Antinausea Drug Withdrawn From US Market

The FDA announced that the 32 mg dose of Zofran (ondansetron), an anti-nausea medication, will no longer be marketed in the US due to the potential the risk of Torsades de pointes, a serious cardiac rhythm abnormality.  The event occurs when there is a prolongation in the QTc interval, an important part of the electrical activity of the heart.  Prolongation of the QTc can be fatal.  Information from the FDA can be found here.

Statin-Associated Muscular and Renal Adverse Events

Using the US Food and Drug Administration (FDA) adverse event reports (AERs) system, a group of investigators were able to review muscular and renal adverse events (AEs) reported with the use of statins.

There were 1,644,220 signals in AERs from 2004 to 2009 related to 4 statins.  The signals detected were myalgia, rhabdomyolysis and elevated creatine phosphokinase.  The investigators also noted that signals were seen for acute renal failure.

More than One in Four Medicare Beneficiaries Experience Some Degree of Harm While Hospitalized

This month the Office of Inspector General in the US Department of Health & Human Services has reported that more than one in four medicare beneficiaries experience some degree of harm while hospitalized.

Click here to see table in the report

The report noted that there were issues in the nation's hospital patient harm reporting system.

Findings included that half of States in the US had adverse event (AE) reporting systems in 2008, but only 12% of events met States requirements for reporting.

Of course, this means that half the States do not utilize a reporting system for AEs. This could be due in part to the fact that there are no Federal standards requiring States to have AE reporting systems.

Interestingly the report states that "hospital administrators indicated that staff often did not report events because they identified them not as patient harm, but rather as expected side effects."

Adverse Event Reporting of Lipitor, Lyrica, Viagra and Chantix

In May 2010, the FDA sent a letter to Pfizer's CEO, Jeffrey Kindler, warning the company that it had failed to report serious and unexpected adverse reactions to many of its widely known medications including Viagra (sildenafil), Lipitor (atorvastatin) and Lyrica (pregabalin) in a manner consistent with regulations.

The late reporting of adverse events was found to go back as far as 2004 and was noted to have increased over the six year period.  The FDA found that Pfizer did not report important cases within its 15-day period as a result of "misclassifying and/or downgrading reports to non-serious without reasonable justification."

In the past Pfizer had blamed issues with reporting on the lack of proper training of its employees with a new computerized adverse event reporting system.  Pfizer subsequently informed the FDA that this had been addressed, but the FDA called Pfizer's changes "inadequate" and "ineffective."  The FDA called for a revised "corrective action plan," also known as a CAP at the time.

A year later, in May 2011, the Institute for Safe Medication Practices (ISMP), a nonprofit organization, reported that "the risks of varenicline (CHANTIX) were underestimated in prior adverse event reporting." They outlined how Pfizer had failed to provide hundreds of reports through "the usual channels."  The ISMP noted that of the serious adverse event (SAE) reports, there were 150 patients who had completed suicides dating back to 2007.  As a result of the lapse in Pfizer's pharmacovigilance, more than half of the cases involving suicide were not sent to the FDA.  This meant that FDA analysts could not properly monitor this serious psychiatric issue.

Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I*

Here's an abstract of an interesting article, which first appeared in the New England Journal of Medicine and was subsequently republished:

Background: 

As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care.

Methods: We reviewed 30 121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians.

Results:  

Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test x2 = 21.04, p,0.0001). Using weighted totals we estimated that among the 2 671 863 patients discharged from New York hospitals in 1984 there

were 98 609 adverse events and 27 179 adverse events involving negligence. Rates of adverse events rose with age (p,0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p,0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p,0.0001), but no differences in the percentage due to negligence.

Conclusions: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Reporting A Safety Issue in the US

The U.S. Food and Drug Administration (FDA) is the agency that is accountable for protecting and promoting public heath in the United States. It does this by setting regulations, conducting inspections and analyzing adverse events (AEs). The FDA maintains a computerized database where information related to AEs is stored and then analyzed. This database is called the Adverse Event Reporting System (AERS). The FDA monitors the AEs in the database to determine if there are signals that could represent a health risk to the patients and public. The reporting of AEs is done on a voluntary basis by healthcare providers, patients and the public. Manufacturers of medications are required to report information related to AEs that they become aware of either through the conduct of clinical trials or that occur spontaneously in patients taking medicines that are marketed by the company. Reporting of Adverse Events can be done as follows: Consumers and Healthcare Providers can report Adverse Events online or using a form available through the FDA by clicking here or pasting the following URL into their web browser: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm