Pharmacy Error Injury Lawyer Blog

Recent FDA Warning Regarding Autoinjector Devices and Compatibility with Multiple Sclerosis Treatment Drug Product

August 31, 2022 | Lebowitz & Mzhen

In an ever-changing scientific field, as new information and knowledge are gained each day, there may be important updates regarding your medications. For this reason, it is important to stay in touch with your healthcare providers about possible changes. In August 2022, the Food and Drug Administration (FDA) issued a warning to patients, caregivers, and health care professionals regarding autoinjector devices and their compatibility for use across FDA-approved glatiramer acetate injection drug products. Glatiramer acetate injection is used to treat relapsing forms of multiple sclerosis. There are three FDA-approved glatiramer acetate injection drug products on the market currently. These drug products are all available in a single-dose prefilled syringe with an attached needle, and patients can inject glatiramer acetate using only the syringe or by inserting the syringe into an autoinjector. Autoinjectors are medical devices designed to support patient self-injection of medication.

The FDA announcement lays out the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optimal for its use. According to the announcement, the drug product titled “Copaxone”, manufactured by Teva Pharmaceuticals is compatible with Autoject 2. The drug product titled “Glatopa”, manufactured by Sandoz, is compatible with the Glatopaject autoinjector device. Finally, the drug product titled “Glatiramer Acetate Injection”, manufactured by Viatris/Mylan, is compatible with WhisperJECT autoinjector device. The FDA has requested that the manufacturers update their labeling to instruct users to confirm that the autoinjector is compatible before using it to inject glatiramer acetate. Overall, patients, caregivers, and health care professionals should be sure to confirm that their autoinjector is compatible, and manufacturers should update their labeling to advise patients as such. Failure to do so can and has resulted in missed and partial doses.

What Happens if Drug Manufacturers Fail to Properly Label?

Drug manufacturers have the responsibility of following the regulations placed on medications by the FDA. The FDA requires that drugs go through testing before they are FDA approved, and manufacturers must comply with medication labeling regulations. Because there are various regulations and laws that may be applicable depending on the jurisdiction, the type of drug, whether the drug is brand-name or generic, etc – it is important to connect with an experienced attorney who can help you navigate your case. If you have suffered injuries as a result of negligent drug manufacturing companies, connect with a lawyer today to discuss the details of your case.

Hospital Safety Grades Equip Patients With Knowledge About Local Facilities

August 14, 2022 | Lebowitz & Mzhen

Having to visit a medical center can be nerve-wracking because there may be a lot of unknowns, including what kind of quality of care you will be provided. Whether a hospital has had multiple pharmacy errors or other dangerous incidents at the hospital can be particularly important for patients and potential future patients to know.

According to a recent news article, a medical center in California faced the risk of losing its Medicare funding after state inspectors uncovered multiple dangerous incidents regarding proper drug distribution. In one incident, an 88-year-old woman was hospitalized for chest pain, and instead of receiving medication for her symptoms, she was mistakenly given two doses of a chemotherapy drug used to treat breast cancer, a condition that family members say she didn’t have. According to the patient’s daughter, a nurse dismissed the daughter’s concern that after being admitted to the medical center, at one point, she could not understand her mother over the phone and thus told the nurse that it sounded as if her mother had suffered from a stroke. Because of this growing concern, the patient’s daughter called the nurse the next day and requested the list of medications that had been prescribed for her mother. The woman died less than a month after being admitted to the medical center. In a confidential report, the state’s public health inspectors stated that the medication error “could potentially cause harm or serious adverse drug reactions to the hospital’s patients.”

In addition, in another incident at the same hospital, a patient with dementia and a history of falls attempted to walk unassisted in his room and tripped over a device. As a result, the patient suffered a fractured hip and was found on the floor by a nurse. According to the article, an alarm designed to prevent such falls by alerting staff when a patient leaves a bed had not been turned on. Doctors decided not to repair the patient’s help because of their belief that the surgery was unlikely to improve his quality of life, and that patient was placed on comfort care and died 7 days after the accident.

Improper Prescriptions and Optimization of Medications

July 31, 2022 | Lebowitz & Mzhen

Medication is by far the most common method for the treatment of diseases, with between 75% to 80% of physician office and hospital outpatient clinic visits involving medication therapy. Annually, about 275,000 people die each year, and roughly $528 billion in medicine is wasted due to poorly managed medications. Doctors, pharmacists, and other health care professionals have a responsibility to protect patients and ensure that every prescription is safe, effective, and appropriate for each patient. A recent article in the Pharmacy Times, authored by the executive director of The Get the Medications Right Institute, highlights some of the major barriers to appropriate prescriptions. Issues range from a lack of transparency to inadequate commitment to team-based care and benefit plan design integration by care providers. These problems can compound, ultimately resulting in dangerous results for patients.

According to the article, one of the consistent themes when it comes to the failure of medical professionals to optimize medications or prescribe the proper medicine is the current siloed approach to treatment. With different treatment providers unable or unwilling to communicate with each other in the current health care environment, cost-saving and comprehensive care are significantly more difficult to achieve.

What Are Steps to Prevent Improper Prescriptions?

The piece outlines five straightforward questions that health care providers, patients, and pharmacists can utilize to prevent improper prescriptions and optimize the impact of medication when it comes to health care. Briefly stated, the steps are to ensure the correct medication, allow patients to ask questions, ensure the proper dose, provide patients with a timeline for taking the medication and explain how patients will know the medication is working.

Pharmacy Errors and Covid-19 Antiviral Drugs

July 10, 2022 | Lebowitz & Mzhen

As the medical industry progresses and new treatments are developed to address novel health concerns, pharmacists and pharmacy employees have a responsibility to keep up to date on the safe practices for dispensing the medications that have been prescribed. With the advent of new antiviral treatments for Covid-19 infection, pharmacy errors have unfortunately occurred. The Institute for Safe Medication Practices, a professional organization for the pharmaceutical industry, recently released a report on the misadministration of an antiviral cocktail that had been effective at battling Covid-19 infection.

According to the industry journal, the antiviral medication cocktail marketed as Paxlovid has shown promise at treating Covid-19 infection, however dispensing mistakes have been noticed at pharmacies nationwide. The largest single issue with the administration of the drug appears when it is being administered to patients with kidney disease. If a patient exhibited moderate kidney disease and was prescribed the drug, a pharmacist was supposed to remove some of the pills from the blister pack to avoid damaging the patient’s kidneys, however, this was not always done. Patients with severe kidney disease should not have been prescribed the drug at all.

What Are the Common Causes of Prescription Errors?

A mixture of poor package design, unclear instructions, and pharmacist negligence has resulted in patients receiving the wrong dosage of the medication, potentially causing harm. According to the report, some patients received their prescription with the wrong pills removed, while others were prescribed the medication while suffering from advanced kidney disease, putting them at serious risk. Although the article does not mention any serious negative patient outcomes as a result of these errors, mistakes like these can be fatal in some instances. When dispensing a new medication that a patient has not taken before, a pharmacy employee has a responsibility to confirm that the patient understands the correct dosage and method of administration before sending them home with a bottle of pills.

Preventable Maryland Pharmacy Errors in Vaccine Administration

July 5, 2022 | Lebowitz & Mzhen

Following the Centers for Disease Control (“CDC”) endorsement of the Advisory Committee on Immunization Practices (“ACIP”) recommendation that children six months through 5 years should receive a COVID-19 vaccine, many people are flocking to their doctors and local pharmacies to obtain the vaccine. However, this news comes amid a significant pharmacy worker shortage. As such, in an attempt to avoid a Maryland pharmacy error lawsuit, many chains are reconsidering whether they will provide COVID-19 vaccinations to children under the age of 5.

For instance, recent news outlets reported that Publix would not offer coronavirus vaccines to children under 5 “at this time.” A spokesperson for the chain grocery and pharmacy store declined to elaborate on their decision; however, the website indicates that the store is continuing to accept appointments for children five and older.

Despite some retailers and pharmacies’ reluctance to vaccinate young children, many pharmacies can do so safely and effectively. However, given the current supply chain issues and worker shortages, pharmacies must take steps to prevent errors. When a pharmacy fails to do so, it may be liable for any ensuing damages or injuries.

Recent Pharmacy Error Case Highlights Malice as an Essential Element in Punitive Damages Claim

June 20, 2022 | Lebowitz & Mzhen

Prescription and pharmacy errors can have devastating consequences for patients and can leave the families of loved ones left seeking compensation and punitive measures to ensure that others do not experience similar harms. A recently published news report discusses the decision by a Midwest court to deny an award of punitive damages. This case involved a labeling error and the failure to correct the error by multiple pharmacists, which resulted in the death of a patient.

According to the facts discussed in the recently published news report, a patient’s death resulted in the family suing the pharmacy for both compensatory and punitive damages. A cardiologist issued a prescription of amiodarone for a male patient who suffered from chronic ischemic heart disease and atrial fibrillation. The pharmacist responsible for initially dispensing the medication made an error by failing to completely and accurately record the medication use directions on the container label. The pharmacist’s labeling error led to the patient being instructed to take a higher daily dosage than the cardiologist intended. A second pharmacist and a third pharmacist did not catch the error when the patient returned multiple times for additional supplies of the medication. The patient’s health deteriorated and he eventually passed away.

The family sued, seeking compensatory damages and punitive damages. Compensatory damages seek to compensate a party for their expenses and the loss suffered. A liability insurance policy can cover the amount awarded as compensatory damages. The pharmacy chain in this case had liability insurance. Punitive damages, on the other hand, involve the jury awarding an amount as punishment, and in this case, as punishment specifically for the chain’s pharmacists’ failure to act in a manner that would have prevented death. Punitive damages cannot be covered by the insurance policy.

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.

Helping Maryland Medical Providers Avoid Pharmacy Errors

May 10, 2022 | Lebowitz & Mzhen

Anyone who takes prescription medication on a regular basis understands the importance of consistency and accuracy. Whether you pick up one or several medications on a regular basis at the pharmacy, every patient deserves to have peace of mind when they receive their prescription. After all, if a medication error were to take place, the consequences could result in injury, or in extreme cases, even death.

Improper dispensing of medications is more common than you may think—in fact, one in five Americans has experienced a medical error while receiving health care. The issue was given even greater attention more than four years ago, when a nurse typed two letters into a hospital’s computerized medication cabinet, selected the wrong drug from the results, and then administered a fatal dose to a patient. Because most hospital systems or pharmacies have computerized medicine cabinets, such technological vulnerability is not uncommon—and Maryland is no exception.

How can medication and pharmacy errors be prevented?

According to a recent news report, pharmaceutical safety experts are recommending a new method for medical practitioners to avoid pharmacy errors. With a new software update that requires drug names to be searched with five letters rather than three, experts are hoping that the fix will rectify issues surrounding withdrawing the incorrect drugs. Currently, most computerized medicine cabinet software programs require practitioners to type only three letters to search up a drug. For example, when a nurse types “M-E-T,” the search results could bring up anything from metronidazole to metformin. One of these drugs is an antibiotic—the other is for diabetes. Administering the wrong drug could yield disastrous results.

Spike in Pharmacy Error Claims Downplayed by Lax Reporting Requirements

May 3, 2022 | Lebowitz & Mzhen

A common theme of the last two years has been the burnout suffered by pharmacy employees, and the increase in patient risk that results from the lack of skilled, motivated, and healthy pharmacy staff. Although some symptoms of burnout, such as increased overtime, lack of retention, and mental health issues among employees are easily measurable, the actual number of error claims may not always be. A recently published investigative report demonstrates that a large increase in pharmacy error claims in the last two years has been obscured by lenient reporting requirements that keep such claims out of the public view. The pattern appears to apply nationwide.

According to the investigative report, several public records requests were used to discover that a large increase in pharmacy error claims corresponded with the labor issues related to the pandemic. The correlation serves as further evidence that the pharmacy industry is unable or unwilling to meet the industry standard of care that patients are entitled to and have come to expect. Pharmacies have little incentive to report instances of error when they are not required to, as public dissemination of such information may hurt the pharmacy’s bottom line. A pharmacy is a business after all.

Patients who are victims of pharmacy error and are hurt or killed as a result may have a significant claim for damages against the pharmacy or employees. Pharmacies are accountable for the conduct and mistakes of their employees, and if they are unable to safely staff their businesses, then they should not be operating under dangerous conditions. While the solutions to this problem may vary, the most important matter is that patient health and safety must come first. Maybe pharmacies need to pay more, maybe they need better training, maybe they need more safeguards, or maybe they need to temporarily close until the adequate standards can be met. Regardless of this, patients can expect adequate care and take legal action in the event of an error or 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.