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

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

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.

IN-2007-03

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

Cindy Flannery, FSME

(301) 415-0223 E-mail: cmf@nrc.gov

Enclosure:

List of Recently Issued NMSS Generic Communications

IN-2007-03

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

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

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

Enforcement Discretion When

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.