Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)

Proper Handling of Hazardous Drugs: Topics for Oncology Nursing

Presented by

Kerry Mahar, RN, MSN, AOCNDana Farber Cancer Institute

Norwell, MA

1

Disclosure

• Kerry Mahar serves as an Advisory Board member for Carmel Pharma.

• This program has been supported by an unrestricted educational grant provided by Carmel Pharma.

• This program is intended strictly for educational purposes and does not constitute as an endorsement of any product or off-label usage.

2

CPE Program Information

ANCC Program CNE #: O-AO-12716-04-081.5 Contact HoursExpires: April 21, 2010

• Questions:STAT Educational Servicesphone 888-247-8700fax 888-247-8706

3

Program Learning Objectives

At the completion of this program, participants should be able to:

1. Describe the potential health risks of handling hazardous drugs in oncology nursing practice.

2. Identify the appropriate PPE needed for safe handling of hazardous drugs.

3. Review current recommendations and guidelines for safe handling of hazardous drugs.

4. List recommended practices for the safe handling of hazardous drugs during drug administration and disposal of drugs.

5. List recommendations for medical surveillance for nurses who handle hazardous drugs.

6. Describe essential elements of staff education/training related to safe handling of hazardous drugs.

4

Exposure Opportunity is Increasing

• WHO estimates a 50% increase in cancer patients in the next 20 years

• Use of drugs for non-malignant disease (RA, SLE)

• Anti-viral agents for HIV treatment and other viral illnesses

• Investigational (IND) Drug Development/Clinical Trials

5

Definition of Hazardous Drugs

• Carcinogenic

• Teratogenic

• Reproductive toxicity

• Organ toxicity at low doses

• Genotoxic

• Structure or toxicity similar to drugs classified as hazardous

(NIOSH, 2004)

6

End Organ Damage

• By definition a drug is deemed hazardous if it

causes harm to organs

• Liver damage was reported in the literature on three nurses (working 6, 8 and 16 years) with chemotherapeutic agents

• Cardiotoxicity related to the use of anthracyclines

Source: Sotaniemi EA, Sutinen S, Arranto AJ et al. Liver damage in nurses handling cytostatic agents. Acta Med Scand. 1983; 214:181-9.

7

Cancer Risk in Workers

• Leukemia in nurses (Skov et al, 1992)

(RR = 10.65)

• Cyclophosphamide (Sessink et al, 1993)

(1.4-10 excess cases/million)

• NHL & skin cancer (Hansen & Olsen, 1994)

(SIR = 3.7)

• Overall increased cancer risk (Martin, 2005)

(OR = 3.27)

RR = Relative Risk; SIR = Standardized Incidence Rate; OR = Odds Ratio8

Reproductive Risks in Workers

• Fetal abnormalities (Hemminki et al, 1985)

• Spontaneous Abortions (Stucker, 1990)

• Infertility (Valanis et al, 1997)

• Miscarriages (Valanis et al, 1999)

• Infertility, premature labor, low-birth weight, learning disabilities in offspring (Martin, 2005)

• Infertility (Fransman, 2007)

9

Occupational Exposure to Antineoplastic Agents

• Kaiser Permanente Center for Health Research

• 7,094 pregnancies of 2,976 pharmacy and nursing staff studied

• Exposure of mother to handling antineoplastic agents during pregnancy was associated with a significant increased risk for spontaneous abortion and stillbirth

• Increased risk for miscarriages by 40 - 50%• Increased risk for low birth weight by 17-fold• Increased risk for congenital malformations by 5-fold

Source: Journal of Occupational & Environmental Med Vol.41; 8: 632-638

10

Teratogenicity

• Conflicting opinion on exposure during 2nd and 3rd trimesters

• Greatest danger during 1st trimester

• Hemminki case control study of Finish oncology nurses actively handling chemotherapy during 1st trimester

• Demonstrated statistically significant increase in risk for malformations

• Odds ratio of 4.7 (p=0.02)

Source: Hemminki K, Kyyronen P, Lindbohm ML. J Epidemiol Community Hlth 1985

11

Modes of Contact for Drug Exposure to Healthcare Worker

• Dermal*– Direct contact– Contaminated surfaces

• Ingestion– Food, gum– Hand-to-mouth

• Inhalation– Aerosols– Vapors

• Injection– Sharps– Breakage

*Most common source of exposure (NIOSH, 2004) 12

Evidence of Exposure

• Positive florescent scans (Valanis, 1998)

• Positive urine tests for drug exposure

– 18 Published studies

• 16 detected drugs in urine

• In 4 studies, drugs were found in the urine of workers

with no direct HD contact

• Contaminated vials - 12 studies since 1992

• Surface contamination - 14 studies since 1994

13

Drug Reconstitution With Needle & Syringe

14

Drug Transfer With Needle & Syringe

15

Transfer of Contamination from IV Bag

Photographs courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 16

Chemotherapy on Plastic-Backed Pad

Photograph courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 17

Where Else?

Photographs courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission. 18

On the Floor…

Photograph courtesy of Libby Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission.19

Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States

Source: AJHP 1999. 56:1427-32.

Objective:

This study was designed to demonstrate the presence of ctyotoxic drugs in the workplace.

Thomas H. Connor, Roger W. Anderson, Paul J. M. Sessink, Larry Broadfield, Luci A. Power

20

Evaluation of Surface Contamination

Study was conducted at six cancer treatment centers

– 3 in the United States and 3 Canadian centers

– Wipe samples analyzed for • Cyclophosphamide and ifosfamide by GC-MS-MS• Fluorouracil by reverse-phase HPLC with UV-light detection

– All pharmacies used class II Biological Safety Cabinets (BSCs)

Source: AJHP 1999. 56:1427-32.

21

Evaluation of Surface Contamination

• Measurable levels of antineoplastic agents were detected in

– 75% of the pharmacy samples• Top area of BSC airfoil• Floor in prep room and in front of BSC • Work surface inside BSC

– 65% of the administration samples• Floor around chair and patient bed• Top of preparation area

Source: AJHSP 1999. 56:1427-32.

22

Personal Protective Equipment to Prevent Exposure in Healthhcare Workers

• Gloves: tested with hazardous drugs, powder-free, latex,

nitrile, neoprene

– Double gloves

– 30-min wear time

• Gowns: tested with hazardous drugs, disposable, single-

use, cuffs, back closure

• Eye protection:

– when splashing is possible

• Respirator/mask:

– for aerosols & spill clean-up

• Close System Transfer Device (CSTD)

23

Using a closed-system protective device toreduce personnel exposure to antineoplastic agents

Source: Wick C. AJHP 2003; 60 (15): 2314-2320

This study examined pharmacists, technicians and nurses at the Huntsman Cancer Center in Salt Lake City, Utah. Urine samples were collected separately from each group over a 24-hour time period.

Catherine Wick, Matthew Slawson, James Jorgenson, Linda Tyler,Huntsman Cancer Institute, Salt Lake City, Utah

24

Agent # positive samples* %

Pre-PhaSeal Cyclophosphamide 18/48 38

Ifosfamide 10/47 21

Post-PhaSeal Cyclophosphamide 0/49 0

Ifosfamide 0/49 0

Total Positive Urine Samples

• All 3 groups, pharmacists, pharmacy technicians and nurses had positive urine samples Pre-PhaSeal.

• All locations were contaminated with 100% of RN’s and RPh’s contaminated and 30% of Pharmacy technicians

• After using PhaSeal for 6 months, there were no positive urine samples recorded and surface level contamination was reduced 10X.

Source: Wick C. AJHP 2003; 60 (15): 2314-232025

Contamination Comparison of Transfer Devices Intended for Handling Hazardous Drugs

ObjectiveFluorescein, a fluorescent indicator, was used to determine if the Tevadaptor™ System, Alaris System or PhaSeal System have the potential to allow drugs to escape into the environment during the preparation and administration phases of hazardous drug handling.

Presented at ONS Congress, April, 2007, Las Vegas, NV.

Susan Spivey, RPh, DDS, PharmD, Pharmacy ManagerJames A. Jorgenson, RPh, MS, FASHP, Director of Pharmacy

University of Texas, MD Anderson Cancer Center and University of Utah Health Care, Salt Lake City, Utah

26

Utah & MD Anderson StudyAre Connections Really Dry?

• Evaluated dry connection of three commercially available systems for chemotherapy preparation

• Utilized flourescein dye and transferred from a vial to syringe

• Photographed vial and syringe adaptors under UV light

• “Tapped” syringe adaptor on gauze to determine any leakage

27

PhaSeal® Protector, Injector Luer Lock &Y-site Connector by Carmel Pharma

28

Alaris Smartsite® & Texium by Cardinal Health

29

B. Braun OnGuard™Vial Adaptor, Syringe Adaptor & Luer Lock Adaptorby Teva Medical Ltd.

30

Results

• With the PhaSeal System, no leakage was observed during any of the preparation or administration manipulations.

• Both the Tevadaptor™ System and the Cardinal Health/Alaris System showed visible fluorescein leaks on the outside of each component during all manipulations of drug preparation and administration.

31

Leakproof Connection Integrity TestFor Devices Intended for Handling Hazardous Drugs

James A. Jorgenson, RPh, MS, FASHP, Director of PharmacyUniversity of Utah Health Care, Salt Lake City, Utah

Objective

To determine if the ICU Medical System,B. Braun/Tevadaptor™ System, Cardinal/Alaris System or PhaSeal® System connections are leak proof or have the potential to allow drugs to escape into the environment during the preparation and administration phases of hazardous drug handling.

32

Methods

• A liquid with low pH was used as a substitute for active drug. Litmus paper was used as pH indicator. Blue litmus paper turns red under acidic conditions.

• Syringes were filled with fluid and injected into vials attached to the above transfer devices. After aspirating back and disconnecting, the connections of each device were pressed against litmus paper to detect the presence of any fluid.

• Every component of each device was tested for 10 manipulations.

33

Clave® Vial Adaptor& Spiros™ Male Connector(ICU Medical, Inc.)

B. Braun OnGuard™Vial Adaptor & Syringe Adaptor(Teva Medical Ltd.)

34

Alaris SmartSite® Vented VialAccess Device & Texium™ Male Luer (Cardinal Health)

PhaSeal® Protector& Injector Luer Lock(Carmel Pharma, Inc.)

35

Results

• Visible leakage occurred outside of the components on theICU Medical System Clave® and Spiros™ connections,the B. Braun/Tevadaptor™ System and theCardinal Health/Alaris System during all manipulations.

• No leakage was observed in any of the manipulations with the PhaSeal® System.

36

“Workers who are potentially exposed to chemical hazards should be monitored in systematic program of medical surveillance to prevent occupational injury and disease… The purpose of surveillance is to identify the earliest reversible biological effects so that exposure can be reduced or eliminated before the employee sustains irreversible damage”

Source: OSHA Technical Manual: Controlling Occupational Exposure to Hazardous Drugs US Department of Labor 1999

Medical Surveillance

37


For Who & Why…– To develop a standard that applies to all employees that support

patient care services Product preparation Product administration & infusion Acquisition transportation Environmental service/housekeeping Waste disposal

– To identify biologic effects in anticipation that exposure will be reduced or eliminated [before an employee sustains irreversible damage or injury]

38


• NIOSH recommends (not a mandate) workers handling hazardous drugs be monitored

– Medical history

– Exposure history

– Physical examination

– Selected lab tests (complete blood count, reticulocyte count, or occult blood in urine)

Source: NIOSH 117 document April 2007;www.cdc.gov/niosh/docs/wp-solutions/2007-117/NIOSH

39


Elements of a medical surveillance program• Reproductive and health questionnaires at hire and periodically• Laboratory work

– Complete blood count, Urinalysis, Reticulocyte count, Transaminases (AST, ALT), Alkaline Phosphatase

• Physical examination at hire and thereafter for abnormal findings on health questionnaire

• Follow-up for those workers who have health changes or significant exposures

• Tracking trends with questionnaires and sick-call

40


• NIOSH also suggests environmental sampling and/or biological monitoring when exposure is suspected

• Some organizations considering urine testing for presence of chemotherapeutic agents

41

Environmental and Biological Monitoring

Environmental Monitoring(Wipe Testing)

• Measures the presence/release of the drug in the environment

• No information about uptake of the drug in the body of the worker

• No information about health-risk for the worker

Biological Monitoring(Urine Testing)

• Assessment of uptake of the drug in the body of the worker

• Estimation of health-risk for the worker

42

USP 797 Recommendation for Environmental Sampling

• Suggests routine environmental sampling to detect uncontained hazardous drugs

• Initial benchmark and every 6 months or more as needed

• Surface wipe sampling of BSC or CACI and adjacent areas including the floor directly under the work area, counter tops, and patient care areas

• Common marker drugs include cyclophosphamide, ifosfamide, methotrexate, and fluorouracil

43

USP 797 Recommendation for Environmental Sampling

• If any measurable contamination is found, practitioners shall make the decision to identify, document and contain the cause

• Action may include retraining, thorough cleaning, and improving engineering controls

• USP notes that cyclophosphamide levels greater than1.0 ng/cm2 has been found to cause human uptake

44

Sessink Stride Risk Level Model

• Based on predictive model for additional cancer cases per million workers based on cyclophosphamide urine levels

• Stride risk level is 1 extra cancer case a year per million workers

• Prohibitory risk level is 100 extra cancer cases a year per million workers

Source: Dr. Paul Sessink Exposure Control; 2008

45

Sessink Model

Stride Risk Level Prohibitory Risk Level

Urine CP (ug/24 hr) < 0.02 0.02 – 0.2 0.2 – 2 > 2

Contamination CP (ng/cm2)

< 0.1 0.1 – 1 1 – 10 > 10

Action None Yes

At short notice

Yes

Immediately

Yes

Stop Working

Monitoring Periodic Regular Regular Regular

46

Training on Handling of Hazardous Medications

• ASHP (1990) and OSHA (1995) agencies must have a system for validating staff performance, and this must be documented

• USP 797 revisions state all personnel who compound hazardous drugs shall be fully trained in the storage, handling and disposal of these drugs

• Training must occur prior to preparing or handling hazardous CSPs & effectiveness must be verified by testing specific hazardous preparation techniques at least annually with results documented

• Current MSDSs must be readily available in the areas hazardous drug preparation and administration

Source: ASHP;Gullo, 1988:OSHA, 1990, 1995: USP 797 revisions (2007)

47


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

48


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

49


Storage and Compounding• Evaluation of work environment and equipment• Policy & Procedures

– Delineation of hazardous materials• Develop list with Safety departments

– Labeling, storage, personnel issues, spill control– Education, preparation, administration, disposal

• Evaluation of workspace– Ventilated cabinets

• Use of equipment or devices to minimize exposure– Personal Protective Equipment (PPE)– Closed-system drug transfer device (CSTD)

Source: Massoomi, 200750


Decontamination Procedures• “Decontamination” of cabinets

– Surface Safe (15/case) $1.43 each• Step 1: 2% sodium hypochlorite detergent• Step 2: 1% sodium thiosulfate & 0.9% benzyl alcohol• 6% Hypochloride solution

– Combination of surface safe & cationic soap solution• “Sterilization” of cabinets

– Caution isopropyl alcohol use in Type II-A and II-B3– Must be in contact for 30 seconds

Source: Massoomi, 2007

51


Appropriate Personal Protective Equipment (PPE)• Gloves

– Use good-quality gloves made of latex, nitrile, polyurethane, neoprene, or other materials that have been tested with hazardous drugs.

– Select powder-free gloves. – Inspect gloves for visible defects. – Wear double gloves for drug preparation. – Change gloves every 30 minutes or immediately if damaged or

contaminated.• Eye Protection

– When splashing is possible

Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26

52


Appropriate Personal Protective Equipment (PPE) - continued• Gowns

– Wear gowns that are disposable, made of a lint-free, low-permeability fabric.

– They should have a solid front (back closure) and knit or elastic cuffs.

– Laboratory coats and other cloth fabrics absorb fluids, so they provide an inadequate barrier to hazardous drugs and are not recommended.

– The existing guidelines do not contain a recommendation for the maximum length of time that a gown should be worn. Because no recommendations are stated in the literature, at a minimum, change the gown every time it is contaminated or gloves are changed.

• Respirator/masks– For aerosols & spill clean-up

Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26 53

Staff Education & Training

• Educator/CNS Role & Accountability

– Competence• Theory• Principle

– Validation• Practical application• Skill

– Documentation• Initial• Annual• PRN

54

Staff Education & Training

– Continuous Assessment

– Inservices

– Products Studies Modification/revision Defect Incidence report

55

Factors to be considered when selecting a closed-system drug transfer device system.

56

ISOPP* Standards of Practice

• Know Your Risk• Staff Training• Levels of Protection• Closed-System

– Definition– Clinical Evidence

*ISOPP =International Society of Oncology Pharmacy Practice

J Onc Pharm Pract 2007; 13 Suppl.57

What is the Risk?

• Hazardous drug exposure– Skin rashes– Infertility– Miscarriages– Birth defects– Malignancy

• Leukemia• Other cancers

58

Staff Training

• Aseptic technique• Safe handling of hazardous drugs• Ongoing feedback

– Annual competency training– Assessment/review on a regular basis

• Multi-disciplinary approach

59

Levels of Protection

• Level 1 – Elimination/substitution/replacement

• Level 2 – Isolation of the hazard/source containment

• Level 3 – Engineering controls/Proper ventilation

• Level 3b – Administrative controls/ Organization measures

• Level 4 – Personal protective equipment (PPE)

60

What is a Closed-System?

“A closed system drug transfer device mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system”

NIOSH*

* National Institute for Occupational Safety & Health

61

What is the Clinical Evidence?

62

63

Questions to ask when evaluating a drug transfer device

1. Does the device have independent, peer-reviewed clinical evidence that proves the efficacy in reducing surface contamination?

2. Does the device have more than one piece of clinical evidence?

3. Does the device have any published data that shows that healthcare workers will not excrete chemotherapy in their urine if the product is used?

4. Does the device integrate with all phases of preparation, administration, and disposal?

5. Can you reconstitute powdered medications with the device?

64

Questions to ask when evaluating a drug transfer device (cont)

6. Does the system have universal capability

7. Does the product remain closed throughout multiple manipulations in preparation and administration as defined in the NIOSH and ISOPP guidelines as the standard?

8. Does the device protect over a full spectrum of hazardous drugs?

9. Was the device beta tested by a third party for this product?

10. Does the company offer ongoing clinical support and safe handling training/education for all staff?

65

Plan of attack…..

• Cytotoxic Drug Handling• NIOSH Official Statement• ISOPP Standard of Practice• Overview of our “testing” of the product.

– Explanation– Data overview– Cost

66

Documents

Nursing Grassroots - Mahar.ppt 7376.384 KB (7376384 bytes)