Recently in Medication Error Category

May 9, 2012

FDA Warns of Threat to Children from Discarded Pain Patches

Fentanyl patch packagesThe fentanyl patch, which delivers a potent narcotic painkiller through the skin to people receiving treatment for injuries and pain management, poses a serious threat to children. The U.S. Food and Drug Administration (FDA) recently issued a warning to the public that exposure to the patch can be deadly to children, and that patients using the patch should take great care in disposing of used patches.

Fentanyl is a synthetic narcotic analgesic used as a painkiller and anesthetic, available in generic form or under the brand name Duragesic. It is about one hundred times stronger than morphine, and its effects have a rapid onset and short duration. It is used to treat patients suffering from chronic pain, where ordinary pain medications cannot provide relief. It is commonly delivered to a patient through a skin patch that provides a continuous low dosage of the medication. The drug can be addictive, and doctors only prescribe it for people who are already used to the effects of narcotic pain medications. One patch will last at least seventy-two hours. Fentanyl patches should never be placed in the mouth or swallowed. Patients are specifically cautioned to keep patches away from children under the age of two.

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May 3, 2012

Prescription Drug Errors and Abuse Causing an Increasing Number of Deaths Nationwide

800px-US_Army_52156_VA_warns_veterans_of_telephone_prescription_scam_05032012.jpgA survey by the U.S. Department of Health and Human Services (HHS) reveals that as many as 22 million Americans use illegal drugs of one kind or another. "Illegal drugs," as defined by the survey, includes both controlled substances like cocaine and marijuana and prescription medications used improperly. A report from the Centers for Disease Control and Prevention (CDC) issued in April indicates that prescription drug abuse has led to a ninety percent increase in poisoning-related deaths among teens aged fifteen to nineteen between 2000 and 2009. Prescription drug abuse is evidently becoming more common, and studies suggest much of it involves legally-obtained medications. In terms of civil liability for medical professionals, the question is not as clear as it is for a medication error.

The CDC reports that 27,000 people died in 2007 from accidental drug overdoses in the United States. The agency also says that deaths due to drug overdose and abuse have overtaken car accidents as a cause of death among teenagers. As much as twenty percent of teens surveyed by the CDC in 2009 said they had taken prescription medications without a prescription. A large number of these may be painkillers, which have a high potential for abuse, fatal drug interactions, or overdoses. Opioid analgesics, which are common active ingredients in painkillers and other drugs, now cause more fatal overdoses than cocaine and heroin combined, according to the CDC.

Although some people who abuse prescription drugs may obtain them illegally, many obtain them directly through a physician's prescription or from a person with a valid prescription. Doctors and pharmacies must take great care in how they prescribe painkillers and other high-alert drugs. The Drug Enforcement Agency (DEA) recently suspended the licenses of two Florida CVS pharmacies because they allegedly dispensed more units of the painkiller oxycodone than any other pharmacy in the state, thus endangering public safety. According to the DEA, they filled multiple prescriptions for out-of-state patients and dispensed hundreds of thousands of tablets. This allegedly suggests dispensation of painkillers to addicts. Regulators also suspended a Florida distributor's license to distribute controlled substances for allegedly "selling excessive amounts of oxycodone" to the two CVS stores and other pharmacies. The pharmacies and the distributors face license revocation hearings.

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February 29, 2012

Confusion Over a Drug Name Leads to Eye Injury and Lawsuit

Eye green smallThe U.S. Food and Drug Administration (FDA) recently issued a warning to pharmacists and other medical professionals of the potential for confusion between two medications on the market, Durezol and Durasal. Although they have similar-sounding names, the two drugs have very different purposes. Durezol is an FDA-approved prescription eye medication consisting of a 0.05% solution of difluprednate ophthalmic emulsion. In short, it is a highly-diluted solution of a medication used with eye surgery patients. Durasal, on the other hand, is used to treat warts, and it consists of a 26% solution of salicylic acid. This means it has a high concentration of a rather caustic acid. Putting Durasal into your eyes is not a good idea.

The FDA normally reviews drug names to check for potential conflicts like this. Durasal entered the market shortly after the FDA approved Durezol, but it never went through the FDA's approval process. When the FDA was considering Durezol, therefore, it had no way of knowing of the possible naming conflict. The FDA reportedly asked Durasal's manufacturer to initiate a recall of the drug while the FDA assesses the risk to patients posed by the similar drug names, but says it has not received a response.

As an image of the two drugs' packaging posted at the Consumerist's website shows, the two drugs have vaguely similar color schemes in their packaging but very different design. The main distinguishing factor is the all-caps warning on the Durasal box that states the product is "NOT FOR USE IN EYES." It is not clear if this warning appears on the medication bottle itself, or if pharmacists dispensing Durasal even keep it in the original container. For at least one person in New York City, the warning was not enough.

Queens resident Smith Maceus went to a Walgreens pharmacy after a routine surgical procedure on his eye, intending to fill a prescription from his eye doctor for eye drops. The pharmacist allegedly gave him a bottle of Durasal instead of the prescribed Durezol. He has filed a $1 million lawsuit against Walgreens over the incident, claiming that the pharmacy's error caused him "grievous personal injury."

An incident in Arizona in 2010 demonstrates the importance of closely checking labels and other packaging on medications, especially ones that treat delicate areas such as the eyes. A woman recovering from cataract surgery reportedly confused a bottle of superglue for her eye drops. She reportedly required the assistance of paramedics to pry her eyelids apart and remove the adhesive material. She told local news that the bottles look almost identical, and that she simply confused them. It is possible that her vision, while in recovery from cataract surgery, was not very good.

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September 12, 2011

Another Connecticut Nursing Home Fined for Inadequate Medical Care

We recently blogged about cases of neglect at Connecticut nursing homes.

The New Haven Independent reported last Tuesday of yet another instance of poor medical care at a Connecticut nursing home. In this case, a nursing home was fined $3,000 by the State Department of Public Health after investigators determined that multiple nurses at the facility had withheld from patients medications prescribed by their physicians.

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September 9, 2011

Contaminated Avastin Causing Eye Infections and Blindness in Patients

Connecticut patients being treated for wet age-related macular degeneration (AMD) with eye injections should be aware that, last week, the U.S. Food and Drug Administration (FDA) issued a release alerting health care professionals to a cluster of serious eye infections suffered by patients in Florida and Tennessee who received eye injections of repackaged Avastin (bevacizumab). Avastin is approved for treatment of various cancers, but used off-label in smaller doses by many ophthalmologists to treat wet AMD due to its substantially lower cost than alternatives ($50/dose vs. $2,000/dose for Lucentis). Tragically, some of the patients were blinded.

As explained on EyeDocNews (a blog covering new treatments for eye conditions), in order to convert Avastin from a cancer drug to a wet AMD drug, pharmacies must repackage the vials into much smaller doses. If that repackagaging process is not handled with proper aseptic techniques, product sterility can be compromised, which puts patients at risk for microbial infections.

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