9-Requisition of cytostatic solutions Requisition form:

Name & gender Body weight, height and /or BSA Cytostatic prescribed Dosage Type of carrier solution Volume of the ready-to-administer solution Required administration time Signature of doctor, date Etc….

10-Preparation

A-Work Sheet for the Drug Name of cytostatic Kind and name of finished drug to be

used Types and names of medical devices Method of proper preparation Kind of packaging Information on label

10-Preparation (ct’d)

B-Documentation Time at which the preparation started Batch number of the finished drug used

( cytostatics, solvents,..) Quantity of cytostatics used Unusual incidents during the preparation Name and signature of the person Etc…

10-Preparation (ct’d)

C-Label Name of the pharmacy Name of the patient Ward, bed number Name and quantity of the cytostatic Type and volume of carrier solution Method of administration Required time of administration Storage conditions Date of expiry

11- Administration

General RecommendationsIV Cytotoxic chemotherapy should be administered by nursing personnel who have received specialized education and training, and they should be able to demonstrate their competency on a regular basis.

What to Check before Administration

Pre-Infusion parameters have to be met Required laboratory tests Echocardiogram All pre-medications are given Etc…

What to Check before Administration

Review the Physician Order Read the label on the infusion bag:

Check for the name of the patient Check for the name of drug (same as

order) Check for the dose Check for the Administration route Check for the rate of infusion Check for any special handling conditions

11- Administration IV Preparations

PPE: Gloves, Gowns, Eye protection Staff should check the blood return in

the catheter to confirm the patency prior to administration.

On completion of administration, an appropriate solution should be infused to flush any remaining cytotoxic out of the line, then the line may be disconnected.

Personnel Protection Use a new pair of gloves for each

patient. Change the gloves if damaged or

significant contamination occurs Any cuts or scratches on the nurse’s

hands should be covered with waterproof dressings to prevent infiltration of the site.

Vials containing drugs requiring reconstitution should be vented to reduce the internal pressure with a venting

device using a 0.22 micron hydrophobic filter or other

appropriate means such as a chemotherapy dispensing pin. This reducesthe probability of spraying and spillage.

If a chemotherapy dispensing pin is not used, a sterile Alcohol pad should be carefully placed around the needle And vial top during withdrawal from the septum.

The external surfaces contaminated with a drug should be wiped clean with an alcohol pad prior to transfer or transport.

When bubbles are removed from syringes or I.V. tubing, An alcohol pad should be placed carefully over the tip of such items in order to collect any of the cytotoxic drugs.

When opening the glass ampule, 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.

Syringes and I.V. bottles containing cytotoxic drugs should

be labeled and dated. Before these items leave the preparation

area, an additional label reading, "Caution-chemotherapy,

Dispose of Properly" is recommended.

6. Designate a workplace for handling hazardous drugs.

7. Have a spill kit and hazardous drug waste container readily available.

8. Procedure for gowning and gloving: Wash hands, don first pair of gloves, don gown and face shield, and then don second pair of gloves. Gloves should extend beyond the elastic or knit cuff of the gown. Double-gloving requires one glove to be worn under the cuff of the gown and the second glove over the cuff.

9. Always work below eye level.

10. Visually examine hazardous drug dose while it is still contained in transport bag.

11. If hazardous drug dose appears intact, remove it from the transport bag.

12. Place a plastic-backed absorbent pad under the administration area to absorb leaks and prevent drug contact with the patient’s skin.

14. Place a gauze pad under the connection at injection ports during administration to catch leaks.

15. Use the transport bag as a containment bag for materials contaminated with hazardous drugs, drug containers, and sets.

16. Discard hazardous drug containers with the administration sets attached; do not remove the set.

17. Wash surfaces that come into contact with hazardous drugs with detergent, sodium hypochlorite solution, and neutralizer, if appropriate.

18. Wearing gloves, contain and dispose of materials contaminated with hazardous drugs and remaining PPE as contaminated waste.

19. Hazardous drug waste container must be sufficiently large to hold all discarded material, including PPE.

20. Do not push or force materials contaminated with hazardous drugs into the hazardous drug waste container.

21. Carefully remove, contain, and discard gloves. Wash hands thoroughly after removing gloves.

General Guidelines Be careful while giving injections in

order to prevent extravasations. Be careful during the

connection/disconnection of the bag or syringe to the administration device.

Never remove the tubing from an IV bag containing a Cytotoxic drug, and don’t disconnect the tubing at other points in the system until the tubing has been flushed well with a non toxic solution.

11- Administration

Oral Preparations PPE: Gloves, Gowns Number of tablets to be given

should be shaken from the bottle into a medicine cup, without skin contact.

Cytotoxic tablets and capsules must never be crushed, powdered or opened in any way, for ease of administration.

Hazardous drugs should be labeled or otherwise identified as such to prevent improper handling.

Tablet and capsule forms of hazardous drugs should not be placed in automated counting machines, which subject them to stress and may introduce powdered contaminants into the work area.

1. Double gloves are required, as is a face shield if there is a potential for spraying, aerosolization, or splashing.

2. Workers should be aware that tablets or capsules may be coated with a dust of residual hazardous drug that could be inhaled, absorbed through the skin, ingested, or spread to other locations and that liquid formulations may be aerosolized or spilled.

3. No crushing or compounding of oral hazardous drugs may be done in an unprotected environment.

Hazardous drugs should be dispensed in the final dose and form whenever possible. Unit-of-use containers for oral liquids have not been tested for containment properties. Most exhibit some spillage during preparation or use. Caution must be exercised when using these devices.

Bulk containers of liquid hazardous drugs, as well as specially packaged commercial hazardous drugs (e.g., Neoral [manufactured by Novartis]), must be handled carefully to avoid spills. These containers should be dispensed and maintained in sealable plastic bags to contain any inadvertent contamination.

12- Spill Management

Policies & Procedures: To attempt to prevent spills To govern cleanup of spills (size,

location,…) To define the responsibility of spill

management

12- Spill Management

A spill kit should be present at the nursing unit where administration takes place.

The concerned personnel should be trained to the use of the kit.

Do not forget to report any accidental spillage.

Decontamination Set-Spill kit

Instructions for use Emergency signs Single-use overall or gown Overshoes Respiratory protection

mask Protective gloves Disposable clothes Water and ethanol Waste containers Documentation forms

13-Waste Management

Cytotoxic waste is considered to be all those materials which have come into contact with cytotoxic drugs during reconstitution and administration:

Syringes, needles, transfusion sets… Empty or partially used vials PPE Materials used for clean up Air filters Expired drugs

13-Waste Management

Cytotoxic waste must be segregated, packaged and disposed of in a way that personnel and environment are not contaminated.

Cytotoxic waste must be incinerated in a facility approved by an environmental protection authority.

آلودگی شخصی دستکش ها یا روپوش را در آورده و در ظرف a فورا

مخصوص زباله های شیمی درمانی بیندازید. .پوست آلوده شده را با آب و صابون بشوئید a فورا دقیقه زیر شیر 15چشم آلوده شده را به مدت حداقل

آب مخصوص شستشوی چشم، نگه داشته، یا با آب یا محلول ایزوتونیک مخصوص شستشوی چشم بشوئید.

اقدامات پزشکی الزم را انجام دهید. پروتکل هایاقدامات پزشکی در شرایط اورژانسی باید در مکان های

مخصوص و قابل دسترس، نگهداری شوند. همچنین در صورت استنشاق داروهای خطرآفرین پودری، باید

مراقبت های پزشکی الزم را انجام دهید. .این حادثه را در گزارش پزشکی فرد مورد نظر ثبت کنید

Guidelines on hazardous drugs

American society of health system pharmacists 1985,1990 2005: guidelines on handling hazardous drugs

http://www.ashp.org/bestpractices/new/HD-Prepub-final.pdf NIOSH (Natl. Institutes of Occupational Safety and

Health) 2004:NIOSH Hazardous Drug Alert

Appendix A: Sample list http://www.cdc.gov/niosh/docs/2004-165/

ISOPP Standards International Society of Oncology Pharmacy Practitioners

OSHA (Occupational Safety and Health Administration) 1986 1995: Controlling Occupational Exposure to Hazardous Drugs

http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

Training on Handling of Hazardous Medications

Training must include at least:• Use of engineering controls including correct use of closed-system

transfer devices• Use of PPE• Drug preparation• Drug Transport• Drug administration• Disposal of hazardous materials• Management of hazardous drug spills• Management of acute exposure

30

Training on Handling of Hazardous Medications

Education Plan• Orientation to hazardous chemicals

– Key contacts within the organization– Location of policies

• Encourage employees to notify their physician of their possible occupational exposure to hazardous drugs

• Educate employees of signs and symptoms– Based on the agents

• Acute vs. chronic– Annual review of critical process and hazardous chemicals– Plan in place to educate on new chemicals

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American Society of Health-System American Society of Health-System Pharmacists Guidelines (2006)Pharmacists Guidelines (2006)

“Until the reproductive risks (or lack thereof) associated with handling hazardous drugs within a safety program have been substantiated, staff who are pregnant or breast-feeding should be allowed to avoid contact with these drugs. Policies should be in effect that provide these individuals with alternative tasks or responsibilities, if they so desire. In general, these policies should encourage personnel to solicit recommendations from their personal physicians regarding the need for restricted duties. In the case of personnel actively trying to conceive or father a child, a similar policy should be considered, and a specific time period (e.g., three months) should be agreed upon. Legal counsel should be sought when establishing policies.”

MNA Survey: Hazardous MNA Survey: Hazardous Drug Information FormDrug Information Form 20062006 2000 nurses surveyed at 3 facilities2000 nurses surveyed at 3 facilities 400 responses400 responses 87% reported handling/administering 87% reported handling/administering

hazardous drugshazardous drugs Only 54% aware of programs re: safe Only 54% aware of programs re: safe

handling of hazardous drugs and traininghandling of hazardous drugs and training Only 30% read programsOnly 30% read programs Only 12% had classroom trainingOnly 12% had classroom training Only 6% had hands-on-trainingOnly 6% had hands-on-training

Survey results cont.Survey results cont.

Nurses do not identify many drugs Nurses do not identify many drugs they administer as hazardousthey administer as hazardous

Continue to handle in same mannerContinue to handle in same manner Not aware of changes in controlsNot aware of changes in controls 70% use personal protective 70% use personal protective

equipment, likely glovesequipment, likely gloves Use of face shields, and gowns or lab Use of face shields, and gowns or lab

coats much less likelycoats much less likely 10% do not use any PPE10% do not use any PPE

تاریخچه و آزمایشات پزشکی اولیه کارکنان اطالعات شغلی و تاریخچه پزشکی و بارداری

(تولید مثل) افراد هنگام استخدام افراد معاینات کامل بالینی باید

سال تکرار شود1-2کامل انجام شده و هر پس از مورد جدی تماس با داروهای خطرآفرین داشتن گزارشاتی از داروهایی که فرد ساخته یا

تزریق کرده

No single process has been found to deactivate all currently available hazardous drugs. The use of alcohol for disinfecting the BSC or isolator will not deactivate any hazardous drugs and may result in the spread of contamination rather than any actual cleaning.

The MSDSs for many hazardous drugs recommend sodium hypochlorite solution (strong oxidizing agent) as an appropriate deactivating agent.

Appropriate preparation of materials used in compounding before introduction into the Class II BSC or isolator, including spraying or wiping with 70% alcohol or appropriate disinfectant, is also necessary for aseptic compounding.

The area under the work tray should be cleaned at least monthly to reduce the contamination level in the Class II BSC (and in isolators, where appropriate).

For surface decontamination the use of gauze moistened with alcohol, sterile water, peroxide, or sodium hypochlorite solutions may be effective.