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Drug recalls have been on the rise over recent years, affecting an estimated 81% of consumers in the United States. But when the federal Food and Drug Administration (FDA) finds a problem with a drug, what happens when a drug is recalled? And what does it mean for victims who want to file a Maryland product liability claim? A recent industry news source outlined the drug-recall process, which provides a good overview for those unfamiliar with the process.

A drug recall is an action by the manufacturer of the drug to remove a defective or harmful product from the market after the drug is found to be in violation by FDA laws or regulations. The FDA cannot pull a product from the market. It can only request that a drug be recalled, but ultimately the pharmaceutical company must decide whether to pull the drug.

The FDA then assesses whether the recall was appropriate, classifies the recalls, and oversees the recall strategy. A recall is classified by the FDA as a class I, II, or III recall. Class I recalls are the most serious, as they are for products that could cause serious harm or death. Class II recalls are for products that pose a notable risk and threat. Class III recalls are for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences. Once a drug recall has been issued, officials from state health departments and pharmacy boards, drug manufacturers, and others may contact pharmacies to let them know about the drug recall. The pharmacies are then responsible for making sure that the recalled product is removed and dispensed of properly. They also have to help patients by counseling them on their options in light of the recall.

Most cases of pharmacy error involve negligent conduct and generally include careless mistakes. For this reason, punitive damages are rare in Maryland pharmacy error claims. Punitive damages are typically imposed to punish a defendant for their wrongful conduct and serve as a warning sign for others to dissuade them from engaging in such behavior.

In Maryland courts, to award punitive damages, a plaintiff has to show that a defendant acted with knowing and deliberate wrongdoing. A plaintiff must prove this by clear and convincing evidence—a higher standard than the preponderance of the evidence standard, which is generally applicable in civil cases. Thus, in many pharmacy error cases, punitive damages are not awarded because a plaintiff is unable to establish the defendant’s knowing and deliberate wrongdoing. The deliberate or intentional administration of the wrong drug is not a common occurrence. However, as a recent news report illustrates, it does occur.

Pharmacist Suspended After Purposely Giving Patient Wrong Drug

A pharmacist was recently suspended from practicing and fined after she purposely gave a patient the incorrect drug, according to one news source. Evidently, the pharmacist was working alone on a Saturday night, and a customer came in to fill a prescription for Suboxone for the patient’s opioid addiction. The pharmacist had already closed the safe where the drug was held and could not open it. The patient reportedly did not want to wait, and threatened to call the police. According to a report, the pharmacist became stressed and took some Apo-Prednisone pills and crushed them. Apo-Prednisone is commonly used to treat allergic reactions, arthritis, and severe asthma, among other conditions.

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As people across the United States and throughout the world have made adjustments due to the COVID-19 pandemic, and, likewise, Maryland pharmacies have done the same. For many pharmacists, they communicate with patients through masks and plastic barriers—if they communicate with patients at all. Medication pickups over the counter have also decreased, as many patients have shifted to other forms of delivery.

As in many other fields, pharmacies face new challenges pertaining to patient care and safety due to the COVID-19 pandemic. There has been an increase in prescriptions made over the telephone, as well as an increase in prescriptions being delivered by mail and through curbside pickup. These changes and others, implemented to maintain distance between people, can also lead to an increase in medication errors.

According to a recent industry news report, the new protocols can limit a pharmacist’s ability to identify and educate a patient, and it may make it easier to mix up patients with similar biographic information. Indeed, the Institute for Safe Medication Practices received regular reports of mistakes at pharmacy drive-throughs, even before the onset of the pandemic. For example, some prescribers use a pharmacy’s voice response system to call in prescriptions, which may not convey all information accurately. Additionally, physical barriers, such as masks and plastic barriers, when combined with an increased distance between pharmacists and patients, can also increase the chance of miscommunication.

During the COVID-19 pandemic, more and more people have been relying on delivery services and online retailers such as Amazon to supply them with their everyday needs and wants. Some popular products, such as face masks have even been on back order, as many individuals quarantined at home attempt the order them online. But Maryland residents may be surprised to hear that, in rare cases, the Amazon package left on your front porch may not be what you ordered at all. It could, instead, be the result of a major Maryland pharmaceutical error or package mix-up, like the package left on a California woman’s door earlier this month.

As reported by one local news source, a woman in California was recently excited to see an Amazon package on her front porch. As many of us would, she thought it was her order, which had been on back order and took a while to be delivered. Instead, when she opened it, she found something else entirely: seven bottles of powerful narcotics, including oxycodone, hydrocodone, and morphine, along with an invoice from the Drug Enforcement Administration (DEA). Of course, the woman wants to know how all of these powerful pills—literally hundreds—ended up in her Amazon package.

A DEA Special agent stated that he believes a pharmacy that was attempting to dispose of the drugs used a third-party shipper to send the package to Texas for proper disposal. However, the shipping labels may have been switched, leading to the unfortunate mix-up. Amazon, in a written statement, said it thought that perhaps the seller made the error, and instead of shipping the requested product they incorrectly included the drugs. Whatever the case may be, the DEA is investigating the incident. The drugs in the package are extremely dangerous, so the DEA wants to make sure there’s nothing more sinister going on.

Pharmacists are trained professionals. Yet, pharmacy errors occur with frightening regularity. According to a recent industry news report, there are at least 1.5 million preventable pharmacy errors each year in the United States. While many Maryland pharmacy errors are the result of a pharmacist mixing up the names of similar-sounding drugs, the dosing errors are also very common.

Math is a very important part of a pharmacist’s job. In fact, a life changing pharmacy error can be caused by a very simple mistake involving simple arithmetic. The aforementioned article explains several pharmacy errors and how easy they can happen. For example, one pharmacy received a prescription for a baby weighing 13 pounds, 5 ounces. The prescription called for 333 milligrams Amoxicillin suspension every 12 hours for 7 days. Thus, according to the prescription, the child would receive 666 milligrams of the medication per day. The general medication guidelines for Amoxicillin provide for up to 25 milligrams of medication per kilogram, given in evenly-divided doses ever 12 hours.

The proper way to fill the prescription is as follows: The child weighs 13 pounds, 5 ounces, or approximately 6.05 kilograms. By multiplying this number by 25, the daily dose for the child should be about 151 milligrams. Because the medication should be dosed twice per day, 12 hours apart, each dose should be about 76 milligrams.

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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For those that have suffered an injury because of a Maryland pharmacy error, there several different types of damages that may be recoverable if they are successful. Damages in a Maryland personal injury case are generally divided into two categories. The first, special damages, are economic damages. These are typically the out-of-pocket expenses that a plaintiff incurs because of the incident. Special damages often include medical treatment, lost income, and future expected costs and lost income, and others depending on the scenario. The second, general damages, are non-economic damages, as well as other types of damages. These generally do not have a fixed monetary value. General damages often include pain and suffering, which involves the physical and emotional distress the victim suffered, as well as loss of consortium and “other nonpecuniary injury.”

In some cases, punitive damages may be available. Punitive damages can be challenging to prove, because a plaintiff must prove that the party at fault had actual knowledge of the wrongful conduct. Punitive damages ate intended to punish the defendant and to stop others from engaging in such behavior.

There is a cap on non-economic damages in Maryland injury cases. The cap increases each year on January 1 of each year by $15,000. As of January 1, 2020, the non-economic damages cap is $830,000. More can be recovered in wrongful death cases with two or more claimants or beneficiaries. Earlier this year, a Maryland appeals court upheld the non-economic damages cap, finding that it did not interfere with the role of the jury in jury trials.

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.

A recent article written by two medical professionals sheds insight into how and when prescription errors occur. According to the article, 7,000 to 9,000 people in the United States die each year as the result of a medication error. In addition, hundreds of thousands of other patients experience an adverse reaction or some other medical complication related to a medication. As we’ve written about before, these pharmacy and prescription errors can cause severe and life-threatening injuries to Maryland patients, so it is essential to be aware of them.

The article discusses the various types of medication errors. While doctors and pharmacists generally do a great job, sometimes errors do occur. A doctor might make an error when prescribing, for example, and may prescribe the wrong drug or the wrong dose. Pharmacists may give the medication to the wrong patient or accidentally tell the patient to take the medicine twice a day instead of twice a week.

These errors have three leading causes, as identified in the article. First, distraction, which accounts for nearly 75 percent of medication errors. Medical professionals are often busy and have many duties in a hospital. While speaking to patients, examining lab results, and ordering imaging studies, for example, they may be asked to quickly write a prescription. In these cases, when the job is done in haste, a medication error may occur—even with the best doctor. Second, distortion. Sometimes a doctor will prescribe a drug but use a symbol not widely recognized, or it will be translated improperly, and the actual drug administered will be slightly off. Last, illegible writing, as simple as it sounds, also leads to medication errors- a pharmacist may be unable to read what the prescription says and may thus use their best judgment and then administer the wrong medication.

When people experience medical issues, they will, understandably, rely on healthcare professionals to provide them with appropriate treatment. Individuals should expect that their medical providers quickly and accurately diagnose them and prescribe the correct treatment and medication. When someone suffers injuries after taking the wrong medication or dosage, the provider or pharmacist may be liable under Maryland’s medical malpractice laws. Although mistakes can happen, medical providers have a duty to provide their patients with necessary and appropriate medical care. The failure to provide a patient with correct medication can lead to serious and life-threatening illnesses.

About 20 years ago, the Institute of Medicine released its “To Err is Human” report, highlighting the importance of building a safer health system. However, medication errors continue to be a serious risk for patients throughout Maryland and the United States. As the report suggests, pharmacists play a critical role during the prescribing, dispensing, and administration of medication, and they must take steps to prevent medication errors. A recent news report summarizes some of the most crucial steps pharmacies can take to reduce the likelihood of a Maryland pharmacy:

Organize the pharmacy: The inherent fast-paced and intense nature of pharmacies can result in disorganized and chaotic work spaces. Pharmacists should have a system in place to ensure that patients’ prescriptions and medications do not become lost or misidentified. The Institute for Safe Medication Practices (ISMP) advises that pharmacies use consistent systems, such as bins or baskets, to separate different patients’ prescriptions and medications.

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