General Chapter <800> Open Microphone Web Meeting NOTICE TO PARTICIPANTS: To minimize background noise, all lines will be muted upon joining the session. During the meeting, you may ask questions or make comments at any time by posting through the WebEx Q&A process. Access this feature through the Q&A tab at the top of the right hand column of your WebEx view page (the? symbol) Use the text box at the bottom of the right hand column to enter your question or comment In the ASK dropdown, select All Panelists Send your question to the Panelists. Questions and comments will be collated for the Q&A portion of the WebEx.
General Chapter <800> Open Microphone Web Meeting NOTICE TO PARTICIPANTS: Please note this session is currently being recorded and will be made available on USP s website at http://www.usp.org/uspnf/notices/compounding-notice.
USP General Chapter <800> Hazardous Drugs Handling in Healthcare Settings Open Microphone Meeting June 12, 2014 2:00 p.m. to 4:00 p.m. EDT
Agenda Welcome Overview of U.S. Pharmacopeial Convention Introductions Background on Proposed General Chapter <800> Hazardous Drugs Handling in Healthcare Settings Next Steps Q&A Session 4
5 Overview of the U.S. Pharmacopeial Convention
About USP Scientific non-profit organization that sets standards for the identify, strength, quality, and purity of medicines, food ingredients, and dietary supplements USP s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries USP Headquarters Rockville, MD 6
Council of Experts 7
Compounding Expert Committee Chair: Gigi S. Davidson, B.S.Pharm., DICVP Vice Chair: Lisa D. Ashworth, R.Ph. Gus S. Bassani, Pharm.D. Linda F. McElhiney, Pharm.D. Edmund J. Elder, Jr., Ph.D. William A. Mixon, M.S. Maria do Carmo M. Garcez, B.S.Pharm. Deborah R. Houston, Pharm.D. Patricia C. Kienle, M.P.A. Keisha D. Lovoi, B.S.Pharm. David W. Newton, Ph.D. Alan F. Parr, Pharm.D., Ph.D. Regina F. Peacock, Ph.D. Robert P. Shrewsbury, Ph.D. Keith St. John, M.S. 8
Compounding with Hazardous Drugs Expert Panel Chair: Patricia C. Kienle, RPh, M.P.A. Thomas H. Connor, Ph.D. Eric Kastango, B.S.Pharm., M.B.A., Melissa A. McDiarmid, M.D., M.P.H. Kenneth R. Mead, Ph.D. Martha Polovich, R.N., Ph.D. Lucille A. Power, B.S.Pharm., M.S., RPh James T. Wagner 9
USP Healthcare Quality Standards Staff Shawn Becker, M.S., B.S.N. Senior Director - Healthcare Quality Standards SCB@usp.org Rick Schnatz, Pharm.D. Manager - Compounding and Healthcare Standards RXS@usp.org Jeanne Sun, Pharm.D. Associate Scientific Liaison JHS@usp.org Emily Ann Meyer, J.D. Expert Committee Manager EAM@usp.org 10
Background on Proposed General Chapter <800> Hazardous Drugs Handling in Healthcare Settings 11
Pharmacopeial Forum (PF) Proposed General Chapter <800> is posted online at https://www.usp.org/usp-nf/notices/compounding-notice Submit comments with corresponding line numbers Email comments to CompoundingSL@usp.org Comments due July 31 st, 2014 12
Background Objective To protect personnel and the environment when handling hazardous drugs (HDs) Purpose To define processes intended to provide containment of hazardous drugs to as low as reasonably achievable Address all processes involving HDs and all personnel who handle HDs HDS shall be compounded in proper engineering controls, as defined in the chapter 13
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) 14
Existing References Chapter builds on the standards existing in compounding chapters Adds in the elements of containment of hazardous drugs (HDs) Existing references OSHA Standards NIOSH Alert ASHP Guidelines on Handling Hazardous Drugs ONS Publication Incorporates principles of medication safety and worker protection 15
List of HDs Chapter references NIOSH list Drugs considered hazardous include those that exhibit one or more of the following characteristics: Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria http://www.cdc.gov/niosh/docs/ 2012-150/pdfs/2012-150.pdf 16
Scope Chapter addresses, but is not limited to the: Receiving Storing Mixing Preparing Compounding (sterile and nonsterile) Dispensing Administering Disposing Manipulating (altering, counting, crushing, pouring) Standards apply to all healthcare settings where HDS are prepared including: Pharmacies Hospitals and other healthcare institutions Patient treatment clinics Physician s practice facilities Veterinarians offices 17
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 C-SEC Spill kits shall be accessible in the receiving area 18
Storing Facility Designs HDs shall be separate from storage of non-hds Storage of non-antineoplastic HDs shall be separate from storage of non-hds, unless only coated, finalmanufactured dosage forms are clearly labeled as HDs and safety strategies are included in the entity s SOPs HDs shall not be stored, unpacked, compounded, or otherwise manipulated in an area that is positive pressure relative to the surrounding areas. 19
Manipulation Facility Nonsterile powder hood Sterile as listed in USP <797> Elimination of low use exemption Compounding Includes repackaging 20
Compounding Work practices include: Using requirements listed in <795> and <797> Avoiding use of bulk active pharmaceutical ingredients when possible Use appropriate Containment Primary Engineering Control (C-PEC) Ensuring processes for labeling the compound do not introduce contamination in non-hd areas Compounding area should be properly cleaned after compounding activities 21
Dispensing Dispensing HD dosage forms not requiring alteration For unit-dose or unit-of-use packaging, no further requirements for containment* For transfer of non-antineoplastic HDs to prescription containers, no further requirements for containment* Counting of HDs Dedicated equipment No automated counting or filling machines *unless otherwise required by manufacturer 22
Facilities Containment Primary Engineering Control Externally vented Placed in a restricted access segregated room Containment Secondary Engineering Control Minimum negative pressure of 0.01-inches of water column Sink for hand washing and eyewash station 23
Administering Work practices include: Use protective medical devices and techniques Use Closed System Drug-Transfer Devices (CSTDs) when the dosage form allows Wear Personal Protective Equipment (PPE) Provide safety training for all staff members Minimize risk of open systems when administering through unusual routes or in non-traditional locations 24
Pharmacopeial Forum (PF) Proposed General Chapter <800> is posted online at https://www.usp.org/usp-nf/notices/compounding-notice Submit comments with corresponding line numbers Email comments to CompoundingSL@usp.org Comments due July 31 st, 2014 25
Timeline and Next Steps Date March 28, 2014 March 28 July 31, 2014 June 12 th, 2014 Early August through October Activity General Chapter <800> Proposed for Public Comment Public Comment Period Open Microphone Web Meeting Hazardous Drug Expert Panel and Subcommittee Reviews ALL comments submitted Next steps Subcommittee and Expert Panel will review all comments submitted Comments will be addressed through commentary posted online Dependent on comments, the chapter may be revised, posted again for further comments, or balloted by the Expert Committee 26
Open Microphone Q&A Session 27
General Chapter <800> Open Microphone Web Meeting NOTICE TO PARTICIPANTS: You may ask questions or make comments by posting through the WebEx Q&A process. Access this feature through the Q&A tab at the top of the right hand column of your WebEx view page (the? symbol) Use the text box at the bottom of the right hand column to enter your question or comment In the ASK dropdown, select All Panelists Send your question to the Panelists. After the web meeting, participants are encouraged to submit written comments to CompoundingSL@usp.org.