Title: Safe Handling – Recommendations & Best Practices
1Safe Handling Recommendations Best Practices
2Disclosure
- ltUPDATEgt
- 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.
3CPE Program Information
- ltUPDATE FORgt
- ltACPEgt
- ltANCCgt
- ltASHRMgt
- QuestionsSTAT Educational Servicesphone
888-247-8700fax 888-247-8706
4Program Learning Objectives
- At the completion of this program, participants
should be able to - Evaluate emerging data on the potential high
risks of handling hazardous drugs. - 2. Outline new recommendations and guidelines for
personnel handling hazardous drugs. - 3. Analyze the effectiveness of closed-system
drug transfer devices using new published
research/data.
5Exposure 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
6Definition of Hazardous Drugs
- Carcinogenic
- Teratogenic
- Reproductive toxicity
- Organ toxicity at low doses
- Genotoxic
- Structure or toxicity similar to drugs classified
as hazardous
(NIOSH, 2004)
7End 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 214181-9.
8Cancer 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
9Reproductive 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)
10Occupational 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
11Teratogenicity
- 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 (p0.02)
- Source Hemminki K, Kyyronen P, Lindbohm ML. J
Epidemiol Community Hlth 1985
12Modes 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)
13Evidence 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
14Drug Reconstitution With Needle Syringe
15Drug Transfer With Needle Syringe
16Transfer of Contamination from IV Bag
Photographs courtesy of L. Hampton, RN, MS, FNP
Donayre Cancer Center, Whiteville, NC.
Reproduced with permission.
17Chemotherapy on Plastic-Backed Pad
Photograph courtesy of L. Hampton, RN, MS, FNP
Donayre Cancer Center, Whiteville, NC.
Reproduced with permission.
18Where Else?
Photographs courtesy of L. Hampton, RN, MS, FNP
Donayre Cancer Center, Whiteville, NC. Reproduced
with permission.
19On the Floor
Photograph courtesy of Libby Hampton, RN, MS,
FNP Donayre Cancer Center, Whiteville, NC.
Reproduced with permission.
20Surface 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. 561427-32.
21Evaluation 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. 561427-32.
22Evaluation 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. 561427-32.
23Personal 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)
24Using a closed-system protective device toreduce
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
25Total Positive Urine Samples
- All 3 groups, pharmacists, pharmacy technicians
and nurses had positive urine samples
Pre-PhaSeal. - All locations were contaminated with 100 of RNs
and RPhs 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
26Contamination Comparison of Transfer Devices
Intended for Handling Hazardous Drugs
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
- 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.
27Utah 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
28PhaSeal Protector, Injector Luer Lock Y-site
Connector by Carmel Pharma
29Alaris Smartsite Texium by Cardinal Health
30B. Braun OnGuardVial Adaptor, Syringe Adaptor
Luer Lock Adaptorby Teva Medical Ltd.
31Results
- 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.
32Leakproof Connection Integrity TestFor 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.
33Methods
- 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.
34Clave Vial Adaptor Spiros Male Connector (ICU
Medical, Inc.)
B. Braun OnGuardVial Adaptor Syringe
Adaptor(Teva Medical Ltd.)
35Alaris SmartSite Vented VialAccess Device
Texium Male Luer (Cardinal Health)
PhaSeal Protector Injector Luer Lock (Carmel
Pharma, Inc.)
36Results
- 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.
37Workers 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
Medical Surveillance
- Source OSHA Technical Manual Controlling
Occupational Exposure to Hazardous Drugs US
Department of Labor 1999
38Medical 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
39Medical 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
2007www.cdc.gov/niosh/docs/wp-solutions/2007-117/
NIOSH -
40Medical 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
41Medical Surveillance
- NIOSH also suggests environmental sampling and/or
biological monitoring when exposure is suspected - Some organizations considering urine testing for
presence of chemotherapeutic agents
42Environmental 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
43USP 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
44USP 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
45Sessink 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
46Sessink Model
47Training 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 ASHPGullo, 1988OSHA, 1990, 1995 USP
797 revisions (2007)
48Training 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
49Training 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
50Training 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
51Training 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
52Training 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
53Training 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
54Staff Education Training
- Educator/CNS Role Accountability
- Competence
- Theory
- Principle
- Validation
- Practical application
- Skill
- Documentation
- Initial
- Annual
- PRN
-
55Staff Education Training
- Continuous Assessment
- Inservices
- Products
- Studies
- Modification/revision
- Defect
- Incidence report
56Factors to be considered when selecting a
closed-system drug transfer device system.
57ISOPP 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.
58What is the Risk?
- Hazardous drug exposure
- Skin rashes
- Infertility
- Miscarriages
- Birth defects
- Malignancy
- Leukemia
- Other cancers
59Staff Training
- Aseptic technique
- Safe handling of hazardous drugs
- Ongoing feedback
- Annual competency training
- Assessment/review on a regular basis
- Multi-disciplinary approach
60Levels 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)
61What 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
62What is the Clinical Evidence?
63(No Transcript)
64Questions to ask when evaluating a drug transfer
device
- Does the device have independent, peer-reviewed
clinical evidence that proves the efficacy in
reducing surface contamination? - Does the device have more than one piece of
clinical evidence? - Does the device have any published data that
shows that healthcare workers will not excrete
chemotherapy in their urine if the product is
used? - Does the device integrate with all phases of
preparation, administration, and disposal? - Can you reconstitute powdered medications with
the device?
65Questions 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? - Was the device beta tested by a third party for
this product? - Does the company offer ongoing clinical support
and safe handling training/education for all
staff?
66Plan of attack..
- Cytotoxic Drug Handling
- NIOSH Official Statement
- ISOPP Standard of Practice
- Overview of our testing of the product.
- Explanation
- Data overview
- Cost