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Chemotherapy Preparation and Safe Handling FAQs

Frequently Asked Questions About Biohazardous Drugs


Q. What is a biohazardous drug?


BC Cancer pharmacy defines a biohazardous drug as a drug that contains living organisms with potential to cause infections in humans. Bacille Calmette-Guerin (BCG), a vaccine used to treat bladder cancer, is an example of a biohazardous drug; it contains the attenuated microorganism Mycobacterium bovis. Newer biohazardous drugs are beginning to emerge in clinical trials. For example, REOLYSIN®, an oncolytic reovirus, is being studied for a variety of cancers (e.g., prostate, lung, colorectal, etc.).


Q. I have heard other terms used to describe similar drugs (e.g., gene therapies, gene medicines, biological drugs, etc.). Are they the same as biohazardous drugs?


Drugs like gene therapies, gene medicines and biological drugs are sometimes biohazardous, but not always. The way to determine if a drug is biohazardous is to check for the presence of viable microorganisms with potential to cause infections in humans. For example, riTUXimab and BCG are both biological drugs: drugs made from a living organism or its products. RiTUXimab is not biohazardous, because it does not contain any mircroorganisms; whereas, BCG is biohazardous, because it contains the viable microorganism Mycobacterium bovis.


Q. Are biohazardous drugs considered to be hazardous drugs?


Yes, biohazardous drugs are included in the Hazardous Drug Definition [Safe Handling Standards Manual - Glossary] and will be included online in the Hazardous Drug List [Cancer Drug Manual - Safe Handling].


Q. Why do biohazardous drugs require special precautions?


Although the microorganisms used in biohazardous drugs are unlikely to cause infections in healthy individuals, they do have the potential to cause infections in immunocompromised individuals.  BCG has been implicated in causing nosocomial infections in immunocompromised patients when chemotherapy products became cross contaminated during preparation in the same cabinet. It has been postulated that the likely cause of the nosocomial transmission of BCG was failure to properly disinfect equipment used during sterile drug preparation. Theoretically, when other biohazardous drugs are prepared in the same Biological Safety Cabinet (BSC) as chemotherapy, cross contamination and nosocomial infections in immunocompromised patients could result; therefore, special handling procedures are required.


Q. What procedures are required for biohazardous drugs?


Because biohazardous drugs are also hazardous drugs, procedures for both hazardous and biohazardous drugs must be followed.


1. Hazardous Drug Procedures 


All Health Care Professionals must follow the procedures outlined in the following BC Cancer Policies [Systemic Therapy - Policies & Procedures]: 


  • V-10 - Hazardous Drug Safe Handling Standards
  • V-20 - Employee Health: Management of Risks Related
  • V-30 - Hazardous Drug Spill Management   

Pharmacy-specific Hazardous Drug Procedures:


2. Biohazardous Drug Procedures


Procedural additions/exceptions specifically for biohazardous drugs are outlined in the questions that follow. 


Q. How do you disinfect the BSC and other surfaces exposed to biohazardous drugs?


All surfaces exposed to biohazardous drugs during drug preparation, as well as any surfaces where a biohazardous drug spill has occurred, must be disinfected with an effective disinfecting agent for the required contact time after exposure. See the Policy V-30: Hazardous Drug Spill Management [Systemic Therapy - Policies & Procedures] for examples of effective disinfecting agents for the specific biohazardous drugs. Pharmacy-specific procedures, including BSC decontamination and purging before preparing a different drug, can be found in the VI-40 Safe Handling of HD Dosage Forms in the Safe Handling Standards Manual [Module 1 - Directives].


Q. Are special signs/labels required for biohazardous drugs?


A sign incorporating the universal biohazard symbol  must be posted on:


  • the biohazardous drug storage bins/shelves
  • the outside of the fridge where biohazardous drugs are stored
  • at the entrance to the room where biohazardous drugs are prepared

Dispensed biohazardous drugs must be labelled as ‘BIOHAZARDOUS’.


Q. Is the personal protective equipment (PPE) required for biohazardous drugs different than for other hazardous drugs?


No, the same PPE is required. The difference is that the PPE worn while preparing biohazardous drugs (chemotherapy gloves and gown) must be removed and disposed of into biohazardous (cytotoxic, hazardous) waste, hands washed, and then new PPE donned before the preparation of a different drug in the BSC.


Q. Can we do other procedures in the sterile preparation room while performing procedures with biohazardous drugs?


The answer depends on the activity:


  • In a clean room with multiple BSCs, while a biohazardous drug is being prepared in one BSC, the other BSCs may be used to prepare other drugs, unless the two BSC openings are face to face.
  • No sterile hazardous drug preparation should take place in the clean room while a BSC viewing window is raised for decontamination or disinfection-following-biohazardous drug preparation.
  • Sterile drug preparation may take place in another BSC while a BSC in the same room is purging (with the viewing window lowered to the height specified by the manufacturer for hazardous drug preparation). 

For additional information on biohazardous drugs, see the Safe Handling Standards Manual  [Module 1 - Directives] for the following directives:


  • VI-10 - Hazardous Drug Spill Control in Pharmacy
  • VI-30 - Personal Protective Equipment
  • VI-40 - Safe Handling of HD Dosage Forms

Reviewed July 12, 2017     

 

Q:  We have a pharmacy staff member who is planning to get pregnant and has requested to be removed from activities involving the preparation or checking of chemotherapy. Does BC Cancer have any policies which apply to this situation?


The governing regulation regarding this situation is actually from Work Safe BC. The Occupational Health and Safety (OHS) Regulation 6.49 relating to Reproductive Toxins states the following:


  1. At any worksite where a worker is occupationally exposed to a cytotoxic drug that is a reproductive toxin, the employer must develop policy and procedures appropriate to the risk, which may include protective reassignment.
  2. The policy and procedures must inform workers about the reproductive toxin and identify ways to minimize exposure to the reproductive toxin for a worker who has advised the employer of pregnancy or intent to conceive a child.

There are two BC Cancer Policies [Systemic Therapy - Policies & Procedures] that address this situation:


  1. V-10 – Hazardous Drug Safe Handling Standards states that: It is the responsibility of Directors/ Managers and Supervisory Staff to make every effort to accommodate requests to change work assignments from staff who are pregnant, breastfeeding or attempting to reproduce.
  2. V-20 – Employee Health: Management of Risks Related to Hazardous Drugs regarding pregnancy states that:
    • Employees must be fully informed of the potential reproductive hazard.
    • It is the responsibility of the employee handling cytotoxic agents to discuss with their immediate supervisor any desired change in work assignment as a result of their pregnancy, breast-feeding or attempt to reproduce.

Organizations are required to have policies and procedures in place to minimize exposure to chemotherapy and hazardous drugs for all employees at all times. Protective reassignment may not always be feasible due to staffing or other constraints. However, whenever possible, anyone who is pregnant, breastfeeding or actively trying to conceive should not handle chemotherapy or hazardous drugs. Individual employers or health authorities should be contacted for guidelines relating to the duration of time allowed for the protective reassignment of duties for someone who is attempting to conceive or is breastfeeding.


BC Cancer considers each employee request for protective reassignment on an individual basis, since the circumstances of each situation can be quite varied.

Reviewed July 12, 2017     

Q:  Can you recommend a respirator mask for people who are difficult to fit?


Some procedures that involve handling chemotherapy or hazardous drugs (HDs), such as HD spill clean up or any activity performed in the biological safety cabinet when the viewing window is raised, require the worker to wear a particulate respirator mask. A particulate respirator mask is suitable for use with HDs if it is NIOSH-approved and has a rating of N95 or greater. The following are three different kinds of particulate respirators masks available:


  • Disposable/filtering face piece respirator with built in filters
  • Reusable or elastomeric respirator mask with filter attachments
  • Powered Air Purifying Respirator (PAPR) masks

Disposable/filtering face piece and elastomeric1 respirators require fit testing, while PAPR masks do not. A staff member who is having trouble fitting a disposable or elastomeric respirator has a couple of options: 


  1. Try different brands. There is more than one brand of disposable/filtering face piece respirator (e.g., Kimberly-Clark and 3M) and they tend to fit differently. Or try different facial coverage (i.e., full vs. half face piece) for elastomeric masks.
  2. Obtain a PAPR with a hood or a loose-fitting face piece that does not require fit testing. This is a good option for staff members with facial hair (e.g., beards) that make them difficult to fit. Note that these are larger masks that require cleaning of non-disposable parts and require a power source to function.

References 

1. BC Cancer Provincial Pharmacy Directive VI-30 – Personal Protective Equipment (PPE), July 31, 2013.

Reviewed June 29, 2017     

 

Questions about Maximum Volumes for IV Bags and Syringes


Q: How much solution should be withdrawn from a bag before adding a hazardous drug?


A: The volume to be withdrawn from a bag depends on the original bag size and the volume of drug that is to be added. Solution bags are quite flexible and allow fairly large volumes to be added without difficulty. The intention of prior withdrawal is to ensure that the final volume of the bag is not so large that administration is difficult and that there is no risk of the bag rupturing. If the volume of drug to be added is small enough, no prior withdrawal is required.

The table below provides an example of guidelines for determining the volume to be withdrawn from a bag prior to adding hazardous drug.


Original Bag Volume

Maximum Volume Addition Permitted Without Withdrawal

Maximum Final Volume Permitted

Maximum Final Volume Permitted
(if you factor in overfill volume)

25 mL

25 mL (100%)

50 mL

55 mL (overfill = 5 mL)

50 mL

25 mL (50%)

75 mL

80 mL (overfill = 5 mL)

100 mL

50 mL (50%)

150 mL

160 mL (overfill =10 mL)

250 mL

50 mL (20%)

300 mL

325 mL (overfill =25 mL)

500 mL
(Braun)

50 mL (10%)

550 mL

575 mL (overfill = 25 mL)
500ml
(Baxter)

50 mL (10%)

550 mL

600 mL (overfill = 50 mL)

1000 mL

100 mL (10%)

1100 mL

1150 mL (overfill = 50 mL)


If drug volume to be added exceeds the maximum volume addition permitted without withdrawal, as listed above, the difference will be withdrawn. For Example; the maximum volume that can be added to a 250 mL bag is 50 mL. To add 70ml of riTUXimab (700mg) remove 20ml of NS from the bag first.

Here is another option to consider for adding large volumes of drugs to a bag:


Bag SizeDrain Bag When
250 mLGreater than 85 mL:
drain 250 mL from 500 mL bag
500 mLGreater than 85 mL:
drain 500 mL from 1000 mL bag
1000 mLGreater than 110 mL:
put into empty 2000 mL bag


Q: What is the maximum volume that a syringe can be filled with a hazardous drug?


A: Syringes should be filled to a maximum of 75% volume for hazardous drug preparation as illustrated in the table below. Note that at the BC Cancer, the volume of syringes for parenteral administration is limited to a maximum of 30 mL. This is to prevent repetitive strain injuries in nurses who administer the drug. For drug volumes greater than 30 mL, multiple syringes are supplied.


SYRINGEMAXIMUM DRUG VOLUME
(3/4 full)
1 mL0.75 mL
3 mL2.25 mL
5 mL3.75 mL

6 mL

4.5 mL
10 mL7.5 mL
12 mL9 mL
20 mL15 mL
30 mL22.5 mL
35 mL26 mL
50 mL37.5 mL
60 mL45 mL

Reviewed June 29, 2017     

 












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