Compounding is defined as the preparation, mixing, assembling, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription for an individual patient, based on a professional agreement between the practitioner, patient, and pharmacist in the course of professional practice.1
While compounding intravenous (IV) medications and solutions is an essential component of pharmacy practice, nurses also are responsible for compounding. Most often, IV medications and solutions are prepared in a centralized pharmacy, especially in acute care and hospital settings. However, in other care settings, such as outpatient infusion centers, prescriber infusion suites, and patients' homes, it is common practice for nurses to compound medications before administration. For this reason, it is important that nurses understand the risks in sterile compounding that can have an impact on patient care, such as contamination, infection, and incorrect dosing. Without the guidance of standards, there is a risk of adverse outcomes, including death, that can occur if medications become contaminated or if their potency is altered.
Standard 17 of INS' Infusion Therapy Standards of Practice, "Compounding and Preparation of Parenteral Solutions and Medications,"2(pS39) supports compounding in accordance with state and federal regulations and guidelines from professional associations, such as the American Society of Health-System Pharmacists and the United States Pharmacopeia (USP). Several of Standard 17's Practice Criteria reference USP General Chapter <797>: Pharmaceutical Compounding-Sterile Preparations.2(pS39-S40)
Adherence to USP <797> reduces the risk of potential contamination from unclean environments and a lack of quality control. It also prevents harm to patients, which could result from microbial contamination, unintended chemical and physical contaminants, and ingredients of inappropriate quality. USP <797> requirements outline the responsibilities of compounding personnel and necessary training, as well as environmental monitoring, storage, and testing of final preparations.
The most recently published version of USP General Chapter <797> went into effect June 1, 2008. It is currently undergoing revision and has an anticipated implementation date of December 2019. INS has been a member of USP since 1996, and of USP's 458 voting members, INS is only one of a handful of nursing organizations who are also members. As a member, INS provided feedback to USP for the 2008 version of the chapter, and we have the opportunity to participate in the public comment process for proposed revisions. The comment period opens July 28, 2018 and closes November 30, 2018. Written comments can be submitted through the USP website. Information and updates are posted on the USP website at https://www.usp.org/compounding/updates-on-standards.
Currently, USP <797> allows the preparation of a compounded sterile preparation (CSP) for immediate use. The definition includes the fact that the preparation involves 3 or fewer manipulations to compound the final product. Many of the CSPs that might be prepared (eg, chemotherapy, Remicade, and so forth) require many more than 3 manipulations to prepare the final CSP. Several boards of pharmacy have interpreted this process to be in violation of USP <797> and other board of pharmacy rules/regulations, and require this practice to stop. When you think of your ability to prepare a CSP for patients in their homes, in an ambulatory infusion suite, or a prescriber's office where establishing vascular access is often needed, the potential impact can be significant. And because many of these drugs have short-term stability and beyond-use dating, the ability of a pharmacy to compound, ship to a patient's home or place of infusion, and make sure the nurse is there will be severely hampered.
Why is it important that INS members provide feedback? Stakeholder engagement is important to recognize a broad spectrum of perspectives that could influence the final version of the standards. How might changes to USP <797> have an impact on your clinical practice? It is important that we ensure that patients' access to care and their infusions are not hampered and that as clinicians, we provide feedback to our regulatory boards as issues such as this come up. Become aware, become involved. Compounding isn't just for pharmacists and pharmacies; it affects many providers of health care.
Mary Alexander
REFERENCES