Onco PP

MANUAL TITLE DOCUMENT NO.
ANCILLARY SERVICES MANAGEMENT SYSTEMS MANUAL ASMSM-PHA-44

DOCUMENT NAME REVISION NO. 01
PREPARATION OF CYTOTOXIC DRUGS EFFECTIVITY DATE

November 25, 2017
PAGE NO. 1 of 4
I. OBJECTIVE
To establish a standard policy and procedure in preparation of cytotoxic drugs
II. SCOPE
This policy covers standard procedures in preparing cytotoxic drugs that must be observed by the
pharmacists, nurses, residents and oncologists
III. REFERENCE
Chemotherapy and Biotherapy Provider Training Course Philippine Children’s Medical Center.
IV. POLICIES
1. Only qualified personnel are allowed to reconstitute cytotoxic drugs.

2. Preparation of cytotoxic drug/s should be done in the Onco Reconstitution Room provided for
located at the 3rd floor.
3. Wearing of Personal Protective Equipment during preparation is a must.
4. Aseptic technique should always be observed before, during and after preparation.
V. PROCEDURE (for IV admixture)
1. Wear appropriate protective equipment.
2. Cover the work table with an absorbent sheet with plastic backing.
3. If chemodrug is photosensitive, cover the top of the biosafety cabinet with any cloth to protect
the chemo drug from direct exposure to light.
PREPARED BY: APPROVED BY:

NOEL V. FABIA
NOTED BY: ROLANDO A. BALBURIAS
GINA A. NOBLE President / General Manager
Head, Ancillary Services

November 25, 2017
PAGE NO. 2 of 3
4. Vials containing drugs requiring reconstitution should be vented to reduce the internal pressure
with a venting device using a 0.22micron hydrophobic filter or other appropriate means such as
chemotherapy dispensing pin. This reduces the probability of spraying or spillage.
5. If chemotherapy dispensing pin is not used, a sterile cotton pad should be carefully placed
around the needle and vial top during withdrawal from the septum.
6. The external surfaces contaminated with a drug should be wiped clean with an alcohol pad prior
to transfer or transport.
7. When opening the glass ampoule, wrap it and then snap it at the break point using an alcohol
pad to reduce the possibility of injury and to contain the aerosol produced. Use a 5 micron filter
needle or straw when removing the drug solution.
8. Syringes and IV bottles containing cytotoxic drugs should be labelled and dated. Before these
items leave the preparation area, an additional label reading ”Caution-chemotherapy, Dispose of
Properly” is recommended.
9. After completing the drug preparation process, wipe down the interior of the safety cabinet with
soap and water or 5% sodium hypochlorite solution followed by 70% alcohol using disposable
towels. All wastes are considered contaminated and should be disposed of properly.
10. Contaminated needles and syringes, I.V. tubing, butterfly clips, etc., should be disposed of intact
to prevent aerosol generation and injury. Do not recap needles. Place this items in a puncture
resistant container along with any contaminated bottles, vials, gloves, absorbent paper,
disposable gowns, gauze and other waste. The container should then be placed in a box labelled
“Cytotoxic waste only” , sealed and disposed of according to National and local requirements.
Linen contaminated with drugs, patient excreta or body fluids should be handled separately.
11. Hands should be washed between gloves changes and after glove removal.

NOEL V. FABIA

November 25, 2017
PAGE NO. 3 of 3
12. Cytotoxic drugs are categorized as hazardous wastes and therefore, should be disposed of
according to regulatory requirements.
PROCEDURE Non-parenteral preparations (extemporaneous)
1. Wear appropriate protective equipment.
2. Cover the work table with an absorbent sheet with plastic backing.
3. If chemodrug is photosensitive, cover the top of the biosafety cabinet with any cloth to protect
the chemo drug from direct exposure to light.
4. Use purposely-dedicated equipment (mortars & pestle, graduated cyclinder etc) provided for
use only in the Chemo Reconstitution Room.
5. Make mixtures by dispersing tablets in water inside the biosafety cabinet .
6. If tablets needs to be crushed do not crushed in an open mortar. Place mortar inside the
biosafety cabinet.
7. Clean equipments immediately after use with strong alkaline detergent.

NOEL V. FABIA
MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

November 25, 2017
PAGE NO. 1 of 5
I. OBJECTIVE
To establish a standard policies and procedures in managing cytotoxic spills inside and
outside the biosafety cabinet and on healthcare worker.
II. SCOPE
This policy covers standard procedures in managing cytotoxic spills that must be
observed by the pharmacists, nurses, residents, oncologists and housekeepers.
III. REFERENCE
Chemotherapy and Biotherapy Provider Training Course Philippine Children’s Medical

Center, Agham Road Quezon City Nov 22-24, 2013
IV. POLICY
1. Cytotoxic drugs are hazardous to the health of those handling it, therefore extra precaution
should be strictly observed in preparing it.
2. Reconstitution must be done inside the biohazard cabinet (improvised) to contain the fumes
emitted during the reconstitution.
3. Prepare incident report for any spillage by the person/s involved.
4. Train staff who will be doing the reconstitution on decontamination.
5. Two sets of spill kit should always be available. One for the onco reconstitution room and one
for the station.
6. Contents of spill kit should always be complete and replenished once used.

NOEL V. FABIA

November 25, 2017
PAGE NO. 2 of 5
7. Only trained personnel (onco nurses,trained pharmacists and trained housekeeping staff) are
authorized to manage cytotoxic spills.
8. Spill Kit shall be composed of :
a) Face mask
b) Cover-all gowns
c) Head covering
d) Closed footwear or overshoes
e) Protective gloves
f) Protective eyewear
g) Large quantities of swabs or absorbent towel
h) Small scoop to collect glass fragments
i) Absorbent material (chemical absorbent pads, protective mats)
j) Two clearly labeled cytotoxic plastic waste bags signs to isolate and identify spill.
k) Detergent
V. A) PROCEDURE FOR MANAGING SPILL IN THE BIOSAFETY CABINET
1. Ensure that the cabinet remains operating
2. Absorb liquid spill with absorbent pads and dispose them into a sealable bag.
3. Absorb powder spill with wet towels and dispose them into a sealable bag.
4. Wash the entire area with detergent solution.
5. Rinse well with clean water.
6. Repeat washing and rinsing until all of the drug has been removed.

NOEL V. FABIA

November 25, 2017
PAGE NO. 3 of 5
7. Discard all contaminated items into a sealable bag.
8. Remove outer pair of gloves and dispose them into a sealable waste bag.
9. Discard all sealed waste bags and contaminated items into a cytotoxic waste
bag or bin.
10. Remove protective clothing and discard into a cytotoxic disposal waste bag.
11. Wash hands thoroughly.
V.B ) PROCEDURE FOR MANAGING SPILL OUTSIDE THE BIOSAFETY CABINET
1. Secure the area and place signs if required.
2. Assess the situation and determine how to deal with the spill.
3. Access the nearest spill kit.
4. Allocate the responsibility for managing the spill.
5. Use the personal protective equipment provided in the spill kit.
6. Contain and cover the spill with appropriate absorbent material provided in the spill kit.
7. If the spill involves a powder, carefully place a mat over the powder, ensuring minimal dust
production, then carefully wet the mat so that the powder dissolves and is absorbed by the mat.
8. Gather absorbed material, being careful to collect any broken glass.

NOEL V. FABIA

November 25, 2017
PAGE NO. 4 of 5
9. Discard collected waste into the cytotoxic waste container.
10. Wash area with 5% sodium hypochlorite solution.
11. Rinse area thoroughly.
12. Dry the affected areas with absorbent towels.
13. Discard the waste into the cytotoxic waste container.
14. Wash hands thoroughly with soap and water.
15. Complete the incident report.
16. Inform management.
17. Ensure that the spill kit is replenished and maintained.

NOEL V. FABIA

November 25, 2017
PAGE NO. 5 of 5
The following are the suitable reagents for treatment of cytotoxic spills:
5% SODIUM 5% SODIUM HYRDOXIDE

HYPOCHLORITE
Carboplatin Etoposide
Cisplatin Vincristine
Cytarabine
Doxorubicin
Fluorouracil
Methothrexate
Idarubicin
Mitoxanthrone
Vinblastine
Bleomycin
V.C ) PROCEDURE FOR MANAGING SPILL ON HEALTHCARE WORKERS
1. Remove contaminated clothing.
2. Skin contaminated with a solution of Anti-Cancer Drug must be rinsed immediately with copious
amounts of water, followed by washing with soap.
3. Mucous membranes should be rinsed with water only.
4. Eye contact with Anti-Cancer Drug : rinse with copious amount of water or physiologic saline.
5. Prepare incident report.

NOEL V. FABIA
NOTED BY: ROLANDO A. BALBURIAS CONTROLLED
GINA A. NOBLE President / General Manager COPY

INCIDENT REPORTING IN CASES OF CYTOTOXIC SPILLS EFFECTIVITY DATE

November 25, 2017
PAGE NO.1 of 2
I. OBJECTIVE
To establish standard policies and procedures in preparation of incident report in cases of

cytotoxic spills.
II. SCOPE
This policy covers standard procedures in preparation of incident reports in cases of

cytotoxic spills that must be observed by the pharmacists, nurses, residents, oncologists
and housekeepers.
III. REFERENCE
Chemotherapy and Biotherapy Provider Training Course Philippine Children’s Medical Center,
Agham Road Quezon City Nov 22-24, 2013
IV. POLICY
1. Incident reports should be prepared/ accomplished immediately after management of cytotoxic

spills by the staff directly involved in the incident.
2. Incident reports should include the following but not limited to; Date & Time, Persons Involved ,
Location (ward/unit/department),drug, quantities involved, how it was cleared, how it was disposed
V. PROCEDURE
1. All incident reports should be submitted to the Nursing Supervisor/s if the spillage happened in the
patients room, hallways (during transport), and Nursing stations.
2. Nursing Supervisors will conduct initial investigation and submits the report to the Head of Division of
Nursing.
NOEL V. FABIA
NOTED BY: ROLANDO A. BALBURIAS MASTER COPY

INCIDENT REPORTING IN CASES OF CYTOTOXIC SPILLS EFFECTIVITY DATE

November 25, 2017
PAGE NO. 2 of 2
3. The Head, Division of Nursing after completing the incident report will submit a copy to Chief
Pharmacist.
4. If the spillage happened in the reconstitution room, the incident report should be submitted to the
Chief Pharmacist.
5. The Chief Pharmacist will provide Committee on Patient Safety and Security or Committee on
Occupational Safety and Health as the case maybe.
NOEL V. FABIA
ADMINISTRATIVE FEE FOR CHEMO DRUGS EFFECTIVITY DATE

November 25, 2017
PAGE NO.1 of 2
I. OBJECTIVE
To establish standard policies and procedures in charging of chemo drugs.
II. SCOPE
This policy covers standard procedures in the preparation of charges for chemo drugs brought –in
by the patient or doctor and reconstituted by the pharmacists.
III. REFERENCE
Current practices of benchmarked hospitals
IV. POLICY
.
1. A 5% of the cost of drug will be charge as administrative fee.
2. A proof of purchase or invoice will be required by the Pharmacy Department as basis of

Administrative Fee.
3. A waiver signifying that chemo drug/s was purchased outside JDMH shall be signed by the
patient and Oncologists
4. PPE & Supplies used for every Chemo Preparation will be charged to the patient.
5. The Oncologist has the option to reconstitute the drug himself .
6. Pharmacists are the legally allowed health professional to reconstitute chemo drugs and not the
nurses.

NOEL V. FABIA
ADMINISTRATIVE FEE FOR CHEMO DRUGS EFFECTIVITY DATE

November 25, 2017
PAGE NO. 2 of 2
V. PROCEDURE
1. Admitting staff will inform Pharmacy of admission of Onco patient.
2. Pharmacy will communicate with the Oncologists or the Oncologists Secretary to get a
photocopy of the proof of purchase or invoice of chemo drugs of said patient.
3. Pharmacy will charge the corresponding Administrative Fee and attaches the photocopy of
invoice or proof of purchase in the chargeslips.
4. Pharmacist/s files the chageslips with proof of purchase / invoice.

NOEL V. FABIA
REQUEST, PURCHASE AND CHARGING OF CHEMO EFFECTIVITY DATE

November 25, 2017
DRUGS PAGE NO.1 of 2
I. OBJECTIVE
To establish standard policies and procedures in requesting, purchasing and charging of chemo
drugs.
II. SCOPE
This policy covers standard procedures in the request, purchase and charging chemo drugs by the
Pharmacy Department and Purchasing Department.
III. REFERENCE
Current practices of benchmarked hospitals
IV. POLICY
.
1. A written request of chemo drugs that will be used should be submitted by the Oncologist
atleast seven (7) working days prior to the actual admission of his/her patient.
2. Purchasing Department should inform Pharmacy 3 days after the submission of PR if the
medicine/s can be delivered or not..
3. Purchasing should be able to supply the drugs to Pharmacy three days prior to admission
of patient..
4. PR’s of chemo drugs are considered “ emergency” and should not follow the regular process
of PRs.
5. Nurses should not give pre meds if Medicines are not yet at the Pharmacy

NOEL V. FABIA
REQUEST,PURCHASE AND CHARGING OF CHEMO EFFECTIVITY DATE

November 25, 2017
DRUGS PAGE NO. 2 of 2
V. PROCEDURE
1. Pharmacist prepares PR of the chemo drugs requested by the Oncologists and attaches
a photocopy of the written request.
2. Pharmacist /Pharmacy Clerk submits the PR to MMS after the required signatories and
informs MMS of the possible day of admission of the patient.
3. Once drugs are delivered, pharmacist informs the resident, Oncologist or the
Oncologists Secretary that the medicine is already at the Pharmacy.
4. Once the patient is admitted, the nurse will inform Pharmacy if the drug will be
reconstituted.
5. Pharmacist prepares corresponding charges..

NOEL V. FABIA

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MANUAL TITLE DOCUMENT NO.

ANCILLARY SERVICES MANAGEMENT SYSTEMS MANUAL ASMSM-PHA-44

PREPARATION OF CYTOTOXIC DRUGS EFFECTIVITY DATE

1. Only qualified personnel are allowed to reconstitute cytotoxic drugs.

V. PROCEDURE (for IV admixture)

1. Wear appropriate protective equipment.

PREPARED BY: APPROVED BY:

PREPARATION OF CYTOTOXIC DRUGS EFFECTIVITY DATE

PREPARED BY: APPROVED BY:

PREPARATION OF CYTOTOXIC DRUGS EFFECTIVITY DATE

PROCEDURE Non-parenteral preparations (extemporaneous)

1. Wear appropriate protective equipment.

5. Make mixtures by dispersing tablets in water inside the biosafety cabinet .

7. Clean equipments immediately after use with strong alkaline detergent.

PREPARED BY: APPROVED BY:

MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

Chemotherapy and Biotherapy Provider Training Course Philippine Children’s Medical

3. Prepare incident report for any spillage by the person/s involved.

4. Train staff who will be doing the reconstitution on decontamination.

PREPARED BY: APPROVED BY:

MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

8. Spill Kit shall be composed of :

V. A) PROCEDURE FOR MANAGING SPILL IN THE BIOSAFETY CABINET

1. Ensure that the cabinet remains operating

4. Wash the entire area with detergent solution.

5. Rinse well with clean water.

PREPARED BY: APPROVED BY:

MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

7. Discard all contaminated items into a sealable bag.

11. Wash hands thoroughly.

V.B ) PROCEDURE FOR MANAGING SPILL OUTSIDE THE BIOSAFETY CABINET

1. Secure the area and place signs if required.

3. Access the nearest spill kit.

4. Allocate the responsibility for managing the spill.

5. Use the personal protective equipment provided in the spill kit.

8. Gather absorbed material, being careful to collect any broken glass.

PREPARED BY: APPROVED BY:

MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

9. Discard collected waste into the cytotoxic waste container.

10. Wash area with 5% sodium hypochlorite solution.

11. Rinse area thoroughly.

12. Dry the affected areas with absorbent towels.

13. Discard the waste into the cytotoxic waste container.

14. Wash hands thoroughly with soap and water.

15. Complete the incident report.

16. Inform management.

17. Ensure that the spill kit is replenished and maintained.

PREPARED BY: APPROVED BY:

MANAGEMENT OF CYTOTOXIC SPILLS EFFECTIVITY DATE

5% SODIUM 5% SODIUM HYRDOXIDE

V.C ) PROCEDURE FOR MANAGING SPILL ON HEALTHCARE WORKERS

1. Remove contaminated clothing.

3. Mucous membranes should be rinsed with water only.

5. Prepare incident report.

MANUAL TITLE DOCUMENT NO.

INCIDENT REPORTING IN CASES OF CYTOTOXIC SPILLS EFFECTIVITY DATE

To establish standard policies and procedures in preparation of incident report in cases of

This policy covers standard procedures in preparation of incident reports in cases of

1. Incident reports should be prepared/ accomplished immediately after management of cytotoxic

MANUAL TITLE DOCUMENT NO.

INCIDENT REPORTING IN CASES OF CYTOTOXIC SPILLS EFFECTIVITY DATE

ADMINISTRATIVE FEE FOR CHEMO DRUGS EFFECTIVITY DATE

To establish standard policies and procedures in charging of chemo drugs.