The Supply and Availability of Radiopharmaceuticals
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As the field of biotechnology advances, the ability to treat previously incurable diseases is becoming more of a reality. One of the champions that’s gaining a lot of attention in the space is radiopharmaceuticals. These medical isotope-fueled compounds are now being used for the diagnosis and treatment of health conditions including cancer, neurological disorders, and cardiovascular disease. And because of this, their availability and reliable supply have become a top priority for healthcare professionals and patients alike.
What are radiopharmaceuticals?
Radiopharmaceuticals are biological compounds that contain radioactive isotopes. These isotopes emit radiation that can be delivered and detected using specialized equipment, allowing doctors to see and pinpoint the internal structures and functions of organs and tissues in the body. Radiopharmaceuticals can be administered orally, intravenously, or by inhalation.
“One of the most common uses of radiopharmaceuticals is in cancer diagnosis and treatment,” said RLS CEO Stephen Belcher. “Cancer cells grow and divide rapidly and can be identified by the high rate of metabolism. Radiopharmaceuticals are designed to bind to specific molecules in cancer cells, allowing physicians to identify and locate the tumor. They can also be used to directly target cancer cells, killing them and reducing the growth of tumors without harming healthy tissues.”
RLS is the nation’s only accredited nuclear pharmacy group, and it owns and operates 31 radiopharmacies across 18 states. The company offers an extensive portfolio of diagnostic products and has become one of the fastest-growing distributors of radiopharmaceutical therapeutics. According to sources, the company dispenses 100% of injectable unit dose products in clean rooms built to ISO 1644-1 specifications. RLS currently has more than 1,500 customers.
Supply chain challenges
The radiopharmaceutical supply chain process represents a complex system involving several crucial steps starting from production, synthesis, quality control, and dispensation to patients. A robust supply chain process ensures these life-saving compounds are readily available at the right time and place. This process begins with radioisotope production, which involves using higher-energy elements like uranium and thorium to produce isotopes such as actinium-225 (Ac-225), Lead-212 (Pb-212), molybdenum-99 (Mo-99), and iodine-131 (I-131). These isotopes are then transported to different laboratories worldwide, where they undergo purification to produce radiopharmaceuticals.
“Once radiopharmaceuticals are produced, they undergo rigorous quality control tests to ensure they meet regulatory standards,” Belcher said. “These strict quality assurance parameters guarantee safety and efficacy. After passing all tests, these radiopharmaceuticals are transported to hospitals and clinics for the benefit of patients.”
However, like all good things, getting radiopharmaceuticals from the lab to patients is an intricate process that involves multiple stages and stakeholders. The most critical of which is the last mile, as it determines the success of the entire process.
The last mile
The importance of the last mile in the radiopharmaceutical supply chain lies in its impact on patient outcomes. Without quality and reliable radiopharmaceuticals delivered safely and timely, the full potential of these molecular imaging probes and therapies will not be realized. Patients who need timely diagnosis and treatment may suffer delays, increased costs, or even risk of further complications and progression of their conditions. Therefore, the last mile is crucial in ensuring that radiopharmaceuticals reach their intended patients timely, safely, and with their full quality intact.
“No matter how much work goes into developing a radiopharmaceutical, they are useless unless they arrive on time, without damage or decay,” Belcher said. “Medical isotopes have an extremely short half-life, so it is essential that the compounds reach patients quickly. Inconsistencies in the last mile could lead to delays that affect a drug’s stability, reducing its efficiency and ultimately patient care.”
Apart from the efficacy and reliability of radiopharmaceuticals, safety is also a significant concern. The use of radioactive materials poses a potential risk to healthcare professionals, patients, and the general public. That’s why radiopharmaceuticals are manufactured in specialized facilities known as radiopharmacies. These facilities are equipped with state-of-the-art equipment and trained personnel to ensure the quality and safety of the products.
“Radiopharmacies like ours follow strict procedures for the production, testing, and release of nuclear medicines to ensure that they meet the required standards,” explained Belcher. “These procedures include regular quality control testing to ensure the purity, radiochemical identity, and radiochemical purity of the products.”
Importance of the last mile
The last mile of radiopharmaceutical delivery is especially important because these drugs have a limited shelf-life and are sensitive to external factors that can affect their potency and safety. For example, some radiopharmaceuticals require refrigeration to maintain their quality while others need to be prepared or activated shortly before use. Any delay or mishandling during the last mile can compromise the drug’s effectiveness, leading to inaccurate diagnoses or ineffective treatments. And that’s where radiopharmacies come in.
“The last mile is the final step in the radiopharmaceutical supply chain,” Belcher said. “It’s where the radiopharmaceuticals are checked, transported, and traced to ensure patient safety, regulatory compliance, and timely delivery.”
Radiopharmacies are an essential component of the modern healthcare system, providing crucial support for physicians, researchers, and patients. Their services are vital to the diagnosis and treatment of complex and challenging medical conditions, providing precise and targeted therapy while maintaining the highest standards of safety and quality. The field of radiopharmaceuticals continues to advance, and radiopharmacies are at the forefront of these developments, providing cutting-edge technology, research, and clinical trials. The future of radiopharmacies is bright, and their role in improving human health is set to continue to grow.