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.
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. 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.
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.
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.
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.
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.
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.
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.
 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
 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.
 NIOSH . 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.
NIOSH . 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 firstname.lastname@example.org