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Administering methorexate

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Mercy Hospitals<br />

Learning Package in<br />

<strong>Administering</strong> Methotrexate<br />

1


© Published by Mercy Hospitals Victoria Ltd.<br />

Authors:<br />

Contributors:<br />

Reviewed by:<br />

Nicole Whiting, Peri-operative Nursing Educator<br />

John Caluza, Clinical Nurse Educator<br />

Natalie Hackett, Clinical Nurse Educator<br />

Caroline Cooper-Blair,<br />

Program Lead<br />

Version: April 2017 / V1.0 Date: April 2017 Review:<br />

A high standard of accuracy is maintained when completing and producing this document. However, the<br />

contents of this document may be altered and / or revised without prior notice; no responsibility is taken<br />

for any consequential issues that may result from using this document.<br />

This document is bound by copyright and has been produced for the intended use of Mercy Hospitals,<br />

Victoria staff only. No part of this document may be reproduced, stored, broadcasted or transmitted in any<br />

form or by any electronic, recording, mechanical, copying or any other means, without prior notice or<br />

permission, except as permitted by the Copyright Act.<br />

For more information, please contact:<br />

Learning Team<br />

Mercy Hospitals Victoria Ltd.<br />

2


Table of Contents<br />

Glossary of Terms 4<br />

What is Methotrexate? 5<br />

Mode of action<br />

5<br />

Indications 5<br />

Precaution and Contraindications 6<br />

How is Methotrexate administered?<br />

a. Intramuscularly<br />

b. Orally<br />

Special considerations 7<br />

6-7<br />

Management and Precaution in administering Methotrexate<br />

a. Health & safety<br />

b. Extravasation<br />

c. Cleaning a spill<br />

d. Staff Decontamination and reporting<br />

7-10<br />

VII. Patient Education of Cytotoxic Drug 11<br />

References 12<br />

3


Glossary of Terms<br />

Competency<br />

Standards<br />

Competent<br />

Not Competent<br />

Key Sites<br />

Key Parts<br />

Industry benchmark for training and assessment which specify the scope of<br />

knowledge and skill sets to be covered in a training package<br />

The learner has achieved required outcomes and can function efficiently and<br />

independently and does not require cues and / or prompting. They can relate<br />

theory to practice commensurate with the level of knowledge and skill<br />

The learner has not achieved required outcomes and cannot function<br />

efficiently and requires assistance. They cannot to relate theory to practice<br />

commensurate with the level of knowledge and skill<br />

The part of the patient that is accessed during an invasive procedure<br />

A part of the equipment that must remain sterile and can only come into<br />

contact with other key parts or key sites.<br />

4


What is Methotrexate?<br />

Methotrexate is a folic acid antagonist that interferes with DNA synthesis in actively proliferating tissues<br />

such as trophoblastic tissue. It interferes with the growth of certain cells of the body, especially cells that<br />

reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.<br />

Methotrexate is also used to treat certain types of cancer of the breast, skin, head and neck, or lung. It can<br />

be used to treat severe psoriasis and rheumatoid arthritis with precaution as per doctors advice. This type<br />

of medicine is usually given after other medications have been tried without successful treatment of<br />

symptoms.<br />

There are many reports in the medical literature of the successful treatment of non-ruptured ectopic<br />

pregnancy with methotrexate administration. Potential side effects of methotrexate use include nausea,<br />

diarrhoea, alopecia, stomatitis, abdominal pain, and serious effects such as pneumonitis, leucopoenia and<br />

hepato/nephrotoxicity.<br />

II. Mode of action<br />

Methotrexate is an antimetabolite that interferes with DNA synthesis, repair, and cellular replication by<br />

inhibiting dihydrofolate reductase. Tissues with high rates of cellular proliferation such as neoplasms, bone<br />

marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are generally more<br />

sensitive to the effects of methotrexate than most normal tissues.<br />

III. Indications<br />

According to treatment protocol, it is indicated to the following type of illness:<br />

Breast cancer,<br />

Bladder cancer,<br />

Squamous cell cancer of head and neck,<br />

Gestational trophoblastic disease,<br />

Acute leukaemias,<br />

Non-Hodgkin lymphomas,<br />

Osteosarcoma, \<br />

Brain tumours,<br />

Graft-versus-host disease<br />

Psoriasis<br />

Rheumatoid arthritis<br />

Crohn’s disease<br />

Ectopic pregnancy<br />

Polymyositis, dermatomyositis


IV. Precaution and Contraindications<br />

Immunodeficiency syndromes—additive immunosuppression.<br />

GI ulceration—may worsen.<br />

Third space fluid collection, eg pleural effusion, ascites—may delay excretion of methotrexate and increase<br />

toxicity; drain before treatment or provide folinic acid rescue.<br />

Contraindications to systemic methotrexate include blood dyscrasias, renal disease, hepatic dysfunction<br />

and active peptic ulcer disease, and pre-treatment exclusion of these conditions is recommended.<br />

V. How is Methotrexate administered?<br />

Methotrexate may cause very serious, life-threatening side effects therefore not only the patients who are<br />

taking the medications need to take precautions but also the staff who handled the drugs and patient’s<br />

bodily fluid, such as the nurses, psa, and other multidisciplinary team.<br />

a. Intramuscularly<br />

This will usually be performed by Nursing Staff, following a<br />

Lap/D&C and if ordered by the doctor. It is local injection<br />

indicated for the ectopic gestational mass and systemic<br />

administration. Systemic administration has been proven<br />

to be more affective in cases of tubal pregnancy. Two<br />

protocols exist for the use of systemic methotrexate –<br />

Single dose (50mg/m2 IMI) and multiple-dose (1mg/kg<br />

IMI days 1, 3, 5 and 7, with folic acid rescue days 2, 4, 6<br />

and 8).<br />

As compared with the multiple-dose protocol, single-dose<br />

methotrexate is less expensive, has fewer side effects,<br />

does not require folic acid and rescue therapy and is more<br />

readily accepted by patients.<br />

The criteria to consider methotrexate treatment of ectopic pregnancy include a low initial hCG (


. Orally<br />

Tablets are taken strictly as directed. It should only be<br />

taken once a week on the same day each week; it must not<br />

be taken every day unless otherwise indicated such as BMT,<br />

Breast Ca treatment. Since these medications decrease<br />

your immune system, it may increase your chances of<br />

getting an infection. Nurses should report to the doctor any<br />

signs and symptoms of cough, difficulty breathing or signs<br />

of infection.<br />

The pharmacist or nurses must obtain drug history before<br />

administering this medication because some medications<br />

together with methotrexate may lead to toxicity.<br />

Staff training and education is needed in order to be competent in giving the medication.<br />

Neoplastic indications: take tablets on an empty stomach with a glass of water, 1 hour before, or 2 hours<br />

after, food.<br />

Eg. Doses of methotrexate<br />

tab, 2.5 mg, 30, Methoblastin, PBS<br />

tab, 10 mg (scored), 15, 50, Methoblastin<br />

VI. Special considerations:<br />

This medicine may also cause bruising and bleeding<br />

secondary to low platelet count (thrombocytopenia).<br />

Avoid excessive or prolonged sun exposure, wear<br />

protective clothing and use sunscreen. A follow up<br />

appointment will be required as further blood test may be<br />

required to determine the effectiveness of the<br />

Methotrexate.<br />

For gynae patients: The follow-up regarding repeat blood<br />

tests performed after 4 days and 7 days to measure the<br />

pregnancy hormone level. If the treatment is effective, the<br />

patient will need to have a blood test to measure the<br />

pregnancy hormone level every week until the result is<br />

zero.<br />

VII. Management and Precaution in administering Methotrexate<br />

Methotrexate is a cytotoxic drug and precautions need to be taken when<br />

administering this agent. Pregnant staff and those breast feeding should avoid<br />

contact with cytotoxic agents. Some mutagenic cytotoxic agents may pose a<br />

greater risk to male staff if there is continuous low-level exposure. For this<br />

reason, guidelines have been drawn up recommending basic safety<br />

procedures and administration techniques, to promote an awareness of the<br />

potential hazards involved and ensure safe practice.


legislative requirements for health and safety<br />

legislative requirements for waste management<br />

the risk management process<br />

occupational hazards of exposure to cytotoxic drugs and waste<br />

control measures and work practices to be adopted when handling cytotoxic drugs and waste<br />

maintenance of equipment<br />

correct selection, use, cleaning and disposal of personal protective equipment<br />

procedures to be adopted in the event of an accident, injury or spill<br />

access to first aid resources<br />

storage, transport, treatment and disposal of cytotoxic waste<br />

Please refer to - Pharmacy Procedure -Safe Handling of Cytotoxic Drugs Mercy Health 2011<br />

Nursing staff who administer Methotrexate needs to complete an annual competency to ensure both<br />

patient & staff safety when giving and disposing of this drug. The staff who have completed the Cytotoxic<br />

Management Module in EVIQ (https://education.eviq.org.au/courses/antineoplastic-drug-administrationfor-the-non-can)<br />

are also a valuable resource when giving<br />

methotrexate in business hours.<br />

When giving methotrexate it is the responsibility of the<br />

registered nurse caring for the patient to ensure that all OH&S<br />

safety requirements are in place prior to giving the drug. The<br />

registered nurse should also be well informed of the route &<br />

side effects of methotrexate prior to its administration. It is<br />

the responsibility of all registered nurses at Mercy Health to<br />

complete their online competencies annually.<br />

a. Health & safety<br />

unless ¾ full.<br />

The greatest risk of occupational exposure to cytotoxic<br />

drugs is during drug manufacture and preparation because<br />

of the concentrations and quantities used. Personal<br />

protective equipment (PPE) must be worn when handling<br />

contaminated waste. This includes closed footwear, nitrile<br />

gloves, non-permeable long sleeved gown and protective<br />

goggles if there is a risk of splashing it is recommended to<br />

use N95 mask -airborne. Use only leurlock or interlink<br />

fittings and connections. All PPE equipment worn while<br />

administering methotrexate, as well as sharps &<br />

ampoules’, should be placed in the purple sharps bin for<br />

disposal. This should be sealed after use but not replaced<br />

The personal protective equipment box must be in placed near the patient’s room, with the purple sharps<br />

bin and contains the relevant protective equipment required to administer cytotoxic drugs. In operating<br />

theatre the equipment is located in the recovery room. The purple sharps bin is required for safe disposal<br />

of sharps used in cytotoxic therapy.


As with the administration of all drugs, the Medication, Double Checking, Drugs, administration Procedure<br />

2011 –Mercy Health should be adhered to.<br />

REMEMBER THE 7 R’S OF SAFE MEDICATION ADMINISTRATION<br />

<br />

<br />

<br />

Right Dose<br />

Right Drug<br />

Right Patient<br />

<br />

<br />

<br />

<br />

Right Time<br />

Right Route<br />

Right Documentation<br />

Right reason<br />

ALWAYS CHECK ALLERGIES/ SENSITIVIES<br />

Please refer to Procedure - Medication, Double Checking, Drugs, and administration Procedure 2011 –<br />

Mercy Health.<br />

b. Extravasation<br />

Extravasion is indicated by the presence of an erratic flow rate, absence of flow, erythema, blister<br />

formation, streaking of the vein and/or pain. If this occurs, it is imperative that extravasation is detected<br />

and managed quickly and efficiently to prevent necrosis and/or functional loss of the limb and tissue<br />

concerned .The Extravasation kit is located in DPU and should be present when giving any cytotoxic drug<br />

intravenously. If methotrexate is given intramuscularly or orally, all staff must be aware of this term & the<br />

location of the kit available.<br />

▪ Please refer to the Procedure -Management of Extravasation: Cytotoxic Drugs Mercy Health 2011 for<br />

further information.<br />

c. Cleaning a spill<br />

Minor spills (cytotoxic spills less than 50mls or spills of body fluids containing cytotoxic agents) Spills<br />

during agent administration, patient care and transport<br />

• Isolate area and place signs if required<br />

• Allocate responsibility for managing the spill staff contaminated by the agent should refer<br />

to Personal Contamination another staff member should be allocated responsibility for<br />

managing the spill<br />

• Wear personal protective equipment; gown, gloves, eyewear, and mask; refer to Personal<br />

Protective Equipment and spill Kit<br />

• Contain and soak up the spill using dry absorbent material wash area with copious amounts<br />

of alkaline detergent rinse area thoroughly with water dry area with absorbent materials<br />

discard all waste into purple cytotoxic waste container remove personal protective<br />

equipment, discard into purple cytotoxic waste.<br />

• Wash hands thoroughly with soap and water complete an incident report<br />

Major spills (cytotoxic spills greater than 50 mls)<br />

• Isolate area and place signs<br />

• Allocate responsibility for managing the spill


Staff contaminated by the agent should ask another staff member should be<br />

allocated responsibility for managing the spill<br />

• Access the nearest spill kit<br />

• Put on gown, mask, protective eyewear, shoe coverings and double gloves (inner latex<br />

glove and outer heavy utility glove) contained in the spill kit.<br />

• Contain and cover the spill using appropriate absorbent material (absorbent side facing<br />

down and plastic backed side up) provided in the spill kit.<br />

• Use spill towels (in spills kit on ward) to wash area with alkaline detergent<br />

• Use spill towels to rinse area thoroughly with water and to dry area fully.<br />

• Discard all waste into large blue poly bag<br />

• Remove shoe coverings and outer utility gloves and discard into blue poly bag<br />

• Wearing inner gloves, seal blue poly bag and place into chemotherapy waste poly bag along<br />

with gown, mask and protective eyewear<br />

• Remove inner gloves and seal chemotherapy waste poly bag<br />

• Place entire bag into purple cytotoxic waste bucket<br />

• Wash hands thoroughly with soap and water<br />

• Complete an incident report form<br />

The spill kit<br />

• A spill kit is available in Day Procedure Unit Nurses Station. Any spills or personnel contamination<br />

must be reported as soon as possible to the director or deputy director of pharmacy. An incident<br />

report must be completed detailing the type of incident, action taken to manage the spill and<br />

action taken to prevent future occurrences.<br />

• The Baxter spill kit is required to clean & contain a spill. This kit contains specific equipment and<br />

signage to contain spills with minimal risk of exposure to others. If the kit is used Pharmacy need to<br />

be advised so it can be replaced. All the waste from the spill is to be placed in the purple bag<br />

provided in the Baxter Kit & sent for disposal.<br />

d. Staff Decontamination and reporting<br />

<br />

<br />

In the event of spillage of cytotoxic agents onto unprotected skin or into the eye, immediate<br />

action should be taken to wash the material away with large volumes of water or sodium<br />

chloride 0.9%.<br />

In the event of a staff member and their clothing being contaminated by spillage of cytotoxic<br />

agents the staff member should proceed immediately to shower and change contaminated<br />

clothes. Contact the AHC and complete a VHIMS. Further medical attention as advised.


The Staff should notify the nurse in charge or the after-hours coordinator, who is responsible<br />

for area at time and report to Medical Team if needed it is advised to be checked in ED. Staff<br />

will complete an incident report.<br />

VII.<br />

Patient Education of Cytotoxic Drugs<br />

It is important that patient and patient families are well educated if a cytotoxic drug has been given. Mercy<br />

Health has a specific instruction sheet for patients on Methotrexate for the treatment and should be given<br />

and explained prior to discharge. This process will occur on the ward prior to discharge.<br />

Discharge instruction sheet will outline this information, as well as safety requirements regarding toilet<br />

flushing etc. Staff will provide this to the patient & explained to them, prior to leaving the hospital.


References:<br />

https://www.petermac.org/services/treatment/medical-oncology/chemotherapy/chemotherapy-drugsand-safety<br />

https://www.petermac.org/sites/default/files/mediauploads/Late%20Effects%20Guidelines%20for%20GPs.pdf<br />

Lipscomb GH, Stovall Tg, Lin FW. Nonsurgical Treatment of ectopic pregnancy. NEJM 2000; 343:1325-1329.<br />

Fylstra DL. Tubal Pregnancy: A review OF Current Diagnosis and Treatment. Obs Gyn Survey 1998; 53:320-<br />

328<br />

Draycott T Read M. The managed care of early pregnancy problems. Current opinion Obs Gyn 1997; 9:262-<br />

266<br />

Sauer MV, Gorrill MJ et al. Nonsurgical management of unruptured ectopic pregnancy: an extended clinical<br />

trial. Fertil Steril 1987; 48:752-755<br />

Lipscomb GH, McCord ML et al. Predictors of Success of Methotrexate Treatment in Women with Tubal<br />

Ectopic Pregnancies. NEJM 1999; 341:1974-1978<br />

Sowter MC, Farquhar CM et al. A randomized trial comparing single dose systemic methotrexate and<br />

laparoscopic surgery for the treatment of unruptured tubal pregnancy. BJOG 2001; 108:192-203.<br />

Hajenius PJ, Engelsbel S et al. Randomized tiral of systemic methotrexate versus laparoscopic salpingostomy<br />

in tubal pregnancy. Lancet 1997; 350:774-779.<br />

▪ Morlock RJ, Lafata JE, Einstein D. Cost-Effectiveness of Single-Dose Methotrexate Compared with<br />

Laparoscopic Treatment of Ectopic Pregnancy. Obstet Gynaecol 2000; 95:407-412<br />

▪ Cytotoxic Agents – Safe Handling and administration.<br />

CLINICAL PRACTICE GUIDELINE - Mercy Health<br />

▪ Procedure - Medication, Double Checking, Drugs, administration Procedure 2011 –Mercy Health .<br />

▪ Pharmacy Procedure -Safe Handling of Cytotoxic Drugs Mercy Health 2011<br />

▪ Procedure -Management of Extravasation: Cytotoxic Drugs Mercy Health<br />

2011

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