Pharmacy Error Injury Lawyer Blog

Utilization of Computer System May Lead to MILLIONS Fewer Medication Errors

March 27, 2013 | Lebowitz & Mzhen

A recent article published in the Pharmacy Times, describes the astounding results of a study regarding the use of computerized provider order entry (CPOE) systems in hospitals. The study determined that as of 2008, the use of such systems has helped to avoid more than 17 million medication errors per year in hospitals nationwide so far.
According to the Institute of Medicine (IOM), hospitalized patients are subject on average to at least one medication error per day, which creates the potential for creating medical complications and lasting injury.
The researchers in the study estimated that as of 2008, around one third of all acute-care hospitals in the United States had begun using these types of systems, but only a little over half of them actually used them regularly. Based on that underlying presumption and other data the researchers collected, they estimated that as of 2008, around 26% of medication orders in acute-care hospitals were processed using the CPOE systems.
The computer systems are believed to reduce the chance of prescription medication error by 48%. Coupled with the degree to which CPOE systems have been adopted in hospitals nationwide, it is estimated that the use of the system has reduced the rate of medication errors by 12.5%. That means 17.4 million fewer medication errors throughout the United States in just one year.

There is a caveat however. The reduced number of errors does not necessarily correlate with less harm to the patient. Additionally, the implementation of the systems allows for new ways of making errors such as when a clinician selects either an incorrect medication or dosage from a pull down menu.

Even though the reduction in the errors was a welcomed achievement, the researchers noted that because there is not a universal use of these computer systems, there is much room for improvement to further reduce the widespread occurrence of medication errors.

Common Pharmacy Errors that May Affect You

March 19, 2013 | Lebowitz & Mzhen

Pharmacy and medication errors are not limited to similar looking pills getting mixed up. A recent article by a pharmacist discusses the value of having an independent verification process in place in order to prevent mix ups or misinterpretations.

For example, in one case an order for the drug “eribulin” was misinterpreted by a pharmacist and entered into the computer system as epirubicin, perhaps because of the similar spellings of the words. Fortunately in that case, a nurse discovered the error when she compared the prescription label with the original order, and as a result the patient did not receive the incorrect medication. Both of the drugs in that case are used in breast cancer treatment, which is another possible explanation for the pharmacist’s misinterpretation.

It is recommended that when the names of drugs are so similar, that hospitals and pharmacies have preventative measures in place to avoid look alike or sound alike mixups. For example, in the hospital where the mixup occurred, the hospital added additional terms to the names, and incorporated caps in the middle of the names to offset any potential misreadings. Additionally, an organization for drug safety has recommendations regarding how to list these medications to avoid other potential misreadings.

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.