Pharmacy Error Injury Lawyer Blog

CVS to Pay $650,000 and Establish Safety Procedures Following Prescription Errors in New Jersey

March 12, 2013 | Lebowitz & Mzhen

The New Jersey Division of Consumer Affairs has announced that it has reached a deal with CVS-Caremark regarding several incidents involving commingled prescription medications.

Under the agreement, CVS will contribute $650,000 to go toward establishing programs regarding prescription drug safety and abuse. The incidents took place over a four month period, from December 2011 to March 24, 2012, in five different New Jersey CVS pharmacies.

The first incident involved a CVS in Chatham, where on at least 15 separate occasions a breast cancer treatment drug was mixed in with prescriptions for children’s chewable fluoride. Apparently, both the medications looked similar, in that they were both small white pills, but were stamped with different identification information.

You read that right, a breast cancer treatment drug, was mixed up with children’s chewable flouride. In other words, what amounts to something comparable to a vitamin was confused with a potentially dangerous substance. Tamoxifen is a cancer-fighting drug that interferes with estrogen. It is used in the treatment for both patients fighting metastatic breast cancer, and those believed to be at risk for developing breast cancer.

Following the investigation of the initial mix ups, authorities eventually discovered several similar incidents involving the co-mingling of prescription pills at other CVS locations. These included:

metoprolol, used to treat high blood pressure, was commingled with risperidone, a schizophrenia medication
pravastatin, a cholesterol drug, was incorrectly given instead of metformin, a diabetes medication
Coreg, a blood pressure drug, was prescribed at 20 milligrams per tablet, but the patient received 80 milligram tablets of Coreg four times the correct dosage as well as the correct concentration
approximately 30 prescriptions from an automated filling machine were filled incorrectly when cholesterol pills were mixed with blood pressure pills

In response to these incidents, it is reported that CVS contacted all of the potentially affected patients, and informed them what measures to take. It also took measures to correct the manner in which the mistakes were made, and notified the Division of Consumer Affairs and the State Board of Pharmacy.

As part of the settlement, in addition to the payment, CVS will take other preventative measures, which include producing pamphlets for public information, providing information regarding pills on its website, and various training programs for its pharmacy staff.

Surgical Never Events Occur at Least 4,000 a Year, Study Finds

March 5, 2013 | Lebowitz & Mzhen

According to a recent study by Johns Hopkins University, surgical “never events,” the term used to describe occurrences that should never occur, such as operations on an incorrect body part or performing the incorrect procedure, are happening at a rate of at least 4,000 times per year.

The study revealed some startling results. The researchers estimate that surgeons within the United States operate on the wrong part of the body at least 20 times a week, perform the incorrect procedure on a patient at least 20 times a week, and leave a foreign object (such as a tool, or sponge, for example) inside a patient’s body after an operation some 39 times a week.

The study was based on an examination of 20 years worth of information from a national database, which hospitals are required to report those never events that lead to a settlement or judgment. However, researchers believe that the incidence of these events is probably higher, because not all items left behind during surgery are ultimately discovered.

Serious Safety Concerns Regarding Compounding Pharmacies Reveal Recurring Bacterial Outbreaks

February 27, 2013 | Lebowitz & Mzhen

The lack of comprehensive regulations regarding compounding pharmacies is cause for great concern. For example, records and otherdocuments show that grave safety lapses, such as that which occurred at a Massachusetts pharmacy last fall linked to a deadly meningitis outbreak, was not an isolated occurrence. Alarming revelations predate the New England Compounding Center’s contaminated steroid shots, which were linked to 45 deaths and 651 illnesses.

Compound pharmacies are entities which compound certain drugs for use in hospitals and the like, which are then used to treat patients. Examples of such compounds include intravenous fluids used to treat various conditions. Compound pharmacies evolved out of the need for hospitals to have readily available intravenous drugs, that couldn’t conveniently and accurately be compounded on site.

A Washington Post analysis reveals unsanitary and loose practices at large specialty pharmacies that have in turn been linked to illnesses and deaths over the past 10 years. The Post reviewed hundreds of documents, including lawsuits and FDA documents, and found serious issues with at least three of the fifteen large scale compounding pharmacies that dominate the industry.

Check Your Pills Twice: Pharmacist Gives Woman Incorrect Pills

February 19, 2013 | Lebowitz & Mzhen

A Seattle woman suffering from multiple sclerosis, who also recently underwent hip surgery, went to her local pharmacy to have her prescriptions filled.

When the woman went to take her pills, she noticed that something was a bit off. She knew that thecapsule was supposed to be white and green and have the numbers “293” imprinted on it, with a 250 milligram dose of her medication. Instead,however, she saw that the pill was light green and dark green, and had the number “294,” indicating that it was in fact a 500 milligram pill. It was then that she realized she had been ingesting doublethe prescribed dose for at least two days.

While it turns out that the printing and information on the label for her prescription pill bottle was correct, apparently the pharmacist at the Rite Aid where her prescription was filled gave her the incorrect dose. In a statement the woman reiterated that her doctor prescribed her medications in order to accommodate her MS, and that the potential impact on her health due to the double dosing is currently unknown.

In a statement regarding the incident, a Rite Aid spokesman stated that their company has a seven point check for accuracy for each prescription before it leaves the pharmacy. The company is now investigating to see if that procedure was followed, and will potentially require retraining for its employees.

Fosamax Plaintiff Receives $285,000 Verdict After Jury Trial

February 12, 2013 | Lebowitz & Mzhen

A plaintiff claiming that the drug Fosamax caused a painful jaw condition has won a $285,000 verdict against the drug’s manufacturer, Merck. Scheinberg v. Merck & Co., Inc., No. 1:2008-cv-04119 (S.D.N.Y., Feb. 5, 2013). While thousands of lawsuits related to Fosamax are currently pending, this is only the second case that a plaintiff was won at trial. Many cases have been consolidated into two federal district courts, one to hear cases alleging jaw injuries, and another to hear cases alleging femur injuries. Several days before the jury verdict in the Scheinberg case, an appellate court affirmed a verdict and a summary judgment order against a different Fosamax plaintiff in Secrest v. Merck, Sharp & Dohme Corp., No. 11-4358-cv (2nd Cir., Jan. 30, 2013).

Scheinberg filed suit against Merck in 2008, alleging that the drug Fosamax caused her to sustain jaw injuries. The drug was approved to treat osteoporosis in menopausal women. It has been linked to a heightened incidence of femur fractures and osteonecrosis of the jaw (ONJ), a painful condition affecting the jawbone and surrounding tissues. The sixty-nine year-old plaintiff alleges that she developed ONJ as a result of taking Fosamax, and that this caused complications after she had a tooth extracted.

The Judicial Panel on Multi-District Litigation began consolidating Fosamax lawsuits, transferring cases alleging ONJ to the Southern District of New York, and cases alleging femur injuries to the District of New Jersey. About 975 ONJ claims are pending in New York, along with 842 femur claims in New Jersey, and various claims in state courts. Scheinberg’s lawsuit asserted causes of action for the products liability theories of design defect and failure to warn of the risks of a dangerous product. Her suit is one of several “bellwether” cases that the judge has allowed to go to trial, to see how similar cases may turn out. Out of seven bellwethers that have gone to trial so far, Merck has won all but two.

Drug Shortages Impact Patient Care at Maryland Hospital

February 5, 2013 | Lebowitz & Mzhen

A nationwide shortage of a wide range of medications, including anesthetics and cancer-treatment drugs, has impacted the level of care at a Maryland hospital, according to a report in the Frederick News-Post. The shortage is affecting patient care all over the country, leading to greater risks for cancer patients, trauma victims, and other patients needing critical care. The situation at Frederick Memorial Hospital (FMH) provides a glimpse into the challenges that countless hospitals are facing. Additionally, a recent medical study showed that, for at least one type of cancer, the medication substituting for the preferred, but scarce, treatment is potentially increasing patients’ risk of relapse. The risks associated with a lack of a needed drug, or the substitution of an inadequate one, has a significant impact on patient safety and hospital liability.

The News-Post reports that FMH is experiencing shortages of about fifty drugs. The hospital’s pharmacy director characterizes twenty of those drugs as “critical.” Most of the drugs in short supply are generics, and while the hospital has reportedly been able to get enough of the scarce drugs to meet its needs, it has had to devise new strategies for patient care when certain drugs are not available. It has also apparently improved communication and cooperation between area hospitals in procuring drugs, with hospitals sharing their supplies when necessary.

Study Examines the Use of Antipsychotic Medications to Treat Children with ADHD

January 30, 2013 | Lebowitz & Mzhen

A study published last year examined the rate at which doctors prescribe antipsychotic medications for children diagnosed with attention deficit hyperactivity disorder, commonly known as ADHD or ADD. The researchers found a significant increase in the rate of prescriptions in recent years, and psychiatrists may now prescribe antipsychotics for children or adolescents with ADHD in one-third of all visits. The U.S. Food and Drug Administration (FDA) has not approved antipsychotic medications for ADHD in children, making it an “off-label” use. While this is not illegal per se, it raises concerns about known and unknown side effects and the risks of dangerous medication errors.

ADHD is a mental health condition that affects both children and adults, and can severely impact a child’s functioning in school and other activities. Symptoms include easy distraction, difficulty focusing, irritability, and difficulty remaining still. The most common pharmaceutical treatment for ADHD consists of stimulant drugs like Adderall and Ritalin. According to the Centers for Disease Control and Prevention (CDC), ADHD affects about 5.2 million children between the ages of three and seventeen, just over eight percent of all children in the U.S. in that age range. About twelve percent of boys and nearly five percent of girls in that age range have been diagnosed with ADHD.

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

January 26, 2013 | Lebowitz & Mzhen

A bill introduced late in the most recent session of the U.S. Congress would have enhanced federal regulation of compounding pharmacies. The bill never made it out of its committee, but the representative who introduced it says he plans to try again in the new session. At least one state governor has also proposed a state-level bill, and a nationwide organization is conducting its own pharmacy inspections. The nationwide outbreak of fungal meningitis in late 2012, traced to a compounding pharmacy in Massachusetts, was a major factor in bringing about these actions.

Congressman Edward J. Markie, the Democratic representative for Massachusetts’ Fifth District, introduced H.R. 6584, The Verifying Authority and Legality in Drug (VALID) Compounding Act on November 2, 2012, not long before the end of the Congressional session and only a few days before the 2012 Presidential Election. It gained eight cosponsors, and was referred to the House Subcommittee on Health, where it remained, and died, at the end of the 112th Congressional Session. Given the turbulent political atmosphere in Washington DC at the time, it is perhaps not surprising that the bill gained little support or attention. Markey has stated that he intends to reintroduce the bill in the 113th Congress.

The VALID Compounding Act would give the U.S. Food and Drug Administration (FDA) authority over large compounding pharmacies, particularly those that act as drug manufacturers. Smaller “traditional” compounding pharmacies would be exempt from FDA regulation, provided that only licensed pharmacists or physicians personally compound drugs for individual patients with valid prescriptions, the pharmacy uses best manufacturing practices and approved ingredients, and it does not copy commercial drugs. Compounding pharmacies could request waivers of the three restrictions from the FDA in cases of drug shortages or if it is deemed necessary for public health. The law would also create a public list of drugs that should not be compounded, and would require labeling of compounded drugs to indicate that the FDA has not tested or approved the drug.

Study Shows Impact of Hospital Medication Errors Involving Injectable Drugs

January 22, 2013 | Lebowitz & Mzhen

A recent study examined the impact of injectable medication errors in hospitals, noting the impact of such errors on both patient health and hospital finances. Costs associated with adverse drug events (ADEs) associated with injectable medications can exceed $5 billion per year, the study found, and can affect over 1 million hospitalizations annually. The study identifies some of the drugs most likely to be involved in medication errors, and has some suggestions for improving patient safety.

A medical device company, Becton, Dickinson and Company, commissioned the study in collaboration with an actuarial consulting firm, Milliman, Inc. The study, entitled “National Burden of Preventable Adverse Drug Events Associated with Inpatient Injectable Medications: Healthcare and Medical Professional Liability Costs,” was published in the online edition of the journal American Health & Drug Benefits on December 10, 2012. It involved the actuarial review of data from the years 2009 to 2011 obtained from MEDMARX, an online system for anonymously reporting medical errors, along with hospital data on medications administered via injection, and data on insurance claims through private health plans and Medicare. The goal was to determine the incremental cost, defined as including all costs from the time of a patient’s admission to the hospital and continuing for a period of four months.

Biotech Company Pleads Guilty to Illegal Marketing of Anemia Drug

January 10, 2013 | Lebowitz & Mzhen

A giant biotechnology company pleaded guilty in December 2012 to a single charge of illegally marketing a drug for uses expressly denied by the U.S. Food and Drug Administration (FDA), thus increasing the risk to patients of medication errors. A years-long investigation by the federal government, reportedly assisted by some company employees, led to a single misdemeanor charge. The guilty plea includes a sizeable criminal fine and civil settlement. The judge presiding over the case has delayed his decision on approving the settlement agreement, although he denied a whistleblower’s challenge to the settlement.

The FDA approved the drug in question, Aranesp, in 2001 to treat anemia in patients undergoing kidney dialysis and for cancer patients undergoing chemotherapy. The drug’s manufacturer, Amgen, is reportedly the world’s largest biotechnology company. Sales representatives employed by Amgen began reporting concerns about the company’s marketing of Aranesp and other drugs to the Department of Health and Human Services, which launched an investigation as early as 2004. Employees wore recording devices during meetings with Amgen managers, which provided evidence that the company was offering doctors financial incentives to prescribe Aranesp over other drugs, and promoting the drug for off-label uses.

Amgen allegedly promoted the use of Aranesp in cancer patients who were not undergoing chemotherapy. At least one study, reportedly sponsored by Amgen, showed an increased risk of mortality for non-chemo cancer patients. The company also allegedly promoted administering Aranesp less frequently but in larger doses, after the FDA refused to approve the drug for such a use. This was supposedly to encourage doctors to use Aranesp over a competing drug. The company allegedly profited $85 million from the misbranded drug.