1. Pharmacy Training Series
Annual
Chemotherapy Certification

2. Section I: Introduction
Research has shown that some chemotherapeutic drugs are potent chemicals that can damage or kill living cells.
In a study of the effect of chemotherapeutic agents on patients, it was found that nurses caring for these patients had evidence of the drugs in their bodies.
While the long term effects of low level exposure to these agents are unknown, continued exposure could pose a serious health threat to persons working with these agents.
Conclusion: It is critical that staff who handle these drugs be informed of risks and thoroughly trained to handle these agents.

3. Summary of Course
To inform health care workers of the risks associated with handling these agents.
To provide health care workers with the knowledge to safely prepare these agents.

4. Who is required to take this course?
All pharmacy personnel who prepare chemotherapeutic agents or are exposed to these agents during job performance.

5. Definitions Aerosolization - suspension of small particles in the air
Carcinogenic - capable of producing cancer
Chemotherapy - term of drugs used to treat cancer
Contamination - presence of chemotherapy drugs in areas other than in designated preparation/administration areas
Exposure - contact with chemotherapeutic drugs
Prime - removal of air by replacing it with drug or soln
Solubility - ease of substance to dissolve in a solution
Sump - drain area located under the chemo hood work area
Vesicant - an agent which causes blistering

6. Section II: Chemotherapy and the Risk of Exposure
Upon completion of this portion of the training you will be able to:
Define the risks associated with acute and long-term exposure to chemotherapy drugs.
Identify four ways exposure may occur on the job.
State three primary ways of reducing exposure.

7. Exposure Risks Associated with Chemotherapy Drugs
Any time chemotherapeutic agents are handled there is a risk of exposure.
Exposure to some chemotherapy agents have been implicated in causing second cancers in patients treated for a first cancer. Some chemotherapy agents are also mutagenic.
Risks associated with mishandling these agents includes:
The drug may get out of the container and into the air.
The drug may enter the handler’s body through absorption, inhalation, ingestion, or accidental injection.
The drug may cause cell damage.
This cell damage MAY result in cancer, miscarriage, or birth defects.

8. Four Ways Exposure Can Occur
Inhalation
Absorption
Ingestion
Accidental Injection

9. Exposure: Inhalation
Exposure is greatest when particles of drug enter the environment, when aerosolization occurs while injecting into a vial or parenteral solution, and when expelling air from a drug filled syringe.
If the technique of negative pressure is not maintained when injecting into a vial, the drug may blow back out of the hole in the rubber stopper.
It is important to always insert the needle slowly into the rubber stopper and to have the vial resting on the work surface so that the powder is on the bottom of the vial, farthest from the hole.
Proper technique in maintaining negative pressure and the use of a Class II Biological Safety Cabinet should reduce the exposure through inhalation.

10. Exposure: Absorption
Absorption may occur when skin comes in contact with the drug through aerosolization, spraying, spills or when the skin contacts a contaminated surface.
The amount of absorption depends on the contact time, amount of drug, the drug involved and thickness of the person’s skin.
It is important to immediately wash the contaminated area to prevent prolonged exposure
It is critical to always wear gloves and protective clothing during preparation and administration.

11. Exposure: Ingestion
Exposure through ingestion occurs when the chemotherapeutic agent enters the body orally.
This may occur if drugs get on food, beverages or anything that may be ingested into the body.
NEVER take food, drinks, or personal medication into the area where the chemotherapy drugs are stored or prepared.

12. Exposure: Injection
Injection of the drug into the body may occur if a contaminated needle or broken glass accidentally punctures the skin.
To prevent this, it s very important to keep the needle capped until ready for use. Punctures can occur during capping and uncapping the needle.

13. Possible Effects of Exposure
Because many drugs used in chemotherapy are vesicants and irritants, acute side effects from skin exposure to the drug may include skin irritation, blistering, and discoloration.
Long term side effects may include cancer, birth defects or miscarriage.

14. Reducing Exposure Good preparation and handling technique.
Using a Biological Safety Cabinet or Barrier Isolator
Using barrier protection

15. Section III: Personal Protection, Equipment, and Transporting
Upon completion of this portion of the training, you will:
Describe the BSC and barrier isolator used in chemotherapy drug preparation and the reason they are used.
Identify protective clothing required and correct donning procedures for.
Identify proper equipment used in chemotherapy drug preparation.
State the procedure for setting up the workplace prior to chemotherapy drug preparation.
Define the importance of labeling.
Define a safe method for transporting chemotherapy agents.

16. Biological Safety Cabinet (BSC)
The Occupational Safety and Health Administration (OSHA) and NIOSH guidelines for handling injectable chemotherapy drugs require the use of a Class II, Type B2 or Class III biological safety cabinet for preparation of these agents. Class III is fully contained and often too expensive
Class II BSCs are designed to protect workers from contamination generated in the work area when handling chemotherapy drugs and provide sterility to the prepared product.
The advantage of the BSC, compared to a horizontal flow hood, is that the BSC’s vertical flow and exhaust grills contain the contaminated air within the cabinet instead of blowing it at worker and into the work room.
When preparing drugs in a BSC, never block the clean air flow to sterile items. All needles, vials and ampoules must be placed to permit non-interrupted air flow from top to bottom, across the sterile points of injection and exposed needles. Avoid working within three inches of the side walls.

17. Barrier Isolators
Barrier isolators provide an enclosed, sterile work area to prepare compounded sterile products (CSP’s).

18. Barrier Isolators
According to USP Chapter 797, barrier isolators are a preferred option for preparing CSP’s to meet the new guidelines.
For non-cytotoxic CSP’s, positive pressure isolators may be used.
For cytotoxic preps, a negative pressure isolator must be used.

19. BSC Should be left running continuously
If turned off, the surface should be cleaned and decontaminated.
It should be certified by a qualified technician at least every 6 months and when the cabinet is repaired or moved.

20. Protective Clothing When using the BSC
To prevent exposure to hands and arms, protective apparel must be worn when preparing chemotherapy drugs. A Chemo Safety Gown and two pair of chemotherapy gloves must be donned prior to beginning work.
Protective clothing should never be worn outside the preparation area.
Gloves must be talc-free, thick latex gloves. Double gloving is required. Gloves should be disposable.
Gowns must be solid front with long sleeves and tight fitting cuffs.
Donning Protective Clothing Procedure: Wash hands thoroughly. Dry with paper towel or warm air blower, if available. Don the gown and pull sleeve down. Don gloves. The inner set of gloves go under the cuff of the gown sleeve, the outer pair over the cuff. If wearing non-sterile gloves, wash with germicidal cleanser. Always prevent the gown from getting wet.
Removing Protective Clothing Procedure: Place protective clothing in a yellow cytotoxic waste container. Always remove the items of greatest contamination first (usually the gloves). Remove the gloves, then the gown, and dispose.

21. Proper Equipment - Syringes, Syringe caps and Needles
Syringes – Luer-locking syringes are used in mixing chemotherapy. For the purpose of maintaining negative pressure and expelling air from the syringe, always use a syringe that will never be more than 3/4 full when preparing or containing the dose.
Syringe cap – Luer-locking syringe caps are used to cap Luer-locking syringes and reduce the risk of leakage.
Needles - When withdrawing a drug or injecting a drug into a vial or IV container, the use of a 18 or 20 gauge needle is recommended..
Use PhaSeal equipment as much as possible, unless the Protector 50’s or 14’s will not attach to vials (ex. Cisplatin, Taxol™)

22. PhaSeal system What is it?
A system designed to keep chemotherapy prep a completely closed system
Protector goes on vial
Injector Luer-locks onto syringe
Adapter attaches between bag and infusion (pump) set
When used correctly, exposure to chemotherapy agents is almost totally eliminated
Even if you use a barrier isolator, USP Chapter 797 still requires use of a closed system such as PhaSeal in the preparation of sterile chemotherapy products

23. PhaSeal system

24. PhaSeal System Injector connects to vial via the Protector
Diluent injected and drug withdrawn completely within system
Drug injected into piggyback or dispensed in syringe

25. Proper Equipment - Parenterals, Vials and Ampoules
Small volume parenterals and large volume parenterals can either be bottles or bags. Small volume parenterals hold 250ml or less.
Most chemotherapy drugs come in vials. Vials are glass or plastic containers with a rubber stopper for piercing. A vial is airtight and requires displacement of any air or liquid volume removed or added.
Ampoules are closed glass containers that are opened by snapping the top off at the neck. Ampoules are used for certain drugs that are not stable in contact with any type of rubber stopper. There are risks associated with ampoules especially when opening or breaking the ampoule. There is an increased risk of spillage because they are “open systems”.

26. Proper Equipment - Other Items
Filter Needles or filter straws are used any time a drug is withdrawn from an ampoule. These items remove glass that may have fallen into the ampoule during opening.
Alcohol swabs and Alcohol are used to disinfect the BSC or Barrier Isolator. They may also be used to disinfect other items in the BSC or Barrier Isolator.
Lint-free paper towels are used for cleaning the BSC or Barrier Isolator and wiping up spills.
Disposal Bags and sharps containers are used to contain and dispose of all chemotherapy supply items and drugs.
Zip Lock bags are used for transporting chemotherapeutic items to the wards.
Prep mats are used in the BSC or Barrier Isolator to absorb any spills which occur during the handling of drugs.

27. Setup and Preparation for BSC
Setting up the work area:
1. Assemble all supplies you will need
2. Double check all calculations
3. Next don the protective clothing
4. Prepare the surface of the BSC using 70% isopropyl alcohol and gauze. Discard into proper receptacle.
5. Set up the BSC for drug preparation
Place the Chemo Prep Mat on work surface
Place all supplies on the mat
6. All ports of injection, vials and ampoules must be disinfected.
7. You are ready to begin the preparation of the chemotherapy drugs.

28. Setup and Preparation for Barrier Isolator
Setting up the work area:
1. Double check all calculations
2. Assemble all supplies you will need
3. Place items in place in plastic bin
4. Open outer airlock door and place bin inside
5. Spray items with alcohol and close outer airlock door
6. Open inner airlock door, bring items into the isolation chamber
7. Close inner airlock door
8. You are ready to begin the preparation of the chemotherapy drugs.

29. Aseptic Technique Vials
No more than 75% of the syringe volume should be filled in the solution.
Once the diluent is drawn up, the needle should be inserted into the vial and the plunger pulled back and air drawn into the syringe
Small amounts transferred as equal volumes of are removed
Excess volume should remain in the vial.
If transferring into a IV bag, care must be taken not to puncture the bag.
Label the bag with auxiliary stickers
Use clean gloves to place in a plastic bag for transferring

30. Aseptic Technique Ampules
Any solution visible in the neck should be transferred into the body
The neck should be clensed with alcohol and the swab left in place. It should be snapped in place
To withdraw medication, it should be tilted and a filter needles used to removed the liquid.

31. Labeling and Transporting
After completing the preparation of the chemotherapy drugs, a warning label must be attached to the product which reads: “Caution: Chemotherapy.” The Zip Lock bags have this warning attached. Waste containers must have the same warning.
All drugs must be placed in the Zip Lock bags before transporting with the label plainly visible. All drugs must be hand carried to their destination.

32. IV. Maintaining a Clean Chemotherapy Drug Preparation Area
Upon completion of this section of the training, you will:
State the difference between disinfecting and decontaminating the BSC or Barrier Isolator.
State when and how the BSC or Barrier Isolator is disinfected.
State when and how the BSC or Barrier Isolator is decontaminated

33. Cleaning the Preparation Area
The chemotherapy drug preparation area must be kept clean at all times to maintain the integrity of the drugs being used and to reduce drug exposure to the preparers working in the area. Since the work area is potentially contaminated with chemotherapy drugs, gloves should always be worn when working in the cabinet.
Disinfecting: the work area is disinfected by wiping it with 70% isopropyl alcohol. Every fourth week, hydrogen peroxide will be used. Disinfecting removes microorganisms from the work area but does not remove chemotherapy contamination.
OSHA recommends that the work area be decontaminated at least once a week. The work area is washed and rinsed with detergent and deionized water. All personnel performing this operation must wear protective clothing and all items used for cleaning must be disposed of as contaminated waste.

34. Waste Disposal
All chemotherapy waste disposal containers must be made of leak proof and puncture-resistant material and must be stored in a secure and separate area until final disposal.
There must be a Chemotherapy waste disposal container in any chemotherapy drug area. These containers must be changed before they are filled to overflowing.

35. V. Emergency Management
Upon completion of this final section of the training, you will:
List the contents of the ChemoSafety Spill Kit.
State the proper way to clean up contaminated spills inside and outside the BSC or Barrier Isolator.
List the contents of a chemotherapy emergency kit
State the immediate action to be taken for direct eye and skin contact with a chemotherapy drug.
State the information that should be reported on an accident report following personal contamination.

36. Accidental Spills and Cleanup
There are two types of accidental spills: those that occur inside the BSC/Barrier Isolator and those that occur outside the BSC/Barrier Isolator.
Each preparation area must have ChemoSafety Spill Kits. The kits contain disposal bags, a respirator, chemical safety glasses, one pair of ChemoSafety gloves, one pair of heavy duty utility gloves, absorbent toweling, ChemoSorb pads, a ChemoGown, shoe covers and SafeLock bags.
Spills inside the BSC/Barrier Isolator: Spills are considered large when they are greater than 50ml. ChemoGown and gloves must be worn. If broken glass is present, a pair of utility gloves should be worn over the gloves. Contain the spill with disposable gauze. If the spill is a powdered drug, cover it with water wet absorbent gauze. Place all contaminated gauze in the disposal bag. Wash and rinse the surface of the BSC three times with detergent and distilled water.
Spills outside the BSC/Isolator: Contact Environmental Engineering and secure the area until they arrive to clean up the spill and follow standard procedures for cleaning spill

37. Policy for Cleaning Spills outside of BSC/Barrier Isolator
Secure area and contact EMS
Open spill kit and don safety gown and gloves, if not already wearing them
Take out absorbent pads, place them on any liquid on site to absorb it
Place pads in chemo zip lock bag when liquid absorbed, using new pads when old pads are full

38. Policy for Cleaning Spills outside of BSC/Barrier Isolator
Check the MDS sheet so EMS can appropriately clean the surfaces
Contact IH&S so they can have proper input on the cleanup process and the reporting mechanisms

39. Accidental Personal Contamination
Skin Contamination: immediately wash the area thoroughly with soap and water. If the skin is intact, wipe the area with diluted chlorine bleach using a gauze pad. If the skin is cut or abraded, use 3% hydrogen peroxide.
Eye Contamination: immediately flood the eye with warm water for at least five minutes.
Seek medical attention after administration of first aid and file an accident report after the situation is stabilized.

40. Congratulations!
You have completed the annual training for chemotherapy certification.
Please turn in self test to the Hem/Onc Pharmacist