Leiter’s Pharmacy

1700 Park Ave Suite 30San Jose, Ca 95126

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PHONE: 800-292-6773 FAX: 408-288-8252

AUTOLOGUS SERUM EYE DROP PROTOCOL

Doctor:

·  Send Rx via fax to Leiters Pharmacy at 408-288-8252

Lab orders are to include the following:

1.  HIV, HEPATITIS B & HEPATITIS C TESTING.

(Virology test results need to be sent to Leiters before blood serum is processed)

Leiter’s can not process known infectious blood serum

Lab results must be updated every 6 months.

2.  100 mls of blood to be drawn and spun down into serum.

(Figure 40-60% serum is recovered after processing)

Lab:

1.  Blood is collected following the same procedure as for all blood donors, except the donation is made into a sterile blood pack without anticoagulant. (Some labs use SST tubes)

2.  The donation should be allowed to sit for 15 to 20 minutes.

3.  Spin down in a centrifuge for 15-20 minutes.

4.  The serum is then drawn off the gel barrier and placed in new tubes and frozen immediately prior to shipping to Leiter’s Pharmacy overnight on dry ice. Do not send red blood cells.

5.  Please send Virology test results to Leiters Pharmacy with the blood serum or fax to (408)288-8252.

6.  Patient’s serum that tests positive for HIV or Hepatitis should be destroyed and not shipped.

7.  It is against Leiter’s policy to work with known infectious blood serum.

Leiter’s Pharmacy

1.  The serum will be matched with the Doctors order once received from lab.

2.  Verify virology results are in system.

3.  Serum is allowed to thaw and is passed through a 0.2 micron filter to sterilize and remove any particulate matter.

4.  Mix aseptically in our clean room with preservative free normal saline to the dilution prescribed by the physician.

5.  Sterile serum is placed in 5ml dropper bottles for patient use.

6.  Bottles are labeled: Refrigerate, Discard in 7 days, Keep unopened bottles in freezer.

7.  Serum tears are shipped to the patient’s home overnight on ice.

Patient:

1.  Store unopened bottles in the freezer.

2.  Thaw 1 bottle and use for 1 week. Store in refrigerator between uses. DISCARD IN 7 DAYS

3.  Each week open new bottle and repeat process.

Note: Serum Tears stored in the freezer are stable for up to 3 months.

(Tsubota et al, Treatment of dry eye by autologus serum application in Sjogrens

Syndrome, Br J Oph 1999,83:390-5)