Informing patients about black box warnings and recalls can be difficult
Notification is only as good as your database
The Food and Drug Administration (FDA) has issued a new black box warning. If you are not doing your best to notify patients taking the drug, you may become liable, says one health system pharmacist.
Not many hospitals have established a formal system to handle black box warnings and recalls. Some post information around the facility. Others include information about it in publications sent to patients. Still others try to identify and notify physicians and pharmacists who have written or dispensed prescriptions for the medication with the black box warning.
"If we have a black box warning, we have been able to search our state Medicaid files to specifically look for the patients who are on the medication," says Julie Kuhle, RPh, senior vice president of Clinical and Quality Assurance Programs, Iowa Pharmacy Association in Des Moines. "We may then send out letters to pharmacists and physicians providing care to those patients."
The key is whether your system allows you to search for patients taking the drug, says Barry A. Browne, PharmD, coordinator of Drug Information Services, Scott & White Hospital in Temple, TX. "We have an integrated health care system with informatics capabilities to identify patients who are on these drugs. Stand-alone operations may not have the ability to identify and notify those patients and to notify medical staff."
Browne discovered the limitations of Scott & White’s previous information system when Janssen Pharmaceutica added a black box warning to cisapride (Propulsid), which eventually was pulled off the market. A pediatrician in the health system became concerned about locating his patients who were taking the drug. Browne found that he could identify patients in the Scott & White Health Plan who were taking cisapride. Unfortunately, 50% or fewer of the health system’s patients were covered by this health plan.
The health system sent a letter to the physicians, along with a list of their patients on the drug. Browne discovered that because of patients’ usual mobility, the physician list wasn’t as precise as it could be. "The teaching point from this experience is that no matter what you do, it is only as good as the data you have," he says.
An upgrade in system and responsibility
Scott & White then upgraded to an electronic medical record. Now the health system can identify all patients on a particular drug. "When a physician dictates his note at the end of the clinic visit, it goes into a searchable, central computerized repository. If we then want to know all of the patients in the year 2001 who were on the antidepressant nefazodone HCL (Serzone), we can pull up all the names of those patients and link them with a physician."
Because of the system’s information-gathering capabilities, Browne now feels a medical and legal responsibility to inform patients of black box warnings and recalls. The health system’s formal policy dictates that all appropriate physicians and patients be notified about black box warnings and recalls. "The specifics of how we do it differ depending upon the drug."
Recently, the health system notified patients of nefazodone’s potential hepatotoxicity problem. "We are sending a letter to those patients on the drug and telling them about the black box warning. We are telling them that they need to come in and have blood work drawn. We phrase it by saying, [This effect] is very rare, but to be careful, we want you to come in and have blood work drawn.’ Any abnormal results will be followed up with the patient."
Browne also feels like Scott & White has an obligation to send out immediate notification to medical staff, to make them aware of the new black box warning and the drug’s potential for hepatotoxicity.
"It could be a difficult situation if a patient received a drug from your pharmacy and you had the ability to retrieve the list of those patients from the last year, and you didn’t do it." The letter may not have to say more than, "You need to contact your physician."
Browne advises against relying on patients to hear about the warnings and recalls through the lay press. That did not work in the case of many patients taking troglitazone (Rezulin), which had a black box warning added about hepatotoxicity and eventually was removed from the market.
"There have been a number of cases of patients who, after the black box warning was added, stayed on the drug, didn’t have any liver monitoring, didn’t know about the risk, and have filed suit," Browne says. "Relying on the warning being adequately publicized in the lay press would be a tenuous position if you had the ability, within 15 or 20 minutes, to produce a list of the patients who had been on that drug in your system in the last year."
Technology has limits
Hospitals without electronic medical records, however, still have limitations in identifying patients on drugs that have black box warnings. One pharmacist says she sees limited information about patients’ medications, even when she is working in an outpatient clinic in a hospital. "We don’t see the inpatient chart when we see the patient in the clinic," says Carla B. Frye, PharmD, professional practice associate, professional practice and scientific affairs, American Society of Health-System Pharmacists in Bethesda, MD. "We don’t always know [about the medications] unless the patient tells us." The situation won’t be fixed until all the medical records are electronic, she says.
A community pharmacist also depends on the correct information being loaded into his database. "Although I am still ultimately responsible for knowing black box warning information, the system has to be designed so it gets that information for me when I am screening that prescription," says Dennis Bryan, RPh, pharmacy manager at Albertson’s in Chicago.
The possible adverse effects should be caught even before they reach the pharmacist, he adds. "It’s a technology issue. The Palm Pilots are here; the database interlinks are here. It’s just a matter of money [to implement them]."
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