Pharmacy Error Injury Lawyer Blog
Posted in: High Alert Drugs
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Drug Manufacturer Recalls Vaccine Due to Expired Ingredients
Two Families Sue Pharmacy, Alleging Their Children Received Incorrect Dosages
Two mothers are suing a pharmacy in Gig Harbor, Washington, claiming that their sons received incorrect dosages of prescription seizure medications. In both cases, the parents claim that the dosages dispensed by Olympic Pharmacy were big enough to be almost fatal for the children. The Washington state Board of Pharmacy has reportedly begun an investigation of the pharmacy based on the claims made in the lawsuits.
Laura Carlson says that Olympic dispensed the wrong dosage of medication for her son Chad twice in a period of about two years. In 2009, 11 year-old Chad received a prescription for 8 mls of Lorazepam, a powerful medication used to treat seizures and anxiety. The pharmacy allegedly dispensed the medication in a single pre-filled syringe. Chad reportedly became dizzy after taking the medication, eventually becoming unresponsive. He ended up hospitalized for four days while enduring hallucinations. Carlson looked at the packaging and saw that the prescription was for eight syringes, each containing a 1 ml. dose. Chad had significantly overdosed.
In 2011, Chad’s prescription had changed to pills rather than injections. Carlson filled a prescription at Olympic for 300 mg pills of Lorazepam. When Chad took them, he reportedly began vomiting repeatedly and violently. The pharmacy, it turned out, had given him 600 mg pills, doubling his dosage.
Kaeley Triller’s 3 year-old son reportedly had a similar experience in January. She says that Tristan Triller suffered insomnia, convulsions, and hallucinations after he took anti-seizure medication obtained at Olympic. Doctors at the ER determined that he had received four times the prescribed dose of medication. Once Tristan recovered, Triller did not consider the matter again until she learned of Chad Carlson’s two overdoses.
Both parents have filed lawsuits against Olympic, claiming the pharmacy negligently dispensed incorrect dosages of medications to their children at least three times in the past three years. Carlson’s suit reportedly claims that the pharmacy “poses an imminent public health danger” because of repeated medication errors and a lack of procedures and oversight to prevent future misfills.
Washington’s Board of Pharmacy also reportedly initiated an investigation of Olympic, based at least in part on the claims made by Carlson and Triller. The Board reportedly conducted fifty investigations of alleged pharmacy errors around the state in 2011. The Board has the authority to penalize licensed pharmacists, such as through fines or license suspensions, but it is limited to an administrative process. It cannot recover damages for the injured parties through litigation.
Family of Woman Who Died After Receiving the Wrong Medication Sues the Pharmacy
The family of a Kentucky woman who died after allegedly receiving the wrong prescription medication has sued the pharmacy that dispensed the medication. The two medications have similar-sounding names but very different purposes. The family’s lawsuit alleges negligence and violations of state law that caused or contributed to the woman’s death.
Mary Moore, an elderly Louisville resident, had just been discharged from the hospital on November 10, 2010, where she had undergone treatment for congestive heart failure, kidney failure, and high blood pressure. She went to a Walgreens pharmacy to fill a prescription from her doctor for Hydralazine, a drug used to treat high blood pressure. The pharmacy instead gave her Hydroxyzine, an antihistamine considered unsafe for people over the age of 65.
Because of the alleged error, Moore’s high blood pressure was completely untreated for two weeks. The pharmacy discovered the error and gave her the correct medication, but by then the damage was done. Moore reportedly could not tolerate the prescribed dose of the blood pressure medication. According to the lawsuit, the medication could not control her blood pressure, and the stress on the heart caused “decompensation” of her congestive heart failure. This was followed by “decompensation of her chronic kidney disease.” Within a few days of starting the Hydralazine, Moore was hospitalized again. She died on December 6, 2010.
The lawsuit names as defendants both Walgreens and the pharmacist in charge at the time the medication was dispensed to Moore. Moore’s family primarily alleges that Walgreens and the pharmacist were negligent in dispensing the wrong medication. They further allege that, by not offering Moore counseling from a pharmacists when she picked up the medication, Walgreens violated state law. The law, according to their complaint, requires a pharmacist to offer a consultation with a patient picking up a medication for the first time. Had the pharmacist offered a consultation with Moore, the plaintiffs argue, one of them would likely have noticed the error with the medication
Hydralazine is a muscle relaxant used to treat high blood pressure and other conditions. It works by relaxing the blood vessels that allow blood free flow through the body. Hydroxyzine, on the other hand, is an antihistamine used to treat allergy symptoms of allergies such as itching, and to treat nausea-related symptoms resulting from conditions like motion sickness. The National Institutes of Health specifically recommend against the use of Hydroxyzine by people over the age of 65, noting that other medications offer similar benefits at a lower risk. In this case, though, the issue was not the treatment of allergies at all.
Voluntary Recall Announced for Certain Oral Contraceptives Due to Packaging Error
The U.S. Food and Drug Administration (FDA) announced on February 24 that Glenmark Generics USA, the North American division of Indian pharmaceutical company Glenmark Generics, Ltd., was voluntarily recalling seven lots of oral contraceptives at the consumer level. The recall is reportedly due to a packaging error, in which blisters were oriented incorrectly within the packaging for the tablets. This may cause the sequence of tablets to be incorrect, causing patients to take the tablets in the wrong order. This could therefore cause the overall treatment to be ineffective, leading to insufficient contraception and other health risks. The FDA recommends that anyone using oral contraceptives with the faulty packaging should immediately switch to a non-hormonal form of contraception.
Glenmark has not said how many total packages are affected by the recall, only the number of lots. It has said that a sufficient amount of the product is still available on the market, so the recall should not significantly impact the total supply. The tablets were reportedly manufactured by Glenmark in India and distributed by its North American division to retail pharmacies and wholesalers.
The affected products contain a mixture of Norgestimate and Ethinyl Estradiol in varying proportions. Both are hormones used in oral contraceptives, the treatment of menopause symptoms, and other conditions. Patients are instructed to take specific tablets at specific times during a 28-day period, and an interruption of the prescribed cycle can interrupt the contraceptives’ efficacy. The specific tablets covered by the recall, according to the FDA, contain tablets with doses of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg of the two compounds.
The FDA says that the packaging error does not pose any immediate health risks to women using the product. The principal risk, it says, is that unintended pregnancy could result from a lapse in contraceptive coverage resulting from the error. It could potentially pose health risks to people using oral contraceptives for non-contraceptive reasons, but that issue is not addressed by the FDA’s announcement.
Earlier in February, pharmaceutical company Pfizer also issued a recall of twenty-eight lots of similar generic tablets and brand-name Lo/Ovral-28 tablets. The tablets, manufactured by Pfizer and labeled under its Akrimax Pharmaceuticals brand, had similar packaging errors to the Glenmark product. Packaging on the Pfizer products might indicate the wrong sequence of tablets and contain inaccurate information on ingredients. Some tablets contain active ingredients and others only inert ingredients, and the sequence is critically important. The recall affected around 1 million packages.
Pharmacy Mistakenly Gives Cancer Medication to Multiple Children
Children who should have received chewable fluoride tablets may instead have received Tamoxifen, a drug used to treat breast cancer, from a CVS Pharmacy in Chatham, New Jersey. Up to fifty families, according to initial reports, may have been affected by the error, in which the pharmacy dispensed the wrong medication over a period from December 1, 2011 to February 20, 2012. The fluoride pills, prescribed by dentists to prevent tooth decay, are typically flavored, while the cancer medication reportedly has a bad taste if chewed. Because of this, pharmacy representatives say that children would probably have noticed that they had received the wrong medication.
CVS issued a statement saying that children from roughly thirteen families mistakenly received Tamoxifen pills mixed in with the fluoride tablets. A spokesperson attributed the error to a “single medication restocking issue” at the one pharmacy location. The error affected the supply of 0.5mg fluoride tablets. The pharmacy reported that, according to the families they contacted, none of the children actually received any of the incorrect pills.
According to the Associated Press, Tamoxifen acts by blocking the female hormone estrogen. As such, it is not likely to cause serious harmful side effects to a child if taken for a short period of time. The New Jersey Attorney General’s office and the state’s Division of Consumer Affairs have nevertheless ordered the pharmacy to produce records for the period from December to February to account for the mixup. The pharmacy reports that it is still investigating the matter and is cooperating fully with state authorities.
The particular incident had a positive outcome because, fortunately, no one was injured, and the particular drug involved in the mixup had limited potential to cause harm. It underscores the critical importance, however, of remaining watchful for errors that can occur. In addition to checking to see that the label on the medication bottle matches the prescription, patients should also confirm that the medication itself matches the description. Many prescription bottles include a physical description of the medication itself, identifying the shape and color of the medication and stating whether it is in tablet, capsule, or another form. Not all pharmacies include this information on the bottle itself, but all prescriptions should include an insert with comprehensive information about the drug, including a physical description. This is a patient’s last line of defense against potential pharmacy errors.
Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements
Shortages of certain prescription medications are nothing new to most pharmacists, hospitals, and doctors. According to the American Hospital Association, nearly 99.5 percent of U.S. hospitals reported some drug shortages in the first half of 2011, with 44 percent experiencing shortages of more than twenty drugs and 78 percent rationing drug supplies to deal with shortages. The Food and Drug Administration (FDA) reports that the number of drugs reported to be in short supply has increased from around 55 in 2006 to 178 in 2011, and the number could go as high as 350 for 2011 when statistics become available. Aside from basic problems of availability of medications to patients who might desperately need them, the situation also lends itself to unscrupulous behaviors like price gouging and hoarding. The nonprofit research and advocacy group CorpWatch recently issued a report on concern over “grey markets” that spring up for certain drugs that are in demand but also in short supply.
“Grey markets” can endanger patients not only by charging high prices for drugs, but also by removing key quality control procedures and the professional safeguards enjoyed when dealing with licensed doctors and pharmacists. The CorpWatch report describes how a New Hampshire woman found her routine appointments for cancer treatment cancelled when the hospital could no longer obtain her medication. Her particular medication, doxorubicin, trade name Doxil, is used to treat breast cancer and many other forms of cancer, and it is one of the few possible treatments for many people.
The CorpWatch report claims that Doxil’s manufacturer, Johnson & Johnson, actually subcontracts many of the stages of production, which has caused significant delays in production schedules for the drug. A single facility in Ohio manufactures Doxil, according to the Los Angeles Times, and it reportedly cannot keep up with demand. The plant closed temporarily due to concerns over product safety, which only made the shortage worse.
The FDA recently announced that it has approved the importation of shipments of substitutes for Doxil and another cancer drug, methotrexate, from foreign manufacturers. Lipodox, a drug manufactured by Indian company Sun Pharma Global, will temporarily replace Doxil. Australian company Hospira will send shipments of its version of methotrexate, a drug used to treat childhood leukemia. At best, these shipments will cover shortages for no more than a few months. Doctors interviewed by the New York Times stressed that this solution is extremely temporary.
Children’s Shelter Staff Prone to Medication Errors, Says Grand Jury
A grand jury in Kern County, California recently asked an emergency juvenile shelter to report on how its staff handles prescription and over-the-counter medications for children that are sheltered there. It also called on the county’s Department of Human Services to make a registered nurse available at the shelter 24 hours a day. The grand jury’s actions came after news of medication errors appeared, along with allegations that the shelter is violating state regulations by having staff members provide medications to children without oversight by medical professionals. The dispute has also sparked a debate over semantic issues of who may “dispense” medications.
The A. Miriam Jamison Children’s Center is a 24-hour emergency shelter for “abused, neglected and exploited children” operated by the Kern County Department of Human Services. It provides temporary shelter for children in the protective custody of law enforcement or social services. Over the past year, news of several errors in providing medications to children at the shelter reached the director of the Department of Human Services. Errors have included incorrect doses of medications and incorrect medications. No serious injuries have been reported, but the risk of injury is certainly present. Children have had to go to Kern Medical Center (KMC) because of medication errors at least twice.
After officials put an employee on administrative leave for a medication error, some shelter employees began to refuse to handle medications for children. The Service Employees’ International Union (SEIU) also stepped in, arguing that employees who were not registered nurses could not legally give medications to children under state nursing regulations. Additionally, the shelter reportedly has an agreement with KMC, which sends nurses to the shelter for children’s medical issues, that shelter employees will not deal with children’s medications.
The grand jury’s investigation centers around state regulations and the shelter’s agreement with KMC, but it has also sparked a debate over exactly what activities by shelter staff are prohibited. State law says that only registered nurses may “dispense” or “administer” medications. Pharmacists “dispense” medications by counting and packing pills. Nurses “administer” medications by giving doses directly to patients. The Department of Human Services argues that shelter employees do not do either of these, but rather “deliver” medications to children by taking them from a labeled container, following the container’s directions, and giving them to the children to take.
Layoffs of School Nurses Lead to Concerns About Medication Errors
The Philadelphia School District laid off 141 employees at the end of 2011, including forty-seven school nurses. Schools across the country, facing budget shortfalls, are turning to layoffs. Many schools now have no full-time nurses, relying instead on other staff, including coaches and teacher’s aides, to dispense medications to students during the school day. Nurses, teachers, and others have complained that this puts students at greater risk of injury due to medication errors. School nurses deal with more than just scraped knees. Many students require careful administration of medications for asthma, diabetes, seizure disorders, attention deficit disorder, and more.
The district’s largest union, the Philadelphia Federation of Teachers (PFT), filed a formal complaint at the end of January, alleging that the use of non-nurse staff to dispense medications to students violates state law. Some nurses, the PFT says, must cover multiple schools, meaning that students have long wait periods for functions schools are required to perform under the Department of Health’s Guidelines for Pennsylvania Schools for Administration of Medications and Emergency Care. Staff members who do not have training and certification in nursing do not always know what sort of care students need, and they are more likely to make mistakes.
The Philadelphia Inquirer has run a series of stories about the risks students face with limited nursing staff available in schools. Accounts of errors range from missed dosages of medicine to accidental administration of the wrong medication. In several instances, staff members confused the drug methyphenidate, the generic name for the ADD drug Ritalin, with the narcotic pain medication methadone. The two drugs have similar names, but very different purposes and effects.
According to the Inquirer, research has suggested that use by schools of “unlicensed assistive personnel” (UAP’s), meaning staff members who are not licensed nurses, makes medication errors three times more likely than when a nurse is available. Schools also take an increasingly active role in medical care for students, as more and more children receive treatment for diabetes and other chronic illnesses, and more students report problems with food allergies. A study from the University of Iowa cited by the Inquirer found that 5.6 percent of children in the surveyed schools received medications in school on a daily basis, with 3.3 percent receiving ADD medications. Nearly half of the nurses reported encountering medication errors. The most common error was missing a dosage that a student should have gotten, but nurses also encountered children receiving someone else’s medication and staff administering medications incorrectly (such as ear drops going in the eye). Most of these errors involved UAP’s.
Pharmacist Institutes Program of Double-Checking Discharge Papers, Cuts Hospital Pharmacy Errors to Near Zero
The hospital pharmacy services director at Minnesota’s Hennepin County Medical Center, Bruce Thompson, noticed several years ago that his staff would often discover medication errors when patients returned to the hospital after treatment. The Minneapolis Star-Tribune recounted the story of a patient who left the hospital after a kidney transplant with incorrect dosage instructions for the prescribed antibiotics. The hospital discharged a patient who had been treated for a pulmonary embolism without an essential blood thinner. Thompson wondered how common such mistakes were at the hospital, so he enlisted some colleagues to review thirty-seven patients who had been discharged from the hospital to area nursing homes during a three-month period at the end of 2008 and beginning of 2009
Thompson discovered that only three of the thirty-seven cases he reviewed had no problems. That meant an error rate of ninety-two percent, with about a third of the errors deemed “likely harmful.” The most common errors included prescriptions with incorrect dosages and duplicates or omissions of medications at discharge.
To reduce the surprisingly-high rate of errors, Thompson and the hospital administration had pharmacists review all patients’ discharge orders before the patients left the hospital. This allowed the pharmacy one last opportunity to spot mistakes and notify the patient’s doctor to resolve the problem.
According to the hospital’s report, the rate of errors dropped to almost none nine months after they started pre-release review by pharmacists. This also reduced the hospital’s readmission rate to around five percent, meaning far fewer patients were returning to the hospital for additional treatment after their discharge.
The Institute for Safe Medication Practices, which offers education and support to healthcare organizations, gave Hennepin County Medical Center one of its “Cheers” Awards in 2010. This award recognizes people, organizations, or businesses that “have set a superlative standard of excellence” in preventing errors relating to medication errors or drug incidents.
The improvement in patient safety in the hospital pharmacy is welcome news, although it is just one part of a hospital’s operations, and mistakes can occur almost anywhere. Hennepin County Medical Center ranked relatively low, for example, in a review of Minneapolis-area hospitals conducted by the U.S. Department of Health and Human Services that looked at infections resulting from central lines used in critically ill patients. This is a relatively rare procedure, and the hospital still performed above the national average. It nevertheless demonstrates that medication errors and infections do not occur solely in the pharmacies or upon discharge.
Jury Awards $12.6 Million to Teenager Who Lost Her Limbs Due to Vaccination Error
A jury in Miami awarded $12.6 million to Shaniah Rolle, a teenager who had to have all four limbs amputated because of a vaccination error thirteen years ago. After a five-week trial, the jury deliberated for three days before reaching a verdict. Rolle will not recover the full amount of the award, however, as the jury also found that her mother was forty percent negligent in the events that led to Rolle’s injuries. The defendant, the University of Miami’s Miller School of Medicine, will probably appeal the verdict.
As a young child, Rolle suffered from intestinal problems. Doctors concluded that they would have to remove her spleen and other organs. Since the spleen ordinarily protects the body from illness by filtering bacteria and other intruders, she would need medication to guard against infection. Her mother took her to the medical school’s pediatric unit in October 1998 for a checkup. A medical assistant gave Rolle an injection of a vaccine formulated for people without spleens. The assistant did not realize that the vaccine had expired five months earlier.
Because the vaccine failed to provide her protection against certain types of infection, Rolle became extremely ill about eight months later. At another hospital in Miami, doctors learned that she had a bacterial infection through her entire body that led to blood clots in her limbs. All four limbs had developed gangrene and had to be amputated above the joints.
Since then, Rolle has reportedly led a normal life. She attends Miramar High School in Miramar, Florida, and with the help of prosthetic limbs, she is on the school’s cheerleading squad.
Rolle’s mother filed suit against the medical school and the doctors who treated Rolle. Defense attorneys argued that Rolle would have become ill with or without the vaccine. A defense expert testified at the trial that the mother did not give Rolle enough medication to allow her to avoid infection. This was the basis of the jury’s conclusion that the mother was forty percent negligent. This means that the total award will be reduced by the amount of the mother’s negligence, so instead of $12.6 million she can recover around $7.56 million. This could be delayed even further, of course, if the hospital appeals.