Some California Hospitals Administered Heparin After FDA Recall
Despite a recall of the blood thinner heparin several months ago, some California hospitals continued to administer the treatment to patients, according to state citations obtained by the Los Angeles Daily Journal.
Previously, Board of Pharmacy regulators fined 94 hospitals for keeping tainted heparin on their pharmacy shelves. Reports that tainted heparin actually reached patients indicate "a more serious breach of patient safety than was previously reported," the Daily Journal reports.
FDA ordered a full recall of the drug in March. In August, Baxter Healthcare, the largest manufacturer of heparin, said that California hospitals stocking heparin had all been told about the recall. According to the Daily Journal, it is not clear whether smaller heparin manufacturers also sent recall notices to California hospitals.
The pharmacy board between Aug. 30 and Sept. 11 fined the 94 hospitals $2,500 to $5,000 each for violating the recall and also fined the head pharmacist at each hospital. Regulators have not released a full list of the hospitals involved.
One out of four of the hospitals violating the recall still had heparin after being warned by pharmacy regulators to remove it. In addition, about 200 patients received heparin after the recall was announced, according to the citations.
The pharmacy board issued $5,000 fines for 16 hospitals that administered the drug to patients. According to the Daily Journal, the hospitals could face $25,000 in further penalties from the Department of Public Health for putting patients in "immediate jeopardy."
Dorel Harms, senior vice president of clinical services for the California Hospital Association, said that at least one large hospital system says it never received information about the recall from Baxter. She added, "When you look at some of the circumstances, the hospitals did not have some of the information needed to treat their patients in a safe manner. It got a little confusing in the field."
Kathleen Billingsley, a deputy director at the Department of Public Health, said, "We are looking at a complex situation and a breakdown." She added that the department has not finished its own investigation but would work with hospitals to determine what went wrong.
Two hospitals -- UCSF Medical Center and Children's Hospital of Central California -- are appealing charges of keeping heparin on their pharmacy shelves and administering it to newborns (George, Los Angeles Daily Journal, 10/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.