Patient Safety

Birth Control Pill Error May Cause Unintended Pregnancy

April 15, 2013 | Lebowitz & Mzhen

Canadian officials have recently announced the recall of a particular lot of birth control pills called Alysena 28. The recall affects a small number of packages which contained 14 placebo and 14 active pills rather than 21 active pills and 7 placebo.

Women who are taking the pill in order to prevent pregnancy could face the possibility of an unintended pregnancy should they take the pills subject to the recall. The particular brand of birth control pill subject to this error, Alysena 28, is sold in British Columbia, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, P.E.I. and Quebec. Many pharmacies are reporting that they did not receive or distribute the affected pills.

Although this error occurred in Canada, there have been many similar birth control pill packaging errors in the U.S. recently. Last February alone, Glenmark Generics and Pfizer, Inc. issued individual recalls for birth control pills which were packaged in the incorrect order. Speculation regarding wrongful pregnancy cases abounded on the internet. Several of the sources regarding these recalls point out the fact that the affected pills are different colors, so patients who have been taking the medications for a period of time may have avoided taking the pills incorrectly.

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.

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.

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.

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.

In an Effort to Reduce Medication Errors, San Diego Hospital Implements High Tech Program

December 19, 2012 | Lebowitz & Mzhen

There are approximately 1.3 million people in the United States injured by medication errors every year. Since 2000, the U.S. Food and Drug Administration (“FDA”) have received more than 95,000 reports of medication errors. These reports are voluntary, however, and it is believed that the rate of error is actually much higher. Medication errors occur for a number of reasons, including miscommunication of drug orders, poor handwriting, drugs with similar names are confused or packaging is poorly designed, and even confusion of dosing units.

The FDA takes a number of measures to help reduce medication errors, including reviewing drug names, labels, and packaging, as well as analyzing reports of error and creating guidance for the industry. The FDA reviews around 1,400 reports of error per month, analyzing the cause and type of error that in turn helps the agency develop guidance for health care professionals.

In a remarkable effort to reduce these types of error, San Diego’s newest hospital, Palomar Medical Center, located in Escondido, CA, has taken substantial steps to ensure the prescription drug process is as safe as possible. The hospital has implemented a program that requires doctors to place medication orders via a sophisticated computerized system. Often times, an error may begin with the doctor’s initial prescription being incorrect or misunderstood. The system is designed to require doctors to confirm the order and the dosage as well as being for the correct patient — the computerized process is key to ensuring there are no mistakes made in the first crucial step of the doctor ordering the medication.

All of the medications are bar coded. When the nurse is at the point of giving medication to the patient, the bar code helps to once again confirm it is the correct medication, dosage and patient. The nurse will scan the bar code on the medication, the nurse’s own badge is scanned, the patient’s bar code is scanned and the system then confirms “this is the correct medication, patient and dosage that should be given at this time,” essentially giving the nurse a green light to proceed.

Contaminated Medicine Believed to Be Source of Nationwide Fungal Meningitis Outbreak

October 27, 2012 | Lebowitz & Mzhen

Lebowitz & Mzhen

October 27, 2012

Updated: October 27, 2012 1:49 pm

Former Healthcare Workers Denied Public Benefits Because of Medication Errors

October 18, 2012 | Lebowitz & Mzhen

Courts in two recent cases affirmed denials of unemployment benefits to healthcare workers, finding that their terminations resulted from employment misconduct. Both workers lost their jobs because of medication errors. In Steffey v. Unemployment Compensation Board of Review, a Pennsylvania court ruled that a nurse intentionally failed to follow protocols for reporting and treating patient complaints. A Minnesota court found that a series of errors constituted employment misconduct in Matoke v. Restart, Inc.

Wanda G. Steffey, the claimant, appealed a denial of unemployment benefits after she was terminated from her position as a licensed practical nurse (LPN) in March 2011. She testified that she had been a LPN since 1978, and had worked at the Berkshire Center since 2005. She allegedly learned, during a shift on March 11, 2011, of a patient complaining of chest pain who had a history of high blood pressure. The employer alleged that she gave the patient medicine for indigestion without authorization, and that she did not report the patient’s condition for up to three hours. This violated the employer’s protocols, which required her to check vital signs and report immediately to the charge nurse.

The claimant testified that she attempted to report to the charge nurse when she realized her medication error, but that the charge nurse was not at the station. She said she decided to monitor the patient’s condition herself, and reported the matter to the charge nurse about ninety minutes later. According to the court, the claimant admitted on cross-examination that she could usually find the charge nurse elsewhere in the facility. The court concluded, based on the claimant’s own testimony, that she intentionally did not follow protocol by providing medication to a patient without orders and by not reporting the matter to the charge nurse right away.

Appellate Court Denies State Access to Pharmacy’s Medication Error Data, Citing Federal Privacy Laws: Department of Financial and Professional Regulation v. Walgreen Company

October 9, 2012 | Lebowitz & Mzhen

A pharmacy resisted a subpoena from Illinois regulators seeking information on medication errors, citing a federal law that encourages pharmacies to track medication errors, but protects the confidentiality of those records. The trial court agreed with the pharmacy’s position in Department of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill. App. 2nd Dist. 2012), and granted its motion to dismiss the subpoenas. The Illinois Court of Appeals affirmed the ruling, finding that federal law privileged the medication error records from disclosure to the state government. Although federal law encourages pharmacies to track medication errors, it limits the uses to which the government may put the resulting records.

The Illinois Department of Financial and Professional Regulation (DFPR) issued three subpoenas to Walgreens in July 2010, seeking reports of medication errors involving three specific pharmacists in Walgreens’ employ. It petitioned the circuit court to enforce the subpoenas in October 2010. Walgreens quickly moved to dismiss the petition, claiming that the records sought by the DFPR were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

The PSQIA provides mechanisms for reporting and analyzing a wide array of medication error data. The law provided for the establishment of Patient Safety Organizations (PSOs) under the Agency for Healthcare Research and Quality (AHRQ). PSOs are independent organizations that gather and analyze medication error reports from doctors, pharmacies, hospitals, and other health care facilities within a designated geographic area. They cooperate and collaborate with the AHRQ and other PSOs with the goal of developing improvements in patient safety and reductions in the number of medication errors. The PSQIA provides that all reports made by pharmacies and other organizations to their local PSO are “patient work product,” and therefore are privileged from disclosure.