Articles Posted in High Alert Drugs

Each year, pharmacies make millions of medication errors, leading to unintended side effects and even death. Recent investigations revealed that pharmacies in California alone are responsible for over five million errors annually. Each year, up to 9,000 people die from medication errors, and hundreds of thousands suffer adverse side effects from taking the wrong medication. Pharmacists report that errors are the result of large pharmacy chains pushing quotes and high sales targets while slashing staff and limiting hiring. There are some simple methods customers can use to cut down on pharmacy errors.

Questioning Change in Appearance of Pills

Dispensing the wrong drug is the most common type of pharmacy lawsuit. Common pharmacy mistakes include pharmacists dispensing the wrong drug, the wrong dose, the wrong directions, and overlooking significant drug interactions or contraindications. As a result, patients should be encouraged to ask their pharmacist if they have any questions about their medications, and those questions should be taken seriously. Some professionals recommend that if the appearance of a dosage form or pill changes for a recurring supply of pills, then the patient should be informed of the change.

When you take a prescription drug, there are often numerous warnings and disclaimers that are included with the medication you are taking. Pharmaceutical drug manufacturers are often subject to labeling requirements and regulations that ensure consumers and their physicians are adequately warned about the potential risks of a medication. Thus, when a warning label fails to account for a risk that and it results in a patient injury, consumers often bring lawsuits against the company alleging a failure to warn and seeking compensation.

In a recent circuit court opinion, the court considered details surrounding warning labels on drugs. In the case at hand, the plaintiff was diagnosed with advanced-stage kidney disease after taking a drug manufactured by the defendant. According to the plaintiff, the defendant pharmaceutical manufacturing company should have more explicitly warned his doctor to regularly monitor his kidney function after prescribing the drug. If the drug’s warning label had been better, the plaintiff contended, then the physician would have monitored him differently after prescribing the drug, discovered the impact on his kidneys sooner, and prevented his injury. The lower court granted summary judgment in favor of the defendant manufacturing company.

On appeal, the court considered whether summary judgment was proper in dismissing the plaintiff’s failure to warn claim. The plaintiff argued that the lower court erred in concluding that his doctor, as a matter of undisputed fact, would have pursued the same course of treatment no matter what the warning label stated. The circuit court agreed, holding that the lower court erred in granting summary judgment to the defendants.

Each year, 7,000 to 9,000 Americans die as a result of a medication error. About 1.3 million people are injured because of a medication error each year. When someone is injured because of a medication error, they may be entitled to financial compensation. A doctor, pharmacist, hospital, or another provider may be liable for their mistakes.

List Released of COVID-19 Related Medication Errors

The Institute for Safe Medication Practices recently published a list of medication errors related to the treatment of COVID-19 patients. According to one publication, the medication errors included in the list were: missed doses linked to rationing of personal protective equipment, lack of staff training in using a medicine bar code, hard-to-read remdesivir labeling, automated cabinets dispensing the wrong drug, and an inability to weigh patients to assure correct dosage.

For example, some hospitals have said that there was an increase in missed doses of medication to patients because staff was hesitant to enter patients’ rooms multiple times because they were worried they might run out of personal protective equipment. Some providers have also reported that the inability to weigh patients during telehealth visits can lead to incorrect dosages of drugs based on the patient’s weight. One hospital reported an error from an automated dispensing cabinet, where a nurse mistakenly selected and gave a COVID-19 patient a high blood pressure medication instead of a sedative, because the drug names were similar.

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Since early March, the COVID-19 pandemic has affected hundreds of thousands of Americans, including many Maryland residents. According to the Maryland Department of Health, there have been over 45,000 confirmed cases of COVID-19 in the state, although many other cases are probably unreported due to lack of widespread testing. At its worst, the illness requires hospitalization and medical treatment, and doctors and medical professionals have been working hard to treat patients as best they can. But a new report from the Institute for Safe Medication Practices (ISMP) sheds light on the concern of medication and pharmacy errors going on as doctors treat the pandemic.

According to the ISMP’s report, in the latest edition of its weekly Acute Care Medication Safety Alert, an unidentified hospital overdosed multiple COVID-19 patients due to confusion over drug labeling. The drug, Remdesivir, is an experimental treatment being used in a clinical trial for severe COVID-19 patients. The ISMP reported that the vials of the drug, however, were not clearly labeled, and that the information on it was crowded and in a small font. Exacerbating the confusion was the fact that the hospital stocked two different versions of Remdesivir, a powder and a solution, each 100 mg of the drug. The second vial was labeled 5mg/mL. These errors and confusion were not caught by the pharmacy technicians or the pharmacists, and eight patients were administered doses way above the standard.

While no adverse reactions or side effects had been reported when the ISMP’s report was published on May 14, delayed reactions may still occur, threatening the already ill patients’ health. But the story also sheds light on a potentially larger problem—overworked hospital staff, working around the clock to care for large numbers of COVID-19 patients, may be unusually fatigued, rushed, and distracted, making pharmacy errors such as this one more likely to occur. Even the smallest pharmacy error can have disastrous consequences—mixing the wrong drugs or giving an overdose can cause severe illness, injuries, or even death.

The COVID-19 pandemic has affected almost all aspects of society for most – if not all – Maryland residents. Since the beginning of the crisis, necessary supplies have been in short supply. Indeed, healthcare workers have been forced to re-use supplies that are designated for a single-use and even rig their own masks because supplies were so low.

Among the newly raised concerns is a potential shortage of drugs that are needed to operate ventilators. Ventilators are machines that help those with COVID-19 breath while they are unable to do so themselves. According to a recent news report, when a patient requires a ventilator, a doctor or nurse must place a tube down the patient’s throat. To do so, medical staff need to give the patient sedative medication, pain killers, and, in some cases, medication to induce temporary paralysis. Evidently, in a letter to Vice President Pence, a spokesperson for the American Society of Health-System Pharmacists explained that ventilators “will be rendered useless without an adequate supply of the medications.”

The concern is that some hospitals are seeing demand for these drugs surge upwards of 600 percent. Part of the problem is that hospitals are attempting to secure a supply of the medication before they actually need it.

Maryland medication errors occur all too frequently and can have dire consequences for patients. The most recent study conducted by the Institute of Medicine found in 2013 that medical errors caused between 210,000 to 440,000 deaths per year. Of course, an exact number is difficult to determine because medical records are not always complete, and providers can be reluctant to disclose mistakes. In 2014, one study found adverse drug events were one of the most common medical errors in the country.

Errors involving what are known as “look alike, sound alike” (LASA) medications involve medications that sound similar or look similar in appearance, packaging, or in the names of the medications. Such drugs pose a higher risk of medication errors. As one recent article found, “Depo-” medications are often the subject of medication errors. There are several medications on the market today that begin with the prefix “Depo-.” The prefix means that the medication is administered via a depot injection that deposits the drug into tissue. However, people have consistently mixed up different “Depo-” medications with one another. Some of the most common errors are: “Depo-Provera,” “Depo-Subq-provera 104,” and “Depo-Provera Contraceptive Injection”; with “Depo-Medrol,” and with “Depo-Testosterone.”

For example, according to a recent news report, a physician mistakenly injected a patient with Depo-Provera instead of Depo-Medrol in 2015, after the medication had been inadvertently stored in a bin where Depo-Medrol was normally kept. In another case, a patient was injected with Depo-Medrol instead of Depo-Provera, which she was being given for contraception. The patient became pregnant as a result of the mistake. In that case, the staff person had mistakenly taken a vial of the drug where both drugs were stored next to each other.

All Maryland personal injury claims, including pharmaceutical claims, are subject to a statute of limitations, which indicates how long after an accident or injury a plaintiff has to file suit against the responsible party. In most cases, the statute of limitations is three years. Waiting too long to file a suit can bar Maryland plaintiffs from recovering, so it is important to be aware of the relevant statute of limitations and file suit in a timely manner when injured.

In cases where the injury was caused by a medication, knowing when the statute of limitations begins can be difficult. Plaintiffs want to push the start point forward, saying the clock did not begin until they knew about their injury, even if it technically happened weeks, months, or years, later. On the other hand, pharmaceutical companies will likely argue that the statute of limitations began to run before the plaintiff even knew about the issue. Oftentimes, the outcome of this disagreement determines whether or not the plaintiff recovers for their injuries.

Take a recent state supreme court case as an example. According to the court’s written opinion, the two plaintiffs, young men, were both prescribed Risperdal for mental health issues in 1997 and 1998. The first plaintiff started experiencing increased breast size, extreme weight gain, and psychological distress in 2001. The second plaintiff suffered from weight gain and diabetes as well, and in 1998 also perceived breast development and psychological distress. The two filed suit against the drug manufacturer and pharmaceutical company, claiming that they failed to warn plaintiffs about the potential of developing Gynecomastia, an endocrine disorder that causes the growth and swelling of the breast tissue in males. The defendants responded by filing a motion for summary judgment, arguing that the statute of limitations had passed. According to the defendants, the statute of limitations had begun almost eight years before the plaintiffs filed suit. The plaintiffs, on the other hand, argued that they did not know about their condition and thus could not have filed suit during that time, and that the statute of limitations did not actually begin until much later.

According to a national news report, several retailers and pharmacy chains are suspending the sale of Zantac, a popular heartburn medication. The decision was made after concerns arose that the drug may contain a substance that can cause cancer. The makers of the drug face a potential class-action lawsuit, and other Maryland pharmacy error lawsuits may arise from those suffering the adverse effects of the drug.

According to the United States Food and Drug Administration (FDA), doctors routinely prescribe Zantac to treat heartburn and stomach acidity issues. Potential issues with the medication arose shortly after approval for mass distribution in the 1980s. However, the FDA did not provide medical professionals with the warning until they discovered that the carcinogenic agent ranged from 3,000 to over 25,000 times the approved limit. The agent has been linked to cancers of the lung, kidneys, bladder, and stomach. Additionally, the toxic agent is related to liver scarring, fibrosis and tumors. The FDA has not issued a formal recall notice, nor did they tell patients to stop taking the product, however, many national retailers have pulled the medication and replaced it with generic versions that lack the specific impurity. This, however, has brought up concerns regarding the safety and efficacy of prescription drugs whose generic equivalents are manufactured in foreign counties where the FDA typically lacks adequate oversight.

Although the FDA has not recalled Zantac, several drugstores voluntarily removed the product, likely in an attempt to avoid liability if the product eventually gets recalled. Those injured after taking a dangerous drug may seek damages for injuries in instances where a product has been recalled but a retailer or hospital does not abide by the notice. Patients and consumers may suffer serious injuries such as permanent organ damage, cancer, and even death when a party fails to comply with a recall notice. Moreover, manufacturers cannot escape liability just because they issue a recall. Manufacturers, distributors, and retailers may still face liability if they did not adequately issue the recall, provide appropriate warnings and remedies, or abide by the recall notice. Patients should heed the warnings from the FDA and their doctors about specific medications. If they do not abide by the warnings and suffer injuries, they may face difficulties holding the responsible parties liable for their damages.

When someone is injured because of someone else’s negligent actions, Maryland law allows the victim to seek monetary compensation from the responsible party. Victims of car or truck accidents, slip and fall cases, or medical malpractice, for example, can bring a Maryland personal injury claim. However, these personal injury cases are all subject to a certain statute of limitations, which is the period of time within which you must bring the case. For example, if the statute of limitations is two years, a plaintiff must file the case within two years after the accident occurs. A failure to do so will result in the claim being barred, and the victim will not be able to receive the compensation they deserve from the responsible party.

In Maryland, the statute of limitations for medical malpractice cases can be complicated, because sometimes the injury can occur long before the victim realizes. Maryland law accounts for this under Maryland Courts and Judicial Proceedings Code section 5-109, which states that a medical malpractice lawsuit must be filed within five years of when the injury occurred, or within three years of when the injury was discovered by the victim, whichever comes first. The discrepancy between the two dates can cause confusion and complicate lawsuits, making it difficult for plaintiffs to receive compensation for their injuries.

In a recent opinion, a state appellate court considered a situation like this, in which the plaintiff was not aware of the injury at the time it occurred. According to the court’s written opinion, the plaintiff, suffering from psoriatic arthritis, was prescribed Remicade by his doctor, which he continued to take for over two years. However, just over two years after he began taking the medicine, the plaintiff developed severe neuropathy. This neuropathy caused weakness, and the plaintiff lost the ability to walk and use his hands and arms. The plaintiff stopped taking Remicade but alleged that he was not aware that the medication was responsible for his injuries. According to the plaintiff, it was over a year before a different doctor told him that Remicade was the likely cause of his injuries. By that point, it had been over a year since the injury occurred, but the plaintiff only just found out about it. Thus, medical malpractice rules that account for this potential discrepancy are incredibly important for preserving a plaintiff’s right to bring a personal injury claim.

Recently, an appellate court issued an opinion addressing issues that frequently occur in Maryland pharmacy error lawsuits. The lawsuit stemmed from the tragic death of a woman who received the wrong medication from her pharmacy. Evidently, the woman was treated at a hospital for fluid buildup in her lungs. At discharge, a nurse called the woman’s pharmacy, spoke to a pharmacy technician, and ordered a prescription for a diuretic. However, the technician made several errors when inputting the patient’s information, including wrong identifying information, incorrect spelling of the nurse’s name, and misspelling of several medications. However, the most egregious error was misreporting a medication and dosage. This error had severe consequences, as the patient died as a result of the incorrect medication.

The woman’s family filed a wrongful death lawsuit against the hospital and the pharmacy, alleging damages for negligence and requesting additional damages due to aggravating circumstances. The hospital settled their claims, and the lawsuit against the pharmacy proceeded to trial. The pharmacy moved to dismiss the aggravating circumstances portion of the lawsuit. The trial court granted the motion, and the jury awarded the family two million dollars in damages; however, the amount was significantly reduced because of the applicable damage caps. The family appealed the judge’s decision to dismiss the aggravating circumstances element of their claim.

Under Maryland law, pharmacy error plaintiffs can recover damages for the injuries they sustained because of the pharmacy’s negligence. Maryland law allows plaintiffs to recover compensatory damages to make them “whole again.” There are two main types of compensatory damages, special and general. Special damages are usually tangible costs that the plaintiff incurred because of the defendant’s negligence. Whereas, general damages are those that cannot be easily quantifiable, such as pain and suffering.

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