Pharmacy Errors in the News

FDA Warns of Compounding and Dosing Errors with Injectable Semaglutide Products

October 30, 2024 | Lebowitz & Mzhen

The United States has become increasingly heavier over the past half century — overall obesity rates have increased three-fold since the 1960s. Currently, more than two-thirds of U.S. residents are now, by definition, overweight with those individuals qualifying as obese making up more than 40 percent of the population. Even more disturbing is the fact that one in ten individuals meet the medical criteria for a person who is morbidly obese, which can be a life-threatening condition if not counteracted by a change of diet and exercise.

Sadly, this increase in national obesity hasn’t happened overnight; in fact, it’s been a gradual and relentless process that has seen the number of overweight individuals in this country tripling over the past 60 years. Furthermore, the incidence of severe (morbid) obesity has increased ten-fold since the 1960s, and shockingly the figures may actually be an underestimation of this nationwide problem. Here in Maryland, the obesity rate is slightly below the national average at 34.3 percent as of 2021, but that is hardly any consolation.

With such a large number of overweight individuals in the U.S., dieting and nutritional advice has become big business over the past several decades. So many people, hoping to shed excessive weight quickly and with less effort, have fueled an entire industry of weight loss programs, supplements and prescription drugs. Enter Semaglutide, an FDA-approved pharmaceutical marketed by Novo Nordisk under several different brand names, which is being used to help patients with Type 2 diabetes and chronic obesity. This latest answer to the country’s obesity epidemic has shown great promise since its introduction several years ago, but as with many medications there are potential pitfalls and dangers facing those who take advantage of this breakthrough drug.

Pharmacy Compounding Errors and Legal Accountability in Maryland

September 30, 2024 | Lebowitz & Mzhen

Pharmacies play a critical role in ensuring patients receive the correct medications. When a pharmacy fails in its duties, particularly with compounded medications, the results can be disastrous, as seen in a recent case where children were hospitalized after receiving incorrectly compounded prescriptions. Pharmacy errors, like improper compounding, can lead to severe consequences. Under Maryland law, pharmacies must adhere to stringent regulations to ensure patient safety. Understanding these regulations and what happens when they are violated is essential for those affected by such mistakes.

Maryland Regulations for Pharmacy Compounding

In Maryland, pharmacies that engage in compounding must comply with state and federal laws designed to protect patients. Compounding is not as simple as filling a prescription—it requires creating custom medication by combining ingredients based on a patient’s needs. This process requires precision and oversight, and pharmacists are legally obligated to ensure that the medications they prepare are accurate, safe, and adequately documented.

Pursuing Damages for Maryland Improper Labeling Injuries

September 24, 2023 | Lebowitz & Mzhen

When a doctor prescribes a medication to treat a health condition, patients will often make the effort to use the medication as prescribed. Patients rely on medications to treat their symptoms, and they trust that taking the proper dosage will improve their health. However, when pharmaceutical companies mislabels a medication, they place patients’ health at risk without their knowledge. A patient could follow the instructions on a label perfectly and still suffer injuries due to a mislabeled dosage. In fact, a recent nationwide recall occurred when a pharmaceutical corporation improperly labeled the dosage of each tablet in a medication box.

Recently, a news article reported that Marlex Pharmaceuticals has recalled two improperly labeled lots of medication. The pharmaceutical corporation incorrectly labeled boxes of Digoxin containing 0.25mg tablets as 0.125mg, and incorrectly labeled 0.125mg tablets as containing 0.25mg each. According to the Food and Drug Administration, the mislabeled drugs could cause overdosing or underdosing in patients who believed they were taking the correct dose. Overdosing on Digoxin can lead to significant drug toxicity, including dizziness, memory loss, and fainting. Underdosing can potentially worsen a patient’s heart failure, which Digoxin typically treats.

What Legal Claims Can You Bring After Maryland Drug Mislabeling?

If you have suffered injuries from an improperly labeled drug, your legal claim for damages will likely depend on the cause of the injury. Many lawsuits over mislabeled drugs allege that the label failed to warn the plaintiff of the medication’s potential risks. The manufacturer will often argue that their label adequately warned consumers. However, the plaintiff may be able to argue that the warning label was somehow deficient. For example, a manufacturer may fail to fully warn consumers about the severity or frequency of potential side effects. That is, an incomplete warning can also be a failure to warn.

Woman Given Adderall Instead of Oxycodone Due to Pharmacy Error

July 30, 2023 | Lebowitz & Mzhen

According to reports, the U.S. Food and Drug Administration (FDA) receives approximately 100,000 medication error reports annually. In 2010, the FDA received only 16,689, but by 2018, the agency was receiving more than 100,000 reports per year. Experts point out that medication error reports are submitted on a voluntary basis, meaning that true medication errors are likely even higher.

Are Pharmacy Errors Underreported?

Dr. Randall Tackett, a clinical and administrative pharmacy professor at the University of Georgia College of Pharmacy states “What’s reported to the FDA usually only accounts for 1 to 10 percent of what actually occurs.” Dr. Tackett went on to theorize that most medication errors result from the extreme workload that pharmacists are faced with. In an effort to combat this issue, some states have implemented prescription shift limits for pharmacists, limiting them to filling 150 prescriptions per shift. A recent news report describes a pharmacy error.

The Cost of Medication Errors

Using Digital Solutions to Prevent Medication Error

January 21, 2023 | Lebowitz & Mzhen

Medication error has been a leading cause of harm for patients, and an expensive cost for healthcare providers. In a digital age, some healthcare providers have implemented digital solutions to medication errors, but these digital solutions can cause doctors to receive too many alerts that lack specificity and that also cause alert fatigue for doctors. However, when science and technology combine to create a unified and efficient approach for drug administration and managing clinical decisions, it can be life-altering. A Healthcare IT News article details the importance of hospitals integrating precision medicine with digital maturity models. The digital maturity models can help technology advances that support clinical decisions. This can help prevent errors and increase efficiency, which thus can save lives and costs for hospitals. Giving users access to a single information source in a unified approach can help with drug administration and minimize alerts.

What Is a Digital Maturity Model?

Some examples of digital maturity models include from Wolters Kluwer, which built Medi-Span Clinical APIs drug data solution and expert services which helps ensure that accurate information is available at key moments rather than reported after the event, and also ensures the precision of alerts. Another example is the National Chen Kung University Hospital in Taiwan, which has used Medi-Span Clinical APIs to overcome challenges faced by pharmacists, including the challenge of the amount of time it takes to update a medication database. Medi-Span’s databases are updated regularly with best practice evidence and recommendations. Clinical APIs are for healthcare professionals only, and there are certain regulations that guide their use in various locations.

The hospital’s data shows that since implementing Medi-Span, the number of alerts has been reduced by 21% and the talerts have captured severe potential Adverse Drug Events. This resulted in saving approximately $39,200 in U.S. dollars a year, and also saved an estimated 266 bed days a year. Technology advances can allow for solutions that help prevent medication errors and help ensure that patients receive the best and safest care possible. When these errors occur but can be avoided by digital maturity, it is up to hospitals to implement unified approaches to avoid such costs.

Errors that Occur During Administration of Medication via Enteral Feeding Tubes

December 11, 2022 | Lebowitz & Mzhen

Feeding tubes can be an essential tool used to administer medicine to patients who need it. People who have difficulty swallowing or difficulty feeding may need enteral feeding tubes. Although an essential tool, more must be done to prevent errors that occur when preparing and administering medications via enteral feeding tubes. Enteral feeding tubes allow liquid food to enter the stomach or intestine through a tube. Enteral feeding tube errors occur for a variety of reasons, including gaps in training, incorrect tube or route size, improper preparation, and utilization of the wrong administration technique.

What Are the Causes of Feeding Tube Mistakes?

In some instances, practitioners have not received the proper training associated with prescribing, verifying, prepping, and administering specific medications through feeding tubes. Knowledge may be passed down from practitioners, but there may lack a standard policy for doing so to ensure that there are no gaps in knowledge. Additionally, there are errors that occur if a prescriber selects an incorrect route, such as selecting the oral route of administration for a patient who actually requires medication via an enteral feeding tube. Improper preparation can result in adverse reactions for the patient and the practitioner. In these scenarios, if a practitioner fails to use proper personal protective equipment (PPE) and crushes a hazardous medication, this can result in toxicity or reduced efficacy of the medication. Additionally, error also occurs if the wrong administration technique is used. This includes mixing multiple medications together to give to a patient at once, failing to flush the tube before and after medication administration, and mixing medications with enteral feedings.

In order to prevent these errors, practitioners should screen for enteral feeding tube restrictions, create policies that are located in a central location for reference, and should ensure that practitioners are properly educated on how to safely prepare and administer medication. In addition, because patients will often follow the same procedure to prepare and administer medications at home, it is important to educate patients about safe practices. If you have reason to suspect that a loved one has suffered injuries due to error that occurred during the administration of medication via an enteral feeding tube, contact an experienced and skilled medical malpractice attorney today to discuss your options.

Tennessee Nurse Sentenced to Probation for Homicide Related to Medication Error

May 31, 2022 | Lebowitz & Mzhen

The nursing community has been on edge awaiting the sentencing of Radonda Vaught, a former Tennessee nurse who was recently convicted of negligent homicide for her role in the death of a patient she was treating at a nursing home. Criminal prosecutions for medication errors are rare, and generally reserved for situations where the conduct of the defendant was grossly negligent, egregious, and preventable. A national news source recently published an article discussing the sentence that the former nurse Ms. Vaught was given, as well as the case as a whole and the effect that Vaught’s prosecution may have on the nursing home industry.

According to the facts discussed in the news report, Ms. Vaught was convicted of negligent homicide in March of 2022 based on the death of a patient she was caring for in 2017 at a nursing home. The jury found beyond a reasonable doubt that Ms. Vaught was criminally negligent when she inadvertently gave her patient a tranquilizer instead of an anti-anxiety medication (the medications had similar sounding names). The dose of the tranquilizer that was given by Ms. Vaught to her patient was unsafe, and ultimately resulted in the patient’s death. The prosecution argued that serious criminal penalties were warranted because several warning signs were ignored, and Ms. Vaught overrode an automated medication dispensing system that would have prevented the mix-up.

After considering arguments from both sides, as well as testimony from the widower and children of the deceased patient, the judge decided to sentence Ms. Vaught to three years of probation in lieu of prison time. Although Ms. Vaught will avoid prison, she has already faced serious consequences for her mistake, as her nursing license was recently revoked based upon the incident. The article noted that the children of the deceased patient testified that their mother was a very forgiving person, and would not want Ms. Vaught to serve prison time for her mistake.

Pharmacy Staff Burnout is Dangerous to Patient Health

April 17, 2022 | Lebowitz & Mzhen

Economic factors have combined with the Covid-19 pandemic to make employment shortages in Maryland and Virginia a reality in many industries today. The medical industry is likely the most affected industry by these staffing issues, as the pandemic-related risks and responsibilities have made jobs in the medical field less desirable. Pharmacists and other pharmacy employees have been suffering from increased symptoms of burnout, as the stress and responsibility of a job in a pharmacy can be too much to handle in these times.

A recently-published article in a national pharmacy trade journal discusses the effects that staff burnout and understaffing have had on the industry, as well as the risks to patient health that will be assumed if nothing is done to address the shortages soon. According to the article, pharmacies were facing staffing issues even before the pandemic hit, and the effects of the pandemic and the broader economy have exacerbated the problems, with dangerous results. Throughout the Covid-19 pandemic, pharmacies have been a primary site for testing people for the virus. The surge in demand for pharmacists and pharmacy technicians was never quite met, and pharmacists have had a difficult time staffing their locations adequately.

With pharmacies understaffed, and remaining staff facing increased stress, hours, and workload; it is the patients who ultimately suffer. Overworked pharmaceutical assistants and technicians have been unable to spend enough time with the pharmacy customers to address their concerns with medication and screen for possible mistakes. As time moves forward and the staffing shortages continue, it is becoming even more difficult to retain employees, as many are leaving the industry entirely to seek out better opportunities.

Pharmacies May Be Held Liable in Future Maryland Pharmacy Injury Suits

November 30, 2021 | Lebowitz & Mzhen

During the course of the COVID-19 pandemic, the importance of quality medical personnel and staff was amplified more than ever.

Pharmacies, doctor’s offices, and hospitals, however, were incredibly busy places even before the pandemic, where medical professionals are often overworked and frequently understaffed. Because overwhelming demand and limited supply can create longer hours and higher pressure working environments for our medical professionals, mistakes often happen. Most commonly, mistakes take place when administering or prescribing medication to patients, which can have deadly consequences.

According to a recent news report, a federal jury found three of the country’s largest pharmacy chains liable for contributing to the opioid crisis in two counties. The verdict was the first time that the retail arm of the drug industry has ever been held accountable in what is now a decades-long opioid epidemic. In this case, the plaintiffs argued that major retailers CVS, Walgreens, and Walmart had turned a blind eye to suspicious opioid orders for years. At both local pharmacies and corporate headquarters, the plaintiffs argued, oversight requirements in all three major retailers failed to take red flags into account, which led to the pharmaceutical companies contributing to the creation and sustained nature of the opioid public health crisis.

Unprecedented Levels of Burnout in Pharmacies May Affect Maryland Patient Safety

October 24, 2021 | Lebowitz & Mzhen

Pharmacy staff members are reporting unprecedented levels of burnout across the country, according to one recent article. In the article, leaders in the pharmacy field explain the negative effects that burnout can have on patient safety—an impact that may be felt among Maryland pharmacy patients who may suffer from Maryland pharmacy errors. Burnout is characterized by emotional exhaustion, a low sense of personal accomplishment, cynicism, and depersonalization. It can happen in any profession, but in the pharmacy field, where it can affect pharmacists and other staff, its effect can result in increased medication errors. A 2018 study found that 53 percent of the health system pharmacists reported a high degree of burnout. One chief pharmacy office reported that record-high hospital volumes and pharmacy technician shortages have been challenges for the field. Another noted that studies have shown that burnout is linked to medical error and medication errors.

Victims of Maryland pharmacy errors can file a claim against the pharmacy or other people or entities responsible for the error. Individuals who may be liable for the error include the doctor who ordered the medication, the pharmacy technician who dispensed the medication, and the pharmacist who provided the medication. Entities may also be liable including pharmacies, healthcare groups, and hospitals. Someone who has been injured because of a medical error has to show that the defendant acted or failed to act in some way that caused the plaintiff harm. A plaintiff has to prove that it is more likely than not that the harm the plaintiff suffered was caused by the defendant’s conduct. This means that a plaintiff must prove both that the defendant’s wrongful conduct was the actual cause of the plaintiff’s harm and also that the harm that occurred was sufficiently foreseeable so that the defendant should be held liable for its wrongful conduct.

How Long Do You Have to File a Maryland Medication Error Lawsuit?

Maryland medication error lawsuits generally have to be filed within three years of the victim’s injury, though there are exceptions in some cases. Consulting with an attorney as soon after the injury is advisable though, as evidence can disappear with time and many cases require a lot of investigation prior to filing the claim—such as finding out who the proper defendants are and gathering evidence of fault and of damages. Patients who file successful medication error claims may be able to recover financial compensation for damages. Compensation for damages may include past and future medical treatment, lost wages, psychological suffering, pain, and more.