Information Notice 2007-03, Reportable Medical Events Involving Patients Receiving Dosages of Sodium Iodide Iodine-131 Less than the Prescribed Dosage Because of Capsules Remaining in Vials After Administration
| ML070190328 | |
| Person / Time | |
|---|---|
| Issue date: | 02/02/2007 |
| From: | Schlueter J NRC/FSME/DMSSA |
| To: | |
| Flannery C | |
| References | |
| IN-07-003 | |
| Download: ML070190328 (7) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555 February 2, 2007 NRC INFORMATION NOTICE 2007- 03: REPORTABLE MEDICAL EVENTS INVOLVING
PATIENTS RECEIVING DOSAGES OF SODIUM
IODIDE IODINE-131 LESS THAN THE
PRESCRIBED DOSAGE BECAUSE OF
CAPSULES REMAINING IN VIALS AFTER
ADMINISTRATION
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) medical use licensees and NRC Master
Materials Licensees. All Agreement State Radiation Control Program Directors and State
Liaison Officers.
PURPOSE
NRC is issuing this information notice (IN) to alert addressees about events in which patients
were administered dosages of sodium iodide, iodine-131 (I-131) that were less than the
prescribed dosages, because of sodium iodide I-131 capsules that remained in vials, containing
multiple capsules, after administration. These occurrences resulted in medical events because
the patients did not receive the prescribed dosages. It is expected that recipients will review the
information for applicability to their facilities and consider actions, as appropriate, to avoid
similar problems. However, suggestions contained in this IN are not new NRC requirements;
therefore, no specific action or written response is required. NRC is providing this IN to the
Agreement States for their information and for distribution to their medical licensees as
appropriate.
DESCRIPTION OF CIRCUMSTANCES
In September 2006, one licensee performed administrations incorrectly on two separate
occasions. In each case, only one sodium iodide I-131 capsule was administered to the
patient, rather than the two capsules containing the total dose. Consequently, the patients did
not receive the dosages prescribed in the written directives. Before these events, the licensee
had received the total prescribed dose of I-131 in a single capsule. In the case of these two
events, instead of the expected single capsule, the commercial radiopharmacy dispensed two
capsules containing the prescribed dose. The licensee measured the radioactivity in each vial
containing capsules, before administration, to ensure the proper dosage amount. When the
content of each of the vials was emptied, for administration, one of the two capsules remained
in the vial. Each vial was placed back into its shipping container and returned to the pharmacy.
Each of the two patients was released, having received only a portion of the prescribed dosage.
Over the last 10 years, there have been 12 reported events of this type (i.e., events in which
patients were administered dosages of sodium iodide I-131 that were less than the prescribed
dosages, because capsules remained in vials after administration). In some of these cases, the
patients were administered one of multiple capsules contained in a single vial. In other cases, patients were administered two of three capsules, where two capsules were placed in one vial
by the commercial pharmacy, and the third capsule was placed in a separate vial. There were a few instances where the errors were discovered shortly after the patients had
been released, and the patients returned to the licensees to receive the remaining portions of
the prescribed dosages. Notwithstanding that in these cases the patients returned to receive
the remaining portions of the prescribed dosages, NRC concludes that the total dose, for
purposes of determining whether the medical event reporting criteria had been met, is the dose
received by the patients at the time when they were released from the licensees control (i.e.,
following administration of the first capsule). Since, at the time of the patients release, the
delivered dosages differed from the prescribed dosages by more than 20 percent and the
thyroid dose reductions resulting from the reduced dosages exceeded the 0.5 sieverts (50 rem)
to an organ, the events required reporting as medical events under 10 CFR 35.3045(a)(1)(ii).
DISCUSSION
NRC regulations, in 10 CFR 35.63, do not require licensees to perform a direct measurement of
a unit dosage in a dose calibrator before administration, if the unit dosage is corrected for
decay based on the activity determined by an appropriately licensed manufacturer, preparer or
licensee (e.g., commercial pharmacy). However, as a measure for prevention of these types of
medical events, a licensee could assay the vial containing I-131 capsules, after administration
of the dosage, to assure that no capsules remain in the vial. To keep occupational doses as
low as reasonably achievable, assay measurement of the vial post-administration is preferred
over visual verification of the content of the vial.
Precautions can also be taken before administration, and include reviewing the packing slip
before administration, to verify the number of capsules shipped by the pharmacy. Further, assaying the activity before administration could identify that the total dose was not in the vial
and that missing capsule(s) may, for example, have been placed in another vial of the
shipment.
Besides resulting in a medical event, another negative consequence of a capsule remaining in
a vial is that the licensee may incorrectly mark and label the vial for transport back to the
commercial radiopharmacy. For example, the vial may be placed back into the original
container and shipped back to the commercial pharmacy with the marking and labeling of a
package that is assumed to be empty, when in fact, it is not. This could result in a violation of
the requirements in 10 CFR 71.5, Transportation of Licensed Material. Another example of an
adverse consequence of a capsule remaining in the vial is that this might result in the
inadvertent disposal of the vial containing I-131 in non-radioactive waste. This could lead to a
violation of the requirements for waste disposal, or the requirements for storage and control of
licensed material in 10 CFR Part 20, Standards for Protection Against Radiation.
CONTACT
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact the technical contact below, or the appropriate regional
office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Cindy Flannery, FSME
(301) 415-0223 E-mail: cmf@nrc.gov
Enclosure:
List of Recently Issued NMSS Generic Communications
CONTACT
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact the technical contact below, or the appropriate regional
office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact:
Cindy Flannery, FSME
(301) 415-0223 E-mail: cmf@nrc.gov
Enclosure:
List of Recently Issued NMSS Generic Communications
DISTRIBUTION:
DMSSA r/f
ML070190328 OFFICE: MSSA MSSA Tech. Ed. OGC MSSA MSSA
NAME: CFlannery SWastler EKraus FCameron MOrendi JSchlueter
DATE: 01/04/07 01/16/07 01/11/07 01/18/07 01/18/07 2/2/07 OFFICIAL RECORD COPY Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject
Addressees
12/7/06 RIS-06-26 TRAINING AND EXPERIENCE All NRC medical licensees and Radiation
AND GRANDFATHER Control Program Directors.
PROVISIONS FOR AUTHORIZED
MEDICAL PHYSICISTS UNDER
10 CFR PART 35
12/7/06 RIS-06-25 Requirements For The Distribution All U.S. Nuclear Regulatory Commission
And Possession Of Tritium Exit (NRC) licensees distributing tritium exit
Signs And The Requirements In 10 signs and those possessing a tritium exit
CFR 31.5 AND 32.51a sign under a general license.
11/15/06 RIS-06-22 Lessons Learned From Recent 10 All Title 10 Code of Federal Regulations
CFR PART 72 Dry Cask Storage (10 CFR) Part 72 specific licensees and
Campaign certificate holders and holders of
operating licenses for nuclear power
reactors (including those who have
permanently ceased operations and have
certified that fuel has been permanently
removed from the reactor vessel) that are
not 10 CFR Part 72 specific licensees.
09/22/06 RIS-06-14 Enforcement Discretion for Facility All fuel cycle licensees regulated under
Changes Under 10 CFR Title 10 of the Code of Federal
70.72(c)(2) Regulations (10 CFR) Part 70, Subpart H.
09/14/06 RIS-06-20 All community water systems (CWSs), in
Guidance for Receiving
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
Concentrating Uranium at
the treatment of drinking water, may
Community Water Systems
accumulate and concentrate naturally- occurring uranium in media, effluents, and other residuals, above 0.05 percent
by weight.
09/14/06 RIS-06-19 Availability of Guidance on All NRC medical licensees.
Radioactive Seed Localization
08/31/06 RIS-06-18 Requesting Exemption from the All NRC medical licensees.
Public Dose Limits for Certain
Caregivers of Hospital Patients
08/15/06 RIS-06-16 Transfer of the Management All NRC materials licensees.
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
07/20/06 RIS-06-11 Requesting Quality Assurance All 10 CFR Part 71 quality assurance
Program Approval Renewals program and certificate holders.
Online by Electronic Information
Exchange
04/23/06 RIS-06-10 Use of Concentration Control for All licensees authorized to possess a
Criticality Safety critical mass of special nuclear material.
01/26/06 RIS-02-15, NRC Approval of Commercial Data All authorized recipients and holders of
Rev. 1 Encryption Products For the sensitive unclassified safeguards
Electronic Transmission Of information (SGI).
Safeguards Information
Enclosure
IN 2007-03 Page 2 3 of 3 Date GC No. Subject
Addressees
01/24/06 RIS-06-01 Expiration Date for NRC-Approved The U.S. Nuclear Regulatory Commission
Spent Fuel Transportation Routes (NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06 RIS-05-27, NRC Timeliness Goals, All 10 CFR Parts 71 and 72 licensees
Rev. 1 Prioritization of Incoming License and certificate holders.
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
11/14/06 IN-06-25 Lessons Learned From NRC All power reactors, category I fuel cycle
Inspection Of Control And facilities, independent spent fuel storage
Accounting Of Special Nuclear installations, conversion facility, and
Material At Commercial Nuclear gaseous diffusion plants. Note that the
Power Reactors information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390
11/7/06 IN-06-23 Events Involving Potential All power reactors, category I fuel cycle
Tampering Or Malfeasance By facilities, independent spent fuel storage
Persons Granted Unescorted installations, conversion facility, and
Access gaseous diffusion plants. Note that the
information notice contains physical
security information and is, therefore, being withheld from public disclosure in
accordance with 10 CFR 2.390
07/10/06 IN-06-13 Ground-Water Contamination All holders of operating licenses for
Due to Undetected Leakage of nuclear power and research and test
Radioactive Water reactors including those who have
permanently ceased operations and
have certified that fuel has been
permanently removed from the
reactor and those authorized by Title
10 of the Code of Federal Regulations
(10 CFR) Part 72 licenses to store
spent fuel in water-filled structures.
07/06/06 IN-06-12 All materials licensees.
Exercising Due Diligence When
Transferring Radioactive
Materials
06/12/06 IN-06-11 Applicability of Patient Intervention All medical licensees.
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
03/31/06 IN-06-07 Inappropriate Use of a Single- All licensees authorized to possess a
parameter Limit as a Nuclear critical mass of special nuclear material.
Criticality Safety Limit
03/21/06 IN-02-23, Unauthorized Administration of All medical licensees.
Supl. 1 Byproduct Material for Medical Use Date GC No. Subject
Addressees
01/19/06 IN-06-02 Use of Galvanized Supports and All holders of operating licenses for
Cable Trays with Meggitt Si 2400 nuclear reactors except those who have
Stainless- Steel-jacketed Electrical permanently ceased operations and have
Cables certified that fuel has been permanently
removed from the reactor vessel; and fuel
cycle licensees and certificate holders.
Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic
Reading Room/Document Collections.