Best Practices for Safe Handling of Hazardous Medications in the

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					Proper Handling of Hazardous Drugs:
    Topics for Oncology Nursing
               Presented by

       Kerry Mahar, RN, MSN, AOCN
        Dana 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-12716-04-08
1.5 Contact Hours
Expires: April 21, 2010




• Questions:
  STAT Educational Services
  phone 888-247-8700
  fax 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 Ratio
                                                                         8
                  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
                                         •      Injection
     – Aerosols
                                                 – Sharps
     – Vapors
                                                 – 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
                                  Thomas H. Connor, Roger W. Anderson, Paul J. M. Sessink, Larry Broadfield, Luci A. Power




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




 Source: AJHP 1999. 56:1427-32.




                                                                                                                      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 to
        reduce personnel exposure to antineoplastic agents
                                                 Catherine Wick, Matthew Slawson, James Jorgenson, Linda Tyler,
                                                                  Huntsman Cancer Institute, Salt Lake City, Utah




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.




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




                                                                                                             24
                            Total Positive Urine Samples


                             Agent              # positive samples*   %
    Pre-PhaSeal              Cyclophosphamide   18/48                 38
                             Ifosfamide         10/47                 21


  Post-PhaSeal             Cyclophosphamide     0/49                  0
                           Ifosfamide           0/49                  0



• 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): 2314-2320
                                                                           25
   Contamination Comparison of Transfer Devices Intended
               for Handling Hazardous Drugs
                                                                      Susan Spivey, RPh, DDS, PharmD, Pharmacy Manager
                                                               James 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




Objective
Fluorescein, 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.




                                                                                                                           26
                     Utah & MD Anderson Study
                    Are 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 Adaptor
by 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 Test
    For Devices Intended for Handling Hazardous Drugs
                                 James A. Jorgenson, RPh, MS, FASHP, Director of Pharmacy
                                          University 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 Vial
  Access Device & Texium™ Male Luer
  (Cardinal Health)




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




                                      35
                           Results



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

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




                                                                 36
                                           Medical Surveillance


“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




                                                                                                                  37
                        Medical Surveillance

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
                                          Medical Surveillance


•    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
                      Medical Surveillance

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
                        Medical Surveillance


•   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               Biological Monitoring
         (Wipe Testing)                       (Urine Testing)

• Measures the presence/release      • Assessment of uptake of the
  of the drug in the environment       drug in the body of the worker

• No information about uptake of     • Estimation of health-risk for the
  the drug in the body of the          worker
  worker

• No information about 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 than
  1.0 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           < 0.1              0.1 – 1         1 – 10              > 10
    (ng/cm2)


      Action               None                Yes             Yes               Yes
                                          At short notice   Immediately     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 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




                                                                       48
       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


                                                                    49
             Training on Handling of Hazardous Medications


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, 2007
                                                             50
             Training on Handling of Hazardous Medications


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
              Training on Handling of Hazardous Medications

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
              Training on Handling of Hazardous Medications

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

				
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