Massachusetts General Hospital, Department of Radiology

Massachusetts General Hospital, Department of Radiology

November 30, 2016

Dear Massachusetts Board of Pharmacy,

Massachusetts General Hospital, Department of Radiology would like to submit the following statements and comments in response to the public hearing on 247 CMR 13 held on November 30, 2016.

The practice of nuclear medicine in Massachusetts in hospitals and clinics, including at Massachusetts General Hospital,is regulated by the Massachusetts Department of Public Health Radiation Control Program (RCP) under 105 CMR 120.000, The Control of Radiation and more specifically detailed in 105 CMR 120.500, Use of Radionuclides in The Healing Arts. MassachusettsDepartment of Public Health Radiation Control Program Website:

The Federal Nuclear Regulatory Commission (NRC) has deferred regulation and enforcement of federal regulations governing radioactive materials to the MassachusettsDPH Radiation Control Program, as Massachusetts is an NRC agreement state. Further details on the NRC/State Agreement State Enforcement Program can be found here:

In clinics and hospitals throughout the Commonwealth, nuclear medicine is practiced under the oversight of a licensed authorized user physician for the preparation and administration of radiopharmaceuticals as allowed under 105 CMR 120.500. Many clinics and hospitals are supplied with radiopharmaceuticals in unit dose form for scheduled patient exams from a commercial nuclear pharmacy. It is also the practice in most nuclear medicine departmentsto receive vials of “Tc-99m sodium pertechnetate” (commonly called bulk tech), an FDA approved drug consisting of the radioisotope Tc-99m in 0.9% sodium chloride, from the commercial nuclear pharmacy.Some hospital nuclear medicine departments may instead of receiving Tc-99msodium pertechnetatefrom a commercial nuclear pharmacy, may have their own Mo-99/Tc-99m radionuclide generators which produce sterile Tc-99m sodium pertechnetate on demand. The Mo-99/Tc-99m radionuclide generators are approved by the FDA as diagnostic radiopharmaceuticals.The Tc-99m sodium pertechnetate is then used to prepare radiopharmaceuticals from sterile, FDA approved kits for emergency exams, add-on exams, as well as routine imaging exams by a licensed nuclear medicine technologist under the oversight and direction of the authorized user physician. The technologist may also dispense a patient dose of Tc-99m sodium pertechnetate from the vial to administer to a patient (without adding it to a kit) for thyroid scans, radionuclide cystourography and other imaging procedures as indicated.

Of particular concern is on the impact on patient care if 247 CMR 13 and 247 CMR 17 are applied to the preparation of radiopharmaceuticals as it is currently practiced as described above is the availability of UltratagTM RBC, Tc-99m Labeled Red Blood Cells. This nuclear medicine kit is used to label a patient’s red blood cells for emergency imaging exams, such as identification of the location of a GI bleed prior to surgery. There are no alternative tests available to diagnose GI bleeds of unknown origin. In addition, it is FDA approved for conducting blood pool and cardiac first pass imaging. Cardiac blood pool imaging is commonly used to calculate the cardiac ejection fraction in patients undergoing certain types of chemotherapy to determine if they can continue with treatment. The manufacturer’s FDA approved package insert calls for the patient’s blood to be labeled with UltratagTM and re-injected “within 30 minutes of labeling or as soon as possible thereafter.” In most nuclear medicine departments, this radiopharmaceutical is prepared within the department to work within the drug preparation and administration time constraints. If 247 CMR 13 and 247 CMR 17 are applied to radiopharmaceutical preparation by a licensed nuclear medicine technologist, this regulation may have an unintended consequenceof affecting the nuclear medicine department’s ability to perform this critical imaging exam for patient care. The UltratagTM package insert is included with our written testimony.

Based on the proposed revision to 247 CMR 13 and the pending new regulation of 247 CMR 17, we have the following general questions on the potential regulatory impact on the practice of nuclear medicine described above:

  1. If the preparation of sterile radiopharmaceuticals occurs according to the manufacturer’s FDA approved package by a licensed nuclear medicine technologist, under licensed authorized physician user oversight in a clinic or hospital setting as currently allowed under 105 CMR 120.500, would it now become a regulated activity under 247 CMR 13 and 247 CMR 17?
  2. If it is proposed to be a regulated activity under 247 CMR 13 and 247 CMR 17, under what regulatory authority does the Board have to regulate these activities if they are not performed by pharmacists and are performed in accordance with the manufacturer’s FDA approved package labeling under physician supervision?
  1. If it is proposed to be a regulated activity under 247 CMR 13 and 247 CMR 17, what type of licensure would be required by the clinic or hospital nuclear medicine departments which currently perform these activities under 105 CMR 120.500?
  1. If it is proposed to be a regulated activity under 247 CMR 13 and 247 CMR 17, how will the preparation of emergency and add-on radiopharmaceuticals be handled to minimize any deleterious impact on patient care as these emergency procedures can often occur after normal working hours?
  1. If it is proposed to be a regulated activity under 247 CMR 13 and 247 CMR 17, would licensed nuclear medicine technologists be allowed to access the licensed facility without a nuclear pharmacist being present?
  1. Would radiopharmaceuticals prepared for immediate use as needed for emergency exams by a licensed nuclear medicine technologist under authorized user physician oversight, such as UltratagTM described above, proposed to be a regulated activity under 247 CMR 13 and 247 CMR 17?
  1. Wouldsterile injectablePositron Emission Tomography (PET) drugs which are prepared for clinical investigational research use under USP <823>, Radiopharmaceuticals for Positron Emission Tomography – Compounding, Investigational and Research Use, pursuant to an Investigational New Drug Application (IND, 21 CFR 312) or under local Radioactive Drug Research Committee oversight (RDRC, 21 CFR 361.1)as allowed under the Federal FDA regulation 21 CFR 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs, now become a regulated act under 247 CMR 13 and/or 247 CMR 17?

Specific comments we would like to provide on 247 CMR 13:

13.02 Definitions –

  1. Authorized practitioner and Qualified nuclear pharmacist terms are different than the terms used in 105 CMR 120 and the corresponding US NRC regulations. The state RCP and NRC regulations use “authorized user” and “authorized nuclear pharmacist” terms respectively instead. Recommend harmonizing these terms throughout 247 CMR 13 with the existing state and federal regulations.

13.03 Requirements for the Issuance of Nuclear Pharmacy –

  1. Recommend removing the requirement for the most recent edition of Remington’s Pharmaceutical Sciences, as this text is no longer relevant to the practice of nuclear pharmacy
  2. The licensure to use radioactive materials in the Commonwealth is regulated by the DPH Radiation Control Program under 105 CMR 120, not NRC as explained above. Recommend harmonizing this regulatory reference throughout 247 CMR 13.

13.05.5 General Requirements for Nuclear Pharmacies – Recommend reversing the proposed change of the record retention requirement from three to two years to harmonize with existing state regulations. The DPH Radiation Control Program under 105 CMR 120.500 requires records be held for three years.

13.05.9 General Requirements for Nuclear Pharmacies – Recommend allowing for a clinic or hospital who has received a radiopharmaceutical, but has not used it to be allowed to keep it onsite and dispose of it in a safe manner in accordance with 105 CMR 120. Since the unused radiopharmaceutical would be radioactive, the site would be required to package it for transport back to the nuclear pharmacy in accordance with state and Department of Transportation regulations for the transport of radioactive materials.

13.05.11 General Requirements for Nuclear Pharmacies – Since these regulations were originally written, the FDA has granted 510k clearance medical devices for the administration of Fludeoxyglucose F18 Injection and Sodium Fluoride F18 Injection which use a multi-dose vial to patients undergoing Positron Emission Tomography (PET) studies. These administration devices are commonly used in busy PET clinics to reduce staff radiation exposure. An example of this type of 510k cleared medical devices is the Bayer Medrad®Intego. Further details on the device can be found here:

Fludeoxyglucose F18 Injection or Sodium Fluoride F18 Injection would be dispensed by the nuclear pharmacy for direct use in the medical device, and not as stated in 13.05.11 as “dispensed in bulk amounts necessary to activate the single unit doses.” As a site may have more than one administration system or may require more than one vial per day of the PET radiopharmaceutical.

13.05.24General Requirements for Nuclear Pharmacies – As stated above, facilities other than nuclear pharmacies, such as hospitals and clinics are currently licensed to stock, prepare and handle radiopharmaceuticals as allowed under 105 CMR 120.500.

Respectively Submitted,

Daniel L. Yokell, Pharm.D.,RPh

For Massachusetts General Hospital Department of Radiology

Presented as Oral Testimony on November 30th 2016

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