Patient Safety: The Facts About Unit Dose Dispensing and Dose Splitting

In conjunction with the National Patient Safety Foundation and the Center for Patient Safety, our nationwide network of pharmacies is recognizing Patient Safety Awareness Week by putting special emphasis on our commitment to the highest patient safety standards.

While it goes without saying that practices designed to ensure patient safety are a 24/7/365 (rather than a week-long) concern, this annual safety week campaign is valuable in providing a dedicated time to re-focus on safety practices and priorities.

As my colleague Laura Bauman pointed out in her recent blog series highlighting the value of a “just culture”, safety-minded organizations are not only reliant upon individuals who make conscious choices to avoid risky behaviors, but also rely on good policies and systems to ensure that making a bad choice is difficult to do.

While ISMP has many guidelines, position statements and white papers available on their website — as along with the 2016-2017 Targeted Best Practices that appear in their Dec. 17, 2015, newsletter — one of the most valuable resources still available to help healthcare providers at all levels identify potential medication safety risks is the 2002 ISMP Medication Safety Self Assessment. The assessment illustrates how 10 key elements can be used to evaluate risk from the perspective of five distinct disciplines: administrators/managers, physicians, nurses, pharmacists and risk managers.

One important safety factor that ISMP encourages providers to assess is the use of medications exclusively in unit-dose form. Its evaluation tool includes this question: “Are all doses of medications in the hospital available only in unit-dose form?”, as well as this statement: “Whenever possible, healthcare organizations should use commercially available solutions and standard concentrations to minimize error-prone processes such as IV admixture and dose calculations.” This same precaution is re-emphasized in ISMP’s 2016-2017 Targeted Best Practices, which warns against drawing more than one dose into a syringe.

This same safety precaution is also called out within The Joint Commission’s Medication Management Standards Regarding Sample Medications, which states in MM.03.01.01.10: “Medications in patient care areas are available in the most ready-to-administer forms commercially available or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager.”

In other words: Unit dose dispensing for single patient use is the best practice in nuclear medicine.

Patient Safety Awareness Week provides an ideal time to remind our customers and readers that the practice standards of USP <797> clearly delineate requirements for single- or multiple-dose containers and for the compounding of sterile preparations, which must be done within a USP <797> compliant cleanroom/segregated compounding area by appropriately garbed and trained individuals in a classified environment. Unless your institution is using its cleanroom facility or segregated compounding area in full compliance with these environmental and personnel testing training standards, it is strongly recommended that nuclear medicine departments opt for having only unit-dose FDA-approved ingredient prepared radiopharmaceuticals dispensed from a compounding compliant pharmacy .

Dose Splitting

An even more risky practice is that of dose splitting, which is the practice of ordering one unit-dose of a radiopharmaceutical agent from a nuclear pharmacy and breaking that medication into two separate units, such as splitting the dose for use in both rest and stress cardiac studies. Considered a violation under the rules of the Centers for Medicare & Medicaid Services (CMS), the practice of splitting doses — which is termed a “perilous process” by ISMP and is considered a contradiction to the CDC’s “Safe Injection Practices” — may also be a violation of state law and can lead to prosecution for Medicare Fraud. Other unintended consequences may also arise, as was seen in 2010 when Medicare contractor Trailblazer Health Enterprises, LLC uncovered potential reimbursement fraud associated with the practice. And CORAR (The Council on Radionuclides and Radiopharmaceuticals, Inc.) has even listed reasons where dose splitting threatens the safe handling and safe administration to patients.

As a part of your Patient Safety Awareness Week activities, we encourage you to visit the Institute of Learning, where you will find a series of educational flyers focused on best practices in nuclear medicine. In addition to more information on topics I’ve touched on today — unit dose dispensing and dose splitting — you’ll find information on techniques to reduce radiation exposure, FDA-approved radiopharmaceutical products, and more.

One of the most popular additions to the Institute of Learning in recent years has been an SNMMI VOICE-accredited CE course on the topic of Managing Risk in Nuclear Medicine, which is available for onsite presentation or through our Online Learning Center.

Each and every week of the year, ensuring best practices in both our operations and those of our customers is a responsibility that we take seriously. Please don’t hesitate to call on our team of specialized, authorized nuclear pharmacists for answers to your questions about patient, product and radiation safety.