Pharmacy Error Injury Lawyer Blog

Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements

February 29, 2012 | Lebowitz & Mzhen

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

February 22, 2012 | Lebowitz & Mzhen

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

February 15, 2012 | Lebowitz & Mzhen

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

February 8, 2012 | Lebowitz & Mzhen

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

January 26, 2012 | Lebowitz & Mzhen

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.

Online Pharmacies Offer Savings, but Also Present Risks

January 19, 2012 | Lebowitz & Mzhen

Online pharmacies have become increasingly common as an alternative to brick and mortar drugstores, offering possible cost savings and saving consumers one or more errands. Many major drugstore chains now offer online ordering in addition to their in-store services. A number of companies have set up exclusively web-based services as well. Some misconceptions exist regarding businesses that sell prescription medications online. Reputable and legitimate online pharmacies invariably require valid prescriptions, and they operate under the same rules as any pharmacy with a physical location.

A minimum amount of diligence can assist a consumer in finding a good online pharmacy. They will either need to receive a paper prescription slip from the consumer by mail, or they may call the doctor to confirm the prescription. Generally speaking, reputable online pharmacies do not solicit business through e-mail marketing. Most people by now have received more than one piece of “spam” e-mail offering discounted medications over the internet. These are not part of the legitimate online pharmacy business, but some scam services mimic legitimate services very effectively.

State pharmacy boards sometimes have information pertaining to illegitimate online operations. When in doubt, the Maryland Board of Pharmacy or the National Association of Boards of Pharmacy may have helpful information. The federal Department of Justice also investigates and prosecutes illegitimate and illegal websites. In September 2011, it reached an agreement with Google in which Google agreed to forfeit $500 million for taking advertisements from and offering support to online pharmacies based in Canada. These Canadian pharmacies target U.S. consumers, although importation of prescription medications violates federal drug laws.

Congress is also weighing in on the safety of online pharmacies. Senators Dianne Feinstein (D-CA) and Jeff Sessions (R-AL) introduced a bill in December called the Online Pharmacy Consumer Protection Act. The bill would enable the government to crack down on online services that dispense medications without a valid prescription. The bill, which the two senators have previously introduced, was originally inspired by a California teen who died of an overdose of Vicodin he purchased online.

Even legitimate online pharmacies can still present risks for consumers. CBS Sacramento reports the case of a woman who repeatedly received the wrong medication from an online service. Instead of Lipitor, the company kept sending her Zocor. Her only means of addressing the problem with the pharmacy was through an 800 telephone number. They finally determined that the woman’s doctor had phoned in the wrong prescription. The virtual nature of the pharmacy proved to be a disadvantage in this situation, since the woman had only a limited ability to address the issue with an actual person by telephone.

Drug Confusion Causes Eye Injury, $1 Million Lawsuit

January 12, 2012 | Lebowitz & Mzhen

The 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.

FDA Weighs in on Marketing Pharmaceuticals via Social Media

January 5, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) released a memorandum in late December laying out guidelines for the use of social media, such as Facebook and Twitter, by pharmaceutical companies in marketing their products. The memo’s release came more than two years after the FDA held hearings on the matter in November 2009. Although the memo provides useful guidance, it is not nearly as comprehensive as industry insiders expected. The guidelines only deal with online discussions of off-label drug uses, those which lack explicit FDA approval.

Social media, the FDA felt, poses different challenges and risks than previous technological advances in marketing, such as television advertising, because social media allows much faster access to information and more direct contact between manufacturers and consumers. It convened hearings in November 2009 to examine these concerns. According to the New England Journal of Medicine, the FDA issued warnings to fourteen drug companies in April 2009 after it found sponsored ads for prescription drugs in search engines that lacked a clear statement of risks.

A major question for the FDA was that of “balance,” making sure consumers had access to all relevant information about a particular drug. This includes not only information about known side effects, but also, when claims are made about a drug, about the financial interests of the person or company making the claim. Among social media services, it is also increasingly difficult to determine whether a pharmaceutical company is responsible for a claim about a medication. Google and sites like Wikipedia make it increasingly easy for the general public to make claims about prescription drugs. The FDA has a responsibility to police the accuracy of claims made by the manufacturers. A major challenge for the FDA is therefore how to deal with inaccurate information widely disseminated by people other than the manufacturers.

The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”
Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.

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.