Standards That Treat Radiological Dyes as Medications

Can you provide me with evidence in the JCAHO or CMS standards related to the need to treat radiological dyes as medications?


In the June 2005 issue of Perspectives, JCAHO announced that a pharmacist review of oral contrast media administration is not always needed.

This does not include orders for oral contrast media for non-urgent testing. Orders for oral contrast media for non-urgent testing should go through the same medication order review as any other medication order.

The following standards must be followed when oral contrast media is administered without the pharmacist’s review. (It is noted in Perspectives that the following standards are not limited to oral contrast media)

  • Approved screening tools and clinical guidelines addressing the administration of contrast media (LD.4.20) are used by the healthcare organization. For hospitals, these guidelines and screening tools must be approved by the medical staff and Pharmacy.
  • Only approved healthcare professionals may access the Pharmacy to obtain the contrast media. The organization’s policies and procedures must be followed for retrieval from the Pharmacy. (MM.4.50, EP 2)
  • A qualified healthcare professional will review the order for contrast media before administration. (MM.4.10, EP 3)
  • Quality control procedures are in place such as a second healthcare professional providing a second check of the order and the contrast media. (MM.4.50, EP 2)
  • A pharmacist is available on call to the healthcare professionals if needed. (MM.4.50, EP 2)
  • The administration of contrast media without a pharmacist’s review will be included in the Pharmacy Department’s Performance Improvement Program to determine if the present system is working and if there room for improvement.

Also in the CAMH manual, under the Medication Management section, it is stated that medication includes prescription medications, sample medications, herbal remedies, vitamins, nutraceuticals, over-the-counter drugs, vaccines, diagnostic and contrast agents used on or administered to patients to diagnose, treat or prevent disease or other abnormal conditions; radioactive medications; respiratory medications; parenteral nutrition; blood derivatives; intravenous solutions; and any product designated by the FDA as a drug. Medication does not include enteral nutrition solutions, oxygen and other medical gases.

See Sec. 482.25 Condition of participation: Pharmaceutical services for regulations regarding drugs and biologicals. You may access the CMS standards at the following link: http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr482_04.html

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