Patient Safety

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.

Prescription Error Overdose Leads to Paralysis, Victim Hopeful for Recovery

May 19, 2011 | Lebowitz & Mzhen

Our Maryland pharmacy misfill injury attorneys have been following the recent developments in the tragic Walmart prescription error incident from 2008 that caused a teenager to suffer a pain medication overdose that led to paralysis.

When Jessie Scott was 18, and suffering from strep throat pain, his doctor prescribed a low-dose of the pain reliever, oxycodone hydrochloride. After receiving the prescription from Walmart, Jessie’s mother administered one dose to her son.

In a grave prescription drug error, the Walmart pharmacist reportedly failed to dilute the drug, and the prescribed dosage of 5 milligrams was actually around 100 milligrams, causing a prescription drug overdose. Jessie went into a coma, suffered organ failure and paralysis.

Scott, who is now 20 years old, has reportedly experienced some remarkable changes physically and psychologically, making incredible strides since the horrific incident that caused his disabilities. Thanks to a court prescription error lawsuit settlement with Walmart, Jessie’s parents were able to build an area in their house with special accommodations that allow him to be transported from room to room. He can now raise his arms, hold his head upright, wiggle his toes, and even kick. Although the odds seem to be against him, Jessie holds out hope that he will walk again.

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.

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.”

Pharmaceutical Company Must Reveal Fentanyl Patch Data in Wrongful Death Lawsuit

April 27, 2011 | Lebowitz & Mzhen

In a recent Maryland pharmacy error injury lawyer blog, our attorneys discussed the increasing medication errors resulting from the incorrect administration of Fentanyl, the strong pain relieving medication patch. If a medication error occurs with Fentanyl, the improper administration of the drug can lead to a drug overdose or even wrongful death.

In a recent wrongful death lawsuit that our Baltimore pharmacy error attorneys have been following, Monika Standing and Chris Bristol are suing Watson Pharmaceuticals and two corporate affiliates after their daughter Nicole died three weeks after using the 75-microgram time-released fentanyl patches in January 2008. Nicole’s parents claim that her fentanyl patch, made by Watson, leaked—causing Nicole to suffer an overdose of the fentanyl gel inside, leading to her death.

According to the lawsuit, the fentanyl patches made by Watson used a faulty design, creating a patch that was prone to leaks, which lead to possible overdoses and deaths. Other patches made by competitors reportedly had a safer patch design that did not leak.

Last week, as the case developed, a Los Angeles County Superior Court Judge reportedly ordered Watson Pharmaceuticals to turn over pain patch samples, any materials used for commercials or marketing, all written communication between Watson Pharmaceuticals and the U.S. Food and Drug Administration involving the usage and safety of the fentanyl patch, all experiments or studies done involving fentanyl patch levels in the user’s bloodstream when using the patch, all autopsy reports and papers involving deaths while using the patch, and transcripts of all depositions taken of any Watson employee or key expert witness in a previous defective fentanyl pain patch lawsuit, and also ordered certain key executives from the company to testify about the pain patches.

Children’s Hospitals Form Collective Effort on Patient Safety to Prevent Medication Errors

April 13, 2011 | Lebowitz & Mzhen

According to a recent article in Pharmacy Practice News that our Washington D.C. pharmacy error injury attorneys have been following, a group of children’s hospitals in Ohio have prevented around 3,600 adverse drug events and surgical site infections, along with saving over $5 million, during an 18-month program initiative that was launched in 2009.

The initiative, called “Solutions for Patient Safety,” was reportedly launched with support of the Cardinal Health Foundation, who gave 1.5 million, along with the shared motivation of children’s hospitals in an effort to work together to eliminate preventable injury or harm to children.

Before the initiative began, each children’s hospital in the state reportedly collected data on adverse drug events in a different way—making it very difficult to compare or share information within hospitals. After conducting audits of a random collection of charts, the group was able to come together and manually identify and review the root cause of adverse events, and pinpoint a set of common concerns.

The initiative found that the main collective medication error problem was constipation from opioids, as well as over sedation as a result of the narcotics. Although constipation is not a life-threatening adverse drug event, it can reportedly add to more time in the hospital, more lab work, and tests, which can all add to additional costs.

Benefits of Robo Pharmacy Technology in Reducing Prescription Errors

April 1, 2011 | Lebowitz & Mzhen

In a recent Maryland pharmacy error injury lawyer blog entry, our attorneys discussed automated hospital pharmacies the use robots instead of people for tasks that are traditionally manual—in an effort to eliminate medication errors that could cause patient harm or personal injury.

According to the Medical Center of the University of California, San Francisco (UCSF), a hospital that recently implemented an automated hospital pharmacy–the benefits of using an robots instead of people are:

• Robots will help take over the manual medication dispensing tasks traditionally performed by pharmacists and nurses, who will in turn have more time to work with physicians to decide what the best patient drug therapy is, and will have more time to monitor each patient for any clinical responses or adverse reactions to medicine.
• The new pharmacy will provide pharmacy students with a strong training ground in the safe medication distribution systems of the future.
• The pharmacy will also enable the center to study new forms of medication delivery in order to share this groundbreaking information with other hospitals all over the country.

• Out of the 350,000 doses prepared by the robo-pharmacy since 2010, there has not been a single medication error or pharmacy misfill.

According to UCSF, the automated medication dispensing system will allow pharmacists to use their expertise in pharmaceutical care to make sure that each patients receives medication therapy that is catered to their individual needs, in a safe and effective way.

500 Unapproved Prescription Cough and Cold Medications Banned by FDA

March 22, 2011 | Lebowitz & Mzhen

Our Maryland-based prescription drug error attorneys have been following the U.S. Food and Drug Administration’s recent announcement, ordering the makers of around 500 prescription cold, cough and allergy medications to take the drugs off the pharmacy shelves, as they have not been proven to be safe and effective.

According to the FDA, the prescription drugs in question have not been linked to any major problems or drug-related injuries, but the FDA is still concerned that the medical problems associated with the drugs could be seriously under reported.

The agency claims that the drugs have not been evaluated by the FDA, and taking them may be more of a risk to the consumer than taking over-the-counter (OTC) medications to treat the same symptoms, that have been approved. The FDA also claimed that the action is necessary to protect consumers from any health and safety risks posed by these unapproved drugs, as the agency does not know how they are made, whether they are effective, or what is in them.

One of the problems that the agency found was with time-release drugs, which are reportedly hard to manufacture, and can release too slowly or not at all if quality controls in the manufacturing of the drug are inadequate. The FDA also made a move against unapproved products that contain drug combinations that could be considered dangerous, like combining two antihistamines, which could react in oversedation.

Prescription Pain Medication Error Due to Alleged Drug Theft

February 14, 2011 | Lebowitz & Mzhen

Our Maryland pharmacy error attorneys have been following the recent news story surrounding a prescription drug error that resulted from drug theft, leaving a man without proper pain medication management while undergoing a kidney stone surgery.

According to Fox-9 News, in November of 2010, Larry King checked into Abbot Northwestern Hospital for kidney stone removal surgery. King was reportedly told that the 30-minute operation would be painless. While receiving Fentanyl, a powerful pain relieving medication that according to a recent Baltimore medication error blog is 100 times more powerful than morphine, Sarah May Casareto, the nurse responsible for administrating his surgery pain medication, allegedly stole 300 micrograms from King’s pain dosage in order to take the drugs herself—telling him that he would have to deal with the pain because they couldn’t give him a lot of medication.

Casareto’s prescription pain medication error and drug theft was reportedly discovered by other medical professionals during the operation, after Casareto started exhibiting strange behavior, which allegedly included slurred speech, dropping syringes in the operating room, and falling asleep. When confronted with drug abuse and drug theft, the nurse allegedly still held four unlabeled syringes in her pocket. King has filed a criminal complaint against Casareto, who refused a drug test and immediately resigned after the incident.

As a result of the drug abuse incident, King reportedly felt an extremely high pain level during the surgery, and doctors eventually gave him additional medication to help him through the rest of the operation. He claimed to have filed criminal and possibly a civil case to make sure that other patients don’t experience the same painful medication error that he went through.