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Pharmacists are medical professionals and – although it is not always evident to patients – a significant amount of work goes into filling each prescription. Aside from making sure that the correct drug, dose, and amount of medication is provided to a patient, pharmacists are also responsible for ensuring the quality of the medicine being provided to patients, and for making sure that prescribed medication is suitable for the patient.

The vast majority of the time, pharmacists deal with controlled substances that have not just the power to help a patient, but also the potential for danger. Some of these drugs may have serious side effects or exact dosing requirements, and many of the drugs handled by pharmacists can be habit-forming or addictive.

A recent article discussed the lack of safeguards in one hospital pharmacy that allowed a physician to overprescribe painkillers in fatal or near-fatal doses to 34 patients. Typically, the hospital required a pharmacist to approve a prescription electronically before a doctor or nurse can access the medication cabinet and obtain the drug to give to the patient. In the event of an emergency, access to the medicine cabinet was allowed through a physician override. Evidently, physicians were able to access all types of dangerous medications, including fentanyl and Versed, without having to justify the circumstances of the emergency.

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Under Maryland law, most cases must be brought within three years from when the claim “accrues.” However, when someone ingests a dangerous medication, the potential harms of the drug may not be immediately apparent. This is true in both pharmacy errors, where a pharmacist provides a patient with the wrong medication, and also in cases involving dangerous prescription drugs that are marketed as safe. This raises the question, when to these Maryland pharmacy error cases accrue?

Maryland courts employ the “discovery of harm” method when determining when a claim begins to accrue. Thus, it is only when a plaintiff becomes aware of their injuries that the clock starts ticking. A recent federal appellate decision involving a dangerous prescription drug illustrates how courts engage in this type of analysis.

The Facts of the Case

According to the court’s recitation of the facts, in 1999, the plaintiff was prescribed Vioxx by her physician to relieve pain and inflammation. The following year, the plaintiff suffered “cardiovascular injuries” while taking the medication. However, the plaintiff’s doctor continued to prescribe Vioxx, and the plaintiff continued to take the medication. In 2002, the plaintiff discontinued the use of Vioxx.

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Any time a pharmacist provides a patient with the wrong medication, there is the possibility that there will be serious, potentially life-threatening consequences. However, when the victim of a Maryland pharmacy error is a young child, the risk that the error will result in serious injury or death significantly increases. And while parents should check all labels and all accompanying literature to ensure that an error has not occurred, the duty ultimately rests with the pharmacist to accurately fill a prescription.

In many cases, after a child is given the wrong medication the parent will quickly realize that there has been an error because their child will exhibit symptoms. However, some symptoms may not arise immediately, and may take days, weeks, or even months to arrive. Generally speaking, a Maryland pharmacy error victim has three years to bring a claim under the statute of limitations. The statute of limitations may be tolled from the time of the error to the point where the patient realizes that she suffered injury. Additionally, if the patient is a minor, the statute of limitations is tolled until the day before the minor turns 18 years old. However, just like most things in life, it is not a good idea to wait until the last minute to file a claim.

Newborn Baby Given the Wrong Medication by Local Pharmacy

Earlier this month, a local news article reported on a pharmacy error that allegedly occurred at a CVS pharmacy. Evidently, a mother picked up what she thought was a prescription for her newborn daughter’s acid reflux. The mother gave the medication to her daughter for two weeks before realizing that the drug the pharmacist provided her was actually a steroid. During the period when the newborn was taking the unprescribed steroid, she was vomiting, swollen, not sleeping and cried more often than usual.

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Medication errors are believed to be one of the leading causes of death across the United States. Indeed, there have been countless studies focusing on the causes of pharmacy errors and the best ways to reduce them. However, the fact remains that medication errors result in over 3.5 million hospitalizations each year, with over a million of those to the emergency room.

The exact number of patients harmed by Maryland pharmacy errors is difficult to determine. In part, this is due to the lax reporting requirements. In Maryland, as is common across the United States, pharmacists are not required to report most of their errors, and do so only voluntarily.

According to a recent investigative report, pharmacy errors are routinely swept under the rug and kept out of the public eye. The report recounts the case of a man who died after ingesting the wrong medication that he obtained from his local pharmacy. The man’s autopsy report confirmed that the pills on the bottle did not match those which he was prescribed. However, pharmacist “neither admitted or denied” the allegations, and was ultimately fined $3,000.

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Recently, the Institute for Safe Medication Practices (ISMP) issued a report asking that Maryland pharmacists, as well as pharmacists across the country, take additional precautions in the wake of a fatal 2017 pharmacy error. The ISMP is a nonprofit organization dedicated to reducing the number of pharmacy errors across the United States. In furtherance of that goal, the ISMP operates a voluntary error-reporting system. The ISMP then uses this data to work with pharmaceutical companies to eliminate the root causes of common errors such as similarly named drugs, confusing packaging, and dangerous device design.

The Error

According to the ISMP report, a patient was admitted into the ICU with a headache and vision loss. An MRI was conducted, and it was determined that the patient had a hematoma of the brain. The patient was transferred, and a full-body scan was ordered. While the radiologist was explaining the procedure to the patient, the patient indicated she had claustrophobia. The radiologist requested the patient be given a dose of Versed to help with her claustrophobia.

Evidently, the patient’s primary nurse requested that a radiology nurse provide the patient with the medication. The radiology nurse declined, stating that the patient would need to be monitored after administration of the drug. The primary nurse indicated she would send another nurse to the radiology department to monitor the patient after she was given the medication.

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A significant number of Maryland prescription drug injuries are caused by opioid use and abuse. Over the last decade, the number of deaths that were related to opioid medications has dramatically increased from about 35,000 in 2007 to over 70,000 in 2017. In an effort to curb these stark statistics, experts began to consider why opioid abuse has become more prevalent over the past few years and what new law or policies could help decrease opioid abuse.

One idea that is starting to gain traction is the concept of partial-fill prescriptions. Under a partial-fill prescription policy, patients who are prescribed certain high-risk opioid medications are given only a few days’ worth of medication at a time. The idea behind the policy is that if patients are given fewer pills they will be less likely to take more than they need. Additionally, proponents of a partial-fill policy hope that it would reduce the number of people who sell some or all of their medication.

According to a local news report, Tennessee recently enacted a partial-fill policy under which patients would only be provided some of their medication on their first visit to the pharmacy. Patients could obtain the rest of their medication, if needed, by returning to the pharmacy once they run out of medication. Under the new policy, pharmacies are responsible for inputting patient data into a state-wide database.

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Maryland personal injury plaintiffs risk having their cases dismissed if they fail to file their claims within the applicable statute of limitations. In a recent case before a state appellate court, the court dismissed the pharmaceutical claim for failing to timely file a claim.

The plaintiff had filed a lawsuit against pharmaceutical companies, alleging that they were liable for his gambling and other losses because he suffered from obsessive-compulsive disorder as a result of taking Mirapex. Mirapex is an FDA-approved medication used to treat Parkinson’s disease, which the plaintiff began taking in 2006 to treat his Parkinson’s disease. After taking it for two years, he told his doctor that he was experiencing increased compulsive behaviors, including gambling. His doctor told him there was a possible association between Mirapex and compulsive behaviors. The plaintiff raised the issue with his doctor several months later. The plaintiff’s family eventually learned of substantial debts resulting from his gambling, at which point the doctor told the plaintiff not to take Mirapex anymore, advising him to use other therapeutic options instead.

When the plaintiff filed the lawsuit against the drug’s manufacturers, the companies claimed that the lawsuit was time-barred, arguing that the plaintiff filed the case after the two-year statute of limitations for personal injury claims under state law. The plaintiff did not dispute that he knew or should have known that he had been wronged by the defendant by April 23, 2008, after discussing the effects of Mirapex with his doctor on more than one occasion. However, he did not file the claim until December 2010. The plaintiff argued that the statute of limitations was tolled until July 2010, because he continued taking Mirapex until that time, and because “continuing violations” are not time-barred. Under that state’s law, a personal injury claim must be filed within two years. However, under what it calls the “continuing accrual” principle, in continuing or recurring liability cases, “a cause of action accrues each time a wrongful act occurs,” which means that the statute of limitations begins again for that act.

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Pharmacy errors can be the result of any number of failures in the medication delivery system. More often than not, however, Maryland pharmacy errors are the result of human error. One of the most commonly cited causes of prescription drug errors is when a pharmacist provides a patient with a medication that has a similar name to the medication the patient was prescribed. In the pharmacy industry, these medications are referred to as look-alike sound-alike (LASA) drugs

According to the Food and Drug Administration, LASA medications are involved in about 41% of all fatal pharmacy errors. An example of two medications that are commonly mixed up and have been placed on the list of LASA medications are Aricept (a drug designed for Alzheimer’s disease), Azilect (an anti-depressant used to treat Parkinson’s disease), and Aciphex (a prescription used to treat acid reflux and stomach ulcers).

Of course, pharmacists have a duty to ensure that they are providing their patients with the correct medication in the right dose. Needless to say, when a pharmacist fails to fulfill that duty, a patient can be exposed to serious risks. In many cases, the symptoms of a pharmacy error are immediately evident; however, that it is not always the case. In some situations, it may take days, months, or even years to discover the extent of the harm caused by an error.

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Companies that manufacture and market prescription medication are under the same duty that all manufacturers are under to make sure that their product is safe. Of course, some medications, especially prescription medications, present the risk of serious adverse side effects, even when the drug is taken according to a physician’s instructions. Thus, a manufacturer must clear about the potential side effects that a medication could cause when marketing the drug. A failure to clearly warn patients about a known risk may result in the drug manufacturer being liable in a Maryland product liability case.

While a drug manufacturer may be able to avoid liability by warning of a drug’s dangerous side effects, there is no excuse for medication that is contaminated during the manufacturing process. Late last month, the U.S. Food and Drug Administration (FDA) announced the latest in a series of recalls affecting blood-pressure medication. According to the FDA, two lots of Losartan potassium tablets contain an ingredient that was discovered to contain an unexpected impurity called N-nitrosodiethylamine (NDEA). The FDA notes that NDEA “is a substance that occurs naturally in certain foods, drinking water, air pollution” however, it is also a known carcinogenic in animals and a suspected carcinogenic in humans according to its classification by the International Agency for Research on Cancer.

Losartan potassium tablets are used to treat hypertension (high blood pressure) as well as neuropathy (nerve pain) in patients who have Type II diabetes. The FDA recommends that patients who are currently taking Losartan continue to take the medication, as the risks involved with suddenly stopping the drug without an alternative treatment are high. The FDA advised patients taking Losartan to contact their pharmacist or physician to discuss alternatives to Losartan, at least until the manufacturing problem has been resolved.

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In a Maryland “failure to warn” claim, a plaintiff may bring a claim against a defendant manufacturer for failing to warn of the risks associated with a product. A product must adequately warn consumers of the dangers and risks in using the product, unless those dangers are a matter of common knowledge or are so obvious that they do not require a warning. For example, a drug manufacturer could be liable for the side effects of a drug if it failed to adequately disclose the risks of the drug, failed to disclose an unreasonably dangerous condition, or failed to instruct consumers on the correct use of the drug.

Courts will consider the knowledge and experience of consumers in determining whether a person can reasonably be expected to understand the use and risks of a product. Warnings and disclosures must be clear, direct, and easy to understand. Instructions and disclosures can be inadequate if they are ambiguous or do not contain enough information about how to safely use the product or the risks of improper use. A plaintiff with a successful failure to warn case can potentially garner a range of compensatory damages, including medical bills, the costs of future treatment, out-of-pocket expenses, loss of income, mental anguish, and pain and suffering.

FDA Issues Safety Announcement for Medication for Leukemia Patients

The U.S. Food and Drug Administration (FDA) recently issued a safety announcement, stating that some leukemia patients receiving the medication Idhifa are showing signs and symptoms of the syndrome that are not being recognized. Idhifa’s Medication Guide already has a warning about differentiation syndrome, but despite this, the FDA has become aware of cases of the syndrome that not being recognized, with patients not obtaining the proper treatment. Idhifa is used to treat patients with acute myeloid leukemia, and works by blocking enzymes that promote an abnormal blood cell growth. However, it can cause differentiation syndrome, which can be life-threatening if not treated quickly.

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