Over the past 8 years, sweeping changes have altered the way US radiology departments operate regarding the use of contrast media. Until very recently, most radiology and pharmacy departments have had limited contact; radiology selected the contrast agents and routinely handled the purchasing, storage, preparation, and administration of contrast media. Interactions with pharmacy were rare and centered around the use other medications within the department. This relationship changed in 2004 when the Joint Commission (JC) issued standards that explicitly defined medications to include contrast agents. This mandate placed contrast agents under the same regulatory supervision as other medications. Immediately, health systems found themselves out of compliance with the JC Medication Management (MM) standards. Since then, radiology departments have struggled to meet these requirements in order to maintain hospital accreditation. Efforts necessary to meet these standards can either be viewed as a bureaucratic hurdle or an opportunity to positively affect patient care and safety. Given what was perceived as an imperative for radiology and pharmacy to cooperate, our department chose to meet these regulations head-on by collaborating with pharmacy by organizing a new committee designed to ensure best practices for both disciplines.
Understanding the role of a joint radiology and pharmacy committee requires a review of the issues health systems are facing incorporating the JC mandates. Standard MM 05.01.01 (formerly MM 4.10) states that all medication orders are to be reviewed by a pharmacist before administration. Two exceptions are allowed: 1) in urgent situations when delay would clinically harm the patient and when 2) a licensed independent practitioner (LIP) oversees the ordering, preparation, and administration of the medication. A LIP is defined as any practitioner permitted by law and the organization to provide care and services, without direction or supervision, within the scope of the practitioner license. At the time of the initial mandate, the mechanism by which these regulations should be enforced within radiology was unclear. In a department in which tens of thousands of contrasted studies are performed a year, how could radiology safely and efficiently comply with MM 05.01?
In June 2005 and 2006, the JC clarified its requirements for use of oral and rectal contrast by determining that administration of these agents is safe in both inpatient and outpatient settings as long as safeguards are followed. In 2007, the JC modified the interpretation of standard MM 05.01.01 to allow for intravenous (IV) contrast media to be administered by defined and pre-set protocol provided that the radiology department defines the role of the LIP in the direct supervision of a patient during and after IV contrast media is administered. Simply put, health systems can approach MM 05.01.01 in two different manners: a pharmacist can review orders for contrast media prior to each and every imaging study or the system can implement a protocol-based approach that defines the role of the LIP in the direct supervision of patients before and after the administration of contrast media. In the latter, radiology takes on the role of the LIP and pharmacist review of orders for contrast media is not required. Pharmacy and radiology must collaborate on development and approval of these protocols that will include preset contrast dose and administration orders that have been reviewed by the radiologist (as LIP) to ensure quality control and patient safety. These decisions fall under the purview of a collaborative committee including representatives from both radiology and pharmacy. In our hospital system, these teams are referred to as Formulary Evaluation Teams (FET).
The FET is charged with reviewing applications for formulary approval as well as supporting current medication prescription, procurement and distribution and medication reconciliation, the JC MM Standard 03.01.01. Our radiology FET comprises pharmacists, technologists, nurses, and physicians. Our responsibilities include development of protocols for medication (ie, contrast) management, clarifying and standardizing practices regarding medication use within the department, finding solutions for medication shortage issues that apply to the department of Radiology, and evaluating the introduction of new medications into the department. Although these initiatives could have been undertaken without committee approval, the collaboration with pharmacists, nurses, and technologists has improved information dissemination and compliance throughout the department.
Some of the most interesting initiatives relate to the team evaluation of new contrast agents for inclusion in the hospital formulary. Because contrast agents are designated as medications, they require the same rigorous evaluation for necessity and safety as other medications proposed for hospital formulary approval. A major role of the radiology FET is to provide a thorough appraisal of each agent with a pharmacist review of medication indications, safety profile, and black box warnings as well as all available investigational data regarding the agent. Armed with this information, the FET provides a recommendation to the Hospital Pharmacy & Therapeutics (P&T) committee for a formal vote.
Most recently we shepherded the approval of ferumoxytol, a Food and Drug Administration-approved superparamagnetic iron oxide nanoparticles product medication used for treatment of iron deficiency anemia in adults with chronic kidney disease, as a formulary-approved contrast agent for vascular magnetic resonance imaging in patients with marked renal insufficiency. As a group of physicians who would administer contrast agents to this patient population, the radiology FET was asked to justify ferumoxytol use as an imaging agent by reviewing appropriate indications, screening processes, and protocol for use in magnetic resonance imaging. A nephrologist member of the P&T committee added data regarding safety of this agent in patients with renal insufficiency. Through this collaborative effort, the radiology FET and subsequently the hospital P&T committee elected to add the agent to the formulary for imaging use.