Section 8 Hazard Communications Program

Sections 1 through 7 of United States Pharmacopeia (USP) Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures with checks and balances for quality control and provision of direct protective measures on our road to compliance. Section 8 falls into requirements of facitilites and employers to include hazardous drug handling within their Hazard Communications Program for employee safety.

What is a Hazard Communication Program?

When you ‘Google’ the term the first hit is a listing by the United States Department of Labor (DOL). Basically, it requires employers to define workplace hazards and provide employees with education and a safe work environment with the proper tools to protect themselves. Under the DOL, employees are given rights and a formal process to file complaints to protect them in their workplace; this highlighted on the DOL banner for Hazard Communication ‘The standard that gave workers the right to know, now gives them the right to understand.’ Employers are required to post the rights of the employee in clear and visiable location for employees.

Example posting click here

Why would USP <800> use a term that falls under the jurisdiction of the DOL?

It starts with the Occupational Safety and Health (OSH) Act of 1970 which sets safety and health standards for United States workers which includes healthcare workers.The OSH is administered by Occupational Safety and Health Administration (OSHA), an agency of the Department of Labor (DOL).

All employers are subject to the OSH Act have a general duty to provide work and a workplace free from recognized, serious hazards. Since the publications 2004 NIOSH alert and proposed USP <800> are available in the public domain, handling certain drugs are considered as a ‘recognized’ hazard. As such, sites handling these products must include them in their Hazard Communications Program.

Although not listed within the USP section, sites are encouraged to read the three OSHA guides specific to Hazardous Drugs:

  1. Controlling Occupational Exposure to Hazardous Drugs.
    • In: OSHA Technical Manual, TED 1–0.15A, Sec VI, Chap II: 1995, 1999
  2. Hazard Communication Standard;
    • (29 CFR part 1910 – 1200) “Right to know”
  3. Hazardous Waste Operations and Emergency  Response (HAZWOPER)
    • Standard (29 CFR 1910.120)

USP does an excellent job of summarizing the three OSHA documents and gives light to the requirements under their term ‘must’. Sights must have a plan in place and a process for implementing and continuously updating their hazardous communication plan. Since manufacturers of drugs are not required to place a symbol or acknowledge a drug is a hazard, the burden of designing a list and adding placards is on each site. DOL mandates the use of the Global Harmonized System of Classification and Labeling of Chemicals (GHS) for classifying hazardous chemcials (drugs). Employers were required to train employees by December 1, 2013 on the new symbology, label elements and safety data sheet format and acknowledge an agreed upon understanding of the system.

Use this link to see common symbology used based on the defined hazard.

It is the responsibility of sites to have readily available current copies of the Safety Data Sheets (formally known as a Material Safety Data Sheet -MSDS); noting that readily available denotes staff (not supervisors) know where to get copies. The use of the GHS symbology should be mirrored on hazardous drugs and corresponding SDSs.

USP notes that sites are required to provide adequate training and employee safety programs and document compliance of the programs. This would include the use of Personal Protective Equipment compliance, engineering control utilization and other tools/devices used to protect the employee. Although not a line listed call-out in Section 8, it is implied throughout sections of USP <800>.

USP hightlights the OSHA requirement that personnel who may be exposed to hazardous chemicals (drugs) when working must be provided information and training before the initial assignment to work with a hazardous chemical (drugs). In addition, this must be modified whenever the hazard changes, such as the addition of a newly defined hazardous drug.

USP further specifices, based on the defined risks of certain drugs, that personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs. This statement is directed towards both female and males. It is in the best interest of sites to get a signed agreement on an annual basis confirming education and acknowledgment.

USP has done a great service by taking a multitude of standards and regualtions from differing state and federal agencies and placing them in an easy to read chapter; USP <800>. As the chapter evolves from Section 1 through to Section 18 we are provided with a logical roadmap to compliance.

As the NEW official implementation date of December 1, 2019 for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance allows time for compliance, the time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP <797>.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.

References

[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.

Section 7 Personal Protective Equipment

Sections 1 through 6 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures with checks and balances for quality control on our road to compliance.

Section 7 of USP 800 personalizes the concept of protecting the healthcare provider with guidance regarding the proper personal protective equipment (PPE). The PPE provides the active barrier to protect healthcare providers from direct contact with hazards.

It is important to note that each component of PPE must be tested to standards that replicate mechanical and clinical practice. It MUST NOT be assumed that any piece of the PPE armor is hazardous drug protective. International standards exist within ISO and ASTM standards and PPE tested to these standards are allowed to label their respective PPE components with standard. Interpretations of the testing is critical to better understand the limitation of the PPE. For example, if a tested glove has a break through time of 1.06 minutes when handling carmustine at a concentration of 3.3mg/mL, this glove is not appropriate for handling this drug.

The PPE required for handling hazardous drugs and the corresponding residue of the drugs must be defined. Sites should conduct a tracer from the dock to the disposal process of hazardous drugs. Within the tracer, identify each job code that may come in contact with hazardous drugs and define personal protective equipment within the job description for each job code. Consideration should be given to the receipt; storage; transport; non-sterile compounding; sterile compounding; drug administration; cleaning; spill cleanup; and waste disposal personnel and the risks associated with their positions and corresponding PPE for protection.

Choosing the Right Equipment

Gloves represent one of the most intimate pieces of the PPE and are often a very emotional topic of discussion at facilities when looking for consolidation for savings. It is important to highlight that gloves should be worn whenever handling hazardous drugs in any step of the process: receipt; storage; transport; non-sterile compounding; sterile compounding; drug administration; cleaning; spill cleanup; and waste disposal. Gloves must be powder free, tested to ASTM D 6978 or newer standards. The terminal glove used for compounding sterile products must be sterile and must be rated to the ASTM standard. The glove provides the healthcare provider with a protective yet tactile sensation that assists the healthcare professional to make decisions while providing protection. The key standard listed within USP 800 for gloves is ASTM D 6978. For a glove to have been tested to this specific standard, it must state it on the glove packaging material or an accompanying document. If a supplier is unable to provide the ASTM D 6978 testing standard results for a specific product, then it would not meet the recommendation listed within USP 800. Here is an example glove with supporting ASTM D 6978 testing listed.

Gloves can be made out of many materials such as natural rubber latex, acrylonitrile-butadiene (Nitrile), polyvinyl chloride (vinyl, PVC). It’s important to note that labeling a glove as being made from a specific material, for example ‘nitrile’, does not equate it to being tested the ASTM D 6978 standard. A best practice is to check the specifics of the glove in reference to Thiotepa and Carmustine permeation; these two drugs represent a true challenge to their abilities to act as protective barriers.

The use of double gloving for higher risk procedures such as compounding and administration of the hazardous drugs is a requirement. When using double gloving with a protective barrier gown/garb, the inner glove should go under the gown cuff and the outer glove over the gown cuff. Gloves should be changed every 30 minutes or immediately when damaged or when contamination by a hazardous drug is known or suspected. If gloves leave the ISO-5 compounding space they should be disinfected with an agent like sterile isopropyl alcohol prior to re-entry into the ISO-5 space.

When gloves are used with gauntlets/sleeves for isolators for compounding, double gloving must still take place. The terminal glove (outer glove) must be sterile and rated to ASTM D 6978 standards. Prior to compounding, particular attention should be directed towards the gauntlet/sleeve-to-glove interface to assure this junction is closed and no tears occurred during changing. As noted, gloves should be changed every 30 minutes or immediately when damaged or when contamination by a hazardous drug is known or suspected. Additional inspection of the integrity of the gauntlets/sleeves should take place while inspecting gloves. Although not listed within USP 800, gauntlets/sleeves should be placed on a routine inspection and replacement program based on the manufacturer’s recommendations. Protection is lost when pinholes, cuts or worn-through gauntlets/sleeves are used during compounding.

USP reminds us that washing hands with soap and water after removing gloves is an important step in minimizing contamination.

Unlike gloves, gowns do not have a testing standard specific to this PPE. However, the general ASTM F 739 standard can be applied: Testing Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Gowns should not be cloth, but made of a material such as polyethylene-coated polypropylene or other laminate, non-absorbent, non-linting, and disposable. Specific design attributes should include tight cuffs (either knit or elastic), long sleeved, back closure, and no seams, openings or closures that allow for the worker to be exposed. USP does not differentiate between smock-system versus full-suited gowns, however full-suited options may provide better overall coverage. USP highlights the concern of not taking home known contaminated clothing if an exposure takes place. Sites should have options available for when clothing becomes contaminated (alternative clothing, compensation for damaged garments, etc.). Gowns must be changed immediately after an overt or suspected contamination or when changing the inner pair of gloves. Otherwise, gowns should be changed every two to three hours if the manufacturer provides no permeation information. Since the outer gown can become contaminated, it should not be worn outside of the hazardous compounding area if it was worn for compounding hazardous drugs.

Hair covers and facial hair covers have the distinct function of preventing hair from entering the ISO rated spaces. Head hair covers should be worn regardless of the quantity of hair on the head. To work properly, the hair cover must cover and contain all hair. If a site struggles with hair (look on the floors, in corners, in the vents), it may want to consider best practice of a hood-type hair cover. Facial hair covers must cover the entire facial hair (excluding eyebrows and eyelashes!). If sites struggle with finding a satisfactory facial hair cover, sites can combine the hooded head covers with facial hair covers to maximize the coverage. If you can see the hair of your staff working in the ISO areas, they are actively contaminating those areas.

Shoe covers or booties are pretty self-explanatory. Their primary role is to cover the entirety of the shoe and prevent any particulate matter from coming off the shoes and into contact with ISO rated spaces. USP 800 requires the use of a second pair to cover the first pair of shoe covers when crossing into the line of demarcation for the hazardous drug compounding space. The outer pair must be removed prior to exiting that space, leaving the inner booties in place. Following this process will minimize the migration of any hazardous drug residue from the compounding location to outside of the designated spaces.

An education point for staff is to never leave ISO rated spaces with shoe covers on and then enter those spaces or other ISO rated spaces (i.e., operating suites) with the same pair. A new pair of booties must always be donned with entering an ISO rated space.

A note on shoes worn into ISO rated spaces: sites should have in place guidelines on the type of shoes (fully covers the entirety of the foot, i.e., no sandals; spiked heels can poke through paper-based shoe covers). Shoes must be visibly clean and dry prior to donning the covers. Think about rainy days or winter where shoes may be wet only to have them covered by paper-based covers that will eventually be soaked through to the floor of the ISO space. A note on socks or hosiery: they should be worn and should be low-linting to minimize exposed skin to the ISO rated spaces.

Sleeve covers are introduced in USP 800 as an additional protectant for areas of the arm that may come into contact with hazardous drugs. Since the section talks about residue, the ancillary sleeves should not be considered as an alternative to the required gowns for compounding. Consider their use for the unpacking or stocking shelves.

Eye and Face Protection are required when there is a potential for exposure to hazardous drugs resulting from spills or splashes. Example exposure scenarios include, but not limited to: the cleaning of primary engineering controls underpans, accessing primary engineering control plenums, addressing spills, and removing large quantities of wastes of hazardous materials that are not in sealed containers. Consideration should be given to nursing and housekeeping where linen changes with noticeable contaminated body fluids present. If sites are looking into various types of eye protection, they should consider goggles that are anti-fogging and fit tight to the face versus safety glasses. Safety glasses do not offer adequate protection from splashes or sprays. The goal of the eye and face protection is minimizing dermal and mucosal exposure.

Respiratory Protection represents a multifactorial and critical piece of PPE. The most important comment within USP 800 with regards to respiratory protection is the note that ‘surgical masks do not provide respiratory protection from drug exposure,’ and thus, should not be used when respiratory protection is required to protect the person. Respiratory protection should be strongly considered when the risk of exposure is high such as in attending to large spills; conducting the USP 800 4-step cleaning process to underpans or accessing plenums of PEC’s; or there is a known or suspected aerosolization of powders or vapors from drugs. USP 800 clearly defines when this level of protection requires a full-face mask with a chemical cartridge-type respiratory or a powered air-purifying respirator (PAPR) be worn. A PAPR cannot protect if worn improperly; cannot protect if the battery is not charged; cannot protect if filters are saturated or loaded; cannot protect you if head cover is damaged; and, PAPR’s should not be used in an oxygen depleted environment. Sites should strongly consider the best practice of having one of the noted units available for staff in the event of a large spill.

USP points to fit-tested, N-95 respirators as means to addressing most activities surrounding the handling of hazardous drugs. Paper surgical mask provides minimal protection with regards to splashes, droplets and sprays and thus it can be interpreted that an N-95 mask for use is best practice. With these types of respirators, each employee must be annually fit tested and trained on how to properly use the respirator. If the employee has any change in facial hair after being fit-tested, they will need to be re-fit tested to assure the sizing and seal is appropriate. N-95 respirators are limited in the ability to protect the employee. N-95 cannot protect if worn improperly or does not fit; cannot protect if folded, damaged or altered; cannot protect from chemicals or drugs especially gases or vapors; cannot be used in an oxygen depleted environment; will not work if it becomes wet (think of sweat and perspiration); and, does not protect eyes or the face. An alternative to N-95 is the R-95 with the major difference of the R-95 mask incorporating the use of carbon/charcoal. The main benefit to the use of the R-95 is the ability to help filter out smells, especially those associated with cleaning solutions.

USP encourages sites to follow all the requirements noted within the Occupational Safety and Health Administration (OSHA)’s respiratory protection standard (29 CFR 1910.134) when choosing the appropriate protection device(s).

Donning and Doffing Procedures should be a formal and competency requirement, although not called out within USP 800. The sequence of putting on the PPE is important to minimize bioburden contamination and to assure maximum protection from the equipment. Equally important is the doffing, or taking off, of the PPE. Little thought is given to this process, however it is a potential exposure point for the staff member. Since the PPE has been in and around the hazardous drugs and their residues, it should be assumed the protective barrier of the PPE is contaminated on the outside. As such, employees should take a methodical approach to taking off the PPE as to prevent exposure to the skin or mucous membranes. To assist staff, sites should develop pictograms of the donning and doffing processes. Here is an example.

Appropriate Disposal of Personal Protective Equipment is a must to prevent cross contamination of hazardous drug residue to other areas or to other people. USP 800 notes that all used PPE should be considered contaminated. With this, examine how staff handles the garb in between uses. Are they draping gowns over chairs or over cloth lab coats for latter use? Have a process in place to handle the safe interim storage of worn gowns, if this is the policy for the site (best practice is to not store worn gowns).

Since the PPE is suspected of being contaminated, they should be disposed of according to your state and federal waste standards. Most facilities use a commercial waste vendor and the vendor should be able to assist with the appropriate waste stream strategy.

As the NEW official implementation date of December 1, 2019, for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance allows time for compliance, the time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP 797. www.USP.org/797

Don’t know where to start with a hazardous drug safety program? Visante, Inc. offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.

References

[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.

United States Pharmacopeia <800>: Hazardous Drugs – Handling in Healthcare Settings

Section 6: Environmental Quality and Control

Sections 1 through 5 of United States Pharmacopeia (USP) Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures for our road to compliance. What metric can we put into place to measure safety and a point in time assessment of progress?

Section 6 of USP <800> introduces the concept of environmental sampling (surface wipe sampling) for hazardous drug residues. Sitting on top of USP <797> requirements for viable (microbiological) and non-viable (non-microbiological) surface sampling, adding hazardous drug residue sampling adds to non-viable sampling program (non-microbiological). Surface wipe sampling is the method of choice to evaluate workplace contamination with hazardous drugs. Currently, there are a considerable number of studies published that have documented variations in the methodologies used for surface wipe sampling and reporting of results for hazardous drug residues. One consistency amongst all the published studies is the identification of residues of hazardous drugs in numerous locations throughout the compounding spaces, drug administration locations and throughout facilities.

USP <800>’s perspective for the use of wipe sampling is a recommendation that should be considered within a hazardous drug safety program. Sampling should be considered on a routine basis (i.e., every 6 months) or more often if spills or concerns over risky processes exist. Section 6 gives a highlight of sampling locations to consider based on published studies and include; primary engineering controls work surfaces (hoods); floor space below the hoods; counters where hazardous drugs are stored; door handles of the compounding areas; delivery locations for drug administration; arms of the chairs used for drug administration to name a few. Sites should perform a tracer (follow the drugs from receipt to disposal) to identify all touch points by personnel and equipment to set a map for sampling.

Environmental wipe sampling for hazardous drug residue does not define the overall efficacy of a program. It merely gives a point in time and the residue that is or is not measurable at that time. Sites should consider sampling for the most common drugs handled and may want to consider one or two representative hazardous drugs; i.e. cyclophosphamide (acidic) and fluorouracil (basic).

USP does not give any specific requirements for the number of samples and sites should choose the number of samples based on what they consider to be at risk, for example, one sample in each PEC and one on the drug administration area.

There are many vendors who provide kits with all the sampling materials needed. It is important to note that the process of sampling for hazardous drug residues is itself a hazardous process. Sites should have personnel don the appropriate personal protective equipment that would be donned for compounding. All materials not sent back to the sampling laboratory must be disposed of as hazardous waste. Personnel may be tempted to keep pens and stickers that are left over, however this should be highly discouraged due to their hazardous nature.

Results for the samples may take anywhere from two weeks up to one month. Once the report arrives, it should be reviewed and assessed by the designated person responsible for managing the hazardous drug program and the administrator in charge. Together, a decision on what to do with the results should be formulated. USP does not give ‘acceptable’ limits for measurable residue; best practice is to have no measurable residue. If the test(s) demonstrates an excursion (i.e., a positive sample for the presence of drug residue) a review of the processes surrounding the location of the positive sample should take place, education of personnel of the results and a thorough deactivation, decontamination, cleaning and disinfection of the area must take place followed by a repeat sampling. Sampling of the area should continue until results return to a baseline of no residue. If continuous positive samples continue, the site may warrant the use of an outside agency to assist with addressing the cleaning processes and operating procedures.

Although a recommendation, it is highly encouraged that sites consider using surface wipe samples as one metric in the measurement of a safe hazardous drug program in addition to the surface viable sampling program outlined within USP <797>.

As the official implementation date of July 1, 2018, for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards.

References

[1] USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.

United States Pharmacopeia 800: Hazardous Drugs – Handling in Healthcare Settings

Section 5: Facilities and Engineering Controls

Sections 1 through 4 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings is the blueprint to our road to compliance. To date we have established the scope of our project, we know risk agents associated with our project, we have our crew and a supervisor assigned to help us meet our timeline.

Section 5 of USP 800 introduces the team to the more non-traditional handling aspects associated within the facilities for consideration where hazardous drugs (HDs) are handled. Formally designated areas where HDs are handled must have signage alerting folks to the hazards that lay within. Designated areas must include receiving/unpacking, storage locations, non-sterile HD compounding, and sterile compounding. These locations must be located away from non-trained staff and the public to reduce the risk of exposure. Some of these areas where HDs are handled may need to be negative pressure in relation to adjacent spaces. The negative pressure helps to keep any residue, spills, and vapors from being disseminated out to other locations. Based on the importance of the ventilation system for this aspect of safety, sites should consider placing this system on emergency power.

Facilities and Engineering Controls for Receiving HDs

The standard states “antineoplastic HDs and all HD APIs must be unpacked (i.e., removal from external shipping containers) in an area that is neutral/normal or negative pressure relative to the surrounding areas.” However, due to the lack of consistent a warning symbol for HDs in the United States, packaging practices by wholesalers and shipping companies are inconsistent with the labeling of totes and boxes with warning labels. Some of these companies may place the most common injectable antineoplastics in Ziploc Baggies and label totes accordingly, however, this should not be relied upon. Due to the concern of breakage, totes and boxes should not be opened in sterile compounding locations or in positive pressure rated rooms. Sites can create a ‘Department HD’ and order all of the HDs on this department account. By doing this, totes will be labeled ‘Department HD,’ thus allowing sites to better control the identification of totes with HDs.

Facilities and Engineering Controls for Storage HDs

Storage considerations outside temperature, humidity and light exposure for HDs should also include a system that prevents spilling and or breakage if the vials fall onto the floor. Bins used for storage should be easy to clean with a high surrounding lip to encompass the entire stock of vials. Over crowding of bins and using bins with a lower front lip may lead to vials falling out. Over crowding of bins can also lead to vials falling behind the bins and also falling into other bins, possibly leading to errors in pulling medications.

Antineoplastics and any other HDs requiring any type of compounding, other than repackaging, must be stored in designated areas away from non-HDs to prevent cross-contamination, in a negative pressure room, and 12 air changes per hour (ACPH). Non-antineoplastics and reproductive risk products in their final dosage form may be stored with non-HDs drugs but should be clearly labeled as hazardous to alert staff.

Antineoplastics requiring refrigeration must be stored in a dedicated refrigerator in a room with at least 12 ACPH with negative pressure and a room exhaust vent located adjacent to the coils or compressor.

Facilities and Engineering Controls for Compounding

When designing the HD compounding practice, emphasis on minimizing cross-contamination between products should be a priority. USP 800 introduces us to three levels of engineering controls: Containment-Primary Engineering Controls (C-PEC; A.K.A. hood); Containment-Secondary Engineering Controls (C-SEC; A.K.A. room) and Supplemental Engineering Controls such as Closed System Transfer Devices (CSTDs). Compounding sterile and non-sterile HDs must be conducted in a C-PEC located within a C-SEC.

The C-PEC for sterile HDs must be externally vented through a HEPA to the outside; in a separate room that is negative pressure of -0.01 to -0.03-inch water column to the adjacent room(s) with adequate ACPH. The C-PEC must run continuously and emergency power should be considered. If the C-PEC is turned off or moved, it must be properly cleaned and purged according to the manufactures recommendations prior to compounding.

A sink and eyewash station must readily available. Water and drains must be more than 1 meter from the C-PEC and it is highly recommended that all water sources not be located in buffer rooms.

Sites that choose to use the same C-SEC (room) for both sterile and non-sterile compounding can do so as long as the C-PEC’s (hoods) are located more than 1 meter apart and powder generating compounding does not occur at the same time that sterile compounding takes place.

Facilities and Engineering Controls for Non-Sterile Compounding

Hazardous Drugs, excluding the antineoplastic HDs, not requiring any physical manipulation activities such as counting and repackaging do not require the use of C-PEC. Manipulation activities such as splitting tablets, opening capsules, crushing doses do require the use of C-PEC such as a Biological Safety Cabinet (BSC) Type I or type II A2 or Type II B2; Compounding Aseptic Containment Isolator (CACI), or, Containment Ventilated Enclosure (CVA). The C-PEC must be located in a separate room with 12 ACPH, negative pressure of -0.01 to -0.03-inch water column to the adjacent room(s). If a BSC or CACI is used for both sterile and non-sterile compounding; it must be properly cleaned between doses.

For the C-SEC (rooms) the same requirements laid out for USP 797 for surfaces, ceilings, walls, doors, fixtures, flooring must be non-porous and easy to clean.

Facilities and Engineering Controls for Sterile Compounding

In addition to the foundation of USP 797, the C-PEC used for sterile compounding must be externally vented and a laminar airflow workbench must NEVER be used to compounding HDs. The C-PECs for sterile HD compounding can be either a BSC Type II A2 (recycles part of air through HEPA filter onto the workspace); or BSC Type II B2 (100% of air vented to the outside); or, a CACI. The C-SEC must be negative pressure versus the positive pressure standard for non-HD compounded sterile products.

In USP 800, a new option for the Containment-Segregated Compounding Area (C-SCA) differs in that this C-SEC room is not fed HEPA air, is not rated to ISO-7 and has only12 ACPH. However, the C-SCA must still be externally vented and negative pressure to adjacent space(s) by at least -0.01 to -0.03 inches of water column. If a site chooses to have a C-SCA, they are NOT allowed to use standard USP 797 BUDs for Low-and Medium- risk products. They use the dating seen in a segregating compounding area(s), BUD 12 hours or less.

For those sites wanting to use the maximal BUDs of USP 797, the C-SEC must have HEPA filtered, ISO-7 air quality or better, 30 ACPH and negative pressure to the adjacent spaces. The movement of products into and out of the rated spaces should be mapped out to minimize the potential for contamination. The use of a pass through and Ziploc Baggies will assist with the transfer. The use of pass through refrigerators are not recommended due to the quality of the air within the refrigerators and do not match the rated rooms spaces.

Containment Supplemental Engineering Controls

Although not a hood or a specially designed room, containment supplemental engineering controls are devices designed SPECIFICALLY for safe compounding and safe administration of hazardous drugs. The primary devices within this class include the Closed-System-Transfer-Devices (CSTDs). CSTDs have been on the US market since 1999, however, the overall adoption rate of these devices for facilities in the US for compounding HDs is around 50%. In place of using a CSTD, sites still opt to use a needle and syringe for the compounding process. The key term of CSTD is the word ‘Closed.’ From mounting the vial, until the disposal of the dose after administration to the patient, the system is closed to the healthcare providers and the environment. It is important to note that a CSTD must be used in conjunction with a C-PEC located within a C-SEC or C-SCA. To date, there are 7 approved CSTDs on the US market and each is cleared by the FDA as CSTDs. However, each CSTD is very different and sites are left to look at each of the devices to see which best fits their practice site. Visante consultants have a considerable amount of experience with CSTDs and are available to assist sites with the CSTD selection process.

Currently, USP 800 recommends the use of CSTD during compounding and mandates the use of the CSTD for drug administration. Best practice is for sites to implement the use of a CSTD for both compounding and drug administration.

As the official implementation date of July 1, 2018, for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Don’t know where to start with a hazardous drug safety program? Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact Fred Massoomi, Pharm.D., FASHP at fmassoomi@visanteinc.com.

References

[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed July 18, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed July 18, 2017.

United States Pharmacopeia <800>: Hazardous Drugs – Handling in Healthcare Settings 

Section 4: Responsibilities of Personnel Handling Hazardous Drugs

Sections 1 through 3 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings defines the broad scope of the risks associated with practice sites, drugs and points within the medication management process critical to preventing occupational exposures. Section 4 assigns accountability to assure a hazardous drug safety program is put into place and is continually monitored. Ultimately the responsibility lies with the pharmacist in charge to assure that compliance with state and federal regulations are met. In the standard, an assigned person must be in place to formally address the complexities of such a program.

USP does not state that the responsible individual is a pharmacist or that the position solely focuses on hazardous drugs. However, given the short time line for compliance sites will need to assess who within their program is best suited to understand the greater than 180 compliance ‘musts’ and if their time can be devoted to other tasks. The assigned responsible person must be able to interpret laws, regulations, and standards and transition them into practice. Nationally, USP 800 must be formally addressed and in practice by July 1, 2018, however, states may require compliance prior to this date, i.e., Washington, California. So, who is the most qualified professional to take on the task of overseeing a hazardous drug safety program? Taking a high-level view, let’s review some of the basic job requirements:

  • Continuous education of self on current regulations, standards and best practice documents from professional societies including pharmacy and nursing practices.
  • Education of administrative leadership of the comprehensive rationale for risk-mitigation procedures and risks of noncompliance is a continuous and engaging requirement of the responsible person.
  • An investigative understanding of highly specialized environmental controls of facilities for storage and compounding areas possibly requiring potential facility upgrades.
  • Complexities of changing practice to meet the standards across pharmacy and nursing practices, documenting required tasks and ensure competency of personnel add to onerous task for compliance.
  • For established programs, the responsible person is responsible for the oversight of monitoring personnel, facility engineering controls and maintaining reports of testing/sampling performed in facilities.
  • Any excursions or deviations from standards or standard operating procedures require acting on the results, continually assessing and reporting potential risks to the administrative teams for support and guidance.
  • Continuous education of healthcare team of program successes, excursion and planning for future needs.

A successful hazardous drug safety program relies on the responsibility of each individual who is fortunate to work within one of these programs. Each person assigned tasks throughout the spectrum of handling hazardous drugs plays an integral part of assuring the next person in the chain is safe: from receiving drugs at the facility to compounding doses to verifying dosages to delivery to patient care units, to administration of the dose to handling wastes and contaminated linen. Each person along the chain should take the time to read and comprehend established regulations and standard operation procedures to better understand the important role they play in the hazardous drug safety program.

Administrative support is a key attribute to organizations and their teams for a continually successful and dynamic hazardous drug safety program.

Has your site assigned someone to be the USP 800 expert?

As the official implementation date of July 1, 2018, for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Don’t know where to start with a hazardous drug safety program, Visante, Inc. offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards

References

[1] USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.

 

Fred Masoommi, PharmD, provides this next installment in his helpful series on reaching compliance with USP 800: Hazardous Drugs – Handling in Healthcare Settings. In addition, don’t forget to review Pharmacy Purchasing & Products Magazine’s Annual State of Compounding special issue for important information on all issues surrounding drug compounding.

Section 3 Routes of Exposure

Section 3 provides information concerning various routes of exposure. The direct exposure of healthcare providers to hazardous drugs is one of the riskiest events that can occur during the care of patients. The impetus for United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings is minimizing the potential exposure to these drugs to healthcare providers while protecting the patient and the environment.[1]

In a 2015 surveillance study conducted by investigators from NIOSH of 221 nurses and 183 pharmacy practitioners (pharmacists, pharmacy interns and pharmacy technicians) who had handled a hazardous drug within 7 days of the survey; 11% of nurses and 4% of pharmacy practitioners reported that their skin came in direct contact with hazardous drugs during compounding activities. More concerning is that 6% of nurses and 8% of pharmacy practitioners reported that they accidentally punctured their skin by a sharp in the previous 12 months while compounding hazardous drugs.[2] Given today’s environment of guidelines and tools to minimize risks to healthcare providers we still have exposures and needle sticks.

Front line staff and most administrators who manage operations where hazardous drugs are managed may not be fully aware of the ways healthcare providers can be exposed. Section 3 of the chapter includes a nice summary of risks throughout the process, which is helpful in educating others about the potential opportunities for exposure.

Receiving

At the top of the table describing the Activity and Potential Risks is the receiving of the drugs from wholesalers and manufacturers. It is important to educate all team members that boxes and vials of hazardous drugs should never be handled with unprotected hands. To date, eleven published papers have demonstrated measurable drug residue on the vials, package inserts and boxes of injectable hazardous drugs. The same is not true for oral products.

Dispensing

The not so obvious practice of counting and packaging medications can lead to nicks in coated tablets and the opening of capsules. Care should be taken when performing these steps and hazardous drugs should never be placed in an automated packaging machine due to the possibility of crushing and aerosolizing powders.

Compounding

Outside of spills, compounding represents one of the highest risk points for handling hazardous drugs. The compounder has the high potential to be exposed to drugs in the medication’s highest concentrations at this stage. Care should be taken when manipulating tablets and when crushing or splitting and when opening capsules; these are steps that should take place in the pharmacy. Pouring liquids and measuring powders pose the risk of spills both wet and dry. The reconstitution and diluting of non-sterile and sterile powders can release lyophilized powder residues during this process and lead to wet or dry spills if the proper supplemental engineering controls are not utilized. Purging syringes of air and priming IV lines with hazardous drugs within them, without proper engineering controls, can easily lead to wet spills.

Compounding Related Manipulations

Consideration of exposure should include the continuous concern that personal protective equipment (PPE) used by staff (garbing) is contaminated. In such, staff in PPE should never enter areas outside of the proper rooms with PPE donned. Performing the 4 step cleaning process for daily hygiene also is a dangerous task where the potential residues of drugs are reconstituted for deactivation and removal from work surfaces and adjacent spaces. Any supplies and equipment located within the hoods (primary engineering controls) or rooms (secondary engineering control) should always be considered contaminated and should not be manipulated without the proper PPE.

Transport of Hazardous Drugs

Moving the hazardous drug throughout a facility may lead to spills if dropped and should be placed in a well-labeled Zip-lock Baggie for delivery. A hard sided delivery container should be considered for additional safety. Liquid hazardous drugs should never be pneumatically transported due to the concern of G-force on drug products and the risk of a spill. Although the risk may be low, it would be devastating to an organization to try to clean up a spill within the pneumatic system.

Hazardous Drug Administration

The requirement of USP 800 is for nursing to utilize a closed system transfer device for the administration of drugs. Having the system closed at the bedside minimizes spills that could impact nursing or the patient. It is important to note that there are times when a CSTD cannot be used for administration and when this occurs it poses a considerable risk to healthcare providers and patients. It is important for sites to map out the administration procedures that cannot use a CSTD (I.E., intrathecal; bladder installation; intraocular) and have a plan in place to minimize exposure risk. Nurses should never spike an IV product with a hazardous drug with an IV set on a patient care unit due to the high likelihood of spills to the nurse and patient. Products should come to the pharmacy in the most ready to use form.

Patient Care

Once a patient receives a dose of a drug, residue of the drug can be measured for days after the dose in measurable concentrations in body fluids. During the course of the hospitalization or infusion center, all linen and items touched by the patient should be considered contaminated with the residue of the drug and should be handled accordingly.

Spill Management

The management of spills requires training and the proper use of PPE and techniques to minimize the spread of the spill. Spill exposure risk should be considered throughout the process of managing the spill; from identification, through cleaning to the disposal of the corresponding waste.

Waste Handling

Corresponding wastes from compounding to administration require special waste streams for the proper deactivation/decontamination of the waste to prevent exposure to the environment. It is important for sites to work with Environmental Services and waste haulers to understand their state’s requirements for the proper disposal of hazardous drug wastes.

As the official implementation date of July 1, 2018, for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Visante offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us to learn more.

References

[1] USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed April 10, 2017

[2] Boiano JM, Steege AL, Seeney MH. Adherence to precautionary guidelines for compounding antineoplastic drugs: a survey of nurses and pharmacy practitioners. J Occ and Environ Hygiene 2015;12:588-602.

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed April 10, 2017.

[3]NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf Accessed April 10, 2017.

Fred Massoomi, Pharm.D., FASHP
; 5618 Nicholas St.
Omaha, NE  68132
 (402) 415-4194
 fmassoomi@visanteinc.com

We hope you found our first installment of this series helpful as you make your path to full compliance with USP 800. We know there are many challenges along the way, and we welcome questions for this blog!

Email fmassoomi@visanteinc.com and we’ll answer them in a future blog.

Section 2 of USP 800 addresses the necessary documentation of hazardous drugs according to the NIOSH list. Here’s our summary of what you need to know in this Section.

United States Pharmacopeia 800: Hazardous Drugs – Handling in Healthcare Settings

Section 2 List of Hazardous Drugs

The approval of USP 800 requires sites to “maintain a list of hazardous drugs, which must include any items on the current NIOSH list that the entity handles. The entity’s list must be reviewed at least every 12 months”.[1] Section 2 of the chapter references the National Institute for Occupational Safety and Health (NIOSH) document “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings”, as the resource and starting point for facilities. The latest version of the NIOSH list was published in 2016 and will be updated approximately every 2 years. [3]

In the 2016 list, NIOSH presented a new process for sub-classifying hazardous drugs according to their risks:

  • Group 1: Antineoplastic drugs, including those with the manufacturer’s safe-handling guidance;
  • Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug, including those with the manufacturer’s safe-handling guidance;
  • Group 3: Non-antineoplastic drugs that primarily have adverse reproductive effects.

Of note, USP added an additional classification to the list provided by NIOSH, any investigational or new drug with insufficient safety information should be considered hazardous until more information is available.

Drugs listed in Group 1 must comply with all containment and handling standards noted throughout the chapter. They are considered the highest risks of the groups. If the final dosage formulation does not require any manipulation other than repackaging or counting you do not need to follow full containment requirements.

Drugs listed in Group 2 and Group 3 represent drugs that may have risks associated with the specific formulations of the drug and specific risks to individuals who have conditions that are sensitive to the drugs (i.e., pregnant individual handling oxytocin).

The new classification should assist sites with a better understanding of the risks and assist with developing a strategy for how these drugs should be handled at their site. Table 5 of the NIOSH 2016 Hazardous Drug list provides sites with recommended personal protective equipment and engineering controls for working with hazardous drugs in healthcare settings. This table is key for understanding the proper process and equipment necessary for safety and will make compliance with USP 800 easier to understand.

Sites can self assess the risk of each drug taking into account the type of hazardous drugs from the Groups, dosage formulations, risks for exposure, manufacturer packaging and any manipulations required to get the product into the most ready-to-administer formulation. The steps of the assessment must be documented and should be educated to the personnel who handle the hazardous drugs. For additional information, please refer to the Visante Newsletter from October 2016 where we describe an eight-step process for developing a hazardous drug list for your facility.

As the official implementation date of July 1, 2018 for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

You’re not alone! Visante offers a full line of consulting services to clients just starting down the road to compliance, as well as to practice sites already on the journey and wanting to go beyond minimal practice standards.

References

[1] USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed March 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed March 10, 2017.

[3] NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). http://www.cdc.gov/niosh/docket/review/docket233a/pdfs/2016-161finalpublication.pdf Accessed March 10, 2017.

Fred Massoomi, PharmD, FASHP
; 5618 Nicholas St.
Omaha, NE  68132
 (402) 415-4194
 fmassoomi@visanteinc.com

As the official implementation date of July 1, 2018, for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.

Each practice site that handles hazardous drugs vary in overall compliance due to the lack a US practice standard prior to February 2016. USP <800> provides the baseline for sites to conduct a gap analysis to minimal practice safety practice standards and prepare investment in capital, personnel and process changes. The mandates and recommendations listed within USP <800> vary from simplistic process changes to complex engineering control changes. Budgeting and scheduling for compliance should be in play today for any healthcare site handling these drugs.

The new chapter provides a framework of 18 sections that guide sites to compliance:

Month Section Reviewed Month Section Reviewed
Feb 2017 Introduction & Scope Nov 2017 Receiving
Mar 2017 List of Hazardous Drugs Dec 2017 Labeling, Packaging, Transport & Disposal
Apr 2017 Types of Exposure Jan 2018 Compounding
May 2017 Responsibilities of Handling Hazardous Drugs Feb 2018 Administering
Jun 2017 Facilities and Engineering Control Mar 2018 Deactivating, Decontamination, Cleaning & Disinfecting
Jul 2017 Environmental Quality & Control Apr 2018 Spill Control
Aug 2017 Personal Protective Equipment May 2018 Documentation and Standard Operating Procedures
Sep 2017 Hazard Communication Program Jun 2018 Medical Surveillance
Oct 2017 Personnel Training Jul 2018 Expected Compliance

Sections Summarized from the following Source: The United States Pharmacopeial Convention; <800> Hazardous Drugs—Handling in Healthcare Settings / Physical Tests First Supplement to USP 39–NF 34; August 1, 2016

Over the coming months, Visante will briefly take a section of the chapter and provide guidance to compliance on the way to the July 1, 2018 deadline.

To further assist clients on the road to compliance, Visante provides a full line of consulting whether clients are just getting started or taking steps to go beyond minimal practice standards. Contact us today to learn more.

References

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed January 8, 2016.