1. SAFE HANDLING OF HAZARDOUS DRUGS
Presented by
Ph Waël ABI GHANEM
Chief Pharmacist
Saint George Hospital
University Medical Center

2. 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.

3. 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

4. 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

5. 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

6. Types of toxicity Immediate : Delayed :
Personnel involved in preparation
Personnel involved in administration
Patient
Delayed :
Personnel

7. 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.

8. 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)

9. NIOSH ALERT 2004
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

10. 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.

11. 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.

12. Recommendations Protect and secure packages of hazardous drugs
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

13. Recommendations TWO GOALS: Maintaining physical integrity of packages
Safe Handling Procedures

14. 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

15. Safe Handling Procedures
Goal 2
Safe Handling Procedures

16. - 1 -
Written policies and standard procedures are maintained.

17. - 2 -
Orientation Program:
Theoretical Knowledge
Practical Training

18. - 3 -
System for verifying and documenting acceptable staff performance

19. - 4 - ⇨MSDS (Material Safety Data Sheets)
Information on the drug (Toxicity, Solubility, Stability…)
⇨MSDS (Material Safety Data Sheets)

20. 5- Rooms and Equipment
A) Work Area

21. 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

22. 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

23. F) Safety work Benches Biological safety cabinets (Ventilated

24. Biological safety cabinets (1)
Different classes: I, II, III
Isolators
Class II : A,B1,B2,B3

25. Biological safety cabinets (2)
A- Differences
Type II A : recirculating to the work room
Type II B : outside exhaust
B1 : exhaust 70 %
B2-B3 : exhaust 100 %
Hepafilters, UV lights
B-Certification
C-Cleaning : water for injection
D-Disinfecting : 70 % alcohol
E-Decontamination

26. Isolators

27. What is recommended?
BSC Type II B Class B2 or B3
Isolators

28. 6- Personal Protective Equipment
It is the third measure to be taken in addition to organizational measures and the technical equipment

29. Personal Protective Equipment
A) 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

30. Personal Protective Equipment
B) 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

31. Personal Protective Equipment
C) Additional PPE
Eye & Face protection: Face shield
Respirators: Fit tested, based on OSHA standards.
Shoe & Hair covering

35. 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,…)

36. 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

39. 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….

40. 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

41. 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…

42. 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

43. 11- Administration General Recommendations
IV 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.

44. 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.

45. 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.

46. 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

47. What to Check before Administration
Pre-Infusion parameters have to be met
Required laboratory tests
Echocardiogram
All pre-medications are given
Etc…

48. 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.

49. 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.

50. 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.

51. 12- Spill Management Policies & Procedures:
To attempt to prevent spills
To govern cleanup of spills (size, location,…)
To define the responsibility of spill management

52. 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.

53. 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

54. 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

55. 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.

56. Guidelines on hazardous drugs
American society of health system pharmacists
1985,1990
2005: guidelines on handling hazardous drugs
NIOSH (Natl. Institutes of Occupational Safety and Health)
2004:NIOSH Hazardous Drug Alert
Appendix A: Sample list
ISOPP Standards
International Society of Oncology Pharmacy Practitioners
OSHA (Occupational Safety and Health Administration)
1986
1995: Controlling Occupational Exposure to Hazardous Drugs

57. THANK YOU