Antineoplastic and Hazardous Drug Safety and Health Plan

9/1/05

 

Index

 

 

1.   PURPOSE

 

      To insure the safe handling, use and disposal of antineoplastic drugs, also called cytotoxic drugs and other hazardous drugs, at the University of Connecticut Health Center (UCHC).

 

 

2.      GENERAL INFORMATION        

 

The Health Center expects all activities and individuals preparing or administering antineoplastic drugs and hazardous drugs (see Attachments 1 and 2 for list) to follow prudent safety practices as outlined in this plan.  This plan has been developed to be consistent with the OSHA Guidelines on Controlling Occupational Exposure to Hazardous Drugs¹ and the regulations of the U.S. Environmental Protection Agency  and CT Department of Environmental Protection on the disposal of hazardous chemicals and antineoplastic drugs.  This plan updates and replaces the Policy “Handling and Disposal of Antineoplastic Drugs” contained in the Quality Management Section of the John Dempsey Hospital Administrative Manual.  All chemical use in the laboratory is covered by the Health Center’s Chemical Hygiene Plan for Occupational Exposures to Hazardous Chemicals in Laboratories.  All exposure risks to human blood and other potentially infectious materials as outlined in the OSHA Bloodborne Pathogen Standard will be controlled in accordance with UCHC’s Bloodborne Pathogen Exposure Control Plan.  These plans are available on the Office of Research Safety’s website (www.ors.uchc.edu), including MSDS’s (Materials Safety Data Sheets).

 

The degree of risk to personnel working with hazardous drugs such as antineoplastic drugs are functions of the drugs inherent toxicity and the extent of the individual’s exposure.  Main routes of exposure are:  inhalation of dusts or aerosols, dermal absorption and ingestion.  Contact with contaminated food or cigarettes represents the primary means of ingestion.  Thus, staff will not drink, apply cosmetics or eat in areas where these drugs or their wastes are prepared or stored.

 

This policy focuses on:  (1)  control of staff occupational exposures from handling and administration of antineoplastic and hazardous drugs; (2)  control of occupational exposure to antineoplastic and hazardous drugs in patient’s excreta and body fluids; (3)  proper disposal of wastes containing antineoplastic and hazardous drugs; and (4) occupational medicine services.  At the Health Center, antineoplastic and hazardous drugs in tablet form are distributed in unit dose packaging by the Pharmacy.  Exposure to dust or powder from coated tablets and capsules is not likely.   However, staff that must handle unwrapped tablets should wear protective gloves as described in paragraph 4.B.2. for liquid antineoplastic drugs.  Bulk counting of such tablets should be done by Pharmacy inside the biological safety cabinet.  Aerosol administration and topical application of antineoplastic agents at the Health Center are not anticipated and such treatments are not covered by this plan.  If the need for such antineoplastic drug treatments becomes necessary, the applicable activity director/manager must give prior approval when the details on the exposure control measures to be followed have been agreed upon.  Specific plans must also be written and coordinated with the Pharmacy and the Environmental Health and Safety Office by any activity providing home care administration of such liquid form drugs. 

 

It is important to note that a major reference cited by OSHA is the American Society of Hospital Pharmacists (ASHP) Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs².  This ASHP document makes clear that their recommendations should be supplemented with the professional judgments of qualified staff.  This plan preserves, where prudent, the use of such professional judgments.  This plan has been developed with the advice of medical experts, occupational physicians, industrial hygienists, and others as recommended by the ASHP.

 

 

 

3.      RESPONSIBILITIES

 

Supervisors of activities covered by this plan are responsible for its implementation and enforcement of its provisions (see also Activity Director/Manager’s below).

 

Individuals are responsible for following the procedures so that their exposure risks are as low as reasonably achievable and disposing of wastes containing such hazardous drugs is accomplished properly.

 

Activity Director/Manager’s prior approval must be obtained by any activity that must administer by aerosol or  topically apply an antineoplastic drug.  This approval will be based on the Nurse Manger’s or Director’s review of the adequacy of the exposure control measures that will be followed and communication of these measures to employees that may be exposed.

 

Facilities Management will provide the services necessary for medical waste disposal described in this plan.

 

Office of Research Safety personnel will provide the technical industrial hygiene expertise necessary for supervisors and individuals to implement this plan and arrange for the disposal of bulk antineoplastic drugs and contaminated materials from spills.

 

Employee Health Service will provide appropriate occupational medicine support to employees working with antineoplastic agents.

 

Pharmacy will maintain a central file of Materials Safety Data Sheets (MSDSs) on antineoplastic and other hazardous drugs.

 

 

 

4.   STANDARD OPERATING PROCEDURES - ANTINEOPLASTIC DRUGS

 

      A.   Pharmacy Preparation of Unit Doses

 

1.      Engineering Controls:  Any preparation procedure with hazardous drugs such as antineoplastic that may release dust or aerosols will be accomplished in Pharmacy (which is a restricted area) inside a certified biological safety cabinet (BSC).  Such activities include formulating and preparing IV solutions and, if release of dust containing the antineoplastic agent is possible, packaging unit doses of such tablets.  Biological safety cabinets used will afford the employee as a minimum the protection of a Class II, Type B cabinet.  Such cabinets will be certified as conforming to National Sanitation Foundation Standard 49 and Class 100 specifications of federal standard 209C prior to initial use, when moved/worked on in a manner that could impact operation and at least every six months per ASHP (American Society of Hospital Pharmacists) recommendations.  Decontamination should consist of surface cleaning with water and detergent followed by thorough rinsing.  The use of detergent is recommended because there is no single accepted method of chemical deactivation for all agents involved.  The use of quaternary ammonium cleaners and alcohols should be limited due to the possibility of vapor build up.  Pharmacy will document that their personnel using biological safety cabinets for preparation of antineoplastic agents have been trained on the proper use of such cabinets.  Completion of a standard training program available from the Office of Research Safety will satisfy this requirement.  Horizontal airflow work benches are not suitable for protection of the employee during antineoplastic drug preparation.  An eyewash, sink, soap and disposable towels will be readily available in the preparation area.

 

Personal Protective Equipment (PPE):  Pharmacy personnel preparing antineoplastic agents will wear suitable disposable FDA approved gloves.  The preferred glove material is latex.  Nitrile may be used for the employee determined by Employee Health Service to be allergic to latex.  In cases when a manufacturer specifies a unique glove material, the disposable glove should be made of the material specified by the manufacturer (see attachment 3).  Gloves with minimal or no powder are preferred since the powder may absorb contamination.  Gloves will be long enough to be worn under or over the cuff on a protective gown.  In Pharmacy, employees will wear gloves when performing a task that has the potential to result in the hands having direct contact with a liquid or solid antineoplastic agent.  Hands will be washed prior to glove use and when gloves are removed.  In case of contact with liquid antineoplastic drugs, the gloves should be promptly removed and the hands washed thoroughly.

 

When using the biosafety cabinet (BSC) for the preparation of antineoplastic drugs, a splash resistant, closed front gown with knit or elastic cuffs will be worn to prevent drug contact with the skin, street clothing, laboratory coat and/or scrubs.  When a single pair of gloves are worn as might be applicable for the preparation of a single dose of an antineoplastic agent, the glove will be worn over or under the cuff (which ever provides the tightest fit).  Double gloving should be considered for production preparation of unit doses.  When double gloving is used, the outer glove should be worn over the cuff.  Such gowns will be provided to the individual and will be removed in the work area when the exposure potential ends.  If the gown has not been contaminated, the individual may mark the gown with their name, hang it in the antineoplastic drug preparation area and use it at other times during that day (provided such reuse is not prohibited because of sterility concerns).  During activities when shoe contamination is an issue (e.g., spill of liquid agent), suitable disposable shoe covers will be worn (e.g., as provided in the antineoplastic spill kit).  Biological safety cabinet work surfaces that may have become contaminated with antineoplastic drugs will be cleaned promptly after any spill and periodically as determined by Pharmacy (e.g., weekly).  Cabinet manufacturer’s instructions should be consulted.  The BSC should be disinfected with 70% alcohol before any aseptic manipulation is begun.  Provided maintenance of aseptic conditions permits, the use of a lint-free, plastic backed disposable liner may be used in the BSC to facilitate splatter and spill cleanup.  Problems with the use of such a liner include introduction of particulates into the work area, lumping of a wet liner that causes unsteady placement of drug containers, poor visibility of spills, and creation of additional contaminated disposables.  If used, the liner should be changed frequently and whenever it is directly contaminated.  If used, the placement of these liners must be exact so that air intake and recirculation patterns are not upset or blocked.  Table 1 lists examples of Pharmacy activities that can cause splattering, spraying, aerosolization and basic exposure control measures to be implemented.

 

 

Table 1

 

Pharmacy Exposure Control Summary

 

 

Note:    BSC    Biological Safety Cabinet

                         (*)  If splash potential to eyes/face exists, use ANSI approved safety goggles (indirectly or non-vented).  If the BSC front is used as a shield to prevent eye/face contact with the drug in cases where the potential for a splash exists, goggles are not required.

            GI       Gloves (disposable, consider double gloving when preparing production doses)

            GN     Gown

            Shc    Shoe covers (disposable)

            Sg      Safety goggles (ANSI approved)

 

 

3.      Waste Management:  Pharmacy must segregate bulk antineoplastic drug wastes (BADW) into covered, impervious containers marked with both “Antineoplastic Drug Waste” and “Hazardous Waste” labels.  These containers will be collected and disposed of by the Office of Research Safety.  For each such collection container, Pharmacy will provide the Office of Research Safety a list containing the written names of the drug(s) inside.  This list will be affixed to the waste container at the time the container starts to be used for the accumulation of such wastes.  Bulk antineoplastic drug wastes include antineoplastic drug containers that are not empty and unit doses of drugs that are not empty (such as doses returned from a nursing unit).  Any needle (sharp) on such a BADW will be removed by Pharmacy and discarded as a “sharp”.  The BADW container will then be securely capped or sealed to prevent leaks and placed in a secondary container which is sealed (bag with twisty) prior to being placed into the marked BADW collection container.  Sharps will not be place in the BADW container.  The Office of Research Safety will be notified by Pharmacy when these containers are full and the Office of Research Safety will collect and dispose of such wastes properly.  Wastes collected during the clean-up of an antineoplastic drug spill in Pharmacy will also be contained and cleaned by Pharmacy personnel following “spill kit” instructions with the spill waste also collected by the Office of Research Safety.

 

Pharmacy will dispose of other wastes which they generate that has been contaminated with trace amounts of antineoplastic drugs (e.g., empty vials, empty syringes and needles, drained/empty IV lines, contaminated PPE, etc.) in red bag lined regulated medical waste boxes.  These will be kept covered.  Sharps contaminated with traces of antineoplastic agents will be placed in a normal plastic (biohazard) sharps container.  When full, Pharmacy personnel will securely close the top of the sharps container and top off the regulated medical marked waste box with the sharps container(s).  Non-sharp items contaminated with trace amounts of antineoplastic drugs will go directly into the regulated medial waste container.  All such waste containers will be handled with care and contents must never be compacted.  Clipping used needles and crushing used syringes is prohibited.  Facilities Management will be contacted for disposal of the regulated medical waste boxes and will, upon request, provide the activity with properly lined and labeled empty regulated medical waste boxes.

 

4.      Spills:  Pharmacy personnel will be trained to clean spills using the supplies and procedures provided by the Office of Research Safety.  When the spill is outside the biosafety cabinet the immediate area of the spill will be restricted to only trained personnel with proper PPE.  Care will be taken to prevent tracking of the contamination to other areas.  The spill will be cleaned from the outside edge of the spill inward with special attention given to protecting shoes (use of impervious shoe covers contained in the spill kit) and using the other appropriate PPE outlined in Table 1.  Antineoplastic drugs used are not volatile.  Normally, by the time spill kit materials are opened and PPE donned any potential aerosol exposure will be such that use of a particulate respirator is not mandated.  The Pharmacy will maintain at least one Routine/Small and one Large antineoplastic spill kit provided by the Office of Research Safety.  Waste antineoplastic waste materials from a Pharmacy spill will be containerized per spill kit instructions and provided to the Office of Research Safety on the next normal work day.  The spill area will not be returned to normal traffic until Pharmacy personnel have cleaned the spill area with disposable sorbent pads, wiped the spill area with damp disposable pads,  rinsed and wiped dry the area two more times and containerized all waste materials.  At this point, the area can be returned to normal use.  Housekeeping should wash the area (no special equipment or procedures required) as soon as Pharmacy personnel have completed the final rinse/wipe and contained the waste material.

  

5.      Employee Exposures/Occupational Medicine:   Direct employee contact with antineoplastic agents is to be prevented by the employee’s proper use of procedures and personal protective equipment described.  In case street clothing contacts antineoplastic drugs, it should be promptly removed, placed in an impervious plastic bag and the Office of Research Safety consulted the next work day.  In case of direct skin or mucous membrane contact with an antineoplastic drug,  the area should be promptly washed and/or flooded with copious amounts of water.  The exposed employee should be seen by or consult with Employee Health Service (EHS) when they are open.  When EHS is not open, the Emergency Department should evaluate significant exposures, especially to the eyes or mouth.  All such exposures must be reported to Human Resources X-2204 so that a report of Occupational Injury or Illness can be completed.  Pharmacy will provide Employee Health Service a list of Pharmacy personnel that prepare antineoplastic drugs.  EHS will determine the type of appropriate occupational medicine programs necessary, if any, for such individuals (see Attachment 4).

 

6.      Transportation of Antineoplastic Agents or Hazardous Drugs:  All containers of prepared drugs must be free of contamination and prepped for transport.  The outside of I.V. bags and bottles should be wiped with moist gauze.  Entry ports should be wiped with moist alcohol pads and capped.  Drugs should be prepped for transportation by individually wrapping each dose in a sealed plastic bag (one dose per bag) to prevent contamination in the event of leakage.  If glass, the bottle should be wrapped in a shock absorbent material prior to placement in the bag.  If transportation of any antineoplastic agent or hazardous drug is accomplished by any individual other than a trained employee, place addition label on the outer container instructing individual (volunteer) the proper response in the event of leakage and place in a secondary containment tray.

 

Sample Label:

 

 

In the event of a spill or leakage, contact the Pharmacy (x-7627)

or the Office of Research Safety (x-2250).  Immediately wash

affected area with warm soapy water.

 

 B.  Nursing Care of Patients Receiving Antineoplastic Drugs

 

1.      Engineering Controls:  When feasible, use IV systems that do not require needles to minimize the risks of needle sticks.  Every attempt should be made to use an approved safety device.  Sharps must be promptly disposed of into properly labeled sharps containers (see 3B (3) below).  A sink, soap and disposable towels will be readily available in the area where antineoplastic drugs are administered.  Antineoplastic drugs will only be prepared and purged in non-carpeted areas.

 

2.      Personal Protective Equipment (PPE):  Providers administering and preparing antineoplastic agents will wear suitable FDA approved disposable gloves.  The glove materials should be latex, nitrile (e.g., for the employee determined by Employee Health Service to be allergic to latex), etc.  In cases when a manufacturer specifies a unique glove material, the disposable glove material should be that specified by the manufacturer.  Gloves with minimal or no powder are preferred since the powder may absorb contamination (see attachment 3). Gloves must be worn by patient care personnel when the task has the potential to result in the hands having direct contact with a liquid or solid antineoplastic agent.  It must be recognized that excreta, urine, vomitus and sweat, etc. from patients receiving antineoplastic agents may contain significant amounts of the drug.  Thus, appropriate PPE as outlined in Table 2 must be worn to prevent contact with these patient fluids until the patient has been off the drug for 48 hours.  When a protective gown must be worn, the gloves will be long enough to be worn under or over the cuff.  Hands will be washed prior to glove use and when gloves are removed.  Gloves should be promptly changed and the hands thoroughly washed in case of contact with antineoplastic agents.

 

When the potential exists for unprotected skin or street clothing contact with antineoplastic containing liquids or wet items (e.g., linen), a splash resistant, closed-front gown with knit or elastic cuffs will be worn.  Such gowns will be provided to the individual and removed prior to leaving the work area.  If the gown has not become contaminated, the individual may mark the gown with their name, hang it in the work area and use it at other times during that workday (provided such reuse is not prohibited because of sterility or isolation concerns).  For experienced personnel using proper techniques to prevent splatter and the release of aerosols (e.g. alcohol dampened pledgelet around the needle and top of vial or bleeding into a priming bag), the risk of liquid contact during the administration of drugs to the patient is mainly to the hands and risk of a spill or splash is very low.  Thus, use of an impervious gown in such a situation is not mandated.  However, for each administration the provider should consider use of a gown based on the drug, dose, patient’s condition and the provider’s experience.  During activities when shoe contamination is an issue (e.g., spill of contaminated material on the floor), suitable disposable shoe covers will be worn (e.g., as provided in the antineoplastic agent spill kits).

 

Preparation of the unit dose for final administration should be done in a clean, uncluttered area, separate from other activities and excess traffic.  A plastic backed absorbent liner should be used to cover the work area to absorb accidental spills.  When possible, prime the I.V. set with plain solution  before connecting the hazardous drug solution.  The priming fluid may also be discarded into a sealable plastic bag containing absorbent materials.  When feasible, a plastic-backed absorbent liner should be placed under the I.V. tubing during administration to absorb any leakage and prevent the solution from spilling onto the patient’s skin.  The use of sterile gauze around any “push” sites will reduce the likelihood of releasing drug into the environment.  Examples of activities involving the care of a patient on antineoplastic drugs and control measures to be implemented are presented in Table 2.

 

 

Table 2

Exposure Control Summary

Nursing Care of Patients Receiving Antineoplastic Drugs

 

 

Note:      (*)            Use of ANSI approved safety goggles (indirectly or non-vented) required only if potential for a splash to       eye and/or face exists (this is normally the exception).  If such splash potential exists, use ANSI approved      goggles.

                (**)          For experienced personnel using proper techniques to prevent splatter and the release of aerosols (e.g.,   alcohol dampened pledgelet around the needle and top of vial or bleeding into a             priming bag),  the risk of    liquid contact during such activity is mainly to the hand(s) and the risk of a spill or splash is very low.                 Thus, GN use is not mandatory or prohibited.  For each administration, the provider should consider use                 of a gown based on the drug, dose, patient’s condition and the provider’s experience.

                GI            Gloves (disposable)

GN           Gown

Shc         Shoe covers (disposable)

Sg           Safety goggles (ANSI approved indirectly or non-vented)

3.      Waste Management:  Patient care activities must return unused and partially used antineoplastic drugs to Pharmacy in closed, impervious containers marked “Antineoplastic Drugs”.   Any needle (sharp) on such unused quantities of antineoplastic drugs should be removed - - provided this can be done without causing a leak.  The removed empty sharp will be discarded as a “sharp”.  In Pharmacy, these bulk antineoplastic wastes will be segregated (see paragraph 3A3) for collection by the Office of Research Safety. Wastes collected during the clean-up of an antineoplastic drug spill will be contained and cleaned by unit personnel following “spill kit” instructions.  The Office of Research Safety must be called on the next regular shift and notified to pick-up the used kit and waste material.  The Office of Research Safety will provide spill kits for management of Routine/Small and Large antineoplastic agent spills, as appropriate to Oncology 6, Medicine 4, Medical/Surgical 2 and the Cancer Signature Program clinic (and others with a need for such a kit(s)).  Other emptied waste items contaminated with only trace amounts of antineoplastic agents (e.g., empty IV bag, tubes, PPE, etc.) will be placed in a normal regulated medical waste box (e.g., red bag waste box lined with a red bag) or a sharps container that will when full, will be tightly shut and then placed in a regulated medical waste box.  Facilities Management will be contacted for disposal of regulated medical waste boxes and will, upon request, provide the activity with properly lined and labeled empty regulated medical waste boxes.

                 

Linen contaminated with antineoplastic drugs (e.g., wet with urine, vomitus, feces, small quantities of liquid drug, etc.) will be carefully rolled (wet portion inside), placed in plastic laundry bag and the bag tightly shut (e.g., twisty, knotted, etc.).  This will then be tagged or labeled as chemotherapy contaminated linen and placed with other soiled linen.  Plastic bags and tape/labels are available from the linen room and also from Oncology 6.  The use of disposable linen or protective pads should be considered for incontinent or vomiting patients.  Any contaminated disposable linen will be placed in RMW (red bag) waste.  Any linen contaminated with large volumes of the drug solution (e.g., greater than 50 ml will be placed in a plastic bag, marked as described above and placed in an area so it can be collected by Office of Research Safety.  Arrange to have the ORS called (x2723) on the next normal workday to pick-up such a bag.

 

4.      Spills:  Nursing personnel will be trained to clean spills using the supplies and procedures provided by the Office of Research Safety.  The spill area will be restricted to the patient and trained personnel with proper PPE.  Care will be taken to prevent tracking of the contamination to other areas.  Care will be taken to clean the spill form the outside edge of the spill inward with special attention given to protecting shoes (use of impervious shoe covers contained in the spill kit) and using the other appropriate PPE outlined in Table 2.  Antineoplastic drugs used are not volatile.  Normally, by the time spill kit materials are removed and PPE donned, any potential aerosol exposure will be such that use of a particulate respirator to prevent chemical over exposure is not mandated.  Oncology 6 and the Cancer Signature Program will maintain one Routine and one Large antineoplastic spill kit provided by the Office of Research Safety.  Waste antineoplastic waste materials from a spill will be containerized per spill kit instructions.  On the next normal work day the Office of Research Safety will be called by the activity and asked to pick-up the used spill kit, and waste material and provide a new kit.  The spill area will not be returned to normal traffic until unit personnel have cleaned the spill area with disposable sorbent pads, wiped the area with damp disposable pads, double rinsed/wiped the area and containerized all waste materials.  At that point, the area can be released to unrestricted use and housekeeping should wash the area (no special equipment or procedures required) as soon as the final rinse/wipe has been completed and the waste material has been contained.

 

5.      Employee Exposures/Occupational Medicine:   Direct employee contact with antineoplastic agents is to be prevented by the employee’s proper use of personal protective equipment.  In case street clothing is contaminated with antineoplastic drugs, it should be promptly removed, placed in an impervious plastic bag and the Office of Research Safety consulted the next work day.  In case of direct skin or mucous membrane contact with an antineoplastic drug, the area should be promptly washed and/or flooded with copious amounts of water.  When Employee Health Service (EHS) is open, they should be consulted with or seen.  When EHS is not open, the Emergency Department should be seen for significant exposures, especially to the eyes or mouth.  All such exposures must be reported to Human Resources X-2204 so that a report of Occupational Injury or Illness can be completed.  EHS will determine the type of occupational medicine monitoring programs appropriate for such individuals (see Attachment 4).  Emptying urine containers, bed pans, vomitus containers, etc. to the sanitary sewer is appropriate provided proper PPE is worn.

 

6.      Prior Approvals:  Topical applications and aerosol administration of liquid antineoplastic drugs require prior approval.  Such prior approval will be based on written standard operating procedures on how occupational exposures will be managed and will be coordinated by the activity with Pharmacy and the Office of Research Safety.

 

 

 

5.         STANDARD OPERATING PROCEDURES - OTHER HAZARDOUS DRUGS

Similar type exposure control should be instituted by the activities for other hazardous    drugs (e.g., Attachment 1 and 2).  For administration of drugs such as Ribavirin by aerosol use of a    locally exhausted or HEPA filter containment hood must be used.

  

 

6.         HAZARD COMMUNICATION/MATERIAL SAFETY DATA SHEETS/LABELS

 

The Pharmacy maintains a central reference service on drugs.  Pharmacy also maintains Material Safety Data Sheets (MSDSs) on drugs, except for those only available in tablet form.  Employees and activities needing MSDSs on such products are encouraged to consult the information sources available from Pharmacy.  The Environmental Health and Safety Office oversees a Health Center wide MSDS database available at http://msdsexpress.uchc/msds.  Difficulties finding an “MSDS” or questions related to “MSDS” should be referred to the Office of Research Safety.  Oncology 6 will keep a hard copy subfile of MSDSs on antineoplastic drugs used.

 

Pharmacy will affix to each antineoplastic drug unit dose a label indicating chemotherapy drug.  The term biohazard will not be used for such chemical hazards.

 

 

 

7.         EDUCATION/TRAINING

 

A.         Pharmacy:  The Director, Pharmacy will designate those Pharmacy personnel with the education, experience and training necessary to safely prepare antineoplastic drugs and comply with these guidelines.  Additionally, the Director, Pharmacy will verify that individuals required to use a biological safety cabinet;  (1) understand the procedures to be followed for its safe use (this may be accomplished using biological safety cabinet training materials provided by the Office of Research Safety);  (2) know their responsibilities; and  (3) know the procedures they must follow in cleaning up an antineoplastic drug spill inside or outside the biological safety cabinet.  These requirements are in addition to the responsibility of the Director of Pharmacy to have all Pharmacy employees complete initial hazard communication training (offered as part of new employee orientation), an initial Pharmacy training session on the risks and control measures to be followed for hazardous drugs (including antineoplastic drugs).

 

B.         Other Activities Using Hazardous Drugs:  The Manager/Director will only assign tasks related to the administration, handling, clean-up of hazardous drugs to those individuals that;  (1) have completed initial hazard communication training (e.g., as offered during new employee orientation);  (2) have received special training on the risks and control measures that must be followed for hazardous drugs; and  (3) have completed yearly refresher hazard communication training which may be given by the activity or Office of Research Safety personnel.

 

 

 

8.         ATTACHMENTS

 

1.                  Some Common Drugs Considered Hazardous¹ 

2.                  Some Aerosolized Agents 

3.           Examples of Personal Protective Equipment  Suitable for Antineoplastic Drug                   Protection

4.                 Employee Health Service Review of Biological Monitoring Issues

 

 

 

9.         REFERENCES

 

1.                  OSHA Technical Manual (CPL -2-2.20B CH-4), Chapter 4 “21. Controlling Occupational Exposures to Hazardous Drugs”.

2.                  American Society of Hospital Pharmacists.  1990.  ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs.  Am. J. Hops. Pharm. 47:1033-49. 

 

Attachment 1

 

 

APPENDIX 21 - 1:

 

SOME COMMON DRUGS CONSIDERED HAZARDOUS

 

Appendix 21-1 is not all inclusive, should not be construed as complete, and represents an assessment of some, but not all, marketed drugs at a fixed point in time. Appendix 21-1 was developed through consultation with institutions which have assembled teams of pharmacists and other health care personnel to determine which drugs should be handled with caution. These teams reviewed product literature and drug information when considering each product.

 

Sources for this appendix are the Physicians' Desk Reference, Section 10:00 in the American Hospital Formulary Service Drug Information IARC publications (particularly Volume 50)(43), the Johns Hopkins Hospital, and the National Institutes of Health, Clinical Center Nursing Department. No attempt to include investigational drugs was made, but they should be prudently handled as hazardo