 non-sterile 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

10 A comprehensive approach to prevent worker and environmental exposure Engineering controls (including primary, secondary and supplemental) Compounding Supervisor who is knowledgeable about the standards Competent personnel Robust work practices Availability of appropriate Personal Protective Equipment (PPE) Medical surveillance program

11 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 Must be knowledgeable about the standards

12 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

13 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 (coated tablets, capsules) What about uncoated tablet forms of NIOSH Listed drugs?

14 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 (i.e. glove box) shall not be used for the compounding of a HD HD s must be received, unpacked and stored in a designated receiving area that has restricted access. HDs should be received from the supplier sealed in impervious plastic to segregate them from other drugs, to allow for safety in the receiving and internal transfer process, and should be immediately delivered to the C-SEC.

15 Storage of antineoplastic HDs shall be separate from storage of non-hds Requires a separate Refrigerator in negative pressure room Storage of non-antineoplastic HDs shall be separate from storage of 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.

16 Containment Primary Engineering Control (C-PEC) Externally vented Containment Secondary Engineering Control Separate room Externally vented Negative pressure Appropriate air changes per hour

17 Containment Ventilated Enclosure (CVE) Class I Biological Safety Cabinet (BSC) Class II BSCs or Compounding Aseptic Containment Isolators (CACIs) may be used for non-sterile compounding if they are dedicated for non-sterile compounding If they are used for occasional non-sterile compounding, Class II BSCs or CACIs must undergo thorough cleaning and disinfection before being using for sterile compounding

18 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 non-sterile compounding can be placed in a room that does not need to be ISO 7 nor have HEPA-filtered air C-PEC Negative

19 Class II Biological Safety Cabinet Compounding Aseptic Containment Isolator - (CACI)

20 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 (CACI) in a non-negative pressure room All hazardous drug compounding shall be done in a separate area designated for hazardous drug compounding

21 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

22 Function C-PEC C-SEC ACPH (Airflow) BUD Compounding sterile HD in a cleanroom BSC or CACI ISO 7 Cleanroom 30 ACPH HEPA filtered Per <797> Compounding sterile HD in a CACI that meets the requirements listed in <797> CACI C-SCA 12 ACPH exhausted outside Per <797> Compounding low- or medium- risk sterile HDs in a BSC BSC C-SCA 12 ACPH exhausted outside Per <797>

23 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.

24 For entities that compound both non-sterile and sterile HDs, the respective Containment Primary Engineering Controls (C-PEC) shall be placed in segregated rooms separate from each other, unless those C-PECs used for non-sterile compounding are sufficiently effective that the room can continuously maintain ISO 7 classification throughout the non-sterile compounding activity. Non-Hazardous Compounds packaged & must be labeled as Hazardous

25 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

26 Gloves ASTM-tested chemotherapy gloves Sterile gloves for sterile HD CSPs Gowns (Impervious) Head, hair, and sleeve covers Eye and face protection Respiratory protection

27 Hazard Communication Program For All personnel who handle HDs Requirements for compounding personnel in <795> and <797>

28 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.

29 If the entity s SOPs permit, non-antineoplastic HDs that require only transfer from the manufacturer s package to a prescription container may be dispensed without any further requirements for containment unless required by the manufacturer Counting of HDs should be done carefully, and clean equipment should be dedicated for use with these drugs Compounding with HD s requires primary and secondary engineering controls as described in the chapter.

30 Deactivation: Chemical process that renders chemical harmless Decontamination: Reduces microbial burden Cleaning HD areas includes Deactivation, Decontamination, & Disinfection Personnel performing cleaning activities (including compounding, direct care, environmental services, laundry, waste handling, and others) shall be protected from inadvertent exposure to HDs. 2 pr ASTM tested chemo gloves Eye protection Face shields if there is a splash hazard Other PPE as required

31 Spills shall be contained and cleaned immediately by trained workers. Signs shall be available to restrict access to the spill area. Only trained workers with appropriate PPE shall manage an HD spill. All workers who may be required to clean up a spill of HDs shall receive proper training in spill management and in the use of PPE and NIOSH901 certified respirators (see 6. Personal Protective Equipment). Policies and procedures shall be developed to prevent spills and to govern clean-up of HD spills. Written procedures shall specify who is responsible for spill management and shall address the size and scope of the spill.

32 Environmental quality and control Documentation Medical surveillance

33 General Chapter <800> is posted online at Submit comments with corresponding line numbers to Comments due July 31 st, 2014

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