Drug Injury Watch

Toprol: AstraZeneca and FDA Warn of Medication Errors Due to Similarly Named Drugs

"Dear Doctor" Letter About Reports of Patients Receiving Topamax and Tegretol Rather Than Toprol

In late September 2005 the FDA and AstraZeneca warned of medication errors and pharmacy mistakes involving three brand-name medications: Toprol, Topamax, and Tegretol.

AstraZeneca said it has received reports of medication errors and pharmacy mistakes involving the extended-release version of Toprol, its beta blocker drug used to treat heart failure and hypertension. Apparently, those medication errors occurred when Toprol-XL has been confused with Topamax, a Johnson & Johnson drug used to treat epilepsy and migraines, or Tegretol, a Novartis AG drug used to treat seizures and neuralgia.

"These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice-versa, some of them leading to adverse events," AstraZeneca said in a September 2005 "Dear Doctor" letter.  AstraZeneca also issued a "Dear Pharmacist" letter at the same time given that some of the errors were due to drug-dispensing mistakes.

According to an AstraZeneca spokesman, Jim Minnick, the drug company was still reviewing reports of medication errors where patients received Topamax or Tegretol rather than Toprol, but so far it appears that the number of reported adverse events have been "very rare."  The FDA did not comment on the AstraZeneca statement about the number of reports of incorrect prescriptions written involving the three drugs nor the number of patients who suffered an adverse event because of the mistakes in dispensing Toprol, Tegretol, and Topomax.

In has been reported, however, that there were some cases where the patient was hospitalized because of the Toprol-Topamax-Tegretol medication errors. Most of those patients who had been hospitalized suffered from a worsening of the underlying condition that was not treated properly as a result of their having received the incorrect medication. In their Dear Doctor letter and Dear Pharmacist letter, AstraZeneca has acknowledged that there were reports of recurrence of seizures, return of hallucinations, recurrence of hypertension, and at least one suicide attempt.

AstraZeneca believes that most of these medication errors were the result of verbal and written prescriptions being incorrectly interpreted or incorrectly filled because of the similarity of the three drug names and because some of the drugs share overlapping strengths.

On their web site, the FDA has an article entitled "Drug Name Confusion: Preventing Medication Errors".  Among some of the steps patients can take to reduce the likelihood of drug-name medication errors are:

• Know the name and strength of prescribed drugs before leaving the doctor's office
• Insist that the doctor include the purpose of the medication on the prescription
• Ensure that a refill is, in fact, what it should be
• Tell your doctor of any medical history changes

(Posted by: Tom Lamb)

Pharmacists in Florida Must Warn Patients About Certain Drug Risks

Appellate Court Imposes New Legal Duty on Florida Pharmacists

In early June 2005 a Florida appellate court ruled that a Florida pharmacist can be held legally liable for failing to warn patients about certain risks associated with their use of prescription drugs, even if the pharmacist is filling a doctor's prescriptions.  This is the first time that a Florida state court has imposed such a legal duty on pharmacists dispensing drugs in Florida.

The patient in this case, a 46-year-old waitress, died from an overdose of prescription drugs. In the time leading up to her death, the patient had been taking six prescription drugs, including the powerful painkillers OxyContin and Percocet, as well as the anti-anxiety drug diazepam. These drugs are generally known to be harmful if taken together, and some of these drugs are highly addictive with long-term, repeated use.

Earlier in the proceedings for this lawsuit, the trial judge ruled that under Florida law a pharmacist is not liable for this type of patient overdose situation if the pharmacist is properly filling a doctor's prescriptions as written. A Florida appeals court, however, reversed that decision in this June 2005 ruling.

As the foundation for its decision, the 4th District Court of Appeals for Florida noted that pharmacists already must have "general knowledge" of the prescription drugs they dispense as well as the side effects risks those drugs present. Building upon this, Judge Mark E. Polen wrote for the Florida court: "Thus a strong policy basis already exists supporting a pharmacist's duty to warn customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences."

In more detail, the 4th District Court of Appeals for Florida observed that its decision in this new case conflicts with rulings issued previously by two other Florida appeals courts in earlier cases with similar facts. This Florida appellate court, however, cited recent cases in Pennsylvania, Arizona, Nevada, Missouri, and Tennessee wherein state courts have found that pharmacists have a legal duty to warn patients, doctors, or both about the possible serious side effect risks which can arise with either using prescription drugs repeatedly over a lengthy period or time, or using prescription drugs in certain combinations.

The attorney for one of the pharmacies named as a defendant in the underlying lawsuit said that this June 2005 appellate court decision would be appealed to the Florida Supreme Court in the near future.

(Posted by: Tom Lamb)

Medication Errors in Hospitals Involve Pharmacy-dispensing Errors in Estimated 10-20% of Incidents

Drug Name Confusion is a Common Cause of Drug-related Errors

A medication error is generally defined as a deviation from the prescription drug order written by the prescribing physician on the patient's chart.  In the hospital setting, it is estimated that medication errors occur at a rate of about one per patient per day.

A sub-set of medication errors is pharmacy dispensing errors.  In the hospital setting, errors made by pharmacists or pharmacy staff in the cart-filling process is one example of a pharmacy mistake.

Medication errors in the hospital setting can be attributed to a failure to follow the basic techniques and guidelines of medication ordering, preparation, and administration.  Combined, these failures result in medication errors affecting 3% to 6.9% of hospital inpatients, according to some controlled studies of medication errors in hospitals.  Moreover, one such study determined that 11% of medication errors in hospitals are pharmacy-dispensing errors in which the wrong drug or incorrect strength is dispensed by the hospital pharmacist.  A different report on hospital medication errors from 1999 found that 17% of medication errors in a hospital setting were due to dispensing errors by the hospital pharmacy.

Drug name confusion is among the most common causes of drug-related errors.  One example of sound-alike drug names involves Lamictal, the antiepileptic drug, and Lamisil, the antifungal drug.  The volume of dispensing errors involving these two drugs caused the manufacturer of Lamictal, Glaxo Wellcome Inc. (as it was known at the time), to launch a campaign warning pharmacists of the potential confusion.  Staying with this example, the possible consequences of dispensing the wrong drug can be grave.  Epileptic patients receiving the antifungal drug Lamisil by mistake could experience continuous seizures.  Patients erroneously receiving the antiepileptic drug Lamictal might experience a serious skin rash, blood pressure changes, or other unwanted side effects.

(Posted by: Tom Lamb)