Articles Posted in Patient Safety

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

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.

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.

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.

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.

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).

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.”

Maryland, along with every other state in the U.S., paused the use of Johnson & Johnson’s coronavirus vaccine last week after six recipients of the vaccine in the country experienced a rare blood-clotting disorder. Over seven million people have received Johnson & Johnson’s vaccine in the United States so far. The six people who experienced the clotting disorder were women between 18 and 48 and experienced the disorder within three weeks of receiving the vaccine. In those cases, the blood clots occurred in the brain, and the women all showed low levels of platelets. One woman died from the illness. In a step to reduce Maryland vaccine errors and adverse reactions, Maryland’s Department of Health decided to pause the use of the Johnson & Johnson vaccine in the state “out of an abundance of caution.”

The AstraZeneca vaccine, which has been distributed in Europe, also had cases of individuals with blood clotting, which were “very, very similar” to the Johnson & Johnson clotting cases, one expert noted. Both vaccines use similar technology. A government committee will meet to evaluate further use of the Johnson & Johnson vaccine. The Centers for Disease Control said that individuals who have received the Johnson & Johnson vaccine in the past month should reach out to their doctors if they have abdominal pain, shortness of breath, leg pain, or severe headaches. Health officials reported that the people who experienced the clotting disorder most commonly had a persistent, moderate to severe headache that started six days or later after receiving the shot.

Can Victims of a Vaccine Error Recover Financial Compensation from a Pharmacy?

Yes, individuals who experience vaccine errors or adverse reactions may be able to recover compensation from the administrator or manufacturer of the vaccine in some cases. A Maryland vaccine error claim based on negligence requires a showing that the defendant owed the individual a duty, the defendant failed to meet the relevant standard of care, the defendant’s negligent conduct caused the individual’s injuries, and the individual suffered damages. These cases can be complicated and often must rely on the testimony of experts to explain the link between the error and the injuries the individual suffered. Victims of a vaccine or medication error may be able to receive financial compensation for past and future medical expenses, loss of wages and earning capacity, and other damages depending on their circumstances. A negligence claim in Maryland has to be filed within three years after the date of the injury.

Most Maryland residents find themselves visiting a pharmacy at one point or another. Medications—whether continual or short-term—are a big part of many people’s health and well-being. And ideally, pharmacists and pharmacies help to keep Maryland patients safe and healthy. But sometimes mistakes are made, and these pharmacy errors can cause significant harm to patients. In fact, Maryland pharmacy errors are more common than most people think and can happen to anyone. Recently, however, the Pharmacy Times published an online article about how specialty pharmacists play an important role in increasing patient safety.

Specialty pharmacies, according to the Academy of Managed Care Pharmacy, are distinct from traditional pharmacies and are designed to efficiently deliver medications that have special handling, storage, and distribution requirements. They are also designed to improve outcomes for patients that have complex, potentially chronic and rare conditions. Typically, patients taking specialty medications require more complex services than those required for a traditional drug, and so specialty pharmacists step in to meet those needs.

According to the Pharmacy Times, specialty pharmacists have a unique role in medication safety. Not only do they take responsibility for ensuring the safe and effective use of specialty medications, but they also play a strong role in promoting a positive safety culture within their specific pharmacy. One of the factors pointed towards as causing pharmacy errors is the culture within the pharmacy. Oftentimes, pharmacists are overworked, hurried, and stressed out, and they may sacrifice safety for speed or fail to engage in regular safety precautions. The Pharmacy Times reports that because specialty pharmacists, working with high-risk specialty medications, often incorporate robust programs to ensure proper medication usage and minimize the potential for error, can be really helpful in setting the tone and expectation for safety in typical pharmacy settings. Additionally, specialty pharmacists can encourage the actual reporting of errors within pharmacies when they do happen, which is critical for addressing the root cause of the problem and making sure the same errors do not continue to happen.

Each year, medicine and technology get more and more advanced, leading to improvements in the quality and delivery of health care across the country. Despite these improvements, however, errors still occur in health care delivery, particularly regarding pharmacy and medication. In fact, Maryland pharmacy errors occur frequently, jeopardizing the health and well-being of patients. The Institute for Safe Medication Practices (ISMP) is a nonprofit organization that works closely with health care practitioners, institutions, regulatory agencies, professional organizations, and the pharmaceutical industry to create awareness of and provide education about medication errors and how to prevent them.

Every other week, ISMP produces a newsletter with timely information related to pharmacy error prevention. Looking at the newsletters from January 2020 through December 2020 provides important insight into the trends seen in pharmacy errors last year. Pharmacy Practice News recently provided a summary of these newsletters on their website.

In the Pharmacy Practice News summary, several key problem areas were identified. One was safety issues related to labeling, packaging, and nomenclature. For example, a pharmacist might mix-up two different medications that have similar labeling or names, giving the wrong one to the patient. Another area of concern was safety issues associated with order communication and documentation. For example, health officials searching for drugs by generic names and accidentally substituting non-substitutable drugs. Finally, there are problems involving drug information, patient information, patient education, and staff education. For example, two patients mixed up their insulin pens which looked alike but with different labels and manufacturers, meaning they gave themselves the wrong insulin, leading to hyperglycemia.

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