SAFE HANDLING OF HAZARDOUS DRUGS

Presented byPh Waël ABI GHANEM

Chief Pharmacist Saint George Hospital

University Medical Center

Hazardous Drugs

Carcinogenicity in animal models, in patient population or both.

Teratogenicity in animal studies or in treated patients.

Fertility impairement Genotoxicity (mutagenicity) Evidence of serious organ, or other,

toxicity at low doses.

Hazardous Drugs Each facility or hospital should create

its own list of hazardous drugs based on specific criteria.

Examples : All Antineoplastic agents Immunosuppressant agents Antiviral agents

Routes of Exposure

Via the lungs (Inhalation)

Via the digestive tract (Ingestion of contaminated food stuffs)

Via the skin and mucous membranes (Mouth contact with hands)

Via injection due to needle stick injuries

Possibility of Exposure

Reconstituting powdered dugs Administering hazardous drugs Counting uncoated oral doses Handling unused hazardous drugs Decontaminating and cleaning

drug preparation or clinical areas Removing and disposing PPE

Types of toxicity

Immediate : Personnel involved in preparation Personnel involved in administration Patient

Delayed : Personnel Patient

Evidence of toxicity exposure

Case reports in the literature range from skin-related and ocular effects to flu-like symptoms and headache.

Reproductive studies on health care workers have shown an increase in fetal abnormalities, fetal loss, and fertility impairment resulting from occupational exposure.

A study done by Sessink et al. estimated that Cyclophosphamide causes an additional 1.4 – 10 cases of cancer per million workers each year.

Evidence of toxicity exposure

39 year old pharmacist suffered episodes of painless hematuria and was found to have cancer (papillary cell carcinoma). 12 years before her diagnosis, she had worked full time for 20 months in a hospital IV preparation of Cytotoxics. She used a horizontal laminar flow hood. Because she was a nonsmoker and had no other known occupational or environmental risk factors, her cancer was attributed to her exposure to antineoplastic drugs.(Levin et al. 1993)

NIOSH ALERT 2004

Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

NIOSH ALERT

WARNING!

Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers.

Recommendations

Policies and Procedures for the safe handling of Hazardous Drugs must be in place for all situations in which these drugs are used throughout a facility.

Recommendations

Developing a “Safety Program” with the following goals:

Protect and secure packages of hazardous drugs Inform and educate all involved personnel about

hazardous drugs Do not let the drugs escape from containers when

they are manipulated Eliminate the possibility of inadvertent ingestion

or inhalation and direct skin or eye contact with the drug

Recommendations

TWO GOALS: Maintaining physical integrity of

packages Safe Handling Procedures

GOAL 1 : Maintaining physical integrity of packages Access to all areas where hazardous drugs are

stored is limited to specific authorized staff A method should be present for identifying to

personnel those drugs (WARNING LABEL ) Methods for identifying shipping cartons

required from distributors Written procedures for handling damaged

packages Facilities for storing hazardous drugs are

designed to prevent breakage Methods for transporting

Goal 2

Safe Handling Procedures

- 1 -

Written policies and standard procedures are maintained.

- 2 -

Orientation Program: Theoretical Knowledge Practical Training

- 3 -

System for verifying and documenting acceptable staff performance

- 4 -

Information on the drug (Toxicity, Solubility, Stability…)

⇨MSDS (Material Safety Data Sheets)

5- Rooms and Equipment

A) Work Area

5- Rooms and Equipment (ct’d)

B) Make ready room Materials needed for the preparation Solutions ready for dispatch

C) Air Lock One room Two separate rooms Windows integrated in the door Sliding mechanism to open the window to

the preparation room

5- Rooms and Equipment (ct’d)

D) Preparation room (1) Room size : min 10 m² Height : min 2.50m Walls, ceilings and floors Cleanness of the room

E) Preparation room (2) Safety workbench Two way intercom Storage facilities for limited quantities of drugs Cleaned seatings Waste containers Decontamination kit Possibility of direct documentation of the preparation

F) Safety work Benches Biological safety

cabinets(Ventilated Cabinets)

Biological safety cabinets (1)

Different classes: I, II, III Isolators Class II : A,B1,B2,B3

Isolators

What is recommended?

BSC Type II B Class B2 or B3

Isolators

6- Personal Protective Equipment

It is the third measure to be taken in addition to organizational measures and the technical equipment

Personal Protective EquipmentA) Overall/Protective

gown Used for:

compounding, administration, spill control, waste management

Closed up to neck Long sleeves with

close-fitting cuffs Lint free Liquid repellent Single-use

Personal Protective EquipmentB) Single-use gloves To be worn at all times Suitable gloves or glove

combinations Sterile, powder free Criteria for selecting gloves:

Material properties Size and fit Safety during use (grip) Tested for freedom from holes Detectability of any damage Health of the personnel

Personal Protective Equipment

C) Additional PPE Eye & Face protection: Face shield Respirators: Fit tested, based on

OSHA standards. Shoe & Hair covering

7- Technical Equipment 3-layer work underlay Sterile compresses and swabs Single-use syringes Cannulas (needles) Container for discarded cannulas Waste container Closed system, Drug-transfer devices

(Mixing adaptor, phaseal,…)

8- Manipulative Procedures General Techniques (Use of luer-lock

syringes….) Aseptic & Negative pressure Techniques Validation:

Rooms with respect of cleaning and hygiene Cytostatics workbench Work materials Starting materials Aseptic Technique: Demonstration of

Competence

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.

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.

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.

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

What to Check before Administration

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

Personnel Protection Strict adherence to safe working practices. Personal Protective Equipment

Gown (of impermeable material) Gloves (the gloves must cover the gown on the

wrist) Mask

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.

Personnel Protection

Nurses should take precautions to prevent skin contact with the Cytotoxic drug that they are administering without causing unnecessary alarm to patients.

Always disinfect hands before the administration procedure.

Wash hands with soap and water after finishing the drug administration.

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.

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.

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

THANK YOU