Articles Posted in High Alert Drugs

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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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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Maryland personal injury plaintiffs can bring failure-to-warn claims if a manufacturer fails to adequately warn consumers of a product’s risks. In one recent case against drug manufacturer GlaxoSmithKline, a patient alleged that the manufacturer failed to warn consumers of its association with suicide for certain patients.

The Facts of the Case

A doctor prescribed a patient Paxil, manufactured by GlaxoSmithKline (GSK) to treat the patient’s depression and anxiety. However, his prescription was filled with the generic version of Paxil, paroxetine. A few days later, the patient committed suicide and paroxetine was found in his system. The patient’s wife sued GSK, alleging that the manufacturer negligently failed to warn patients that paroxetine was associated with suicides in patients older than 24, and that her husband (who was 57) died as a result.

Generic drug manufacturers are required to use a label approved  by the brand-name manufacturer and approved by the U.S. Food and Drug Administration (FDA), and only the brand-name manufacturer can obtain FDA approval to change the label. In this case, the brand-name manufacturer of Paxil, GSK, created the its label, and the generic drug manufacturers were required to use the same label. Labels for paroxetine warned that it was associated with suicide in patients under 24, but did not warn about an association with suicide in older patients.

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Last week, the Food and Drug Administration announced that the manufacturer of a popular blood-pressure medication would be recalling thousands of bottles of the medication after what appears to have been a medication mix-up. According to one news source covering the recall, Accord Healthcare announced that it would be recalling one lot of its Hydrochlorothiazide tablets in the 12.5mg dosage.

The recall was announced after a pharmacist at a local drugstore discovered that a bottle marked as containing the 12.5mg tablets of Hydrochlorothiazide tablets actually contained another medication. None of the medication was provided to patients, and the manufacturer’s initial investigation into the error did not cause them to believe that any other lots suffered from a similar error. However, out of precaution, the manufacturer recalled the entire lot that contained the bottle with the wrong medication.

The Hydrochlorothiazide tablets are round orange pills that have the letter “H” on one side, and the number “1” on the other side.

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Plaintiffs have to be careful when it comes to filing a Maryland pharmacy error claim. A recent case shows how asserting the wrong claim in a case can result in the case’s dismissal.

In that case, the plaintiff brought a claim against a drug manufacturer for allegedly causing her husband’s death due to the manufacturer’s failure to provide a medication guide with her husband’s prescription. The manufacturer made a generic form of amiodarone hydrochloride, a drug used for certain life-threatening heartbeat irregularities. As a generic drug, it is required to have the same labeling as its approved brand-name counterpart. One of the labeling requirements is making medication guides available for distribution to each patient who is prescribed the drug. The medication guides explain the approved uses of the drug and also explain the drug’s side effects “in nontechnical, understandable language.” In amiodarone’s medication guide, it states that the drug should be used only to treat “life-threatening heartbeat problems.”The plaintiff’s husband died after taking amiodarone to treat his non-life threatening atrial fibrillation. The plaintiff alleged that her husband died because he had been taking amiodarone, which he had been prescribed. The manufacturer allegedly failed to provide the medication guide for distribution, which her husband did not receive when he filled his prescriptions in May and June 2015. The plaintiff claimed that her husband was not aware that only those with life-threatening heartbeat irregularities should take the drug, due to its serious side effects. She argued that the manufacturer failed to warn her husband by failing to provide the medication guide, as required under federal law.

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Earlier this month, the Food and Drug Administration announced a voluntary recall of several lots of an increasingly popular drug that is designed to combat the effect of an opioid overdose. According to a recent news report discussing the voluntary recall, two specific lots of the drug Naloxone have been recalled based on the “potential presence of embedded and loose particulate matter on the syringe plunger.”

Hospira, the company that manufactures the drug, moved forward with the recall after it discovered that users may experience certain side effects if they inject the affected medication. These side effects include local irritation, an allergic reaction, inflammation of a vein, restriction of blood supply to healthy tissue, pulmonary embolism, and pulmonary infarction.

The FDA explains that users should be sure to check the medication before injecting it. Specifically, users should look for discoloration or particulate matter. The drug’s manufacturer explained that the recalled medication was provided to medical professionals and law enforcement. The company has stressed that none of the recalled lots were distributed to individual patients.

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Medical errors are all too common in hospitals throughout the country. In any Maryland medical error case, a plaintiff must show that the defendant was negligent in acting or failing to act in some way. There are four elements a plaintiff must prove in order to be successful in a medical negligence claim: a legal duty, a failure to perform that duty, causation, and damages.

Medical errors cases can be hard to prove in some cases because a plaintiff must show that the defendant’s actions or failure to act were the cause of the plaintiff’s injuries. This can be tricky, especially in medical error cases, because patients are often already sick and proving causation is not always clear-cut. Additionally, the issues involved in the case are often complex and involve scientific principles beyond the understanding of most people. For that reason, such cases often rely on the testimony of experts.

In some cases, an expert is needed simply to understand whether mistakes were made and who may be at fault. As one example, a recent study revealed the problem of accidental overdoses from a drug that has been used on cancer patients for many years.

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Shingles is a viral disease characterized by a skin rash consisting of painful blisters that usually appear in a strip across a person’s face or body. While the symptoms of Shingles will usually go away within a few weeks, some experience nerve pain that can last years.

The disease is caused by a reactivation of the varicella zoster virus (VZV), the initial exposure of which causes chicken pox. The reason why the VZV virus reactivates is not widely understood by the medical community, although it is understood to occur more in the elderly and those with a compromised immune system.

There have been several vaccines created to prevent Shingles. As of 2017, a new vaccine called Shingrix was approved for patients over 50 years of age and can prevent most cases of Shingles. Once Shingrix was approved for use, it later became the preferred vaccine according to the Center for Disease Control (CDC). Unfortunately, it has been involved in Maryland pharmacy errors and errors in other states.

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Manufacturers of pharmaceutical drugs – like other products – are responsible for the products they market and release to the public. Some drugs pose a serious health risk due to potential negative interactions with other commonly taken medications, other medications are easily abused and can lead to dependence or addiction, and many pharmaceuticals can have serious side effects when taken improperly.

In general, the manufacturer of a medication is responsible to include an adequate warning, fully disclosing the risks involved with taking the medication. If a drug manufacturer fails to include an adequate warning with their product, they may be held liable for any injuries caused to those who take the medication through a Maryland product liability lawsuit.

Testosterone-Therapy Drugs

Testosterone-therapy drugs have been available for decades, and until recently, they have primarily been prescribed to younger men with low testosterone production. However, over the past few years, doctors have been prescribing testosterone-therapy drugs to older men. These medications, however, are not without their risks.

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