Considerations for Managing Hazardous Drugs

May 2016 - Vol.13 No. 5 - Page #8
Category: Closed System Drug-Transfer Devices (CSTDs)

Q&A with Joseph W. Coyne, RPh, president and chief executive officer, Coyne Consulting, LLC

Pharmacy Purchasing & Products: What are the important considerations for choosing a closed system drug-transfer device (CSTD)?

Joseph W. Coyne, RPh: Using a CSTD for preparing and administering hazardous drugs (HDs) is vitally important to protect health care workers. USP <800> Hazardous Drugs—Handling in Healthcare Settings, which has been finalized and will become enforceable as of July 1, 2018, requires CSTD use for HD administration and recommends CSTD use for drug preparation. While <800> reinforces the importance of utilizing a device, it does not provide guidance about how to choose a CSTD.

To choose a CSTD, begin by reviewing the peer-reviewed data. Peer-reviewed studies can be found on PubMed (www.ncbi.nlm.nih.gov/pubmed) and on CSTD vendors’ Web sites. Moreover, educational articles written by pharmacy leaders who have studied CSTDs can provide excellent guidance (see Ensure the Safe Handling of Hazardous Drugs in the March 2016 issue of PP&P, which includes a comprehensive list of CSTD articles published in PP&P within the last 2 years).

By definition, a CSTD is a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system as well as preventing the escape of HD or vapor concentrations outside the system.1 CSTDs currently utilize two technologies to meet this definition: physical barrier and air filtration. Additional CSTD attributes also should be considered, including:

  • Safety features (eg, needle-free or needle-safe)
  • Impact of CSTD interfaces (ie, device-to-vial, device-to-device, and user-to-device)
  • Necessity of proprietary sets
  • CSTD compatibility (eg, are multiple vial size adapters available? Are spikes required, and if so, how many?)
  • The risk of repetitive stress injury for compounding staff, which is particularly salient in organizations with a high volume of HD compounding

A review of the clinical data and device attributes should allow you to identify a few devices for an in-house trial. Ensure that the trial of each device extends for an adequate period of time. Depending on the volume of HDs used in the institution, an appropriate trial length may span a couple of weeks or a few months. For example, a small hospital that compounds HDs infrequently may require a longer trial of each CSTD versus a large outpatient infusion center that treats multiple chemotherapy patients on a daily basis. Most CSTD manufacturers will gladly trial their devices in hospitals so users can gain sufficient experience to inform their choice. Using each CSTD in the real-world environment is an excellent way to identify which device best suits the needs of the organization.

It is important to note that evaluating CSTDs must be an interdisciplinary undertaking. As we know, the device that pharmacy prefers for compounding may not be the same device that nursing prefers for administration. If this is the case and pharmacy and nursing cannot reach consensus, some hospitals have opted to use one device for drug preparation and another for administration. In any case, CSTD trials must take into account both the pharmacy and nursing experience using the devices. If pharmacy chooses a device without input from nursing, the CSTD may simply not be used for drug administration, which bypasses its significant safety benefits.

PP&P: How should CSTD-incompatible chemotherapy agents be handled?

Coyne: Fortunately, CSTDs can be employed when handling the wide majority of HDs. However, CSTD-incompatible drugs exist. For example, Treanda (bendamustine hydrochloride) solution is not compatible with CSTDs, adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (for more information, see the FDA Safety Alert at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437626.htm).2 Ensuring that staff is correctly using PPE, the appropriate primary engineering control, and excellent negative pressure technique are paramount strategies to employ when CSTD-incompatible agents are handled. In addition, it may be prudent to assign the task of preparing these drugs to technicians with the most experience with negative pressure technique.

For HD preparation without a CSTD, be sure that staff continues to employ the same safety steps that are utilized during preparation with a CSTD. Emphasize the value of using good negative pressure technique. Although this method may seem cumbersome, when done well, it is highly effective at averting exposure. In addition, preparing the medication in a primary engineering control ensures that if any drug is volatized it will be properly exhausted to minimize the risk of exposure.

PP&P: What are the considerations for designing effective HD staff training?

Coyne: Prior to identifying the elements that should be included in HD training, identify who will be responsible for providing this training. The importance of having a dedicated individual for training cannot be overstated. Simply modeling proper handling and expecting staff to follow suit is insufficient; a formal training program that includes a method of verifying competency must be implemented.

After the most qualified trainer is identified, the elements of the HD handling program must be determined. Be sure to address this question comprehensively by starting with the moment the HD enters the facility and continuing through until the moment the HD is wasted. All staff involved in delivery and receipt, pharmacy preparation, nursing administration, housekeeping, and waste disposal must be included in the training program.

Do not assume that all employees understand which medications are hazardous. Formal, didactic HD education is required that defines the types of HDs. The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012,3 defines HDs as those that exhibit one or more of the following six characteristics:

  • Carcinogenicity
  • Teratogenicity or other developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure and toxicity profiles of new drugs that mimic existing drugs
    determining hazardous by the above criteria

Review the list of HDs used in the facility with staff, and discuss which NIOSH categories these medications fall into. In addition, be sure that staff members have a solid understanding of the dire potential consequences of HD exposure, which is a prerequisite for gaining their buy-in to adhere to safe handling practices, including PPE and CSTD use. Only then should specific training and education detailing the requirements for HD safety be presented.

PP&P: What is the value of conducting mock chemotherapy spills, and how should they be undertaken?

Coyne: The importance of conducting periodic, mock HD spill drills often is overlooked. However, performing these drills is vital, as failure to practice this critical competency increases the risk of HD contamination in an actual emergency.

Staff must know who is authorized to clean up a spill (eg, housekeeping, nursing, or pharmacy) and also be proficient in the correct procedure. Implementing mock chemotherapy spills provides an opportunity for pharmacy leadership to evaluate staff competency in proper cleaning and disinfecting technique and provide additional training if required.

Creating a mock spill using a fluorescent dye or spray is a safe method of assessing staff competency in this area. It is important to create the spill in dynamic pharmacy conditions to simulate the environment that would be encountered during an actual spill. Conducting the spill drill in the pharmacy is most effective, as this area is at highest risk for an actual spill. Large volumes of medications, including concentrated vials of solutions and large volumes of powder, are received in the pharmacy in bulk, commercially available state, which carries with it a high potential for harm when spilled. While chemotherapy spilled from a patient bag outside of the pharmacy is clearly still a risk, it has already been diluted and therefore carries less risk than exposure to raw materials.

The benefit of using fluorescent dye is that it is simple to use black light to identify if the spill has been cleaned properly. Experience has shown that even after performing what one considers appropriate cleaning, it is not uncommon for the black light to illuminate residual contamination. Thus, this exercise is highly effective in reinforcing the importance of robust cleaning practices.

Ideally, mock spills should be planned quarterly, or at the least twice per year. Drills should occur frequently enough that staff members expect them occasionally and thus do not engage in practice drift over time. Choose one or two different employees to clean the spill each time a drill occurs, and engage the other staff members to observe and critique the cleanup process. The pharmacy director or other pharmacy leader should oversee the process and stop the cleanup for correction if incorrect practice occurs along the way.

Finally, be sure to critically evaluate the contents of the spill kit. All too often these kits are purchased and immediately stored, never being opened until needed. Best practice requires that the kit be evaluated prior to storage to determine if its contents are appropriate for the staff members who will use them. For example, many kits include one-size-fits-all size gowns and gloves; if the person cleaning up the spill is smaller or larger than average, the PPE might not fit properly, potentially exposing the employee to HDs. Personalize the spill kits to ensure all staff that may clean a spill will be protected. The time of a real emergency is not the moment to discover that the contents of your spill kit are insufficient.

References

  1. DHHA (NIOSH) Pub. No. 2004-165. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings.
    www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf. Accessed March 4, 2016.
  2. US FDA Web site. Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement – Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene. Updated September 4, 2016. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437626.htm. Accessed March 22, 2016.
  3. DHHA (NIOSH) Pub. No. 2012-150. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. www.cdc.gov/niosh/docs/2012-150/pdfs/2012-150.pdf. Accessed March 3, 2016.

Joseph W. Coyne, RPh, graduated from the Philadelphia College of Pharmacy and Science. He has over 25 years’ experience as a pharmacy executive specializing in cancer treatment, hazardous drug handling, sterile compounding, hospital, hospice, and home care management. Joe is currently president and chief executive officer of Coyne Consulting, LLC, which provides clients with the structure and process to create breakthrough projects with an eye toward rapid return on investment, while achieving improvements to patient care, employee safety, and the advancement of pharmacy practice.

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