Advances in Patient Safety

Drug Alert Warns Epinephrine Syringe Shortage Could Lead to Dosing Error Risks

June 30, 2010 | Lebowitz & Mzhen

In yesterday’s blog, our medication error attorneys discussed a recent accidental overdose of epinephrine that led to a man’s death in a hospital. According to the FDA, Epinephrine is a high alert medication that could cause significant patient harm or injury when used in error. Medication error can occur when there is confusion in regard to epinephrine product ratio strengths. The Institute for Safe Medication Practices, ISMP, has received a number of fatality reports due to miscalculations of strengths of epinephrine injections.

In similar epinephrine news, the Institute for Safe Medication Practices (ISMP), and the American Society of Health-System Pharmacists (ASHP), announced a National Alert Network (NAN) message this month, to warn healthcare providers about dangerous medication mistakes that could be caused by a shortage of pre-filled epinephrine syringes.

The NAN warning states that emergency syringes of epinephrine in 1mg/10mL (0.1 mg/ml) are currently on backorder from the Hospira Inc., the only manufacturer of the product after the pharmaceutical company Amphastar stopped making its emergency syringes of the drug in 2009.

According to ASHP’s director of medication use, quality and improvement, Bona Benjamin, Epinephrine is a life saving drug used in ambulances, hospitals and any other emergency settings when a patient’s heart has stopped.

Benjamin claimed that the shortage of epinephrine does not effect quantities of the EpiPen, the epinephrine injection products that are self administered in .3 mg and .15 mg doses, to remedy severe emergency reactions to food, medication, insect bites, and other reactions of an allergic nature.

Man Dies After Receiving Overdose of Drug in Hospital

June 29, 2010 | Lebowitz & Mzhen

Our Maryland Medication Error Attorneys have been reading about the tragic incident that happen in Maine recently, after a local man went to the emergency room with symptoms of anaphylaxis, and was given an overdose of the drug epinephrine—causing his wrongful death.

After suffering an allergic reaction from eating seafood that included facial swelling and thickening of the tongue, Timothy Harvey, 51, went to the Mayo Regional Hospital emergency room for treatment. Harvey was reportedly given 0.3 milligrams of epinephrine, and reportedly showed good signs of improvement.

While Harvey was being observed by the hospital staff, he had another allergic attack, with some of the earlier symptoms. The staff reportedly gave him another dose of epinephrine, but accidentally administered an incorrect dosage of the drug, causing a medication error that was ten times the normal dose, 3 milligrams instead of 0.3 milligrams.

According to the FDA, Epinephrine is a high alert medication that could cause significant harm or patient injury when used in error. When Harvey started to experience chest pain and shortness of breath, the medical team discovered the mistake, and immediately contacted the poison control center to attempt to reverse the effects of the drug, but with no success. The Epinephrine overdose ultimately killed Harvey, despite the hospital staff’s many attempts to save his life.

“July Effect” Study—Report Suggests July is the Worst Month for Fatal Medication Errors

June 21, 2010 | Lebowitz & Mzhen

Researchers from the University of California, San Diego recently published a study in the June issue of the Journal of General Internal Medicine, examining the myth of the “July Effect”—a legend that considers July a dangerous month for hospital patients to undergo treatment.

The study found that fatal medication errors in hospitals are at their highest in July, especially in teaching hospitals. July is reportedly the month when recent medical students graduates report to residencies in teaching hospitals and are given new responsibilities for patient care.

In their research, Dr. David Phillips and Gwendolyn Barker studied the relationship between medication error and inexperience in July, when thousands of medical residents begin their residencies. The research focused on the changes in the total number of medication mistakes; which includes medicine given and taken in error, accidental drug overdose, accidental medication errors in medical and surgical procedures, and drugs taken accidentally.

The study inspected 244,388 death certificates across the country, focusing on fatal medication errors that were recorded as the primary cause of death between 1979 and 2006—comparing the July death numbers with the number of events that are expected in any month in any year.

FDA Accuses Franck’s Pharmacy of Illegal Compounding

May 21, 2010 | Lebowitz & Mzhen

In a highly publicized pharmacy error case from last year that our Washington D.C. Pharmacy Error Attorneys covered in a blog, 21 Venezuelan polo team horses tragically died after being given a drug mixed by Frank’s Pharmacy Compounding Lab, aimed to replicate Biodyl, a vitamin and mineral supplement that is often used to treat muscle fatigue in horses. The drug concoction was allegedly too strong, causing a medication error that lead to the death of the horses at the International Polo Club of Palm Beach in Florida.

This week, Franck’s Pharmacy voluntarily suspended all veterinary compounding in the lab, after reportedly being threatened with an injunction by the U.S. Food and Drug Administration (FDA). Last month, the FDA filed a complaint that Franck’s was going around the law by producing and selling misbranded and adulterated drugs and pharmacy compounds that were too similar to drugs that are FDA-approved.

According to the FDA, compounded drugs are not reviewed by the FDA for effectiveness and safety. Drug compounding has been criticized for lack of oversight—especially when both human and animal patients could be exposed to unapproved medication, that could result personal injury or even in this case death. In an FDA Compliance Policy Guide from 2003, the agency stated concerns about the risks posed by pharmacists and veterinarians who manufacture, distribute, and mass-markets animal drugs that are unapproved.

The FDA has reportedly had a strong interest in this case, as the deaths of these horses were caused by pharmacy error—from the same pharmacy that produces drugs for humans.

The Problem of Prescription Language Translations in Pharmacies

May 17, 2010 | Lebowitz & Mzhen

Our Pharmacy Misfill Attorneys in Baltimore, Maryland recently posted a blog that discussed the epidemic of prescription error stemming from poor language translations in pharmacies across the country—causing pharmacy misfill and medication errors that could lead to patient injury.

In a study that our attorneys discussed, published in the May issue of Pediatrics, researchers found that pharmacies using labels that have been translated into Spanish with a computer program often provide inaccurate or confusing drug instructions filled with medication errors—often delivered in a mix of English and Spanish or “Spanglish.” The study looked at 76 labels for prescriptions generated by 13 different pharmacy translation computer programs, and there was a reported error rate of 50 percent.

Dr. Alejandro Clavier, a doctor in Chicago told the Chicago Tribune that he experiences translation issues with his patients in his practice every day. In one example, a patient who suffers from anemia was not improving after taking the iron supplements that Clavier prescribed. Clavier found that the patient had only been taking one drop of the iron supplement—not the stronger dosage Clavier prescribed. The patient had reportedly received instructions from the pharmacy that were confusing and hard to understand.

According to a study performed by Northwestern University’s Feinberg School of Medicine, many pharmacies in four states with a large and growing Latino population are unable to even provide translations for prescriptions. The 2009 study found that nearly 35 percent of the pharmacies surveyed did not even offer translations services, and 22 percent offered pharmacy translations that were limited.

Electronic Prescriptions and the Path to Preventing Medication Errors

April 30, 2010 | Lebowitz & Mzhen

In yesterday’s blog, our pharmacy error attorneys in Baltimore, Maryland, discussed the rapidly growing numbers of doctors switching from hand-written prescriptions to electronic prescriptions—to create a more efficient system that helps to prevent medication errors in every step of the prescribing and pharmacy process.

The Wall Street Journal documented an example of possible prescription error with 59-year old Debbie Kenny, who was prescribed a new hypertension medication by her doctor that had just become available at the end of last year. Unknown to both Kenny and her doctor, the medication had the potential to interfere with her asthma—a dangerous side effect. Kenny consequently had trouble breathing after coming down with a cold, still not understanding the side effects of the medication.

After Kinney’s doctor started to e-prescribe the following month, the new electronic system indicated very clearly that Kinney should not be taking that particular hypertension drug, because of her asthma, and the drug’s side effects. She was promptly switched to another medication for hypertension that was compatible with her asthma. Kinney said that she feels more comfortable now with the new electronic system. If her doctor prescribes a new drug, she can ask for a clear computerized diagram of the side effects or the drug interactions before taking the medication—to avoid any personal injury.

As of last year, the Center for Medicare and Medicaid Services (CMS) was helping to promote the switch to electronic prescribing by enticing doctors and paying them a bonus for e-prescribing. As of the beginning of 2012, a stronger encouragement will appear, as CMS will begin penalizing doctors who haven’t embraced the electronic system to issue patient’s prescriptions.

Study Shows E-Prescribing Significantly Reduces Prescription Errors

April 29, 2010 | Lebowitz & Mzhen

In a recent news that our Baltimore, Maryland Attorneys have been following, doctors are reportedly increasingly leaving behind paper when prescribing medications, and depending more and more on electronic prescriptions, or “e-prescriptions”—in an effort to avoid pharmacy misfills and medication errors, along with hard-to-read doctor handwriting, or even prescription fraud, as our attorneys reported on in our last blog.

E-prescribing immediately sends the prescriptions to the pharmacy in a digital format through a secured Internet network, from a handheld device or from their computers. The doctor simply selects the drug from a computerized list, with other symbols indicating the best drug option, different dosages, and either generic or name-brand medicine, instead of hand-writing the prescription, which can lead to medication error. Some e-prescribing programs give symbols in the form of colored or smiling faces, delineating between cheapest, preferred, or less desirable drug options.

According to the Wall Street Journal, the number of e-prescriptions almost tripled last year, from 68 million in the previous year, to 191 million in 2009. Surescripts, LLC, the company that handles the majority of the electronic communications in e-prescribing, reports that this represents 12% of the 1.63 billion original prescriptions, which excludes refills. The first three months of this year showed that one out of every five prescriptions is being filed electronically—a number that is rapidly growing, as nearly 25% of doctors based in offices already have the technology to e-prescribe.

In a study published in the Journal of General Internal Medicine in February of this year, e-prescribing was found to reduce common hand-written prescriptions errors significantly, including pharmacy misfills containing the wrong dosage, or incorrect usage instructions that could lead to patient injury or even wrongful death.

Pharmacy Error in English-Spanish translated Drug Labels and Instructions

April 19, 2010 | Lebowitz & Mzhen

In a recent study that our Maryland Pharmacy Misfill Attorneys have been following, the problem of prescription translations from English to Spanish in pharmacies nationwide is being exposed, as well as the potential for medication error with customers.

The study, published in the May issue of Pediatrics, shows that many Spanish speaking people living in the United States are receiving prescription drugs from pharmacies with labels and instructions that have been translated so poorly from English to Spanish, that they are riddled with errors, misspellings, and incorrect phrasing. The prescription medications in these cases proved to have the potential of being more of a health hazard than a health benefit to patients if incorrectly administered—which could lead to personal injury or wrongful death.

According to the study results, the prescription translation errors are occurring because of poor translation systems in the computer programs that most pharmacies depend on for Spanish to English medication translations.

The study focused on 286 pharmacies in the Bronx, New York, where a reported 44 percent of the city’s population speak Spanish. The results found that 86 percent of pharmacies provided Spanish labels and instructions that were translated by computer programs, 11 percent used staff members for translations, and 3 percent of pharmacies used a professional interpreter to translate the labels and instructions.

The researchers reportedly found dozens of incidents where the quality of the medication label and instruction translations were dangerouly inconsistent. A common problem was that the computer program translated the prescription information into “Spanglish”— a mix of English and Spanish that was hard to read and often confusing. One example of a medication translation mistake was the use of the word “once” in English, meaning “once a day” that also means “eleven” in Spanish, which could result in a possible overdose. Other instructions that were not properly translated included phrases like, “apply topically,” or take “with juice,” or “with food,” as well as the length of the drug course, like “for seven days.”

Death from Medication Error Leads to Prevention Awareness

November 10, 2009 | Lebowitz & Mzhen

As Maryland Medication Error Injury Attorneys, we have recently read data from the U.S. Food and Drug Administration (FDA) stating that in the United States, 1.3 million people are injured by medication errors every year, with at least one death reported every day.

According to the National Coordinating Council for Medication Error Reporting and Prevention, (NCCMERP), injury from medication error is an urgent, a widespread public problem, that needs to receive far more public attention. The NCCMERP estimates that 98,000 people die annually from medical errors that occur in hospitals—an amount that is greater than deaths from motor vehicle accidents, breast cancer, AIDS, even workplace injuries. Medication error can happen at any point, and result in injury—from communication, distribution, prescribing, dispensing, administering or monitoring.

A medication error is defined by the the NCCMERP as any event that is preventable, and may cause medication misusage or patient harm while the medication is being controlled by the health care professional, consumer or patient. Medication errors can happen in professional practices and during procedures, as well as in the systems of prescribing, ordering, the labeling of a product, packaging, dispensing, education, monitoring, usage, and naming conventions.

The FDA states that common causes of medication error stem from poor communication between doctor, pharmacist, and patient, with unclear product names or suffixes, medical abbreviations or handwriting, poor techniques or procedures, or a lack of understanding of directions for patient usage. Job stress or lack of training or knowledge can also lead or contribute to pharmacy error injury or misfills.

Veterans Hospital Paves the Way for Computerized Records

October 30, 2009 | Lebowitz & Mzhen

In a post from earlier this year, our attorneys at Lebowitz & Mzhen Personal Injury Lawyers discussed how computerized health records would help Maryland pharmacists and doctors to eliminate Maryland medication mistakes.

According to a recent article in the Wall Street Journal, on how to digitize the health-care industry, Veterans hospitals have proven to have paved the way——showing doctors and pharmacists important lessons on how to effectively make the digital transformation.

The U.S. Department of Veterans Affairs digitized their records years ago, with great results. Independent studies show that the VA outperformed the private sector and Medicare on preventative services and chronic care. VA officials have claimed that the digital technology has helped cut down on patient hospitalizations and has helped patients live longer.

The VA’s digital records system has been a blessing to patients, allowing doctors and nurses at more than 1,400 facilities to share the medical history of the patients—avoiding the unnecessary repetition of costly tests. As well as storing patient data, the system gives screening warnings and keeps an eye on patient levels, like blood pressure and weight—all safeguards for improved quality care.

In a digitized record for a 59-year old Maryland patient at the VA medical center, all of his health problems were listed, like diabetes and hypertension, as well as all of his data since he has been a patient at the center. The screen showed a list of all current medications, including insulin, the drug Furosemide for heart failure, and Oxycodone, the pain medication. The patient’s doctor can reorder a drug through the system, sent directly to the pharmacy—eliminating medication mistakes and pharmacy misfills. If the doctor orders a new prescription that conflicts with a drug the patient is already taking, there is a warning in the system.