USP <800> Readiness and Planning Nick Hopkins, PharmD Discuss - PDF document

9/22/2016 Objectives • Review the standards established by USP Chapter <800>, Hazardous Drugs—Handling in Healthcare Settings USP <800> Readiness and Planning Nick Hopkins, PharmD • Discuss the pharmacy’s role in providing safe work Mona Benrashid, PharmD, BCOP environments for personnel Vanderbilt University Medical Center • Identify common gaps in meeting the standards How confident do you feel in your What has your institution done to start understanding of USP 800? preparing for USP 800? No clue Physical Process Training? Changes? Changes? Eh, kinda sorta I got this Exposure to Hazardous Drugs (HDs) are Associated with Adverse Health Outcomes Acute symptoms Why have these guidelines been put in to place? Organ toxicity Reproductive risks Malignancies U.S. Pharmacopeial Convention. Briefing. <800> Hazardous Drugs ‐ Handling in Healthcare Settings, PF 40(3). http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pr e ‐ post.pdf 1

9/22/2016 1999 Investigation of Pregnancy Loss Associated with Exposure to Antineoplastic Drugs To Whom Does <800> Apply? *7,094 pregnancies of pharmacy and nursing staff • All healthcare personnel who handle HD preparations Outcomes Definitions and all entities that store, prepare, transport, or Miscarriage Failed pregnancy in first 20 weeks administer HDs Stillbirth Failed pregnancy after 20 weeks’ gestation ▫ Hospitals Elective abortion Per respondent report ▫ Physician practices Enforceable by Boards of Live birth Either single or multiple live births Pharmacy, The Joint ▫ Retail pharmacies Commission, CMS, and all ▫ Home infusion facilities Exposed mother: Increased risk for miscarriages by 40 ‐ 50% other regulatory boards. Increased risk for low birth weight by 17 ‐ fold ▫ Veterinarian practices Increased risk for congenital malformations by 5 ‐ fold ▫ Government health clinics ▫ Prisons/jails Exposed father: Patterns of increased risk were similar, though not statistically significant ▫ Emergent care clinics Valanis B; Vollmer WM; Steele P. Occupational Exposure to Antineoplastic Agents: Self ‐ Reported Miscarriages and Stillbirths Among Nurses and Pharmacists. J of Occupational and Enviornmental Medicine . 1999; 41(8)632 ‐ 8 USP <800> Overview Important USP Terminology • Hazardous drug list • Procurement/receiving Must • Designated expert • Compounding • Education and training • Labeling and packaging • “Be commanded or requested to” • Documentation and standard • Transport • Disposal operating procedures (SOPs) Should • Facilities design • Administration • “To express a request in a polite manner” • Environmental design • Deactivation, decontamination, • Environmental quality and cleaning and disinfecting Antineoplastic control • Medical surveillance • Personal Protective Equipment • Inhibiting or preventing the growth and spread of (PPE) neoplasms or malignant cells • Refer to Table 1 of NIOSH Hazardous List High ‐ Level Oversight Requirements Facilities Design • Hazardous drug list • Receiving and Unpacking ▫ NIOSH ▫ MUST be unpacked in an area that is neutral/normal ▫ Annual review pressure  Should be reviewed whenever a new agent or dosage form is used ▫ MUST not be unpacked from external shipping ▫ Assessment of risk (reviewed annually) containers in sterile compounding areas or in positive • Designated expert pressure areas ▫ Development and implementation procedures ▫ Oversight of compliance ▫ Oversight of monitoring the facility and maintenance of reports, testing/sampling, and action on results • Policies and SOPs • Education and Training 2

9/22/2016 Facilities Design Facilities Design • Compounding • Storage ▫ Sterile and nonsterile HDs MUST be compounded ▫ Prevent spillage or breakage in case the container falls within a containment primary engineering control (C ‐ ▫ Do NOT store on floor PEC) located in a containment secondary engineering ▫ Precautions for natural disasters control (C ‐ SEC) ▫ Antineoplastic HDs that require manipulation other  C ‐ SEC (room) MUST than counting/repackaging final dosage forms:  Be externally vented  Be physically separated  Store separate from non ‐ HDs  Have an appropriate air exchange  Negative ‐ pressure room, externally ventilated  Have a negative pressure between 0.01 and 0.03 inches of  Refrigerated antineoplastic HDs: dedicated refrigerator water column in a negative ‐ pressure area Personal Protective Equipment (PPE) Facilities Design When Required What’s Required • Nonsterile compounding required to be performed Sterile AND Non ‐ sterile compounding Gown (to be changed every 2 ‐ 3 hrs, or as stated by manufacturer) Head/hair cover Two pairs shoe covers in a C ‐ PEC unless handling only final dose forms that Two pairs chemo gloves (changed at least every 30 min) do not produce particles, aerosols or gases Administration of antineoplastics Two pairs chemo gloves ***Other PPE as defined by standards other than USP Handling ALL HDs (receiving, unpacking, Chemo gloves checking, etc.) • Sterile compounding requirements: Risk of spills or splashes when working Goggles and/or face shield ▫ All <797> requirements outside of a C ‐ PEC (e.g. surgery, cleaning spills) ▫ MUST not use LAFW and MUST not compound non ‐ ‐ Cleaning large spills Full ‐ face piece, chemical cartridge ‐ type respirator or powdered air ‐ ‐ Deactivating, decontaminating and purifying respirator (PAPR) HDs in hazardous C ‐ PEC unless the prep is placed in cleaning underneath the work surface of (N ‐ 95 NOT sufficient) the C ‐ PEC wrapper and labeled (as hazardous) to require PPE ‐ There is known or suspected airborne exposure to powders or vapors Compounding/Dispensing Labeling and Packaging • Chemo mats SHOULD be used • MUST have SOPs in place that address prevention of • Not only STERILE compounding accidental exposures or spills ▫ Closed System Transfer Devices (CSTDs) listed as an ▫ Dedicated equipment (counting trays, spatulas, example of an exposure ‐ reducing strategy (SHOULD??) mortals & pestles) MUST be used • MUST be clearly labeled at all times ▫ Equipment SHOULD be decontaminated after every • MUST have SOPs in place that describe appropriate use ▫ Tablets and capsules MUST not be placed in shipping containers and insulating materials automated counting or packaging machines 3

9/22/2016 Administration – Beyond the Walls of the Transport and Disposal Pharmacy • HDs MUST be administered safely using protective medical devices and techniques. MUST be labeled, stored and handled in accordance with federal, state and local regulations ▫ Examples of protective medical devices include:  Needleless and closed systems Containers MUST minimize risk of breakage/leakage ▫ Examples of protective techniques include:  Spiking or priming IV tubing with non ‐ HD solution in a C ‐ Pneumatic tubes MUST not be used to transport any liquid HDs or any PEC antineoplastic HDs  Crushing tablets in a plastic pouch • “Appropriate” PPE MUST be worn Personnel who perform custodial waste removal and cleaning MUST be trained to protect themselves and the environment to prevent contamination • CSTDs MUST be used for administration of antineoplastic HDs when dosage form allows Deactivation and Decontamination Deactivation and Decontamination Step Purpose Example Agents • Deactivation ▫ No one proven method to deactivate all compounds Deactivation Render compound Listed on labeling or other agents which ▫ Ultimate goal is complete surface decontamination inert or inactive may incorporate EPA ‐ registered • Decontamination oxidizers (e.g., peroxide formulations, bleach, etc.) ▫ Work surface of C ‐ PEC MUST be decontaminated between compounding of different HDs Decontamination Remove HD residue Validated for HD decontamination ▫ C ‐ PEC MUST be decontaminated at least daily, any time a spill and transfer to including alcohol, water, peroxide, and absorbent, bleach occurs, before and after certification, any time voluntary disposable materials interruption occurs, and if the ventilation tool is moved Cleaning Remove organic or Germicidal detergent ▫ Under the work tray of C ‐ PEC MUST be decontaminated and inorganic material cleaned at least monthly.  Environmental wipe sampling SHOULD be performed at least every 6 Disinfection (for Destroy EPA ‐ registered disinfectant and/or months sterile manipulation) microorganisms sterile alcohol Medical Surveillance Summary • USP <800> sets guidelines to protect patients, Purpose is to minimize adverse health effects by utilizing assessment and documentation of symptom complaints, physical findings, and lab values, personnel and the environment from hazardous drug looking for deviation from expected norms contamination Potentially valuable early detection tool • Proper planning prevents poor performance! Is a SHOULD • Anticipate guidelines to go into effect July 1, 2018 Lists guidance for development of a program and actions for follow up (both on the level of the employee and the entity) 4

9/22/2016 How confident do you feel in your understanding of USP 800? No clue Eh, kinda sorta I got this USP <800> Readiness and Planning Nick Hopkins, PharmD Mona Benrashid, PharmD, BCOP Vanderbilt University Medical Center 5