Managing Radiopharmaceuticals


April 2011 - Vol. 8 No. 4 - Page #2

It is not unusual for the pharmacy department to have little knowledge of the drugs used within radiology. While some institutions have successfully included radiopharmaceuticals and radiopaque contrast media (RCM) into their formulary management, many have yet to do so. This complacency is not limited to pharmacy departments, however; radiologists have been strongly resistant to change and represent a powerful voice in hospital politics. This is further confounded by the common misperception that these products are supplies rather than drugs available only through prescription. The current focus on the safe use of these drugs is driven by The Joint Commission (TJC), who in 2004 expanded the definition of medications to explicitly include RCM and radiopharmaceuticals, a change that rendered many health care systems noncompliant.

Imaging procedures are increasingly common, and millions of these procedures involve the use of prescription drugs annually.1 Radiologic imaging services are provided in a variety of inpatient and outpatient settings, most commonly in radiology, nuclear medicine, and cardiac catheterization laboratories. These services employ a wide variety of imaging modalities, such as radiography (X-ray), computed tomography, magnetic resonance imaging, ultrasound, and nuclear medicine techniques such as positron emission tomography and single-photon emission computed tomography. In areas where diagnostic imaging is performed, drugs such as IV RCM are administered, rates are adjusted for IV fluids, and IV access lines are flushed. These circumstances create an environment in which there is an increased risk of medication-related errors.

Working with Radiology
Lack of written prescriptions or medication orders and poor documentation often compound the risk for medication errors. When RCM do not have formulary status, computerized physician order entry (CPOE) is ineffective and electronic records are left incomplete. The radiology report may contain some information regarding the medications administered, but often it lacks sufficient detail. Radiologists are focused on evaluating image data and making informed judgments regarding the significance of image findings to diagnose, stage, and monitor pathologies, and documentation can sometimes fall by the wayside. Medication information contained only in the radiology report and not integrated in the medical record is difficult to access, which causes suboptimal communication of medications administered during imaging procedures.

This lack of written orders and failure to document medications administered may be due to the fact that radiologists often do not examine or even see the patient before or during the imaging procedure, but simply interpret the resultant images at a later time. Radiologic technologists, who are experts in performing  the imaging procedures, do not typically have the education or training to provide pharmaceutical care for patients receiving imaging drugs. Not only are these circumstances incompatible with general drug-use standards, but they also have been observed to produce less than optimal patient care outcomes and are contrary to TJC’s and other accrediting agencies’ policies.

A 2005 United States Pharmacopeia report on medication errors in radiology revealed that while errors in radiology were not more frequent than in other settings, they have more potential to cause harm.1 Several factors have been identified that increase the risk of medication errors in radiology:

  • The amount of time patients spend undergoing radiologic procedures is a minor component of their inpatient care experience.
  • As patients are transferred to and from radiologic procedure areas and are handed off to caregivers other than those primarily responsible for their inpatient care, the opportunity for miscommunication and lack of access to patient information creates circumstances in which errors may occur.
  • Because the patient care received in radiology is focused on the imaging procedure, drugs that were administered pre-examination, or those to be given or withheld post-examination, may not receive adequate attention.
  • The certification and training requirements for radiologic staff are highly variable and dependent upon setting, state regulations, and institutional policies. Licensed independent practitioners (LIPs) assume responsibility for medications that often are prepared and administered by other personnel, such as technicians, for whom there are no standards for medication-use training. These staff commonly administer RCM, adjust rates of IV fluids, and flush IV access lines—tasks that have the potential to cause harm to patients.


Many pharmacy departments cite their lack of expertise with RCM and radiopharmaceuticals as the reason for avoiding oversight responsibilities. Given the frequency of RCM use and the accompanying high rates of adverse events, it is not surprising many pharmacy directors are anxious to avoid this challenge. The product costs alone are cause for hesitation. In many hospitals, it is not uncommon for radiology to spend over a million dollars per year on RCM and radiopharmaceuticals. With the existing professional demands faced by pharmacy directors, many have been reluctant to take ownership of an additional million dollars per year of drugs.

The Pharmacist’s Responsibility
TJC standards and national patient safety goals indicate that LIPs are responsible for initiating medication orders (see Tables 1-3). Pharmacy departments must intensify and accelerate their efforts to advocate for appropriate procurement, storage, prescribing, preparation, administration, documentation, and drug-use evaluation of imaging drugs. These drugs also should be included in CPOE systems and integrated into the patient medical record.


The fundamental purpose of pharmaceutical services within any health care delivery model is to ensure the safe and appropriate use of drugs. This involvement includes the evaluation, procurement, storage, distribution, and administration of all drugs. The pharmacist is responsible for the development, in consultation with other professionals, of all drug-use control policies and is directly responsible for the control and distribution of all drugs, including radiopharmaceuticals and RCM used in nuclear medicine, radiology, the cardiac catheterization laboratory, and other areas in which imaging occurs (see online-only Table O1 below). Despite this recognition, many pharmacy and radiology departments have little interaction. Radiology departments typically purchase, store, prepare, and administer contrast media without pharmacy involvement.


Caution in Diagnostic Radiopharmaceutical Use
Drug-use controls for radiopharmaceuticals follow a unique model. These drugs are frequently outsourced to commercial nuclear pharmacies, which are licensed by the state boards of pharmacy (or their equivalent). These licensed pharmacies require a written order, have pharmacists who are responsible for the preparation and dispensing of radiopharmaceuticals, and maintain records of prescriptions dispensed. However, the selection of the outsource supplier and monitoring of the products provided often receives little, if any, oversight from pharmacy.

There also are concerns regarding preparation of radiopharmaceuticals in-house by nuclear medicine technologists and other non-LIPs. The Department of Health and Human Services Code of Federal Regulations requires in-house preparation of radiopharmaceuticals to be done by or under the direct supervision of an appropriately trained registered pharmacist or doctor of medicine or osteopathy. During several recent TJC accreditation site visits, hospitals were cited for noncompliance with this statutory requirement as radiopharmaceuticals were being prepared by nuclear medicine technologists. Nuclear medicine personnel cite as their justification that these instances typically occur outside of normal working hours. Rather than engage the commercial nuclear pharmacy for an on-call unit dose radiopharmaceutical, some institutions prefer to have the nuclear medicine technologists prepare the drug onsite to avoid additional costs from pharmacist call services, emergent drug preparation, and delivery fees. Some third parties contracted to administer TJC accreditation standards also have disputed the meaning of direct supervision, insisting that this requires a pharmacist or physician to be physically present.

While some have posited that diagnostic radiopharmaceuticals are inherently safe and therefore should be handled differently from RCM, it is important to note that postmarketing reports of adverse health events, including death, are changing the perception of the risk associated with these drugs. While diagnostic radiopharmaceuticals are themselves safe, there are documented instances of improper compounding or preparation, as well as contaminations, leading to significant adverse events.

Concerns with Contrast Media
RCM issues recently cited by TJC include RCM stored in warmers without consulting manufacturer’s guidelines regarding temperature, time, and monitoring; RCM not stored securely; RCM stored without labeling; injectors prefilled with medication without labels affixed; inability to demonstrate an actual order for RCM; and emergency medications not being monitored for expiration and proper storage conditions.

Ensuring Drug-Use Controls and Compliance
The simplest issues to resolve relate to drug disposition: procurement, storage, return, disposal, etc. These issues are largely unrelated to the care of an individual patient and can be administered by the pharmacy department, consistent with other medications. It can be complicated when radiology procures these legend drugs directly, without pharmacy involvement. However, by sharing pharmacy best practices with radiology, consistent outcomes can be achieved and compliance with applicable institutional policies and TJC standards can be ensured. Working together and openly communicating between departments can ease the transition to pharmacy overseeing radiopharmaceuticals and RCM (for additional resources, see Suggested Reading).

Achieving compliance with policies regarding labeling and storage of medications during imaging procedures is by far the most challenging area. Radiologists often exhibit resistance when requested to modify their behavior related to the use of imaging drugs in their individual practice (ie, adopting standardized concentrations of drugs, using uniform labeling conventions, etc). These efforts should begin with educational programming to inform radiologists of the necessity to comply, specific behavioral modifications such as labeling, and the support mechanisms that are available to them. Once radiologists understand that compliance is necessary to ensure TJC accreditation and ultimately payment for services, they are more likely to modify their behavior.

Conclusion
Drug-use controls in radiology present a difficult and challenging circumstance, one in which millions of patients per year are routinely exposed to dangerous drugs without the protections uniformly offered elsewhere in the hospital. Pharmacy must assume responsibility for the well-being of these patients and ensure best medication-related outcomes for patients referred for medical imaging. All patients should be protected by the safeguards pharmacy is uniquely positioned to provide.

References

  1. Santell JP, Hicks RW, Cousins DD. MEDMARX Data Report: A Chartbook of 2000-2004 Findings From Intensive Care Units and Radiologic Services. Rockville, MD: USP Center for the Advancement of Patient Safety; 2006.
  2. Cohen HI. ASHP Medication Management and Contrast Media Discussion Guide 2010. http://www.ashp.org/DocLibrary/Policy/ContrastMedia/ContrastMediaDiscussionGuide.aspx  Accessed February 9, 2011.

Jeffrey P. Norenberg, MS, PharmD, BCNP, FASHP, FAPhA, is a professor and the director of radiopharmaceutical sciences at the University of New Mexico Health Sciences Center. He also is the executive director of the National Association of Nuclear Pharmacies, a trade association representing 500 commercial nuclear pharmacies in the United States. Jeffrey is a board-certified nuclear pharmacist and a fellow in the American Society of Health-System Pharmacists and the American Pharmacists Association.

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Tips for Working with Radiology and Cardiac Catheterization Labs

Start by getting to know the radiologists and radiologic technologists, and learn about their practice environment and the challenges they face in their daily work. Establishing a rapport with those in radiology will make it much easier to implement process improvements.

Work with the P&T committee to evaluate and maintain compliance with formulary management policies and to develop a means of
medication order entry for radiopharmaceuticals and RCM. Pharmacy should take the lead in developing an order form, which will be signed by the licensed independent practitioner. The order form will serve as a communication tool, which in turn allows for better patient monitoring and helps prevent potential drug misadventures.

Once an order-entry system is implemented, ensure that information is incorporated into patient medical records in a timely manner. This integration of information is necessary to communicate the patient’s receipt of RCM and to help prevent exposure to other potentially nephrotoxic drugs or procedures.

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Suggested Reading

Barrs TJ. X-rays and radiopaque drugs. Am J Health Syst Pharm. 2005;62(19):2026-2030.

European Society of Urogenital Radiology. ESUR Guidelines on Contrast Media, 2008. http://www.esur.org/Contrast-media.51.0.html Accessed February 9, 2011.

Institute for Safe Medication Practices. The Persantine stress test. ISMP Med Saf Alert 1997;2(27):2.

Kanal E, Barkovich AJ, Bell C, et al. American College of Radiology. ACR Guidance Document for Safe MR Practices: 2007. www.acr.org/SecondaryMainMenuCategories/quality_safety/MRSafety/safe_mr07.aspx Accessed February 9, 2011.

Manasse HR Jr. Medication use in an imperfect world: drug misadventuring as an issue of public policy, Part 1. Am J Health Syst Pharm. 1989;46(5):929-944.

Manasse HR Jr. Medication use in an imperfect world: drug misadventuring as an issue of public policy, Part 2. Am J Health Syst Pharm. 1989;46(6):1141-1152.

Nold EG, Sander WT. Role of the director of pharmacy: the first six months. Am J Health Syst Pharm. 2004;61(21): 2297-2310.

Pedersen CA, Gumpper KF. ASHP national survey on informatics: assessment of the adoption and use of pharmacy informatics in U.S. hospitals—2007. Am J Health Syst Pharm. 2008;65(23): 2244-2264.

Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2008. Am J Health Syst Pharm. 2009;66(10):926-946.

Thomsen HS, Webb JAW, eds. Contrast Media: Safety Issues and ESUR Guidelines. (Medical Radiology/Diagnostic Imaging). 2nd ed. Berlin,
Germany: Springer-Verlag; 2009.

US Food and Drug Administration. Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150564.htm Accessed February 9, 2011.


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