with Kara Duncan Weatherman,
PharmD, BCNP, FAPhA

Pharmacy Purchasing & Products: What do pharmacists need to know about proper management of radiopharmaceuticals?
Kara Duncan Weatherman: While pharmacists should be familiar with radiopharmaceuticals and their use, in-depth knowledge of the drugs’ mechanism of action is not required to properly manage them. However, effective management does require an understanding of the procurement methods associated with radiopharmaceuticals. The source of the product—an outsourced central nuclear pharmacy, or in-house preparation—will determine the level of oversight required. For example, an outsourced nuclear pharmacy most likely is USP <797>-compliant, but some in-house nuclear medicine departments might not be aware of and adhere to the same stringent standards. While procurement of radiopharmaceuticals is typically handled completely by the radiology department, per <797> pharmacy should have some level of responsibility and oversight of their compliant storage and use. Thus, pharmacy must understand where radiopharmaceuticals are procured or compounded and ensure that <797> requirements are met. 

PP&P: How can pharmacy ensure patient safety with radiopharmaceuticals?
Weatherman: Pharmacists must make it a priority to develop and maintain close professional relationships with nuclear medicine technologists and radiologists. In the past there has occasionally been a breakdown of communication between pharmacy and these departments, as radiology medications may have been ordered, tracked, and dispensed by radiology, with little pharmacy oversight. However, with the advent of <797> requirements, pharmacy must provide guidance on the storage and use of radiopharmaceuticals and ensure these medications are managed correctly. The current disconnect between the departments is likely a result of radiologists feeling pharmacy may infringe on their autonomy in what was previously a closed system. It is pharmacy’s job to become familiar with the policies and procedures of the radiology department and be prepared to provide education on the storage and management of radiopharmaceuticals and thereby overcome these barriers.

To improve communication, pharmacy should visit radiology and inquire about their workflow and process. In a follow-up visit, pharmacy can provide education on  <797> requirements regarding medication storage and the consequences for the hospital in the event of an audit if these medications are not properly controlled and managed. Making the effort to improve relations through open communication will likely improve workflow and medication storage compliance.



PP&P: What clinical problems are associated with the use of radiopharmaceuticals?
Weatherman: In general, few adverse reactions are associated with the use of radiopharmaceuticals. The purpose of using these agents—combining a small amount of radioactivity with a molecule that will behave in a certain manner once introduced into the body—means that the physical mass of material injected into the patient is so small that adverse medication events are relatively rare. The intent of radiopharmaceuticals is to allow observation of a physiologic process, not to provoke a pharmacologic response in the body. 

However, occasionally unusual outcomes—resulting from altered biodistribution, formulation problems, improper administration techniques, or variation in human anatomy—do occur. It is important to note that patient variants should not be considered synonymous with adverse medication reactions. One of the difficulties in identifying adverse events is understanding and recognizing the subtle differences between a true adverse event and an event that occurs as a result of a patient variant. Unusual uptake of a radiotracer in an area of the body that was not anticipated could be due to the presence of undesired impurities resulting from the formulation of the drug, or could be a result of an underlying physiologic condition that is not directly related to the condition being studied. While this is essentially what the radiologist will be responsible for determining as part of the assessment of the scans, in some cases, information that can be provided by the pharmacist may be useful in helping to clarify this decision.

In the same vein, another difficulty is defining which events are reportable. After determining that the adverse event was not the result of a patient variant, but instead was caused by the radiopharmaceutical, the next step is determining what should and should not be reported. For example, if a patient experiences nausea during an imaging study, is this due to the imaging drug or some other factor? 

PP&P: What role should pharmacy have in the development of imaging and therapeutic protocols?
Weatherman: Given that medication reconciliation is often pharmacy-driven, pharmacists should be highly involved in the development of radiology protocols. Many accrediting bodies recognize the role of the pharmacist in identifying adverse events and creating plans to address issues that arise, and suggest that pharmacists contribute their expertise in developing a systematic approach to identifying, correcting, and reporting these issues when they occur in a radiology department. Much of the daily workflow in radiology is protocol-driven, with a few physicians overseeing trained technologists who are responsible for carrying out imaging procedures. Since the number of adverse events that occur in the radiology department is fairly low, the ability to use well-written protocols with contingencies for issues that arise is essential to maintain the generally high throughput seen in many radiology departments, while keeping staffing requirements reasonable. 

In order to have the necessary knowledge to properly control radiopharmaceuticals and deal with drug-related contingencies, pharmacy must work closely with radiology in protocol development. Most facilities, with the exceptions of very large hospitals or teaching facilities, do not have the benefit of a dedicated nuclear physician or nuclear pharmacist in-house. In this case especially, thorough protocol development—including who should be educating patients before procedures, as well as steps to ensure adherence to <797>—must be discussed and agreed upon, and the resulting decisions recorded in the protocols. It is also important to develop a hospital culture where staff members are expected to follow these protocols and do so consistently. 

PP&P: What is the best approach to managing patient education prior to imaging procedures?
Weatherman: The most important requirement is that patients must receive education; who performs the necessary education should be carefully considered, decided upon, and delineated within the protocol. If no protocol is in place defining who must perform this task, there is a risk that patient education may fall by the wayside, with each clinician assuming another has completed this task. 

In most cases, the person performing patient education would be the clinician who ordered the imaging study, as they have an understanding of why the test was ordered and can give the patient some idea of how to prepare for the test before presenting to the radiology department. In some cases, a member of the radiology staff will contact the patient after the procedure is scheduled to discuss the specific details that are required to ensure a better study—for example, the need to discontinue certain medications or foods prior to the imaging procedure. This information may be presented by the ordering physician, but a follow-up reminder is often useful for the patient. Because pharmacists generally have a basic, but not extensive, understanding of how radiology drugs work, and many of these products are for outpatient use, typically the ordering physician is best suited to educate patients, but this does not preclude a pharmacist from being involved in this process. Many of the requirements for patient preparation before a particular study can be addressed as part of the protocol for that particular procedure.

PP&P: Can you describe the ideal role of the nuclear pharmacist?
Weatherman: As mentioned previously, usually only the largest facilities—specifically, teaching hospitals—will have an on-site nuclear pharmacy. Most hospitals rely on commercial nuclear pharmacies to service their radiopharmaceutical needs. In an ideal world, each hospital would employ its own nuclear pharmacist, but this is simply not an option for most facilities. 

In lieu of having a nuclear pharmacist on staff, it is important that pharmacists within an institution be aware of the commercial nuclear pharmacy source and feel comfortable reaching out to the nuclear pharmacists employed there, who can act as a liaison between the worlds of radiopharmacy and the hospital utilizing the service. The nuclear pharmacy communicates with the staff of the nuclear medicine department several times daily, but the opportunity for interaction with the pharmacy staff is usually nonexistent. Because a typical outside radiopharmacy services the needs of many hospitals concurrently, each hospital using their services should designate a go-to person responsible for communicating with the radiopharmacy partner. Developing and maintaining a relationship between the outside radiopharmacy and a single source of contact within the hospital allows for smoother workflow and ensures all information is communicated effectively.

PP&P: How does appropriate radiopharmaceutical use benefit the hospital?
Weatherman: One of the chief benefits of effective radiopharmaceutical use is the ability to deliver early disease diagnoses. Because these medications are designed as tracers, they have the potential to illuminate functional, physiological problems long before they may be anatomically observable on other diagnostic imaging modalities; thus, appropriate treatment can begin earlier in disease progression. However, because radiopharmaceutical scans do not provide the same high-resolution anatomic images as other modalities, often a functional issue is evaluated by a radiopharmaceutical scan, with an anatomic evaluation using another scanning modality. 

One increasingly popular tool in nuclear medicine is positron emission tomography (PET) scanning, which is used extensively in clinical oncology practice, with applications in neurology and cardiology as well. The most common procedure uses a radio-labeled glucose analog (fluordeoxyglucose or FDG) to evaluate metabolic processes, including the glucose utilization of various tumor types. As the tumor grows, it utilizes more glucose, which can be seen during the imaging study. As a result, physicians can monitor the progression of disease, as well as the effectiveness of treatment. 

PP&P: Are there any nuclear pharmacy–specific drug information resources available?
Weatherman: There are several reliable references available for pharmacists. The gold standard is Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine.¹ The third edition was published last year and includes information detailing the microbiological control of radiopharmaceuticals, including <797> guidelines; special topics, such as formulation problems, pediatric dosing, breast milk excretion, and adverse reactions; molecular imaging and new radiopharmaceutical development; and clinical PET technology. In addition, the American Pharmacists Association published two new nuclear pharmacy references this past December. The first, Nuclear Pharmacy Quick Reference,² compiles important nuclear pharmacy information, including drug interaction tables and a review of the clinical uses of radiopharmaceuticals. Diagnostic Imaging for Pharmacists³ provides pharmacists with a basic understanding of agents used in the imaging process, including practical information not covered in pharmacy school curricula. Topics covered include diagnostic imaging techniques, indications and routes of administration for pharmacologic agents, and an introduction to X-ray, PET imaging, MRI, and ultrasound technologies.

References

1. Kowalsky RJ, Falen SW. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine. 3rd ed. Washington, DC: American Pharmacists Association; 2011.
2. Cole CN, Shaw SM, Kowalsky RJ, eds. Nuclear Pharmacy Quick Reference. Washington, DC: American Pharmacists Association; 2011.
3. Templar Smith B, Weatherman KD, eds. Diagnostic Imaging for Pharmacists. Washington, DC: American Pharmacists Association; 2011.

Kara Duncan Weatherman, PharmD, BCNP, FAPhA, is a clinical assistant professor of pharmacy practice at Purdue University, where she also received her pharmacy degree. Kara’s professional interests include assessing how nuclear pharmacy practice standards influence the biodistribution, quality, and diagnostic efficacy of the radiopharmaceuticals dispensed; validation of current nuclear pharmacy practice standards; and USP <797>-compliant sterile product compounding.