Pharmacy Error Injury Lawyer Blog

Glaxo Pays $750M in Settlement for Violations in Pharmaceutical Drug Manufacturing

November 23, 2010 | Lebowitz & Mzhen

Our Washington D.C. pharmacy error injury attorneys have been following the recent announcement by the U.S. Department of Justice (DOJ) that GlaxoSmithKline (GSK), a research-based pharmaceutical and healthcare company, has agreed to pay the government $750 million in an effort to settle criminal and civil charges alleging that the company sold adulterated drug products to Medicaid and other government health plans, risking the health and safety of consumers.

Cheryl Eckard, a former Quality Assurance Manager for GSK, was reportedly assigned to visit the company’s Cidra, Puerto Rico plant in 2002 with a group of 100 experts and scientists to survey violations cited by the FDA in drug manufacturing. Eckard reportedly discovered major manufacturing and quality testing issues that went beyond the FDA violations, and that could have caused medication error or patient harm.

Deficiencies found in the plant include the release of a topical antibiotic Bacrtoban ointment used to treat skin infections on babies that contained microorganisms, and the production of the Kytril injection, used by cancer patients for nausea that was reportedly not sterile. Deficiencies were also found in the manufacturing of the antidepressant Paxil CR tablets, causing the drug to have the incorrect amounts of active ingredients. Another manufactured drug, Avandamet, a derivative of the drug Avandia, used to treat diabetes, were reportedly found to be superpotent and subpotent.

As the Cidra plant was reportedly GSK’s top manufacturing facility in the world at that time, bringing in $5.5 billion every year, Eckard found that GSK could not assure that they produced contamination-free products that were made in accordance to the drug formula registered with the FDA. She reportedly advised GSK managers to close the plant, and submitted an extensive report to the compliance department at GSK, who claimed her report was unsubstantiated.

Maryland Hospitals Decrease Medication Error with New Technology

November 18, 2010 | Lebowitz & Mzhen

According to a study that our Baltimore, Maryland attorneys reported on in a recent blog, thirty-five Maryland hospitals increased their median safety over the past ten years, reducing medication error and patient injury with new technology.

In Maryland’s Peninsula Regional Medical Center, the hospital is reportedly improving the tracking of patient records and the prevention of complications with drugs that can lead to medication errors, when medication is improperly administered, through technology. The hospital is reportedly using a barcode system that our Maryland medication error attorneys also discussed in a recent blog, that removes the chance for medication errors by using barcode scanners to ensure that the barcodes on the prescription match the patient’s bracelet wrist-band and the medication, as well as the dosage.

The hospital also uses “Rosie” the Pharmacy Robot, who joined the pharmacy in 1999 and fills 2,500 doses daily from the pharmacy with 100% accuracy. By using barcode technology, Rosie finds a patient’s drug that has been ordered by the physician and then entered by the pharmacist, and prepares the medication with a special barcode for patient delivery. The robot reportedly even notes when the medication stocks are running low and creates new orders electronically.

Other Maryland patient safety initiatives include the use of electronic medical records, Acudose Medication Storage Cabinets, where security codes are used and any drug taken from the cabinet is recorded, and Online Point of Care Wireless Patient Charting. The hospital is reportedly working on eliminating all human error, and continues to invest in new strategies and procedures as well as technology to reach “zero errors” to protect the health and safety of patients.

Study Finds Maryland Hospitals Improve Safety and Health Standards

November 17, 2010 | Lebowitz & Mzhen

A recent study, published in the medical journal, Quality & Safety in Health Care, reportedly found that thirty-five Maryland hospitals showed notable improvements in the safe delivery and administration of drugs to patients in hospitals.

The study was performed on behalf of the Maryland Patient Safety Center, whose aim is to create health care in Maryland that is safer than any other state in the country by reducing adverse medication events, improving patient safety, and by focusing on improving the care systems in Maryland hospitals.

Released in October of last year, the study concluded that when measuring the delivery of medication, the combined Maryland safety scores for these hospitals dealing with acute care rose by almost 10 percent in over two years, reducing occurrences of medication errors.

By comparing safety data on medication and drug use between the years of 2005 and 2007, the authors of the study reported that Maryland hospitals received the highest scores in the packaging of drugs, the standardized distribution of drugs and safe labeling, safe storage of drugs, and keeping chemicals that are hazardous away from drug-preparation and patient areas, to reduce patient injury or harm.

Study Shows Barcode eMAR Technology Can Help Reduce Medication Errors

November 3, 2010 | Lebowitz & Mzhen

In a recent blog, our Maryland pharmacy error injury attorneys discussed reducing medication error and patient injury with barcode electronic systems, that link barcodes on the patient’s wrist bracelet with the patient’s electronic records and prescriptions, to ensure that the medication and dosage match the prescription for the patient.

According to a recent study that the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Maryland, has funded, barcode technology, working together with eMAR, the electronic medication administration system, can help reduce medication errors by over 50%. The study was published earlier this year, in the May issue of the New England Journal of Medicine.

Barcode eMAR combines technology to ensure that each patient is given the proper medication with the correct dosage at the right time, in order to prevent medication errors or patient injury. When this combination of technology is used, before administering the medication, the nurses must scan the barcode on the patient’s wrist bracelet, and then scan the medication. If both barcodes don’t match the approved medication, or the timing is not correct for the patient’s next dose, an alert is issued by the system. If the patient’s medication is overdue, warnings are also sent out to the nurses.

In the study, researchers at Boston’s Brigham and Women’s Hospital compared 6,723 medication administrations given on hospital units before the barcode eMAR was introduced with the 7,318 administrations of medication given after the barcode system was introduced.

Children’s Hospital Launches Initiative to Prevent Medication Error

November 1, 2010 | Lebowitz & Mzhen

After two children died from medication errors at Seattle Children’s Hospital over a period of 18 months, as our Baltimore, Maryland medication error injury lawyers recently discussed in a blog, the staff of the hospital held a special ‘Zero Errors Initiative’ Patient Safety Day on Saturday, to prevent tragic medication errors like these from happening to children in the future.

According to the Seattle Post Intelligencer, over 550 physicians, staff, pharmacists, and nurses convened at the hospital for special patient safety sessions, focusing on training designed to prevent future incidents of medication and pharmacy errors.

Pat Hagan, the president of Children’s Hospital reportedly stated that these tragedies and the harm that was done to these children by the hospital will never be forgotten. Hagan said this has been a profound tragedy for the families, and for the hospital staff, and that this feeling will propel the hospital to continue to find ways to prevent life-threatening medication errors from happening.

The sessions during the safety training day included topics such as strengthening the safety of verbal orders, standardizing children’s medications located on care units, prescribing, dispensing and administering medications that are high-risk, improving communication between providers when handing off patients, and patient safety training with the use of simulation.

Pharmacy Error Gives Wrong Drug to Premature Babies

October 29, 2010 | Lebowitz & Mzhen

In a blog from earlier this year, our Washington D.C. pharmacy error injury attorneys discussed Dennis Quaid’s high profile lawsuits against Baxter Heathcare Corporation, that were filed after his newborn twins were given a near-fatal overdose of Heparin, a blood thinner. The medication error was allegedly due to a mistake with Baxter’s look-alike labels, and the twins were given 10,000 units of Heparin instead of 10 units of Hep-Lock, originally prescribed to treat a staph infection.

In a recent medication error in Saskatchewan, Canada, four premature infants in the neonatal intensive care unit at Royal University Hospital were prescribed the drug Heparin, the blood thinner used to prevent clots, and were mistakenly given insulin with the brand name Humulin R, and that was reported to have a similar looking label.

The pharmacy mistake was discovered because all infants were in the same unit, and their conditions were reportedly deteriorating in similar ways due to the insulin, which caused them to have dangerously low blood sugar levels. The infants mistakenly received the insulin in their IV infusion instead of Heparin.

In the review of the incident, the mistake was reported to be caused by an over crowded space in the pharmacy, a possible labeling error that was missed during the many safety checks, or an issue of look-alike labels.

Medication Error Reduced By “Scanning” Patients for Electronic Records

October 28, 2010 | Lebowitz & Mzhen

In a related blog, our Baltimore, Maryland medical error attorneys discussed a recent study showing that implementing electronic health records significantly reduces medical and medication error, by integrating various systems across the country with hospitals and medical groups, to create a common platform for sharing patients’ medical records.

Health-care providers at the Tucson Medical Center (TMC) are reportedly achieving great success with a new electronic system using computerized scanning to verify their work. The electronic system is part of a new protocol at the medical center that was launched on June 1, 2010, after a $30 million upgrade to its electronic medical records system. Under the new system, each patient receives a bar code that is printed on a hospital bracelet. In an effort to reduce medication error and patient injury, before health-care providers can administer any medication, or perform any lab tests, the patient’s bracelet must be scanned, similar to a grocery checkout scanner. The medication must then also be scanned, to make sure that both the dosage and medication match the prescription for the patient.

In the preliminary three months of the new protocol, the system reportedly sent out around 1,500 medication error alerts that the health-care providers immediately corrected. Common medication errors like confusing continuous release and sustained release were also remedied, as the computer caught the medication errors after the patient’s bracelet was scanned.

According to Frank Marini, the CEO and vice president at TMC, the medical center implemented the electronic medical records in 2002, but still had paper charts for patients up until this year. Under the new federal health-reform law electronic medical records are a requirement.

CVS Pays $75 million for Illegal Sale of Pseudoephedrine in Stores

October 20, 2010 | Lebowitz & Mzhen

In recent news that our pharmacy error injury attorneys in Baltimore, Maryland have been following, CVS Pharmacy will reportedly pay $75 million for breaking the law by selling huge quantities of psuedoephedrine, the key ingredient in the manufacturing of methamphetamine, an illegal drug abused widely in California.

Psuedoephedrine, or PSE is found in specific cold and allergy medications, and necessary to produce methamphetamine, a highly addictive stimulant with links to crime and violence in California, among other states. In an effort to reduce pharmacy error, and production of methamphetamine, the Combat Methamphetamine Epidemic Act of 2005 was introduced, to require retailers who carry PSE products to shelf them behind the counter, to check the identification of the person purchasing the drug, and to limit sales to the individual or one package a day, and three a month. Each customer is also required to sign for the purchase.

According to Thomas Ryan, CVS Caremark Chairman, the sale of the products containing PSE was an illegal and unacceptable violation of CVS’s policies, and inconsistent with the drug chain’s values. The CVS company admitted that drugstores in California and Nevada, among other states, were susceptible for over a year to criminal manufacturers who repeatedly bought enough PSE to make Methamphetamine.

The U.S. Drug Enforcement Administration (DEA) stated that CVS’s violations made the company directly linked to the methamphetamine supply chain, and that the company only reversed the problem once the government investigated the pharmacy violation.

Reporting Children’s Medication Errors Can Help in Prevention

October 1, 2010 | Lebowitz & Mzhen

A recent news article reports that medication errors are among the most common mistakes made by healthcare practitioners—and also among the most under reported.

In a tragic medication error from last year, a child at Seattle Children’s Hospital died from a medication error allegedly involving Calcium chloride. The hospital reported its mistakes to the health department and has acknowledged them publicly. Calcium chloride, the medication that reportedly caused the child’s death, is listed on the Institute for Safe Medication Practices’ (ISMP) class of pharmaceuticals as one of the institute’s “high-alert” medications.

According to the Agency for Healthcare Research and Quality (AHRQ), medical errors are one of the leading causes of death and injury in the U.S. The AHRQ reported in a recent study that rates for potential adverse drug events in hospitals were three times higher with children than adults, with an even higher rate for infants in intensive care units.

According to Dr. Allen Vaida, executive vice president of the Institute of Safe Medication Practices (ISMP), acknowledging medication errors and reporting them is the most important step toward prevention. Vaida claims that children are especially vulnerable to drug overdoses in hospitals because of calculation errors that can occur with medications. Nurses must administer the medication dosages according to a child’s body weight and other necessary factors, that can lead to medication mistakes. He claims that in situations like this, it is important to share information about the medication errors that do occur, as reporting them can prevent errors from happening in the future.

Medication Error Causes Death in Washington State Hospital

September 30, 2010 | Lebowitz & Mzhen

In recent news, our Baltimore, Maryland medication error attorneys have been following the story of a recent tragedy, resulting in the death of a patient who went to the hospital for outpatient shoulder surgery, and died shortly after, due to a medication error.

According to the Seattle Post-Intelligencer, Gary William Clezie went to Yakima Regional Medical & Cardiac Center in February 2009, for a simple outpatient arthroscopic shoulder surgery. A few hours after the surgery, Clezie reportedly suffered from brain damage, as a result of an alleged medication error, and died two days later, when his family agreed to remove the construction worker from life support.

After the surgery, Clezie received Dilaudid for his pain, a potent opioid drug for pain management. Clezie was given a device that allowed him to medicate as needed, by self-administering the drug. The doctor reportedly ordered that Clezie have a blood oxygen level monitoring device, that would alert the nursing staff if the oxygen in his blood dipped below a specific level—in which case the staff would alert the doctor, remove drug device from Clezie, and make sure that he was given oxygen.

But according to the Post-Intelligencer, Clezie’s blood-oxygen monitoring device was not attached to him, so when his blood oxygen level plummeted below the doctor’s defined level, his doctor was not notified, he was not removed from the drug device, and he was not given oxygen. Clezie stopped breathing and suffered severe brain damage from the error that led the misadministration of the pain medication.

Clezie’s family reportedly filed a complaint with the Department of Health’s licensing division and the Department of Health determined, as a result of the medication error, that there were grounds for a corrective action against Yakima. The Post Intelligencer claims that Clezie is one of thousands who suffer harm, personal injury, or even wrongful death from medical care in Washington hospitals every year.