Patient Safety

Protecting Yourself against Serious Pharmacy Errors

February 19, 2016 | Lebowitz & Mzhen

Chances are most people have heard of or read about someone being provided the wrong prescription or the wrong dose of a medication when they go to pick up their prescription from a retail pharmacy. In fact, these errors are quite common, with some estimates of the number of errors per year reaching into the millions. However, there are some things that people can do to help protect themselves against a pharmacist’s mistake.

According to a recent article, the best way to think about preventing a pharmacy error is to think about each phase in which the system can break down, potentially leading to an error. Thus, the article discusses the three main locations where a patient should take a few extra steps to ensure their safety.

At the Doctor’s Office

Knowledge is key in the doctor’s office. Knowing which drug a doctor is prescribing for a patient will help a patient be able to identify if they are provided with a different medication. However, knowing why a patient is being prescribed a medication is also important. If the doctor includes the reason for the prescription in the text of the prescription, the pharmacist is much less likely to make an error by providing the wrong medication.

The Nurse’s Role in Preventing Hospital and Nursing Home Pharmacy Errors

February 1, 2016 | Lebowitz & Mzhen

When most people think of a pharmacy error, they think of a retail pharmacist providing the wrong drug to a patient who then takes it up to the register, checks out, and goes home to take the medication in their own home. However, this only accounts for a portion of the prescriptions that are filled each day in the United States. In fact, countless other prescriptions are provided to hospital patients and nursing home residents.

Unlike prescriptions filled at a retail pharmacy, prescriptions that are filled in a hospital have a few added layers of protection in place to prevent against the patient being provided the wrong medication. For example, after a doctor writes a prescription to a hospital patient, and the pharmacy fills the prescription, a nurse must obtain the medication and deliver it to the patient. This is a critical role that allows for the nurse to act as a final line of defense against serious or fatal prescription errors.

However, despite all the precautions in the world, sometimes errors will occur. When a prescription error does occur, it may result in very serious injuries or even death in some cases. Under Maryland law, the victims of these mistakes can look to the legal system for help through a pharmacy error lawsuit.

Appellate Court Holds Pharmaceutical Company Need Only Warn Physician of Side Effects; No Duty to Warn Patients

December 30, 2015 | Lebowitz & Mzhen

Earlier this month, the Sixth Circuit Court of Appeals decided a case reinforcing the laws surrounding whom the manufacturer of a medication must warn about the potentially dangerous side effects of the medication. In the case, Yates v. Ortho-McNeil-Janssen Pharma., Inc., the Court ultimately determined that the duty to warn extends only to the physician, and not to the patient. Thus, the patient’s case against the drug manufacturer was properly dismissed by a lower court.

Yates v. Ortho-McNeil-Janssen Pharma., Inc.

The plaintiff was a sexually active woman who was suffering from extreme menstrual cramps and consulted her doctor about potential medications that may help her. The doctor told her of two choices, ORTHO-EVRA and Depo-Provera. The doctor warned the plaintiff that there was some risk of blood clotting and stroke with ORTHO-EVRA, and the plaintiff decided to first try Depo-Provera.

After a few months, the plaintiff noticed she had gained weight, which was a side effect of Depo-Provera. She consulted her doctor, who again advised her of the risks associated with ORTHO-EVRA, and this time she decided to give it a try. The plaintiff suffered a stroke during the application of her first weekly patch. The woman filed a lawsuit against ORTHA-EVRA’s manufacturer, alleging that the company did not adequately warn her of the risks involved with taking the medication.

Information Is Key to Preventing Pharmacy Errors

December 16, 2015 | Lebowitz & Mzhen

Pharmacy errors occur at an alarming rate across the United States. In fact, according to the Center for Disease Control, there are approximately 1.3 million people who are injured each year by an error made in the pharmacy setting. These errors range in both severity and cause, but the bottom line is that they are almost all due to an overburdened pharmacist making a mistake in the heat of the moment.

Although most pharmacy errors are complete accidents or oversights, that does not excuse the negligent pharmacist from fault. In fact, Maryland law allows for any person who is harmed by a pharmacist’s negligence to recover compensation for their injuries and emotional distress through a personal injury lawsuit.

There are several common scenarios that give rise to serious pharmacy errors, including when a pharmacist provides the wrong type of medication to the patient, provides the right drug but the wrong dose or strength of the medication, provides the wrong dosage instructions, fails to warn the patient of interactions with commonly taken over-the-counter medications or other known prescriptions, or fails to advise the patient of expected or possible side effects of the medication.

FDA Changes Labels on Anti-Bacterial Drug Due to Potential for Easy Mix-Up

September 29, 2015 | Lebowitz & Mzhen

Earlier this month, the Food and Drug Administration (FDA) announced a warning regarding the confusing packaging on the intravenous antibacterial drug Avycaz. According to one industry news source, the announcement was made after there were several reports of errors made in the dosing of the drug to patients. Evidently, the strength of the medication that was listed on the outside of the carton or vial was difficult to decipher for pharmacy personnel.

The confusion apparently arose because of the way that the label listed which substances were actually contained inside each package. Avycaz contains two active ingredients, ceftazidime and avibactam. The previous labels list each separate ingredient and its amount next to the drug’s name. For example Avycaz 2g/.5g means that the drug contained 2g of ceftazidime and .5g of avibactam. The new label will be more descriptive, explaining that the package contains a total of 2.5g of medication, which consists of 2g of ceftazidime and .5g of avibactam.

The Reported Errors

According to the article, there had been three reported errors since the drug’s approval back in February of this year. Two of the errors occurred as the drug was being prepared by the pharmacist, while the third arose due to the confusion in the language on the drug’s packaging. The FDA reported that at least one patient received and ingested a higher-than-prescribed dose, but there had been no adverse effects reported.

Pharmacy Students Participate in Mock Trial to Reduce Future Error Rates

August 28, 2015 | Lebowitz & Mzhen

Earlier this month in Auburn University’s Harrison School of Pharmacy, students and professors put on a mock trial, mimicking a real criminal law trial that alleged criminal negligence on the part of a pharmacist who signed off on an improperly diluted medication that was given to a young child. According to an article by Pharmacy Times, the mock trial is used by administrators to impart the real-world consequences that can result from a pharmacist’s mistake.

The original case arose back in 2006, when a two-year-old girl died as a result of being provided her final chemotherapy session that was improperly diluted. Apparently, rather than having less than 1% salt, the solution contained 23% salt, which ended up being a toxic dose for the two-year-old child. While it was not a pharmacist who prepared the solution, the pharmacist on duty did check the work of the technician who did prepare the solution.

After the error, the girl’s father learned that there were several other problems that contributed to the fatal pharmacy error, including the fact that the pharmacy’s computers were down that day, the pharmacy was understaffed, and there was a backlog of physician orders waiting to be filled. In the real case, the pharmacist was found to be criminally negligent because she inspected and checked off on the work of the technician. She lost her license to practice as a result. The students at the Harrison School of Pharmacy came to the same conclusion, finding that under the facts provided, the pharmacist was acting negligently on the day in question.

Medical Journal Recommends Physicians and Pharmacists Convert Completely to the Metric System to Avoid Medication Errors

May 4, 2015 | Lebowitz & Mzhen

Medication errors are a serious problem in today’s health care world. In fact, it is estimated that there are over 65,000 medication errors that occur across the United States each year, many with disastrous consequences. According to one article published by Modern Healthcare, some are suggesting that the industry shift over to the metric system to decrease the chance of a medication error.

The argument suggests that requiring doctors and pharmacists to document a patient’s weight in pounds is counterproductive and dangerous, given the fact that most medications are dosed according to the kilogram-weight of the patient. In other words, the prescribing physician or filling pharmacist must make the calculations to change a patient’s weight from pounds into kilograms.

While this doesn’t sound all that difficult, in the hustle-and-bustle environment that many doctors and pharmacists find themselves in on a daily basis, anything that can decrease the chance of an error should be considered.

Virginia Pharmacy Shut Down over Numerous Safety Violations

April 23, 2015 | Lebowitz & Mzhen

Earlier this month, a local Virginia pharmacy was shut down by state regulators after myriad safety violations were discovered. According to one news source, not only was the pharmacy shut down and its ability to operate suspended, but the lead pharmacist’s license was suspended.

Evidently, the pharmacy was the subject of two unannounced visits: one in May 2014 and another in February 2015. After the second inspection, regulators called into question the pharmacy’s ability to “assure the quality, sterility, integrity, safety, and efficacy of drugs dispensed, along with its ability to safeguard against the diversion of drugs.”

According to the report, regulators discovered numerous issues during their inspections, including:

Label Design Shown to Have Effect on Medication Accuracy

April 16, 2015 | Lebowitz & Mzhen

When a person goes to their pharmacy to get a prescription filled, they hope that it is accurate. However, if there is a problem with the prescription—whether it be the dosage, the instructions, or the drug itself—the patient has an opportunity to review the prescription before ingesting the medication. However, this is not the case in the fast-paced environment of emergency rooms.

Medication errors in emergency rooms are frighteningly common and can carry with them devastating results. However, according to one recent article by the Pharmacy Times, a newly released study shows that there may be something that drug manufacturers can do to decrease medication errors in the surgical and emergency room settings.

Label Design and Its Effect on Error Rate

According to the new study cited in the article, several types of intravenous medications had their labels redesigned after having a team of pharmacists, anesthesiologists, and nurse anesthetists suggest changes that make the label more reader-friendly. The researchers then conducted a study using trainees where the trainee would have to select the requested medication in a fast-paced environment. Researchers used a control group that consisted of trainees using the old labels in order to compare the results.

Second Largest Operator of Institutional Pharmacies in U.S. Agrees to Settle Federal Lawsuits for Misusing Drugs

April 9, 2015 | Lebowitz & Mzhen

Recently disclosed federal court filings have revealed settlement agreements between the U.S. Government and PhyAmerica Corp, a Louisville, Kentucky company that is the nation’s second-largest operator of institutional pharmacies. One of the lawsuits focused on the company’s widespread misuse of Depakote, a seizure drug. According to one news source, the complaint alleged the drug was routinely being prescribed to elderly patients off label to treat other ailments that would have been better treated with the approved medications.

According to the article, the company was allegedly encouraging doctors to prescribe the drug to patients off-label because of an agreement with the drug manufacturer that gave the defendant financial kickbacks for prescribing Depakote. These were kickbacks that they would not have gotten for prescribing drugs that were approved to treat the underlying conditions.

The vast majority of the patients being misprescribed the drugs had their care being financed by the federal government through Medicare and didn’t notice the increased costs, although Pharmerica Corp. allegedly helped to defraud the government out of billions of dollars by encouraging the prescription of Depakote off label.