Connecticut’s Department of Health (DPH) released its most recent annual report on “adverse events” in October 2012, covering data for the year 2011. The term “adverse events” covers a broad range of incidents in healthcare facilities that result in patient injury or death. Not all adverse events are the result of medical error or malpractice, but most instances of medical error are viewed as adverse events. The report found that the total number of adverse events reported around the state has remained stable for several years, but the types of incidents accounting for the total has fluctuated.
The DPH has required healthcare facilities to report adverse events since 2002. In creating its annual report, it categorizes adverse events by type of event and type of facility making the report. It analyzes adverse events rates at four types of healthcare facility: acute care hospitals, chronic disease hospitals and hospices, psychiatric hospitals, and outpatient facilities like ambulatory surgical or outpatient childbirth centers. The events themselves are organized into seven broad categories, with numerous subcategories: (1) surgical errors; (2) drug- or device-related events; (3) interference by the patient or another person; (4) medication error, drug reaction, other treatment error, or bed sores; (5) burns, falls, shocks, toxic exposure, or other physical injury; (6) criminal activity; and (7) errors occurring in the hospital setting, including surgical injuries, infections, and misreporting of test results.
For the calendar year 2011, the DPH received 271 adverse event reports. This is the highest number received in a single year since at least 2005, a four percent increase over the number reported in 2010, and a two percent increase over 2009. As of the end of 2011, the state has received reports of 1,760 adverse events since it began tracking. The most common category of adverse event, comprising thirty-six percent of the total for 2011, involved falls in healthcare facilities causing a patient’s death or serious injury. Perforations during procedures, including open, laparoscopic, and endoscopic procedures, accounted for over eighteen percent of the total. Pressure ulcers, or bed sores, causing serious injury or death made up nearly fifteen percent of the total.
A court violated the free speech rights of a pharmaceutical sales representative when it convicted him of conspiring to introduce a misbranded drug into interstate commerce. The Second Circuit held in United States v. Caronia, No. 09-5006-cr (2nd Cir., December 3, 2012), that the defendant’s conviction for off-label marketing of the drug Xyrem was based primarily on his speech. It further held that the U.S. Food and Drug Administration’s (FDA’s) off-label regulations were too broad to further the legitimate interest of ensuring safe and consistent drug labeling.
Pharmaceutical companies must obtain FDA approval for specific uses before they may introduce new drugs to the marketplace. Once a drug is in the market, however, the FDA generally does not regulate how physicians promote it to patients. This is partly based on an understanding that doctors may legitimately prescribe drugs for “off-label” uses specific to their patients. The FDA prohibits “misbranding” of a drug, meaning introduction of a drug by a manufacturer with information that differs from its “intended use,” which includes false or misleading information, or uses that could be “dangerous to health.” Caronia at 7, 7 n. 4. The law imposes criminal penalties on pharmaceutical companies and representatives who misbrand drugs, but it does not expressly criminalize promotion of drugs for “off-label” uses.
Xyrem is a product of Jazz Pharmaceutical, formerly known as Orphan Medical. It is a central nervous system depressant used to treat narcolepsy. Its active ingredient, gamma hydroxybutrate (GHB), is also known as a “date rape drug” because larger doses can cause a person to lose consciousness quickly. Its FDA approval included strict limitations, with only two approved uses for narcolepsy patients.
When patients check into the hospital, they usually provide a medical history, including the medications they are taking at the time of admission. Patients cannot always provide a complete and accurate list of medications for various reasons. This and other factors may result in unintentional discrepancies between the medications a patient was taking prior to hospital admission, the medications they receive during their hospital stay, and the medications they are prescribed upon their discharge. Some of these discrepancies may be harmful, resulting in “adverse drug effects” (ADEs). A study by researchers at Johns Hopkins examined whether specially-trained teams of nurses and pharmacists could review patients’ medication histories to identify discrepancies and prevent ADEs. It concluded that such teams could not only prevent many ADEs, but could do so at a potential cost saving to hospitals and patients.
The study, titled “Nurse-pharmacist collaboration on medication reconciliation prevents potential harm” and published in the May/June issue of the Journal of Hospital Medicine, involved 563 patients who stayed at an urban hospital at various times between January 2008 and March 2009. Doctors conducted interviews with patients to obtain a home medication list (HML), which they used to determine what medications to administer during their hospital stay. Nurses would interview the patients a second time, creating another medication list. The nurses would review electronic records from prior hospital discharges, and sometimes they would contact a patient’s pharmacist, primary care physicians, and family members to obtain additional information on their medications. The lead researcher described this process as “detective work.” The patients could review these second HML’s for accuracy.
For hospital patients who speak limited English, miscommunication between hospital staff and doctors is a serious risk with potentially dire consequences. A misunderstood word or phrase could lead to an incorrect diagnosis or prescription error. A recent study reviewed cases of emergency room visits by patients with limited English proficiency, and concluded that the use of trained interpreters in such situations can dramatically reduce the number of errors.
The researchers, who published their findings in the online edition of the Annals of Emergency Medicine on March 19, 2012, reviewed visits to emergency rooms by patients and families with limited English proficiency. They focused their review on Massachusetts’ two largest pediatric emergency departments, covering a period of thirty months. They identified fifty-seven qualifying emergency room visits within that time period. By reviewing audio recordings of those fifty-seven visits, they identified 1,884 errors in interpretation and determined that eighteen percent of those errors had “potential clinical consequences.”
The National Transportation Safety Board (NTSB), a federal agency that investigates automobile and aviation accidents and makes recommendations for improvements to safety regulations, would serve as an excellent model for an agency to monitor patient safety, according to a recent medical journal article.
The article was written by a medical doctor, an attorney, and two celebrities: actor Dennis Quaid and airline pilot Chesley B. Sullenberger III. They draw on examples of aviation safety improvements to make the case for a similar body to handle medical issues, and they each draw on personal experiences to show how such an agency could help prevent medication errors and other potential harms.
The four authors each have experience as pilots and have personal stories relevant to the issue of aviation and patient safety. They use the aviation system as a model because it has had great success with safety improvements. In the 1970’s, air travel reportedly had a risk of death from crashes of one in two million. Now, the risk is down to one in ten million. A well-organized system of investigating and reporting on aviation accidents led to extensive improvements in training, equipment maintenance, and overall management of air travel. The authors cite the link between investigations and “preventive action” as the key to the NTSB’s success. The same link is needed in medicine, they say, where inefficient systems prevent broad safety reforms, costing both lives and money.
A 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.
The 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.