Pharmacy Error Injury Lawyer Blog

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.

Continue reading " Shortages of Important Drugs Give Rise to Concerns Over Safety of "Grey Market" Replacements " »

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.

Continue reading " Children's Shelter Staff Prone to Medication Errors, Says Grand Jury " »

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.

Continue reading " Layoffs of School Nurses Lead to Concerns About Medication Errors " »

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.

Continue reading " Pharmacist Institutes Program of Double-Checking Discharge Papers, Cuts Hospital Pharmacy Errors to Near Zero " »