Pharmacy Error Injury Lawyer Blog

A patient at Alta Bates Summit Medical Center in San Francisco, California died over the weekend, allegedly due to an incorrect medication dosage from a replacement nurse. About 23,000 nurses across California went on strike on Thursday, September 22, 2011 due to a dispute between the nurses’ union and the healthcare network that runs Alta Bates and other hospitals. The strike was meant to last one day, but the nurses found themselves locked out when they tried to return to work Friday. The lockout continued through the weekend. The hospital brought in replacement nursing staff to cover the shifts for the union nurses.

The patient was a 66 year-old Oakland resident who had been receiving treatment at Alta Bates since July 2011. Preliminary findings indicate that her death resulted from the wrong dosage of a medication, which was administered by one of the replacement nurses.

The nurses’ union, the California Nursing Association, has questioned the qualifications of the replacement nursing staff. The American Nurses Association, which represents nurses nationwide, allows nurses to strike if the intent is to advocate for changes in hospitals to benefit patient health. The ANA’s ethics rules requires nurses going on strike to provide advance notice of their plans and to take steps to minimize any potential harm to patients. The purpose of Thursday’s strike was to protest contract concessions demanded by the healthcare network that, according to the union, would negatively affect patient safety.

Hospital officials have defended the replacement nursing staff, saying that they are all highly experienced, and that the hospital “did not skimp on any of the nurses." While the question of liability and “fault” may take some time to resolve, this incident clearly demonstrates the difficulties inherent in patient safety in hospitals, especially where medications are concerned. A hospital mired in confusion carries a great risk of pharmacy errors.

This Pharmacy Error Injury Blog has previously noted the high rate of risks for medication errors in hospitals despite efforts at accountability among doctors and nurses. This incident in San Francisco demonstrates a phenomenon noted by a recent study from Johns Hopkins, which found an increased risk of medication errors in hospitals that use temporary doctors and nursing staff. The study concluded that a lack of familiarity with a particular hospital’s systems and procedures among temporary staff can lead to an increased number of medication errors.

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A system developed at Johns Hopkins Medicine in Baltimore, Maryland intends to prevent accidents before they happen by encouraging clinicians to report situations that might lead to dangerous or even life-threatening incidents for patients. Known as the “Good Catch Awards,” the program distributed 27 honors in its first two years for reports that led to positive changes in patient safety. Such changes ranged from modifications in pharmacy order sheets to a national recall of improperly-labeled drugs.

The “Good Catch” program operates on the theory that, instead of errors being attributable to one individual, most errors result from a flawed system in a hospital. It stresses to doctors and other medical practitioners that its purpose is to find solutions to common errors, not to assign blame for those errors. Not all doctors and others have embraced the system yet, but most acknowledge that it is a vast improvement over safety systems at most hospitals. Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation, compared the system to those used in nuclear plants and airlines, where the responsibility for safety is shared by everyone. He suggests the creation of a national database to collect hospitals’ self-reports of “errors and so-called near misses” in order to better share safety information and create greater opportunities to improve patient safety.

Other hospitals have implemented their own “Good Catch” programs, inviting clinicians to share examples of near misses that could have resulted in patient injury but did not. The University of Connecticut Health Center offers a “Good Catch” award for near misses that lead to improvements in patient care. The Minnesota Hospital Association awards a “Good Catch for Patient Safety Award” to clinicians “who demonstrate their commitment to keeping patients safe by ‘speaking up’ to prevent potential harm to a patient.” The Brantford Community Healthcare System in Brantford, Ontario, Canada solicits stories from its medical staff about incidents that contribute to its “culture of safety.”

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A report from the Institute of Medicine finds that hospital patients in the U.S., on average, experience one medication error per day. Errors may include incorrect dosages, administering a drug with the incorrect method, or administering the wrong drug altogether. Some errors involve prescription of a drug with incomplete information about a patient's health history or allergies, leading to harmful reactions. Researchers also found instances of errors in which doctors and nurses did not have up-to-date information on the drugs they were prescribing and therefore did not know of newly-discovered risks. The report found a hospital medication error rate of eleven percent in its study and estimated that hospital patients receive an average of ten medication dosages each day.

Current estimates place the total number of annual deaths due to hospital medical errors at 7,000, and the total number of injuries at 1.3 million. Research shows that medication errors can lead to extensions of hospital stays of 8 to 12 days on average, leading to additional costs of $16,000 to $24,000 for the patients. Studies have found medication errors to occur in up to 3.7 percent of all hospitalizations. The total cost of injuries and deaths due to medication errors could be as high as $5.6 million per year per hospital.

Researchers have proposed many possible reasons for the number of medication errors known to occur. A 2002 study in the Journal of the American Medical Association linked a patient’s chancing of dying during routine hospital procedures to lower nurse-to-patient ratios, finding that the risk decreased as the number of patients assigned to each nurse in a hospital decreased. A recent study from Johns Hopkins University found a connection between medication errors and widespread use of temporary staff, including temporary doctors and nurses, in hospital emergency rooms. Johns Hopkins researchers concluded that errors may result from temporary staff’s lack of familiarity with a particular hospital’s systems and procedures. A 2006 study from the University of California at San Diego found a ten percent increase in fatal medication errors in area with teaching hospitals during the month of July. July is the month when medical school graduates first report to teaching hospitals. The study seems to confirm anecdotal evidence of the “July Effect,” where injuries and deaths in hospitals allegedly spike during the summer months.

Regardless of the conditions of hospital facilities or staff, hospitals, doctors and nurses have a duty of care to their patients to provide competent service, and this includes taking care to ensure correct prescription, dosage, and administration of medications. The fast-paced and often overcrowded nature of many hospitals creates a risk of error, and while a patient should certainly exercise diligence in monitoring their own treatment and medication as much as possible, the responsibility mainly lies with the nurses and doctors and the hospitals that employ them.

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A New York federal judge is allowing a lawsuit over the osteoporosis drug Fosamax to go forward, but with limitations. Judge John Keenan will allow plaintiff Linda Secrest to pursue her claim against Merck & Co., but she will not be able to claim punitive damages or to argue that Merck failed to warn her about potential risks in taking the drug. Secrest claims that a defect in Fosamax caused osteonecrosis of the jaw (“ONJ”), a condition in which the tissue in her jaw decayed. Secrest’s lawsuit is the fourth bellwether case against Merck over Fosamax, and the outcome will affect thousands of other Fosamax claims. Significantly, Judge Keenan stated in his decision that he found no evidence that any warning label would have caused Secrest’s prescribing physician to take her off the medication.

Fosamax, or its generic equivalent alendronate, treats and prevents osteoporosis, a condition in which the bones weaken and can easily break. It first came on the market in 1995. The drug works by inhibiting bone resorption, the process by which bones break down with age. Doctors often prescribe the drug for women who have gone through menopause.

The FDA began to collect reports of ONJ as far back as 2000, and other complaints such as broken legs began to come in as well. A 2008 finding from the FDA indicated a possible link between the drug and certain cases of esophageal cancer. A report from the American Dental Association followed soon after that suggested a connection between ONJ and medications in the same class as Fosamax. A 2010 press release from the FDA warned of a possible elevated risk of thigh bone fractures. These correlations led quickly to litigation.

Secrest’s lawsuit began in Florida, and in August 2006 it moved to the U.S. District Court for the Southern District of New York to be consolidated with other similar lawsuits. Secrest, along with dozens more plaintiffs around the country, filed suit against Merck, Novartis Pharmaceuticals, Procter & Gamble Pharmaceuticals, Aventis Pharmaceuticals, Sanofi-Aventis, Walgreen Co. and Mouhannad Budeir DDS. The lawsuit, styled In Re: Fosamax Products Liability Litigation, seeks tort damages for personal injury and products liability. Three bellwether cases preceded Secrest’s case. Merck one two of those cases at trial, and the third resulted in am $8 million jury verdict against Merck, which Judge Keenan reduced to $1.5 million.

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