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Pharmacy Guide to Hazardous Drug Safety

Managing hazardous drugs in the pharmacy requires a multi-faceted safety approach. This is necessary to avoid contamination and associated health risks resulting from mishandling of cytotoxic drugs and related waste materials. The effects of exposure to hazardous drugs can include an array of harmful health conditions: recurring skin rashes, infertility, miscarriages, stillbirths, and even cancer (Valanis, Vollmer, et al., 1997). The National Institute for Occupational Safety and Health (NIOSH) provides employers with guidelines to minimize hazardous drug exposure through protocols regarding personal protective equipment (PPE).

Simplivia Pharmacy Guide Hazardous Drug Safety

Pharmacists Face Hazards

While NIOSH offers a list of all drugs classified as hazardous, with updates once every two years, new drugs become available far more frequently. To avoid mishandling Hazardous drugs, pharmacists should take advantage of drug safety fact sheets to stay current. Handling, preparing, storing, and disposing of hazardous drugs and related waste without proper protection puts staff at risk. While NIOSH and, more recently, USP<800> offer guidelines for proper handling of hazardous drugs in pharmacy, many pharmacists fail to recognize the importance of following these procedures while working with.

Unfortunately, pharmacy personnel may not understand the health risks involved in every hazardous drug interaction. Harmful exposures can occur through dermal absorption, ingestion of contaminated food or other substances, contact with droplets and inhalation of aerosols or vapors. Pharmacy employment trends reveal that the number of pharmacists is increasing. This means that it is likewise increasingly important to break bad habits, educate employees about the dangers related to handling hazardous drugs, and to put into place proper safety techniques (U.S. Census Bureau, 2018).

Primary Exposure Prevention Methods

Pharmacists know that hazardous drugs are dangerous, yet fail to recognize the dangers of workplace contamination and the ease with which it occurs. Too many pharmacists skip safety protocols. When receiving, storing, or preparing hazardous drugs, many pharmacy personnel neglect to follow facility procedures and do not dispose of PPE correctely or treat hazardous drug waste as contaminated. Multiple avenues exist to increase the safety of pharmacy technology and end direct and indirect exposure to hazardous drugs. These range from Containment Primary Engineering Control (C-PEC) to training and education to the use of Closed System Drug-transfer Devices (CSTDs). All of these different safety aspects combine to prevent contact with hazardous drugs.

Implementing administrative and engineering controls, adhering to the latest hazardous drug handling standards, and increasing staff training can all contribute to better pharmacists safety. NIOSH recommends the use of PPE when controls are no sufficient to reduce the risk of hazardous drug exposure. By making safety a priority, pharmacy staff can better ensure a healthy workplace environment and reduce the risk of hazardous drug contamination.

Simplivia Pharmacy Guide Hazardous Drug Safety

Engineering and Work Practice Controls

A hierarchy of administrative and engineering controls can minimize the risk of contamination and promote safe handling. These controls include specified areas for storing and handling hazardous drugs in accordance with manufacturer specifications. They also include the use of dedicated biological safety cabinets (BSCs). Engineering controls and physical barriers are implemented to prevent potential widespread contamination and are a key part of facility design.

These measures include negative pressure rooms for dealing with volatile hazardous drugs, as well as restricting access to spaces where hazardous drugs are received, unpacked, stored, and handled. Both the American Society of Hospital Pharmacists and OSHA recommend that all hazardous drug preparation be limited to a signposted and locked restricted area (OSHA, 1983). This will prevent unauthorized access and potential cross-contamination into other areas. Available controls also include special equipment such as chemotherapy hoods, and the implementation of Closed System Drug-transfer Devices (CSTDs). A CSTD, llike those provided by Simplivia, prevents hazardous drugs from seeping into the environment. The United States Pharmacopeia (USP) General Chapter <797> and NIOSH both recommend using CSTDs to reduce the risk of accidental exposure to hazardous drugs (ASHP, 2006; U.S. Pharmacopoeial, 2008). In fact, NIOSH defines a CSTD as “A drug transfer device that… - mechanically prohibits the transfer of environmental into the system - and the escape of hazardous drug or vapor concentrations outside the system.”

Training, while an effective administrative control, is most successful when it is ongoing. USP <800> states that all pharmacy personnel who deal with hazardous drugs must receive training relevant to their position. Training should recommence whenever a new hazardous drug is introduced, if equipment changes, or if there is a modification in the standard operating procedure (SOP), with competency-based staff training and reassessments to be held at a minimum of once a year. Training sessions must be documented for future reference (U.S. Pharmacopoeial, 2008).

However, some pharmacists undermine safety controls by failing to use the protective gear or following protocols. This risks exposure to hazardous drugs with potentially devastating health effects for themselves and others. In a recent study of cases involving contaminated products, improper equipment use, lack of training, careless staff, and minimal compounding technique was found to be the cause of almost every incident involving hazardous drug contamination (ISMP, 2012).

Adhere to these safety guidelines regarding administrative and engineering controls:

  • Do not eat, drink, or loiter in the space where hazardous drugs are stored or prepared (ASHP, 2006).
  • Staff training should be assessed yearly and ongoing in the event of a new hazardous drug introduction and changes in facility procedure or equipment
  • Pharmacy personnel must follow standard procedures when receiving and unpacking hazardous drug shipments due to potential exterior container contamination
  • CSTDs offer an enhanced layer of protection; however, PPE should still be used in accordance with safety recommendations from hazardous drug manufacturers in addition to engineering controls
  • Pharmacy employees must know emergency procedures to follow in case of accidental exposure, splash, or spillage of a hazardous drug

Ventilated Cabinets

A ventilated cabinet uses a HEPA filter system to provide personal protection while handling hazardous, non-sterile drugs. These cabinets minimize exposure to the drugs by controlling emissions of airborne contaminants. The cabinet re-circulates some air back into the cabinet and then exhausts the rest outdoors. A ventilated cabinet is not suitable for drugs that require a sterile environment.

Simplivia Pharmacy Guide Hazardous Drug Safety

Class II Biological Safety Cabinet

A Class II Biological Safety Cabinet utilizes directional airflow and HEPA filters to control airborne particles. Designed for use with biological materials, they are also suitable for pharmacies, especially for sterile compounding. These safety cabinets are a practical approach for smaller pharmacies that can’t afford  a cleanroom. The biosafety cabinet can effectively protect
pharmacy personnel handling hazardous drugs and patients receiving medication that requires sterile compliance.

Compounding Aseptic Containment Isolators

A compounding aseptic containment isolator provides a clean and safe environment for pharmacists compounding hazardous drug preparations. It complies with USP <797> and      USP <800> criteria and is used for:

  • Hazardous materials
  • Antineoplastic drugs
  • Cytotoxic compounding applications

The isolators consist of a work zone along with pass-through chambers that remain under negative pressure for the protection of the pharmacist in case of a breach. Clean air in the work area enters through a microbial retentive filter system that contains any airborne contaminants.

Simplivia Pharmacy Guide Hazardous Drug Safety

USP<800> Compliant Hazardous Drug Spill Control Kits

As of December 2019, compounding pharmacies and healthcare facilities must carry USP<800> compliant hazardous drug spill control kits. Spill kits contain materials needed to clean up hazardous drug spills immediately such as: Absorbent powder, Absorbent pad, Chemosorb pad, Antiseptic towel and a Chemi-bio wipe. They also contains standard clean-up tools and personal protective gear necessary to prevent contact with the hazardous drugs.

Personal Protective Equipment (PPE)

Frequent exposure to hazardous drugs can cause a multitude of health problems. However, a survey of 183 pharmacists showed that a whopping 47% did not double-glove, 10% decided not to wear any gloves at all, and 20% didn’t wear a disposable gown as recommended (Boiano, Steege et al., 2015). There is no such thing as a “safe” level of contact when it comes to hazardous drugs, further illustrating the importance of PPE, including hair, shoe, and beard covers as the situation requires.

Gowns
Gowns with polyethylene or vinyl coatings have been shown to provide splash protection (Harrison, Kloos, 1999). The easiest way to avoid skin contact is with a disposable gown and not
a lab coat due to its absorbent nature. Gowns must be backclosing, with closed cuffs and long sleeves, and worn with every hazardous drug interaction.

Gloves
Double gloves are mandatory when dealing with hazardous drugs. One glove cuff must go underneath the disposable gown cuff, while the other glove cuff must go above to best protect
skin against accidental contact. Longer gloves are the preferred top layer.

Respiratory and Eye Protection
Pharmacy personnel should wear a fit-tested N95 filtering facepiece respirator (FFR) or N-100 particle masks for hazard protection (OSHA, 1983). Glasses and surgical masks do not protect against splashes or vapors. All personnel, glasses wearers or not, must wear protective goggles or a full face shield.

Simplivia Pharmacy Guide Hazardous Drug Safety

Personal Protective Equipment Disposal

All waste, such as used gowns, gloves and other items that have come into contact with hazardous drugs must be treated as contaminated. Dispose of PPE in accordance with federal, state, and local laws. Report known contamination incidents as per facility guidelines.

  • Consider single-use PPE as hazardous and contain or dispose of the items as per your facility’s procedures (Conner & McDiarmid, 2006).
  • The disposal container should be labeled, sealed, and covered.
Sources
1. Boiano JM, Steege AL, Sweeney MH. Adherence to Precautionary Guidelines for Compounding Antineoplastic Drugs: A Survey of Nurses and Pharmacy Practitioners. J Occup Environ Hyg. 2015 ;12(9):588-602. doi: 10.1080/15459624.2015.1029610.
2. Connor TH, McDiarmid MA. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin. 2006 ;56(6):354-65. doi: 10.3322/canjclin.56.6.354.
3. Esco Pharma, Compounding Aseptic Containment Isolator (CACI), 2019. https://www.escopharma.com/compounding-aseptic-isolator/
4. Hammond D, Meda K. Preventing Exposure to Hazardous Drugs: Engineering-Control Recommendations in the NIOSH Alert. Pharmacy Purchasing & Products. https://www.pppmag.com/article_print.php?id=262
5. Harrison BR, Kloos MD. Penetration and splash protection of six disposable gown materials against fifteen antineoplastic drugs. Journal of Oncology Pharmacy Practice. 1999 ;5(2):61-66. doi:10.1177/107815529900500201.
6. International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007 ;13 Suppl:1-81. doi: 10.1177/1078155207082350.
7. Jeffrey, LP. Recommendations for Handling Cytotoxic Agents. National Study Commission on Cytotoxic Exposure. 1983.
8. Lingner, W. USP <800> Compliant Hazardous Drug Spill Control Kits from Sharps Compliance. Sharps Compliance, Inc. 2019. https://blog.sharpsinc.com/usp-800-compliant-hazardous-drug-spill-controlkits-from-sharps-compliance
9. NIOSH. National Institute for Occupational Safety and Health list of antineoplastic and other hazardous drugs in health-care settings (2016).
10. Power LA, Coyne JW. ASHP Guidelines on Handling Hazardous Drugs. Am J Health Syst Pharm. 2018;75(24):1996-2031.
11. Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings. Centers for Disease Control and Prevention; Available at: https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html
12. Sterile compounding tragedy is a symptom of a broken system on many levels. ISMP Med Saf Alert 2012. Available from: www.ismp.org/Newsletters/acutecare/showarticle.asp?id=34
13. U.S. Census Bureau. (2018). 2017-2018 American Community Survey 1-year Public Use Microdata Samples. https://www.census.gov/programs-surveys/acs/microdata.html
14. 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. 2016-161.
15. U.S Pharmacopeial Convention. USP<797> Guidebook to pharmaceutical compounding – sterile preparations. In: The United States Pharmacopeial Convention, Rockville, MD, 2008.
16. USP General Chapter Hazardous Drugs-Handling in Healthcare Settings. USP. June 2020, https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
17. Valanis B, Vollmer W, Labuhn K, Glass A. Occupational exposure to antineoplastic agents and self-reported infertility among nurses and pharmacists. J Occup Environ Med. 1997 ;39(6):574-80. doi: 10.1097/00043764-199706000-00013.

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