Articles Posted in Patient Safety

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.

Unless a danger is obvious and widely known, the 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.

In cases where a patient is injured due to a lack of sufficient instructions or failure to adequately disclose risks, the patient may be able to file a Maryland injury claim and recover financial compensation for the injuries. Successful plaintiffs may be able to recover financial compensation for damages including medical bills, psychological suffering, future medical expenses, lost wages, and more. One recent study revealed that at half of the patients were using inhalers incorrectly.

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.

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.

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.

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.

Victims of Maryland medication errors may be dealing with the stress of the injury, medical bills, and wage losses—and filing a Maryland medication error lawsuit may not be at the forefront of their minds. However, victims have to be careful not to wait too long, because it could be too late.

The statute of limitations dictates the time in which any claim must be filed in Maryland. Failure to file a lawsuit within the applicable statute of limitations generally will result in the claim being dismissed, though there are some exceptions. Generally, the statute of limitations for a medication error claim in Maryland (and other personal injury claims) is three years. Wrongful death claims also have a statute of limitations of three years. The statute of limitations varies depending on the type of case and there may be exceptions in some cases. The statutes of limitations also can change if there is a change in the law so it is important to meet with an experienced medication error attorney who understands the statute of limitations that applies in a specific case.

The statute of limitations generally begins to run when an injury occurs, though it may start to run later in some cases. An experienced medication error attorney can help medication error victims properly file a claim within the applicable statute of limitations.

Amazon is one of the most valuable companies in the United States, and is getting even more and more utilization during the COVID-19 pandemic, as Americans order an increasing amount of things online, from groceries to pet supplies, books, and décor. Now, Maryland shoppers may be able to get one more thing from this giant retailer: their prescriptions. Last month, Amazon announced the launch of Amazon Pharmacy, a delivery service for prescription medications. The service would allow Amazon customers to purchase prescription drugs with or without health insurance, which Amazon claims will save them money, up to “80 percent off generic and 40 percent off brand name medications when paying without insurance.” Is is unclear, however, how Amazon Pharmacy could impact the prevalence of Maryland pharmacy errors.

While the potential savings on drug prices sound great, experts say that Amazon Pharmacy is likely not going to be a game-changer when it comes to the high cost of prescription medications.  Customers may enjoy some savings, but this online option is likely to work similarly to other online pharmacies and cannot solve the large and complicated problem of U.S. drug pricing. Still, professionals are watching to see what impact Amazon Pharmacy has and how many Americans utilize it for their medications.

Maryland pharmacy errors are a persistent problem, sometimes causing severe injury or illness. And, unfortunately, anyone who has ever ordered something online can tell you that online shopping does not always go off without a hitch—sometimes the wrong product or item can be sent, items can be swapped with others, or a package could get lost or never arrived. Pharmacy safety advocates should watch closely to see whether or not Amazon Pharmacy falls prey to the same errors that occur in pharmacies every day. It’s very possible that pharmacy errors continue to plague Maryland patients, regardless of where they get their prescription.

Laws vary from state to state regarding the authority of certain persons to dispense medication. In Maryland, physicians are permitted to dispense medication subject to certain regulations. Maryland physicians who are permitted to dispense medication must obtain a dispensing permit from the Maryland Board of Physicians. But the ability to dispense medication poses additional avenues of liability for physicians and raise concerns among some and may pose additional risks for Maryland patients, as one recent article showed.

The article raised the issue of whether physicians should be permitted to dispense medications. In an editorial in another paper, a writer had suggested that it is a good idea to have doctors dispense medications directly to patients, because it may be easier and cheaper for patients. Three doctors in Montana recently filed a lawsuit seeking to be allowed to dispense medications directly to their patients. Dispensing medication directly to patients is prohibited in that state. However, critics say that dispensing medication directly to patients raises serious medication safety concerns. In particular, there is a concern that there would not be a second review by a pharmacist of the prescription. There is also a concern about the lack of regulatory oversight, such as labeling, supervision, and storage.

Pharmacy errors can occur at different stages in the process. Having a pharmacist dispense and administer the medication means that the pharmacist can act as a check on errors that can occur when prescribing medication. Allowing a doctor to prescribe and dispense a medication means that there would likely be no second person reviewing and checking for errors before the medication reaches a patient. Prescribing errors can, of course, cause significant harm to patients.

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