Prepared by: Environment, Health and Safety Office, Pharmacy, Employee Health, Nursing Services, Respiratory Therapy
Revised: August 1990, May 1991, June 1993, February 1996
TABLE OF CONTENTS
STATEMENT OF AUTHORITY
I. INTRODUCTION
II. HAZARDOUS DRUGS AND POTENTIAL RISKS
A. Antineoplastic Agents
B. Other Hazardous Drugs
III. GUIDELINES FOR HAZARDOUS DRUG USE AND HANDLING
A. Drug Preparation
1. Preparation Area
2. Preparation Equipment
3. Personal Protective Equipment (PPE)
4. Work PracticesB. Drug Administration
1. Personal Protective Equipment
2. Work PracticesC. Patient Care Precautions Following Drug Administration
1. Personal Protective Equipment (PPE)
2. Linen
3. Reusable Items
4. Waste Disposala. Equipment
b. Handling
c. DisposalD. Waste Collection and Disposal
1. Trace Contaminated Material
2. Bulk Contaminated Materials
3. Hazardous Drug Waste Handling
4. Scheduled pick-upsE. Spill Clean-Up, Decontamination, and Reporting Procedures
1. Small Spills (<100 ml)
2. Larger Spills [>1 Ampule or >100 ml] And Any Spill In Public Access Areas
3. Surface/Equipment Decontamination
4. Personnel Decontamination
5. Reporting ProceduresF. Medical Surveillance
1. Screening
2. Records of Potentially Exposed Employees
3. Treatment of Acute ExposuresG.Special Exposure Concerns
1. Reproductive Hazards
2. Personnel Breast-Feeding InfantsH. Receipt, Storage, and Transport of HDs
1. Receipt
2. Storage/Handling
3. Damaged Packages
4. Transport.I. Education, Training, and Information Dissemination
POLICY
It is a policy of the University of Kansas Medical Center that no faculty, staff or student shall engage in any task which presents a risk of exposure to hazardous drugs without first receiving appropriate instructions pertaining to the risks associated with exposure to hazardous drugs, as well as standard operating procedures, work practices, and protective equipment to be used to minimize risk of exposure.
Each department is responsible for ensuring that faculty, staff, and students receive adequate training and are competent to work with hazardous drugs.
Faculty, staff, and students are responsible for complying with the policies and procedures contained in this document.
I. INTRODUCTION
There has been increasing use of hazardous drugs (HD’s) in health care and growing evidence of potential hazards of handling, preparation, administration, and disposal of these agents. The enclosed guidelines have been developed specifically for the protection of all personnel involved in the handling of HD's from the time the drugs arrive at the hospital until their wastes are transported for disposal.
The mutagenic, teratogenic, and carcinogenic potential of many of the hazardous drugs have been well established, and represent possible health hazards for exposed individuals. Determining the magnitude of the degree of risk to any potentially exposed individual or group is still very difficult due to the limited number of exposure studies performed to date. Until more extensive information is available, the enclosed guidelines are and will remain reasonably conservative in nature. They will be updated or modified as necessary.
Included in the guidelines is a brief summary of the known hazards of the drugs; procedures and equipment necessary for the safe handling, use, and disposal of the drugs; and a list of hazardous drugs currently in use.
II. HAZARDOUS DRUGS AND POTENTIAL RISKS
A. Antineoplastic Agents
The hazards associated with drug usage in health care were first recognized for antineoplastic agents. The attempt to stop or reverse the growth of malignant growing cells began in the late 1940's when nitrogen mustard and its derivatives were first used therapeutically.
In spite of the medical benefits resulting from use of these drugs, they may be potentially harmful to workers handling them. Adverse health effects from both acute and chronic exposures have been demonstrated in health care personnel. Over a long term, almost all of these drugs have the potential of damaging cells or adversely affecting cellular growth and reproduction. The drugs bind directly to genetic material in the cell nucleus, or affect cellular protein synthesis.
In vivo, in vitro, and human studies have implicated antineoplastic drugs in chromosomal damage, teratogenesis, and carcinogenesis. Testicular and ovarian dysfunction including permanent sterility have been demonstrated in male and female patients, respectively, who have received these drugs singly or in combination. Finnish studies have shown an increased incidence of fetal loss among nurses routinely working with antineoplastic agents than among those who do not. Other studies have suggested a correlation between exposure to antineoplastic agents and fetal malformation in pregnant nurses.
Additionally, organ damage has been associated with exposure to some antineoplastic agents. Liver damage has been reported in oncology employees, and appears to be related to the duration and the concentration of the exposure.
Many questions concerning risks to personnel handling these drugs remain to be answered. Synergistic effects of antineoplastic agents in conjunction with other chemicals and physical agents are still relatively unknown. Exposure risks for particular groups, such as persons actively attempting to conceive a child, or mothers who are breast-feeding, have not been accurately determined.
The risks to workers handling antineoplastic agents are a result of the inherent toxicity of the drugs themselves, and the actual dose which a worker receives. The dose is dependent on the concentration of the drug, the duration of the exposure, and the route of entry. The possibility of adverse health effects as a result of exposure to a particular drug may depend on whether the drug enters the body through inhalation, absorption through the skin, or ingestion.
B. Other Hazardous Drugs
It is clear that other drugs used in health care may also pose occupational risk to employees. Therefore, in 1994, the Occupational Safety and Health Administration (OSHA) revised its guidelines for the safe handling, storage, and disposal of antineoplastic agents to include all hazardous drugs. Because of all the variables involved, as well as a lack of effective exposure monitoring (which will be discussed in a later section), it is very difficult to assess the degree of risk for personnel handling the drugs. Therefore, it is imperative that effective controls be implemented to minimize exposures to the extent reasonably feasible.
III. GUIDELINES FOR HAZARDOUS DRUG USE AND HANDLING
A. Drug Preparation
1. Preparation Area
Whenever possible, HDs shall be prepared in the specifically designated area of the pharmacy, or in a dedicated Class II Biological Safety Cabinet (BSC) in a clinic or oncology unit. Preparations of HDs anywhere else shall not be permitted, except in those cases where the drug must be reconstituted and administered immediately secondary to rapid degenerations, or where patient body fluids are needed.
Warning signs designating areas as hazardous drug preparation areas shall be clearly posted. Eating, drinking, smoking, chewing gum or tobacco, applying cosmetics, and storing food and smoking materials in or near a preparation area is forbidden. Emergency procedures shall be posted in the immediate area.
2. Preparation Equipment
In the Pharmacy, mixing of parenteral hazardous and cytotoxic drugs will be performed in a Class II Vertical Laminar Flow Biological Safety Cabinet.
a. To the extent possible, the vertical flow biological safety cabinet (BSC) will be used only for the preparation of hazardous and cytotoxic drugs.
b. The BSC will be certified by a qualified technician semi-annually, and any time it is physically moved.
c. The BSC will be operated with the blower on 24 hours per day, 7 days per week.
d. Drug preparation will be performed with the viewing window at the required access opening.
e. The inside of the BSC will be cleaned at least once each shift that the hood is in use. Water soluble material will be removed using a gauze pad soaked in benzalkonium chloride 1:750 solution. The BSC will then be disinfected with alcohol 70% solution. This cleaning will be documented by initialing the sheet on the outside of the hood.
f. The BSC surface will be decontaminated on a monthly basis and whenever there is a spill or the BSC is moved or serviced.
1) Decontamination will consist of removal of contamination from the cabinet to a disposable surface (e.g., gauze, towels) by using a cleaning agent that removes chemicals from stainless steel.
2) During decontamination, the operator will wear a disposable closed-front gown, disposable latex gloves covered by disposable utility gloves, safety goggles, a hair covering and a disposable respirator.
3). The blower will be left on.
4) Disposable heavy toweling or gauze will be used.
5) Decontamination will be done from top to bottom by applying the cleaner, scrubbing, and rinsing thoroughly with distilled water.
6) All contaminated disposables will be contained in sealable bags for transfer to larger waste containers.
7) The HEPA filter must not become wet during cleaning of the protective covering.
8) Rinse water and gauze will be disposed of as contaminated waste.
9) All protective apparel will be disposed of as contaminated waste.
10) The monthly decontamination will be documented on the form affixed to the hood.
3. Personal Protective Equipment
Protective apparel will be worn by staff members compounding cytotoxic and hazardous drugs.
a. Staff members will wear powder-free disposable surgical latex gloves when preparing hazardous drugs. Double gloving is recommended. The outer glove will be changed immediately if contaminated. To limit transfer of contamination from the BSC into the work area, outer gloves will be removed after each batch and will be placed in zip-lock bags for disposal. Staff members working in the BSC will not touch objects outside of the hood while wearing gloves that have been exposed to cytotoxics.
b. Staff members will wear a protective disposable gown made of lint-free low-permeability fabric with a solid front, long sleeves, and tight fitting cuffs when preparing hazardous drugs. When double gloving, one glove will be placed under the gown cuff and one over.
c. Gloves and gowns will not be worn outside the immediate preparation area.
d. An eyewash station will be available in the area where hazardous drugs are compounded.
e. Whenever splashes, sprays, or aerosols of HD’s may be generated, which can result in eye, nose, or mouth contamination, chemical-barrier face and eye protection must be provided. Eye glasses with temporary side shields are inadequate protection.
f. In those instances where a hazardous substance are handled outside of the BSC, for example, prepackaging oral chemotherapy agents, it may be necessary to wear a respirator. If a respirator is worn to provide respiratory protection and splashes, sprays, or aerosols are possible, then eye and face protection should be:
1. A full-face respirator, or
2. Use of a plastic face shield or splash goggles complying with ANSI Standard Z.07.2 when using a half-mask respirator.
NOTE: Surgical masks offer little or no protection against inhalation of HD's. Do not rely on surgical masks for adequate personal protection.
4. Work Practices
Proper manipulative technique to maintain the sterility of the injectable drugs and to prevent the generation of hazardous-drug contaminants will be used consistently.
a. All drug and non drug items required for completing a dose or batch and for containing the waste will be assembled and placed near the BSC. Care will be taken not to overload the BSC work area.
b. Calculations and any label preparation will be completed prior to beginning work in the BSC.
c. Appropriate gowning, hand washing and gloving (or glove changing), will be completed before manipulations begin.
d. The BSC will be cleaned and disinfected regularly. The BSC will be disinfected with alcohol 70% before any aseptic manipulation is begun. A lint free plastic-backed disposable liner will be used in the BSC to facilitate spill cleanup.
e. Unnecessary moving in and out of the BSC will be avoided during aseptic manipulations.
f. Syringes and sets with luer-lock type fittings will be used for preparing and administering hazardous drug solutions. Care will be taken to ensure that all connections are secure. Syringes will be large enough so that they are not full when containing the total drug dose.
g. The contents of an ampule will be gently tapped down from the neck and top portion of the ampule before it is opened. The ampule will be wiped with alcohol before being opened. A sterile gauze pad will be wrapped around the neck of the ampule when it is opened.
h. Substantial positive or negative deviations from atmospheric pressure within drug vials and syringes will be avoided.
i. Staff members reconstituting hazardous drugs will use a venting device with a 0.2 micron hydrophobic filter (i.e., a Chemo Dispensing Pin).
j. Commercially available drugs already in solution will be used when possible.
k. Entry ports will be wiped with sterile, alcohol dampened pads after compounding.
l. Final drug measurement will be performed prior to removing the needle from the stopper of a vial or the filter straw from the neck of an ampule.
m. All waste items from hazardous drug preparation will be discarded in the special contaminated waste trash receptacles.
1) All used IV tubing, empty syringes, empty drug vials, gloves and gowns will be considered to have "trace" amounts of hazardous drugs and will be disposed of in the yellow chemotherapy containers.
2) Other waste is considered "bulk". This includes unused chemotherapy IV solutions, partially filled drug vials, and partially filled syringes. Items in this category will be disposed of in chemotherapy containers that are marked with a pink auxiliary sign that says "Bulk Chemotherapy".
n. Final products will be placed in sealable containers (e.g., zip-lock plastic bags) to reduce the risk of exposing ancillary personnel or contaminating the environment.
o. All products will be labeled as "Chemotherapy" agents.
B. Drug Administration
1. Personal Protective Equipment (PPE)
Personnel administering Class I HDs must wear surgical latex gloves (see section III.A.3.a). Two pair offer significantly greater protection, and shall be worn if double-gloving does not interfere with techniques. Other protective equipment such as gowns, chemical splash shields, goggles, or respirators may also be required depending on the drug characteristics and the conditions of drug administration.
Disposable chemotherapy gowns, of the type described in the Drug Preparation section, are not required while administering HDs, but shall be available for employees choosing to wear them. CAUTION: Lab coats, and the disposable isolation gowns presently used on nursing units, are easily permeated by these drugs. Do not rely on them to adequately protect you from skin absorption if they become contaminated.
2. Work Practices
a. Hands shall be washed before putting on gloves, as well as after gloves are removed.
b. Gloves (and disposable gowns, if worn) that become contaminated shall be changed immediately.
c. Infusion sets and pumps shall be watched for signs of leakage during use. An absorbent pad shall be used during tubing change or IV push administration to catch any leakage.
d. Disposal of appropriate items shall be handled according to the instructions found in the section on waste disposal.
C. Patient Care Precautions Following Drug Administration
In accordance with the Infection Prevention and Control, Standard Precautions must be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids should be considered potentially infectious materials and must be managed as dictated in the Infection Prevention and Control manual.
1. Personal Protective Equipment (PPE)
Personnel dealing with excreta, primarily blood, urine, stool or vomitus from patients who have received HDs in the last 48 hours should be provided with and wear latex (chemotherapy gloves) or other appropriate unpowdered gloves and disposable gowns. The gloves should cover the cuffs of the disposable gown when being worn. These items are to be discarded after each use or whenever contaminated, as detailed under Waste Disposal. The permeability of gloves increases with time, therefore gloves should be changed regularly (every 30 minutes) or immediately if they are torn or punctured. Eye protection should be worn if splashing is possible. Such excreta contaminated with blood, or other potentially infectious materials as well, should be managed according to the Infection Prevention and Control procedures. Hands shall be washed after removal of gloves or after contact with the above substances.
2. Linen
Linen contaminated with HDs or excreta from patients who have received HDs in the past 48 hours is a potential source of exposure to employees. Linen soiled with blood or other potentially infectious materials as well as contaminated with excreta must also be managed according to the Infection Prevention and Control manual. Linen that is grossly contaminated with HDs should be placed in a large chemotherapy waste container for disposal. Linens used by patients who have received HDs, which are not grossly contaminated, shall be handled as other linen. Laundry personnel shall wear latex gloves and gowns while handling linens.
3. Reusable Items
Any contaminated reusable items such as bedpans or commodes, shall be thoroughly washed in a sink with detergent two times, followed by a clean water rinse. Double latex gloves must be worn.
4. Waste Disposal
a. Equipment
Discarded gloves, gowns, all HD’s and any other disposable material should be placed in Chemotherapy/Biohazard Waste Buckets, which are clearly marked hazardous waste only.
Needles, syringes, and breakable items not contaminated with blood or other potentially infectious materials should be placed in the sealed zipper-type closure bag provided by the Pharmacy, and then placed in the Chemotherapy/Biohazard Bucket. Needles should not be clipped or capped nor syringes crushed (except as on a rare instance when a medical procedure requires recapping). At least one such receptacle should be located in every area where the drugs are prepared or administered. Waste should not be moved from one area to another and the lid should be kept on the container at all times.
b. Handling of HDs
Present practice dictates that every precaution be taken to prevent contamination of the exterior of the container. Personnel disposing of HD waste shall wear gowns and protective gloves when handling waste containers with contaminated exteriors. Prudent practice further dictates that such a container with a contaminated exterior should be placed in a second container in a manner which eliminates contamination of the second container. HD waste handlers shall also receive hazard communication education such as offered in the Chemotherapy Course Curriculum and the Safety Manual.
c. Disposal of HDs
Hazardous drug related wastes should be handled separately from other hospital trash and disposed of in accordance with applicable EPA, state and local regulations for hazardous waste. See section D.
D. Waste Collection and Disposal of HDs
1. Trace Contaminated Material:
These are items considered "empty" by the EPA. Empty is defined as a container that contains less that 3% by weight of the original quantity of HD. Trace waste would include IV tubing, gowns, gloves, gauze pads, empty medication vials, and empty syringes. These items must be disposed of in a rigid puncture-proof plastic container designed and purchased specifically for contaminated hazardous drug waste. The lids must be kept on these containers at all times, except when depositing waste materials in them. These containers will be destroyed locally at the KUMC contracted site.
2. Bulk Contaminated Materials:
Bulk contaminated items include expired or unused vials, ampules, syringes, bags and bottles of HDs or solutions of any other items with more than trace contamination from HD’s. All bulk contaminated items should be returned to the Pharmacy for disposal. As an extra safety precaution, all HD's should be transported in the sealed "zipper" closure bag provided by the Pharmacy.
3. Hazardous Drug Waste Handling:
Hazardous drug waste will be identified, contained and segregated from all other waste.
a. In all areas that handle chemotherapy, two types of rigid plastic contamination receptacles will be available at all times. These containers will be used for all waste from preparation and administration of hazardous drugs.
1) The standard chemotherapy container will be used to dispose of items containing traces of hazardous substances. This would include used tubing, empty drug vials, empty syringes, gloves and gowns.
2) The chemotherapy containers with the pink "BULK" label are for unused doses of chemotherapy, partially filled vials, and partially filled syringes.
b. Filled receptacles will be placed in a designated area to be picked up by the KUMC Safety Office.
c. The rigid plastic receptacles used for disposing of hazardous drugs are obtained from the KUMC Storeroom.
d. Unused doses of chemotherapy that are returned to pharmacy will be disposed of in the "BULK" chemotherapy receptacles.
4. Scheduled pick-ups
The Safety Office has regular weekly pick-ups for hazardous chemical wastes. Once a week rounds are made by Safety Office personnel to collect these wastes. Those areas which require weekly pick-ups need to contact the Safety Office to establish a weekly pick-up. If generation of this waste is infrequent such that weekly pick-ups are not needed, the department/unit must call the Safety Office (ext. 6126) to schedule a pick-up.
E. Spill Clean-Up, Decontamination, and Reporting Procedures
Spills of HDs must be cleaned up as quickly as possible, by a person familiar with the proper procedures. Other persons in the immediate area must be informed of the existence of the spill.
Spill kits containing absorbent materials and protective gloves will be kept in all areas where hazardous drugs are used. These will be used according to package directions for large spills inside or outside the BSC.
Spills occurring in the BSC will be cleaned up immediately; a spill kit will be used if the volume exceeds 50ml or the contents of one drug vial or ampule. If there is broken glass, utility gloves will be worn to remove it and place it in the puncture resistant container located in the BSC. The BSC, including the drain spillage trough, should be thoroughly cleaned. If the spill is not easily and thoroughly contained, the BSC should be decontaminated after cleanup. If the spill contaminates the HEPA filter, use of the BSC should be suspended until the cabinet has been decontaminated and the HEPA filter replaced.
1. Small Spills (< 100 ml)
a. Spills shall be cleaned up immediately by area personnel wearing disposable gowns and a double layer of surgical latex gloves or other approved alternative. Chemical splash goggles shall be worn if such protection is necessary. A NIOSH-approved respirator should be used for either powder or liquid spills where airborne powder or aerosol is or has been generated.
b. Liquids shall be cleaned up with absorbent pads or other absorbent materials; solids shall be wiped with wet absorbent gauze; spill areas shall be cleaned (three times) with a detergent solution, followed by a clean water rinse.
c. Any broken glass shall be picked up using a small scoop (not with hands) and placed in a "sharps" container; All waste items, including used absorbent pads, gown, gloves, and any non-cleanable contaminated items shall be placed in waste bags designated for HD waste collection and disposed per the contaminated waste guidelines.
d. Any contaminated reusable items shall be thoroughly washed in a sink with detergent, followed by a clean water rinse. Double gloves must be worn.
2. Larger Spills [>1 Ampule or >100 ml] And Any Spill In Public Access Areas (not including patient rooms)
a. Limit the spread of the spill by carefully covering liquid with absorbent pads, spill control pillows, or other absorbent materials, solids shall be covered with a damp cloth or towel. Care must be taken not to create aerosols. Restrict access to the spill area.
b. Call extension 911 to report a spill. Tell them:
i. Reporting a chemical spill.
ii. Your name and the extension from where you're calling.
iii. The exact location of the spill (building, floor, and room number).
iv. The chemical(s) spilled, the quantity, and the known hazards of the chemical(s).
v. Any injuries or contamination of personnel.
c. Wait safely outside the spill area until Safety Office or other emergency response personnel arrive to clean up the spill.
3. Surface/Equipment Decontamination
After a spill clean-up has been completed, all contaminated surfaces shall be thoroughly cleaned with a detergent solution three times, followed by a rinse with clean water. This shall be done by an area person familiar with these guidelines and the potential hazards of HDs. Double gloves shall be worn and all waste disposed of properly.
Any non-cleanable contaminated items shall be disposed of according to the contaminated waste guidelines.
Any personal items which become contaminated with HDs, whether disposed of as waste or not, shall necessitate the completion and filing of an incident report, per departmental guidelines.
4. Personnel Decontamination
Gross contamination of gloves, gown, or other clothing, or direct skin or eye contact with HDs must be treated as follows:
a. Immediately remove contaminated gloves, gown, or other clothing. If clothing is contaminated with large quantities of HDs, the individual shall proceed as rapidly as possible to the nearest safety shower (or ordinary shower). Contaminated clothing shall not be removed until the individual is standing under the flow of the water.
b. Any contaminated skin area must be washed with soap and water for not less than 15 minutes. After flushing the affected area, seek medical attention immediately.
c. For eye exposure, flood the eye(s) with water or isotonic eyewash solution for not less that 15 minutes. Hold the eyelids open to ensure that all of the eye, including under the eyelid, is thoroughly flushed. Seek medical attention immediately.
d. For inhalation of HD’s in powder form, seek medical attention immediately.
e. For needlesticks from syringes containing HDs, express some blood from the area, wash the area with a antimicrobial soap and water for 10 minutes, and seek medical attention.
Report for medical attention as follows: Employees will report to the Department of Occupational Health and Environmental Medicine during business hours (M-F, 8:00 a.m. to 4:30 p.m.) or to the Emergency Department after hours. Students will report to
Student Health Services during business hours (M-F, 7:00 a.m. to 3:30 p.m.) or to the Emergency Department after hours.
5. Reporting Procedures
a. Spills or other incidents which do not result in personal injury or contamination shall require that an Confidential Incident Report be filled out as soon as possible. Follow departmental guidelines on reporting procedures.
b. Spills or other incidents resulting in personal injury or contamination of employees shall require an Employer’s Report of Accident (1101-A) form be completed. Students will complete a Student Incident Report form. Follow departmental guidelines on reporting procedures
F. Medical Surveillance
Medical information regarding the HD exposure will be maintained in the employee’s medical record in the Department of Occupational Health and Environmental Medicine or the student’s medical record in Student Health Services.
1. Screening
Occupational exposure to HDs may not result in any detectable physiological changes which would be noted during routine medical examinations. Certain tests, such as urine mutagenesis, or checking for the presence of certain HDs in the urine, have not proven to be reliable indicators of occupational exposure levels. Personal physicians should be advised for their records that an employee works with HDs.
Employees working with HDs will complete a medical and occupational history at the time they are hired at the Medical Center. Personnel cleaning the BSC used to prepare Cytotoxic Drugs will wear a respirator and will participate in the Medical Center’s Respiratory Protection Program. The medical surveillance portion of the program will be administered by the Department of Occupational Health and Environmental Medicine. Fit testing and respirator training will be administered by the Safety Office. Students working with HDs will complete a Student Health and History form at the time they enroll in school at the Medical Center.
2. Records of Potentially Exposed Employees
A registry of all staff and students who prepare or administer HDs shall be permanently maintained by each appropriate department.
3. Treatment of Acute Exposures
After an acute exposure to a HD, the procedure in the section of Personal Decontamination shall be followed. Employees will report to the Department of Occupational Health and Environmental Medicine during business hours (M-F, 8:00 a.m. to 4:30 p.m.) or to the Emergency Department after hours. The employee will bring a completed Employer’s Report of Accident (1101-A) form and the appropriate MSDS for the HD. Students will report to Student Health Services during business hours (M-F, 7:00 a.m. to 3:30 p.m.) or to the Emergency Department after hours. The student will bring a completed Student Incident Report form and the appropriate MSDS for the HD
G. Special Exposure Concerns
1. Reproductive Hazards
Some studies have shown increased risks of miscarriage or of giving birth to malformed infants for persons occupationally exposed to certain HDs. The degree of risk for employees who are pregnant, or who are actively trying to conceive a child (female or male personnel) is uncertain at the present time.
2. Personnel Breast-Feeding Infants
No data is available as to whether these persons are at increased risk.
If they so desire, a person who is pregnant, breast-feeding, or actively trying to conceive a child may request, in writing, a change to a job assignment which does not involve handling HDs. Such request shall be made to the nurse manager, and shall be acted upon on an individual basis.
H. Receipt, Storage, and Transport of HDs
1. Receipt
HDs are delivered directly to the Pharmacy storeroom. Only properly trained personnel familiar with these guidelines shall handle HD packages.
When a damaged package is discovered, all contaminated packaging material will be handled with double gloves and a protective gown. Small broken items can be disposed of in the "BULK" chemotherapy receptacles. Large items must be placed in a red contamination bag or the Safety Office called for pick-up.
If there is a possibility of exposure to airborne HDs, the damage material shall be packed in a waste disposal container within an approved BSC. Double gloves and any other appropriate protective equipment must be worn.
2. Storage/Handling
Accidental contamination of the health-care environment, resulting in exposure of personnel to hazardous substances will be prevented by maintaining the physical integrity and security of packages of hazardous drugs.
a. Access to areas where hazardous drugs are stored is limited to authorized staff.
b. Orange "CHEMOTHERAPY" labels will be used to label shelves and bins where cytotoxic drugs are stored.
c. Cytotoxic products dispensed from the pharmacy will bear a label identifying them as such.
d. Hazardous drugs will be stored on shelves or in bins that will limit contamination in case of leakage.
e. Hazardous drugs requiring refrigeration will be stored separately from non hazardous drugs and will be stored in bins designed to contain leakage.
3. Damaged Packages
The following procedure will be followed for handling damaged packages of hazardous drugs:
a. Damaged shipping cartons of hazardous drugs will be received and opened in an isolated area.
b. Protective apparel will be worn when handling damaged packages. This will include a chemo gown and disposable utility gloves over latex gloves. Eye protection and a mask will be worn.
c. Broken containers and contaminated packaging materials will be paced in designated chemo receptacles.
4. Transport.
Hazardous drugs will be transported to the nursing units by pharmacy messenger in bags clearly labeled "Cytotoxic". These items will then be signed for by nursing personnel and pharmacy messenger on the pharmacy delivery slip and each will receive a copy. They will not be transported in the pneumatic tube or telelift. The drugs will be in securely capped or sealed containers and packaged during transport to further reduce the chance of breakage and spillage in a public area.
Appropriate containers will be provided to patients for transporting discharge and home care medication that require special precautions.
I. Education, Training, and Information Dissemination
In accordance with the KUMC Hazard Communication Program, all personnel involved in any aspect of the handling or use of HDs shall participate in all applicable training including the Hazard Communication class for new employees. Each department must also inform new employees of the known risks, relevant techniques for use and handling, the proper use of protective equipment and materials, waste disposal, spill procedures, medical surveillance policies, and any other pertinent information related to the handling, storage, and disposal of the specific HD’s that they may encounter during the performance of their duties. This information must be reviewed annually. Competency shall be evaluated following the initial training and at least annually.
Medical staff who are not Medical Center employees shall be informed of this policy and the expectation that they must comply with all applicable sections.
Documentation shall be maintained by each department indicating that all personnel involved with the handling or use of HD's have received this information and training. The documentation must include the date of attendance, the contents/summary of the training, names of those providing the training, and names and titles of those receiving the training. These records must be maintained for 3 years from the training date.
Pertinent emergency information can be obtained from Material Safety Data Sheets (MSDS’s). Additional information can be obtained from the Poison Control Center, extension 6633.
A copy of these guidelines, along with copies of standard operating procedures for work involving HDs, shall be available in each work area or department. Other interested employees may refer to a copy within the Medical Center Safety Office, KU Hospital Building, anytime Monday through Friday, 8:00 a.m. to 5:00 p.m.
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The University of Kansas Medical Center