Pharmacy Errors and Children

Pharmacy Mistakenly Gives Cancer Medication to Multiple Children

March 7, 2012 | Lebowitz & Mzhen

Children who should have received chewable fluoride tablets may instead have received Tamoxifen, a drug used to treat breast cancer, from a CVS Pharmacy in Chatham, New Jersey. Up to fifty families, according to initial reports, may have been affected by the error, in which the pharmacy dispensed the wrong medication over a period from December 1, 2011 to February 20, 2012. The fluoride pills, prescribed by dentists to prevent tooth decay, are typically flavored, while the cancer medication reportedly has a bad taste if chewed. Because of this, pharmacy representatives say that children would probably have noticed that they had received the wrong medication.

CVS issued a statement saying that children from roughly thirteen families mistakenly received Tamoxifen pills mixed in with the fluoride tablets. A spokesperson attributed the error to a “single medication restocking issue” at the one pharmacy location. The error affected the supply of 0.5mg fluoride tablets. The pharmacy reported that, according to the families they contacted, none of the children actually received any of the incorrect pills.

According to the Associated Press, Tamoxifen acts by blocking the female hormone estrogen. As such, it is not likely to cause serious harmful side effects to a child if taken for a short period of time. The New Jersey Attorney General’s office and the state’s Division of Consumer Affairs have nevertheless ordered the pharmacy to produce records for the period from December to February to account for the mixup. The pharmacy reports that it is still investigating the matter and is cooperating fully with state authorities.

The particular incident had a positive outcome because, fortunately, no one was injured, and the particular drug involved in the mixup had limited potential to cause harm. It underscores the critical importance, however, of remaining watchful for errors that can occur. In addition to checking to see that the label on the medication bottle matches the prescription, patients should also confirm that the medication itself matches the description. Many prescription bottles include a physical description of the medication itself, identifying the shape and color of the medication and stating whether it is in tablet, capsule, or another form. Not all pharmacies include this information on the bottle itself, but all prescriptions should include an insert with comprehensive information about the drug, including a physical description. This is a patient’s last line of defense against potential pharmacy errors.

Children’s Shelter Staff Prone to Medication Errors, Says Grand Jury

February 22, 2012 | Lebowitz & Mzhen

A grand jury in Kern County, California recently asked an emergency juvenile shelter to report on how its staff handles prescription and over-the-counter medications for children that are sheltered there. It also called on the county’s Department of Human Services to make a registered nurse available at the shelter 24 hours a day. The grand jury’s actions came after news of medication errors appeared, along with allegations that the shelter is violating state regulations by having staff members provide medications to children without oversight by medical professionals. The dispute has also sparked a debate over semantic issues of who may “dispense” medications.

The A. Miriam Jamison Children’s Center is a 24-hour emergency shelter for “abused, neglected and exploited children” operated by the Kern County Department of Human Services. It provides temporary shelter for children in the protective custody of law enforcement or social services. Over the past year, news of several errors in providing medications to children at the shelter reached the director of the Department of Human Services. Errors have included incorrect doses of medications and incorrect medications. No serious injuries have been reported, but the risk of injury is certainly present. Children have had to go to Kern Medical Center (KMC) because of medication errors at least twice.

After officials put an employee on administrative leave for a medication error, some shelter employees began to refuse to handle medications for children. The Service Employees’ International Union (SEIU) also stepped in, arguing that employees who were not registered nurses could not legally give medications to children under state nursing regulations. Additionally, the shelter reportedly has an agreement with KMC, which sends nurses to the shelter for children’s medical issues, that shelter employees will not deal with children’s medications.

The grand jury’s investigation centers around state regulations and the shelter’s agreement with KMC, but it has also sparked a debate over exactly what activities by shelter staff are prohibited. State law says that only registered nurses may “dispense” or “administer” medications. Pharmacists “dispense” medications by counting and packing pills. Nurses “administer” medications by giving doses directly to patients. The Department of Human Services argues that shelter employees do not do either of these, but rather “deliver” medications to children by taking them from a labeled container, following the container’s directions, and giving them to the children to take.

Jury Awards $12.6 Million to Teenager Who Lost Her Limbs Due to Vaccination Error

January 26, 2012 | Lebowitz & Mzhen

A jury in Miami awarded $12.6 million to Shaniah Rolle, a teenager who had to have all four limbs amputated because of a vaccination error thirteen years ago. After a five-week trial, the jury deliberated for three days before reaching a verdict. Rolle will not recover the full amount of the award, however, as the jury also found that her mother was forty percent negligent in the events that led to Rolle’s injuries. The defendant, the University of Miami’s Miller School of Medicine, will probably appeal the verdict.

As a young child, Rolle suffered from intestinal problems. Doctors concluded that they would have to remove her spleen and other organs. Since the spleen ordinarily protects the body from illness by filtering bacteria and other intruders, she would need medication to guard against infection. Her mother took her to the medical school’s pediatric unit in October 1998 for a checkup. A medical assistant gave Rolle an injection of a vaccine formulated for people without spleens. The assistant did not realize that the vaccine had expired five months earlier.

Because the vaccine failed to provide her protection against certain types of infection, Rolle became extremely ill about eight months later. At another hospital in Miami, doctors learned that she had a bacterial infection through her entire body that led to blood clots in her limbs. All four limbs had developed gangrene and had to be amputated above the joints.

Since then, Rolle has reportedly led a normal life. She attends Miramar High School in Miramar, Florida, and with the help of prosthetic limbs, she is on the school’s cheerleading squad.

Rolle’s mother filed suit against the medical school and the doctors who treated Rolle. Defense attorneys argued that Rolle would have become ill with or without the vaccine. A defense expert testified at the trial that the mother did not give Rolle enough medication to allow her to avoid infection. This was the basis of the jury’s conclusion that the mother was forty percent negligent. This means that the total award will be reduced by the amount of the mother’s negligence, so instead of $12.6 million she can recover around $7.56 million. This could be delayed even further, of course, if the hospital appeals.

Pharmacist Jailed for Fatal Medication Error

November 16, 2011 | Lebowitz & Mzhen

An Ohio pharmacist spent six months in jail for a medication error that led to the death of a two year-old child. Emily Jerry’s parents took her to a Cleveland hospital in February 2006 for the last of a series of cancer treatments. Her doctors ordered an intravenous chemotherapy solution. A pharmacy technician prepared her medication with the incorrect dosage of saline, 23 percent instead of 1 percent, and supervisor Eric Cropp signed off on the technician’s work. The saline amount proved to be lethal. Emily slipped into a coma shortly after the solution was administered, and she died several days later.

Cropp lost his pharmacist license and was charged with involuntary manslaughter for Emily’s death. The pharmacy technician who prepared the solution testified to the Ohio Board of Pharmacy that she told Cropp something was wrong with the mixture, but that he approved it anyway. Evidence presented in the criminal case depicted an overburdened pharmacy and staff, indicating that the pharmacy’s computer system was down the day of Emily’s death and the pharmacy was short-staffed, leading to a backlog of orders. Testimony suggested that the pharmacy had rushed and difficult working conditions. The specific chemotherapy solution for Emily was also evidently requested on an expedited basis. Cropp was found guilty and sentenced to six months in prison in August 2009. The pharmacy tech who actually mixed the solution apparently faced no criminal penalties.

Pharmacy representatives and advocates criticized the verdict and punishment for criminalizing a human error, albeit a tragic one. The Institute for Safe Medication Practices compared the process of investigating and criminally prosecuting a pharmacist to a game of “Whack-A-Mole,” with multiple government entities each swinging at the exposed medical professional. It also claimed that the pharmacist in this case was just one part of a larger, often-dysfunctional process. As a convicted felon, Cropp will never work in a pharmacy again.

While Cropp’s criminal case was ongoing, lawmakers were reviewing the fact that Ohio did not require pharmacy technicians to be licensed by the state. Republican state senator Ted Grendell proposed a bill that became known as “Emily’s Law” in July 2007, requiring a competency test for pharmacy technicians and imposing criminal penalties on both pharmacists and technicians for performing pharmacy work without meeting the new qualifications. Governor Ted Strickland signed the bill into law in January 2009.

Infant Dies of Accidental Antibiotic Overdose in Hospital

November 9, 2011 | Lebowitz & Mzhen

A six-month-old child died in a Brooklyn hospital on October 25, 2011 after receiving an incorrect dosage of intravenous antibiotics. An investigation determined the overdose to be an accident, but the child’s family is reportedly weighing their legal options regarding claims against the hospital. Amaan Ahmmad’s family brought him to the hospital for a fever of around 100 degrees. Hospital records suggest the child was otherwise “alert and responsive.” After an examination, the child reportedly received a diagnosis of clinical pneumonia. No beds were available at the time, so hospital staff hooked Amaan up, while in his stroller, to an IV for the antibiotic Zithromax, known generically as azithromycin. An appropriate dose for an infant is around 80 milligrams, but the nurse setting up the IV reportedly gave him 500 milligrams. This is an appropriate dosage for an adult, not a 17-pound infant.

After receiving the antibiotic, the child immediately fell into a coma. Hospital records indicate that hospital staff did not notice anything wrong for about thirty-six minutes. The child’s mother told the media that she tried to tell hospital staff something was wrong, but they assured her the child was just sleeping. Once they realized the mistake, hospital staff put the child on life support, but it was apparently too late. After less than 24 hours, the child was removed from life support and pronounced dead.

One day after Amaan’s death, the New York City Medical Examiner ruled his death an accident, identifying complications following an adult dose of azithromycin as the cause of death. According to family members of the child, the hospital fired the nurse who administered the lethal dosage of antibiotics. The hospital reportedly expressed condolences to Amaan’s family but declined to comment to the media. The family told reporters that they are considering their legal options. They laid Amaan to rest on October 27.

This Pharmacy Error Injury Lawyer Blog has previously reported on efforts in some Maryland hospitals to catalogue pharmacy errors in the hopes of preventing future catastrophic mistakes. At this time, not enough information is available to determine how the medication error in Brooklyn occurred. The child clearly received an extremely excessive dose of the antibiotic. The error could have occurred in the pharmacy, at the point of administration of the drug, or at any point in between. A combination of errors could have contributed to the tragic outcome, or the negligence of a single hospital worker could prove to be the cause.

The Benefits and Problems of Electronic Medical Records Systems

August 10, 2011 | Lebowitz & Mzhen

In a recent Baltimore County pharmacy misfill injury blog, our attorneys discussed a tragic medical error that caused the death of an premature infant, after a pharmacy technician accidentally entered the wrong information into the computer, causing the intravenous solution prepared buy an automated machine to contain a lethal dose of sodium chloride. This pharmacy error has reportedly brought the issue of electronic medical health records safety concerns back into the forefront of patient safety.

As our attorneys have reported in a related Hartford County medication error injury blog, the medical industry is shifting toward electronic medical records and computerized systems that make medical processes and prescription orders automatic, in an effort to reduce pharmacy error injury or wrongful death.

The Chicago Tribune reports that the federal government is also currently helping the digital shift by giving $23 billion in incentives to healthcare providers who purchase the electronic systems, with the hopes that these medical technologies will help increase access to patients’ medical information, help healthcare providers communicate better with each other, help doctors to see test results more quickly, and implement electronic safeguards to remind doctors about recommended medical practices, or to alert them about harmful drug interactions before prescribing.

With all of the benefits that come with electronic medical records and computerized systems, potential problems are also taking place, like crashing of hospital computers, or software bugs that interfere with important data, or even delete information from computerized records. Computerized systems also reportedly can produce data about patients that is disorganized or difficult to read, especially when a doctor is quickly looking for critical patient information.

Safety of Electronic Medical Records Questioned After Pharmacy Error Leads to Death of Infant

August 3, 2011 | Lebowitz & Mzhen

A recent Chicago Tribune article, that our Baltimore pharmacy misfill injury attorneys have been following, looks closely at electronic medical record safety, after a tragic medication error occurred, stemming from a computer mistake made at the Chicago-area Advocate Lutheran General Hospital, that caused the death of a newborn infant.

According to the article, Genesis Burkett, an infant born 16-weeks premature, was given a fatal overdose of sodium chloride last year, receiving over 60 times the dosage ordered by the physician. The hospital pharmacy error was reportedly made after a technician from the hospital pharmacy misread and inaccurately typed the doctor’s handwritten prescription orders into a hospital computer—a common source of pharmacy misfills and errors, as attorneys have discussed recently in a Baltimore pharmacy error injury blog.

The data entry mistake then caused a pharmacy misfill, as the automated machine prepared an intravenous solution containing a lethal overdose of sodium chloride that caused the infant’s heart to stop. Advocate Health Care’s chief medical officer, Dr. Lee Sacks stated that the pharmacy error could have been prevented by the automated alerts on the IV compounding machine, but at the time that the customized bag was prepared for the infant, the alerts were not activated and connected to the main pharmacy information systems at the hospital. The family’s attorney reportedly blamed the pharmacy error and wrongful death on a mislabeled IV bag.

After the medication error led to the infant’s tragic death, Advocate has since added electronic alerts to the IV compounders and initiated other medication safety measures to prevent this kind of pharmacy error from happening in the future.

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.

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.