January 12, 2012

Drug Confusion Causes Eye Injury, $1 Million Lawsuit

455386_40748548_01182012.jpgThe U.S. Food and Drug Administration (FDA) issued an alert to pharmacists nationwide on December 28, 2011 regarding two drugs with similar-sounding names but very different uses, warning them of the risk of serious injury if one drug is accidentally substituted for the other. Durezol is an FDA-approved eye medicine that consists of a 0.05% solution of ophthalmic chemicals. Durasal, meanwhile, is a topical wart remover. It is not formally approved by the FDA, and it consists of a 26% solution of salicylic acid. Both drugs are available with a doctor’s prescription.

Ordinarily the FDA would screen trade names to see if they were substantially similar to an existing name in a way that might confuse consumers, but it never subjected Durasal to is formal approval process. Durasal reportedly went on the market shortly after the FDA approved Durezol.

Complaints about confusion between the two drugs began as early as 2009, with ophthalmic patients accidentally receiving the wart remover Durasal. Obviously a solution of more than a quarter acid is not ideal to place into one’s eye, and several patients have allegedly suffered severe eye injuries as a result. Durasal’s manufacturer, Elorac, Inc., has reportedly not responded to the FDA’s request to discuss a possible recall of the drug. The Philadelphia Inquirer reported that a company spokesperson at one time said the company planned to introduce a new product, also containing salicylic acid but with a different name. As of early January 2012, however, Durasal remains on the market.

A New York City patient filed a lawsuit against pharmacy chain Walgreens in early 2011 for mixing up the two medications. The man had just undergone minor eye surgery and went to fill a prescription for Durezol, the eye medicine. The pharmacy allegedly gave him Durasal instead, causing what he described as “grievous personal injury.”

The Consumerist reports that, despite packaging and warning labels, medicine mix-ups are a fairly common occurrence. They reference the story of an Arizona woman who mistook superglue for eyedrops in 2010 and needed emergency medical intervention. Eye drops may present a particular problem, since some patients may not able to immediately review the label and instructions due to impaired vision. The packaging for Durasal includes a clear warning that the product is “NOT FOR USE IN EYES,” but media reports do not indicate if pharmacies ordinarily dispense the medication in its original packaging, or if the warning was visible to the particular injured individuals.

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December 27, 2011

FDA Wants More Warning Label Information for Yaz

360579_3475_12172011.jpgA panel at the U.S. Food and Drug Administration (FDA) recommended that the labels for certain popular birth control pills, including the pill marketed as Yaz, should be updated to include new data that suggest an elevated risk of blood clots. The affected drugs are manufactured by Bayer. A panel of experts met for over nine hours on Thursday, December 8, to discuss data regarding blood clot risks with contraceptives containing the synthetic hormone drospirenone. It ultimately voted 21-5 to urge Bayer to update its labels. The panel had earlier voted 15-11 in support of keeping drospirenone-containing drugs on the market, a vote of confidence that the drugs still offer a benefit to patients. A full third of the panel voted against that recommendation. The FDA did not set a timetable for Bayer to change its labeling.

Bayer first released Yaz in 2006, and within a year its annual sales had reached $2 billion. This was boosted by an aggressive advertising campaign targeting women in their 20’s and touting the overall health benefits of the drug. In addition to its contraceptive benefits, ads claimed that Yaz could provide relief from PMS and acne. Millions of women started taking the drug, but by 2008 the possible health risks were becoming clear. Five studies conducted since 2009 have suggested a higher risk of potentially fatal blood clots, with one finding a 75 percent higher chance of developing blood clots as compared to patients taking older contraceptive drugs.

ABC News reports on a 24 year-old woman in Madison, Wisconsin who started taking Yaz in 2007 after seeing its ads on television. Within three months, she began to feel pain in her legs, which she attributed to time spent on her feet in her job as a nurse. The pain quickly turned out to be blood clots that traveled to her lungs, where they caused a pulmonary embolism. She spent almost two weeks in a coma, and when she woke up she had lost her sight. Whether her blindness is in anyway related to the drug is not known, but her blood clots are consistent with the findings of numerous studies of drugs containing drospirenone.

The Associated Press has a report on a 20 year-old California woman who died on Christmas Eve 2008 of a blood clot that had traveled to her lung. She had started taking Yaz two months earlier.

In 2008, the FDA sent a letter to Bayer regarding their advertisements for Yaz. FDA studies had shown that Yaz was not an effective treatment for PMS, and that it was not very effective at treating acne. State health authorities also made allegations of false advertising regarding Yaz’s supposed health benefits. Bayer reached a settlement in which it agreed to launch an expensive series of “corrective” television ads. These ads stated that Yaz could treat premenstrual dysphonic disorder (PMDD), a severe form of PMS, but was not indicated for the treatment of regular PMS.

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October 19, 2011

Study Shows Further Links between DES Exposure and Cancer in Women Exposed In Utero

A study recently published in the New England Journal of Medicine has expanded on the links between diethylstilbestrol (DES) and many forms of cancer. Researchers looked at 6,500 women, 4,600 of whom received exposure to DES while in the womb. They found substantially higher risk of cancer, including breast cancer and adenocarcinoma. They also found a higher risk of infertility and neonatal death. The study serves as a reminder of the risks posed during widespread use of DES decades ago, which led to a landmark court decision regarding liability for drugs that cause medical complications.

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DES is a synthetic form of estrogen first developed in 1938 and used to treat breast and prostate cancers, among other uses. The U.S. Food and Drug Administration approved it in 1941 to treat menopausal symptoms, vaginitis, and to suppress lactation after childbirth. It was used from the 1940’s to the 1980’s in estrogen-replacement therapy. It was a standard treatment for prostate cancer for 40 years, until more effective treatments were approved in the 1980’s. DES was also a common treatment for breast cancer from 1960 to 1977.

For a period of about 30 years, doctors gave DES to pregnant women believing it could reduce the risk of complications or losses in pregnancy in women with a history of miscarriage. The FDA approved DES for this use in 1947, but withdrew it from use with pregnant women in 1971 after studies linked it to certain tumors in girls and women exposed to the drug in utero. Further study showed medical complications in people exposed after birth. Women exposed to DES in the womb have been encouraged by the National Cancer Institute to seek regular specialized medical examinations to look for complications due to the drug.

Women who took DES while pregnant have shown a slightly higher rate of breast cancer. Women exposed in the womb, known as “DES daughters,” have shown a wide array of health complications, including multiple types of cancer. In addition to its carcinogenic properties, DES is considered a teratogen, meaning it can cause malformations in children exposed in utero. Men exposed to DES in utero have shown elevated rates of testosterone deficiency and neurological issues.

Once negative publicity developed around DES, multiple lawsuits were filed against the drug’s manufacturers across the United States in the 1970’s. This led to the California Supreme Court’s 1980 decision in Sindell v. Abbott Laboratories, which demonstrated the legal doctrine of market share liability. The plaintiff had developed cancer because of her mother’s use of DES. Due to the number of years that had passed from the time the mother took the drug to the time the daughter learned of her injuries, she could not identify the specific manufacturer of the pills her mother took. The doctrine put forth by the California court made all manufacturers of the drug liable in proportion to their share of the drug’s market at the time of use. Since then, courts have only applied the market share doctrine to cases involving pharmaceutical products.

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September 8, 2011

Fosamax Lawsuit in New York May Proceed, but With Limitations

A New York federal judge is allowing a lawsuit over the osteoporosis drug Fosamax to go forward, but with limitations. Judge John Keenan will allow plaintiff Linda Secrest to pursue her claim against Merck & Co., but she will not be able to claim punitive damages or to argue that Merck failed to warn her about potential risks in taking the drug. Secrest claims that a defect in Fosamax caused osteonecrosis of the jaw (“ONJ”), a condition in which the tissue in her jaw decayed. Secrest’s lawsuit is the fourth bellwether case against Merck over Fosamax, and the outcome will affect thousands of other Fosamax claims. Significantly, Judge Keenan stated in his decision that he found no evidence that any warning label would have caused Secrest’s prescribing physician to take her off the medication.

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Fosamax, or its generic equivalent alendronate, treats and prevents osteoporosis, a condition in which the bones weaken and can easily break. It first came on the market in 1995. The drug works by inhibiting bone resorption, the process by which bones break down with age. Doctors often prescribe the drug for women who have gone through menopause.

The FDA began to collect reports of ONJ as far back as 2000, and other complaints such as broken legs began to come in as well. A 2008 finding from the FDA indicated a possible link between the drug and certain cases of esophageal cancer. A report from the American Dental Association followed soon after that suggested a connection between ONJ and medications in the same class as Fosamax. A 2010 press release from the FDA warned of a possible elevated risk of thigh bone fractures. These correlations led quickly to litigation.

Secrest’s lawsuit began in Florida, and in August 2006 it moved to the U.S. District Court for the Southern District of New York to be consolidated with other similar lawsuits. Secrest, along with dozens more plaintiffs around the country, filed suit against Merck, Novartis Pharmaceuticals, Procter & Gamble Pharmaceuticals, Aventis Pharmaceuticals, Sanofi-Aventis, Walgreen Co. and Mouhannad Budeir DDS. The lawsuit, styled In Re: Fosamax Products Liability Litigation, seeks tort damages for personal injury and products liability. Three bellwether cases preceded Secrest’s case. Merck one two of those cases at trial, and the third resulted in am $8 million jury verdict against Merck, which Judge Keenan reduced to $1.5 million.

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August 3, 2011

Safety of Electronic Medical Records Questioned After Pharmacy Error Leads to Death of Infant

A recent Chicago Tribune article, that our Baltimore pharmacy misfill injury attorneys have been following, looks closely at electronic medical record safety, after a tragic medication error occurred, stemming from a computer mistake made at the Chicago-area Advocate Lutheran General Hospital, that caused the death of a newborn infant.

According to the article, Genesis Burkett, an infant born 16-weeks premature, was given a fatal overdose of sodium chloride last year, receiving over 60 times the dosage ordered by the physician. The hospital pharmacy error was reportedly made after a technician from the hospital pharmacy misread and inaccurately typed the doctor's handwritten prescription orders into a hospital computer—a common source of pharmacy misfills and errors, as attorneys have discussed recently in a Baltimore pharmacy error injury blog.

The data entry mistake then caused a pharmacy misfill, as the automated machine prepared an intravenous solution containing a lethal overdose of sodium chloride that caused the infant’s heart to stop. Advocate Health Care’s chief medical officer, Dr. Lee Sacks stated that the pharmacy error could have been prevented by the automated alerts on the IV compounding machine, but at the time that the customized bag was prepared for the infant, the alerts were not activated and connected to the main pharmacy information systems at the hospital. The family’s attorney reportedly blamed the pharmacy error and wrongful death on a mislabeled IV bag.

After the medication error led to the infant’s tragic death, Advocate has since added electronic alerts to the IV compounders and initiated other medication safety measures to prevent this kind of pharmacy error from happening in the future.

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July 29, 2011

Risperdal Recalled by Manufacturer Due to Drug Contamination

Our Talbot County, Maryland pharmacy error injury lawyer blog recently discussed a series of recalls drug maker Johnson & Johnson made last year, in an effort to maintain the health and safety of consumers—after complaints of an unusual smell causing nausea, vomiting, diarrhea and gastrointestinal pain were reported, due to trace amounts of 2, 4, and 6-tribomoanisole (TBA), a chemical used to preserve wood necessary in the construction of pallets used for transportation and shipping of the product packaging materials.

In related news, Ortho-McNeil-Janssen Pharmaceutical, the drug manufactures of Risperdal (risperidone), an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in adolescents and children, recently voluntarily recalled 16,000 bottles of the brand name drug and 24,000 bottles of the generic drug—also because of an unusual odor.

The Risperdal drug manufacturers found that the unusual smell was also caused by trace amounts of TBA, used to preserve wood pallets for the transportation and storage of product materials. While not considered to be toxic, a small group of patients have reported gastrointestinal symptoms when taking products with this offensive odor. The drug maker claims that the presence of TBA has not caused any reported serious adverse events, but the company has instituted a series of actions to reduce the potential of TBA contamination in the future, to avoid personal injury or harm to any consumers.

This is the second medication error warning surrounding Risperdal this year. Last month our attorneys discussed another warning involving Risperdal in a Baltimore pharmacy error injury blog, issued by the U.S. Food and Drug Administration, discussing potentially dangerous medication errors associated with Risperdal and Requip, a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, with 226 reports of patients receiving the incorrect medication.

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June 27, 2011

FDA Warns of Confusion between Risperdal and Requip, Leading to Medication Error

The Food and Drug Administration recently issued a warning about the potentially dangerous medication errors occurring with the drugs Risperdal (risperidone) and Requip (ropinrole)—with 226 reports of patients accidentally receiving the wrong drug, causing sickness and at least one death.

Risperdal (risperidone) is an antipsychotic used for the treatment of schizophrenia, autism side effects and bipolar disorder, and is reportedly being confused with Requip (ropinirole), a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, that acts in place of dopamine.

According to the Food and Drug Administration report, the medication errors are happening as a result of the drug name similarity as well as the similarity in generic drug labels and packaging, with overlapping drug characteristics such as the drug strengths, and dosing intervals. Other errors have reportedly stemmed from illegible handwriting on prescriptions.

Patients who were victims of the medication errors have reportedly experienced confusion, tiredness, hallucinations, and an altered or changed mental status, among others health problems.

The FDA warns patients who are taking the generic versions of Requip or Risperdal to notice the name and appearance of their medication, to know exactly why they are taking the drug, and to ask any questions and to report any difference in medication appearance to their pharmacists—to avoid pharmacy misfills or medication errors.

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May 19, 2011

Prescription Error Overdose Leads to Paralysis, Victim Hopeful for Recovery

Our Maryland pharmacy misfill injury attorneys have been following the recent developments in the tragic Walmart prescription error incident from 2008 that caused a teenager to suffer a pain medication overdose that led to paralysis.

When Jessie Scott was 18, and suffering from strep throat pain, his doctor prescribed a low-dose of the pain reliever, oxycodone hydrochloride. After receiving the prescription from Walmart, Jessie’s mother administered one dose to her son.

In a grave prescription drug error, the Walmart pharmacist reportedly failed to dilute the drug, and the prescribed dosage of 5 milligrams was actually around 100 milligrams, causing a prescription drug overdose. Jessie went into a coma, suffered organ failure and paralysis.

Scott, who is now 20 years old, has reportedly experienced some remarkable changes physically and psychologically, making incredible strides since the horrific incident that caused his disabilities. Thanks to a court prescription error lawsuit settlement with Walmart, Jessie’s parents were able to build an area in their house with special accommodations that allow him to be transported from room to room. He can now raise his arms, hold his head upright, wiggle his toes, and even kick. Although the odds seem to be against him, Jessie holds out hope that he will walk again.

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May 9, 2011

FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury

According to a recent article in the Wall Street Journal, a new national initiative is underway to make prescription medications clearer, and to decrease the rise of medication error that lead to hospitalizations and emergency room visits from patients who take their medication incorrectly—which according to the National Community Pharmacists Association happens to three out of every four Americans.

The U.S. Food and Drug Administration (FDA) is reportedly planning to test a new one-page information sheet to replace the many leaflet inserts and medication guides that are widely used in retail pharmacy chains across the country. And the U.S. Pharmacopeial Convention, the organization responsible for setting quality standards that are enforced by the FDA for the strength, purity and quality of medicines, has also developed a new program to create national standards for prescription labels, which currently vary greatly from pharmacy to pharmacy. The national label standard would require clearer instructions on the medication dosage, the medication timing and clearly state the purpose of the medication—to reduce medication and pharmacy error injury.

Currently, in pharmacies across the country, consumers may receive three different forms of drug information and pamphlets with their prescription medication—drug package inserts that are written by the drug manufacturer with FDA approval, drug guides for specific classes of drugs and products that are required by the FDA, and third-party consumer medical information. And according to the WSJ, recent FDA studies have shown that the drug information offered to consumers does not provide reliable understanding with the people taking the drugs, and is often conflicting in instruction, or even inaccurate, which could lead to patient harm or injury.

According to a recent FDA risk-communication advisory panel, more than half of adults misread or misunderstand one or more of common drug prescription precautions or warnings. In one study, patients were found to better understand language on warning labels that was simple and specific, like “use only on your skin” as opposed to “for external use only.” For consumers with lower English literacy skills, picture icons were provided, like a sun with a black bar, with the phrase, “limit your time in the sun.”

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April 27, 2011

Pharmaceutical Company Must Reveal Fentanyl Patch Data in Wrongful Death Lawsuit

In a recent Maryland pharmacy error injury lawyer blog, our attorneys discussed the increasing medication errors resulting from the incorrect administration of Fentanyl, the strong pain relieving medication patch. If a medication error occurs with Fentanyl, the improper administration of the drug can lead to a drug overdose or even wrongful death.

In a recent wrongful death lawsuit that our Baltimore pharmacy error attorneys have been following, Monika Standing and Chris Bristol are suing Watson Pharmaceuticals and two corporate affiliates after their daughter Nicole died three weeks after using the 75-microgram time-released fentanyl patches in January 2008. Nicole’s parents claim that her fentanyl patch, made by Watson, leaked—causing Nicole to suffer an overdose of the fentanyl gel inside, leading to her death.

According to the lawsuit, the fentanyl patches made by Watson used a faulty design, creating a patch that was prone to leaks, which lead to possible overdoses and deaths. Other patches made by competitors reportedly had a safer patch design that did not leak.

Last week, as the case developed, a Los Angeles County Superior Court Judge reportedly ordered Watson Pharmaceuticals to turn over pain patch samples, any materials used for commercials or marketing, all written communication between Watson Pharmaceuticals and the U.S. Food and Drug Administration involving the usage and safety of the fentanyl patch, all experiments or studies done involving fentanyl patch levels in the user’s bloodstream when using the patch, all autopsy reports and papers involving deaths while using the patch, and transcripts of all depositions taken of any Watson employee or key expert witness in a previous defective fentanyl pain patch lawsuit, and also ordered certain key executives from the company to testify about the pain patches.

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April 13, 2011

Children's Hospitals Form Collective Effort on Patient Safety to Prevent Medication Errors

According to a recent article in Pharmacy Practice News that our Washington D.C. pharmacy error injury attorneys have been following, a group of children's hospitals in Ohio have prevented around 3,600 adverse drug events and surgical site infections, along with saving over $5 million, during an 18-month program initiative that was launched in 2009.

The initiative, called “Solutions for Patient Safety,” was reportedly launched with support of the Cardinal Health Foundation, who gave 1.5 million, along with the shared motivation of children’s hospitals in an effort to work together to eliminate preventable injury or harm to children.

Before the initiative began, each children’s hospital in the state reportedly collected data on adverse drug events in a different way—making it very difficult to compare or share information within hospitals. After conducting audits of a random collection of charts, the group was able to come together and manually identify and review the root cause of adverse events, and pinpoint a set of common concerns.

The initiative found that the main collective medication error problem was constipation from opioids, as well as over sedation as a result of the narcotics. Although constipation is not a life-threatening adverse drug event, it can reportedly add to more time in the hospital, more lab work, and tests, which can all add to additional costs.

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March 22, 2011

500 Unapproved Prescription Cough and Cold Medications Banned by FDA

Our Maryland-based prescription drug error attorneys have been following the U.S. Food and Drug Administration’s recent announcement, ordering the makers of around 500 prescription cold, cough and allergy medications to take the drugs off the pharmacy shelves, as they have not been proven to be safe and effective.

According to the FDA, the prescription drugs in question have not been linked to any major problems or drug-related injuries, but the FDA is still concerned that the medical problems associated with the drugs could be seriously under reported.

The agency claims that the drugs have not been evaluated by the FDA, and taking them may be more of a risk to the consumer than taking over-the-counter (OTC) medications to treat the same symptoms, that have been approved. The FDA also claimed that the action is necessary to protect consumers from any health and safety risks posed by these unapproved drugs, as the agency does not know how they are made, whether they are effective, or what is in them.

One of the problems that the agency found was with time-release drugs, which are reportedly hard to manufacture, and can release too slowly or not at all if quality controls in the manufacturing of the drug are inadequate. The FDA also made a move against unapproved products that contain drug combinations that could be considered dangerous, like combining two antihistamines, which could react in oversedation.

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March 22, 2011

Hospital Sued for Wrongful Death After Patient Dies from Drug Error

Our Baltimore-based pharmacy error injury attorneys have been following the recent and tragic news story surrounding a Massachusetts woman, who endured a hospital medication error during a routine hospital stay that reportedly led to her wrongful death.

According to the Boston Globe, Geraldine Oswald was hospitalized in November of last year to clear up an infection that had developed after breaking her shoulder. While staying in the hospital, she reportedly received too much Lepirudin, a blood-thinning drug used to prevent the formation of potentially dangerous blood clots. The medication overdose affected Oswald’s own blood clotting ability, leading to internal bleeding. While in the hospital’s care, Oswald reportedly hemorrhaged for 12 hours before her wrongful death—which the hospital later stated could have been preventable.

The family of Oswald recently stated that they plan to file a wrongful death lawsuit against Massachusetts General Hospital, two nurses and five doctors, claiming that Oswald was supposed to be treated for a common infection, and instead received a blood thinner that was 30 times too high in dosage, and proved to be lethal.

According to the hospital’s report, the on-duty nurse understood the dosage intended for Oswald, but made a medication error while administrating the dose into the I.V. pump. In a meeting with Oswald’s family members after her death, the hospital reportedly stated that the medical error was preventable.

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February 5, 2011

Dangerous Safeway Pharmacy Mix-up Gives Pregnant Woman Wrong Medication

In recent news that our pharmacy misfill injury attorneys in Washington, D.C. have been following, a medication error occurred in a local pharmacy, after a pregnant woman in Colorado was mistakenly given the incorrect medication for another patient who had a similar sounding name.

According to KDVR-TV, Mareena Silva, who is six weeks pregnant, went to Safeway to pick up her antibiotics and was mistakenly given the prescription for Maria Silva, containing Methotrexate, a medication reportedly used to treat cancer.

By the time Silva realized the pharmacy misfill, she had already reportedly taken the first pill. Silva reportedly rushed back to Safeway, where the pharmacist recommended that she throw the pill up, as it had been 30 minutes since she took the medication. Her doctor then sent an ambulance to Safeway.

Methotrexate, the drug Silva took due to the prescription mix-up, can reportedly cause birth defects in an unborn baby. The drug is also reportedly used to cause abortions in pregnancies that are troubled. The manufacturer also warns that there have been reported deaths linked to the incorrect administration of this drug.

After picking up what she thought was the antibiotic, the pharmacist reportedly even stated that the prescribed drug was not good for a pregnant woman. What Silva didn’t realize at the time is that the pharmacist was talking about the Methotrexate.

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February 4, 2011

Study Finds Small Doses of Drugs From Syringes Could Cause Medication Error in Children

As our Baltimore County pharmacy error attorneys discussed in a recent blog, according to a recent study by the Agency for Healthcare Research and Quality (AHRQ), medical errors are a leading cause of personal injury and death in this country, and rates for possible adverse drug events were three times higher with children than adults in hospitals, with an even higher rate for infants in intensive care units.

In a new study, published in the Canadian Medical Association Journal, a report found that preparing small medication dosages from syringes for infants and children can be dangerously inaccurate and cause medication dosing errors.

According to the report, in administering potent drugs to young patients, small doses are often prepared from medication stock of less than 0.1 milliliter (mL) in size, but the current equipment used to administer the drug does not allow for the correct and accurate measuring of drug volumes that are less than 0.1 mL.

Dr. Christopher Parshuram, the author of the study, who works in the University of Toronto's Department of Pediatrics and directs the University of Toronto Center for Patient Safety's Pediatric Patient Safety Research, stated that medications regularly requiring small doses include narcotics and sedatives that are extremely powerful, such as morphine and fentanyl—both drugs that as our Maryland medication error attorneys have reported in a recent blog, have a high-risk for medication mistakes which could lead to patient injury or wrongful death.

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January 26, 2011

FDA Reports on Fatal Morphine Oral Solution Medication Errors

According to a recent report from the U.S. Food and Drug Administration (FDA) that our Washington D.C. medication error lawyers have been following, a morphine solution that was approved by the administration last year, has been linked to a series of morphine overdoses and deaths due to medication error—leading federal regulators to issue a warning and initiate a label change to prevent personal injury or death.

The FDA’s recent notification to the health care industry and consumers reported on the overdoses and deaths that have occurred as a result of morphine sulfate oral solution medication errors, most of which are linked to the high potency (100 mg per 5mL) product, where solutions ordered in milligrams (mg) were erroneously mistaken for milliliters (mL) of the drug, causing fatal overdoses.

When milligrams (mg) are misread and confused for milliliters (mL), the patient dosage could reportedly be as high as 20 times stronger than the dosage intended for the patient, which could result in a drug overdose. Other medication mistakes were reportedly caused by confusion in medication dosage, and understanding the morphine concentration in the oral solution.

As our medication mistake attorneys in Baltimore, Maryland have reported in a related blog, according to the Institute of Medicine’s (IOM), 1.5 million people are injured by preventable medication errors every year, with 98,000 annual deaths from medical errors—7,000 of which are due to medication mistakes.

The morphine sulfate oral solution is manufactured by Roxane Laboratories, Inc., and is used to tread moderate to severe chronic and acute pain with patients who are opioid-tolerant. In a blog from this week, our attorneys discussed the danger associated with an incorrect administration of a powerful prescription pain medication and the prevalence of fatal medication overdoses with patients who are opioid-intolerant and are erroneously prescribed these medications.

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January 25, 2011

ISMP—Prescribing Fentanyl Pain Medication for Short-Term Pain Be Deadly

In a recent blog, our Baltimore County pharmacy misfill attorneys discussed the prevalence of medication error cases resulting from the incorrect administration of the strong pain relieving medication Fentanyl, also called Duragesic—that if used erroneously can lead to a drug overdose and even wrongful death.

According to a recent article by Michael Cohen, president of the Institute for Safe Medication Practices, (ISMP), Fentanyl is around 100 times more powerful than morphine and for that reason should only be prescribed to people with chronic and long-term pain, like cancer patients, who are opiod-tolerant from already taking heavy prescription narcotics, or opioids, for one week or longer. As Cohen describes, Fentanyl is effective for three days, keeping patients with long-term pain from having to medicate repeatedly during the day.

As our Baltimore, Maryland medication error attorneys reported in a related blog, Fentanyl should only be used with patients who are opioid-tolerant because even the lowest strength Fentanyl patches have the ability to cause major side effects, like breathing difficulties, which can lead to wrongful death. According to the 2007 FDA warning, the Fentanyl patch should not be used with patients who are not opioid-tolerant.

Cohen explains that patients who are opioid tolerant and tolerant of other prescription pain medications have less of a chance of experiencing breathing difficulty when using a Fentanyl patch that is properly prescribed, as stopped breathing is often what kills patients in an overdose. According to Cohen, the big medication mistake currently being made by doctors is using Fentanyl to treat pain post-surgery pain, called acute postoperative pain, which should be treated by using other painkillers.

The ISMP has reportedly been receiving fatality reports since the drug has been introduced, but September of last year proved to be a devastating month for Fentanyl medication overdoses, as three tragic deaths occurred after patients were given Fentanyl by their doctors erroneously, with doses that were too high, at 50mcg/hour.

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January 4, 2011

Man Died from Overdose of Fentanyl—Widow Sues Center for Medication Error

Last year, our Baltimore medication error attorneys reported on two cases involving alleged overdoses of the powerful pain medication Fentanyl—one blog discussed a wrongful death lawsuit, where an 68-year-old died after allegedly receiving an incorrect dosage of the potent pain killer, and another blog discussed an overdose of duragesic pain patches, where a care center staff reportedly failed to follow the doctor’s prescription and wait 72 hours before increasing the pain dosage, which also led to a fatal overdose.

In recent news, the widow of a man from Illinois is suing a local pain treatment center for the wrongful death of her husband, due to a medication error of Fentanyl, administered through a SynchroMedII pump. According to Sue Daniels, her husband Tony was admitted in December 2009 to the Piasa Pain Center and was given an incorrect dosage of Fentanyl, which caused him to overdose from the medication error and led to his death. When Daniels became unresponsive from the overdose, he was transferred to Alton Memorial Hospital. Sue claims that the Fentanyl injections caused him to suffer from severe brain damage and lung injuries. He died two years later.

Sue Daniels accuses the pain center of negligence for administering the lethal dosage of pain medication, and blames the managers of the pain center for failure to properly train the medical staff on how to use the equipment. Alton hospital is also named in the suit for not treating Daniels fast enough after the overdose, and for running the Piasa Pain clinic that reportedly administered prescription drug error. Medtronic is also listed as a defendant for manufacturing a pain pump that is allegedly defective.

Sue Daniels is asking for over $500,000 in damages for medical bills, court costs, pain and suffering.

The opioid fentanyl is a narcotic used for patients who are opioid-tolerant from using another potent narcotic pain medication for a week or more. The opioid-tolerant patients are often prescribed Fentanyl when they need an even stronger narcotic for strong pain relief. Fentanyl is only recommended for patients who are opioid-tolerant, as even the lowest strength fentanyl patch has the ability to cause severe side effects, and even wrongful death, according to the FDA. The FDA does not recommend fentanyl patch usage with patients who are not opioid-tolerant—as the warning stated in 2007.

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November 3, 2010

Study Shows Barcode eMAR Technology Can Help Reduce Medication Errors

In a recent blog, our Maryland pharmacy error injury attorneys discussed reducing medication error and patient injury with barcode electronic systems, that link barcodes on the patient’s wrist bracelet with the patient’s electronic records and prescriptions, to ensure that the medication and dosage match the prescription for the patient.

According to a recent study that the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Maryland, has funded, barcode technology, working together with eMAR, the electronic medication administration system, can help reduce medication errors by over 50%. The study was published earlier this year, in the May issue of the New England Journal of Medicine.

Barcode eMAR combines technology to ensure that each patient is given the proper medication with the correct dosage at the right time, in order to prevent medication errors or patient injury. When this combination of technology is used, before administering the medication, the nurses must scan the barcode on the patient’s wrist bracelet, and then scan the medication. If both barcodes don’t match the approved medication, or the timing is not correct for the patient’s next dose, an alert is issued by the system. If the patient’s medication is overdue, warnings are also sent out to the nurses.

In the study, researchers at Boston’s Brigham and Women’s Hospital compared 6,723 medication administrations given on hospital units before the barcode eMAR was introduced with the 7,318 administrations of medication given after the barcode system was introduced.

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October 1, 2010

Reporting Children’s Medication Errors Can Help in Prevention

A recent news article reports that medication errors are among the most common mistakes made by healthcare practitioners—and also among the most under reported.

In a tragic medication error from last year, a child at Seattle Children’s Hospital died from a medication error allegedly involving Calcium chloride. The hospital reported its mistakes to the health department and has acknowledged them publicly. Calcium chloride, the medication that reportedly caused the child’s death, is listed on the Institute for Safe Medication Practices' (ISMP) class of pharmaceuticals as one of the institute's "high-alert" medications.

According to the Agency for Healthcare Research and Quality (AHRQ), medical errors are one of the leading causes of death and injury in the U.S. The AHRQ reported in a recent study that rates for potential adverse drug events in hospitals were three times higher with children than adults, with an even higher rate for infants in intensive care units.

According to Dr. Allen Vaida, executive vice president of the Institute of Safe Medication Practices (ISMP), acknowledging medication errors and reporting them is the most important step toward prevention. Vaida claims that children are especially vulnerable to drug overdoses in hospitals because of calculation errors that can occur with medications. Nurses must administer the medication dosages according to a child's body weight and other necessary factors, that can lead to medication mistakes. He claims that in situations like this, it is important to share information about the medication errors that do occur, as reporting them can prevent errors from happening in the future.

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