Regarding the potential hospitalization of patients treated with the Coulter NHL product, the Nuclear Regulatory Commission has just issued its Final Rule - Criteria for the Release of Individuals Administered Radioactive Material. After reading through the background material that accompanies the rule, there is still some question as to whether patients who receive the Coulter treatment for NHL will require hospitalization. If I were a betting man (and I'm long on IDPH so obviously I am), I'd say that most of the time they will not, and choices between Coulter and IDPH treatments may hinge less on cost than previously thought. For those interested in a fairly long-winded rationale (you may reach a different conclusion!), read on:
As I mentioned in earlier posts, the new rule establishes criteria for the release of patients based on how much radiation dose a person other than the patient may receive. The hospital must demonstrate that no member of the public (family member, friend, etc.) will receive a dose > 0.5 rem. This "dose-based" limit differs from the old, superseded limits, which were based on either (a) how much radioactivity remained in the body (limit=30 mCi), or (b) what was the radiation level around the patient (limit=5 mrem/hr at 1 meter). The problem with the dose-based limit is that it requires the application of exposure scenarios (e.g., how long and at what distance will a family member or friend remain next to the patient), which makes it inherently subjective. The NRC has prepared a "Regulatory Guide" to help hospitals make this determination. The guide includes numerical criteria ("default values")for radionuclides, which in the case of I-131 is 33 mCi (compared to the Coulter therapeutic dosages of 34 to 161 mCi that Brad reported). If the patient contains less radioactivity than the default value, he or she can be released without further ado. If the hospital wishes to release a patient with activity greater than the default value, they must do a dose calculation using case-specific factors to show compliance with the dose limit. According to the NRC medical advisory experts, there is no common radiopharmaceutical procedure (diagnosis or treatment) likely to cause the 0.5 rem dose limit to be exceeded, even in the case of multiple administrations in the same year. This includes current treatments for thyroid cancer or hyperthyroidism, which can involve up to a few hundred mCi of I-131. Thus, it is clear to me that any physician or medical physicist, if motivated to reduce costs, can draw on valid data and easily optimize the analysis to show that patients administered I-131 in amounts representative of the Coulter treatment (even though well above the default value) will not require hospitalization.
Anyone interested in obtaining more info on this feel free to drop me an e-mail (new address: rbelanger@isat.com)
Rich |
