Patient Safety

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.

When States Step In: Pharmacies Sanctioned by Board of Pharmacies for Prescription Errors

April 26, 2023 | Lebowitz & Mzhen

A recent news report details just how troublesome prescription errors by pharmacies can be, resulting in sanctions. In the state of Iowa, state regulators recently penalized a drugstore accused of destroying relevant paperwork after dispensing the incorrect medication to a customer. According to the Iowa Board of Pharmacy, in 2020 the Walgreen store dispensed the incorrect strength of insulin pens and the incorrect test strips to a patient. During an investigation the Walgreens was unable to provide some of the original documentation related to the prescription. It was determined that the prescription records had been destroyed, which is in violation of Iowa regulations. As a result, the Board of Pharmacy issued a warning and imposed a $1,500 civil penalty, in addition to requiring the store to provide two hours of educational training on patient safety to all permanent pharmacists and technicians on staff. In addition to the one Walgreens being sanctioned, at least one other pharmacy in Iowa was sanctioned for dispensing a prescription with incorrect directions which led to a customer taking a higher dosage than was prescribed. In one case, a pharmacist’s license was placed on probation after a criminal conviction.

How Does Maryland Protect Pharmacy Patients?

Pharmacy boards are administrative agencies created by state governments “to protect the health, welfare, and safety of the public through the regulation of pharmacy practice.” In large part, these entities are responsible for preventing pharmacy errors. State pharmacy boards have taken important steps to regulate and discipline pharmacies and drug laws. For example, in the state of Maryland, the Maryland Board of Pharmacy has a mission of “protect[ing] Maryland consumers and to promote quality healthcare in the field of pharmacy through licensing pharmacists and registering pharmacy technicians, issuing permits to pharmacies and distributors, setting pharmacy practice standards and through developing and enforcing regulations and legislation, resolving complaints, and educating the public.” Guidance by the Office of Inspector General in the United States Department of Health and Human Services outlines that state pharmacy boards should review the outcomes of their disciplinary process and evaluate whether they are affording the public the maximum protection.

While state pharmacy boards play an important role in regulating and disciplining pharmacies and helping protect patients, in some prescription error incidents, victims or the loved ones of victims may consider filing a lawsuit to recover damages. These suits can be complex as you navigate the laws and court system, but connecting with an experienced attorney who can help you navigate your case can be beneficial.

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.

New Best Practices Released for Ensuring Medication Safety

September 29, 2022 | Lebowitz & Mzhen

People that regularly take prescription medicine or have received prescription medication in a hospital or clinic setting can appreciate the vital importance of best practices when it comes to receiving medicine. Whether it is at the pharmacy or in the hospital, it is essential to be aware of safety measures that could make a major difference in the care you receive. Every patient deserves peace of mind when it comes to their medications, and to live free of the consequences of medical and pharmaceutical malpractice.

How Common Are Medication Mistakes?

Incorrect or erroneous distribution or application of medications is surprisingly present in the United States. In fact, some sources cite a rate of one in five Americans experiencing a medical error while receiving health treatment. Unfortunately, Maryland is no exception to this trend, and Maryland residents should be aware of emerging best practices in the face of the increased computerization of pharmacies and hospital medication cabinets.

Emerging Best Practices to Reduce Harm

Employee Shortage May Result in More Maryland Pharmacy Errors

December 31, 2021 | Lebowitz & Mzhen

COVID-19 has made an indelible impact on almost every aspect of a person’s life, and while there is hope on the horizon, the effects continue to reverberate. One significant impact is the ongoing staff and supply shortages at many pharmacies. Pharmaceutical shortages can be deadly to some consumers, but employee shortages can also result in Maryland pharmacy errors. A recent piece from NBC highlighted how these shortages impact the health of those throughout the country.

Pharmacy technicians primarily work in retail pharmacies and hospital pharmacies. Pharmacies are reporting that many of their technicians are leaving in droves because of the increasing demand. The majority of the workers behind a pharmacy counter are pharmacy technicians. These positions are often low-wage and do not require an advanced degree. Technicians are responsible for counting pills, filling prescriptions, and checking inventory. All of these duties are fundamentally important to ensuring consumer safety.

Although many understand that working in a pharmacy is inherently fast-paced, many technicians argue that the wage has not kept up with the workload. Most importantly, workers explained that the demands led to safety issues for consumers. Workers expressed that the stresses and influx of work made them far more likely to make mistakes or catch errors. These errors can have life-threatening and deadly consequences for those who rely on pharmacists and technicians for their medication.

Understaffing at Pharmacies May Affect Maryland Patients

November 11, 2021 | Lebowitz & Mzhen

When customers pick up medicine at the pharmacy, they should have a reasonable expectation that the pharmacists dispensing your prescription are well trained, proactive, and detail-oriented so that your medication is filled properly and correctly. What happens, however, when pharmacies are unable to provide patients with the high-quality care they deserve and wrong medications or doses put patients at risk for injury or death?

According to a recent news report, understaffing at various pharmacies has placed various patients at risk and has raised concerns about patient safety. After a pharmacist at a particular pharmacy gave a patient a hundred extra doses of a powerful prescription opioid and gave another patient an antibiotic that landed them in the hospital because of a known allergic reaction, there has been increased scrutiny on chronic understaffing and unsustainable workloads prevalent in pharmacies. One pharmacy chain, in particular, received a $427,000 fine after an investigation found that basic protocols were not being followed.

Because pharmacies, especially those that operate at high volume locations, are responsible for filling anywhere between 500 to 1,000 prescriptions a day, can receive upwards of ten phone calls at a time, and operate drive-thrus and in-store services such as medication counseling and flu vaccines, many pharmacists and technicians report being overworked and under-supported, leading to mistakes.

Lack of Medication Instructions Presents Serious Risks for Maryland Patients

September 16, 2021 | Lebowitz & Mzhen

Medications not only have to be safe but also must contain sufficient warnings and instructions so that patients will know how to use them safely. A medication’s lack of clear instructions and warnings puts patients at risk. A plaintiff may bring a Maryland pharmacy claim against a drug manufacturer for failing to warn of the dangers of taking a medication.

Do Drug Manufacturers Need to Put Warnings on Dangerous Drugs?

Unless a danger is obvious and widely known, a medication must provide adequate warnings concerning the medication’s risks, such as known side effects. Warnings must also be clear and easy to understand. The medication also must include adequate instructions on how to take the medication safely. Courts will consider the knowledge and expertise of the average consumer that uses the medication. If a medication’s instructions are not clear enough or do not contain sufficient information so that consumers will know how to safely use the medication, the instructions are not sufficient, and the manufacturer may be liable for injuries that occur as a result.

Changing the Health Care System to Prevent Maryland Medication Errors

August 31, 2021 | Lebowitz & Mzhen

Medication errors are an unfortunate yet avoidable part of the healthcare system in the United States. While technology, training, and oversight aimed at reducing medication errors have improved over the years, these instances continue to occur. According to the Academy of Managed Care Pharmacy (AMCP), Maryland medication errors cost patients, consumers, and the healthcare system millions of dollars. Further, data indicate that medication errors harm over 1.5 million people each year.

Medication errors are preventable events that result in inappropriate medication use and patient harm. The events may stem from a healthcare professional’s conduct, a specific product, or a system. For instance, errors may stem from communicating prescriptions, dispensing or administration, marketing or labeling, or monitoring. Many errors stem from illegible handwritten prescriptions, missing information, incorrect drugs or dosage, orally transmitted prescriptions, or medication samples.

What Are the Causes of Medication Errors?

While advanced technology, reporting technology, and monitoring address some of the common causes of medication errors, there are fundamental issues with addressing systematic attitudes of blame and liability. Medication errors can result in serious formal punishment against the healthcare provider. These punishments can include fines, license suspension, or revocation. As a result, many healthcare providers focus on shifting blame rather than addressing the system issues that caused the error.

Labeling and Packaging of Medications May Contribute to Maryland Pharmacy Errors

August 11, 2021 | Lebowitz & Mzhen

Pharmacy errors can occur at different stages of the process of prescribing and dispensing a medication. And although some pharmacy errors may be caught quickly or may have a short-time effect, others can be devastating for Maryland pharmacy error victims. To decrease the prevalence of pharmacy errors, many researchers have looked to documented cases to determine where and how changes can be made.

According to a recent article, the labeling and packaging of medication contributed to two recent pharmacy errors. In one case, the prescriber of a mediation had prescribed sacubitril-valsartan (Entresto), a multi-ingredient medication that combined two drugs. The prescriber listed the strength of the medication prescribed as 100 mg, which was to be taken twice a day. When the pharmacist was filling the prescription, the pharmacist saw that the medication did not include a 100-mg strength, so the pharmacist chose the closest choice—97/103 mg strength (97 mg of one drug and 103 mg of another). However, the prescriber had intended that the patient take the total amount of the 2 drug ingredients (49/51) with 100 mg total.

The patient’s doctor later increased the dose to 100 mg, which was to be taken twice a day. The pharmacist dispensed the same 97/103 mg medication and gave instructions to take two tablets twice a day. The patient had severe adverse effects and the error was discovered. The insert on the medication suggested that the total amount was the basis for clinical trials, but the label listed the ingredients separately. To make matters more confusing, other combination tablets are prescribed according to the strength of each drug rather than the total, such as carbidopa-levodopa (for example 25-100).

What Compensation Can a Victim Recover in Maryland After a Medication Error?

May 14, 2021 | Lebowitz & Mzhen

Victims of a Maryland medication error may be able to recover financial compensation through filing a civil claim against the people and entities responsible for the medication error, such as a pharmacy or a medical provider. Filing a civil claim against those responsible (generally through a negligence claim) includes investigating, preparing, and filing the claim in court. Some defendants may choose to settle the case, while others may proceed to trial. In a successful claim, a victim may be able to recover a range of damages.

What Are the TYpes of Damages in a Maryland Pharmacy Error Case?

Generally, damages fall into two categories: economic and non-economic damages. Economic damages are damages with a fixed dollar amount, whereas non-economic damages do not have a fixed value. Examples of economic damages are past and future medical treatment, lost income, transportation costs, and physical therapy treatment. Examples of non-economic damages are pain and suffering, disfigurement, loss of companionship, and loss of parental care. Both economic and non-economic damages are considered “compensatory” damages—intended to compensate the victim for the losses the victim suffered. There is a cap on non-economic damages in injury cases in Maryland, though there is no cap on economic damages, and more can be recovered in some instances.

In certain cases, punitive damages are appropriate. Punitive damages are reserved for cases in which the defendant acted with actual malice or with deliberate wrongdoing. They are meant to serve as a punishment for the defendant and as a deterrent for others. At trial, the victim has to prove all of the damages they are claiming. Generally, a plaintiff has to prove all damages under the “preponderance of the evidence” standard, but punitive damages must be proved by the higher standard of “clear and convincing evidence.”