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.
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
AND GRANDFATHER
PROVISIONS FOR AUTHORIZED
MEDICAL PHYSICISTS UNDER
10 CFR PART 35
All NRC medical licensees and Radiation
Control Program Directors.
12/7/06 RIS-06-25
Requirements For The Distribution
And Possession Of Tritium Exit
Signs And The Requirements In 10
CFR 31.5 AND 32.51a
All U.S. Nuclear Regulatory Commission
(NRC) licensees distributing tritium exit
signs and those possessing a tritium exit
sign under a general license.
11/15/06 RIS-06-22
Lessons Learned From Recent 10
CFR PART 72 Dry Cask Storage
Campaign
All Title 10 Code of Federal Regulations
(10 CFR) Part 72 specific licensees and
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
Changes Under 10 CFR
70.72(c)(2)
All fuel cycle licensees regulated under
Title 10 of the Code of Federal
Regulations (10 CFR) Part 70, Subpart H.
09/14/06 RIS-06-20
Guidance for Receiving
Concentrating Uranium at
Community Water Systems
All community water systems (CWSs), in
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
the treatment of drinking water, may
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
Radioactive Seed Localization
All NRC medical licensees.
08/31/06 RIS-06-18
Requesting Exemption from the
Public Dose Limits for Certain
Caregivers of Hospital Patients
All NRC medical licensees.
08/15/06 RIS-06-16
Transfer of the Management
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
All NRC materials licensees.
07/20/06 RIS-06-11
Requesting Quality Assurance
Program Approval Renewals
Online by Electronic Information
Exchange
All 10 CFR Part 71 quality assurance
program and certificate holders.
04/23/06 RIS-06-10
Use of Concentration Control for
Criticality Safety
All licensees authorized to possess a
critical mass of special nuclear material.
01/26/06 RIS-02-15, Rev. 1
NRC Approval of Commercial Data
Encryption Products For the
Electronic Transmission Of
Safeguards Information
All authorized recipients and holders of
sensitive unclassified safeguards
information (SGI). Date
GC No.
Subject
Addressees
01/24/06 RIS-06-01 Expiration Date for NRC-Approved
Spent Fuel Transportation Routes
The U.S. Nuclear Regulatory Commission
(NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06 RIS-05-27, Rev. 1 NRC Timeliness Goals,
Prioritization of Incoming License
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
All 10 CFR Parts 71 and 72 licensees
and certificate holders.
11/14/06 IN-06-25
Lessons Learned From NRC
Inspection Of Control And
Accounting Of Special Nuclear
Material At Commercial Nuclear
Power Reactors
All power reactors, category I fuel cycle
facilities, independent spent fuel storage
installations, conversion facility, and
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
11/7/06 IN-06-23
Events Involving Potential
Tampering Or Malfeasance By
Persons Granted Unescorted
Access
All power reactors, category I fuel cycle
facilities, independent spent fuel storage
installations, conversion facility, and
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
Due to Undetected Leakage of
Radioactive Water
All holders of operating licenses for
nuclear power and research and test
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
Exercising Due Diligence When
Transferring Radioactive
Materials
All materials licensees.
06/12/06 IN-06-11
Applicability of Patient Intervention
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
All medical licensees.
03/31/06 IN-06-07 Inappropriate Use of a Single- parameter Limit as a Nuclear
Criticality Safety Limit
All licensees authorized to possess a
critical mass of special nuclear material.
03/21/06 IN-02-23, Supl. 1
Unauthorized Administration of
Byproduct Material for Medical Use
All medical licensees. Date
GC No.
Subject
Addressees
01/19/06 IN-06-02
Use of Galvanized Supports and
Cable Trays with Meggitt Si 2400
Stainless- Steel-jacketed Electrical
Cables
All holders of operating licenses for
nuclear reactors except those who have
permanently ceased operations and have
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.