The pharmacy malpractice lawsuit was filed by the family of Beth Hippely, who died in January 2007. According to a report in The Ledger, Hippely’s family sued Walgreens, alleging that a teenaged pharmacy technician accidentally gave her a blood thinner dosage that was ten times more powerful than she had been prescribed.

The drug, Warfarin, had been prescribed to Hippely since 2002 as part of her breast cancer treatment. The pharmacy error caused her to suffer a cerebral hemorrhage and paralysis before her death.

A Florida jury ruled in the family’s favor at trial for the wrongful death lawsuit in August 2007, awarding the $33.3 million, but Walgreen’s appealed the verdict. Last month, the 2nd District Court of Appeals in Lakeland, Florida affirmed the lower court’s decision and upheld the verdict and the award.

According to a 2006 report by the National Academies of Science’s Institute of Medicine, there are about 1.5 million medication errors every year which result in injuries. These mistakes are largely preventable and could be caused by a doctor prescribing the medication incorrectly, the pharmacy filling the wrong dosage or by nurses dispensing a different patient’s drugs.

Approved by the FDA in January 2009, Kapidex (dexlansoprazole) is a proton pump inhibitor approved for treatment of heartburn and acid reduction. It is manufactured by Takeda Pharmaceuticals North America, Inc.

The FDA name change approval was issued on March 4, indicating that Kapidex will become known as Dexilant in late April. The medication will also receive a new National Drug Code number, but no other changes will be made to the drug.

The Kapidex name will be changed to avoid medication errors where it may be confused with AstraZeneca’s Casodex, which is used to treat prostate cancer by reducing male hormones, or Actavis’s Kadian, a morphine-based pain killer.

Although there have been no reports of injuries or deaths associated with mixing up the medications, incorrect use of Kadian (morphine sulfate extended release) in particular could lead to a morphine overdose if it were confused for heart burn pills. Morphine is an opioid which can lead to a fatal overdose if too much medication is taken. A morphine overdose can cause respiratory depression and low blood pressure.

The confusion over medication names was identified as part of the FDA’s Safe Use Initiative, which started in November. The initiative is designed to reduce the number of preventable medication errors.

FDA officials said all drug names are evaluated before they go on the market, and FDA reviewers did not expect Kapidex to be confused with Casodex or Kadian.

According to the Institute of Medicine and FDA, there are 1.5 million preventable medication injuries in the U.S. each year, which add an additional $4 billion to the cost of health care. About 60,000 children are seen in emergency rooms nationwide each year due to accidental drug ingestion.

In a statement issued Wednesday, the FDA warned about the risk of Maalox problems and announced that Novartis will change the name and label of Maalox Total Relief to avoid confusion with other Maalox products, such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength. Maalox Total Relief is a medication intended to treat upset stomachs, nausea and diarrhea, whereas other Maalox products are sold as antacids.

The over-the-counter medications have entirely different active ingredients, with Maalox Total Relief (bismuth subsalicylate) being similar to aspirin. The FDA says that it is concerned that consumers will mistakenly take Maalox Total Relief, thinking that it is an antacid, which could lead to problems from Maalox for some users.

Regular Maalox products have the active ingredients of aluminum hydroxide, magnesium hydroxide and simethicone. They are intended for the relief of acid indigestion, heartburn and gas.

“Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder,’” the FDA warned in a press release. “Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.”

The FDA says Novartis has agreed to change the name of Maalox Total Relief to a new name that does not include the word Maalox, and will also change the label design, which is currently nearly identical to Maalox antacid products. In addition, the company will conduct an educational campaign to highlight the differences between the products for healthcare professionals and consumers.

Novartis will also monitor for adverse events and side effects caused by consumers mistakenly taking Maalox Total Relief when they intended to take one of the company’s antacid products. The new, renamed product will be released in September 2010.

The pharmacy error lawsuit was filed earlier this month in Wayne County Circuit Court in Michigan, alleging that a Detroit metro-area Rite-Aid pharmacists erroneously gave John Sheridan, 54, an overdose of the cancer treatment drug Temodar in September 2007, killing him. According to a report in the Detroit Free Press, the prescription was written incorrectly by Sheridan’s oncologist at 10 times the appropriate dose and it was negligently filled by the Rite Aid pharmacists.

Sheridan’s family has already reached a settlement with the oncologist, but the plaintiffs claim that Rite Aid pharmacy employees should have caught the prescription error.

Temodar (temozolomide) is an antineoplastic agent by Schering-Plough Corporation approved for the treatment of brain tumors by the FDA since 1999. Overdoses on Temodar are usually associated with taking the medication more than five days in a row. Symptoms can include thirst, dry or pale skin, fever, bruising, bleeding, confusion, weakness and a lack of urination.

According to a 2006 report by the National Academies of Science’s Institute of Medicine, there are about 1.5 million medication errors every year which result in injuries. These mistakes are largely preventable and could be caused by a doctor prescribing the medication incorrectly, the pharmacy filling the wrong dosage or by nurses dispensing a different patient’s drugs.

The study, published in the December 9 issue of the Journal of the American Medical Association, found that many dialysis patients are prescribed enoxaparin (Lovenox) and eptifibatide (Integrilin) after angioplasty, despite a determination by the FDA that neither drug should be given to patients undergoing dialysis. Both drugs are contraindicated for dialysis patients on the labels.

The study looked at data on 22,778 dialysis patients who had undergone angioplasty between 2004 and 2008. Angioplasty is a procedure used to widen blood vessels to increase blood flow through arteries. Researchers found that 22.3% of patients who had undergone the procedure were given one of the two drugs.

Those dialysis patients given Lovenox or Integrilin had a 66% increased chance of in-hospital bleeding and potentially an increased risk of death as well.

The study’s author, Dr. Thomas Tsai, director of interventional cardiology at the Denver VA Medical Center, said that the study validated FDA’s contraindication of the two drugs for use with dialysis patients. Tsai said the revelation that doctors were giving dialysis patients drugs which had been specifically contraindicated on the label by the FDA “reflects poorly” on the health care process.

The study’s results did not identify where in the health care process the mistake of giving the dialysis patients the contraindicated drugs occurred. Tsai said that the findings should be used as a call to action at all levels of the health care process for those dealing with dialysis patients who receive angioplasty.

An investigation by the Hartford Courant found that hospital errors, including those that resulted in more than 50 deaths, are being kept from the public due to changes to the state’s adverse event reporting law that were enacted five years ago. Many of the unreported medical mistakes are “never events” – or errors that should never occur if the proper standards of medical care are followed.

The law was originally passed in 2002 to force hospitals to honestly report all serious medical errors to the public. However, the revelations of medical mistakes in the wake of the law caused hospitals to balk, according to the Courant investigation, and hospital lobbyists convinced state lawmakers to change the law in 2004. The state saw a 90% drop in the number of hospital errors being reported following the changes, which allow hospitals to police themselves as far as what’s being reported, and keep secret any error that does not result in a state investigation.

The investigation found numerous deaths resulting from hospital error went unreported and uninvestigated, including cases where patients died due to medication mistakes and bled to death after having arteries mistakenly severed. So-called “never events,” such as surgery errors where sponges or surgical instruments are left inside the patients’ bodies, also often went unreported.

While hospital and state officials say that Connecticut hospitals are meeting the requirements of the reporting law and that the low numbers are a good sign, patient advocates and other critics say that the law has been so narrowly redefined that only the most egregious errors have even the slightest chance of seeing daylight, and many of those are likely never reported to the state either. Additionally, the state does not appear to have the resources or motivation to investigate whether the hospitals are adhering to the law.

The problem is similar to those being experienced by states nationwide, and on a national level as well. More than 20 states have similar reporting laws on the books. There is a federal National Practitioner Data Bank, which requires that hospitals report disciplinary actions taken against physicians.

In June, the Washington Post ran a report about the failure of Maryland hospitals to report medical mistakes. The Post found that only one hospital had been fined for failing to report in the five years the law had been in place.

According to a report by the consumer advocacy group, Public Citizen, hospitals also routinely fail to report disciplinary actions taken against their physicians as required by law. The group indicated that many hospitals exploit loopholes in the law and off-the-record disciplinary actions to avoid reporting, depriving state medical boards of information needed to protect patients from a potential risk of medical malpractice.

The program will create partnerships with federal agencies, healthcare professionals, hospitals, pharmacies and consumer organizations to identify specific, preventable medication risks and implement plans to mitigate those risks. Preventable medication risks can include medication errors, accidental exposure, intentional misuse or abuse and drug quality problems.

The details of the program were outlined in a report released on Wednesday, called “FDA’s Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.” The agency released the report at the annual Science Writers Symposium in Silver Springs, Maryland.

The federal drug regulatory agency intends to schedule public meetings to get feedback on the report and the “Safe Use Initiative.” A public docket will also be opened to allow the public to submit comments on the report.

New FDA guidance in association with the initiative has already been released, which targets drug makers who manufacture over-the-counter liquid medications. The guidance aims to standardize dosage delivery devices, like cups, droppers, syringes and spoons, so that dosages are easily understood by consumers. The FDA hopes the new guidance will cut down on accidental overdoses with such medications, particularly acetaminophen problems, which the FDA says results in 55,000 emergency room visits each year, primarily due to medication errors that result in liver damage.

According to the Institute of Medicine and FDA, there are 1.5 million preventable medication injuries in the U.S. each year, which add an additional $4 billion to the cost of healthcare. About 60,000 children are seen in emergency rooms nationwide each year due to accidental drug ingestion.

“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the program. “All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use.”

The New York Nursing Care Quality Protection Act will require hospitals to report incidents of adverse patient events, including incidents of potential medical mistakes and medication errors. The law, signed by Governor David Patterson on September 17, also requires hospitals across the state to provide detailed information on their nursing staff and unlicensed personnel providing direct care to patients.

Proponents of the new law indicate that making the data publicly available will be indispensable to people trying to decide which hospital to go to for quality care.

The New York State Nurses Association, which lobbied in support of the new law, cited a study published in the Journal of the American Medical Association that found the risk of patient death increased significantly when there were fewer nurses per patient at a hospital. The study found that each additional patient per registered nurse increased the death risk for the patient by 7%.

The new law is also designed to work as an indicator of potential problems at hospitals, alerting state officials to extremely low staffing levels, as well as high amounts of adverse patient incidents, such as bedsores, hospital infections and potential medical malpractice.

Hospitals will also be required to make public any data regarding complaints filed with any state or federal regulatory agency, or accreditation agency, as well as data on the investigations and findings of those complaints, under the new regulation. The number of full-time registered nurses, licensed practical nurses and unlicensed personnel providing direct care to patients will also need to be reported together with nurse-to-patient ratios.

All of the reported information will be made available to the general public once the law goes into effect in six months.

The lawsuit was filed by Mary Ellen Pfeifer against University of Pittsburgh Medical Center’s (UPMC) McKeesport Hospital in the Court of Common Pleas of Allegheny County, Pennsylvania.

Pfeifer was admitted to the emergency room on December 21, 2006, and blood test revealed that she was suffering from confusion and difficulty walking caused by critically low sodium. The treatment plan called for her low sodium to be corrected at a rate of 125 cc per hour. However, due to a medication error by the hospital staff, she received 1000 cc in one hour.

This rapid intravenous infusion of sodium led to permanent brain damage known as central pontine myelinolysis. As a result, Pfeifer now has a difficult time walking, has impaired thinking, slurs when she speaks, has been unable to return to work and requires in-home care.

The hospital medication error lawsuit resulted in a total verdict of $5,003,000, which included $2.4 million for her past damages and $105,000 per year for the next 25 years to cover her medical expenses.

Over the past decade, the number of serious and life-threatening injuries caused by hospital medication mistakes has increased substantially.

According to a 2006 report by the National Academies of Science’s Institute of Medicine, there are about 1.5 million medication errors every year which result in injuries. These mistakes are largely preventable and could be caused by a doctor prescribing the medication incorrectly, the pharmacy filling the wrong dosage or by nurses dispensing a different patient’s drugs.

The risk of medication errors is not limited to hospitals, but has also been seen in nursing homes and retail pharmacies.

Last week, it was announced that a Maryland Wal-mart pharmacy lawsuit was settled for an undisclosed sum after a 66 year old man died from complications after he was given someone else’s medication due to an error by the pharmacy.

On July 6, 2008, administrators at Christus Spohn Hospital South in Corpus Christi, Texas discovered that a number of babies in the neonatal intensive care unit (NICU) were given doses of the blood thinner Heparin, which contained much higher concentrations than was appropriate. As many as 17 infants who were prescribed pediatric versions of the drug to flush intravenous lines and help prevent the development of blood clots, were administered doses that were 100 times stronger than prescribed.

Three of the babies have died since the occurrence, but the hospital claims that their death was caused by natural causes as opposed to the heparin overdose. The parents of many of the babies who were given the excessive doses of heparin have retained Texas personal injury lawyers and obtained court orders demanding that the hospital preserve records related to the care of their children.

Under a provision of Texas law, lawyers may conduct certain discovery through the court, even though a lawsuit has not been filed. This allows plaintiffs to review documents, preserve evidence and interview witnesses without facing deadlines, such as the requirement that an expert express an opinion on how the death or injury occurred.

Although the Texas statute does not allow healthcare providers to be questioned during these pre-lawsuit proceedings, Judge James Klager ruled last week that lawyers for the families can ask questions about the role of the drug manufacturer and the company that manages the hospital’s pharmacy.

When the heparin overdose lawsuits are eventually filed, they could contain both allegations under theories of medical malpractice, as well as product liability.