MS, RPh, BCNP
Pharmacy Purchasing & Products: What oversight should the pharmacy director assume for the medication management aspects of radiopharmaceuticals?
Allegra DePietro: For TJC-accredited hospitals, there are several medication management (MM) standards, as well as a leadership standard, that are within the purview of the pharmacy director. MM 02.01.01 states that the hospital selects and procures medications; MM 05.01.07 states that in-house preparation of radiopharmaceuticals is done by or under the supervision of an appropriately trained pharmacist or physician, ensuring safety; and LD 04.03.09 states that care, treatment, and services provided through contractual agreement are provided safely and effectively. Because these standards directly address medication safety, they are clearly in pharmacy’s sphere of influence, and the director of pharmacy (DoP) should ensure that the hospital is in compliance with these standards.
Radiopharmaceuticals are either prepared onsite by the nuclear medicine department or purchased from a commercial nuclear pharmacy vendor. Regardless of how they are procured, the director of pharmacy must ensure that robust policies and procedures (P&Ps) are in place to manage their use and that these P&Ps are in line with hospital-wide P&Ps. The DoP must be aware of and oversee all medication usage throughout the hospital, including all medication products and adjunct imaging agents used in the nuclear medicine department. Multiple adjunct IV imaging agents—such as dipyridamole, dobutamine, adenosine, regadenoson, furosemide, and heparin—are commonly used in nuclear medicine. Although medications are most often purchased through the pharmacy department, alternate purchasing procedures are usually required for radiopharmaceuticals. Due to the short shelf life of radiopharmaceuticals (typically less than 12 hours), they need to be ordered and/or prepared on a daily basis. The ordering is usually performed by the nuclear medicine department.
MM 05.01.01 states that a pharmacist reviews the appropriateness of all orders for medications to be dispensed in the hospital. Currently there are some exemptions for contrast imaging agents; however, no exemptions exist for radiopharmaceuticals—which are different from contrast agents—and other adjunct medications used in the nuclear medicine department, so pharmacy must provide oversight of radiopharmaceutical management as well. The DoP should be cognizant of whether this MM standard is being met in the nuclear medicine department.
A nuclear pharmacist is best trained to review radiopharmaceutical orders, but if the hospital does not have a nuclear pharmacist on staff, the DoP should assume responsibility and patient assessments should be written to assist with this process. The assessment should facilitate identifying any potential issues or problems that may occur from administering the medication to the patient. Components of the patient assessment should include medication, route of administration, adult and pediatric dosing, patient screening, and contraindications.
PP&P: What role should pharmacy play in reviewing the use of non-radiopharmaceutical drugs in the nuclear medicine department?
DePietro: This is an area where pharmacy guidance can be particularly useful. For example, during the recent aminophylline shortage, Massachusetts General Hospital pharmacy leaders assisted in identifying other suitable pharmacologic stress-reversal agents to use in place of aminophylline. If a patient needs a cardiac stress test but is not able to run on the treadmill, the patient can be given regadenoson, adenosine, dipyridamole, or dobutamine to simulate stress on the heart. Pharmacy also identified other agents and helped create procedures for use, such as using theophylline in lieu of aminophylline, or prescribing caffeine tablets for patients experiencing minor side effects such as a lingering headache.
The pharmacy also can provide assistance with reviewing medication preparation procedures, protocols, and infusion pump guidelines for non-radioactive medications. MM 02.01.01, EP 6, states that the hospital standardizes and limits the number of drug concentrations available to meet patient care needs. A pharmacist can help evaluate the non-radioactive medications available and provide information on how they are prepared to confirm compliance with this standard. For example, having only one concentration of dobutamine prepared for all patients and limiting the storage of multiple concentrations of heparin in the department improve safety.
PP&P: Who should be responsible for ensuring nuclear medicine’s compliance with USP <797>?
DePietro: The nuclear medicine department likely is aware of USP <797>, yet may struggle with interpreting the regulations and determining what may need to be modified to ensure compliance. The DoP and pharmacy department should make themselves available as a resource for <797> guidance, as well as for developing P&Ps for proper cleaning, training, and medication preparation per <797>. Although many nuclear medicine departments outsource the majority of radiopharmaceutical preparation, the pharmacy department should help ensure that medications prepared onsite meet the immediate-use exemption or CSPs-as-radiopharmaceuticals regulations in USP <797>.
PP&P: Should standardized protocols be developed and implemented in nuclear medicine?
DePietro: The nuclear medicine physician may sometimes choose to write a specific radiopharmaceutical prescription for an individual patient, but generally a standardized protocol should be established that dictates the medication, dose, route of administration, patient preparation, and imaging procedure. These protocols should be developed collaboratively by the nuclear medicine physician, nuclear pharmacist, and nuclear medicine technologist.
PP&P: What is pharmacy’s role in the overall radiopharmaceutical management program?
DePietro: Pharmacy should be involved in multiple areas of radiopharmaceutical management, including aseptic technique training and media fill testing; medication review, approval, ordering, labeling, and storage; approving appropriate adult and pediatric doses; determining dosing for obese patients; and reviewing SOPs for receiving deliveries of radiopharmaceuticals.
If the nuclear medicine department does not already have an aseptic technique training and media fill testing program in place for staff preparing low-risk compounded sterile preparations (CSPs), it will likely benefit from pharmacy sharing its aseptic technique training program. For example, the nuclear medicine department may need guidance in establishing media fill testing processes and locating testing components.
Pharmacy should review the medication labeling, storage, and dispensing procedures already in place and make recommendations where necessary. In addition, the pharmacy should ensure that medication labeling, storage, and dispensing procedures are in line with hospital-wide procedures to ensure TJC compliance. Many nuclear medicine departments utilize multidose vials, so the pharmacy should be aware of this and review these procedures to be sure they match the hospital policies.
When a new radiopharmaceutical comes on the market and the nuclear medicine department decides that it would like to offer an associated imaging exam or radiopharmaceutical therapy (which may or may not include imaging), some choices must be made. Will the new radiopharmaceutical be prepared in-house or outsourced from a commercial nuclear pharmacy? Procedures for ordering, storage, preparation (if applicable), and quality control testing (if prepared in-house) should be established by the nuclear pharmacist. A protocol and patient assessment should be written by the nuclear medicine physician, nuclear pharmacist, and nuclear medicine technologist.
Adult and pediatric dosing guidelines can typically be found in the package insert or in Society of Nuclear Medicine practice guidelines. The imaging protocol and patient assessment must establish a weight-based dose and a minimum dose for pediatric procedures to ensure that images are interpretable. If a pediatric patient needs to be sedated or put under with general anesthesia for the scan to be completed, it is crucial to ensure that the dose is sufficient to obtain an interpretable image the first time to avoid delaying diagnosis and treatment, as well as the added radiation exposure and risk associated with another dose of the radiopharmaceutical and anesthesia.
Because more than one-third of Americans are obese, it is vital to determine a dosing protocol for obese patients. At Massachusetts General Hospital, patients with a BMI greater than 31 receive an increased dose to obtain optimal images.
Carefully consider storage and ordering issues for newly adopted products. All radiopharmaceuticals must be stored in a secure, locked room that is licensed to store radioactive materials. Products such as I-123 ioflupane—a Schedule II controlled substance and radiopharmaceutical—require additional storage and ordering procedures dictated by the DEA.
The nuclear medicine department, along with the radiation safety officer, should establish delivery procedures for all radiopharmaceuticals. The packages must be surveyed and wipe tested within three hours of delivery or within three hours of the facility opening, if delivered after-hours. These are Department of Transportation and Nuclear Regulatory Commission regulations and safety measures to check for excess or removable radioactive contamination from a package.
PP&P: How should a protocol be established for adding drugs to the nuclear medicine permit/hospital formulary?
DePietro: At our hospital, we add radiopharmaceuticals to the physician’s radioactive materials permit for human use, since we have a broad scope radioactive materials license; radiopharmaceuticals are not added to the hospital’s formulary in the same way other medications are. First, the nuclear medicine physicians and departmental management evaluate what types of imaging studies should be offered in the department. A radiopharmaceutical is designated for each exam; typically, there are only one or two radiopharmaceuticals to choose from. The nuclear medicine department then writes an imaging protocol, which includes adult and pediatric dosing guidelines, route of administration, patient preparation for the exam (if any, such as NPO or avoid caffeine), and camera imaging parameters (see Figure 1). It also is recommended that a patient assessment for each imaging exam is written for the technologist, physician, and pharmacist to assess the patient’s ability to proceed with radiopharmaceutical administration and the imaging exam (see Figure 2). The pharmacy director should review and approve the patient assessments written for each radiopharmaceutical that is added to the permit.
PP&P: How can nuclear pharmacists and DoPs ensure the integrity of radiopharmaceuticals?
DePietro: Ensuring the quality and safety of radiopharmaceuticals is one of the major concerns of nuclear pharmacists and DoPs involved in purchasing these medications. If the hospital does not have a nuclear pharmacist and a nuclear pharmacy, the nuclear medicine department will need to decide whether to prepare the radiopharmaceuticals in-house under the supervision of a physician or to outsource from a commercial nuclear pharmacy.
Recent events involving contaminated outsourced medications, which have tragically impacted so many lives, have placed outsourcing CSPs under the microscope; thus, the selection of an outsourced compounding vendor must be made carefully. The pharmacy department should accompany the nuclear medicine department on any site visits to a commercial pharmacy vendor to assist with the vendor evaluation. ASHP has guidelines for outsourcing CSPs and a contractor assessment tool that are helpful resources to utilize during this process (the contractor assessment tool is available at http://www.ashpfoundation.org/sterileproductstool).
Allegra DePietro, MS, RPh, BCNP, is the nuclear pharmacy manager in the division of nuclear medicine and molecular imaging at Massachusetts General Hospital in Boston. She currently serves as the chair of the Board of Pharmacy Specialty Council on Nuclear Pharmacy. Allegra received a BS in pharmacy from Purdue University and an MS in administrative studies from Boston College.
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