Sterile Products and Aseptic Techniques for the Pharmacy

Sterile Products and Aseptic Techniques for the Pharmacy Technician CHAPTER 8 Chemotherapy Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cancer Overview • DNA is damaged & cells grow out of control • Most cancers produce tumors • Cancers behave differently, grow at different rates • Treatment is specific to cancer type • Early detection, treatment = better survival chances Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cancer Overview (cont’d) • Treatment includes – Surgical removal of tumor – Chemotherapy – Radiation Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cancer Overview (cont’d) • Viruses linked to cancer – Epstein-Barr virus – HIV – HPV • Chemotherapy also used to treat – Rheumatoid arthritis – Lupus – Psoriasis – Autoimmune diseases Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cytotoxic Agents • Also known as antineoplastics • Used to treat patients with various forms of cancer • Specific drugs indicated for specific tumors/cells • Extremely toxic to cells • Drugs can’t distinguish between healthy & sick cells Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cytotoxic Agents (cont’d) • Many side effects (hair loss, etc. ) • Two main types – Cycle-phase nonspecific – Cycle-phase specific Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Risk-Related Characteristics of Chemotherapy Agents • • Mutagenic: can cause cells to mutate Carcinogenic: can cause cancer Teratogenic: can cause birth defects Immunosuppressive: lowers immunity Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Biological Safety Cabinets • Vertical airflow, top to bottom • Protects personnel, product, & environment • ISO Class 5 environment Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Biological Safety Cabinets (cont’d) • Classes – Class I: protects personnel & environment only – Class II: protects personnel, product, & environment – Class III: provides maximum protection Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Compounding Aseptic Isolator • Glove box isolator: a contained unit • Restricts movement of contaminants • Operator slips hands into long glovelike parts • Highly favored by USP 797 for multitasking • Requires less space, has monitoring controls Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Proper Use of the BSC Keep insides & tops clear Turn off all UV lights when lab is occupied Wash hands & arms with germicidal soap Wear long-sleeved gown & gloves Don’t eat, drink, apply makeup, smoke in lab • Dispose of sharps appropriately • Clean up spills immediately • • • Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Proper Use of the BSC (cont’d) • Dispose of all waste in biohazard containers • Disinfect surfaces with sterile water & alcohol Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Preparing to Use the Hood • Turn off UV light upon entering room • Check flow alarm system audio & visual • Decontaminate surfaces & wait 10 min Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cleaning and Decontaminating the BSC • Dress in usual garb + chemo-specific gown • Wash hands & put on chemo & sterile gloves • Clean bar at top of hood • Clean back panel of hood • Clean side panels • Clean work surface area Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Cleaning and Decontaminating the BSC (cont’d) • With blower on, scrub from top to bottom • Repeat steps 3 -7 using 70% IPA • Leave moveable parts in hood Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Shutting Down the BSC • • Decontaminate all items in interior area Turn on UV light Allow 5 min of operation to purge system Turn off BSC blower, if it is facility’s procedure Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Personnel Training • Competency should be assessed – Annually (at least) – Any time employee is not following protocol Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Personnel Training (cont’d) • Training program – Should include certification course – Recertification required regularly (yearly) – Trainer: several years experience with chemo – Should cover chemo procurement, storage, safe handling procedures, prep & waste guidelines Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Attire Guidelines • Low-permeability, solid-front gown with ties in back • Disposable, high-cuff, latex chemo/nitrile gloves • Thickest gloves allowed by workplace • 2 pairs of thinner gloves under outer gloves Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Attire Guidelines (cont’d) • Disposable lab coat, closed & with sleeves tucked into gloves • Don’t wear lab coat outside the lab • Eye protection (goggles) Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Withdrawing a Cytotoxic Agent 1. 2. 3. 4. Gather all materials Don’t block airflow Swab rubber top with alcohol Use only Luer-lock syringe; make sure it’s tight 5. Pull plunger back halfway from what is needed 6. Remove cap from needle & insert needle Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Withdrawing a Cytotoxic Agent (cont’d) 7. Add air to vial, then withdraw drug 8. Remove needle, remove air bubbles 9. Recap syringe 10. Perform final check Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Handling Hazardous Drugs • Ensure syringes/IV sets have Luer-to-Luer connection • Don’t fill syringe >3/4 full • Use venting devices with – 0. 2 micron hydrophobic filters – 5 micron filter needles/straws • Dispense final products ready to administer Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Handling Hazardous Drugs (cont’d) • Wipe outsides of containers, IV sets, IV ports • Label final products; put in zip-lock container Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Pha. Seal • Closed system • Reduces/eliminates human exposure to chemo • Set of disposable containment devices • Used in drug mixing & administering • Connect original drug vial, syringe & IV set • Sealed pathway Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Pha. Seal (cont’d) • Has double membrane to prevent drug leakage • Expansion chamber equalizes pressure in system Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Disposal of Cytotoxic Medications • Use yellow, puncture-resistant hazardous container • Chemo waste – Discarded gloves – Disposable gowns – Disposable goggles – IV bags/bottles, tubing, needles, syringes Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Disposal of Cytotoxic Medications (cont’d) • Place all cytotoxic waste in sealed zip-lock bag • Don’t clip or cap needles & syringes Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Chemo Spill Kit • Chemical splash goggles • Low-permeability disposable gown & shoe covers • 2 sheets of absorbent, plastic-backed material • 250 m. L & 1 L spill control pillows • Puncture-resistant sharps container • Small scoop to collect glass fragments Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Chemo Spill Kit (cont’d) • 2 large, labeled, sealable hazardous drug waste bags • Appropriate respirator Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Chemo Spill Kit (cont’d) FIGURE 8 -14 Chemotherapy waste container Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

ASHP Guidelines for Safe Handling of Cytotoxic Drugs Limit access Identify & label all hazardous drugs Educate patient & family of precautions Have a written procedure & kit for chemo spills • Design facility to prevent easy spillage, breakage • • Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

ASHP Guidelines for Safe Handling of Cytotoxic Drugs (cont’d) • Have written policies/procedures for chemo prep • Conduct orientations & yearly process validations • Keep MSDS for each hazardous drug accessible • Require employees to wear appropriate apparel Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

A Final Caution • Avoid compounding cytotoxic agents if pregnant • Most cytotoxic drugs target fast-growing cells (ovaries & sperm) • Some chemo drugs are mutagenic, which may increase risk of miscarriages & birth defects • Drug may get out of container & into air Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

A Final Caution (cont’d) • Drug may be inhaled, absorbed, ingested, or accidentally injected • Drug may cause cell damage Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.