BIO 221
REGULATORY AFFAIRS COMPLIANCE IN BIOMANUFACTURING
ASSIGNMENT 7
Heparin Mix-Up
The following safety alert was posted by FDA on its MedWatch site.
Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL
Medication Errors
Audience: Pharmacists, neonatology/pediatric healthcare professionals
[Posted 02/07/2007] Baxter and FDA notified healthcare professionals of the
potential for life threatening medication errors involving two Heparin products,
Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL.
Baxter is aware of fatal medication errors that have occurred when two Heparin
products with shades of blue labeling were mistaken for each other. Three infant
deaths resulted when the higher dosage Heparin Sodium Injection 10,000
units/mL was inadvertently administered instead of the lower dosage of HEPLOCK U/P 10 units/mL. The currently marketed 1 mL vials of both Heparin
products use blue as the prominent background color on their labels.
Also read below the Safety Alert issued by Baxter and the news article about the use of heparin of the
wrong concentration. Consider the following fictitious scenario. Baxter’s attorney comes to your desk in
the Office of Regulatory Affairs for Baxter. He seems rather stressed. He asks if you could come up with
reasons that Baxter had acted appropriately when it first became aware of fatal medication errors with
its heparin products. He asked you if you could communicate them to him when they are ready. To help
clarify your thoughts on this matter you wrote down a list of questions:
1. Did Baxter address the issue when it first arose?
2. What were the five points that Baxter, in its safety alert of February 6 2007, reminded
healthcare professionals that they should do?
3. Does the labeling itself appear sufficiently clear to differentiate the two doses?
4. Was Baxter thinking of how the packaging and labels could be changed so as to more readily
distinguish the two products and reduce the risk of future medication errors?
How would you answer these questions and why would you answer each of them that way?
IMPORTANT MEDICATION
SAFETY ALERT
BAXTER HEPARIN SODIUM INJECTION 10,000 UNITS/ML AND HEPLOCK U/P 10 UNITS/ML
February 6, 2007
Dear Healthcare Provider:
This important safety information concerns the potential for life threatening medication
errors involving two Heparin products:
• Heparin Sodium Injection 10,000 units/mL
• HEP-LOCK U/P 10 units/mL
Baxter is aware of fatal medication errors that have occurred when two Heparin products
with shades of blue labeling were mistaken for each other. Three infant deaths resulted
when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently
administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL.
The currently marketed 1 mL vials of Heparin Sodium Injection
10,000 units/mL and the HEP-LOCK U/P 10 units/mL use shades of blue as the
prominent background color on their labels.
Healthcare professionals should be reminded to:
• Never rely on color as a sole indicator to differentiate product identity.
• Always carefully read the product label to verify that the correct product
name and strength have been selected.
• Always carefully review both the drug name and dose on the label before
dispensing and administering these products.
• Double-check your inventory as soon as possible, to ensure that there is
no mix-up of the products.
• Notify all staff of the potential for errors in dispensing and administering
these products. It is advised that you provide color photographs (see
below) to staff to assist in their understanding of the product
similarities.
To assist you in your review of these two labels, a side-by-side color photograph is provided
below:
Baxter provides bar codes on its product labels and is considering ways to differentiate the
packaging and labels to decrease the risk of medication errors. While Baxter seeks to more
clearly differentiate the appearance of these two products, the Food and Drug
Administration (FDA) suggests that your institution review your medication identification and
administration policies and procedures. Please ensure that all staff responsible for the
dispensing and administration of Heparin Sodium Injection and HEP-LOCK U/P products
are aware of these medication errors and that the staff are familiar with your policies and
procedures.
If you have any questions regarding this letter, please contact Baxter at 1-800-ANA-Drug (1800-262-3784). FDA requires hospitals and other user facilities to report deaths and serious
injuries associated with the use of drugs and medical devices. If you suspect that a
reportable adverse event related to Baxter’s Heparin Sodium Injection and HEP-LOCK U/P
has occurred, please report the information to Baxter and to MEDWatch at 1-800-FDA-1088
or online at www.fda.gov/medwatch/report.htm.
Sincerely,
[ Signature ]
Jonathan Deutsch, M.D.
Medical Director
Anesthesia and Critical Care
Baxter Healthcare Corporation
DENNIS QUAID'S TWINS AMONG THREE NEWBORNS
GIVEN DRUG OVERDOSE
Wednesday, November 21, 2007
AP
Dennis Quaid and his wife, Kimberly Buffington
LOS ANGELES — The newborn twins of actor Dennis Quaid were among three patients accidentally
given 1,000 times the common dosage of a blood thinner, but hospital officials said Tuesday that
none of the overdose victims had suffered any ill effects.
Cedars-Sinai Medical Center declined to identify the patients, but a representative for the actor told The
Associated Press that they included the two-week-old children of Quaid and wife Kimberly, Thomas
Boone and Zoe Grace.
"Dennis and Kimberly appreciate everyone's thoughts and prayers and hope they can maintain their
privacy during this difficult time," Quaid's publicist, Cara Tripicchio, said in a statement Tuesday.
The hospital declined to release the patients' conditions Wednesday, citing privacy laws.
The celebrity Web site TMZ.com, which first reported the overdoses, said the children were in stable
condition in the neonatal intensive care unit. A Cedars-Sinai official said tests indicated that none of the
patients suffered any ill effects from the overdose on Sunday, but apologized to their families.
"I want to extend my deepest apologies to the families who were affected by this situation," CedarsSinai's chief medical officer, Michael L. Langberg, said.
The state Department of Public Health is investigating reports of an incident involving newborn twins at
the hospital, said agency spokeswoman Suanne Buggy, who declined to elaborate.
Langberg said three patients on Sunday each received vials containing 10,000 units per milliliter of
heparin, a blood thinner, instead of vials with a concentration of 10 units per milliliter. The patients were
receiving intravenous medications and the heparin was used to flush the catheters to prevent clotting.
Once the hospital staff realized the error, they tested to measure the patients' blood clotting function,
Langberg said. One test was normal, but the other two were given another drug, protamine sulfate, that
reverses the effects of heparin.
It was not immediately clear which two of the three patients had received the second drug. Further tests
on those two "indicated no adverse effects from the higher concentration of heparin," Langberg said.
"Doctors continue to monitor the patients."
Protamine sulfate is generally effective in restoring normal clotting function, said Steven Kayser,
professor of clinical pharmacy at the University of California, San Francisco.
Heparin, used to treat and prevent blood clots in the veins or arteries, comes in different concentrations
and too much can be life-threatening, Kayser said. Overdose symptoms can include nosebleed and
bruising.
"Heparin is a good drug, but you have to pay very careful attention because of the varying
concentrations," he said.
Last year, three premature infants at an Indiana hospital died after a pharmacy technician mistakenly
stocked the medicine cabinet with heparin vials containing a dose 1,000 times stronger than what the
babies were supposed to receive. Three others also suffered overdoses but survived.
Quaid and his wife are the biological parents of the twins, who were born Nov. 8 to a surrogate mother.
"God has definitely blessed us," the couple said in a statement announcing their birth.
Quaid, 53, has a 15-year-old son, Jack Henry Quaid, from his marriage to Meg Ryan.
His screen credits include "Great Balls of Fire!" "Any Given Sunday" "The Big Easy" and "Far From
Heaven."