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Preparation and Dispensing of Sterile Radiopharmaceuticals (17.1)

Preparation and Dispensing of Sterile Radiopharmaceuticals (17.1) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Nuc Pharmacy

17.1





Effective Date:
May 2007
 Pharmacy Policy Manual
Chapter: Nuclear Pharmacy
Operations Procedure Manual
Chapter

Policy #: 17.1
Original
 Revision
02/2016

Page 1
of 6

Title: Preparation and Dispensing of
Sterile Radiopharmaceuticals


I. PURPOSE: To outline procedures to be followed by nuclear pharmacy staff for preparing and
dispensing sterile radiopharmaceuticals to ensure accuracy and sterility.

II. PROCEDURE:

A. General Considerations
1. The University of Wisconsin Hospital and Clinics (UWHC) Department of
Radiology, Nuclear Pharmacy policy for Safe Handling of Radiopharmaceuticals
will be followed.
2. When applicable, the UWHC Department of Radiology, Nuclear Medicine
standard operating procedure for Therapeutic Radiopharmaceuticals will be
followed.
3. Do not interrupt anyone while they are in the process of preparing a
radiopharmaceutical, dispensing a patient dose, or inputting data into the Nuclear
Pharmacy computer system.
4. All sterile radiopharmaceuticals will be prepared in a vertical flow hood behind
shielding, using aseptic technique.
a. Radiopharmaceuticals involving patient blood will be done according to
Nuclear Medicine guidelines.
5. Radiopharmaceuticals are stored in appropriate shielding, appropriately labeled,
in the designated storage area on the counter or in the refrigerator as indicated.
6. Any personnel entering the clean room will follow Pharmacy Policy and
Procedure 6.0 (Sterile Product Preparation – Aseptic Technique) and 6.1 (Sterile
Product Preparation –Personal Hygiene).
a. Nuclear Pharmacy Personnel will clean one section of the pharmacy each
monthly rotating through each section.
b.Once weekly Nuclear Pharmacy Personnel will clean the laminar flow
hoods with Asepti-HB quat cleaner per directions and follow with sterile
water and sterile alcohol.
7. Preparing radiopharmaceuticals under supervision of an Authorized User or
Authorized Nuclear Pharmacist is a part of a medicine technologist’s professional
training and credentials, and their work to prepare these agents is an industry
standard.
a. Verification of diagnostic radiopharmaceuticals preparation by Nuclear
Medicine Technologists staff is not required for doses prepared and
administered at the direction of a UWHC Nuclear Medicine physician
(Authorized User) to a patient within UWHC.
b. Verification of diagnostic radiopharmaceuticals prepared by Nuclear
Pharmacists is not required for any purpose.





Effective Date:
May 2007
 Pharmacy Policy Manual
Chapter: Nuclear Pharmacy
Operations Procedure Manual
Chapter

Policy #: 17.1
Original
 Revision
02/2016

Page 2
of 6

Title: Preparation and Dispensing of
Sterile Radiopharmaceuticals

c. Radiopharmaceuticals prepared by a pharmacy technician or a
pharmacist assistant (PHA) for doses ordered by a UWHC Nuclear
Medicine physician for a patient within UWHC may be done with
appropriate verification by either a nuclear medicine technologist or
pharmacist.
8. Preparing radiopharmaceuticals for patients outside of the UWHC is only within
the scope of practice of an Authorized Nuclear Pharmacist, and preparation of all
doses for such patients must be done or verified by a pharmacist.
B. Radiopharmaceutical Preparation
1. The Nuclear Medicine schedule will be accessed through HealthLink by the
Nuclear Pharmacy the business day prior to the scheduled test date.
a. Nuclear pharmacy staff will assess which radiopharmaceuticals need to
be prepared the next business day. These non-radioactive kits will be set
out the evening before use without removing the flip tops on the vials. .
b. If a kit needs to be prepared during the same business day, the kit will be
double-checked by a nuclear pharmacist or a Nuclear Medicine
Technologist prior to dispensing.
2. The staff member preparing the radiopharmaceuticals at the beginning of the day
will verify that the correct radiopharmaceuticals are in the correct vial shields
when removing the flip tops of the vials prior to preparation
3. The amount of radioactivity added to the radiopharmaceutical kit varies
depending on the number of patients scheduled, available radioactivity, and
preparation parameters
a. In-house preparation parameters are programmed in to the Nuclear
Pharmacy computer system: instructions can be viewed on the help
screen, or follow the manufacturers package insert instructions. Further
information can be found in the Pharmacy Operations Manual.
4. The proper radiopharmaceutical vial and source radioisotope vial are placed in the
vertical flow direct working area and disinfected with sterile alcohol.
5. Shielding used to store the kit vial will be disinfected with sterile alcohol
6. Only the radiopharmaceutical being prepared and the source radioisotope may be
on the working area at any one time
7. If a shielded kit is brought into the direct working area for a dose to be drawn, the
contact area of the vial shall be disinfected with an alcohol swab, being wiped
with a hemostat to ensure ALARA.
8. The required activity of the source radioisotope is drawn into a syringe and
measured in the dose calibrator
9. The activity of the source radioisotope is added to the radiopharmaceutical vial
following in-house protocols as defined in the Radiopharmacy Information
Booklet.





Effective Date:
May 2007
 Pharmacy Policy Manual
Chapter: Nuclear Pharmacy
Operations Procedure Manual
Chapter

Policy #: 17.1
Original
 Revision
02/2016

Page 3
of 6

Title: Preparation and Dispensing of
Sterile Radiopharmaceuticals

a. A kit label is generated through the Nuclear Pharmacy computer system
using the kit preparation program. This label is placed on the outside of
the vial shield and contains the name of the radiopharmaceutical, lot
number and expiration time.
b. A kit label will be placed on the kit prep sheet
10. The nuclear pharmacist will check all vial shields containing
radiopharmaceuticals prepared by nuclear pharmacy technicians or PHAs to
verify that the appropriate radiopharmaceutical is in the correctly labeled vial
shield. This will be done by opening the vial shield (behind appropriate shielding
to comply with ALARA) and verifying that the original drug vial is in the
correctly labeled shield. This will be done before any doses leave the nuclear
pharmacy.
a. If the nuclear pharmacist is not available to verify the vials, a nuclear
medicine technologist may perform the verification for doses
administered in the UWHC Nuclear Medicine Department.
b. The kit preparation sheet and label on the vial will be initialed by the
person verifying the vial after completion of this process.
11. Radiochemical purity will be determined on all radiopharmaceuticals prepared
in-house by nuclear pharmacy staff, with the assistance of nuclear medicine
technologists when indicated, including generator elutions that will be used to
dispense pertechnetate doses
a. For emergency Nuclear Medicine procedures, radiochemical purity
determination is required only on the following radiopharmaceuticals:
i. MAA (macroaggregated albumin)
ii. MAG3 (mertiatide)
iii. Sestamibi
iv. Tetrofosmin
v. Radiopharmaceutical Dose Dispensing
C. Patient orders will be entered into the Nuclear Pharmacy computer system
1. Nuclear Medicine schedulers will provide Nuclear Pharmacy staff with written
orders for nuclear medicine tests which include patient name, age and weight,
procedure type, and the time and date of procedure.
a. Nuclear Pharmacy staff will determine the appropriate
radiopharmaceutical and dose based on Nuclear Medicine protocol
b. Any deviation from protocol requires a written order from the nuclear
medicine physician
i. If an order is entered by a pharmacy technician or PHA the
Pharmacist will verify the order entry for accuracy
c. If the nuclear pharmacist is not available to verify the order entry, a
nuclear medicine technologist may perform the verification for doses
administered in the UWHC Nuclear Medicine Department.





Effective Date:
May 2007
 Pharmacy Policy Manual
Chapter: Nuclear Pharmacy
Operations Procedure Manual
Chapter

Policy #: 17.1
Original
 Revision
02/2016

Page 4
of 6

Title: Preparation and Dispensing of
Sterile Radiopharmaceuticals

i. Order entry verification will include the following checks:
 The correct radiopharmaceutical was selected based upon
the test ordered and nuclear medicine protocol.
 The dose entered is correct based upon the test ordered and
the patient’s weight and nuclear medicine protocol.
 The calibration time entered is correct based upon the time
of the test and radiopharmaceutical administration time and
nuclear medicine protocol.
 After verification of the above elements the pharmacist or
nuclear medicine technologist will initial the order as
documentation that the checks have been completed and
order entry is accurate.
2. The proper radiopharmaceutical vial is placed in the direct working area and
disinfected with sterile isopropyl alcohol
3. Only the radiopharmaceutical vial being dispensed may be in the direct working
area at any one time
4. The label must be read three times during the dispensing process:
a. When picking up the product from the shelf and placing it in the direct
working area
b. Upon dispensing the dose and placing the label on the syringe
c. When returning the product to storage
5. The required activity and volume to draw is determined by the Nuclear Pharmacy
computer system. If there is a discrepancy between the volume or activity
provided by the computer, compared to what is dispensed, dispensing personnel
will stop the process and notify the pharmacist.
a. All doses must be measured in the dose calibrator and must be within
10% of the prescribed activity. The computer program will display a
warning if the entered activity exceeds this activity.
b. All volumes must be dispensed within 10% of the volume provided by
the Nuclear Pharmacy computer system. If a diluent is added to a dose
for additional volume, it must be written on the prescription.
6. After printing the prescription label, the dispensing clinician will immediately
place the syringe in a syringe shield, label the syringe and initial the prescription.
7. Sending doses
a. All doses should be prepared in the appropriate size syringe with the
needle still attached and minimum volume of 0.5mls (unless noted
otherwise for Vet School Doses, which should have needle removed and
blue Luer lock cap attached)
b. Completed doses should be labeled properly and placed in the
appropriate shielded pig
c. Print a DOT report of all the doses prepared for each site.





Effective Date:
May 2007
 Pharmacy Policy Manual
Chapter: Nuclear Pharmacy
Operations Procedure Manual
Chapter

Policy #: 17.1
Original
 Revision
02/2016

Page 5
of 6

Title: Preparation and Dispensing of
Sterile Radiopharmaceuticals

8. Packing Doses:
a. Pack doses in a black carrier for all Tc99m products or a black carrier
with a blue lid for all other products/doses.
b. Rubber band the smaller top label around the container and keep the
larger bottom label that does not have the radioactive symbol, the other
large label can be tossed into the confidential blue bin.
c. All vials being sent should additionally be packed into a foam insert
made specifically to hold vials.
d. Once packaged into carrier use a pancake probe to survey the inside of
the carrier, the lid, and any shielded pigs inside the carrier.
e. Also perform a wipe test on the shielded pigs only to ensure no
spreadable contamination is present.
f. Either the pharmacy technician or the Pharmacist may sign off on the
DOT report indicating that the wipe test showed no contamination
greater than what is present in the background.
g. UW Rad Safety will perform an independent wipe and metering of the
package and comply with any placarding placed on the carrier. Rad
Safety will then deliver the doses to the appropriate sites.
9. Receiving Empty Carriers
a. Use a pancake probe to survey the carrier for any contamination.
b. If no contamination is present wipe down the shielded pigs with sterile
alcohol and gauze wipe, survey the gauze wipes to ensure no
contamination is present.
10. The labeled, shielded dose will be placed in a syringe carrier.
a. If the dose is prepared by a nuclear pharmacy technician or PHA, the
carrier will be placed on the counter near the quality control station, with
the drug vial and the printed prescriptions in front of the carrier. The
pharmacist, or nuclear medicine technologist if doses are used within
UWHC, will verify the product stated on the printed labels match the
label on the kit shield and will initial the prescription label indicating the
verification process is complete.
b. The nuclear pharmacist, or designated personnel, will place the dose
carrier and prescriptions on the counter in the dose pick-up area. The
prescriptions will be placed, face up, in front of the carrier.
11. When picking up the dose for injection in the UWHC Nuclear Medicine
Department, the nuclear medicine technologist will verify that they have a dose
for the correct patient, the correct calibration, and the correct activity, according
to the patient’s weight and procedure being performed.



Approved By: ____________________________
Director of Pharmacy Services

Date: ________________


KIT PREPARATION DATE:________________________
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