Pharmacy Error Injury Lawyer Blog

FDA Wants More Warning Label Information for Yaz

December 27, 2011 | Lebowitz & Mzhen

A 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.

State Revokes Three Professionals’ Licenses to Prescribe Medication

December 20, 2011 | Lebowitz & Mzhen

The Delaware Secretary of State’s Office has suspended the Controlled Substance Registrations of two medical doctors and a nurse practitioner because of allegations that they overprescribed a number of controlled substances in unreasonable and excessive amounts. Complaints filed against the the three, who all worked in the pain management field, further allege that they disregarded evidence that some of the prescribed medications were being abused or even diverted. The suspension immediately halted their legal authority to write prescriptions. One physician and the nurse practitioner reportedly also surrendered their Drug Enforcement Agency (DEA) registrations to federal authorities. The doctors may face further disciplinary action beyond the Secretary of State’s investigation.

One of the physicians, Dr. Mohammed Niaz, worked with the nurse practitioner, Jean Binkley, as her supervisor. The Secretary of State alleges that Dr. Niaz wrote prescriptions for over 57,000 tablets of various controlled substances during the first seven months of 2011. This amount included 42,000 tablets of the Schedule II narcotic Oxycodone. Binkley is alleged to have separately written prescriptions for over 89,000 Oxycodone tablets.

The state further alleges that one patient, using prescriptions obtained from Niaz and Binkley, obtained 360 Oxycodone tablets and 90 tablets of Alprazolam within a two-week period earlier this year. This is considered an unreasonable amount for one person for such a brief period of time. Alprazolam is the generic name for the drug Xanax, a Schedule IV controlled substance used to treat anxiety, but also highly prone to abuse. Both types of drug can be highly addictive and dangerous if abused, and their distribution is strictly controlled. The state alleges that many of the drugs obtained through prescriptions written by Niaz and Binkley ended up in the hands of people who did not have a prescription and did not have guidance on how to use the drugs safely.

Dr. Patrick Titus allegedly wrote an even greater number of irregular prescriptions. One pharmacy’s records reportedly showed 3,941 prescriptions written by Dr. Titus between January and November 2011, accounting for almost 750,000 pills of seventeen Schedule II narcotic pain medications such as Oxycodone, Oxycontin, and Morphine.

The Secretary of State launched an investigation with the assistance of the Delaware Attorney General’s office and the Division of Professional Regulation. Delaware law empowers the Secretary of State to revoke a medical professional’s license to prescribe medicine if “continued registration would be inconsistent with the public interest.” The Secretary of State’s reasoning in this case seems to be that these three medical professionals have established a sufficiently questionable prescription history, and that they would constitute a threat to the public interest if allowed to continue writing prescriptions.

Doctors Offer Five Steps to Help Seniors Reduce Their Risk of Drug Side Effects

December 14, 2011 | Lebowitz & Mzhen

For people over the age of 65, two-thirds of emergency room visits result from side effects of medications in two broad categories, according to the Boston Globe and the New England Journal of Medicine. The categories are medications used to treat heart disease and those taken for diabetes. The study specifically lists blood thinners and anti-platelet drugs in the heart disease category, and blood-sugar-lowering drugs and insulin in the other. Numerous emergency room visits happen because of dangerous, and preventable, interactions between these drugs and other common medications.

The Globe goes on to list a series of tips to help seniors educate themselves about their medical conditions, their treatments, and the most common dangers inherent in their prescribed medications. Many medications require frequent, often constant, adjustments in dosage, so close communication with your doctor is essential. Long-term use of some medications can often cause their own medical complications and side effects, such as hypoglycemia with blood-sugar-lowering medications. The author quotes five tips from the American Association of Family Practitioners:

1. Obtain both written and verbal instructions from your doctor about the proper use of your medication. Ask your doctor to repeat the instructions as many times as it takes until you understand them. Understanding exactly how and when to take your medication is perhaps the most important step in avoiding injury.

2. Read your prescription, then read the label of the drug once you get it from the pharmacy. Read both the label on the bag and on the bottle itself. Make sure your name appears on all labels, and make sure the name and dosage of the drug match the prescription. Incorrectly-filled prescriptions are a frequent cause of medication-related injuries.

3. Talk to the pharmacist about possible side effects. You have an opportunity to do this whenever you pick up a prescription. The pharmacist can explain possible side effects and common drug interactions to you. That is part of why the pharmacist is there.

4. Stay in contact with your doctor and show up when requested for further testing. Notify the doctor of any side effects you are experiencing, no matter how minor they may seem to you. Failure to follow up once a medication is prescribed can lead to negative side effects down the road if the doctor cannot make adjustments to your treatment based on new information or changing circumstances. The doctor may also need to adjust medication based on unforeseen side effects, drug allergies, or other drug interactions.

Hospital Patient Mistakenly Given Drug Used in Executions

December 7, 2011 | Lebowitz & Mzhen

The family of a south Florida man has filed a lawsuit against North Shore Medical Center in Miami. The man, 79 year-old Richard Smith, died in July 2010 when he went to the hospital complaining of shortness of breath and received the wrong medication. The nurse who administered the allegedly fatal dosage received disciplinary sanctions and paid a fine, which the family does not find satisfactory.

Smith told doctors he had shortness of breath and an upset stomach. His treating physician ordered Pepcid, an antacid available over the counter. The ICU nurse instead took a vial of Pancuronium from a locked cart and put it in Smith’s IV. Pancuronium is a muscle relaxant used by the ICU when intubating a patient. In larger doses, it is used by the Florida prison system in executions as part of a three-drug cocktail. The drug does not affect consciousness, but does significantly impair motor functions. At high enough doses, a person would not be able to breathe.

According to hospital records, no one noticed Smith’s condition for thirty minutes. When hospital staff finally recognized the problem, Smith’s heart had stopped. Resuscitation efforts did not succeed in reviving him. An investigation by the state found that the nurse on duty not only failed to read the label on the medication, but failed to scan both the drug label and Smith’s patient ID bracelet. These would have alerted the nurse to the problem. Another report indicated that the nurse did not follow safeguards established for the drug cart containing the Pancuronium. The state cited the hospital for this failure. The hospital has reportedly removed Pancuronium from most nursing areas in the hospital and created a new packaging system with clearer warnings.

According to local news covering the story, the nurse still works at North Shore. He reportedly received a reprimand, paid a $2,800 fine to the state, and attended remediation courses. The hospital described this as appropriate counseling and re-training. Smith’s family disagrees, saying through their attorney that the nurse should not still be permitted to work with patients. This Pharmacy Error Injury Lawyer Blog has previously reported on cases where medication errors causing death have led to criminal convictions for involuntary manslaughter. In this instance, the consequences apparently end at professional discipline.

Government Promotes Communication Between Doctors and Patients to Reduce Pharmacy Errors

November 28, 2011 | Lebowitz & Mzhen

https://www.youtube.com/watch?v=VuGuYC80XxsThe Agency for Healthcare Research and Quality (ARHQ), an agency of the federal government, has partnered with the Ad Council to promote two-way communication between patients and their doctors as a means of improving care and reducing errors. The campaign currently focuses on public service advertisements targeting clinicians and emphasizing the idea that simple communication with patients can be one of the most powerful diagnostic tools. According to research, patients are more likely to adhere to their treatment plans if they engage in direct communication with their doctors. Communication can also help doctors understand a patient’s condition and make more informed decisions as to medications.

This Pharmacy Error Injury Lawyer Blog has previously reported on various efforts by doctors and hospitals to improve patient safety. Both Maryland and Oregon have shown signs of improvement in communication between pharmacies and state pharmacy boards, leading to successes in both reporting of errors and prevention of future errors in hospitals. The “Good Catch” program, pioneered at Baltimore’s Johns Hopkins, promotes voluntary reporting of errors through internal hospital channels in the hopes of preventing more serious errors before they occur. The program has caught on in other hospitals around the country and has produced positive results.

The ARHQ/Ad Council campaign differs from the above programs in that it is an initiative of the federal government, and therefore has potential to reach doctors, hospitals, and pharmacies nationwide. It also represents a collaboration between the public and private sectors, with the nonprofit Ad Council distributing PSA’s for the ARHQ. The ARHQ is part of the U.S. Department of Health and Human Services. Its mandate is to conduct and support research regarding issues of health care such as safety, quality, cost, and access. It publishes and disseminates this research to clinicians nationwide. The agency also regulates certified Patient Safety Organizations, groups authorized by federal statute to promote reduction of medical errors and improvement of patient safety.

Pharmacist Jailed for Fatal Medication Error

November 16, 2011 | Lebowitz & Mzhen

An Ohio pharmacist spent six months in jail for a medication error that led to the death of a two year-old child. Emily Jerry’s parents took her to a Cleveland hospital in February 2006 for the last of a series of cancer treatments. Her doctors ordered an intravenous chemotherapy solution. A pharmacy technician prepared her medication with the incorrect dosage of saline, 23 percent instead of 1 percent, and supervisor Eric Cropp signed off on the technician’s work. The saline amount proved to be lethal. Emily slipped into a coma shortly after the solution was administered, and she died several days later.

Cropp lost his pharmacist license and was charged with involuntary manslaughter for Emily’s death. The pharmacy technician who prepared the solution testified to the Ohio Board of Pharmacy that she told Cropp something was wrong with the mixture, but that he approved it anyway. Evidence presented in the criminal case depicted an overburdened pharmacy and staff, indicating that the pharmacy’s computer system was down the day of Emily’s death and the pharmacy was short-staffed, leading to a backlog of orders. Testimony suggested that the pharmacy had rushed and difficult working conditions. The specific chemotherapy solution for Emily was also evidently requested on an expedited basis. Cropp was found guilty and sentenced to six months in prison in August 2009. The pharmacy tech who actually mixed the solution apparently faced no criminal penalties.

Pharmacy representatives and advocates criticized the verdict and punishment for criminalizing a human error, albeit a tragic one. The Institute for Safe Medication Practices compared the process of investigating and criminally prosecuting a pharmacist to a game of “Whack-A-Mole,” with multiple government entities each swinging at the exposed medical professional. It also claimed that the pharmacist in this case was just one part of a larger, often-dysfunctional process. As a convicted felon, Cropp will never work in a pharmacy again.

While Cropp’s criminal case was ongoing, lawmakers were reviewing the fact that Ohio did not require pharmacy technicians to be licensed by the state. Republican state senator Ted Grendell proposed a bill that became known as “Emily’s Law” in July 2007, requiring a competency test for pharmacy technicians and imposing criminal penalties on both pharmacists and technicians for performing pharmacy work without meeting the new qualifications. Governor Ted Strickland signed the bill into law in January 2009.

Infant Dies of Accidental Antibiotic Overdose in Hospital

November 9, 2011 | Lebowitz & Mzhen

A six-month-old child died in a Brooklyn hospital on October 25, 2011 after receiving an incorrect dosage of intravenous antibiotics. An investigation determined the overdose to be an accident, but the child’s family is reportedly weighing their legal options regarding claims against the hospital. Amaan Ahmmad’s family brought him to the hospital for a fever of around 100 degrees. Hospital records suggest the child was otherwise “alert and responsive.” After an examination, the child reportedly received a diagnosis of clinical pneumonia. No beds were available at the time, so hospital staff hooked Amaan up, while in his stroller, to an IV for the antibiotic Zithromax, known generically as azithromycin. An appropriate dose for an infant is around 80 milligrams, but the nurse setting up the IV reportedly gave him 500 milligrams. This is an appropriate dosage for an adult, not a 17-pound infant.

After receiving the antibiotic, the child immediately fell into a coma. Hospital records indicate that hospital staff did not notice anything wrong for about thirty-six minutes. The child’s mother told the media that she tried to tell hospital staff something was wrong, but they assured her the child was just sleeping. Once they realized the mistake, hospital staff put the child on life support, but it was apparently too late. After less than 24 hours, the child was removed from life support and pronounced dead.

One day after Amaan’s death, the New York City Medical Examiner ruled his death an accident, identifying complications following an adult dose of azithromycin as the cause of death. According to family members of the child, the hospital fired the nurse who administered the lethal dosage of antibiotics. The hospital reportedly expressed condolences to Amaan’s family but declined to comment to the media. The family told reporters that they are considering their legal options. They laid Amaan to rest on October 27.

This Pharmacy Error Injury Lawyer Blog has previously reported on efforts in some Maryland hospitals to catalogue pharmacy errors in the hopes of preventing future catastrophic mistakes. At this time, not enough information is available to determine how the medication error in Brooklyn occurred. The child clearly received an extremely excessive dose of the antibiotic. The error could have occurred in the pharmacy, at the point of administration of the drug, or at any point in between. A combination of errors could have contributed to the tragic outcome, or the negligence of a single hospital worker could prove to be the cause.

Hospitals and Pharmacies Hit by Nationwide Drug Shortages

November 3, 2011 | Lebowitz & Mzhen

A shortage of commonly-used drugs is impacting care in hospitals nationwide. Reports released by the American Hospital Association and the American Journal of Health-System Pharmacists indicate a chronic shortage of crucial medications, with over 800 AHA-member hospitals reporting shortages. Shortages can appear quite suddenly in a hospital environment, with the need for a specific drug suddenly spiking to an amount greater than the supply. Hospitals and pharmacies struggle to compensate for these shortages, sometimes by prescribing alternative drugs, and sometimes by turning to less-than-scrupulous vendors with uncertain records of quality. The possibility for errors, both in prescribing and dispensing medications, is great in such situations.

In a report published by the Patriot-News, one Pennsylvania hospital stated that, out of around three thousand prescription medications commonly used, it experienced shortages of 211 drugs in 2010, up from 70 in 2006. This mirrors conditions in hospitals all over the country. Healthcare administrators around Pennsylvania have reported shortages of fifty or more medications in their facilities, often stating that the shortages are the worst in at least twenty years. This puts significant pressure on doctors, nurses, and pharmacists to identify and locate acceptable substitute medications, often with very little time to spare.

The Food and Drug Administration reported shortages of 178 drugs in 2010. The majority of the shortages are of older drugs administered in hospitals by injection or intravenously. Shortages can result from problems with raw materials and problems arising in the process of producing and distributing drugs. Some drugs may be held up by new regulations, but many drugs fall by the wayside if manufacturers find them not to be profitable.

When a particular drug is unavailable due to a shortage, medical professionals must locate another treatment. This often involves an alternative medication that may not be as effective, that may not be recommended for a particular use, or that may not have equally good quality control. Nine patients died at Alabama hospitals earlier this year, allegedly due to a substitute drug contaminated with bacteria commonly found in tap water and bathrooms.

Patient Safety Initiatives in Maryland and Oregon are Showing Signs of Success

October 26, 2011 | Lebowitz & Mzhen

Pharmacy and medication errors in hospitals and elsewhere in the health care system create substantial risks to patients, along with errors in diagnosis and treatment, equipment problems, and others. State governments often work to promote and improve protection of patient safety in health care. Oregon, as an example, has taken a step towards improving patient safety by encouraging self-monitoring and reporting by hospitals, doctors, and pharmacies statewide. The Oregon Legislature passed a bill in 2003 that created the Oregon Patient Safety Commission, a collaboration between the health care industry and state agencies to prevent medical errors. The state estimates that, last year, at least 34 deaths throughout Oregon resulted from medical errors. The program encourages the submission of detailed reports on medical errors to the Commission, which compiles the data and keeps track of statistics and trends.

Oregon has 58 community hospitals, and all of them have agree to submit reports. Most of the state’s hospitals have been reporting since the program started in 2007, and only two hospitals were still holding out as of last year. According to the Oregon Association of Hospitals and Health Systems, hospitals are reporting errors at a rate to similar to that in states that mandate reporting. The system is far from perfect, though. Because of its voluntary nature, hospitals do not always provide patients with notifications of errors, even if they report those errors to the state. Hospitals also do not report every error known to have occurred.

Pharmacies and surgical centers in Oregon have some catching up to do. According to an investigation by the Oregonian newspaper, the state’s pharmacy board receives about 600 complaints per year, but the Commission only received six error reports from pharmacies between the fall of 2008 and the summer of 2011. About half of Oregon’s licensed surgical centers have agreed to participate with the Commission, and of those who have agreed, only two-thirds actually reported anything in the past year.

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

October 19, 2011 | Lebowitz & Mzhen

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.

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.