Advances in Patient Safety

Risperdal Recalled by Manufacturer Due to Drug Contamination

July 29, 2011 | Lebowitz & Mzhen

Our Talbot County, Maryland pharmacy error injury lawyer blog recently discussed a series of recalls drug maker Johnson & Johnson made last year, in an effort to maintain the health and safety of consumers—after complaints of an unusual smell causing nausea, vomiting, diarrhea and gastrointestinal pain were reported, due to trace amounts of 2, 4, and 6-tribomoanisole (TBA), a chemical used to preserve wood necessary in the construction of pallets used for transportation and shipping of the product packaging materials.

In related news, Ortho-McNeil-Janssen Pharmaceutical, the drug manufactures of Risperdal (risperidone), an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in adolescents and children, recently voluntarily recalled 16,000 bottles of the brand name drug and 24,000 bottles of the generic drug—also because of an unusual odor.

The Risperdal drug manufacturers found that the unusual smell was also caused by trace amounts of TBA, used to preserve wood pallets for the transportation and storage of product materials. While not considered to be toxic, a small group of patients have reported gastrointestinal symptoms when taking products with this offensive odor. The drug maker claims that the presence of TBA has not caused any reported serious adverse events, but the company has instituted a series of actions to reduce the potential of TBA contamination in the future, to avoid personal injury or harm to any consumers.

This is the second medication error warning surrounding Risperdal this year. Last month our attorneys discussed another warning involving Risperdal in a Baltimore pharmacy error injury blog, issued by the U.S. Food and Drug Administration, discussing potentially dangerous medication errors associated with Risperdal and Requip, a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, with 226 reports of patients receiving the incorrect medication.

Report Warns Consumers to Take Precautions With Drug Labels and Instructions

July 25, 2011 | Lebowitz & Mzhen

In a previous Baltimore medication error injury blog post, our attorneys discussed a recent investigation by Consumer Reports Health that found evidence of inconsistency among prescription drug labels for warfarin, a blood thinner. The report found that important safety warnings and medication guides that are required by the federal government in order to prevent medication errors, were often omitted or left out of patient’s warfarin prescriptions.

As our Maryland pharmacy mistake lawyer blog has reported previously, every year, according to research by the Institute of Medicine, there are 1.5 million preventable medication error injuries, one third of which take place outside of hospitals, where consumers must make their own decisions about following medication instructions. Consumer Reports Health suggests that these medication errors happen because consumers are confused by the material that is included with prescriptions, and that they rely heavily on the medication bottle label—a problem if there are omissions or inconsistencies with the drug label.

The report found the following discrepancies:

• Four out of five pharmacies neglected to provide the medication guides that are required by the FDA for certain drugs, including warfarin.
• All of the pharmacies provided their own materials for the patients, but these conflicted with the guides for warfarin approved by the FDA. The FDA recommended that patients abstain from alcohol while taking the drug, while two pharmacies warned patients that they should just limit or avoid alcohol usage.

Consumer Reports Health Investigation Finds Drug Label Warning Inconsistency

July 18, 2011 | Lebowitz & Mzhen

A recent investigation that our Hartford County pharmacy error injury attorneys have been following found evidence that drug labels are often missing the important safety warnings necessary to prevent medication error and that many pharmacies neglect to include the proper medication guides that are required by the U.S. Food and Drug Administration (FDA).

The investigation was performed by Consumer Reports Heath, by filling warfarin prescriptions at five different New York drugstores. Warfarin is a blood thinner used for stroke prevention that is one of the most frequently prescribed drugs in the country.

The results found that four out of the five pharmacies neglected to provide the FDA-approved medication instructions that are required for specific drugs, warfarin included. Although the pharmacies reportedly provided their own medication materials, they were different from the warfarin drug information approved by the FDA, in that the warnings about the usage of alcohol were different. Warfarin can reportedly cause life-threatening internal bleeding if used incorrectly, and is the second in line for drugs that cause emergency room visits in hospitals across the country, due to medication error.

Another goal in the investigation was to see how certain drug labels, consumer drug information sheets, and medication warning stickers differed in each pharmacy. Although a certain degree of variation was expected, as various drugstore chains use different software to print labels and drug instructions, the findings raised significant concern.

FDA Tips for Administering OTC Medication to Children—to Reduce Medication Error Injury

June 6, 2011 | Lebowitz & Mzhen

In a previous Washington D.C. medication error injury lawyer blog, we covered the recent guidelines announced by the U.S. Food and Drug Administration (FDA) aimed to prevent medication errors and overdoses with children’s over-the-counter (OTC) medications.

According to the FDA, accidental medication errors and overdoses in young children are a common health problem, but a problem that is entirely preventable. The new guidelines are aimed to reduce frequent medication administration errors that happen as a result of confusing label instructions, inconsistency with the drug measuring devices, and confusion over the exact units of medication measurement—to prevent harm or injury.

Along with the new medication error prevention guidelines, the FDA also outlined tips for parents and caregivers, to reduce administration error when giving medicine to a child or infant.

According to the FDA, always:

• Know the active ingredients in the medicine that you are giving to your child.
• Read and follow the drug facts label on all medicines that are OTC.
• Use the tools for dosage administration that come with the medicine. Never use tools from other medication.
• Be aware of the difference between a teaspoon and a tablespoon.
• Know your child’s weight exactly.
• Check the medicine three times.
• Make sure to give the right medicine in the exact amount that is directed.
• Ask your doctor, nurse or pharmacist to make sure which medicines can be used at the same time.
• Store your medicines in a safe place that is out of reach for children.
• Make sure to use caps on all medicines that are child-resistant.

Hospital Fined $50K in Medication Mistake

June 3, 2011 | Lebowitz & Mzhen

In recent news that our Rockville, Maryland medication error injury attorneys have been following, twelve Los Angeles-area hospitals were hit with administrative penalties this week by the California Department of Public Health, ranging from $25,000 up to $75,000, after the facilities were found to be non-compliant with requirements that were likely to cause serious injury or death to patients.

One medical center, Promises Hospital, was reportedly fined $50,000 for a medication mix-up that caused a patient with a heart condition to require emergency response.

According to the Los Angeles Times, a medication error was reported in 2010 that led to the inspection of Promises Hospital. The inspectors reportedly found that a patient was given a dose of Cardizem, the drug used to treat irregular heart rhythms, that was 10 times the ordered dose—causing the patient’s heart rate to drop so quickly that the nurse was unable to get a blood reading for almost 10 minutes.

According to the department, when problems are found in facilities, hospitals must take corrective actions to prevent any similar medication errors or other problems from happening in the future, and causing injury or death to patients.

Promises Hospital reportedly claimed that it has initiated an investigation into the drug error, and has taken the necessary steps to prevent this medication mix-up for happening again in the future.

New FDA Guidelines to Prevent Children’s OTC Medication Errors

June 1, 2011 | Lebowitz & Mzhen

In a recent Baltimore, Maryland pharmacy error injury lawyer blog, our attorneys discussed an FDA panel’s recent recommendation that dosing instructions be based primarily on children’s weight, and not age—as studies found that many parents administer the wrong drug dosage to their children because of confusing medication label instructions.

The FDA has recently released new guidelines that are expected to reduce the prevalence of medication error and overdoses with Children’s liquid over-the-counter (OTC) medication, which is administered and dispensed with cups, spoons and droppers.

The guidance was reportedly developed after past reports of medication errors revealed that labels often cause confusion with administration, the measuring devices provided in drug packages are often inconsistent with the labels, and parents often used devices from other drug products to dispense the medication that do not match the label instructions—leading to medication error.

According to the FDA recommendations:

• Dosage dispensing devices (cups, spoons, droppers) should be included with all OTC medications that are liquid and taken orally.
• Over-the-counter (OTC) drugs will reportedly now come with dispensing devices that are calibrated to match the exact units of measurement specified on the drug label—to avoid drug error or injury.
• Companies should make sure that the liquid dispensing devices are used only to measure the intended drug products.

• The markings on the dispensing devices should be visible when the liquid medication is added for measurement.

And as our Maryland medication mistake attorneys discussed previously, the FDA is also advising that liquid acetaminophen products will be changed to one concentration only, with age-appropriate dosages, to reduce medication dosing errors.

FDA Panel Looks to Prevent Drug Error by Changing Children’s Acetaminophen Product Labels

May 27, 2011 | Lebowitz & Mzhen

In recent pharmacy error injury news that our Hartford County, Maryland attorneys have been following, a panel advising the U.S. Food and Drug Administration (FDA) has recommended that dosing instructions for children’s acetaminophen be based primarily on a child’s weight and not age, and be changed to include children under two years—to reduce the risk of medication error.

According to the Wall Street Journal (WSJ), a majority of dosing information for over-the-counter (OTC) children’s medicine containing acetaminophen have instructions based on age, with only some information on dosing by weight, causing confusion in dosing that could lead to error or injury. Acetaminophen is the most commonly used OTC medication to lower fevers in children and relieve pain, with the best-known brand being Children’s Tylenol.

The federal advisory panel has recently recommended that all acetaminophen products should contain a standard label with updated weight tables to reflect average weight increase among children over the past 20 years.

According to the FDA reports from 2000 to 2010, there were 14 fatalities and 74 non-fatal adverse events that were related to acetaminophen drug errors in infants and children from the age of 13 and younger. Some of the medication error fatalities were due to incorrect usage of the more-concentrated infant drops that were meant for older children, but used on infants.

The FDA panel reportedly recommended a single infant and children’s medication formula in 2009 that is slated for release this summer. The panel also recommends that the FDA should consider a single concentration of acetaminophen in solid forms, to avoid possible drug errors or overdoses with children.. The panel also voted to add dosage instructions for children from six months to two years onto liquid products. Currently on acetaminophen formulations for children, the dosing information is for children from 2-12 years old, with instructions to contact your doctor for children under 2 years.

Lack of Medication Adherence Can Cause Serious Medication Reactions and Injury

May 16, 2011 | Lebowitz & Mzhen

The Institute of Medicine, reports that every year, 1.5 million people are injured by medication-related events. According to an article in the Wall Street Journal (WSJ), that our Baltimore medication error injury attorneys have been following, a recent report from the Agency for Healthcare Research and Quality (AHRQ), found that the number of patients treated in hospitals across the country for illnesses and personal injuries from incorrectly taking medications like sedatives, blood thinners, corticosteroids and other drugs, increased over 50% from 2004 to 2008.

The report also found that over 800,000 U.S. patients were also treated in emergency rooms across the country in medication-related events, stemming from the incorrect usage of antibiotics, insulin, painkillers, and cardiovascular and other drugs. The WSJ looked at some of these individual drugs, to examine how they can cause personal harm or injury if taken incorrectly. According to the report:

• Antibiotics can cause an allergic reaction if taken incorrectly, and can also fail to properly fight infections. Also, when taking antibiotics, patients are generally cautioned to limit sun exposure, as it can cause extreme sunburns.
• Painkillers can cause breathings problems or even death if taken with alcohol or other sedatives or painkillers. OTC products that contain the ingredient acetaminophen can harm the liver if taken with a combination of opioid-acetaminophen drugs.
• Antidepressants and tranquilizers, if taken incorrectly, can lead to panic attacks and suicidal tendencies or actions.
• If taken erroneously, corticosteroids prescribed for asthma, arthritis, transplant patients, ulcerative colitis, and other conditions, can worsen other health conditions, like high blood pressure, blood sugar problems, ulcers, and diabetes, and can also lead to withdrawal if a patient stops taking them suddenly.
• Insulin, if not taken as prescribed, can both increase or reduce a patient’s blood-sugar levels, leading to shock and other health complications.
• If a patient fails to take blood thinners correctly, a high dose that is too high can cause bruising, excessive bleeding, whereas a dose that is too low can cause clotting. Effectiveness of the drug can also be threatened when interacting with other medications.
• Blood pressure drugs can also, if the medication is taken erroneously, cause a spike in blood pressure, and an overdose can cause chest pain, dizziness, shortness of breath, a fast or abnormally slow heartbeat, and can also cause coma.
• Cancer drugs, when taken in error, can cause fever, nausea and vomiting, shortness of breath, diarrhea, cause confusion and fatigue, and when an overdose is taken, can even cause death.

NCL Campaign to Improve Medication Adherence and Patient Safety

May 15, 2011 | Lebowitz & Mzhen

As our attorneys reported in a recent Rockville, Maryland pharmacy misfill blog post, according to the National Consumers League (NCL), around three out of four consumers in this country admit they don’t take their prescription drug medication as directed—causing an increase in medication error and injury that has a huge impact on patients and the healthcare industry.

To combat medication error, the NCL has launched a national multi-media medication adherence campaign this month with the Agency for Healthcare Research and Quality (AHRQ), that will aim to raise patient awareness on the importance of taking medication as directed.

According to the NCL, when consumers fail to take medications as instructed by their healthcare professionals, it creates a problem that impacts not only the patient, but the caregivers, employers, researchers, health care practitioners, and tax payers as well. Nonadherence to prescribed medications can also result in injury or death.

Research presented by the league shows that one in three prescriptions never get filled, with 1/3 and 2/3 of hospital admissions linked to medication errors that stem from poor drug adherence. The total cost for nonadherence leads to a reported $300 billion a year.

The campaign will strive to enhance patient safety and improve the healthcare system, encourage health practitioners to properly and effectively communicate the importance of prescription medication adherence to patients, and raise awareness of the problem through public education and a national campaign.

FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury

May 9, 2011 | Lebowitz & Mzhen

According to a recent article in the Wall Street Journal, a new national initiative is underway to make prescription medications clearer, and to decrease the rise of medication error that lead to hospitalizations and emergency room visits from patients who take their medication incorrectly—which according to the National Community Pharmacists Association happens to three out of every four Americans.

The U.S. Food and Drug Administration (FDA) is reportedly planning to test a new one-page information sheet to replace the many leaflet inserts and medication guides that are widely used in retail pharmacy chains across the country. And the U.S. Pharmacopeial Convention, the organization responsible for setting quality standards that are enforced by the FDA for the strength, purity and quality of medicines, has also developed a new program to create national standards for prescription labels, which currently vary greatly from pharmacy to pharmacy. The national label standard would require clearer instructions on the medication dosage, the medication timing and clearly state the purpose of the medication—to reduce medication and pharmacy error injury.

Currently, in pharmacies across the country, consumers may receive three different forms of drug information and pamphlets with their prescription medication—drug package inserts that are written by the drug manufacturer with FDA approval, drug guides for specific classes of drugs and products that are required by the FDA, and third-party consumer medical information. And according to the WSJ, recent FDA studies have shown that the drug information offered to consumers does not provide reliable understanding with the people taking the drugs, and is often conflicting in instruction, or even inaccurate, which could lead to patient harm or injury.

According to a recent FDA risk-communication advisory panel, more than half of adults misread or misunderstand one or more of common drug prescription precautions or warnings. In one study, patients were found to better understand language on warning labels that was simple and specific, like “use only on your skin” as opposed to “for external use only.” For consumers with lower English literacy skills, picture icons were provided, like a sun with a black bar, with the phrase, “limit your time in the sun.”