As promised in case 0006 posted in the June Brachyblast, we are eager to present the feedback (corrective and preventive measures) that we have collected from several colleagues (medical physicists and radiation oncologists). As a reminder to readers, case 0006 related to a patient receiving iodine (I-131) for ablation of residual thyroid tissue. Hours after the delivery of the treatment, a positive pregnancy test result was received by the delivering licensee. The patient terminated the pregnancy.
IMMEDIATE (SHORT TERM) ACTIONS
CORRECTIVE
Prior to delivery of a radioisotope, the female patient should be informed at time of consultation about the radiation effects (with details) on the fetus should they become pregnant shortly before or after the treatment. This might include recommendation of a pregnancy test which should be performed as close as possible to the treatment date.
In addition, other practical solutions (when possible) should also be discussed by the AU.
Perhaps liability should also be discussed in case of any undesirable outcome to the newborn directly associated with the treatment itself.
The consent form signed by the patient should inform them of the possible effects of radiation to a fetus.
PREVENTIVE
The licensee should be made aware of all lab orders the referring physician made prior to treatment that are relevant to the recent pregnancy test (and results) and should be part of the checklist and the timeout procedure.
Every effort should be done to ensure that all patients (use of an interpreter when needed) fully understand this safety issue and its consequences.
Treatment should not be performed when feedback and results remain questionable.
While it might difficult to envision all scenarios, every effort should be made to provide the patients with all viable options to minimize such a risk.
Female patients less than 55 years old who have a uterus should have typical risk counseling and have a serum pregnancy test either the day before or in morning of the thyroid ablation. Urine test could also be considered because of its rapid results but caution should be used for false negative cases. Women with 55<age(years) <65 with a uterus should be counseled about risks and offered the pregnancy test. They are usually forthcoming about menopausal status as well as sexual practices/status. Any practices which yield anything beyond a zero risk of pregnancy (e.g. abstinence) yields a pathway towards the pregnancy test as stated above. Stated menopausal status by patients might be risky as well so the AU might defer to the pregnancy test.
All patients who are of potential childbearing age, which should be defined, should have serum pregnancy testing performed before administration of radio iodine. In this era of assisted reproduction technology, this needs to be strictly adhered to at ages where pregnancy is not usually expected. Preparation of these patients with thyroid carcinoma generally consists of administration of thyrogen, and generally administered a therapeutic dose of 50-150 mCi of I-131. Institutions should have a policy applicable to different ages and menopausal status.
LONG TERM ACTIONS
Institutional policy regarding premenopausal and postmenopausal women should be well established and updated on a regular basis.
Institution policy regarding mandatory pregnancy tests for women with a uterus of childbearing age prior to treatment with a radio-isotope should be in place and executed in the form of a checklist items and the timeout procedure
We would like to thank Tamara Weiss MD and John Schallenkamp MD, Rashmi K Benda MD for their valuable feedback.
We encourage our readers to continue to submit their ideas to PreventMedEvent@gmail.com as there may have been preventive and corrective actions we did not identify. Be sure to check out next month's BrachyBlast where we will present Case 0007.
New item to all users: if you think you have an interesting near miss or an actual medical event that you would like to share with us please send it to PreventMedEvent@gmail.com . We will be happy to evaluate it and provide you and the rest of the brachytherapy community with some feedback (short term preventive/corrective and long term actions). We ask you not to send the name of the institution and the individuals involved in the case. Please provide us with information related to the” when, how, where”, etc. Your contact information (which will remain confidential) is needed for follow up questions and clarification only.
